Monday, July 4, 2011

Health - In the ‘Stroke Belt,’ Erosion of Memory Is More Likely Too

Health - In the ‘Stroke Belt,’ Erosion of Memory Is More Likely Too

In the ‘Stroke Belt,’ Erosion of Memory Is More Likely Too

Posted: 04 Jul 2011 11:30 AM PDT

People in a large area of the American South have long been known to have more strokes and to be more likely to die from them than people living elsewhere in the country.

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Now, a large national study suggests the so-called stroke belt may have another troubling health distinction. Researchers have found that Southerners there also are more likely to experience a decline in cognitive ability over several years — specifically, problems with memory and orientation.

The differences to date in the continuing study are not large: Of nearly 24,000 participants, 1,090 in eight stroke-belt states showed signs of cognitive decline after four years, compared with 847 people in 40 other states.

But the geographic difference persisted even after the researchers adjusted for factors — like age, sex, race and education — that might influence the result. The most recent data from the study were published in Annals of Neurology.

None of the people with cognitive decline in the study had had detectable strokes. But some experts believe their memory problems and other mental issues could be related to the same underlying risk factors, including lifestyle patterns that contribute to hypertension, high cholesterol, diabetes and obesity.

Is it the fried food beloved by Southerners? Limited access to doctors? Too little exercise? Researchers are investigating those and other possible causes. Some experts also suggest that the participants could have had small, undetectable strokes that subtly affected brain function.

“This should be a very strong alarm signal,” said Dr. Gustavo C. Roman, who leads the neuroepidemiology section of the American Academy of Neurology and was not involved in the study. The finding suggests that “if you want to keep your marbles, you need to control your blood pressure, excessive weight and other risk factors for stroke.”

Dr. Kenneth Langa, a professor of internal medicine at University of Michigan who was not involved in the research, said the size of the study and the geographic diversity, encompassing 1,588 of the country’s 3,000 counties, made the findings powerful.

They could also be instructive because, while there is currently almost no treatment for memory problems later in life, there are effective ways of combating or preventing many causes of stroke. “Pinning down this relationship between hypertension, diabetes, physical inactivity and the effects on the brain” could help people learn to protect their mental capacities for longer, Dr. Langa said.

Experts do not know exactly why more strokes occur in a region stretching across Alabama, Arkansas, Georgia, Louisiana, Mississippi, North Carolina, South Carolina and Tennessee (sometimes additional Southern states are included in the stroke belt). Financed by two federal health agencies as part of a broader study of stroke and health, the new research followed non-Hispanic blacks and whites age 45 and older for about four years.

At the beginning of the study, the participants, assessed in a detailed phone interview and home visit, had experienced no strokes or cognitive problems. Each year, researchers conducted telephone interviews, asking the subjects to recall words and demonstrate knowledge of the day, week and year. Every two years, there were longer telephone assessments with more extensive word-recall tests and tasks like naming items in a category — animals, for example.

As of October 2010, 8.2 percent of stroke-belt participants showed signs of cognitive decline; 8 percent of participants in other areas did. The small difference was nonetheless significant in such a large study, experts said.

“The difference is actually larger than those two numbers seem to suggest,” said George Howard, the study’s principal investigator and chairman of the biostatistics department at the University of Alabama at Birmingham. By chance, the particular Southerners in the study had qualities that should have made them less vulnerable to cognitive problems, not more so. They were younger and more of them were women, compared with study subjects elsewhere, and fewer were African-American, a group that is more prone to strokes.

“If region didn’t make any difference, the South should have been significantly less likely to be declining” in the study results, Dr. Howard said.

In both stroke-belt and non-stroke-belt groups, older age, less education, and being African-American were associated with increased chances of cognitive decline. But even when those factors were accounted for, residents of the stroke belt still were 18 percent more likely to show impairment.

“These effects are so large, it overcomes these differences in the population,” Dr. Howard said. Most memory and orientation problems detected in the four years were subtle, he added, although a few cases were more severe.

Well: Giving Medical Receptionists Their Due

Posted: 30 Jun 2011 07:42 AM PDT

When ‘Take as Directed’ Poses a Challenge

Posted: 04 Jul 2011 11:30 AM PDT

If the label on one bottle of prescription drugs says, “Take one tablet twice daily,” and the label on another says, “Take one tablet every 12 hours,” would you realize that you could take both medications at the same time?

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What if one bottle says, “Take with food and water,” but the second doesn’t?

Given that the average adult over age 55 juggles six to eight medications daily, the ability to consolidate pill-popping is no minor matter. “I’m more likely to be able to sustain a medication regimen if I only have to take it three or four times a day,” said Michael Wolf, an associate professor of medicine at Northwestern University who studies drug safety. “Seven or eight times a day is complicated to fit into your daily schedule.”

His sister, who has lupus, sometimes takes up to 16 different drugs, he noted. “Why can’t we standardize prescriptions?’

Why indeed? The idea has been kicked around for years. Nearly three years ago, the Institute of Medicine proposed that pharmaceutical manufacturers adopt a universal dosing schedule that would make it possible for people to take medications at just four times of day: morning, noon, evening and bedtime.

Virtually all drugs could be formulated to fit into this framework, Dr. Wolf said: “It’s ridiculously simple, an incredibly basic idea.”

As it stands now, however, patients must fight their way through a thicket of often conflicting instructions when taking more than one drug. Many studies suggest that most of them don’t do it very well, even when relatively few medications are involved.

Recently Dr. Wolf and his team interviewed 464 adults ages 55 to 74 who were patients at several Chicago medical practices and clinics. The researchers presented each patient with seven typical amber pill bottles with dosing instructions on the labels and a slotted tray marked with times of day. “Show us how you’d take these medications over 24 hours,” the interviewers instructed the patients.

“There was no reason to take these medications more than four times a day,” Dr. Wolf said. In fact, he pointed out, 90 percent of all prescription medications can be taken no more than four times a day.

Yet the patients struggled to consolidate their doses in the experimental tray. About a third didn’t think to take two of the drugs together, even though the instructions on their labels were identical. When one drug was supposed to be taken with food and water and another carried no such instructions, half the study participants didn’t plan to take them at the same time, though they could have.

Two-thirds of the subjects wouldn’t take pills together if one label specified “twice daily” and the other said “every 12 hours,” though those phrases mean the same thing.

“Less than 15 percent succeeded in dosing in the most efficient way,” Dr. Wolf said. Instead, the participants indicated they’d take pills an average of six times a day, with some setting up as many as 14 doses a day.

The more cumbersome and harder to remember a medication schedule becomes, the greater the likelihood that people will misunderstand instructions, skip doses or abandon their drug regimen altogether. “This could be a major risk factor for adherence,” Dr. Wolf said.

The need for more simplified dosing instructions has been demonstrated in several such studies, but change has been slow to come, partly because pharmacists in each state are regulated by a different board of pharmacy. But a bill requiring a universal medication schedule has been introduced in New York State, and a similar measure has already become law in California.

For now, Dr. Wolf advises patients to regularly review the medications they take with a physician and to ask for help in simplifying the dosing. His suggested script: “Help me reduce the number of times I have to take these medications, so that over months and years, it doesn’t become a drag.”

Paula Span blogs at The New Old Age: nytimes.com/newoldage.

Researchers Link Deaths to Social Ills

Posted: 04 Jul 2011 12:52 PM PDT

Poverty is often cited as contributing to poor health. Now, in an unusual approach, researchers have calculated how many people poverty kills and presented their findings, along with an argument that social factors can cause death the same way that behavior like smoking cigarettes does.

In an article published online for the June 16 issue of The American Journal of Public Health, scientists calculated the number of deaths attributable to each of six social factors, including low income.

To estimate the number of deaths caused by each factor, the scientists reviewed 47 earlier studies on the subject, combining the data in a meta-analysis. The studies were generally based on large national surveys like the National Health and Nutrition Examination Survey, a continuing study by the Centers for Disease Control and Prevention.

Then, using the pooled data, the researchers calculated the “population-attributable fraction” of deaths — that is, the number of deaths caused by living with a given social disadvantage.

Finally, they multiplied that fraction by the total number of deaths in the year 2000 to come up with a number of deaths caused by each of the six social conditions. The researchers then separated the contribution of each social factor.

“The methods we’re using are limited,” Dr. Sandro Galea, the lead author, acknowledged. “Any time you try to say that death is attributable to a single cause, there’s a problem — all deaths are attributable to many causes. But what we did is just as valid as what was done to establish smoking as a cause of death.”

“This is a very interesting paper,” said Roger T. Anderson, a professor of public health sciences at Pennsylvania State College of Medicine who was not involved in the study. “It’s simple and elegant, a very straightforward approach to looking at these kinds of data.

“It brings to the surface what the impact of social disadvantage is in terms of numbers of deaths, and the authors have done a very nice job of laying out the argument.”

The researchers used various criteria to define an adverse social condition. Low education, for example, was defined as not having graduated from high school. Poverty was defined as a household income of less than $10,000. A population in which more than 25 percent of people reported their race or ethnicity as non-Hispanic black was considered racially segregated.

The study also calculated the effect of an area’s overall poverty level, income differential and low social support.

For 2000, the study attributed 176,000 deaths to racial segregation and 133,000 to individual poverty. The numbers are substantial. For example, looking at direct causes of death, 119,000 people in the United States die from accidents each year, and 156,000 from lung cancer.

Social factors are not the same as diseases or accidents, but Dr. Galea argues that they are equivalent to a behaviors like smoking, and that, as with smoking, there is evidence of the mechanism involved. He said that the causal chain between, for example, poverty and death from heart disease has many well-established links.

Dr. Galea also said that poverty results in poor access to health screening, poor access to quality care for those who actually have heart disease, greater vulnerability to stresses associated with heart disease and a greater likelihood of engaging in unhealthy behavior.

“In some ways,” Dr. Galea added, “the question is not ‘Why should we think of poverty as a cause of death?’ but rather ‘Why should we not think of poverty as a cause of death?’ ”

If they had not smoked, 400,000 people each year would not have died, Dr. Galea said. Similarly, he said, if they had graduated from high school, the 245,000 people whose cause of death he attributes to low education would still be alive.

“This might be a useful lens to help focus our minds,” said Dr. Galea, who is the chairman of the department of epidemiology at the Mailman School of Public Health at Columbia University. “If you say that 193,000 deaths are due to heart attack, then heart attack matters. If you say 300,000 deaths are due to obesity, then obesity matters.

“Well, if 291,000 deaths are due to poverty and income inequality, then those things matter too.”

The Then and Now of Memory

Posted: 04 Jul 2011 11:35 AM PDT

Researchers have long known that the brain links all kinds of new facts, related or not, when they are learned about the same time. Just as the taste of a cookie and tea can start a cascade of childhood memories, as in Proust, so a recalled bit of history homework can bring to mind a math problem — or a new dessert — from that same night.

For the first time, scientists have recorded traces in the brain of that kind of contextual memory, the ever-shifting kaleidoscope of thoughts and emotions that surrounds every piece of newly learned information. The recordings, taken from the brains of people awaiting surgery for epilepsy, suggest that new memories of even abstract facts — an Italian verb, for example — are encoded in a brain-cell firing sequence that also contains information about what else was happening during and just before the memory was formed, whether a tropical daydream or frustration with the Mets.

The new study suggests that memory is like a streaming video that is bookmarked, both consciously and subconsciously, by facts, scenes, characters and thoughts. Experts cautioned that the new report falls well short of revealing how contextual memory and different cues interact; some words might throw the mind into a vivid reverie, while others do not. But the report does provide a glimpse into how the brain places memories in space and time.

“It’s a demonstration of this very cool idea that you have remnants of previous thoughts still rattling around in your head, and you bind the representation of what’s happening now to the fading embers of those old thoughts,” said Ken Norman, a neuroscientist at Princeton who did not participate in the study. “I think they have very good evidence that this process is crucial to time-stamping your memories.”

In the new study, appearing in the current issue of the journal PNAS, doctors from the University of Pennsylvania and Vanderbilt University took recordings from tiny electrodes implanted in the brains of 69 people with severe epilepsy. The implants are standard procedure in such cases, allowing doctors to pinpoint the location of the flash floods of brain activity that cause epileptic seizures.

The patients performed a simple memory task. They watched a series of nouns appear on a computer screen, one after another, and after a brief distraction recalled as many of the words as they could, in any order. Repeated trials, with different lists of words, showed a predictable effect: The participants tended to remember the words in clusters, beginning with one and recalling those that were just before or after.

This pattern, which scientists call the contiguity effect, is similar to what often happens in the card game concentration, in which players try to identify pairs in a grid of cards lying face-down. Pairs overturned close in time are often remembered together.

Recording from the electrodes, the researchers looked for a neural firing pattern that had a very distinct signature — it updated continually, like a news ticker tape. They found a strong signal in the temporal lobe of the brain, an area extending roughly between the temple and the ear. When participants recalled a word — “cat,” for example — the pattern in this region looked identical to when “cat” was originally seen on the computer screen.

Moreover, the pattern was only slightly different when they recalled the words just before, and just after, “cat” on the list.

“Here we have shown, in effect, that the word before ‘cat’ — let’s say it’s ‘tree’ — has colored or influenced the encoding for ‘cat,’ just as ‘cat’ has influenced the encoding of the next word, let’s say ‘flower,’ ” said Michael J. Kahana, a neuroscientist at the University of Pennsylvania and an author of the paper. His co-authors were Jeremy R. Manning, Dr. Gordon Baltuch and Dr. Brian Litt, all of Penn; and Sean M. Polyn of Vanderbilt.

The way the process works, the authors say, is something like reconstructing a night’s activities after a hangover: remembering a fact (a broken table) recalls a scene (dancing), which in turn brings to mind more facts — like the other people who were there — and so on. Sure enough, the people in the study whose neural updating signals were strongest showed the most striking pattern of remembering words in clusters.

“When you activate one memory, you are reactivating a little bit of what was happening around the time the memory was formed,” Dr. Kahana said, “and this process is what gives you that feeling of time travel.”

Study Links Smoking Cessation Drug to Cardiovascular Problems

Posted: 04 Jul 2011 09:01 AM PDT

Chantix, the best-selling prescription drug for smoking cessation, was linked to an increased risk of a heart attack, stroke or other serious cardiovascular event for smokers without a history of heart disease compared with smokers who did not use the drug, according to a Canadian medical journal report released on  Monday.

The finding added to previous warnings about the pill’s connection to psychiatric problems and cardiovascular risks for people with a history of heart disease.

It posed a new challenge to a product that has been prescribed to 13 million people and had $755 million in sales last year.

Officials of Pfizer, the manufacturer of Chantix, and the Food and Drug Administration responded that they had been planning to conduct a joint analysis of clinical trials on whether Chantix posed heart risks, due next year.

“This would have raised a red flag for us if the flag hadn’t already been flying,” Dr. Celia Winchell, a team leader with the agency’s Center for Drug Evaluation and Research, said in an interview.

Pfizer, in a statement, said the analysis in the Canadian Medical Association Journal was based on too few heart or cardiovascular events to draw conclusions about the risks. The company said Chantix brought “immediate and substantial” health benefits to smokers who quit.

The senior author of the new report, Dr. Curt D. Furberg, a Wake Forest medical professor, said there were better ways to quit and called for removal of the drug from the market.

“It piles up,” he said. “I don’t see how the F.D.A. can leave Chantix on the market.”

The lead author, Dr. Sonal Singh, assistant professor of medicine at Johns Hopkins University, said the agency and Pfizer had failed to pursue signs of cardiovascular risk since Chantix was approved in 2006.

“The F.D.A. should have already put it on their warning label,” Dr. Singh said. “The risk is substantial, the risk is present in smokers without heart disease, and Pfizer knew about this for five years.”

Last month, the agency issued a safety notice about cardiovascular risk from Chantix use by people with a history of cardiovascular disease, based on a study of 700 people.

The new report is broader, analyzing 14 randomized clinical trials involving 8,200 patients, excluding those with cardiovascular disease so that it gives a better picture of which heart problems the drug could cause in otherwise healthy people trying to quit smoking.

The new study, known as a meta-analysis, compiled data from 14 random, blinded, placebo-controlled clinical trials that tracked cardiovascular outcomes. It found 52 out of 4,908 people taking Chantix had serious cardiovascular events, a rate of 1.06 percent, compared with 27 out of 3,308 people taking a placebo, a rate of 0.82 percent. While the absolute difference is only 0.24 percent, the weighted, relative difference is 72 percent.

“We have known for many years that Chantix is one of the most harmful prescription drugs on the U.S. market, based on the number of serious adverse effects reported to the F.D.A.,” Dr. Furberg said in a statement. “It causes loss of consciousness, visual disturbances, suicides, violence, depression and worsening of diabetes. To this list we now can add serious cardiovascular events.”

Dr. Furberg, who once directed clinical trials for the government and writes widely about drug safety, has been paid as an expert witness in cases against Pfizer. Dr. Singh and two other researchers said they had no conflicts of interest.

When combining studies of smokers with and without pre-existing disease, the study found that doctors could expect to get one extra cardiac event associated with Chantix for every 28 smokers they treated with the drug. The researchers also estimated one additional person would quit for every 10 treated with Chantix.

The benefit of Chantix was emphasized in a separate commentary in the journal by Dr. J. Taylor Hays of the Mayo Clinic in Rochester, Minn. He described the meta-analysis as “timely and important” but said it lacked overall size and standardization. Dr. Hays, who has been paid by Pfizer to study Chantix, said the benefits of quitting smoking outweighed the risks of the drug.

Chantix is selling well overseas. In Japan, for instance, some pharmacies ran out for a while recently, even as the drug failed to meet expectations in the United States because of health warnings and bad publicity.

Global Update: Senegal: Canadian Company to Help Finance Zinc Supplements for Children

Posted: 04 Jul 2011 10:11 AM PDT

A Canadian zinc mining company and a Canadian nonprofit devoted to getting vitamins and minerals to children in poor countries recently joined forces to create a new partnership, the Zinc Alliance for Child Health.

Zinc, the metal used to line the bars of traditional Paris bistros, is a mineral crucial in trace amounts to children’s growth, brain development and immune system functions. It is found in red meat, beans and peanuts, but many malnourished children eat almost nothing but cornmeal, cassava or other starches.

Teck Resources, a mining company with headquarters in Vancouver, announced that it would give $6.2 million to help six million children in Senegal get zinc supplements. Its partners in the new alliance are the Micronutrient Initiative, a nonprofit group based in Ottawa, and the Canadian International Development Agency, through which Canada channels foreign aid.

A 2006 World Health Organization review of nutrition studies concluded that zinc supplements help save the lives of children with severe diarrhea when given in conjunction with oral rehydration solution. Zinc also helped save severely underweight children.

It was less clear whether children benefited from getting routine zinc supplements, , but many poor children suffer from intestinal illnesses that make it hard to absorb the mineral. The W.H.O. said more study was needed into the best forms to offer supplements.

“The challenge the world faces is not producing more zinc,” said Don Lindsay, president of Teck Resources, pictured above. “It’s getting zinc into the diets of people suffering from zinc deficiency.”

Vital Signs: Patterns: No Lasting Problems Seen for Late Talkers

Posted: 04 Jul 2011 08:35 AM PDT

Parents often worry when their toddlers are slow to start talking, but a long-term study has found that these children have no more emotional or behavioral problems than others by age 5 — as long as they are otherwise developing normally.

The study, published online on Monday in the journal Pediatrics, followed children who were part of the Western Australian Pregnancy Cohort Study, including 1,245 children whose speech was not delayed — they were using at least 50 words and could string two or three words together in a phrase — and 142 who had not reached this milestone.

The children were all born to women who were pregnant between 1989 and 1991 when they joined the study. The children were tracked through age 17.

At age 2, the children identified as “late talkers” were more likely than other toddlers to have behavioral problems. But there was no difference between the groups at ages 5, 8, 10, 14 and 17.

The paper’s lead author, Andrew J. O. Whitehouse of the Telethon Institute for Child Health Research in Perth, Australia, suggested that the early behavioral problems stem from a child’s frustration at being unable to communicate. “When the late-talking children catch up to normal language milestones, which the majority of children do, the behavioral and emotional problems are no longer apparent,” he said.

Vital Signs: Prevention: Many False Alarms in Scans That Cut Cancer Deaths

Posted: 04 Jul 2011 08:35 AM PDT

Federal health officials announced last fall that smokers screened for cancer by low-dose spiral CT scans were 20 percent less likely to die of lung cancer than those who had chest X-rays. But the study’s final results, published online Wednesday in The New England Journal of Medicine, also describe the downsides of screening, including a high rate of false-positive scares.

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The National Lung Screening Trial was a decade-long randomized clinical trial involving more than 53,000 former and current smokers ages 55 to 74 who were screened annually with either low-dose spiral computer tomography (CT) or standard chest X-rays. Smokers screened by low-dose CT suffered 20 percent fewer deaths from lung cancer than those screened by X-ray, because their cancers were more likely to be found at an early stage, the study authors found.

But nearly one in four CT scans picked up an abnormality that required more testing, and a vast majority turned out to be harmless. Overall, nearly 40 percent of patients who received regular CT scans had a false-positive scare.

CT scans also expose patients to more radiation, and they are expensive, said Dr. Denise R. Aberle, a professor of radiology at the University of California, Los Angeles, and a principal investigator of the study.

To use this screening method effectively, she said, “we need to do a better job of identifying which smokers are at highest risk.”

Vital Signs: Prevention: A Better Use for Cotton Swabs Than Ear Cleaning

Posted: 04 Jul 2011 08:30 AM PDT

Could a dry cotton puff — something as ubiquitous and low-tech as a Q-tip — protect patients from dangerous infections after surgery?

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Dry, sterile cotton-tipped applicators are being used to swab surgery wounds in patients at Cedars-Sinai Medical Center in Los Angeles, after a clinical trial found the simple technique significantly reduced infections in appendectomy patients.

Among patients whose surgical wounds were probed with a cotton swab daily, only 3 percent developed surgical site infections, compared with 19 percent of patients in a comparison group.

Surgical site infections are a major cause of patient injuries and prolonged hospitalizations, and they have been linked to some 8,000 deaths annually. Last year the Joint Commission Center for Transforming Healthcare initiated a project aimed at reducing the high rate of surgical site infections in patients undergoing colorectal procedures.

Dr. Shirin Towfigh, an associate professor of surgery at Cedars-Sinai Medical Center and leader of the cotton swab experiment, said that technique appeared to help release contaminated fluid from the wound. “This is actually not something revolutionary — in certain pockets of the country, some surgeons have been doing this based on where they were trained,” she said. “It’s very simple to do.”

Recipes for Health: Summer Vegetable Sauces

Posted: 04 Jul 2011 12:48 PM PDT

Tomatoes aren’t the only vegetable that you can turn into a sauce or condiment. Onions and fennel cook down to a thick, sweet, jammy confit. Roasted peppers can be simmered until they’re soft and saucy, then tossed with pasta, piled onto bruschetta or spooned over fish or chicken.

Recipes for Health

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

Mediterranean cooks have always been my inspiration when it comes to vegetable-based sauces. Traditionally they’ve had to be clever about putting by, taking the abundance of one season and cooking it down (into a tomato sauce, for instance, or puree) or blending it with olive oil (pesto) so that it lasts until winter’s end.

Use this week’s recipes to gussy up a simple bowl of grains and vegetables, enjoy the sauces with crusty bread or atop a good piece of fish or chicken, or serve with anything grilled. They all keep well in the refrigerator, and they also can be frozen, perfect for pulling out on a summer day when the heat has sapped your desire to cook.

Pungent Tomato Sauce With Capers and Vinegar

There are so many ways to enjoy this sauce. You can serve it with pasta or grains, over vegetables (try it with cauliflower) or on a bruschetta. I recently tried it with Israeli couscous, sautéed in olive oil then simmered in stock and topped with this sauce. 

2 tablespoons extra virgin olive oil

1/2 medium onion, finely chopped

1 large garlic clove, minced

1 pound fresh tomatoes, grated, or 1 can chopped tomatoes

1 basil sprig

1 tablespoon capers, rinsed and finely chopped

Salt and freshly ground pepper to taste

1 tablespoon red wine vinegar or sherry vinegar (more to taste)

1 to 2 tablespoons minced parsley or slivered basil (optional) 

1. Heat 1 tablespoon of the olive oil in a medium, heavy saucepan. Add the onion. Cook, stirring often, until tender, about five minutes. Stir in the garlic. Cook, stirring, until fragrant, about 30 seconds. Stir in the tomatoes, basil sprig, capers, salt and pepper. Bring to a simmer over medium-high heat, stir and reduce the heat. Simmer 10 to 15 minutes until cooked down and very fragrant. Remove the basil sprig. Stir in the vinegar, the remaining tablespoon of olive oil and the optional parsley or basil. Taste and adjust seasonings. Serve hot or cold.

Yield: About 1 1/4 cups, serving four to six.

Advance preparation: You can keep this sauce for about a week in therefrigerator. It freezes well.

Nutritional information per serving (four servings):  87 calories; 1 gramsaturated fat; 1 gram polyunsaturated fat; 5 grams monounsaturated fat; 0milligrams cholesterol; 6 grams carbohydrates; 2 grams dietary fiber; 70milligrams sodium (does not include salt to taste); 1 gram protein

Nutritional information per serving (six servings):  58 calories; 1 gramsaturated fat; 1 gram polyunsaturated fat; 3 grams monounsaturated fat; 0milligrams cholesterol; 4 grams carbohydrates; 1 gram dietary fiber; 47milligrams sodium (does not include salt to taste); 1 gram protein

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

European Union to Send Food Aid to North Korea

Posted: 04 Jul 2011 02:25 AM PDT

BRUSSELS — Responding to the growing threat of a humanitarian crisis in North Korea, the European Union announced on Monday that it will provide about $14.5 million in emergency aid to feed more than some 650,000 North Koreans.

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The bloc’s executive body, the European Commission, said that after its experts witnessed evidence of a developing crisis last month during a mission to North Korea, it negotiated an agreement with the North Koreans about how to monitor the delivery of assistance.

“Increasingly desperate and extreme measures are being taken by the hard-hit North Koreans, including the widespread consumption of grass,” the European Commission said in a statement.

The severity of the situation prompted a switch of tactics by the commission. In 2008, it stopped sending humanitarian aid to North Korea in favor of offering financing for longer-term development projects.

“The purpose of this aid package is to save the lives of at least 650,000 people who could otherwise die from lack of food,” Kristalina Georgieva, a European commissioner, said in the statement. “Our experts saw severely malnourished children in hospitals and nurseries where no treatment was available.

“North Korea’s chronic nutrition problem is turning into an acute crisis in some parts of the country.”

Former President Jimmy Carter and two other former presidents, Mary Robinson of Ireland and Martti Ahtisaari of Finland, and former Prime Minister Gro Harlem Brundtland of Norway traveled to North Korea in April and issued grave warnings about the food situation there. (All four are members of the Elders, an independent group of world leaders established by Nelson Mandela.)

Mr. Carter was particularly concerned about the refusal of the United States and South Korea to send humanitarian assistance to the North, saying their deliberate withholding of food aid amounted to “a human rights violation.”

Mr. Carter, 86, who was not traveling as an official American envoy, had been invited to North Korea for meetings with senior political and military officials.

Mrs. Robinson echoed Mr. Carter’s concerns about what she called the “very serious crisis” over food supplies in North Korea because of a harsh winter, severe flooding and an outbreak of foot-and-mouth disease. She said the withdrawal of American and South Korean food shipments had aggravated a dire situation, which had become, she said, “a matter of life-and-death urgency.”

The United States recently sent a team of experts to evaluate food and hunger conditions in North Korea. But the Obama administration has not yet decided about a resumption of food shipments.

Secretary of State Hillary Clinton said recently that “North Korea must address our serious concerns about monitoring.” Integral to any agreement to restart American aid deliveries, she said, would be “our ability to ensure and monitor that whatever food aid is provided actually reaches the people who are in need.”

After his trip in April, Mr. Carter said North Korean officials had guaranteed to make changes to the aid-distribution system so that Western governments and donors could track their deliveries and be certain that their aid was not being diverted to the military or the ruling elite.

The European aid will be distributed through the World Food Program, which has been used by the United States and other countries and donors. Ms. Georgieva said it would be strictly monitored, from the point of delivery at ports to when it reached recipients.

“If at any stage we discover that the aid is being diverted from its intended recipients, then the commission will not hesitate to end its humanitarian intervention,” she said.

According to the European Commission, its experts found that in North Korea the state-distributed food rations had been more than halved in recent months. Two-thirds of the population depends on the rations, it said.

The per-person ration, which had been 400 grams of cereals per day, about 14 ounces, was reduced to 150 grams, about 5.3 ounces, in June. That is a fifth of the daily average nutritional requirement, according to European experts. Most of the rations consist of corn.

“Food assistance will reach children under 5 who have already been hospitalized with severe acute malnutrition,” the commission said in the statement. “Children in residential care will also be fed, as well as pregnant and breast-feeding women, hospital patients and the elderly.”

The food shortages have been caused by years of economic mismanagement and underinvestment, and have been made worse by poor weather and a reduction of food imports from China and South Korea. The next main grain harvest is in October.

Initially, the North Koreans had planned to import 353,000 tons of grains, but that target was reduced to 220,000 tons, of which about half has been secured so far, European experts said.

The North Korean government has promised unrestricted access for random checks related to the aid, the commission said. While distributing the European aid, the World Food Program will pay 400 visits per month to warehouses, institutions caring for children, hospitals and distribution sites.

Some With Histories of Mental Illness Petition to Get Their Gun Rights Back

Posted: 03 Jul 2011 08:57 PM PDT

PULASKI, Va. — In May 2009, Sam French hit bottom, once again. A relative found him face down in his carport “talking gibberish,” according to court records. He later told medical personnel that he had been conversing with a bear in his backyard and hearing voices. His family figured he had gone off his medication for bipolar disorder, and a judge ordered him involuntarily committed — the fourth time in five years he had been hospitalized by court order.

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Don Petersen for The New York Times

BOBBY BULLION
Mr. Bullion, showing how he carries a gun in his truck, got his rights back with a doctor's endorsement.

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JOSHUA ST. CLAIR
An Iraq war veteran who had his gun rights restored after a hearing that he said “lasted maybe about five minutes.”

When Mr. French’s daughter discovered that her father’s commitment meant it was illegal for him to have firearms, she and her husband removed his cache of 15 long guns and three handguns, and kept them after Mr. French was released in January 2010 on a new regime of mood-stabilizing drugs.

Ten months later, he appeared in General District Court — the body that handles small claims and traffic infractions — to ask a judge to restore his gun rights. After a brief hearing, in which Mr. French’s lengthy history of relapses never came up, he walked out with an order reinstating his right to possess firearms.

The next day, Mr. French retrieved his guns.

“The judge didn’t ask me a whole lot,” said Mr. French, now 62. “He just said: ‘How was I doing? Was I taking my medicine like I was supposed to?’ I said, ‘Yes, sir.’ ”

Across the country, states are increasingly allowing people like Mr. French, who lost their firearm rights because of mental illness, to petition to have them restored.

A handful of states have had such restoration laws on their books for some time, but with little notice, more than 20 states have passed similar measures since 2008. This surge can be traced to a law passed by Congress after the 2007 massacre at Virginia Tech that was actually meant to make it harder for people with mental illness to get guns.

As a condition of its support for the measure, the National Rifle Association extracted a concession: the inclusion of a mechanism for restoring firearms rights to those who lost them for mental health reasons.

The intent of these state laws is to enable people to regain the right to buy and possess firearms if it is determined that they are not a threat to public safety. But an examination of restoration procedures across the country, along with dozens of cases, shows that the process for making that determination is governed in many places by vague standards and few specific requirements.

States have mostly entrusted these decisions to judges, who are often ill-equipped to conduct investigations from the bench. Many seemed willing to simply give petitioners the benefit of the doubt. The results often seem haphazard.

At least a few hundred people with histories of mental health issues already get their gun rights back each year. The number promises to grow, since most of the new state laws are just beginning to take effect. And in November, the Department of Veterans Affairs responded to the federal legislation by establishing a rights restoration process for more than 100,000 veterans who have lost their gun privileges after being designated mentally incompetent by the agency.

The issue goes to the heart of the nation’s complicated relationship with guns, testing the delicate balance between the need to safeguard the public and the dictates of what the Supreme Court has proclaimed to be a fundamental constitutional right.

Mike Fleenor, the commonwealth’s attorney here in Pulaski County, whose office opposed restoring Mr. French’s rights, worries that the balance is being thrown off by weak standards.

“I think that reasonable people can disagree about issues of the Second Amendment and gun control and things like that, but I don’t believe that any reasonable person believes that a mentally ill person needs a firearm,” Mr. Fleenor said. “The public has a right to be safe in their community.”

In case after case examined by The New York Times, judges made decisions without important information about an applicant’s mental health.

Toby Lyles, Lisa Schwartz and Jack Styczynski contributed research.

Novelties: Beyond the Breathalyzer: Seeking Telltale Signs of Disease

Posted: 02 Jul 2011 09:30 PM PDT

PEOPLE who are worried about bad breath often reach for a toothbrush, a Tic Tac or an Altoid.

Jim Lang/Cleveland Clinic

“My sense is that breath analysis is the future of medical testing,” says Dr. Raed Dweik, holding a breath sensor he is developing.

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Menssana Research

Anirudh Chaturvedi of Menssana Research demonstrated its BreathLink system.

But in the future, personal breath monitoring may include far more than breath fresheners.

Scientists are building sophisticated electronic and chemical sniffers that examine the puffs of exhaled air for telltale signs of cancer, tuberculosis, asthma and other maladies, as well as for radiation exposure.

“There are clear signatures in the breath for liver disease, kidney disease, heart disease” and diseases of the lungs, said Dr. Raed Dweik, director of the pulmonary vascular program at the Cleveland Clinic, who studies breath analysis. “My sense is that breath analysis is the future of medical testing, complementing many of the blood and imaging steps we do today.”

“Breath is a rich matrix that can reflect our state of health or disease,” Dr. Dweik said. In fact, he observed, breath is so rich in chemical compounds that fully understanding it has proved challenging. Each exhalation contains gases like carbon dioxide, of course, but also the volatile remains of recent snacks, medicines and even compounds inhaled from things like carpeting, upholstery or various kinds of air pollution.

But monitors can sort out these exhaled substances with increasing sensitivity, bringing breath analysis closer to widespread use as a noninvasive tool in medical diagnosis and treatment.

Menssana Research, a biotechnology company in Fort Lee, N.J., is testing a desktop system called BreathLink for use in rapid identification of active pulmonary tuberculosis and other diseases, said Dr. Michael Phillips, the company’s chief executive and a professor of clinical medicine at New York Medical College in Valhalla, N.Y. The system is designed to work wherever there is an Internet connection.

Its analyzers can detect compounds in the breath in concentrations of parts per trillion — a billion times more sensitive than breath analyzers used by the police to detect blood-alcohol concentrations, Dr. Phillips said. To use Breathlink, a person breathes into a long tube, and a breath sample is collected and analyzed within the apparatus. The device can then detail chemical concentrations of the breath in graphics.

“Then we can send that information to our lab in New Jersey from anywhere in the world” for further analysis, he said.

BreathLink grows out of the company’s earlier work on Heartsbreath, a procedure that monitors exhalations of patients with heart transplants for signs of rejection. Heartsbreath, approved by the Food and Drug Administration as a humanitarian device, has not yet been widely adopted, Dr. Phillips said, in part because Medicare has declined to cover the test until further clinical studies demonstrate its efficacy. Those studies are continuing, Dr. Phillips said.

The detection of one compound in the breath, nitric oxide, is already used widely in treatment of asthma, said Dr. Marielle W. H. Pijnenburg, who specializes in pediatric respiratory medicine at Erasmus University Medical Center in Rotterdam, the Netherlands.

“It’s a very small molecule,” she said, “but if you look at patients of asthma, they have higher levels of it in their exhaled air. It reflects their allergic inflammation in the lungs.”

Dr. Pijnenburg said that the breath analyzers used to detect nitric oxide are expensive, however — and that the results, while useful, are not applicable to all asthma patients. “Nitric oxide alone is too simple to reflect the complex processes going on in the lungs for asthma,” she said. Future devices will measure many other molecules that may be related to the disease.

One of these devices may be a portable breath analyzer for pediatric asthma that will look for five common inflammatory markers of the disease, said Frederick A. Dombrose, president of the Hartwell Foundation in Memphis. The foundation, which supports research in children’s health, has awarded a grant to Cristina E. Davis, an associate professor of mechanical and aerospace engineering at the University of California, Davis, to develop the analyzer.

“We want a hand-held device that is convenient for children to hold and use, so that they can monitor their condition,” Mr. Dombrose said.

AT the Cleveland Clinic, Dr. Peter Mazzone is analyzing the breath of patients to determine whether they have lung cancer. In his test, breath is drawn across sensors that change color and are then captured on digital cameras. The patterns are then compared with those of people without the disease. His tests have reached 85 percent accuracy so far in spotting people with the illness, he said.

But some trained dogs, he pointed out, can sniff out cancer with 99 percent accuracy — although without, for example, the ability to identify particular compounds the way some analyzers can.

“We are getting better and better,” he said. “But whether we will ever approach the accuracy of the dog — we don’t know.”

E-mail: novelties@nytimes.com.

When Bell Sounds, Surgeon Answers Ringside Calling

Posted: 04 Jul 2011 12:09 PM PDT

One recent Friday, the orthopedic surgeon Victor Khabie performed seven operations, grabbed a sandwich and fought traffic to a ballroom in Queens to care for athletes who walked willingly into fists. They call themselves boxers. Khabie, though, calls them patients.

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Michael Appleton for The New York Times

Dr. Khabie, an orthopedic surgeon, moonlights as a ringside physician.

This presents a contradiction for Khabie and other doctors who moonlight as ringside physicians. They come from the world of medicine, which is predicated on healing, into the world of boxing, which is predicated on pain. Khabie must reconcile these worlds, for a few hundred dollars a fight, while his patients cut, bruise and disfigure each other for sport.

“It’s tough, but we do the best we can for them,” Khabie said. “If society says we don’t want boxing, then I wouldn’t be taking care of boxers. But I’m not a politician. I do know these boxers need help, these boxers are hurt, and often they have no one to take care of them.”

On Saturday, the heavyweight champion Wladimir Klitschko defeated David Haye in Germany, a fight shown on HBO. Khabie watched both boxers and the physicians who watched over them. In 2006, he examined Klitschko before a bout at Madison Square Garden.

That fight, with the boxer Laila Ali on the undercard and her father, Muhammad Ali, in attendance, served as a career highlight. Just like the time Evander Holyfield raised his left glove between rounds when Khabie instructed him to lift his right, inadvertently smacking Khabie in the face.

Khabie long ago learned the violence inherent in his favorite sport. He tried boxing with a friend and ended up with broken ribs. His wife, Brenda, told Khabie: “You’re a surgeon. You need those hands.” But she also understood that the violence, so different from his daily routines, drew him ringside in the first place.

“If he wasn’t a surgeon,” she said, “he’d be a boxer.”

By day, Khabie can be found in Mount Kisco, N.Y., where he is the chief of sports medicine at Northern Westchester Hospital and also helps operate the Somers Orthopedic Surgery and Sports Medicine Group. On fight nights, he makes a mental switch, from repairer of torn ligaments and busted knees to caretaker of battered faces, from central figure in the operating room to anonymous face at ringside.

Khabie described his job like this: between rounds, he fights through camera crews and trainers into a designated corner, where he attempts to pepper a boxer who is often injured and trying to catch his breath with questions for 10 to 15 seconds. He then makes a decision on whether the bout should continue, one he must live with through the next round.

If all goes well, Khabie operates unseen. This being boxing, “all goes well” means none of the combatants end up in the hospital. Those are the fights that stick with Khabie, that keep him awake at night, like a bout a few years ago at a beer garden on Long Island where a boxer was knocked unconscious. For five minutes that felt like five hours, the boxer did not move.

Khabie never expected to work in boxing, but knew early he would become a doctor, even back in Boy Scouts when his favorite tasks included constructing a bandage in the woods. A longtime sports fan, he entered orthopedics because it combined both passions, because the first time he removed a screw from a leg, his instructors asked not about removal technique, but about a football game the night before.

After college at the University of Pennsylvania and Harvard Medical School, Khabie worked at the Kerlan-Jobe Orthopedic Clinic in California. There, he served as assistant physician for the professional sports teams in Los Angeles. Lakers center Shaquille O’Neal occasionally pulled pranks on him.

Khabie enjoyed caring for athletes (as an assistant doctor, he examined and called in a prescription for the tennis champion Steffi Graf at the United States Open). But boxing, with no place to hide, all the energy and raw aggression, drew him in. His first bout as a ringside physician took place at a cafe in the Bronx, which later became a Red Lobster and had a makeshift ring inside.

On the recent Friday in Queens, Khabie called his work typical: eight fights, three boxers knocked down, two repeatedly, one serious gash opened by a head butt.

Books: A Timely E. Coli Story, Spun as a Legal Thriller

Posted: 28 Jun 2011 08:40 AM PDT

If little mental woodpeckers of guilt begin to hammer away every time you reach for a John Grisham novel (shouldn’t you be reading something factual and relevant to current events?), your perfect beach book has arrived. With “Poisoned,” Jeff Benedict manages to deliver the full literary experience of a medico-legal thriller in a work of nonfiction that, fortuitously enough, could not be more relevant to recent headlines.

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Patricia Wall/The New York Times

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Mr. Benedict’s subject is one of the first outbreaks of E. coli-related diarrhea to sicken and kill innocent diners. Last month’s outbreak in Germany was traced to salad vegetables, probably bean sprouts, but back in the winter of 1993 it was Jack in the Box hamburger meat that catapulted this new threat into the public eye and left enduring repercussions in the worlds of medicine, law and food services.

At the end of 1992, Jack in the Box was the fifth-largest fast-food chain in the country, courting the market with the Monster Burger and its soon-to-be-immensely-regretted slogan, “So good it’s scary.” The first sign of trouble was a desperately ill girl in San Diego (this was Lauren Rudolph, who died in late December 1992, and in whose memory a pivotal 1996 California food safety act is named). Then dozens of children were sickened in Washington State, and the hamburger connection slowly became clear.

Over a period of a few weeks, more than 700 cases scattered across four Western states; four children died gruesomely, with bleeding intestines and kidney failure. But Mr. Benedict, a lawyer turned journalist, pays relatively little attention to the story’s medical complexities; his focus is the gruesome and complicated legal tangle that ensued.

Nowadays we are all too familiar with the practices of giant processing plants, but back in those innocent times it was all new and appalling — the poorly regulated slaughterhouses, the batching of meat for grinding, the wide distribution of product, which maximized the spread of any contaminant.

Meanwhile, it turned out that Jack in the Box corporate cooking policies left some patties so noticeably underdone that at least one restaurant manager had complained. Further, almost a year earlier the State of Washington had mandated a cooking temperature for burgers higher than the usual federal standard, a regulation that people at Jack in the Box had apparently never heard of. Or had they? The situation quickly became a lawyer’s dream come true.

Enter a legal David and his Goliath. Bill Marler (our hero) was a financially struggling young lawyer who, through a series of happenstances, came to represent Seattle’s most damaged victim. This girl was given up for dead in the intensive care unit (“her appearance reminded him of a mummy, shriveled, brittle, haunting”), only to survive with significant disabilities. Through a series of ingenious tactical maneuvers, Mr. Marler then became the lawyer for other local cases, as well as for a large class-action suit.

His opponent was Bob Piper, an established Seattle lawyer retained by Jack in the Box. A stout, hard-drinking man who sported pictures of nude women on his suspenders, Mr. Piper was known to be devastatingly effective in court.

Also involved were a large crowd of other men in suits, including the hapless chief executive of Jack in the Box and the company’s beleaguered food safety experts, all of whom managed in interviews to be simultaneously contrite and defensive, while paying intermittent lip service to thousands of employees financially dependent on the company’s staying afloat.

By the time it was all over, Mr. Marler had won $15.6 million for his young client, setting a record for the largest personal-injury award in state history, and wheels were set in motion to clean up the nation’s ground beef. (In 1996, Taco Bell suffered its own outbreak, but the culprit turned out to be lettuce.)

Mr. Benedict delivers the story in a staccato, you-are-there fashion that unfortunately mimics much of the cardboard characterization and leaden dialogue often found in this genre’s fiction. It must be said, as well, that his medical fact-checking was remarkably cursory (for example, people need emergency appendectomies not because the appendix has “failed” but because it has begun to rupture). But even somewhat muted and undercut, this story is completely gripping, reminding us how far from the hospital the ripples of epidemic disease can spread.

There is only one supremely colorful character in the story that Mr. Benedict overlooks, and that is E. coli itself. This prokaryotic Zelig is generally such an unremarkable, utterly inoffensive germ that billions live comfortably in the intestines of every single human being. But some strains manage to imitate other virulent germs well enough to become killers, using a virtuoso range of mechanisms. The O157:H7 strain that caused the Jack in the Box fiasco is the best known of these, but new ones, like O104:H4 in Europe last month, continue to appear.

In the years since the Jack in the Box outbreak, Bill Marler has become one of the country’s leading legal authorities on food safety. He drives a red Volkswagen, Mr. Benedict notes in an afterword, with “ECOLI” on the plates. In a sense, the bacteria thus honored are not dissimilar figures: Consider them nonentities at your peril, for actually they are major players, canny and infinitely resourceful.

Well: Transforming Beans Into Vegetarian Patés

Posted: 01 Jul 2011 12:00 PM PDT

Well: What Cellphone Calls Say About Parent-Teenager Relations

Posted: 01 Jul 2011 10:52 AM PDT

Well: Lessons From Exercising in the Heat

Posted: 29 Jun 2011 07:34 AM PDT

Well: Vaccines Protect the Youngest Babies

Posted: 28 Jun 2011 09:43 AM PDT

Well: A Telltale Sign of Bone Loss

Posted: 28 Jun 2011 08:55 AM PDT

Personal Health: For Many Millions, Psoriasis Means Misery

Posted: 04 Jul 2011 12:49 PM PDT

This is the best time of year for many of the 7.5 million people in the United States who suffer from a chronic skin disease called psoriasis. Although lighter clothing worn during the summer months reveals more of their troubled skin, the season’s warmth, humidity and sunshine can heal many of the lesions, at least temporarily.

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Longer-lasting relief may eventually result from a better understanding of the various genetic and molecular mechanisms that underlie the disease, bringing more individualized and effective treatments. But there is much that can be done now to ease the symptoms, which include intense itching, pain and cracked or bleeding skin. The name of the disease comes from the Greek word for itch, “psora,” but scratching can cause bleeding and make the problem worse.

Psoriasis can also result in embarrassment, employment problems, reduced income, social discrimination and diminished quality of life.

Although the disease is not contagious and has nothing to do with cleanliness, people may avoid contact with affected individuals when the lesions or their consequences are obvious. I once saw passengers on the subway move away from a man with severe psoriasis of the scalp whose suit jacket was covered with white flakes. The stigma of psoriasis is pervasive, people with the condition will tell you, which adds to their challenges.

A Common Disorder

Psoriasis (pronounced sore-EYE-ah-sis) is one of the most common skin ailments, affecting about 2 percent of the population, with no respect for gender, age or socioeconomic status. Caucasians, however, are twice as likely as African-Americans to have it.

As with other genetically influenced diseases, psoriasis tends to run in families. If both parents have it, their children have about a 40 percent chance of also developing it; the risk drops to 14 percent if only one parent is affected.

The disorder involves an abnormally rapid growth of skin cells. Normally, skin cells mature and are shed in an ongoing cycle of 28 to 30 days. In psoriasis, these cells mature in just three or four days and accumulate to form thickened patches of skin.

Recent evidence suggests that T-cells, a type of white blood cell that plays a key role in the body’s immune defenses, overreact in the presence of certain environmental factors, speeding the production of skin cells. Among common triggers are stressful events, injury to the skin, a strep throat and certain medications, including lithium, antimalarial drugs, some beta-blockers (used to treat high blood pressure), overuse of corticosteroids and even nicotine patches.

Certain lifestyle factors are also often involved in the onset of psoriasis or its flare-ups: smoking, heavy alcohol use and a sedentary lifestyle, especially if it results in weight gain.

Winter, with its cold, dry air, is especially challenging because it robs the skin of needed moisture and thick clothing blocks exposure to the sun. Ultraviolet light, particularly UVB, penetrates the skin and helps slow the overproduction of skin cells.

Some people affected by the disease believe dietary factors are involved, and everything from sugar to coffee to eggs has been blamed. No such link has been demonstrated in rigorous studies. Still, if in individual cases a certain food is suspected as a trigger, dermatologists suggest that it be eliminated temporarily to see if the effect is real.

Beyond a possible benefit from fish oil, be wary of claims that certain alternative food products or supplements are helpful.

There are five major types of psoriasis, the most common of which is plaque psoriasis (medically called psoriasis vulgaris), which accounts for 80 percent of the cases. Red, raised, inflamed patches covered with a silvery white scale can affect skin anywhere on the body, though most often the knees, elbows, lower back and scalp.

Next most common, occurring in 10 percent of cases, is guttate psoriasis. It causes small red spots, usually on the trunk and limbs. An acute illness, like strep throat, is a common trigger, resulting in a sudden appearance of psoriasis. My husband had this type, but for much of his life was mistakenly thought to have a penicillin allergy, as the lesions appeared after he was treated with the antibiotic for strep throat.

The remaining 10 percent of cases are divided among three types: inverse psoriasis, which produces smooth, shiny red patches in skin folds; pustular psoriasis, causing red patches with tiny blisters, often limited to the hands and feet; and erythrodermic psoriasis, rare but most devastating because it produces burnlike lesions over most of the body. Flare-ups of this last type may be life-threatening, causing a rapid heart rate and disruptions in body temperature that require immediate medical attention.

Psoriasis, in the form of a debilitating condition called psoriatic arthritis, can also affect the joints. A warning sign may involve changes in the nails of the fingers or toes: a pulling away from the nail bed, pitting, ridges or a yellow-orange discoloration.

Skin Care and Treatment

Keeping the skin well moisturized helps to control the dryness and cracking common to psoriasis. To lock in moisture, take regular but short showers with warm (not hot) water; use a fragrance-free moisturizing cleanser: and pat (do not rub) the skin dry. Follow immediately with application of a moisturizing lotion during the day or a heavier cream or ointment at night.

Do not scratch if itching is intense. Apply a cold compress, a menthol-based ointment or topical steroid, or soak in an oatmeal bath. Wear nonirritating clothing that “breathes,” like pure cotton. Overheating can intensify the itch.

Be patient. Currently, finding the most effective treatment for individual cases is often a matter of trial and error. Steroid-based topical medications, applied in very thin layers, are effective in most cases. There are many such drugs, and if one does not help, it pays to try others until one is found to reduce symptoms.

In more severe cases, an oral or injected medication may be required. In a report in 2009 in The New England Journal of Medicine, three dermatologists noted that “biologic therapies in psoriasis are highly effective.” The agents in question take aim at the T-cells or cytokines, both immune system cells involved in inflammation. These treatments are costly, however, and their long-term safety has not yet been established.

There is also increasing evidence that psoriasis is more than skin deep. People with moderate to severe psoriasis may also be at risk for other disorders involving chronic inflammation, including Crohn’s disease, diabetes and heart disease — in particular, an increased risk of heart attack. Depression is also more common in people with psoriasis, although whether it is a cause or an effect of the disease has not been established.

Well: The Claim: Hospital Mortality Rates Rise in July

Posted: 04 Jul 2011 10:19 AM PDT

The New Old Age: Empty Plates for Low-Income Seniors

Posted: 01 Jul 2011 08:26 AM PDT

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The New Old Age: Hospice and Its Costs

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Reporter's File: Making Sickle Cell Disease a Manageable Illness

Posted: 04 Jul 2011 08:38 AM PDT

On most days Giovanna Poli acts like a typical 12-year-old. She enjoys riding bikes with her brother, likes learning about the planets in science class and wants to be a pediatrician when she grows up.

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Giovanna Poli is living with sickle cell disease.

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But Giovanna, a brown-haired girl from West Palm Beach, Fla., also suffers from debilitating pain, recurring infections and organ damage. She was born with sickle cell disease, a genetic disorder with unpredictable complications that causes the red blood cells to assume an abnormal sickle shape, making it difficult for blood to flow through vessels and deliver oxygen throughout the body.

“I usually feel good,” she says. “But some days it hurts so much in my legs and arms. I can’t really walk, and I don’t like people touching me. If it’s really bad, I have to go to the hospital.”

Every year, nearly 1,000 babies in the United States are born with sickle cell disease, which is thought to affect about 100,000 Americans. Forty years ago, the outlook for babies born with the disease was pretty bleak; the average child lived to be only 14. However, over the last four decades, new treatments, early intervention techniques and newborn screening programs have helped turn this disease, which was once a death sentence, into a manageable chronic illness.

“Our entire approach to treating sickle cell disease has changed,” said Dr. Clinton H. Joiner, director of the division of hematology at Cincinnati Children’s Hospital Medical Center. He notes that today, most patients live to see their 40th birthday.

“Over the last 20 years, we have shifted from treating the complications that arose to preventing the complications altogether,” he said. “It has had a dramatic impact on morbidity and mortality. Today, children are living long enough to become adults.”

Babies with sickle cell disease typically do not exhibit symptoms until after 6 months of age. In the 1970s and ’80s, parents would bring what they thought was an otherwise healthy 6-month-old with a high fever to the emergency room, and the child would often die a few hours later from an overwhelming infection. It was a story all too common; according to Dr. Joiner, some 10 percent of babies with sickle cell disease died within the first four years of life, many before the condition had even been diagnosed.

During the late ’80s, physicians began to realize that the simple act of starting a baby on penicillin could change all that. A major study published in The New England Journal of Medicine in 1986 found that babies with sickle cell anemia — the most common and usually the most serious form of sickle cell disease — who were started on the antibiotic at 4 months of age were less likely to die from pneumococcus, a bacterial infection that commonly strikes children with the disease, than those who did not take the drug. “This has been the single most important disease-modifying therapy,” said Dr. Lanetta B. Jordan, chief medical officer for the Sickle Cell Disease Association of America. “It’s simple, cheap and readily available.”

But having the right drug wasn’t enough. To save lives, penicillin had to be started at an early age, because by the time most babies developed symptoms and a diagnosis was reached, it was usually too late. “It made people realize that if we could diagnose immediately after birth, we could do something to prevent it,” Dr. Joiner said.

As a result, states began to pass legislation requiring that all newborns be screened for sickle cell disease before they leave the hospital. “The goal,” said Dr. George R. Buchanan, director of the Southwest Comprehensive Sickle Cell Center at UT Southwestern Medical Center at Dallas, “was to identify these babies immediately and get them into care.” Since 2006, newborn screening tests for sickle cell disease have been performed in all 50 states.

In addition to infection, stroke was also a leading cause of death in children with sickle cell disease. In fact, before the new millennium, some 10 percent of patients suffered a stroke in the first decade of life. In the late 1990s, however, researchers found a way to identify children who were at risk for stroke using a specialized ultrasound known as transcranial Doppler testing. Today, all children who have sickle cell disease are screened routinely starting at age 2, and those who are found to be at risk are treated with monthly blood transfusions, which can help reduce the risk of stroke by at least 80 percent.

Such screening techniques and early intervention therapies have sharply lowered the mortality rate in children with sickle cell disease. Today, about 90 percent of children make it to adulthood. But according to Dr. Kwaku Ohene-Frempong, an attending hematologist at the Children’s Hospital of Philadelphia, when it comes to quality of life, “we have not made enough progress.”

New therapies, he says, hold promise not only to ease symptoms but also to cure the disease. A drug known as hydroxyurea, which was originally designed to treat cancer, has been found to cut the number of complications from sickle cell disease in half in adults. Recent studies show it has similar benefits in children as well.

“The drug makes the red blood cells look bigger, healthier and behave much better,” Dr. Joiner said. “Some patients go from being completely disabled by their disease to being able to go to school and work after just a few months on this medication.” Physicians like Dr. Joiner are beginning to consider using the drug routinely in young children.

There is also the promise of a cure. Over the last 20 years, at least 400 patients have been cured of sickle cell disease through hematopoietic stem cell transplant, a procedure that replaces the unhealthy sickle-shaped cells with healthy cells from a donor.

The problem, Dr. Jordan points out, “is not that there are not cures, but that the cures that exist cannot be used in the masses.” The procedure is risky at best, the costs are exorbitant, and only 10 to 15 percent of patients are even eligible because they have a full-match donor.

Still, it has patients excited. Giovanna Poli, for one, recently learned her brother is a match, and the family is considering a transplant. Other researchers are working on gene therapy as another approach to cure sickle cell disease, but progress has been slow.

“The future is hopeful, but I don’t see gene therapy or stem cell transplant curing large numbers of patients,” Dr. Buchanan said. “I think it will come down to developing inexpensive, user-friendly, nontoxic medications that keep the cells from causing the damage that they do.”

For now, says Giovanna’s mother, Vivian Poli, the hardest part is the uncertainty. “One minute Giovanna is playing, and the next minute she is in agonizing pain, and there is not much I can do to help her. It is the worst feeling in the world for a parent.”

Letters: The Value of Hospice (2 Letters)

Posted: 04 Jul 2011 11:50 AM PDT

To the Editor:

Re “Concerns About Costs Rise With Hospices’ Use” (June 28): In 1996, suffering from inoperable cancer, my father received hospice care in the last three weeks of his life from a nonprofit agency. The physical comfort those dedicated nurses and social workers gave him — and the emotional support they offered to the whole family, strengthening our own ability to care for him — was extraordinary, incalculable, life-changing. The thought that for-profit health care chains are cynically exploiting this model of care to fill their own pockets, and might even endanger Medicare funding for hospice, is beyond appalling. They are vandalizing sacred ground. Anne Berrill Carroll

Manhattan

To the Editor:

Studies show that health care costs are far less for those enrolled in hospice at death compared to those who are not, and that hospice patients have a better quality of life. The larger concerns that need to be addressed are that only 41 percent who die are on hospice (only about 25 percent in New York State) and that too many patients are enrolled for a very short time, less than three weeks on average. When hospice use increases, as it should, greater cost savings will result. David C. Leven

Pelham, N.Y.

The writer is executive director, Compassion & Choices of New York.

Letters: Balance for the Back (1 Letter)

Posted: 04 Jul 2011 11:50 AM PDT

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To the Editor:

Re “Sit Up Straight. Your Back Thanks You.” (The Health Consumer, June 25): The too-often-repeated advice to “stand up straight” is causing as many back problems as the too-often-seen “relaxed” slump and subsequent compression.Almost every student comes in my Alexander technique studio with a distorted understanding of posture and alignment, and they must learn postural balance. How this basic information can still be so misunderstood boggles my mind.

Constance Clare-Newman

Oakland, Calif.

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What’s Inside The Bun?

Posted: 01 Jul 2011 10:01 PM PDT

If there is no such thing as a healthy hot dog, how do you limit the damage at this weekend’s weenie roast?

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Jim Wilson/The New York Times

Bruce Aidells, with slabs of bacon behind him, says the labels mislead consumers about nitrate.

Aaron Houston for The New York Times

Linda Boardman, president of Applegate Farms, has proposed new labels to the U.S.D.A. to no avail.

Don’t count on the label to help much. Those pricey “natural” and “organic” hot dogs often contain just as much or more of the cancer-linked preservatives nitrate and nitrite as that old-fashioned Oscar Mayer wiener.

And almost no one knows it because of arcane federal rules that make the labels on natural and organic hot dogs, luncheon meats and bacon virtually impossible to decipher when it comes to preservatives. That includes products made from beef, pork, turkey and chicken.

“If you actually surveyed consumers going out of their way to buy no-nitrate products, they’d be very surprised to learn that there’s plenty of nitrates in there,” said Bruce Aidells, a chef and cookbook author. “It’s very misleading.” In a role reversal, food manufacturers are now pushing the federal government for more truthful labeling that would allow them to tell consumers clearly that some products contain nitrate and nitrite, just from natural rather than synthetic sources. The current rules bizarrely require products that derive the preservatives from natural sources to prominently place the words “Uncured” and “No nitrates or nitrites added” on the label even though they are cured and do contain the chemicals.

“Nitrite is nitrite and consumers should be aware of what they’re eating,” said Marji McCullough, director of nutritional epidemiology for the American Cancer Society, which recommends that people reduce consumption of processed meats because of studies that link them to colon cancer.

The United States Department of Agriculture says it is aware of the labeling problem and may take a fresh look. “We feel strongly that labels should help consumers make informed decisions and we are open to reviewing additional information to enhance accuracy in labeling,” said a spokesman for the department. Nitrate and nitrite have been used for centuries to cure meat, giving products like hot dogs, bacon and ham their characteristic flavor and color and killing the bacteria that causes botulism. Today, conventional meat packers typically use a synthesized version known as sodium nitrite.

But companies that label their products natural or organic must use natural sources of the preservatives. They usually employ celery powder or celery juice, which are high in nitrate. A bacterial culture is used to convert that to nitrite. The resulting chemicals are virtually identical to their synthetic cousins. When the products are packaged, both conventional and natural products contain residual amounts.

A study published earlier this year in The Journal of Food Protection found that natural hot dogs had anywhere from one-half to 10 times the amount of nitrite that conventional hot dogs contained. Natural bacon had from about a third as much nitrite as a conventional brand to more than twice as much.

The current U.S.D.A. labeling rules require natural products to indicate there may be naturally occurring nitrate or nitrite, but it often appears in small print. When combined with the more prominently displayed “No nitrates or nitrites added” banner, many consumers are left scratching their heads.

“The most consistent feedback we get is, ‘I don’t understand what that means,’ ” said Linda Boardman, president of Applegate Farms, the leading brand of natural and organic processed meats. “It’s confusing and it’s not adding anything to the consumer decision-making process.”

Applegate and other natural companies have proposed alternate wording to the U.S.D.A. in the past without success. They say they are confident their products offer enough other benefits — all natural ingredients, meeting the standards for the humane treatment of animals, for example — that it is best to be upfront with consumers about the preservatives. Ms. Boardman said tests showed the amount of nitrite and nitrate in Applegate products was similar to conventional brands.

Consumer advocates agree the problem does not lie with the meat companies. “We see the problem lying squarely with U.S.D.A.,” said Urvashi Rangan, technical policy director of Consumers Union.

Since the 1970s, concerns about the health effects of nitrate and nitrite have focused on the potential for nitrite to combine with meat protein to form carcinogenic substances called nitrosamines.

The U.S.D.A. responded by limiting the amount of nitrate and nitrite that goes into processed meats, and today they contain far less than they did 40 years ago.

But since the health concerns first emerged, scientists have gained more understanding of the role of nitrate and nitrite in human health and have discovered the preservatives also have benefits, for example, in the healthy functioning of the cardiovascular and immune systems.

Some in the meat industry have seized on these discoveries to dismiss as outdated the link between nitrite in processed meat and cancer. They insist processed meats are safe.

But many scientists say the evidence of health risks remains persuasive. While the occasional hot dog or piece of bacon is probably O.K., they point out that high levels of salt and saturated fat in processed meats also contribute to health problems.

“What’s very clear is that consuming processed meats is related to higher risk of diabetes, heart attacks and colon cancer,” said Dr. Walter C. Willet, chairman of the nutrition department of the Harvard School of Public Health. “If you tweak the cured meat a little bit like some of these new products, that’s no guarantee that’s going to make it any better.”

And that weekend weenie roast? George L. Siemon , the chief executive of Organic Prairie, an organic meat processor, said that when he tried selling meats with no nitrates from any source, they didn’t taste the same and no one wanted them.

“We tried the non-anything,” he said. “It just didn’t work for the customer.”

Medicare Will Continue to Cover 2 Expensive Cancer Drugs

Posted: 30 Jun 2011 10:00 PM PDT

Medicare confirmed on Thursday that it would continue to pay for two expensive cancer drugs that had been at the center of debate — Avastin from Genentech for breast cancer and Provenge from Dendreon for prostate cancer.

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A spokesman for the Centers for Medicare and Medicaid Services said the agency would continue to pay for Avastin for breast cancer, even if the Food and Drug Administration revoked the drug’s approval as a treatment for that disease.

“The label change will not affect our coverage,” the spokesman, Don McLeod, said.

An advisory committee to the F.D.A. voted unanimously Wednesday in favor of rescinding the breast cancer approval, saying the latest evidence suggested the drug was not effective. The final decision will be made by the F.D.A. commissioner, Dr. Margaret A. Hamburg, after a public comment period ends on July 28.

Avastin would retain approval for other cancers so doctors could still use it off label for breast cancer. But some women fear that insurers will no longer pay for the drug, putting the medicine, which costs about $88,000 a year, out of reach for most women.

Mr. McLeod’s statement could allay those concerns, at least for women covered by Medicare. He said that Medicare commonly paid for off-label use of cancer drugs.

Still, Mr. McLeod said that while there were no plans for one right now, he could not totally rule out that Medicare might one day undertake a national coverage determination to decide whether to pay for Avastin. That process would take at least a year and involve public input.

Such a national coverage determination was undertaken for Provenge, which costs $93,000 for a complete course of treatment.

The final decision, issued Thursday, said the evidence was adequate to conclude that Provenge “improves health outcomes for Medicare beneficiaries” and was therefore “reasonable and necessary” for their treatment.

The result confirmed a preliminary decision announced three months ago.

The decision applies to men who meet the criteria in the drug’s label, meaning the cancer has spread beyond the prostate gland, it is no longer controlled by hormone therapy and the men have few or no symptoms.

The national coverage determination drew outcries from some men with prostate cancer, investors in Dendreon and critics of health care reform, who said the government was singling out the drug because of its cost and was on its way to rationing health care. Similar accusations about rationing greeted the F.D.A.’s proposal to remove the breast cancer approval for Avastin.

Both Medicare and the F.D.A. said the costs of the drugs were not a factor in their deliberations.

Private insurance companies must also decide whether to continue paying for Avastin as a breast cancer treatment.

WellPoint said it would review the medical necessity after the F.D.A. makes its final determination.

Cigna and the Health Care Service Corporation, which operates Blue Cross and Blue Shield plans in Illinois, Texas, Oklahoma and New Mexico, both said they would evaluate their coverage positions after the F.D.A. made a final decision.

UnitedHealthcare said its chemotherapy coverage decisions were based on a reference published by the National Comprehensive Cancer Network. That reference lists Avastin as a valid treatment for breast cancer.

The Big Picture: Local Laws Fighting Fat Under Siege

Posted: 01 Jul 2011 11:17 AM PDT

Several state legislatures are passing laws that prohibit municipalities and other local governments from adopting regulations aimed at curbing rising obesity and improving public health, such as requiring restaurants to provide nutritional information on menus or to eliminate trans fats from the foods they serve.

David Maxwell/Bloomberg News

Ohio Gov. John Kasich  signed a bill on Thursday that will limit local control over restaurants.

The Big Picture

Articles in this series are examining the campaigns and research efforts to combat obesity.

Previous Articles in the Series »

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In some cases, lawmakers are responding to complaints from business owners who are weary of playing whack-a-mole with varying regulations from one city to the next. Legislators have decided to sponsor state laws to designate authority for the rules that individual restaurants have to live by.

Florida and Alabama recently adopted such limits, while Georgia, Tennessee and Utah have older statutes on their books. Earlier this year, Arizona prohibited local governments from forbidding the marketing of fast food using “consumer incentives” like toys.

And this week, Ohio Gov. John Kasich signed the state budget, which contains sweeping limitations on local government control over restaurants.

“All of sudden we’re seeing this legislation get slipped into pending bills at the 11th hour under the radar of public health advocates, which will pre-empt local governments from adopting policies that would improve health in their communities,” said Samantha Graff, senior staff lawyer at Public Health Law & Policy, a nonprofit group that works to combat obesity, among other issues.

The new state laws will have no effect on a federal law that requires menu labeling by chains with 20 or more restaurants by 2013. But more than half of the nation’s restaurants will not be required to meet the federal rules for listing calories and fat content.

Sue Hensley, a spokeswoman for the National Restaurant Association, said it supported the efforts of its state members to protect restaurants from what she described as “a patchwork of regulation.”

“We feel it is in the best interests of the consumer to have one uniform standard,” Ms. Hensley said.

Public health advocates worry that the new laws will stall a movement among cities and counties that are putting in place a wide range of policies and tools aimed at stemming the rising tide of obesity among their residents. The mayor of Oklahoma City, Mick Cornett, for example, has challenged its citizens to lose a million pounds collectively, and cities around the country have worked to ensure that more nutritious meals are served at schools.

Towns and cities like Louisville, Ky., often serve as laboratories where new policies can be tested and tweaked, to develop public support that then unfolds across states and even nationally. The federal law passed last December that will set nutritional standards for food sold or otherwise provided in schools nationally is one example: Requirements for healthier foods in school cafeterias began in local school districts.

“This battle will involve policy changes at all levels of government, but it is easier fought locally because it allows greater accountability to ensure implementation and addresses the unique needs of communities,” William H. Roach Jr., chairman of the American Heart Association, wrote in an e-mail.

Margo G. Wootan, director of nutrition policy at the Center for Science in the Public Interest, a nonprofit research and advocacy group, said state restaurant groups were leading the recent pushes for state legislation that pre-empted local governments. “Politicians go out to eat a lot, so restaurant owners know their state lawmakers very well,” Ms. Wootan said. “They’re quite formidable opponents.”

State legislators who have sponsored pre-emptive legislation in Florida and Alabama say they were contacted by their state’s restaurant associations, which expressed concern that California’s latest food rules would be adopted by their own local governments.

For example, the Los Angeles City Council banned fast food restaurants in South Los Angeles, where rates of poverty and obesity are high. In April, the Santa Clara County supervisors adopted a policy that forbids fast food restaurants from selling meals with toys, like those connected with movie promotions.

“We didn’t want to give those kinds of things a chance to become a problem for the restaurant industry here,” said Steve Crisafulli, the Florida state representative who sponsored the law limiting local authorities’ ability to regulate restaurants in their jurisdiction. “It’s always easier to take care of these things before they become an issue rather than after the fact.”

Round 1 in Appeals of Health Care Overhaul Goes to Obama

Posted: 30 Jun 2011 11:36 AM PDT

The Obama administration prevailed Wednesday in the first appellate review of the 2010 health care law as a three-judge panel from the United States Court of Appeals for the Sixth Circuit held that it was constitutional for Congress to require that Americans buy health insurance.

The ruling by the Cincinnati court is the first of three opinions to be delivered by separate courts of appeal that heard arguments in the health care litigation in May and June. Opinions are expected soon from panels in the Fourth Circuit in Richmond, Va., and the 11th Circuit in Atlanta.

Lawyers on both sides of the case widely expect the Supreme Court to take one or more of the cases, perhaps as soon as its coming term, which starts in October. The speed of the Sixth Circuit ruling could help ensure that timing.

The opinion was the first not to break down strictly along seemingly partisan lines. In the 2-to-1 ruling, a judge appointed by a Republican president joined one named by a Democrat to write the majority opinion.

In various cases at the lower District Court level, five judges have divided on the question, with three Democratic appointees backing the law and two Republican appointees rejecting it.

As they look ahead to the Supreme Court, the law’s defenders can take encouragement from the concurring opinion written by Judge Jeffrey S. Sutton, an appointee of President George W. Bush, a Republican. Judge Sutton is typically considered conservative on questions of constitutional reach.

After acknowledging the difficulty of pinpointing the limits on Congress’s power to regulate interstate commerce, Judge Sutton wrote, “In my opinion, the government has the better of the arguments.” He added, “Not every intrusive law is an unconstitutionally intrusive law.”

Joining Judge Sutton was Judge Boyce F. Martin Jr., an appointee of President Jimmy Carter, a Democrat. Dissenting on the central issues was Judge James L. Graham, a District Court judge appointed by President Ronald Reagan who is on temporary assignment to the Sixth Circuit.

The appeal, which was heard by the panel on June 1, came in a challenge filed by the Thomas More Law Center, a conservative public interest firm in Ann Arbor, Mich. In its 69-page ruling, the panel upheld Judge George C. Steeh of Federal District Court in Detroit, who concluded that choosing not to buy health insurance was a consequential commercial decision that could be regulated by Congress under the Commerce Clause of the Constitution.

Starting in 2014, the Affordable Care Act will require most Americans to buy health insurance or pay an income tax penalty. The administration argues that without the insurance mandate it is not reasonable to require insurers to cover all applicants regardless of their health status.

The Sixth Circuit majority held that the mandate was “facially constitutional under the Commerce Clause” for two reasons.

“First, the provision regulates economic activity that Congress had a rational basis to believe has substantial effects on interstate commerce,” Judge Martin wrote. “In addition, Congress had a rational basis to believe that the provision was essential to its larger economic scheme reforming the interstate markets in health care and health insurance.”

The court directly addressed whether a choice to go without health insurance qualifies as an “activity” that substantially affects interstate commerce, which is the standard set in prior Supreme Court decisions on the breadth of the Commerce Clause.

“The activity of foregoing health insurance and attempting to cover the cost of health care needs by self-insuring is no less economic than the activity of purchasing an insurance plan,” the opinion stated.

The majority emphasized that the case should not hang on distinctions about whether the failure to buy insurance should be defined as activity or inactivity, a question the Supreme Court has never considered. “The constitutionality of the minimum coverage provision cannot be resolved with a myopic focus on a malleable label,” the judges said.

In his concurrence, Judge Sutton added, “Inaction is action, sometimes for better, sometimes for worse, when it comes to financial risk.” Whether an individual buys an insurance policy or not, the judge wrote, “each requires affirmative choices; one is no less active than the other; and both affect commerce.”

Judge Graham countered in his dissent that if the mandate was allowed, “it is difficult to see what the limits on Congress’s Commerce Clause authority would be.”

But the majority agreed with Neal K. Katyal, the acting United States solicitor general, who argued that individual choices not to buy insurance, when taken in aggregate, have clear commercial effects because they shift the cost of caring for the uninsured to other payers.

The judges adopted Mr. Katyal’s argument that because the need for health care is unpredictable, it is impossible for individuals to opt out of the market. And they agreed that cost-shifting was inevitable as long as the federal government required hospitals to treat those who show up with life-threatening conditions.

Panel Advises F.D.A. to Narrow Its Approval for Avastin

Posted: 29 Jun 2011 09:59 PM PDT

A resounding vote by a federal committee of cancer experts on Wednesday makes it more likely the drug Avastin will no longer be readily available as a treatment for breast cancer, dealing a blow to women who think the drug is helping them.

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Joshua Roberts/Bloomberg News

Betsy Swersky, a breast cancer patient, testifying in favor of the blockbuster drug Avastin, which studies now indicate is ineffective.

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In a series of 6-0 votes, an advisory committee to the Food and Drug Administration endorsed the agency’s proposal to revoke the approval of the drug for use against advanced breast cancer.

The committee members voted that the drug was neither safe nor effective. It also unanimously rejected a proposed compromise offered by the drug’s manufacturer, Genentech, that the approval remain in place while the company conducts another clinical trial to try to confirm that the drug works.

The votes came at the end of an emotional two-day hearing at which about a dozen women, many of whom said the drug was saving their lives, and some cancer support group advocates, pleaded with the F.D.A. and the advisory committee to keep the drug available.

“A panel of six, none of which specialize in metastatic breast cancer, decided that we are statistically insignificant,” Crystal Hanna, one of the patients who testified, said in an e-mail after the vote. “How do I explain that to my 4-year-old and 7-year-old?”

But the members of the advisory committee said the results from clinical trials suggested Avastin was not helping women, though it was exposing them to potentially serious side effects like high blood pressure, gastrointestinal perforations and hemorrhaging.

“The agency has to look at protecting a larger number of patients,” said one committee member, Dr. Ralph Freedman, a gynecologic oncologist at the M. D. Anderson Cancer Center in Houston. “Sometimes they have to make a decision that doesn’t favor individual patients, but it’s on the basis of the whole.”

Avastin received so-called accelerated approval for metastatic breast cancer in 2008 under a program that allows drugs for serious diseases to reach the market quickly, subject to further study.

The F.D.A. said in December that these later studies had not confirmed the initial findings that Avastin was effective, so the agency proposed to revoke the approval. The hearing this week, which took place on the F.D.A. campus in Silver Spring, Md., was to hear Genentech’s appeal.

The final decision will be made by the commissioner of the F.D.A., Dr. Margaret A. Hamburg. She is not obligated to follow the advice of the committee.

Genentech, a subsidiary of Roche, and some patient groups are trying to bring Congressional pressure to bear on the F.D.A. At a time of controversy over the federal health care legislation, the Obama administration might not want to provoke renewed accusations of rationing care, which had been leveled during earlier stages of the agency’s deliberations over revocation.

Edward Lang Jr., a spokesman for Genentech, said the company would propose some middle grounds to the F.D.A., like restricting use of the drug to aggressive cancers or changing the drug’s label.

Genentech might also challenge an unfavorable decision in court.

Even if the breast cancer approval is withdrawn, Avastin will remain on the market as a treatment for several other types of cancer, so doctors could use it off label to treat breast cancer. But insurers might be less likely to pay, which would put Avastin, which costs about $88,000 a year, out of reach for most patients.

Even that is not certain. Medicare is supposed to pay for off-label uses of cancer drugs listed in references called compendia. One such compendium, published by the National Comprehensive Cancer Network, reaffirmed support for Avastin last year.

Still an explicit rejection of the drug by the F.D.A. might prompt the compendia to re-evaluate the drug or prompt insurers to ignore the compendia.

“My own guess is that third-party payers, including Medicare and Medicaid, would look at the F.D.A. decision and say this is a special circumstance,” said Dr. Harold J. Burstein of the Dana-Farber Cancer Institute in Boston. Dr. Burstein, who is on the cancer network’s breast cancer guidelines committee, said he did not know if the committee would re-examine Avastin at its annual meeting next month.

Avastin is the world’s best-selling cancer drug, with sales last year of roughly $7 billion. Analysts have estimated that loss of the breast cancer indication could cost Roche as much as $1 billion a year.

Sales of Avastin have already started dropping as doctors use it less. Mr. Lang, the Genentech spokesman, said that only 20 percent to 25 percent of eligible breast cancer patients in the United States were now receiving the drug, down from 60 percent a year ago. There are about 29,000 new cases a year of the type of breast cancer for which Avastin is approved, he said.

The committee’s votes on Wednesday were not surprising given that five of the six members voted the same way last July, when the committee initially recommended the approval be revoked.

The trial that led to approval indicated that Avastin, when combined with the chemotherapy drug paclitaxel, delayed the median time before tumors got worse by 5.5 months compared with paclitaxel alone.

But in two subsequent studies, Avastin delayed tumor progression by only 1 to 3 months. And none of the studies, including the original one, showed Avastin prolonged women’s lives or improved the quality of their lives.

“We’ve tried to slice this pie in a lot of different ways to try to find some kind of benefit for this drug,” said one committee member, Dr. Mikkael Sekeres of the Cleveland Clinic. “All we’re left with are crumbs.”

Genentech argued that subsequent trials might not have shown as large a benefit because Avastin had been combined with different chemotherapy drugs. It said the approval should remain in place while it conducted another study in which Avastin would be combined with paclitaxel, as in the original study.

“The law provides this flexibility and this middle course best meets the purposes of accelerated approval to facilitate needed treatment options,” Michael S. Labson, a lawyer representing Genentech, told the committee.

But the trial would take several years. Committee members suggested that the F.D.A. had to act to maintain the integrity of the accelerated approval program.

“We have a standard,” said Dr. Wyndham Wilson of the National Cancer Institute, a committee member, “and we shouldn’t be changing that standard unless we have a very good reason.”

Spine Experts Repudiate Medtronic Studies

Posted: 28 Jun 2011 09:53 PM PDT

In an extraordinary move, a group of spine specialists are publicly repudiating the research of other experts that has backed the widespread use of a Medtronic bone growth product. In a series of reports published in a medical journal on Tuesday, the specialists called the research misleading and biased.

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Infuse, a bone growth product from Medtronic, has been used with implanted devices like the one above.

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Ethan Kaplan for The New York Times

Dr. Eugene Carragee, editor of The Spine Journal, said he and other experts hoped to cleanse the scientific record on Infuse.

The repudiation, appearing in a full issue of The Spine Journal devoted to the topic, represents a watershed in the long-running debate over conflicts of interest for the sponsorship of scientific studies by makers of drugs and medical devices. It is extremely rare for researchers to publicly chastise colleagues, and editors of leading medical journals said they could not recall an instance in which a publication had dedicated an entire issue for such a singular purpose.

Medtronic, the nation’s biggest maker of medical devices, has been facing intensifying scrutiny over its promotion of Infuse, the bone growth product at the center of the controversy. The bioengineered material is used primarily in spinal fusions, a procedure in which spinal vertebrae are joined to reduce back pain.

Infuse is used in about a quarter of the estimated 432,000 spinal fusions performed in this country each year. The articles published on Tuesday charge that researchers with financial ties to Medtronic overstated Infuse’s benefits and vastly understated its risks by claiming there were none.

“It harms patients to have biased and corrupted research published,” five doctors wrote in a joint editorial that accompanied the reports. “It harms patients to have unaccountable special interests permeate medical research.”

“The spine care field is currently at a precarious intersection of professionalism, morality and public safety,” Dr. Christopher M. Bono, editor of the special edition, said in a statement. “As physicians and journal editors, we felt an obligation to present a thorough examination of this controversial issue.”

It is too early to predict how the articles will affect the financial fortunes of Medtronic, which earned an estimated $900 million from Infuse in its most recent fiscal year. But the potential consequences seem significant, and the company’s new chief executive, Omar Ishrak, decided to issue a statement in response.

Mr. Ishrak noted that the articles did not challenge the data Medtronic had submitted to the Food and Drug Administration that led to Infuse’s approval in 2002 for use in one type of spinal fusion. Separately, other company officials said Medtronic planned to retain independent experts to examine the issues raised by the publication.

“Integrity and patient safety are my highest priorities,” Mr. Ishrak said.

Medtronic officials acknowledged in interviews that it was common for them to review studies of its products before publication. However, they sought to distance themselves from the content of the published reports, and said outside researchers, not the company, had determined the significance of data and how it should be presented. At the heart of the issue are potential side effects related to Infuse’s use that emerged during patient studies conducted about a decade ago by outside researchers with significant financial ties to Medtronic.

Medtronic, as required, reported that data to the F.D.A., and the agency considered the rate of those complications significant enough in some cases to require the company to list them on Infuse’s label. But in reporting on such studies in 13 medical journal articles published during the last decade, researchers whose studies were paid for by Medtronic maintained that Infuse’s use was not tied to any complications.

In one article released Tuesday, experts said those reports played down Infuse’s risks and slanted them to favor Infuse’s performance over a bone graft, the material traditionally used in a fusion. Those experts estimated that the incidence of adverse events in connection with Infuse’s use ranged from 10 to 50 percent, depending on how it was used.

Those side effects, they said, include male sterility, infection, bone loss and unwanted bone growth. A stronger version of Infuse, called Amplify, was recently rejected for approval by the F.D.A. because of concerns about possible cancer risks.

In 2008, the agency warned the public that it had received reports of life-threatening injuries associated with the use of Infuse in the cervical portion of the spine, a use that was not approved by the agency.

Dr. Eugene J. Carragee, editor of The Spine Journal, said he believed that Infuse was a valuable product for patients who were not candidates for a bone graft. But he added that the publication had undertaken the review because he and other experts hoped to cleanse the scientific record.

Vital Signs: Awareness: H.I.V. Campaign Finds 18,000 New Cases

Posted: 27 Jun 2011 11:10 PM PDT

A three-year campaign intended to expand testing for H.I.V. and get people into treatment turned up more than 18,000 adults who were not aware that they were infected, the federal Centers for Disease Control and Prevention reported last week.

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Over all, some 2.7 million H.I.V. tests were performed between October 2007 and September 2010. Just over 1 percent of those tested, or 29,503, were found to be infected. Of those, 18,432 were not aware of their status, C.D.C. officials said.

Some 12,711 of those for whom the diagnosis was new, or about 75 percent, were routed into the health care system.

The drive, which targeted at-risk populations and blacks in particular, included $111 million provided to 25 health departments serving communities disproportionately affected by H.I.V. Men accounted for 72 percent of the new H.I.V. diagnoses, and blacks accounted for a similar percentage.

An estimated 240,000 Americans — a fifth of the nearly 1.2 million living with H.I.V. — do not know they are infected, said Dr. Kevin Fenton, director of the C.D.C.’s AIDS prevention center.

“The majority of the estimated 56,000 new H.I.V. infections that occur each year are transmitted by those who are unaware of their infection,” he said.

Vital Signs: Patterns: After Heart Attack, Delays in Critical Care

Posted: 27 Jun 2011 11:10 PM PDT

When heart attack victims are taken to hospitals that aren’t equipped to perform lifesaving procedures to open blocked arteries, standard medical guidelines recommend they be transferred to another hospital within 30 minutes. Yet only one in 10 patients is transferred in that time, a new study has found.

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Researchers at Duke University analyzed the medical records of patients in hospitals for angioplasty between Jan. 1, 2007, and March 30, 2010. The data were drawn from the National Cardiovascular Data Registry’s Acute Coronary Treatment and Intervention Outcomes Network.

Of 14,821 patients who had major heart attacks and were sent to these hospitals from other facilities, only 1,627 patients, or 11 percent, were in and out of the referring facility in 30 minutes or less, according to the researchers. About 56 percent of the patients spent more than an hour in the first facility before being transferred, and 35 percent spent an hour and a half there.

The patients whose transfers were delayed were more likely to die than those transferred quickly, the researchers also found. Nearly 6 percent of those who waited more than 30 minutes to be transferred died, compared with 2.7 percent of those transferred in less than 30 minutes.

The analysis was published on June 22 in The Journal of the American Medical Association.

Recipes for Health: Edamame Pâté

Posted: 30 Jun 2011 11:50 PM PDT

This is an adaptation of a dish that I created in my early vegetarian days, when we cooked a lot with soybeans — although nobody really liked them. It occurred to me one day to add Marmite or Savorex, yeast extracts with an intense, somewhat meaty taste, and to use other seasonings from traditional pâtés to achieve a liverlike flavor.

Recipes for Health

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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Now, of course, shelled edamame is available on most produce shelves, so there is no need to cook up dried soybeans. I recreated this pâté with fresh green soybeans, which takes all the hassle out of the original recipe.

A quick word about the yeast extract, which many of you may object to because of the high glutamate content. If you use Vegemite, which is lower in glutamates than Marmite, one serving of this pâté (if serving eight) will contain 29 milligrams of free glutamates. To put that in perspective, one ounce of Parmesan cheese contains 300 milligrams of glutamates.

3 tablespoons extra virgin olive oil

1/2 cup finely chopped onion

1 12-ounce bag frozen edamame (or use 2 heaped cups unfrozen), simmered for five minutes in lightly salted water and drained

2 eggs

1/3 cup milk (1 percent or 2 percent)

2 tablespoons brandy (optional; if not using, add 2 more tablespoons milk)

2 teaspoons yeast extract, like Vegemite, Savorex or Marmite

2 teaspoons tamari soy sauce

2 garlic cloves

1 teaspoon fresh thyme leaves, chopped, or 1/2 teaspoon dried thyme

1/8 teaspoon ground allspice

1/8 teaspoon ground ginger

1/4 teaspoon salt (more to taste)

1/4 teaspoon freshly ground pepper

1. Preheat the oven to 350 degrees. Oil a 5-cup pâté tureen, casserole or bread pan.

2. Heat 1 tablespoon of the olive oil over medium heat in a small skillet. Add the onion. Cook, stirring often, until tender, about five minutes. Remove from the heat.

3. Place the edamame in a food processor fitted with the steel blade, and pulse several times. Add all of the remaining ingredients except the onion, and process until smooth. Stop the machine and scrape down the sides, then process again until completely smooth. (This is important.) Add the onion, and pulse a few times to combine.

4. Scrape the mixture into the prepared baking dish, cover tightly, and bake 40 to 45 minutes until set. Remove from the heat, and allow to cool. Refrigerate overnight for the best flavor.

Yield: Eight to 10 servings.

Advance preparation: This pâté will keep for about five days in the refrigerator.

Nutritional information per serving (eight servings): 135 calories; 1 gram saturated fat; 1 gram polyunsaturated fat; 4 grams monounsaturated fat; 47 milligrams cholesterol; 6 grams carbohydrates; 2 grams dietary fiber; 233 milligrams sodium (does not include salt to taste); 8 grams protein

Nutritional information per serving (10 servings): 108 calories; 1 gram saturated fat; 1 gram polyunsaturated fat; 3 grams monounsaturated fat; 38 milligrams cholesterol; 5 grams carbohydrates; 2 grams dietary fiber; 187 milligrams sodium (does not include salt to taste); 4 grams protein

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

Recipes for Health: Lentil Pâté With Cumin and Turmeric

Posted: 04 Jul 2011 09:02 AM PDT

Lentils and curry flavors go together beautifully. This pâté tends to be dry if you overcook it, so remove it from the oven when it’s just set, before the top cracks.

Recipes for Health

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 cup brown lentils, picked over and rinsed

1 quart water

1 bay leaf

1 medium onion

4 garlic cloves, 2 crushed, 2 minced

Salt to taste

2 tablespoons peanut oil or canola oil

1/4 teaspoon cayenne (more to taste)

1/2 teaspoon ground turmeric

1 tablespoon cumin seeds, toasted and coarsely ground

1 teaspoon black or yellow mustard seeds

1 tablespoon tomato paste

2 eggs

2 tablespoons extra virgin olive oil

1/4 cup chopped cilantro

4 teaspoons lemon or lime juice

1. Place the lentils in a medium saucepan with the water and bay leaf. Cut the onion in half, and add one half to the pot along with the crushed garlic cloves. Bring to a boil, add salt to taste, reduce the heat, cover and simmer 35 to 45 minutes until the lentils are tender. Remove the onion half, and taste and adjust seasoning. Drain and set aside.

2. Preheat the oven to 350ºF. Butter or oil a 5-cup paté tureen or baking dish, or bread pan. Finely chop the other half of the onion. Heat the peanut or canola oil over medium heat in a medium skillet. Add the chopped onion and a pinch of salt. Cook, stirring often, until the onion is tender, about five minutes. Stir in the garlic and spices, and cook, stirring, until the mixture is fragrant and the spices are sizzling, about 30 seconds. Add the tomato paste, and continue to stir over medium heat until it has darkened, one to two minutes. Stir in the cilantro. Remove from the heat.

3. Place the lentils and eggs in a food processor fitted with the steel blade. Turn it on, add the olive oil and lemon or lime juice and process until smooth. Add the onion mixture, and pulse to combine. Season to taste with salt and pepper. Scrape into the prepared baking dish and cover tightly.

4. Bake for 40 minutes until just set. Remove from the heat and allow to cool. For best results, refrigerate overnight. Serve at room temperature or cold.

Yield: Serves 8 to 10.

Advance preparation: This keeps for about five days in the refrigerator.

Nutritional information per serving (eight servings): 168 calories; 1 gram saturated fat; 2 grams polyunsaturated fat; 5 grams monounsaturated fat; 47 milligrams cholesterol; 16 grams carbohydrates; 6 grams dietary fiber; 26 milligrams sodium (does not include salt to taste); 8 grams protein

Nutritional information per serving (10 servings): 135 calories; 1 gram saturated fat; 1 gram polyunsaturated fat; 4 grams monounsaturated fat; 37 milligrams cholesterol; 13 grams carbohydrates; 5 grams dietary fiber; 21 milligrams sodium (does not include salt to taste); 7 grams protein

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

Recipes for Health: Black Bean Pâté

Posted: 28 Jun 2011 11:40 PM PDT

I prefer to cook my own black beans for this pâté. With white and red beans, the difference between canned and home-cooked isn’t significant enough to matter in the pâté. It does matter with the black beans, though. This tastes like a very light version of refried beans.

Recipes for Health

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

Related

1 can black beans, rinsed, or (preferably) 1 2/3 cups cooked black beans

1/4 cup extra virgin olive oil

1/2 cup finely chopped onion

3 garlic cloves, minced

2 teaspoons cumin seeds, ground

1 teaspoon mild chili powder

2 eggs

1/4 cup finely chopped cilantro

Salt to taste (about 3/4 teaspoon)

Freshly ground pepper to taste

1. Preheat the oven to 350 degrees. Butter or oil a 5-cup pâté tureen or baking dish, or a bread pan.

2. Heat 2 tablespoons of the olive oil over medium heat in a medium skillet. Add the onion. Cook, stirring, until tender, about five minutes. Add 2 cloves of the garlic, the cumin and the chili powder. Cook, stirring, until the garlic is fragrant, about one minute. Stir in the cilantro. Remove from the heat.

3. Turn on a food processor fitted with the steel blade, and drop in the remaining clove of garlic. When the garlic is chopped and adhering to the sides of the bowl, stop the food processor and scrape down the bowl. Place the beans and eggs in the food processor, and turn on the machine. Add the remaining 2 tablespoons of olive oil, and process until smooth. Add the onion mixture, and pulse to combine. Season to taste with salt and pepper. Scrape into the prepared baking dish, and cover tightly.

4. Bake for 40 to 45 minutes until the pâté is set and the top is just beginning to color. Remove from the heat, and allow to cool. For best results, refrigerate overnight. Serve at room temperature or cold.

Yield: Serves 8 to 10.

Advance preparation: This pâté keeps for about five days in the refrigerator.

Nutritional information per serving (eight servings): 131 calories; 1 gram saturated fat; 1 gram polyunsaturated fat; 5 grams monounsaturated fat; 47 milligrams cholesterol; 9 grams carbohydrates; 3 grams dietary fiber; 394 milligrams sodium (does not include salt to taste); 5 grams protein

Nutritional information per serving (10 servings): 105 calories; 1 gram saturated fat; 1 gram polyunsaturated fat; 4 grams monounsaturated fat; 37 milligrams cholesterol; 7 grams carbohydrates; 3 grams dietary fiber; 315 milligrams sodium (does not include salt to taste); 4 grams protein

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

Recipes for Health: Red Bean and Pepper Pâté

Posted: 28 Jun 2011 09:42 AM PDT

Because red beans conjure up Cajun cooking for me, I spiced this bean pâté with paprika and cayenne and added red peppers and tomatoes.

Recipes for Health

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

Related

1 can red beans, rinsed, or 1 2/3 cups cooked red beans

1/4 cup extra virgin olive oil

1/2 cup finely chopped onion

1 cup finely diced red pepper

1 serrano chili, minced

3 garlic cloves, minced

1/2 pound grated tomatoes or 1/2 (14-ounce) can chopped tomatoes with juice

1 teaspoon paprika

1/4 to 1/2 teaspoon cayenne (to taste)

2 eggs

2 tablespoons lemon juice

Salt to taste (about 3/4 teaspoon)

Freshly ground pepper to taste

1. Preheat the oven to 350 degrees. Butter or oil a 5-cup pâté tureen or baking dish, or a bread pan.

2. Heat 2 tablespoons of the olive oil over medium heat in a medium skillet. Add the onion, red pepper and serrano chili. Cook, stirring, until tender, about five minutes. Add 2 of the garlic cloves. Cook, stirring, until the garlic is fragrant, about one minute. Stir in the tomatoes, paprika and cayenne, and season to taste with salt and pepper. Cook, stirring often, until the tomatoes have cooked down and the mixture is thick, about 10 minutes. Remove from the heat.

3. Turn on a food processor fitted with the steel blade, and drop in the remaining clove of garlic. When the garlic is chopped and adhering to the sides of the bowl, stop the food processor and scrape down the bowl. Place the beans and eggs in the food processor. Turn it on, and add the lemon juice and remaining 2 tablespoons of olive oil. Process until smooth. Add the tomato-onion-pepper mixture, and pulse to combine. Season to taste with salt and pepper. Scrape into the prepared baking dish, and cover tightly.

4. Bake for 40 to 45 minutes until the pâté is set and the top is just beginning to color. Remove from the heat, and allow to cool. For best results, refrigerate overnight. Serve at room temperature or cold.

Yield: Serves 8 to 10.

Advance preparation: This will keep for about five days in the refrigerator.

Nutritional information per serving (eight servings): 129 calories; 1 gram saturated fat; 1 gram polyunsaturated fat; 5 grams monounsaturated fat; 47 milligrams cholesterol; 11 grams carbohydrates; 4 grams dietary fiber; 329 milligrams sodium (does not include salt to taste); 5 grams protein

Nutritional information per serving (10 servings): 103 calories; 1 gram saturated fat; 1 gram polyunsaturated fat; 4 grams monounsaturated fat; 37 milligrams cholesterol; 9 grams carbohydrates; 3 grams dietary fiber; 263 milligrams sodium (does not include salt to taste); 4 grams protein

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

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