W.H.O. Issues Guidelines for Earlier H.I.V. Treatment

People infected with H.I.V. should be put on antiretroviral therapy even sooner than they are now, the World Health Organization said Sunday as it released new treatment guidelines.

While the new guidelines, issued at an international AIDS conference in Malaysia, were an aggressive step forward, they also represent a compromise between how much the world could do to suppress the epidemic if money were no object and how much donor countries are willing to pay for.

Dr. Margaret Chan, the W.H.O.'s director general, called the guidelines "a leap ahead in a trend of ever-higher goals and ever-greater achievements," while Michel Sidibé, the executive director of the United Nations AIDS agency, who several years ago called for universal treatment, said the step-by-step rise of the guidelines "gets most of the people we want on treatment, but not all — so it shows that you have limits to the system."

The new guidelines recommend that drugs be initiated as soon as a patient's CD4 count falls below 500 cells per cubic millimeter of blood. CD4s are the white blood cells that the virus first attacks. The count is an index for how much of the immune system has been destroyed; 500 is the bottom of the normal range while a patient below 200 is at high risk of fatal infections. The previous cutoff point, recommended in 2010, was a count of 350; a decade ago, when donors first began buying drugs, it was 200.

For some subgroups, the new guidelines recommend starting treatment immediately upon a positive H.I.V. test, regardless of CD4 count. Those include people with active tuberculosis or hepatitis B liver disease, those whose regular sex partners are not infected, women who are pregnant or breast-feeding, and children under age 5.

Many scientists now recommend that all patients start treatment immediately regardless of CD4 levels. The evidence is overwhelming that they are far less likely to infect anyone else if they do so. They also may live longer, healthier lives because their immune systems are not allowed to sink before being revived. In rare cases when the infection is caught very early, some may even be able to safely stop treatment after a year or two.

W.H.O. guidelines, however, are used mostly by the health ministries of poor countries that depend on donors. Not nearly enough money is contributed each year to treat everyone infected, so poor countries perform triage, telling about half of their infected citizens to wait until they get sicker.

The new guidelines mean that about 26 million people in poor and middle-income countries will be eligible for the drugs, up from 17 million under the previous guidelines. Almost 10 million people are on the drugs now. Globally, more than 34 million people are infected.

Two trends are helping increase the number of people getting treatment. The prices of drugs and diagnostic tests keep dropping, and middle-income countries are relying less on donors. South Africa, for example, has increased its AIDS budget by 500 percent in recent years.

The new guidelines also call for universal use of the simplest, most effective treatment with the least side effects: a once-daily pill containing three drugs — tenofovir, efavirenz and either lamivudine or emtricitabine.

For diagnosis, the guidelines suggest that, in addition to CD4 counts, countries do more expensive viral load tests. Tracking viral loads is the best way to tell when a patient needs a new drug regimen, said Dr. Gilles van Cutsem, medical coordinator in South Africa for Doctors Without Borders, the medical charity. And, he said, there is "no greater motivating factor for people to stick to their treatment than knowing the virus is 'undetectable' in their blood."

The guidelines do not call for giving healthy people who are at high risk — drug addicts, prostitutes, gay men, male prisoners and people whose sex partners are infected — a daily tenofovir pill to keep them uninfected.

Mr. Sidibé called that "a missed opportunity" and said that it was still being discussed.

The new guidelines drew mixed reactions from advocates.

Doctors Without Borders, which treats 285,000 H.I.V. patients in 21 countries, applauded the guidelines.

But Asia Russell, an activist with Health GAP, which lobbies for more generosity from donors and drug makers, called them "the absolute bare minimum steps that needed to be taken — because stingy donors and U.N. technocrats and national governments in the global south tend to seek incrementalism."

Behind the scenes, the proposed guidelines engendered a long debate. One fear is that countries already struggling to reach rural citizens who are close to death will run out of drugs if they start treating people who live near government clinics and have CD4 counts just below normal.

In coming years, Mr. Sidibé said, he expects the guidelines to keep shifting toward treatment upon testing, especially as recognition spreads that reducing the viral load early, when people are teeming with the virus, is the best way to stop them from spreading the disease.

"What is holding us back is that we lack a vision for ending the epidemic," he said. "If we think we'll just manage it like a chronic disease for the next 50 years, we'll never get to the end."

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News Analysis: Why Healthy Eaters Fall for Fries

LAST Tuesday, Connor Moran, a limit-the-red-meat, increase-the-greens, eat-salad-for-lunch kind of guy, stopped into a Bronx Dunkin' Donuts for his usual black coffee, no sugar, no cream.

He walked out with a sandwich of egg and bacon between two halves of a glazed doughnut.

Such is the puzzle of the food industry: American consumers, even otherwise healthy ones, keep choosing caloric indulgences rather than healthy foods at fast-food restaurants.

Public health officials have been pushing fast-food restaurants to offer more nutritious foods to help combat excess weight in the United States, where more than one-third of American adults are obese. And restaurants have obliged by adding healthy menu items. But it's the sugary, fatty items that are flying — or waddling — out the door.

The new menu items added by fast-food chains this year indicate as much: a brownie-batter-filled doughnut (Dunkin' Donuts), a bacon habanero ranch Quarter Pounder (McDonald's), bacon-filled tater tots (Burger King), a six-slices-of-bacon-and-cheese burger (Carl's Jr. and Hardee's), a choco-covered pretzel and choco chunk vanilla Blizzard (Dairy Queen), and a chocolate molten lava cake (Arby's).

Then there's the Glazed Donut Breakfast Sandwich from Dunkin' Donuts that Mr. Moran tried. It was rolled out nationally this month after a Massachusetts test that was a "viral hit," the company's executive chef told The Boston Globe earlier this month. "Within days of the test, people were sending pictures, tweeting 'look what I got!' or 'this is so wrong!' and it was just incredible."

If unhealthy food is wrong, restaurant visitors apparently don't want to be right.

McDonald's chief executive officer, Donald Thompson, said recently that although the chain had devoted one-sixth of its advertising time to salads, they make up 2 to 3 percent of sales, and don't drive growth. Perhaps it would make more sense to give consumers vegetables by stuffing them inside McWraps, Mr. Thompson said.

And while restaurants try lower-calorie options — an egg-white sandwich here, a turkey burger there — the unhealthy stuff is "what consumers order — it's, quite frankly, on them," said Darren Tristano, executive vice president at Technomic, a food-industry consulting firm.

Gavan J. Fitzsimons, a professor who studies consumer psychology at Duke's Fuqua School of Business, has researched the disconnect.

In studies, he has presented participants with a range of menu choices — sometimes just unhealthy items, sometimes neutral items (like a fish sandwich) and sometimes healthy choices like salad. It turned out that including a healthy option did change people's behavior — by making them eat more unhealthily.

"When you put a healthy option up there on an otherwise unhealthy menu, not only do we not pick it, but its presence on the menu leads us to swing over and pick something that's worse for us than we normally would," Mr. Fitzsimons said.

Why? Mr. Fitzsimons called the phenomenon "vicarious goal fulfillment." By seeing a healthy menu option at a restaurant, "it basically satisfies that goal to be healthy," he said, and gives consumers leeway to order what they want.

And health-conscious eaters are the most susceptible to picking unhealthy items when the menu also has healthy ones. "It's often the ones raising their hands, saying they would pick the salad, those are the ones that are the most at risk when they walk in," he said.

The road to hell may be paved with good intentions, but so, apparently, is the road to high cholesterol.

It's a conflict the Nobel-winning economist Thomas C. Schelling described in his book "Choice and Consequence": "People behave sometimes as if they had two selves, one who wants clean lungs and long life and another who adores tobacco, or one who wants a lean body and another who wants dessert," he wrote. "The two are in continual contest for control."

Even when consumers are explicitly told the calories a food contains, it doesn't change their behavior much.

Brian Elbel, an assistant professor of population health and health policy at New York University's School of Medicine, studied consumer behavior before and after the city required chain restaurants to post calorie counts in 2008.

He found that 54 percent of respondents in New York City said they noticed the calorie labeling. Of those, less than a quarter said they ate fewer calories as a result.

BUT their behavior did not, in fact, change. When Dr. Elbel analyzed consumers' receipts, he found that there was no difference in calories consumed, whether people said they responded to the calorie counts or not. Consumers may be engaging in what behavioral economists call hyperbolic discounting, he said. "It's just easier to imagine what this is going to feel like now, and harder to think through what it feels like later," he said.

When New York City financed another study after the calorie labeling went into effect, over all, the study found no difference in calories consumed before and after the labeling requirement. But there were specific changes.

While just 15 percent of customers said they used the calorie information, those who did ate 106 fewer calories than those who didn't. Some chains like McDonald's and KFC saw significant reductions. But at Subway, which nutrition experts say has one of the healthier menus around, and where a higher-than-average percentage of customers said they read calorie information, the number of calories consumed actually increased, from 749 to 882. The researchers hypothesized this was because Subway was promoting $5 footlong subs at the time, and economic incentives trumped healthy intentions.

"What we're learning from what's happening in the industry is, consumers don't see fast food as a place to eat healthy," said Mr. Tristano, the food consultant. "It's indulgence that's important."

Researchers are thinking of new ways to signal nutritional value: how much exercise it would take to burn off a menu item, symbols like traffic lights, or educational campaigns on understanding calories.

But they are not leaving it up to the restaurants.

"They're not social service agencies — they're places that are trying to make money by selling food. That's their business," said Marion Nestle, a professor of nutrition, food studies and public health at New York University. "Sugar, salt and fat sells."

As Mr. Thompson of McDonald's put it, "We're in this time period where people are defining — quote-unquote — healthy and non-healthy, and the question really is, in the restaurant business, what does the customer want?" he said.

For Hannah Terry-Whyte, an Australian food blogger visiting the United States last week, it wasn't so much the indulgence she was after as the cultural experience when she ordered the doughnut breakfast sandwich.

"As an Australian, that, to me, is such the epitome of crazy American food behavior that I kind of had to try it," she said.

Still, even she wasn't immune to its meat-and-sugar seductiveness. Asked if she would try it again, she said, "You know what? Maybe. Yeah. Probably."

Stephanie Clifford is a business reporter for The New York Times.

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Local Officials Asked to Help on Health Law

WASHINGTON — The White House is recruiting mayors, county commissioners and other local officials to promote and carry out President Obama's health care law in states like Florida and Texas, where governors are hostile to it.

Ron T. Ennis/The Fort Worth Star-Telegram, via Associated Press

Mayor Robert Cluck of Arlington, Tex., shown last year. Mr. Cluck, a Republican, said he wanted to help people get "proper health care." As a community leader, he said, "it's our responsibility."

The effort comes as the administration is intensifying its campaign to publicize new health insurance options and to persuade consumers, especially healthy young people, to sign up for coverage when open enrollment starts on Oct. 1.

To bring people into the insurance market, the White House is using techniques it used to mobilize voters during Mr. Obama's re-election campaign, with a particular focus on Hispanics, who are much more likely than other Americans to be uninsured. About 7 in 10 Hispanic voters nationally and 6 in 10 in Florida voted for Mr. Obama last year, according to exit polls by Edison Research.

White House officials say the law will provide 10 million uninsured Hispanics with an opportunity to get affordable insurance. They account for 40 percent of the 25 million uninsured Americans expected to gain coverage in the next three years.

Texas and Florida refused to set up regulated marketplaces, known as exchanges, for the sale of subsidized insurance, leaving the task to the federal government. And they have refused to expand Medicaid to provide insurance for low-income people who do not already qualify.

Florida led legal challenges to the law, which was eventually upheld by the Supreme Court. Gov. Rick Perry of Texas, a Republican, said that expanding Medicaid would be like "adding a thousand people to the Titanic." The expansion of Medicaid and the creation of an insurance exchange, he said, "represent brazen intrusions into the sovereignty of our state."

But many local officials said they would help people take advantage of the law.

The chief executive of Dallas County, Tex., Judge Clay Lewis Jenkins, a Democrat, said: "The exchange is a tremendous opportunity to reduce the number of uninsured. It's important that we move aggressively, as soon as possible, to get information to our citizens in a format they can use."

Many people who could benefit from the law are unaware of it, according to surveys by the Kaiser Family Foundation and others. Early this month, Kaiser found that 79 percent of the public and 87 percent of the uninsured had heard little or nothing about the health insurance marketplaces, a centerpiece of the 2010 law.

To reduce those numbers, White House officials met recently with state library officials. Consumers often turn to public libraries for information about government services, and the American Library Association is telling its members to expect a "rush of patrons" who will need help completing insurance application forms.

"We are in the business of providing factual information," said Maureen Sullivan, the president of the association.

In Texas, as in a number of states, counties have legal obligations to help pay for the care of the indigent. County officials see the federal law as a way to help reduce those expenses.

"More than almost anyone else," Mr. Jenkins said, "we will benefit from a reduction in the cost of unreimbursed care, on which we spend $562 million a year. I have reached out to public relations firms, to hospitals, to insurance companies, to the bishop of the Catholic Diocese of Dallas, to a lot of churches and religious institutions, and urged them to join our effort."

Some Republicans will also spread the word.

Mayor Robert Cluck of Arlington, Tex., a Republican, said he did not want to discuss the Affordable Care Act but did want to help people get "proper health care."

"When the new health insurance system begins, it will be very complicated and very confusing," Mr. Cluck said. "A lot of people will need a lot of help. Whatever we can do as community leaders, to help people understand the changes, it's our responsibility to do."

In Houston, State Representative Garnet F. Coleman, a Democrat, said, "We will hold events at zoos, museums and other sites where people can fill out applications and enroll on the spot."

In Florida, two Democratic legislators, Representative José Javier Rodriguez of Miami and Senator Eleanor Sobel of Broward County, said they recently participated in a conference call organized by White House officials who sought their help in carrying out the law.

"We clearly do not have an ally in Tallahassee," Mr. Rodriguez said. "So we are working directly with community groups and officials in Washington to make sure people here have access to affordable health insurance plans in the exchange."

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Breaking the Seal on Drug Research

Steve Ruark for The New York Times

Peter Doshi, in background, wants to give consumers "the full picture" on drug data. He shared an article with Kevin Fain in a Johns Hopkins cafe.

PETER DOSHI walked across the campus of Johns Hopkins University in a rumpled polo shirt and stonewashed jeans, a backpack slung over one shoulder. An unremarkable presence on a campus filled with backpack-toters, he is 32, and not sure where he'll be working come August, when his postdoctoral fellowship ends. And yet, even without a medical degree, he is one of the most influential voices in medical research today.

Dr. Doshi's renown comes not from solving the puzzles of cancer or discovering the next blockbuster drug, but from pushing the world's biggest pharmaceutical companies to open their records to outsiders in an effort to better understand the benefits and potential harms of the drugs that billions of people take every day. Together with a band of far-flung researchers and activists, he is trying to unearth data from clinical trials — complex studies that last for years and often involve thousands of patients across many countries — and make it public.

The current system, the activists say, is one in which the meager details of clinical trials published in medical journals, often by authors with financial ties to the companies whose drugs they are writing about, is insufficient to the point of being misleading.

There is an underdog feel to this fight, with postdocs and academics flinging stones at well-fortified corporations. But they are making headway. Last fall, after prodding by Dr. Doshi and others, the drug giant GlaxoSmithKline announced that it would share detailed data from all global clinical trials conducted since 2007, a pledge it later expanded to all products dating to 2000. Though that data has not yet been produced, it would amount to more than 1,000 clinical trials involving more than 90 drugs, a remarkable first for a major drug maker.

The European Medicines Agency, which oversees drug approvals for the European Union, is considering a policy to make trial data public whenever a drug is approved. And on June 17, the medical world saw how valuable such transparency could be, as outside researchers published a review of a spinal treatment from the device maker Medtronic. The review, which concluded that the treatment was no better than an older one, relied on detailed data the company provided to the researchers.

For years, researchers have talked about the problem of publication bias, or selectively publishing results of trials. Concern about such bias gathered force in the 1990s and early 2000s, when researchers documented how, time and again, positive results were published while negative ones were not. Taken together, studies have shown that results of only about half of clinical trials make their way into medical journals.

Problems with data about high-profile drugs have led to scandals over the past decade, like one involving contentions that the number of heart attacks was underreported in research about the painkiller Vioxx. Another involved accusations of misleading data about links between the antidepressant Paxil and the risk of suicide among teenagers.

To those who have followed this issue for years, the moves toward openness are unfolding with surprising speed.

"This problem has been very well documented for at least three decades now in medicine, with no substantive fix," said Dr. Ben Goldacre, a British author and an ally of Dr. Doshi. "Things have changed almost unimaginably fast over the past six months."

Much of that change is happening because of what Dr. Goldacre calls an "accident of history." In 2009, Dr. Doshi and his colleagues set out to answer a simple question about the anti-flu drug Tamiflu: Does it work? Resolving that question has been far harder than they ever envisioned, and, four years later, there is still no definitive answer. But the quest to determine Tamiflu's efficacy transformed Dr. Doshi and others into activists for transparency — and turned the tables on drug makers. Until recently, the idea that companies should routinely hand over detailed data about their clinical trials might have sounded far-fetched. Now, the onus is on the industry to explain why it shouldn't.

IN summer 2009, Dr. Doshi received a call from Dr. Tom Jefferson, a British epidemiologist based in Rome. That year, the swine flu pandemic was spreading worldwide, and Dr. Jefferson had been hired by the British and Australian governments to update an earlier review of Tamiflu, a drug produced by the Swiss company Roche, aimed at reducing the flu's severity and preventing more serious complications. He asked if Dr. Doshi wanted to help.

Determining Tamiflu's efficacy had significant economic as well as health consequences. Around the world, private companies and governments — including that of the United States — were stockpiling Tamiflu in case of influenza outbreaks, and their spending accounted for almost 60 percent of the drug's $3 billion in sales in 2009.

The review of Tamiflu was being conducted under the auspices of the Cochrane Collaboration, a well-regarded network of independent researchers, including Dr. Jefferson, who evaluate medical treatments' effectiveness by analyzing all available research.

At the time, Dr. Doshi knew little about clinical trials or even much about the drug industry. But he knew Dr. Jefferson. Dr. Doshi, after receiving undergraduate and master's degrees in anthropology and East Asian studies from Brown and Harvard, had shifted focus and was pursuing a doctorate at M.I.T., studying the intersection of medicine and politics. He met Dr. Jefferson, a prominent skeptic of the flu vaccine, after researching whether the Centers for Disease Control was exaggerating the deadliness of the disease.

"We were both lone wolves in the field of influenza," Dr. Doshi recalled.

Dr. Jefferson had conducted a Cochrane review of Tamiflu's effectiveness a few years earlier, concluding that the drug reduced the risk of complications from the flu. He assured Dr. Doshi and other researchers on his team that the update would be fairly simple.

But just as their work was getting under way, a simple comment arrived on the Cochrane Web site that changed the course of the research and would ultimately fuel a worldwide effort to force drug companies to be more transparent.

The author of that comment, Dr. Keiji Hayashi, had no connection to the Cochrane group; he was a pediatrician in Japan who had prescribed Tamiflu to children in his practice, but had come to question its efficacy. He was curious about one of the main studies on which Dr. Jefferson had relied in his previous analysis. Called the Kaiser study, it pooled the results of 10 clinical trials. But Dr. Hayashi noticed that the results of only two of those trials had been fully published in medical journals. Given that details of eight trials were unknown, how could the researchers be certain of their conclusion that Tamiflu reduced risk of complications from flu?

"We should appraise the eight trials rigidly," Dr. Hayashi wrote.

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Doctor and Patient: The Gulf Between Doctors and Nurse Practitioners

Not long ago, I attended a meeting on the future of primary care. Most of the physicians in the room knew one another, so the discussion, while serious, remained relaxed.

Toward the end of the hour, one of the physicians who had been mostly silent cleared his throat and raised his hand to speak. The other physicians smiled in acknowledgment as their colleague stood up.

"Nurse practitioners," he said. "Maybe we need more nurse practitioners in primary care."

Smiles faded, faces froze and the room fell silent. An outraged doctor, the color in his face rising, stood to bellow at his impertinent colleague. Others joined the fray and side arguments erupted in the back of the room. A couple of people raised their hands to try to bring the meeting back to order, but it was too late.

The physician had mentioned the unmentionable.

I remembered the discord and chaos of that meeting when I read a recent study in The New England Journal of Medicine of nurses' and physicians' opinions about primary care providers.

For several years now, health care experts have been issuing warnings about an impending severe shortfall of primary care physicians. Policy makers have suggested that nurse practitioners, nurses who have completed graduate-level studies and up to 700 additional hours of supervised clinical work, could fill the gap.

Already, many of these advanced-practice nurses work as their patients' principal provider. They make diagnoses, prescribe medications and order and perform diagnostic tests. And since they are reimbursed less than physicians, policy makers are quick to point out, increasing the number of nurse practitioners could lower health care costs.

If only it were that easy.

Three years ago, a national panel of experts recommended that nurses be able to practice "to the full extent of their education and training," leading medical teams and practices, admitting patients to hospitals and being paid at the same rate as physicians for the same work. But physician organizations opposed many of the specific suggestions, citing a lack of data or well-designed studies to support the recommendations.

In an effort to build consensus, the Robert Wood Johnson Foundation then invited a dozen leaders from national physician and nursing groups to discuss their differences. The hope was that face-to-face discussions would help physicians and nurses understand one another better and see beyond the highly charged and emotional rhetoric. The approach worked, at least initially; after three meetings, the group drafted a report filled with suggestions for reconciling many of the differences.

But an early confidential draft was leaked to the American Medical Association, a group that had not been invited to participate, and the A.M.A. immediately expressed its opposition to the report. Soon after, three of the participating medical organizations — the American Academy of Family Physicians, the American Osteopathic Association and the American Academy of Pediatrics — withdrew their support, and the effort to bring physicians and nurse practitioners together and complete the report collapsed.

Nonetheless, many health care experts remained confident, believing that the large professional organizations had grown out of touch with grass-roots-level health care providers. The guilds might oppose one another, but every day in medical practices, clinics and hospitals across the country, physicians and nurse practitioners were working side by side without bickering. Surely, the experts reasoned, providers who knew and liked one another would be receptive to trying new ways of working together.

Wrong.

Analyzing questionnaires completed by almost 1,000 physicians and nurse practitioners, researchers did find that almost all of the doctors and nurses believed that nurse practitioners should be able to practice to the full extent of their training and that their inclusion in primary care would improve the timeliness of and access to care.

But the agreement ended there. Nurse practitioners believed that they could lead primary care practices and admit patients to a hospital and that they deserved to earn the same amount as doctors for the same work. The physicians disagreed. Many of the doctors said that they provided higher-quality care than their nursing counterparts and that increasing the number of nurse practitioners in primary care would not necessarily improve safety, effectiveness, equity or quality.

A third of the doctors went so far as to state that nurse practitioners would have a detrimental effect on the safety and effectiveness of care.

"These are not just professional differences," said Karen Donelan, the lead author of the study and a senior scientist at the Mongan Institute for Health Policy at Massachusetts General Hospital in Boston. "This is an interplanetary gulf," she said, echoing a point in an editorial that accompanied her study.

The findings bode poorly for future policy efforts, since physicians are unlikely to support efforts to increase the responsibilities and numbers of advanced-practice nurses in primary care. And most nurse practitioners are unlikely to support any proposals to expand their roles that do not include equal pay for equal work.

Peter I. Buerhaus, senior author of the study and a professor of nursing at Vanderbilt University Medical Center in Nashville, is chairman of a commission created almost three years ago under the Affordable Care Act to address health care work force issues. But his group has yet to convene because a divided Congress has not approved White House requests for funding.

"We're running out of time on these issues," Dr. Buerhaus said. "If the staffing differences remain unresolved, we are just going to cause harm to the public."

Still, by providing a clearer picture of the extent of these professional differences, the study should help future efforts. "It's too easy to say that everyone should just get along," Dr. Donelan said. "These arguments touch on the whole nature of these professions, their core values and how they define themselves."

"It's like when family members are warring over a sick patient," she added. "We need first to acknowledge the others' position and the full extent of our differences before we can reach any kind of resolution."

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Hepatitis Threat Forces Another Frozen Fruit Recall

The Food and Drug Administration said on Friday that it had identified another product contaminated with Hepatitis A, which was the cause of a recall of frozen organic berries earlier this month.

As a result, the Scenic Fruit Company of Gresham, Ore., has recalled three different lots of its Woodstock Frozen Organic Pomegranate Kernels, which were shipped from February through May to United Natural Foods Inc. distribution centers in 12 states – California, Colorado, Connecticut, Florida, Georgia, Indiana, Iowa, New Hampshire, Pennsylvania, Rhode Island, Texas and Washington.

The F.D.A. said the centers might have distributed the pomegranate seeds to grocery stores in other states.

The pomegranate seeds in the Scenic Fruit product came from the same shipment of pomegranate seeds from Turkey that were used in a frozen berry mixture made by Townsend Farms of Fairview, Ore. Townsend recalled packages of its Organic Antioxidant Blend sold in Costco stores on the West Coast and in Harris Teeter grocery stores, primarily located in the southeast.

The Centers for Disease Control has identified 127 people who became ill with the virus caused by Hepatitis A after eating the Townsend Farms berries, although none so far from the Harris Teeter stores.

In a statement, the agency said it would continue "working with the firms who have distributed pomegranate seeds from this shipment from Turkey to help ensure that all recipients of these seeds have been notified."

That berry contamination case cropped up shortly after Shuanghui International, a large Chinese meat processor, announced plans to buy Smithfield Foods, one of the biggest pork producers in the country, raising public awareness of how much food is imported to the United States.

The particular strain of Hepatitis A found in clinical specimens taken from 56 of the people who were sickened belongs to a genotype rarely seen in the United States but that is circulating in North Africa and the Middle East.

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National Briefing | Mid-Atlantic: Pennsylvania: Transplant Recipient Gets Second Set of New Lungs

A 10-year-old Pennsylvania girl who had a double lung transplant amid a debate over the organ allocation process got a second transplant after the first one failed and is now taking some breaths on her own, the parents of the girl, Sarah Murnaghan, said Friday. Janet Murnaghan, Sarah's mother, said the first set of lungs failed within hours of the transplant on June 12, and Sarah was placed on machines. She went back on the lung transplant list and got a second set of lungs on June 15. Explaining why Sarah's second transplant was not made public, Ms. Murnaghan said her daughter had not been expected to live.

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F.D.A. Approves a Drug for Hot Flashes

The first nonhormonal drug to treat hot flashes won approval from the Food and Drug Administration on Friday, offering a new alternative to menopausal women.

The move was surprising because an advisory committee to the F.D.A. voted 10 to 4 in March against approval.

The treatment, which will be called Brisdelle, was developed by Noven Pharmaceuticals and consists of a low dose of paroxetine, which is used at higher doses in the antidepressant Paxil.

Approved treatments for menopausal hot flashes until now have all contained the hormone estrogen, sometimes in combination with progestin. But hormone use has decreased sharply since a study in 2002 suggested that the combination of estrogen and progestin could increase the risk of cardiovascular problems and cancer.

"There are a significant number of women who suffer from hot flashes associated with menopause and who cannot or do not want to use hormonal treatments," Dr. Hylton V. Joffe, director of the F.D.A's division of bone, reproductive and urologic products, said in a statement.

While the F.D.A. does not have to follow the recommendations of its advisory panels, it is highly unusual for it to approve a drug that receives a strong negative vote. Committee members who voted against it said while there was a need for a nonhormonal therapy, Noven's candidate was only minimally effective.

The agency did not explain why it went against the panel's recommendation, saying only that it viewed Brisdelle as a useful treatment that had met its goals in clinical trials.

Women in the clinical trials for Brisdelle started out with a median of about 10 hot flash episodes a day. After 12 weeks, those who took the drug had a median of nearly six fewer episodes a day, compared with a reduction of four or five episodes a day for those receiving the placebo.

While the difference was statistically significant, many members of the advisory committee said such a difference would not be meaningful to women.

Noven, which is based in Miami and is a subsidiary of Hisamitsu Pharmaceutical of Japan, said Brisdelle would be available in November. It did not say how much the drug would cost.

Dr. Joel Lippman, chief medical officer of Noven, said in a statement that 24 million women in the United States had moderate to severe hot flashes and that two-thirds of them were not currently treating them.

Brisdelle's label has a strong warning that the drug can increase suicidal thoughts or behavior, language similar to that on the labels of other drugs containing paroxetine. Other warnings include an increased risk of bleeding, and possible reduction in the effectiveness of the breast cancer drug tamoxifen if both drugs are used together.

The advisory panel in March gave an even stronger no vote to another proposed nonhormonal treatment for hot flashes, an extended-release version of the neurology drug gabapentin. In that case, the F.D.A. went along with the panel, rejecting the drug, according to an announcement by its developer, Depomed.

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Well: Getting Men to Want to Use Condoms

It takes just a peek at the online store Condomania to appreciate the variety of condoms out there.

Flavors like island punch, banana split and bubble gum. Vibrating condom rings with batteries that last up to 20 minutes. Glow-in-the-dark condoms promising "30 minutes of glowing fun."

And under the category "Celebrity Condoms," there is the "Obama Condoms Stimulus Package," each condom embossed with an image of the president giving two thumbs up.

But even if that presidential seal of approval were real, it would not overcome a chronic and serious public health obstacle: Most men do not like condoms.

Now an influential player in global health, the Bill and Melinda Gates Foundation, is getting into the game. The foundation just finished collecting applications for what it calls a Grand Challenge: to develop "a next-generation condom that significantly preserves or enhances pleasure."

The goal is to address two significant problems: unintended pregnancies and sexually transmitted diseases like AIDS. Condoms cheaply and effectively prevent both, but around the world only 5 percent of men wear them and there are 2.5 million new H.I.V. infections a year. To stem that tide, health experts say, the number of men regularly using condoms needs to double.

"Decreased sexual pleasure is typically the predominant reason for not using them," said Stephen Ward, a program officer for the Gates Foundation. "Can we actually make them more desirable? That's what we're shooting for."

More than 500 applications poured into the Gates contest, which will award winners $100,000 this fall, and up to $1 million subsequently. And in a first for a Gates challenge, Mr. Ward said, people sent samples.

"Boxes of condoms, condom accessories, condom cases that look like something else so women can be very discreet while carrying them," he said. "We received a completely stocked carrying case with condoms, lubricant and breath mints."

Contestants have been advised not to discuss their applications publicly, meaning that the creator of a YouTube video who pitched Mr. Gates a condom applied via slingshot is probably not a serious contender.

But condom experts — some of whom have studied the subject for years — have ideas of what might work and what decidedly won't.

"I don't think we've seen the condom that knocks the socks off for everybody," said Ron Frezieres, vice present of research and evaluation at the California Family Health Council, a longtime tester of condoms for industry, government and nonprofit organizations.

"Guys would like it if they, first of all, don't believe they're wearing it," Mr. Frezieres continued. "And second of all, it's got to be a little better than what they're used to. We still have to find that perfect bullet."

Perfect may not be the enemy of the good in this case, but it is awfully hard to pin down.

"When I saw that Gates announcement," said Jeff Spieler, a senior technical adviser on population and reproductive health at the United States Agency for International Development, "I wrote and said, 'It's great that you're doing this, but I've been there before, and I hope you're going to surface something that I couldn't surface.'

"This has been my passion for years and years," Mr. Spieler added. "I started thinking, 'Gosh, if we could develop a condom that made sex better with the condom than without … .' If at least it didn't take sexual pleasure away, it would not be like taking a shower with a raincoat on."

At first, he recalled, his bosses said: "Hey, Jeff, be careful. We don't want Congress to come beating down on this because Jeff Spieler's trying to make sex better."

Several manufacturers have worked on more appealing condoms. Some models, like Pleasure Plus and Twisted Pleasure, designed by an Indian surgeon, Alla Venkata Krishna Reddy, whom Mr. Spieler called the "Leonardo da Vinci of condoms," addressed complaints of tightness and friction. They are roomy, ballooning, "sort of like the swirl of a Dairy Queen ice cream," Mr. Spieler said. The movement of extra material is intended to be stimulating.

Another design, the eZ-On condom, was aimed at the "donning problem." Made of polyurethane, not latex, it was baggy, "gathered up inside what I call a tutu," Mr. Frezieres said. "It was not directional, so you could pull it down from either side" — or as Mr. Spieler put it, "like slipping your foot into an open sock."

But only some men appreciate that feature. It turns out that condoms are subject to a wide array of likes and dislikes.

"Some men want it absolutely clear so if they look down they can think they don't have anything on," Mr. Frezieres said. "Others want to make it red and vibrating, like a neon sign."

Mr. Frezieres and his colleague Terri L. Walsh conducted studies involving condoms with lubricants that create a heating sensation. "Some people said, 'This is burning me,' " he said, but others reported a mild, pleasant feeling or even more intense orgasms. On the other hand, as Ms. Walsh pointed out, a stimulating condom could make matters worse for men with premature ejaculation, so for them, the question is, "How much more exciting do you want to make a condom?"

Another testing quandary, Mr. Spieler said, is that "you can't compare one sex act to another sex act. You can come into a sex act having just argued and having makeup sex. You could have three days of bad sex, so you don't rate the condom you're testing very well."

That has not stopped innovation in the condom industry. There are vibrating condom rings like the Durex Play – Ring of Bliss, said Bidia Deperthes, a senior H.I.V. technical adviser for the United Nations Population Fund. (Mr. Spieler calls her "the condom czarina.") Some men invariably gripe about the battery life: "Bidia, 20 minutes, it's not that long." Her response: "Guys, give me a break. Fifteen minutes is already flattering you."

Ms. Deperthes, whose office features a wall of condoms, has versions packaged like lollipops, miniature chocolate milk cartons and cellophane-wrapped taffy.

And what's that pinned to her silk blouse? A brooch of batik fabric. But on the flip side of the pin is, yes, a condom. Talk about wearable art.

One unsuccessful innovation was the Hat condom, resembling a little shower cap, designed, said Mr. Frezieres, "to fit just over the tip," to "provide maximum sensation." Alas, "in clinical testing, couples experienced difficulty keeping the Hat condom from popping off," he said.

Another idea was the spray-on condom, applying liquid latex to create a condom shaped for the man using it. "Great concept," Mr. Frezieres said. But it did not have a tip to collect fluid, and "we were like, how do you get it off afterward?"

One promising design, already available in some parts of the world, is the Pronto 4:Secs condom, its box decorated with racy Dick Tracyesque cartoons. 4:Secs, its name both a pun and the time it is supposed to take to put on, is a condom in a plastic applicator resembling a life preserver.

"This is really cool," said Ms. Deperthes, demonstrating how the applicator splits apart to allow the condom to be put on right-side up.

And perhaps the most innovative new American-made product is the Origami condom, still in clinical trials. Its inventor, Danny Resnic, said he was motivated by his own experience when "a latex condom broke and I wound up with an H.I.V. diagnosis."

Years of experimenting led him to devise a condom with accordionlike pleats, loose to allow movement inside. Made of silicone, which is meant to feel more like skin, it "goes on in less than a second," he said, and "there's no wrong way to put it on."

Besides male condoms, which Origami calls "external condoms," the company has a female version (an "internal condom"), and the first condoms for anal sex and oral sex, Mr. Resnic said.

The Gates Foundation contest also welcomed designs for female condoms, but female condoms have historically been less popular.

While some men prefer the experience, and some women feel it affords them greater ability to protect themselves, it is much more expensive and needs to be positioned correctly to avoid getting pushed in or shifted to one side.

One idea to make it more attractive, Mr. Frezieres said, is to attach the female condom to a "string-bikini-looking panty, like a thong."

In the developing world, condoms raise other issues. In some cultures, men are so resistant that women must engage in delicate "condom negotiation." And women who carry condoms might be assumed to be prostitutes.

Ms. Deperthes and Franck DeRose, executive director of the nonprofit Condom Project, use songs and dances about condoms to try to make them seem fun, and give women ways to carry condoms discreetly, including containers that look like breath mint boxes.

Ms. Deperthes also wants more options; for example, she noted that the two standard sizes were too big for some men, so smaller sizes should be included in packages donated to developing countries.

And she wants more variety.

"I told the condom working group at U.S.A.I.D., 'Guys, you are boring, boring, boring,' " Ms. Deperthes said. The standard condom that countries receive "doesn't smell good — it smells like rubber."

Told that 18 choices are offered, she said better marketing was needed, since most countries choose the same plain-vanilla type. Ms. Deperthes is developing a "chocolate box," displaying different condoms like truffles, to send to foreign health ministers. Indeed, given the wide array of personal and cultural differences, she and others said, the value of the Gates Foundation contest may be in finding several types of condoms — perhaps of new materials — and in helping them be produced inexpensively enough for the developing world.

As Mr. DeRose put it: "Sometimes you want to wear boots, sometimes you want to wear flip-flops."

---

Testing Condoms: Someone Has to Do It

As guinea pigs in scientific clinical trials, Amy and Max H. take their commitment seriously. They perform the required tests of each product at least several times. They fill out the required forms. After all, they consider it a big responsibility: testing condoms for the California Family Health Council.

"We call it sex for science," said Amy, who, like Max, is 26. (They agreed to speak only if their full names were withheld.)

They are so diligent that they fill out the forms right after testing a condom. "If I fall asleep and I wake up in the morning and do it, I'm not going to be able to remember the answer to any of the questions," Max said.

The questions couples are asked are detailed. They include "what they like, didn't like, did it break, did it flip, did it hurt, how was sex, how was orgasm," said Ron Frezieres, vice president of research and evaluation for the council, which recruits many of its study participants through Craigslist.

Max has not been a great fan of condoms. For about 18 months he and Amy, who live in Los Angeles and have been together for eight years, used condoms for birth control, and "God, it was stressful," he said.

"While you're naked and you're with another naked person and you're in bed, and you're not 100 percent focused on, like, how I put this on properly. It's really difficult. And it's a situation where you often don't probably find yourself with two hands free."

Also, he said, "if surprise sex happens and you're not near your condom drawer, you have to go get your condom."

Amy had fewer quibbles. "Yes, sometimes, it was like the worst thing to ever happen on the planet," she said. "But even if you're, like, 'I want you right now,' it can be almost like a fun pause because you're forced to let it linger for a little bit longer."

When they started testing condoms for the council, neither was overwhelmingly impressed with the new versions, which were mostly standard-design condoms made of materials besides latex.

They had some differences of opinion. Amy liked polyurethane, for example, because "it kind of heats up a little bit more," she said. But Max said: "They felt very plastic-y. Latex stretches, and the other materials didn't so much."

But they were unanimous in their antipathy to the female condom. As Max put it: "We both found the female condom to be aggressively unsexy. It didn't really seem to make much difference in terms of feeling, but visually we were like, 'Oh, man, we should just stop.' "

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Well: The Problem With Pain Pills

In the new e-book "A World of Hurt: Fixing Pain Medicine's Biggest Mistake," the New York Times reporter Barry Meier explores the murky world of prescription pain medicine. He makes a strong case that opioid drugs used to treat chronic pain, like OxyContin, not only are addictive and deadly but often don't work for many people who use them and lead to a range of additional health problems.

It's Mr. Meier's second foray into the complicated world of pain relief. His first book, "Pain Killer: A 'Wonder' Drug's Trail of Addiction and Death," focused on the potential for abuse of OxyContin, particularly by teenagers. In the new, shorter e-book, Mr. Meier focuses on the long-term consequences of widespread use of opioid drugs to treat pain. I recently spoke with Mr. Meier about the problems associated with painkillers, why doctors and patients resist giving them up and some of the surprising side effects of these drugs. Here's our conversation.

Q.

Why did you decide to revisit the topic of opioid painkillers?

A.

I wrote a book 10 years ago about the rise of OxyContin and the pain management industry. That book was focused on abuse. The prevailing medical notion was that there was this bright line involving the opioids — that they were great for patients but the problems happened when they went out on the streets and were abused by kids and others. But today it's clear that the long-term use of these drugs can not only be ineffective for chronic pain, but they also create bad side effects for patients. Not just addiction but powerful psychological dependency, depression of hormone production, lethargy and listlessness and sleep apnea, among others. These drugs do work well for some patients, but for many other patients, they're not working well at all.

Q.

What made you realize that more needed to be written about the consequences of these drugs?

A.

There were two powerful factors. The number of annual overdose deaths from narcotic painkillers has grown four times higher than it was a decade ago. The current statistic is that about 16,000 people a year die of overdoses involving prescription narcotics. The thing that was even more powerful for me was the growing realization that there are risks of these drugs for patients themselves, not just for people who are out-and-out abusing these drugs. People taking these drugs as directed have far more significant negative consequences than have been previously appreciated. It became of question of, "How are we treating chronic pain over the long term and are these drugs really the answer?"

Q.

Given these concerns, why are opioid pain relievers like OxyContin the drug of choice for doctors and patients?

A.

Insurers and government agencies seized on opioids much like the use of antidepressants for psychological problems. Drugs are cheaper than talk therapy. Drugs are cheaper than a multidisciplinary approach to chronic pain. Doctors get reimbursed to treat people quickly, so funding for other approaches is cut out. These drugs became the treatment method of choice.

Q.

Are doctors beginning to question the use of these drugs now?

A.

There is probably a real shift going on in the medical community. There have been increasing questions raised, even among those who once promoted the drugs, that they are not the panacea to treating chronic pain. One leading expert said: "We thought the big problem with these drugs is addiction. Now we realize the problem is with patients who take them and basically opt out of life." There is a general realization that while they do work for some patients, using them on a massive scale to treat chronic pain has had really disastrous consequences.

Q.

What is it about these drugs that creates such concern?

A.

You look at things like disability statistics — one of the biggest indicators of disability is use of these drugs. For instance, back pain is probably the leading workplace injury. What insurers and workers' comp agencies are discovering is that when workers are treated with high doses of opioid drugs fairly soon after these injuries, it's the leading predictor for them not coming back to work for long periods of time, or ever.

These drugs have a very powerful impact on our production of sexual hormones — testosterone in men and estrogen in women. Lower hormone production is not just about growing hair or sexual performance; it's about your entire energy level. These drugs are depleting people of energy. There are even data showing that the more powerful opioids, the long-acting OxyContin, methadone, fentanyl, which is sold as Duragesic, have an even more powerful effect on depressing hormone production than short-acting opioids. These drugs are not just blocking pain receptors so you don't feel pain; they are having powerful systemic effects on people,

Q.

You also make the point that these drugs can actually lead to more pain. How does that happen?

A.

When you take a narcotic painkiller it sets off a natural reaction called tolerance, which means your body adjusts to it. You have to take more of the drug to get the same painkilling effect. Patients would come back to doctors and say, "This drug was working really well for me, but now I'm feeling pain again." The doctor would increase the dose. The prevailing ideology during the war on pain was that these drugs had no ceiling dose. You could keep increasing them. The doctors kept boosting them every six months. People started taking higher and higher doses of these drugs. At a certain point it appears they create a change in the neurological system where people develop hyperalgesia and they become far more sensitive to pain than when they started out on these drugs.

Q.

So what is a person who has chronic pain supposed to do?

A.

There was an interesting German research study earlier this year that looked at what happened when people are weaned off these drugs to a nondrug treatment plan. When they are weaned off high levels of opioids, they experienced less pain than when they were on high doses.

Part of the reason for writing this book is there is an antidote to dependence on these drugs. There are plenty of data suggesting that a multidisciplinary approach to chronic pain works as effectively as high-dose opioid treatment. Patients experiencing chronic pain for whatever cause will be put through a program where they receive intensive physical therapy, behavioral counseling, intensive psychological counseling.

One of the problems with chronic pain – there's a lot of catastrophizing around it. People think this is the way it's going to be for the rest of their life, and that they are trapped in this horrible pain and it's only going to get worse. There is tremendous anxiety associated with that. They not only end up taking pain drugs and strong narcotics, but they take a lot of anti-anxiety medications as well.

The whole focus on multidisciplinary programs is to get people functioning again. One of the big drawbacks of long-term opiate use is many people who take these drugs over a long period of time lose physical function. The goal is to restore physical function and to help people learn if they do have chronic pain conditions, they may experience pain for the foreseeable future, but that is not necessarily a barrier to prevent them from living a full, active life.

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Counterfeit Food More Widespread Than Suspected

Jennie Kendall/HMRC

Liters of fake vodka were distilled and pumped into genuine Glen's Vodka bottles, and packed with forged labels and duty stamps.

GREAT DALBY, England — Invisible from the roadway, hidden deep in the lush English countryside, Moscow Farm is an unlikely base for an international organized crime gang churning out a dangerous brew of fake vodka.

Jennie Kendall/HMRC

Fake Glen's Vodka has high levels of methanol, and bleach was added to lighten its color.

But a quarter of a mile off a one-lane road here, tens of thousands of liters of counterfeit spirits were distilled, pumped into genuine vodka bottles, with near-perfect counterfeit labels and duty stamps, and sold in corner shops across Britain. The fake Glen's vodka looked real. But analysis revealed that it was spiked with bleach to lighten its color, and contained high levels of methanol, which in large doses can cause blindness.

No one knows the harm done to those who drank it — or whether they connected any illness with their bargain vodka — but cases of poisoning have been reported throughout Europe, including in the Czech Republic, where more than 20 people died last year after drinking counterfeit liquor.

The Europe-wide scandal surrounding the substitution of cheaper horse meat in what had been labeled beef products caught the most attention from consumers, regulators and investigators this year. But in terms of food fraud, regulators and investigators say, that is just a hint of what has been happening as the economic crisis persists.

Investigators have uncovered thousands of frauds, raising fresh questions about regulatory oversight as criminals offer bargain-hunting shoppers cheap versions of everyday products, including counterfeit chocolate and adulterated olive oil, Jacob's Creek wine and even Bollinger Champagne. As the horse meat scandal showed, even legitimate companies can be overtaken by the murky world of food fraud.

"Around the world, food fraud is an epidemic — in every single country where food is produced or grown, food fraud is occurring," said Mitchell Weinberg, president and chief executive of Inscatech, a company that advises on food security. "Just about every single ingredient that has even a moderate economic value is potentially vulnerable to fraud."

Speaking at a recent conference organized by the consulting firm FoodChain Europe, Mr. Weinberg added that many processed products contain ingredients like sugar, vanilla, paprika, honey, olive oil or cocoa products that are tainted.

Increasingly, those frauds are the work of organized international criminal networks lured by the potential for big profits in an illicit trade in which most forgers are never caught. The vodka gang boss, Kevin Eddishaw, was — but not before he had counterfeited liquor on an industrial scale, generating profits to match, according to investigators, who estimated that his distillery produced at least 165,000 bottles costing the British government £1.5 million, or $2.3 million, in lost tax revenue.

"He was living a very nice lifestyle," said Roddy Mackinnon, criminal investigation officer for Her Majesty's Revenue and Customs, "a couple of properties, nice cars: a Range Rover, a Mercedes."

Here at Moscow Farm, the gang used the production techniques of a modern-day factory equipped with at least £50,000, or $77,200, in equipment (while ignoring safety rules). Gang members bought bottles from the supplier of the real makers of Glen's vodka, saying they were destined for Poland. When forged label prototypes printed in Britain were deemed unpersuasive, higher-quality ones were brought from Poland. The gang faked duty stamps on boxes.

"They tried to do as much as they could to replicate the real thing," Mr. Mackinnon said. "They were very professional, there was attention to detail."

So well was the secret plant hidden that it was detected only when someone suspected in another case led investigators there in 2009.

Though Mr. Eddishaw worked through intermediaries and used pay-as-you-go cellphone numbers, investigators tracked his calls, proving from the location where they were made that the phone belonged to him and linking him to a fraud that brought him a seven-year prison term.

The plot fits a pattern, identified by Europol, the European Union's law enforcement agency, which says organized crime groups have capitalized on the economic downturn.

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Well: How Carbs Can Trigger Food Cravings

Are all calories created equal? A new study suggests that in at least one important way, they may not be.

Sugary foods and drinks, white bread and other processed carbohydrates that are known to cause abrupt spikes and falls in blood sugar appear to stimulate parts of the brain involved in hunger, craving and reward, the new research shows. The findings, published in The American Journal of Clinical Nutrition, suggest that these so-called high-glycemic foods influence the brain in a way that might drive some people to overeat.

For those who are particularly susceptible to these effects, avoiding refined carbohydrates might reduce urges and potentially help control weight, said Dr. David Ludwig, the lead author of the study and the director of the New Balance Foundation Obesity Prevention Center at Boston Children's Hospital.

"This research suggests that based on their effects on brain metabolism, all calories are not alike," he said. "Not everybody who eats processed carbohydrates develops uncontrollable food cravings. But for the person who has been struggling with weight in our modern food environment and unable to control their cravings, limiting refined carbohydrate may be a logical first step."

Regardless of the diet they choose, most people who lose a great deal of weight have a difficult time keeping it off for good. For many people, despite their best efforts, the weight returns within six months to a year. But a few studies of weight loss maintenance, including a large one in The New England Journal of Medicine in 2010, have reported some success with diets that limit high-glycemic foods like bagels, white rice, juice and soda.

In addition to raising blood sugar, foods that are sugary and highly caloric elicit pronounced responses in distinct areas of the brain involved in reward. Earlier imaging studies have shown, for example, that the main reward and pleasure center, the nucleus accumbens, lights up more intensely for a slice of chocolate cake than for blander foods like vegetables, and the activation tends to be greater in the brains of obese people than it is in those who are lean.

But do rich desserts have a select ability to change our longer-term eating habits?

To get a better idea, Dr. Ludwig and his colleagues recruited a dozen obese men and then fed them milkshakes on two different occasions separated by several weeks. In each case, the milkshakes were nearly identical: flavored with milk and vanilla, and containing the same amount of calories, carbohydrates, protein and fat.

But on one occasion, the shakes were made with high-glycemic corn syrup; on the other, a source of low-glycemic carbohydrates was used. "These test meals were identical in appearance and tastiness, and we verified that our subjects had no preference for one or the other," Dr. Ludwig said.

As expected, blood sugar levels rose more quickly in response to the high-glycemic milkshake. But the researchers were especially interested in what happened several hours later, about the time most people are ready for their next meal.

What they found was that four hours after drinking the high-glycemic shake, blood sugar levels had plummeted into the hypoglycemic range, the subjects reported more hunger, and brain scans showed greater activation in parts of the brain that regulate cravings, reward and addictive behaviors. Although the subject pool was small, every subject showed the same response, and the differences in blood flow to these regions of the brain between the two conditions "was quite substantial," Dr. Ludwig said.

"Based on the strength and consistency of the response," he added, "the likelihood that this was due to chance was less than one in a thousand."

Previous research suggests that when blood sugar levels plummet, people have a tendency to seek out foods that can restore it quickly, and this may set up a cycle of overeating driven by high-glycemic foods, Dr. Ludwig said. "It makes sense that the brain would direct us to foods that would rescue blood sugar," he said. "That's a normal protective mechanism."

Christopher Gardner, a nutrition scientist at Stanford University who was not involved in the new study, said that after decades of research but little success in fighting obesity, "it has been disappointing that the message being communicated to the American public has been boiled down to 'eat less and exercise more.'"

"An underlying assumption of the 'eat less' portion of that message has been 'a calorie is a calorie,'" he said. But the new research "sheds light on the strong plausibility that it isn't just the amount of food we are eating, but also the type."

Dr. Gardner said it was clear that the conventional approach of the past few decades was not working. A more helpful message than "eat less," he said, may be "eat less refined carbohydrates and more whole foods."

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U.S. Unveils Health Care Web Site and Call Center

WASHINGTON — The Obama administration announced new steps to expand coverage under the federal health care law on Monday, less than a week after the Government Accountability Office, a nonpartisan investigative arm of Congress, found that the federal government and many states were "behind schedule" in setting up marketplaces where Americans are supposed to be able to buy insurance.

The steps — establishing a Web site and a telephone call center to provide information to consumers — are in preparation for what the government anticipates will be a flood of people buying health insurance starting Oct. 1.

Kathleen Sebelius, the secretary of health and human services, said the call center would be in operation 24 hours a day. The phone number is 800-318-2596. The Web site, www.healthcare.gov, provides information promoting the 2010 health care law and describing new insurance options. The Web site and call center currently have only general information about coverage.

Details about the prices and benefits of health insurance plans to be offered by Blue Cross and Blue Shield and companies like Humana and Kaiser Permanente will be available later this summer. Consumers can file online applications starting Oct. 1. Coverage is to begin on Jan. 1, when most Americans will be required to have insurance.

In a statement, Ms. Sebelius said, "The new Web site and the toll-free number have a simple mission: to make sure every American who needs health coverage has the information they need to make choices that are right for themselves and their families or their businesses."

The Congressional Budget Office predicts that seven million people will buy private insurance next year through marketplaces, or exchanges, while nine million people will gain coverage through Medicaid. By 2016, it says, the number of uninsured, now estimated at 56 million Americans, may be reduced by 25 million as a result of the law.

The federal government will be running insurance exchanges in more than half the states. The administration had said previously that the federal exchanges would be open — at least in 2014 — to any insurers that met basic federal standards.

But Ms. Sebelius, a former Kansas insurance commissioner, told reporters on Monday that "we will be negotiating for rates across the country." She emphasized the federal role, saying that "we intend to do rate negotiation to make sure that plans are going to offer consumers the best possible choices."

Federal officials said the negotiations would focus on rates that were much higher or much lower than those proposed by other insurers.

The Web site asks consumers for information about their household incomes, to determine if they may be eligible for federal subsidies, in the form of tax credits, to help pay premiums.

Ms. Sebelius said "we are very concerned" that low-income people in some states will not have access to either Medicaid or subsidies for the purchase of private insurance. However, she said, "there is no timetable" for states to expand Medicaid, and states that rejected the expansion of eligibility this year could reconsider next year.

The federal Web site acknowledges that some states are not expanding Medicaid. "Under the health care law," it says, "states have the choice to cover more people."

The Web site says that people eligible for Medicaid should not try to buy insurance in the exchange, because they will not receive subsidies. "A marketplace plan will be more expensive than Medicaid and usually won't give you additional coverage or benefits," it says. "You wouldn't be eligible for any savings on marketplace insurance and would have to pay the whole cost."

In states that do not expand Medicaid, insurance subsidies will generally be available to people with incomes from the poverty level up to four times that amount ($23,550 to $94,200 a year for a family of four). But in those states, the subsidies will not be available to some of the neediest — people with incomes below the poverty level who will generally not qualify for the new financial assistance with health insurance.

More than half of all people without health insurance live in states that are not planning to expand Medicaid.

Marketing insurance in those states "will be complicated," Ms. Sebelius said.

Administration officials said the call center would eventually have 9,000 customer service representatives fielding calls. Consumers can also seek information in live Web chats.

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In 5-4 Ruling, Justices Say Generic Makers Are Not Liable for Design of Drugs

Cheryl Senter for The New York Times

Karen Bartlett with her dog, Molly, in Plaistow, N.H. Ms. Bartlett developed a debilitating skin disease after taking a generic version of the pain medication sulindac.

The Supreme Court ruled on Monday that generic drug manufacturers could not be sued by patients who claim that drugs they took were defectively designed. The decision is a significant victory for the generic drug industry, but further narrows the recourse for people who are injured by such drugs.

The 5-to-4 decision overturned the verdict of a New Hampshire jury, which in 2010 awarded $21 million to a woman who developed a debilitating skin disease after taking a generic version of the pain medication sulindac.

The court found that because the drug's manufacturer, the Mutual Pharmaceutical Company, was required by federal law to make a copy of the brand-name drug, Clinoril, it could not be held responsible for claims that the drug was unsafe.

Writing for the majority, Justice Samuel A. Alito Jr. acknowledged the horrific injuries sustained by Karen Bartlett, who lost nearly two-thirds of her skin, was placed in a medically induced coma and is legally blind after suffering a reaction to the medication she took for a sore shoulder.

"But sympathy for respondent does not relieve us of the responsibility of following the law," Justice Alito wrote.

The ruling is similar to a decision by the court in 2011, in Pliva v. Mensing, which found that generic drug makers could not be held liable for failing to warn about a drug's dangers because they must use the same safety label as the brand-name version. Monday's decision further limits the legal avenues for people who take generic drugs, which now account for more than 80 percent of all prescriptions.

"Now, presumably, a patient harmed by those drugs has no remedy, either through a defective warning or a defective design argument," said Bill Curtis, a Houston lawyer who specializes in pharmaceutical cases.

Generic drug manufacturers hailed the decision, arguing that the decisions of state courts should not supplant the authority of the Food and Drug Administration, which approves the brand-name drugs and the generic copies.

"It makes much more sense to rely on the judgments of the scientific and medical experts at the F.D.A, who look at drug issues for the nation at large, than those of a single state court jury that only has in front of it the terribly unfortunate circumstances of an adverse drug reaction," said Jay P. Lefkowitz, who represented Mutual before the Supreme Court and also argued on behalf of generic companies in the Pliva v. Mensing case.

Mutual is a subsidiary of Sun Pharmaceutical Industries of India.

In a dissenting opinion, Justice Sonia Sotomayor said a decision by the F.D.A. to approve a drug should not absolve a company of its responsibility to sell a safe product.

"Manufacturers regularly take drugs off the market when evidence emerges about a drug's risks, particularly when safer drugs that provide the same therapeutic benefits are available," she wrote in her dissent, which was joined by Justice Ruth Bader Ginsburg. Justice Stephen G. Breyer wrote a separate dissent, which was joined by Justice Elena Kagan.

Some have called on Congress and the F.D.A. to make generic drug companies more accountable by permitting them to change their warning labels when they become aware of a safety risk. Brand-name companies can already do so. Such a change would, presumably, allow the generic manufacturers to be sued again.

Generic drug makers now have a responsibility to mirror the safety label of the brand-name company and to alert the F.D.A. whenever they learn of an adverse event related to their products. It is then up to the agency to decide whether to change the label.

Critics have said the current system works too slowly, and does not account for situations when problems arise with a drug after the brand-name manufacturer has left the market.

The consumer advocacy group Public Citizen released a report Monday that found 11 instances over the last five years in which serious safety warnings were added to the labels of drugs for which there were no longer any brand-name versions on the market.

This situation "poses a threat to the safety of prescription drugs, creating unnecessary risks to patients," Dr. Michael Carome, director of the Health Research Group at Public Citizen, said in a statement Monday.

Sandy Walsh, a spokeswoman for the F.D.A., said the agency was considering permitting generic companies to change warning labels on their drugs, but said it would be premature to discuss specifics.

Generic drug companies have argued that such a change could create a chaotic situation, with the potential for the same drug to bear different warning labels depending on the manufacturer. "That would be terribly confusing, and, I think, harmful for public health," Mr. Lefkowitz said.

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Hepatitis C Test for Baby Boomers Urged by Health Panel

An influential health advisory group has reversed itself and concluded that all baby boomers should be tested for hepatitis C, meaning that under the new health law many insurance plans will have to provide screening without charge to patients.

The group, the United States Preventive Services Task Force, announced its change of heart on Monday, saying there was likely to be some benefit from such screening.

An estimated 15,000 Americans a year die from the consequences of hepatitis C infection, which can cause liver scarring, liver failure and liver cancer, although such effects typically do not show up for decades, if at all.

About three-quarters of the more than three million Americans with hepatitis C are baby boomers, most of them infected decades ago. But most do not know it because they have no symptoms. Those at highest risk for the infection include users of injected drugs and recipients of blood transfusions before 1992, when screening of donated blood for the virus began.

The task force had said in a preliminary decision in November that screening all baby boomers would probably offer only a small benefit.

That finding put it at odds with the Centers for Disease Control and Prevention, which had said a few months earlier that all people born between 1945 and 1965 should be offered a one-time test to see if they are infected with the hepatitis C virus.

But the task force said on Monday that after reviewing some new studies and the public comments that it had received on its preliminary decision, it decided to recommend screening of baby boomers, saying there was a "moderate certainty" it would have a "moderate net benefit."

The decision is good for drug companies selling or developing drugs to treat hepatitis C, like Merck, Vertex, Gilead and AbbVie, because it means more people who harbor the virus but do not know it will be discovered, making them candidates for treatment. The decision could also help companies that make hepatitis C tests, like OraSure Technologies.

New drugs introduced by Merck and Vertex Pharmaceuticals have increased the cure rates for hepatitis C when used along with existing drugs. Companies including Gilead Sciences and AbbVie are racing to bring drugs to market in the next two or three years that would do away with the need for weekly injections of a harsh drug, alpha interferon.

The task force, which is made up of independent experts appointed by the government, said in its preliminary decision that the C.D.C. might have overestimated how many infected people would develop liver problems or die, thus overstating the benefits of screening.

But in its final decision, the task force said new studies and the growing effectiveness of treatment buttressed the case for screening even those without any symptoms or risk factors.

Many of those who had submitted public comments after the preliminary decision had argued that screening all baby boomers would be more effective than testing only those thought to be at risk, like people who had used injected drugs. Many people either do not remember risky behavior from decades ago or do not want to tell their doctors about it.

The task force's preliminary recommendation had a grade C, meaning testing could be offered to select patients and would probably have a small benefit. The final recommendation has a grade B, suggesting a moderate benefit.

Under the Affordable Care Act, preventive services that get a grade A or B from the task force are supposed to be provided without co-payments from patients, although some existing health plans are grandfathered in and would be exempt.

Although the task force is considered quasi-governmental — and its recommendations are meant for primary care physicians — it can be ignored. It encountered significant resistance from doctors and other medical experts when it recommended a reduction in mammography screening. It also got criticism over its recommendation against prostate screening, although the American Urological Association eventually reached a similar conclusion.

Legislators in New York State this month passed what advocates called the first state bill that would require hospitals and other health care providers to offer hepatitis C screening. The bill will now go to Gov. Andrew Cuomo for his signature.

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Phys Ed: The Rise of the Minimalist Workout

Phys Ed

Gretchen Reynolds on the science of fitness.

In an article under his byline for Sports Illustrated in December 1960, "The Soft American," President-elect John F. Kennedy lamented the state of the nation's fitness. As president he exhorted citizens to plunge into activities like 50-mile hikes.

As anyone sitting quietly and reading this article probably knows, that message did not resonate with most Americans. And these days, a majority get no planned exercise at all.

So at the recent annual meeting of the American College of Sports Medicine, one of the hottest topics was not how much exercise Americans should be completing, but how little.

Dozens of presentations and seminars examining a variety of activities concluded, essentially, that a few minutes of any strenuous exercise is sufficient to improve various measures of health and fitness.

"Everyone was talking" about those findings, said Linda S. Pescatello, a professor of kinesiology at the University of Connecticut, Storrs, who attended the conference, in Indianapolis. "It's very appealing, obviously, the idea that you can get fit in a very short period of time."

But she and other experts say there are still many unanswered questions about the long-term effects and efficacy of the wildly shrinking doses of exercise being studied and promoted by scientists and journalists, (including this writer).

"People have been trying to figure out forever what the right amount of exercise is," said Dr. Paul Thompson, a cardiologist at Hartford Hospital in Connecticut, who has long studied exercise.

In the past, formal recommendations have called for a substantial amount of regular exercise. For example, published guidelines from the Health and Human Services Department in 2008 suggested 150 minutes of moderate exercise per week — the equivalent of five 30-minute walks. The guidelines added that 75 minutes of vigorous exercise a week, like jogging, could be substituted.

These guidelines were based on a large body of science showing that 150 minutes of moderate exercise was associated with a longer life span and a reduced risk of heart disease, diabetes and other illnesses.

But in practical terms, the guidelines have not been a success. By most estimates, at least 80 percent of Americans don't meet the recommendations. That has led to the quest to find a smaller amount of exercise that will produce health and fitness benefits without intimidating the millions who don't work out.

And that, in turn, has resulted in the rise of interest in very brief, high-intensity interval training.

This approach to exercise started to take off in 2006, when Martin Gibala, a physiologist at McMaster University in Ontario, and his colleagues published a study showing that a three-minute sequence on an electronic stationary bicycle — 30 seconds of punishing, all-out pedaling followed by a brief rest, repeated five or six times — led to the same muscle-cell adaptations as 90 to 120 minutes of prolonged bike riding.

The study, which was published in The Journal of Physiology, soared to the top of the journal's "most e-mailed" list and stayed there for years.

Since then, Dr. Gibala and his colleagues, as well as other groups of scientists, have been closely parsing the effects of brief bouts of intense exercise, trying to determine just what happens in the body when you work it very hard for a short period of time, and what dosage of such intense effort is likely to be most effective and tolerable for a majority of people.

The most recent research suggests that a few minutes per week of strenuous exercise can improve aerobic fitness, generally more quickly than moderate activity does.

In a representative study, which I wrote about this week, Norwegian scientists found that three four-minute runs a week — at a pace equivalent to 90 percent of a person's maximal heart rate, an intensity that will feel, frankly, unpleasant — improved volunteers' endurance capacity by about 10 percent after 10 weeks.

Other recent studies have shown that 16 to 30 minutes per week (depending on the study) of highly intense exercise also improves certain markers of health, with volunteers developing improved blood pressure and blood sugar levels after several weeks of these truncated workouts.

But so far, all the studies have been small, usually with only a few dozen volunteers, most of them men and often young. None have been longer than a few months.

"We know from some very good epidemiological studies," said Dr. Thompson, "that 150 minutes of moderate exercise each week is clearly associated with improved health outcomes," including longevity and reduced risk of many diseases. What we don't know, he added, is whether that will be the case if people rely solely on a few minutes of intense exercise a week.

It's particularly unclear whether short, hard workouts can help people maintain their weight. Weight maintenance means burning more calories than consumed, Dr. Thompson said, and "these short sessions do not result in much energy expenditure."

Nor do they aid much in building muscle, Dr. Gibala said, adding that short, intense exercise "does not seem to stimulate the hypertrophic physiological pathways" that result in larger, stronger muscles.

What the new, abbreviated approach to exercise has going for it is brevity. In a 2011 study, eight male recreational runners in Britain reported preferring a workout of six three-minute intervals to one involving an easy 50-minute jog, because the interval session was soon over.

"It may not be the ideal form of exercise for everyone," Dr. Gibala said. "And we have a lot more science to do."

But he added: "I'm 45, with a family, and very busy," and he has found the brief, intense sessions to be very helpful. So, he said, "this is how I work out now."

Many scientists, in the United States and abroad, are conducting or planning additional studies of the effects of brief, intense training, Dr. Gibala said. But financing for large studies in this field is difficult to obtain, and results from long-term studies won't, of course, be available for years.

For now, he says, if you'd like to try a high-intensity session, first visit a doctor for clearance, then simply push yourself very hard during your next workout, whether it is running, cycling or Zumba.

Researchers haven't established a definitive period of time for an interval to provide maximum health benefits, Dr. Gibala said — although in his research and experience, a minute of hard effort followed by a minute of gentle recovery is effective.

Complete 10 such intervals three times a week for a total of 30 minutes of strenuous effort, he said, and "our data would indicate you'll be in pretty good shape."

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State Rewards Home Care Firms Once Rebuked

The cost of caring for frail elderly and disabled people at home had more than doubled from 2003 to 2010, to $1.3 billion, even though fewer people were being served. And that huge cost increase had been driven by just a half-dozen certified home health agencies out of 140, most located in Brooklyn.

Two names stood out: Excellent Home Care and Extended Home Care. During a broad investigation of Medicaid fraud he conducted as attorney general, Gov. Andrew M. Cuomo had showcased his role in reclaiming $3.7 million from Excellent and $9.5 million from Extended in a settlement of false-claims suits against them. The agencies admitted no wrongdoing.

Now a transformation of the state's long-term care system is in high gear, as the state has extended invitations to agencies to be a part of the new system. Among those chosen: Excellent and Extended.

"I don't know what an organization would have to do to be disqualified," said Susan Regan, a longtime member of the state's public health planning council who was outraged to discover, on Page 221 of a meeting agenda, that the Health Department had endorsed Excellent for an expanded license.

State officials view the new system as a national model for permanently curbing Medicaid costs. They said Excellent and Extended had both improved and had been approved to take on bigger roles through a standard application process.

But both companies' ties to policy makers run deep. Excellent's owners have contributed and raised money for both parties, and its lawyer has been a fund-raiser for Mr. Cuomo, a Democrat.

As for Extended, which paid $150,000 to the lobbying firm of former Senator Alfonse M. D'Amato of New York last year, and whose owners until recently included Joseph Zappala, a longstanding Republican fund-raiser, it was recommended for a new, potentially more lucrative role in the revamped system by Dean G. Skelos, the Republican leader in the State Senate. Under state law, the leaders of the Legislature can each nominate four agencies for such roles.

Extended was seeking a coveted role as a managed long-term care plan, and three months ago, the health commissioner awarded that H.M.O. status to the company after a yearlong review, according to its chief executive, Vincent Achilarre, who donated $10,000 last year to the Senate Republican Campaign Committee of New York.

"We earned this approval, and the support we received for our application, on the merits," Mr. Achilarre said in an e-mail that cited "high-quality care, delivered with compassion and understanding for our patients' needs."

In his nominating letter, Mr. Skelos cited Extended's "unique experience in working with a diverse home care population." A spokesman for the senator said, "As always, the decision was made on the merits."

Richard Azzopardi, a spokesman for Governor Cuomo, said: "As attorney general, the governor commenced action against these and other companies that also happened to contribute to his past campaigns, clearly demonstrating that there is no relationship between donations and government action."

Just who is involved in the other applications is hard to discern, because the Cuomo administration would not release the applications that have been approved, or those that are still pending.

Home care was originally promoted as a cheaper alternative to hospitals and nursing homes, but as agencies proliferated in the 1990s their billings soared, and government auditors were overwhelmed. Gov. Mario M. Cuomo imposed a moratorium on licensing new agencies in 1994, as President Bill Clinton did nationwide in 1997.

The administration of Gov. George E. Pataki soon opened a loophole: limited licenses for the care of groups with special needs. Extended and Excellent each secured one, contingent on their limiting service to people with developmental disabilities. The Health Department was supposed to monitor their compliance.

"It isn't like this is going to grow into thousands and thousands of cases," a member of the state's health planning council said in 1998, when Excellent's special license was granted. But by 2010, when the state finally took a look, Excellent did have thousands of patients, only 5 percent of whom had developmental disabilities, and was collecting $93 million from Medicaid.

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