Health

Treating Eating Disorders and Paying for It
By LESLEY ALDERMAN

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

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

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

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

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

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

The result?

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

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

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

Whatever the cause, early intervention is critical.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

“Something needs to be done,” said Dr. Emmanuel Katsanis, a bone marrow transplant expert at the University of Arizona. “There’s no doubt that people aren’t going to make it because of this decision. What do you tell someone? You need a transplant but you have to raise the money?”

Just before the Oct. 1 deadline, Mark Price, a father of six who was fighting leukemia, learned he needed a bone marrow transplant. But his doctor, Jeffrey R. Schriber, found donor matches for his transplant the very day the new rules went into effect, and Mr. Price no longer qualified for coverage by the Arizona Health Care Cost Containment System, the formal name for the state’s Medicaid program.

What happened next was at once inspirational and heart-rending.

Out of the blue, an anonymous financial donor quickly stepped forward and agreed to cover the hundreds of thousands of dollars needed for Mr. Price’s surgery. But Mr. Price died last weekend, after his cancer returned before the operation could be done. He was buried on Thursday, next to his grandfather.

“It’s not correct to say that he died as a result of the cuts,” said Dr. Schriber, who is active in lobbying for the financing to be restored. “Did it prey on his mind? Did it make his last days more difficult? No doubt.”

Elsewhere, the fund-raising is already under way.

Mr. Felix and others are now trying to raise enough for new organs through NTAF, a nonprofit organization based in Pennsylvania formerly known as the National Transplant Assistance Fund that helps transplant patients pay for their medical costs. National coverage of their plight has already led to more than $100,000 in donations for some of the patients affected by the budget cuts. The Felix family is also planning a yard sale this weekend so he does not lose the chance to get another liver.

There has been a flurry of lobbying to persuade the state to reverse the decision. Dr. Gruessner said he and others met with state health officials recently to propose other cuts associated with transplants, like eliminating tests typically conducted before surgery.

If the Legislature does decide to reconsider the cuts, one of the affected people, a plumber and father of three named Randy Shepherd, 36, who has an ailing heart and needs a transplant, plans to attend the debate.

“I’m trying not to take it personally,” he said of being cut out of the program. “None of the politicians had heard of me when they made their decision. They didn’t say, ‘Let’s kill this guy.’ ”
Congress Approves Child Nutrition Bill
By ROBERT PEAR

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

For the salad:

2 cups mizuna or arugula

3 cups shredded or diced cooked turkey

Salt and freshly ground pepper

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

1 bunch scallions, white part and green, thinly sliced

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

1/4 cup chopped cilantro

1 small red bell pepper, cut in thin strips

2 tablespoons coarsely chopped walnuts

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

For the dressing:

2 tablespoons fresh lime juice

1 tablespoon seasoned rice wine vinegar

1 garlic clove, minced or put through a press

2 teaspoons finely minced fresh ginger

1 tablespoon soy sauce

2 tablespoons dark Chinese sesame oil or walnut oil

2 tablespoons canola or peanut oil

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

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

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

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

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

Yield: Serves six.

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

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

Martha Rose Shulman is the author of “The Very Best of Recipes for Health.”
Microbe Finds Arsenic Tasty; Redefines Life
By DENNIS OVERBYE

Scientists said Thursday that they had trained a bacterium to eat and grow on a diet of arsenic, in place of phosphorus — one of six elements considered essential for life — opening up the possibility that organisms could exist elsewhere in the universe or even here on Earth using biochemical powers we have not yet dared to dream about.

The bacterium, scraped from the bottom of Mono Lake in California and grown for months in a lab mixture containing arsenic, gradually swapped out atoms of phosphorus in its little body for atoms of arsenic.

Scientists said the results, if confirmed, would expand the notion of what life could be and where it could be. “There is basic mystery, when you look at life,” said Dimitar Sasselov, an astronomer at the Harvard-Smithsonian Center for Astrophysics and director of an institute on the origins of life there, who was not involved in the work. “Nature only uses a restrictive set of molecules and chemical reactions out of many thousands available. This is our first glimmer that maybe there are other options.”

Felisa Wolfe-Simon, a NASA astrobiology fellow at the United States Geological Survey in Menlo Park, Calif., who led the experiment, said, “This is a microbe that has solved the problem of how to live in a different way.”

This story is not about Mono Lake or arsenic, she said, but about “cracking open the door and finding that what we think are fixed constants of life are not.”

Dr. Wolfe-Simon and her colleagues publish their findings Friday in Science.

Caleb Scharf, an astrobiologist at Columbia University who was not part of the research, said he was amazed. “It’s like if you or I morphed into fully functioning cyborgs after being thrown into a room of electronic scrap with nothing to eat,” he said.

Gerald Joyce, a chemist and molecular biologist at the Scripps Research Institute in La Jolla, Calif., said the work “shows in principle that you could have a different form of life,” but noted that even these bacteria are affixed to the same tree of life as the rest of us, like the extremophiles that exist in ocean vents.

“It’s a really nice story about adaptability of our life form,” he said. “It gives food for thought about what might be possible in another world.”

The results could have a major impact on space missions to Mars and elsewhere looking for life. The experiments on such missions are designed to ferret out the handful of chemical elements and reactions that have been known to characterize life on Earth. The Viking landers that failed to find life on Mars in 1976, Dr. Wolfe-Simon pointed out, were designed before the discovery of tube worms and other weird life in undersea vents and the dry valleys of Antarctica revolutionized ideas about the evolution of life on Earth.

Dr. Sasselov said, “I would like to know, when designing experiments and instruments to look for life, whether I should be looking for same stuff as here on Earth, or whether there are other options.

“Are we going to look for same molecules we love and know here, or broaden our search?”

Phosphorus is one of six chemical elements that have long been thought to be essential for all Life As We Know It. The others are carbon, oxygen, nitrogen, hydrogen and sulfur.

While nature has been able to engineer substitutes for some of the other elements that exist in trace amounts for specialized purposes — like iron to carry oxygen — until now there has been no substitute for the basic six elements. Now, scientists say, these results will stimulate a lot of work on what other chemical replacements might be possible. The most fabled, much loved by science fiction authors but not ever established, is the substitution of silicon for carbon.

Phosphorus chains form the backbone of DNA and its chemical bonds, particularly in a molecule known as adenosine triphosphate, the principal means by which biological creatures store energy. “It’s like a little battery that carries chemical energy within cells,” said Dr. Scharf. So important are these “batteries,” Dr. Scharf said, that the temperature at which they break down, about 160 Celsius (320 Fahrenheit), is considered the high-temperature limit for life.

Arsenic sits right beneath phosphorus in the periodic table of the elements and shares many of its chemical properties. Indeed, that chemical closeness is what makes it toxic, Dr. Wolfe-Simon said, allowing it to slip easily into a cell’s machinery where it then gums things up, like bad oil in a car engine.

At a conference at Arizona State about alien life in 2006, however, Dr. Wolfe-Simon suggested that an organism that could cope with arsenic might actually have incorporated arsenic instead of phosphorus into its lifestyle. In a subsequent paper in The International Journal of Astrobiology, she and Ariel Anbar and Paul Davies, both of Arizona State University, predicted the existence of arsenic-loving life forms.

“Then Felisa found them!” said Dr. Davies, who has long championed the idea of searching for “weird life” on Earth as well as in space and is a co-author on the new paper.

Reasoning that such organisms were more likely to be found in environments already rich in arsenic, Dr. Wolfe-Simon and her colleagues scooped up a test tube full of mud from Mono Lake, which is salty, alkaline and already heavy in arsenic, and gradually fed them more and more.

Despite her prediction that such arsenic-eating organisms existed, Dr. Wolfe-Simon said that she held her breath every day that she went to the lab, expecting to hear that the microbes had died, but they did not. “As a biochemist, this stuff doesn’t make sense,” she recalled thinking.

A bacterium known as strain GFAJ-1 of the Halomonadaceae family of Gammaproteobacteria, proved to grow the best of the microbes from the lake, although not without changes from their normal development. The cells grown in the arsenic came out about 60 percent larger than cells grown with phosphorus, but with large, empty internal spaces.

By labeling the arsenic with radioactivity, the researchers were able to conclude that arsenic atoms had taken up position in the microbe’s DNA as well as in other molecules within it. Dr. Joyce, however, said that the experimenters had yet to provide a “smoking gun” that there was arsenic in the backbone of working DNA.

Despite this taste for arsenic, the authors also reported, the GFAJ-1 strain grew considerably better when provided with phosphorus, so in some ways they still prefer a phosphorus diet. Dr. Joyce, from his reading of the paper, concurred, pointing out that there was still some phosphorus in the bacterium even after all its force-feeding with arsenic. He described it as “clinging to every last phosphate molecule, and really living on the edge.”

Dr. Joyce added, “I was feeling sorry for the bugs.”
Obesity Surgery May Become Option for Many More
By ANDREW POLLACK

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

One factor that is moving some experts to advocate surgery for lower body mass index levels is its effectiveness in resolving diabetes, hypertension and some other ills associated with obesity.

“There are dramatic metabolic effects that in many cases go well beyond the weight loss effects,” said Dr. Lee M. Kaplan, director of the weight center at Massachusetts General Hospital.

He said that while it was once thought that surgery worked mainly by mechanically restricting how much one can eat, it is becoming clear that gastric bypass, at least, has effects on hormones.

Some experts say body mass index does not adequately measure risk of health problems. For instance, Asians tend to get diabetes at a lower B.M.I. than whites.

“The B.M.I. limitation of 35/40, set in the period when the major objective of the operations was weight control, is no longer the primary appropriate guideline for the selection of candidates for bariatric surgery,” Dr. Walter J. Pories, a surgeon, and colleagues wrote in the journal Obesity earlier this year. Dr. Pories will be a member of the F.D.A. advisory committee on Friday.

Allergan, known mostly for its Botox product, which is approved for cosmetic and medical ailments like chronic migraines, wants to reverse slowing sales of the Lap-Band that the company attributes to the weak economy. In the first nine months of this year, sales of its obesity products, mostly Lap-Band, fell 4 percent, to $182.4 million.

Even if Allergan’s application is approved, perhaps a small fraction of the new candidates are likely to opt for surgery because many people avoid operations. “I don’t think it’s enough to overwhelm the health care system,” said Dr. Bruce Wolfe, president of American Society for Metabolic and Bariatric Surgery, whose executive council unanimously endorsed Allergan’s proposal. “That’s not happening with the people who are heavier and need it even more.”

The society says that 220,000 bariatric surgeries of all kinds were performed in the United States last year. That is more than twice as many as in 2003, but represents a small fraction of the potential pool.

Still, some less obese patients do want the surgery. Some online discussion boards tell of people who purposely gained weight to qualify, and some messages give advice to others on wearing hidden weights.

Rashida Brown says she wants surgery to help control her diabetes, high cholesterol and hypertension. But her insurer has refused to pay twice in the last few years. At the time, Ms. Brown, who is 5 feet 7 inches, weighed 195 to 220 pounds, putting her index below 35.

“I am willing to bet there are quite a few people in the same category as myself — just waiting,” said Ms. Brown, 53, a clinical social worker from Boston.

She may still have to wait, now that she weighs 175 pounds — putting her below even the proposed lower threshold.
F.D.A. Panel Rejects Expanded Use of Prostate Drug
By GINA KOLATA

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

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

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

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

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

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

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

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

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

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

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

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

Finasteride investigators published detailed analyses also reaching that conclusion.

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

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

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

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

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

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

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

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

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

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

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

This article has been revised to reflect the following correction:

Correction: December 3, 2010

An article on Thursday about the Food and Drug Administration’s decision not to approve two prostate drugs for use in reducing cancer risk misstated the academic affiliation of Dr. Ian Thompson, a urologist who led a study of one of the drugs, finasteride. He is with the University of Texas Health Science Center at San Antonio, not the University of Texas at San Antonio.
Opponents Take Aim at Limited Health Plans
By REED ABELSON

Maybe something isn’t always better than nothing.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Almost one-third of people who learn they are infected find out only when they fall seriously ill, the disease centers said, meaning they have presumably infected others during that time and have also missed the opportunity to get treatment.
Scans Could Aid Diagnosis of Brain Trauma in Living
By ALAN SCHWARZ

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

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

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

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

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

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

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

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

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

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