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Our Feel-Good War on Breast Cancer

Written By Unknown on Senin, 29 April 2013 | 13.57

I used to believe that a mammogram saved my life. I even wrote that in the pages of this magazine. It was 1996, and I had just turned 35 when my doctor sent me for an initial screening — a relatively common practice at the time — that would serve as a base line when I began annual mammograms at 40. I had no family history of breast cancer, no particular risk factors for the disease.

So when the radiologist found an odd, bicycle-spoke-like pattern on the film — not even a lump — and sent me for a biopsy, I wasn't worried. After all, who got breast cancer at 35?

It turns out I did. Recalling the fear, confusion, anger and grief of that time is still painful. My only solace was that the system worked precisely as it should: the mammogram caught my tumor early, and I was treated with a lumpectomy and six weeks of radiation; I was going to survive.

By coincidence, just a week after my diagnosis, a panel convened by the National Institutes of Health made headlines when it declined to recommend universal screening for women in their 40s; evidence simply didn't show it significantly decreased breast-cancer deaths in that age group. What's more, because of their denser breast tissue, younger women were subject to disproportionate false positives — leading to unnecessary biopsies and worry — as well as false negatives, in which cancer was missed entirely.

Those conclusions hit me like a sucker punch. "I am the person whose life is officially not worth saving," I wrote angrily. When the American Cancer Society as well as the newer Susan G. Komen foundation rejected the panel's findings, saying mammography was still the best tool to decrease breast-cancer mortality, friends across the country called to congratulate me as if I'd scored a personal victory. I considered myself a loud-and-proud example of the benefits of early detection.

Sixteen years later, my thinking has changed. As study after study revealed the limits of screening — and the dangers of overtreatment — a thought niggled at my consciousness. How much had my mammogram really mattered? Would the outcome have been the same had I bumped into the cancer on my own years later? It's hard to argue with a good result. After all, I am alive and grateful to be here. But I've watched friends whose breast cancers were detected "early" die anyway. I've sweated out what blessedly turned out to be false alarms with many others.

Recently, a survey of three decades of screening published in November in The New England Journal of Medicine found that mammography's impact is decidedly mixed: it does reduce, by a small percentage, the number of women who are told they have late-stage cancer, but it is far more likely to result in overdiagnosis and unnecessary treatment, including surgery, weeks of radiation and potentially toxic drugs. And yet, mammography remains an unquestioned pillar of the pink-ribbon awareness movement. Just about everywhere I go — the supermarket, the dry cleaner, the gym, the gas pump, the movie theater, the airport, the florist, the bank, the mall — I see posters proclaiming that "early detection is the best protection" and "mammograms save lives." But how many lives, exactly, are being "saved," under what circumstances and at what cost? Raising the public profile of breast cancer, a disease once spoken of only in whispers, was at one time critically important, as was emphasizing the benefits of screening. But there are unintended consequences to ever-greater "awareness" — and they, too, affect women's health.

Breast cancer in your breast doesn't kill you; the disease becomes deadly when it metastasizes, spreading to other organs or the bones. Early detection is based on the theory, dating back to the late 19th century, that the disease progresses consistently, beginning with a single rogue cell, growing sequentially and at some invariable point making a lethal leap. Curing it, then, was assumed to be a matter of finding and cutting out a tumor before that metastasis happens.

This article has been revised to reflect the following correction:

Correction: April 28, 2013

An article on Page 36 this weekend about breast cancer awareness misidentifies the reduction in the chance that a woman in her 50s will die of breast cancer over the next 10 years if she undergoes screening. It is .07 percentage points, not .07 percent.


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Video Scrutinizes Late-Term Abortion Practices at Bronx Clinic

Lila Rose, president of Live Action, said the group would release more videos as part of its campaign against late-term abortions. Sunday's video was shot at the Dr. Emily Women's Health Center on Southern Boulevard in the Bronx. The release comes as Gov. Andrew M. Cuomo, a Democrat, has thrown his support behind legislation that will guarantee a woman's right to an abortion after 24 weeks of pregnancy, if her health is in danger or if the fetus is not viable. The current law permits abortion after 24 weeks only if a woman's life is in danger, although it is not enforced because federal court rulings have allowed less restrictive late-term abortions.

"The gruesome and inhuman practices exposed in Gosnell's 'House of Horrors' are business as usual for the abortion industry in America," Ms. Rose said in a statement, calling on the New York State Health Department to investigate Dr. Emily and other clinics performing late-term abortions. Both the Health Department and Dr. Emily center did not respond to requests for comment.

Live Action, based in Arlington, Va., has previously made covert videos at several Planned Parenthood clinics in New York and other states in an effort to cut off the organization's government financing. On Sunday, the group posted two versions of its latest video, one condensed and one a few hours long.

When a pregnant woman posing as a patient asked what happens if the fetus accidentally "comes out" at home before the final procedure, a staff member replied, "If it comes out, it comes out. Flush it."

The woman also asked what happens if the removed fetus is still "twitching" or "breathing." The staff member said all aborted fetuses are placed in jars of solution and sent to a laboratory for weighing; if the fetus is still moving, "the solution will make it stop."

The longer video shows that the staff member has been assigned to record the woman's medical history, but is not an abortion counselor. In the same video, an abortion counselor gives the woman somewhat different explanations.

When the woman asks the counselor what will happen if the fetus emerges from the abortion breathing, the counselor explains that it is unlikely, but that the doctor will send it to a hospital or resuscitate it: "Once that pregnancy comes out alive, he will do everything he can to save it."

The counselor also explains that the woman will not be dilated enough to accidentally deliver at home.


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Arizona Haven for Deaf Faces Discrimination Charges

Joshua Lott for The New York Times

Mary Susan Case in her apartment at Apache ASL Trails, a subsidized complex in Tempe, Ariz.

TEMPE, Ariz. — When the subsidized housing complex for senior citizens opened its doors here last year, it already had a waiting list. Designed by a deaf architect to fit the needs of the deaf, its units have video phones and lights that flash when the phone or the doorbell rings. Wiring in common areas pipes announcements made through loudspeakers into residents' hearing aids.

The complex, meant to foster a sense of community among residents who use sign language to communicate and socialize, was the first of its kind in the Southwest. For the Arizona Department of Housing, which allocated federal money to help pay for it, it was a milestone, one that advocates for the disabled hoped would be a model for similar projects.

Preference was given to deaf and hard-of-hearing applicants, who occupy 69 of the complex's 75 units. The arrangement seemed to make sense; the state and the project's developer were convinced that they stood on solid legal ground.

But after an audit last year, the federal Department of Housing and Urban Development began raising questions.

The project, named Apache ASL Trails in a reference to American Sign Language, now finds itself in an unlikely spot, facing charges of discrimination for favoring deaf and hard-of-hearing people over others, disabled or not. The federal agency released its finding in January after examining marketing materials and the project's criteria for tenant selection, even though the developer assured it that the documents in question had been misinterpreted or were outdated.

Last June, HUD drafted a compliance agreement limiting the number of units set aside for deaf residents, which seems to have only stoked the dispute. State officials said the agency at one point threatened to withhold money from the state if it did not continue with the plan. But the state housing director, Michael Trailor, did not back down, saying he had to "stand up for the rights of disabled people."

Advocates for the disabled fear that the finding might complicate other projects in which federal money would be used to build housing for adults with special needs. Already, the Southwest Autism Research and Resource Center, based in Phoenix, has scrapped plans to use federal grants to help pay for a development designed for autistic adults, opting instead to pursue private financing.

Through combative legal correspondence and in emotional meetings, the parties in the Tempe project, working to negotiate a compromise, have argued over the meaning of the federal statute governing fair housing practices and the word "discrimination" as it applies to the deaf.

John Trasviña, HUD's assistant secretary for fair housing and equal opportunity, said in a statement that "federal law prohibits facilities that receive HUD funds from providing separate or different housing for one group of individuals with disabilities because this practice denies or limits access to housing for other individuals based on the types of disabilities they have." (The agency did not make Mr. Trasviña or other officials available for on-the-record interviews.)

In interviews, Mr. Trailor and the developer, Erich Schwenker of Cardinal Capital Management, which is based in Milwaukee, said the units were advertised in publications that focused on the deaf population, but also in the state's largest newspaper and in a local magazine.

"Our intention has never been to exclude, but to make sure the units are utilized to the fullest extent possible, as the law requires," Mr. Schwenker said.

The demands from HUD mobilized advocacy groups across the country. Last week, 75 of them signed a letter from the National Association of the Deaf to the federal housing secretary, Shaun Donovan, accusing HUD of "forcing deaf and hard-of-hearing individuals to only live according to an ideological vision of forced integration."

In an interview, the association's chief executive officer, Howard Rosenblum, said the approach "ignores the unique communication needs" of the deaf, making them more isolated. Denise Resnik, a co-founder of the Southwest autism center, said the agency's attitude felt "like reverse discrimination."

By Friday, HUD had scaled back its efforts. A spokesman said the agency had decided to "take a pause" in the negotiations to give the state and the developer time to submit evidence demonstrating the housing needs of the deaf population to justify the use of federal money in the project.


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Well: An Exam With Poor Results

In America, when a woman goes to her gynecologist, she is typically given a pelvic exam whether or not she has symptoms or concerns that might warrant one. That's one reason an estimated 63.4 million pelvic exams are performed annually in this country.

Now a growing number of experts are asking whether it's necessary to do so many.

"This is not the case in other countries that get better results without doing routine pelvic exams," Dr. Carolyn L. Westhoff, a gynecologist at Columbia University Medical Center, said in an interview.

"I'm an American gynecologist, and that's how we were trained. It took many years for me to ask, 'Why are we doing this?' "

For most women, Pap smears are now recommended just once every three to five years — and for some, not at all. No doubt many women would be delighted to skip the routine pelvic exam, too, which many find uncomfortable and embarrassing.

A woman undergoing the exam is bare below the waist. She lies on the examining table on her back with her knees bent and legs spread apart, her feet in stirrups and her buttocks near the end of the table. The doctor inserts a lubricated, gloved finger into her vagina and, with the other hand, presses down on her abdomen to check the shape and size of her uterus and ovaries.

It's called a bimanual exam. Dr. Westhoff is among an increasing number of experts now challenging the value of this time-honored practice, which is done as a matter of course when women come in for routine gynecological checkups or Pap smears.

These experts say that for women who are well, a routine bimanual exam is not supported by medical evidence, increases the costs of medical care and discourages some women, especially adolescents, from seeking needed care.

Moreover, the exam sometimes reveals benign conditions that lead to follow-up procedures, including surgery, that do not improve a woman's health but instead cause anxiety, lost time from work, potential complications and unnecessary costs.

"The number of women who follow this unfortunate path each year is unknown but is likely sizable given the sheer number of pelvic examinations performed each year in the United States," Dr. George F. Sawaya wrote in the Archives of Internal Medicine in December 2011.

"In my experience as a practicing gynecologist, I frequently have had to take patients into the operating room because I found an enlargement during a bimanual pelvic exam," Dr. Sawaya, a professor of obstetrics at the University of California, San Francisco, said in an interview.

"I then follow up with a sonogram which shows a mass, but I can't tell what the mass is without surgical exploration. Yet nearly always it's benign."

Dr. Sawaya says it's time to change this practice, in which doctors "put patients in a perilous situation and then act like they're rescuing them." He admits that his position "won't win any popularity contests, but I'm trying to do what's right for patients."

Dr. Westhoff and colleagues wrote in January 2011 in The Journal of Women's Health, "Frequent routine bimanual examinations may partly explain why U.S. rates of ovarian cystectomy andhysterectomy are more than twice as high as rates in European countries, where the use of the pelvic examination is limited to symptomatic women."

She and others say that the justifications gynecologists typically offer for doing the pelvic exam — screening for a sexually transmitted infection and cervical cancer, early detection of ovarian cancer, and evaluating a woman for hormonal contraception — either do not require a bimanual exam or are not supported by research.

In a multicenter trial supported by the National Cancer Institute, for instance, no cancers of the ovaries were detected by a pelvic examination alone. The test sometimes did produce suspicious findings that resulted in further procedures.

"The pelvic examination is not an effective screening tool for ovarian cancer," Ms. Analia Stormo, a researcher at the Centers for Disease Control and Prevention, and colleagues wrote last March in the journal Preventive Medicine.

Yet Ms. Stormo also found that "almost 70 percent of obstetrician-gynecologists reported believing that a pelvic examination is an effective means of screening for ovarian cancer."

To screen for sexually transmitted Chlamydia and gonorrhea, tests done on a urine sample or vaginal swab obtained by the patient "have numerous advantages" over the pelvic exam, Ms. Stormo and colleagues noted.

Although a pelvic exam has been traditionally coupled with prescriptions for contraception, both the American College of Obstetricians and Gynecologists and the World Health Organization have said that hormonal contraceptives like the birth control pill can be prescribed without first doing a pelvic exam.

"Whenever doctors are doing things by rote, we have to rethink whether what they're doing is really helpful," Dr. Sawaya said.

Dr. Westhoff concurs: "We should limit the well-woman checkup to proven procedures."

That is likely to be an uphill battle. Recent surveys by Dr. Sawaya and colleagues, among others, have shown that most gynecologists in the United States consider the routine bimanual exam of internal reproductive organs an important part of a well-woman visit. The practice is endorsed by the American College of Obstetricians and Gynecologists, which nonetheless admits that medical evidence to justify it is lacking.

In the latest study, published online in November in the college's journal, Jillian T. Henderson, an assistant professor of obstetrics at the University of California, San Francisco, Dr. Sawaya and colleagues examined the circumstances under which a national sample of obstetrician-gynecologists would conduct a bimanual pelvic exam. The doctors were presented four vignettes about healthy patients, ages 18, 35, 55 and 70, who come "for a routine health visit."

Nearly all 250 doctors who took the survey said they "would conduct bimanual pelvic examinations in routine visits with asymptomatic women across the life span," even in a 55-year-old woman described as having no ovaries, uterus or cervix.

Most of the clinicians surveyed said the exam was important to identify benign uterine fibroids, even though the value of this finding in women lacking symptoms is unclear, the team reported. Most clinicians also maintained that the pelvic exam was important "to reassure patients of their health."

How important is this exam to a doctor's income? Slightly more than half of those surveyed ranked "ensuring adequate compensation" as very important or moderately important.

One of the most vexing problems in medicine today is the fact that doctors get paid only for performing procedures, not for the time they spend talking with patients to discuss issues of possible medical importance.

The next time you see your gynecologist for a routine checkup, ask if a pelvic exam is planned and, if so, what the doctor expects it to accomplish.


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Well: Spring Pasta Recipes for Health

Written By Unknown on Sabtu, 27 April 2013 | 13.57

To make a quick meal with spring vegetables, try one of these new pasta dishes from Recipes for Health columnist Martha Rose Shulman. She writes:

The beautiful, sweet vegetables of spring ― artichokes and peas, favas and tender young asparagus, spring garlic and sweet spring onions ― come and go so quickly that I find myself impulse buying at the market and using them up in the simplest of dishes. They beg nothing more than pasta, and that's a good thing because many of these vegetables are labor-intensive. It's worth the time it takes to shell the peas, to free the heart of the artichoke from its leaves, to shell and skin favas. Then little more is required than a quick sauté or simmer with aromatics. You can always embellish, though, as I am doing this week with some recipes, with a pesto or, in the case of a baked orzo pastitsio with artichokes and peas, a béchamel.

In most of this week's recipes, a ladleful of the cooking water from the pasta ― which in many cases has also been used to blanch some of the vegetables ― stands in for a sauce. A small amount of this water, which has become starchy from the pasta, adds just enough moisture and body to the vegetable mix so that when you toss it with the pasta you'll get a moist, inviting combination that can be finished with cheese or not.

Here are five new ways to spring into pasta.

Orzo With Peas and Parsley Pesto: This is like a pasta version of the classic rice and peas risotto, risi e bisi.


Baked Orzo With Artichokes and Peas: A light yet comforting Greek-inspired dish enriched with béchamel.


Farfalle With Artichokes, Peas, Favas and Onions: The vegetable ragout is a simplified version of a classic Sicilian spring stew.


Penne With Peas, Pea Greens and Parmesan: A beautiful springtime pasta that makes the most of the pea plant.


Whole-Grain Pasta With Mushrooms, Asparagus and Favas: This dish has heft and depth, but still showcases the delicate flavors of spring.



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Living With Cancer: Living Without Hair

While packing up scarves and hats to mail to a member of my cancer support group, I remember her lament. "After the major loss of body parts, why do I weep over my lost hair?" she wondered. "I know it will grow back, but somehow it feels like the last straw — figuratively and literally!"

When my hair began falling out in clumps during chemotherapy, I asked a friend to shave my head. It hardly helped to conjure up Yul Brynner, Samuel Jackson and Daddy Warbucks, even though they seemed more realistic role models than the aliens played by gorgeous actresses. Why is this temporary loss different from all the other losses, at least for some cancer patients?

There are, after all, so many inventive ways to deal with alopecia. Many women exult in an assortment of wigs, ranging from zany to realistic, that lend them a chameleon ability to try on a variety of impersonations. "Cranial prostheses," which can be covered by health insurance, require less attention than their own hair and at times look more attractive. Others twist scarves into turbans or flaunt cowboy hats or fedoras.

Those who find wigs and caps uncomfortable or inauthentic often seek the courage to bare themselves in public. A few women use henna to produce elaborate designs and even political slogans on their scalps; you can see a henna tattoo on the Chemo Chicks Web site. Venturing out with adorned or unadorned bald heads, some want that sign to inform strangers of the arduous treatments to which they are subjecting themselves. Exposure might be considered an act of defiance, an appeal for sympathy, an effort to unsettle bystanders, or an assertion that bald is beautiful.

Yet it is hard for even the bravest not to feel vulnerable or despondent at first — and also cold. I doubt that this response springs from the historical use of head-shaving as a shaming device. How many people today know that after the war in Europe the heads of women who collaborated with the Nazis were shorn to expose them to scorn? Of course, the inmates of concentration camps were shaved as part of a grotesque process of dehumanization. When cancer patients suffer severe weight loss, they might see an image from Auschwitz in the mirror. But probably they, like me, reject such an analogy since we have voluntarily undertaken medical protocols for our own good.

Especially for women, does hair loss represent a loss of sexuality? As long ago as biblical times, Paul, who believed that a woman's long hair serves as her glory, preached that a woman's head should be veiled during prayer. From the wanton ringlets of Eve to the abundant tresses of Rapunzel and the synthetic mane of Barbie, luxuriant locks bespeak attractive femininity in opposition to the chaste head coverings of asexual nuns. Does hairlessness degender us? With my round dome atop loosefitting clothes, will I be mistaken for a man?

Of course, the loss of fur above reflects the (less discussed) loss of fur below. It seems odd that as genitals became visible, I felt further unsexed. When pubic hair disappeared, I hurtled backward into the period before latency. A man whose chin or chest no longer sprouts bristles can also be plummeted back to his childhood. As we careen forward into the past, do we fear that we will soon drop down on all fours and start drooling? Will our heads next loll onto our chests?

And what about all the other body curls? Will we, like them, be here today, gone tomorrow? Who praises the delicate threads of the nose until an ever-present handkerchief teaches us that without them we have perpetually runny noses? The disappearance of eyebrows and eyelashes looks like a de-facing. Without underarm hair, arm hair, leg hair, it is as if we are being erased. Hairless we may have come into the world, and now hairless we will leave it. We might dread every deceased follicle in light of Matthew's admonition about our looming mortality: "And even the very hairs on your head are numbered."

Not surprisingly, given the current vogue for youthful skin, the Web site called Hair Today, Gone Tomorrow turns out to be a commercial enterprise offering laser hair removal. But it reminds me of my girls' boisterous rendition of the children's song about Little Rabbit Fu Fu, hopping down the meadow, scooping up the field mice and bopping them on the head. Little Rabbit Fu Fu gets three chances to mend his rambunctious ways until the Good Fairy loses her patience and turns him into a goon: "Hare today, goon tomorrow."

Problem is that during my hairless days, I felt more like the field mice than the reckless rabbit. And now, with a thin pelt on my pate, I think more favorably of Little Rabbit Fu Fu's final condition. I'd rather be a goon than a goner.


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Well: God and Doctor

When he came to the hospital, he did not look well.

You might think that everyone with a recent leukemia diagnosis appears ill, but that isn't true. Some go to their primary care doctor with vague complaints of feeling tired or of having a cold, and a few hours after having their blood drawn are stunned to receive a phone call that they must get to the hospital immediately. Some get "stuck" in the Kübler-Ross stage of denial, refusing to believe they have leukemia even after they've received chemotherapy for it, or in the bargaining stage, negotiating for just one more bone marrow biopsy to confirm the diagnosis.

Others look like my new patient.

"His hemoglobin is 2.7," my leukemia fellow told me. A normal hemoglobin for a man should be closer to 15. "When we drew his blood, it came out almost clear."

"How many bags of blood are you going to give him?" I asked.

She hesitated. "He's refusing any blood product transfusions. He's a Jehovah's Witness."

The Jehovah's Witnesses are a religious group that believe, among other things, that only a minority of people reach heaven. They also believe that it is wrong to receive the tissue of another human being, and that doing so violates God's law, even if it is potentially lifesaving.

This presented quite an ethical quandary. To treat our patient's cancer adequately, we would need to give him chemotherapy at doses high enough to obliterate his entire bone marrow, at least for a while. During this time, he would not be able to manufacture his own red blood cells or platelets, so we would have to support him with transfusions — sometimes as frequently as daily. Supportive measures like blood product transfusions and antibiotics have led to a marked drop in mortality from the actual leukemia treatment over the past half century, to less than 5 percent. Without such supportive measures, death is almost guaranteed. Without chemotherapy, though, death is certain, at the hands of the leukemia itself.

My fellow and I walked into our patient's room to talk with him. He was lying in bed and surrounded by his relatives, who were sitting in chairs or on his bed. He smiled weakly at us, pale but handsome. We introduced ourselves to everyone and then started talking about how to treat his leukemia.

"So, you understand that the therapy we recommend has the potential to cure you, but it is unlikely you'll be able to survive the chemotherapy without receiving blood transfusions?" I summarized.

"I understand," he said.

"But if we don't treat your leukemia, you will die from it." I looked him in the eyes, at the crow's-feet that told me he had laughed a lot of times in his life, and down to his hands, holding those of his niece, sitting by his side. Tears were streaming down her cheeks.

"I know."

"I heard that you're a Jehovah's Witness. I come from a different background — I'm Jewish."

"Well, nobody's perfect!" his brother piped up. Everyone laughed, easing the tension in the room.

"I have different beliefs from you, so I can't say I totally understand where you're coming from, but I respect your faith, and we'll follow your lead on what you want to do," I told the patient. "You're the boss."

"No, he's the boss," he said, pointing toward the ceiling, and beyond. Others in the room nodded in agreement.

He declined transfusions, but he did want to receive chemotherapy, so we compromised on a lower-dose treatment, and minimized our lab draws to one per week, to preserve what blood he had. After two weeks his hemoglobin dropped to 2.1; after three weeks, it fell to 1.8. One month into his hospitalization, he became too dizzy to stand, and his heart, starved for the oxygen his missing red blood cells would have carried, just stopped beating. He went into cardiac arrest and died.

The staff on the leukemia floor took his death hard, all plagued by the same question: Had we done enough for him?

We enter our chosen profession to kill that malignant golem, leukemia. But our patient approached his leukemia focusing more on eternity than his time on earth. While many felt his belief had tied our hands so that we couldn't treat his leukemia optimally, ultimately our responsibility must be to our patient's goals more than to our own: in this case, his relationship to God, and his desire to reach heaven. I hope he made it.



Dr. Mikkael Sekeres is director of the leukemia program at the Cleveland Clinic.


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U.S. Files 2nd Suit Accusing Novartis of Kickbacks to Doctors

The United States government on Friday announced its second civil fraud lawsuit against the Swiss drug maker Novartis in four days, accusing a unit of the company of paying multimillion-dollar kickbacks to doctors in exchange for prescribing its drugs.

The authorities said that for a decade, the company lavished healthy speaking fees and "opulent" meals, including a nearly $10,000 dinner for three at the restaurant Nobu, to induce doctors to prescribe its drugs.

They said this led to the Medicare and Medicaid programs' paying millions of dollars in reimbursements based on kickback-tainted claims for medication like the hypertension drugs Lotrel and Valturna and the diabetes drug Starlix.

The charges are described in a whistle-blower lawsuit first filed against Novartis Pharmaceuticals by a former sales representative in January 2011 and which the federal government has now joined.

Twenty-seven states, the District of Columbia and Chicago and New York are also plaintiffs in the lawsuit, which seeks triple damages under the federal False Claims Act.

"Novartis corrupted the prescription drug dispensing process," Preet Bharara, the United States attorney in Manhattan, said in a statement. "For its investment, Novartis reaped dramatically increased profits on these drugs, and Medicare, Medicaid and other federal health care programs were left holding the bag."

On Tuesday, the government accused Novartis of inducing pharmacies to switch thousands of kidney transplant patients to its immunosuppressant drug Myfortic in exchange for kickbacks disguised as rebates and discounts.

Julie Masow, a Novartis spokeswoman, said the company disputed the claims in both lawsuits and would defend itself. Ms. Masow said speaker programs were "promotional programs" meant to inform physicians how to use the company's medicines.

Novartis "invests significant time and resources to help ensure these programs are conducted in an ethical and responsible manner," she said.


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New Bird Flu Strain Spreads Outside of China

Written By Unknown on Kamis, 25 April 2013 | 13.57

BEIJING — The new strain of avian influenza that has infected more than 100 people in China in the last two months has, for the first time, been reported outside mainland China.

Peter Parks/Agence France-Presse — Getty Images

On Tuesday, people in Shanghai took precautions after an outbreak of the H7N9 bird flu virus.

Officials in Taiwan reported one case in a 53-year-old Taiwanese citizen who traveled regularly to the Chinese city of Suzhou for work, where he probably contracted the virus. He fell ill on April 12, three days after returning to Taiwan. Tests revealed on Wednesday that he was infected with the H7N9 bird flu virus. As of Tuesday, Chinese officials had reported 108 cases and 22 deaths from the new flu.

The case has set off alarms in Taiwan, where the Central Epidemic Command Center says that it has "continued to strengthen surveillance and fever screening of travelers arriving from China."

The patient in Taiwan, described as severely ill, is being treated in a special isolation room, and 139 people who had contact with him — including 110 health workers — are being watched for symptoms. So far, there is no evidence that any have contracted the disease, which has not been found to spread from person to person.

Officials elsewhere in the region are increasingly jittery about the spread of the virus from China. On Wednesday, Japan said it was racing to make changes that would essentially allow local governments to consign bird flu patients or suspected patients to hospitals, and order them to stay away from their workplaces. The Japanese government took similar precautions during epidemics of the H5N1 and severe acute respiratory syndrome, or SARS, viruses in the last decade.

Hong Kong, scarred by an outbreak of SARS in 2003 that started with an infected visitor from mainland China and that killed 299 Hong Kong residents, has also been making preparations. Concerns have focused on the annual influx of vacationers from all over mainland China next week during the annual May Day holiday. But with nearly three dozen flights arriving on a typical day from Shanghai during the rest of the year, the possibility of the disease spreading has been a worry for health policy makers.

The Hong Kong government has put on standby several hundred hospital beds specially designed after SARS for the isolation and treatment of highly infectious respiratory diseases. A system of infrared scanners operating at the territory's borders ever since the SARS outbreak checks arrivals for fever, and nurses take aside anyone who seems sick for further questioning and sometimes testing.

In a news conference Wednesday in Beijing, a World Health Organization official described this type of bird flu as "unusually dangerous."

The virus is "definitely one of the most lethal influenza viruses we've seen," said Dr. Keiji Fukuda, an assistant director general at the World Health Organization.

"The potential development of human-to-human spread cannot be ruled out," the health organization said in a statement.

In the United States, scientists at the Centers for Disease Control and Prevention have received samples of the virus from China and have shared them with five other laboratories to study the virus and work on a vaccine.

Health officials in the United States have not advised against travel to China.

Scientists think people catch the virus from poultry, not from other humans. But if it could spread among people, a deadly pandemic could result. Researchers say it is worrisome that the new virus may be better than other types of bird flu at jumping from birds to humans.

The H5N1 bird flu virus, which emerged about a decade ago, has killed 371 people, nearly 60 percent of the 622 known to be infected since 2003, according to the World Health Organization. Because of its apparently high death rate, that virus touched off global fears of a lethal pandemic and led to the slaughter of millions of birds. But it could not be stamped out.

The patient in Taiwan said he had not been exposed to birds or eaten undercooked poultry or eggs. Cases like his have puzzled scientists and led some to suspect that an animal other than birds is harboring the virus and spreading it to humans. But so far no other animals have been found to be infected.

Bree Feng reported from Beijing, and Denise Grady from New York. Hiroko Tabuchi contributed reporting from Tokyo, and Keith Bradsher from Hong Kong.


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Legal Aid Ordered for Mentally Disabled Immigrants

A federal judge in California has ordered immigration courts in three states to provide legal representation for immigrants with mental disabilities who are in detention and facing deportation, if they cannot represent themselves. The decision is the first time a court has required the government to provide legal assistance for any group of people before the nation's immigration courts.

The ruling by Judge Dolly M. Gee, of federal court for the Central District of California, in Los Angeles, was handed down late Tuesday in a class-action lawsuit brought in 2010 by the American Civil Liberties Union, among other groups. One plaintiff in the case is José Antonio Franco González, 33, an immigrant who was detained for more than five years after his deportation case was closed, because severe mental retardation prevented him from arguing for himself in court or even understanding his situation.

On Monday, federal immigration officials issued a new policy that would, in practice, expand the California ruling nationwide, making government-paid legal representation available to people with mental disabilities in immigration courts in every state. The release of that policy indicates that the Justice Department, which runs the immigration courts, broadly accepts the approach ordered by Judge Gee.

The new practice is an unprecedented expansion of protections for people appearing before the immigration courts, lawyers and federal officials said. Unlike in the criminal courts, immigrants facing deportation or other proceedings do not have a right to a lawyer provided by the government, if they cannot afford to pay for one. Children, including those who are not accompanied by family members, and people with mental disabilities must represent themselves to fight deportation before immigration judges if they do not have private lawyers.

"It is the first step in recognizing that, given the complexity of our immigration laws, it is not appropriate to force a vulnerable population through the system without appointed counsel," Laura L. Lichter, president of the American Immigration Lawyers Association, said Wednesday.

Judge Gee also ordered immigration courts in the three states — Arizona, California and Washington — to offer bail hearings for immigrants with mental disabilities who have been detained for more than six months.

The judge said her order should take effect immediately, because without it, mentally disabled immigrants could not "fairly participate in removal proceedings" and could be exposed to "prolonged detention without adequate representation."

The federal government "has long taken the position that it does not have to provide representation for anyone in immigration court and that has now been rejected by the court," said Ahilan Arulanantham of the American Civil Liberties Union Immigrants' Rights Project, one of the lawyers who brought the lawsuit.

"With counsel, these mentally disabled immigrants will not only have the chance to present their best cases on why they should not be deported," said Michael H. Steinberg, a lawyer at Sullivan & Cromwell who worked on the case as a volunteer. "They will also have a chance to fight for release under bond."

Mr. Franco is an immigrant from Mexico who does not know his age, and cannot tell time or remember telephone numbers, according to court documents. Detained for deportation in April 2005, Mr. Franco was shuffled for five years among immigration detention centers in California without a hearing to determine whether he presented a safety risk or was mentally competent to face an immigration judge.

Mr. Franco had to represent himself even though a psychiatrist had determined he did not understand the proceedings. The class-action case started after a chance encounter between Mr. Franco and a lawyer for Public Counsel, another nonprofit group bringing the lawsuit.

Under Judge Gee's order, the immigration courts could provide representation by lawyers, by students participating in law school clinics, or by the immigration system's equivalent of a paralegal. While there are no precise numbers of how many mentally disabled immigrants would be affected by the new policy, lawyers estimated it could be several thousand people a year.

Under the new guidelines by the Executive Office for Immigration Review, the Justice Department branch in charge of the courts, immigration judges will be able to order mental competency hearings for immigrants who, based on medical or other records, may have serious disorders. The judge can order legal assistance for an immigrant at government expense, said Lauren Alder Reid, a spokeswoman for the immigration office.

At the request of the Obama administration, a bipartisan bill before the Senate to overhaul the immigration system includes provisions to provide lawyers to young unaccompanied children and the mentally disabled in immigration court. Justice officials have argued that although the federal government would have new costs to pay for legal assistance, the measures would save money over all by reducing expensive prolonged detention for disabled immigrants.


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Boston Bomb Victims’ Hidden Injury: Hearing Loss

Initially preoccupied by the severe injuries sustained by victims of the Boston bombings, hospitals are now grappling with a more subtle medical consequence: widespread hearing loss among those closest to the blasts.

Acoustic trauma of this sort can rupture the delicate eardrum, and hearing experts at several hospitals in Boston said on Wednesday that torn eardrums accounted for most of the hearing loss they have seen among those near the explosions.

In most of these cases, the eardrum will heal in a few weeks or months. If not, a tear can be repaired with an outpatient surgical reconstruction called a tympanoplasty, which can restore normal hearing.

But proximity to an explosion also can cause "sensorineural" hearing loss: damage to hair cells in the inner ear, which is potentially permanent, said Dr. Daniel Lee, an ear surgeon at Brigham and Women's Hospital in Boston. Hair cells cannot be regenerated.

"We're generally seeing patients who have a conductive hearing loss associated with traumatic eardrum perforation," he said. "Some of the patients may develop a progressive sensorineural hearing loss in the future."

At present, most of the patients with sensorineural damage have suffered only mild to moderate hearing loss. There is great variability in the hearing loss experienced by people exposed to acoustic trauma, based on things like which way they were facing or what was between them and the explosion.

Nick Yanni, 32, a student at Bunker Hill Community College, and his wife, Lee Ann Yanni, 31, a physical therapist, were 10 feet from the first bomb when it went off. Ms. Yanni said she immediately lost hearing in her left ear, but at the time was far more worried about her broken left fibula.

At the emergency room at Tufts Medical Center, she struggled to answer doctors' muffled questions about her leg.

Mr. Yanni discovered at the E.R. that he could not hear in either ear and tried to read lips. An hour or two later, his ears became painfully sensitive to background noise, so he put in earplugs. By nightfall, his hearing had returned.

"We were standing right next to each other," Ms. Yanni said. "His hearing loss turned out to be temporary, and mine is lasting."

After three operations for her leg fracture in five days, she was discharged on Monday. "I know I can function even if my hearing isn't perfect, but I'd like to get it back," Ms. Yanni said.

Within 24 hours of the bombings, Beth Israel Deaconess Medical Center in Boston began auditory evaluations of bombing victims after several mentioned that voices sounded as if they were underwater or that their own voices seemed louder.

Dr. Selena E. Heman-Ackah, medical director of otology, neurotology and audiology at Beth Israel Deaconess, has evaluated roughly 20 patients with hearing loss in wake of bombings. All but two suffered perforations of the eardrums, she said.

Given the loudness of the explosions, Dr. Heman-Ackah said she expected to see more patients with nerve-related hearing loss. She believes that the eardrum perforations might have been protective against the more permanent neural loss.

The night of the bombings, Dr. Alicia M. Quesnel, an ear specialist at the Massachusetts Eye and Ear Infirmary, began doing consultations with some patients injured by bomb blasts, once they had been stabilized, using a tuning fork to gauge the type of auditory loss.

If patients can hear the tuning fork touching their skull, the hearing loss is probably conductive — related to a torn eardrum or damage to the tiny bones behind it. But if they can hear a tuning fork held in front of the ear better, or cannot hear either one, Dr. Quesnel said, "you worry about inner ear hearing loss that's neural."

"Most of what we are seeing is conductive hearing loss," she said. "It will either heal on its own, or down the line they won't end up with a huge hearing loss because it can be fixed."

Dr. Jonathon Sillman, an ear specialist at Tufts Medical Center, has evaluated about 10 bombing victims for hearing injuries. All were given audiograms as soon as they could sit in a wheelchair in a soundproof booth.

"One of the most striking things about this experience is how variable the injuries were," Dr. Sillman said.

One patient was standing next to a person who lost her legs, he said, yet "her only injury is one perforated eardrum with no neural hearing loss." He suspects the person who lost her limbs must have shielded his patient from the energy of the blast.


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Study Ties Autism Risk to Creases in Placenta

After most pregnancies, the placenta is thrown out, having done its job of nourishing and supporting the developing baby.

But a new study raises the possibility that analyzing the placenta after birth may provide clues to a child's risk for developing autism. The study, which analyzed placentas from 217 births, found that in families at high genetic risk for having an autistic child, placentas were significantly more likely to have abnormal folds and creases.

"It's quite stark," said Dr. Cheryl K. Walker, an obstetrician-gynecologist at the Mind Institute at the University of California, Davis, and a co-author of the study, published in the journal Biological Psychiatry. "Placentas from babies at risk for autism, clearly there's something quite different about them."

Researchers will not know until at least next year how many of the children, who are between 2 and 5, whose placentas were studied will be found to have autism. Experts said, however, that if researchers find that children with autism had more placental folds, called trophoblast inclusions, visible after birth, the condition could become an early indicator or biomarker for babies at high risk for the disorder.

"It would be really exciting to have a real biomarker and especially one that you can get at birth," said Dr. Tara Wenger, a researcher at the Center for Autism Research at Children's Hospital of Philadelphia, who was not involved in the study.

The research potentially marks a new frontier, not only for autism, but also for the significance of the placenta, long considered an after-birth afterthought. Now, only 10 percent to 15 percent of placentas are analyzed, usually after pregnancy complications or a newborn's death.

Dr. Harvey J. Kliman, a research scientist at the Yale School of Medicine and lead author of the study, said the placenta had typically been given such little respect in the medical community that wanting to study it was considered equivalent to someone in the Navy wanting to scrub ships' toilets with a toothbrush. But he became fascinated with placentas and noticed that inclusions often occurred with births involving problematic outcomes, usually genetic disorders.

He also noticed that "the more trophoblast inclusions you have, the more severe the abnormality." In 2006, Dr. Kliman and colleagues published research involving 13 children with autism, finding that their placentas were three times as likely to have inclusions. The new study began when Dr. Kliman, looking for more placentas, contacted the Mind Institute, which is conducting an extensive study, called Marbles, examining potential causes of autism.

"This person came out of the woodwork and said, 'I want to study trophoblastic inclusions,' " Dr. Walker recalled. "Now I'm fairly intelligent and have been an obstetrician for years and I had never heard of them."

Dr. Walker said she concluded that while "this sounds like a very smart person with a very intriguing hypothesis, I don't know him and I don't know how much I trust him." So she sent him Milky Way bar-size sections of 217 placentas and let him think they all came from babies considered at high risk for autism because an older sibling had the disorder. Only after Dr. Kliman had counted each placenta's inclusions did she tell him that only 117 placentas came from at-risk babies; the other 100 came from babies with low autism risk.

She reasoned that if Dr. Kliman found that "they all show a lot of inclusions, then maybe he's a bit overzealous" in trying to link inclusions to autism. But the results, she said, were "astonishing." More than two-thirds of the low-risk placentas had no inclusions, and none had more than two. But 77 high-risk placentas had inclusions, 48 of them had two or more, including 16 with between 5 and 15 inclusions.

Dr. Walker said that typically between 2 percent and 7 percent of at-risk babies develop autism, and 20 percent to 25 percent have either autism or another developmental delay. She said she is seeing some autism and non-autism diagnoses among the 117 at-risk children in the study, but does not yet know how those cases match with placental inclusions.

Dr. Jonathan L. Hecht, associate professor of pathology at Harvard Medical School, said the study was intriguing and "probably true if it finds an association between these trophoblast inclusions and autism." But he said that inclusions were the placenta's way of responding to many kinds of stress, so they might turn out not to be specific enough to predict autism.

Dr. Kliman calls inclusions a "check-engine light, a marker of: something's wrong, but I don't know what it is."

That's how Chris Mann Sullivan sees it, too. Dr. Sullivan, a behavioral analyst in Morrisville, N.C., was not in the study, but sent her placenta to Dr. Kliman after her daughter Dania, now 3, was born. He found five inclusions. Dr. Sullivan began intensive one-on-one therapy with Dania, who has not been given a diagnosis of autism, but has some relatively mild difficulties.

"What would have happened if I did absolutely nothing, I'm not sure," Dr. Sullivan said. "I think it's a great way for parents to say, 'O.K., we have some risk factors; we're not going to ignore it.' "


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Smoking? Combat? Wait Until 21 to Decide, Young Recruits Say

Written By Unknown on Rabu, 24 April 2013 | 13.57

Nicole Michell Phipps, a soft-spoken 21-year-old woman in a furry hood who showed up at the Navy recruitment center in Harlem on Tuesday, said she was drawn to the military in search of more "structure" in her life.

She was hesitating about signing up for the military because she knew she could be risking her life. At 18, she said, she had not been ready for such a choice.

"I would say, yeah, 18, you just come out of high school," Ms. Phipps said. "You're really not sure what to do. I would say 21 is probably the best."

The same went for smoking, she said. Voting? "I think 18 is good for that," she said. "It's not causing harm to your body."

When New York City officials proposed on Monday to raise the minimum age to legally buy tobacco in the city to 21 from 18 — which would make it the highest of any major city in the United States — people across the country, commenting on news Web sites, were outraged by a seeming inconsistency. Updating a well-traveled argument about minimum drinking ages, they considered it ludicrous that 18-year-olds would be able to fight in wars but not buy cigarettes.

As it turned out, many of the young people walking into the military recruitment center on 125th Street the next day also saw the inconsistency. In general, they thought that it was true that they were not mature enough to make life-or-death decisions on their own before 21. That applied not only to smoking and drinking, but also to combat.

They saw a dangerous world out there, and they wanted to be protected from it as long as they could be.

If it were up to them, they said, no one could fight in a war until 21. And if the city wanted to act in loco parentis on something as bad as smoking, well then, that seemed right to them, too.

Patrick Brown, a lanky 21-year-old with braces on his teeth, said that just three years ago, he would never have enlisted on his own. It would have to be "50-50" with his mother, and even now, he said, he had consulted her, and felt better knowing that "she was O.K. with it."

Eighteen, Mr. Brown said, is too young to fight and die for your country.

Is it too young to smoke? "If the parent condones it, then I guess it's acceptable," Mr. Brown, a nonsmoker, said.

Ms. Phipps said she had once tried cigarettes but did not like them. Every decision is like a life lesson, Ms. Phipps said. "At 18, you are supposed to make bad decisions."

Brain experts say that Ms. Phipps is right, that the teenage brain is different.

"The executive function, the portion of the brain which is capable of making certain types of decisions, is really not fully developed until actually over 21," said Cheryl G. Healton, dean of Global Public Health at New York University, and a supporter of the higher age minimum.

Older adults with the benefit of a lot of hindsight might tend to agree. But a few veterans interviewed Tuesday saw the city's proposal as patronizing.

Raul Gonzalez, 34, of the Bronx, a corporal in the Persian Gulf War, smokes a pack of cigarettes a day as a way to take his mind off back pain from years of lifting heavy artillery.

"If you're old enough to serve your country, then you're old enough to make your own decisions on what you do to your body," he said while outside a Veterans Affairs center in Lower Manhattan.

But a few moments later, he began to rethink his position. "It could help a lot of people out," noting that a week ago he buried his 60-year-old father, a heavy smoker who died from throat cancer. But Mr. Gonzalez added that for anyone under 21 who is serving in the military, "there should be exceptions" to the law.

At the Harlem recruitment center, Dana Farmer Jr., 24, said he thought that 18-year-olds were not mature enough to make decisions about war or smoking, but also that raising the age to buy cigarettes would not stop them from smoking if they wanted to.

He said he hoped to play tenor sax in the Navy band as a strategy to avoid being shot at in Afghanistan. He was considering signing up so he could pay off his college loans faster than if he continued to work for low wages at Duane Reade, but he knew he was potentially endangering his life. "You've got to take the good with the bad," he said.

At 18, was he mature enough to figure that out? He answered instantly: "No, no, no."

Meredith Mandell contributed reporting.


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U.S. Accuses Novartis of Providing Kickbacks

Federal prosecutors in New York filed a lawsuit on Tuesday accusing Novartis of providing illegal kickbacks to pharmacies, in the form of discounts and rebates, to promote use of one of the company's drugs.

"Using the lure of kickbacks disguised as rebates, Novartis co-opted the independence of certain pharmacists and turned them into salespeople for one of its drugs," Preet Bharara, the United States attorney for the Southern District of New York, said in a statement.

The drug involved, Myfortic, is an immune suppressant used to help prevent rejection of transplanted kidneys. It competes with the Roche drug CellCept and, since 2009, with generic versions of CellCept.

The lawsuit, filed in Federal District Court in Manhattan, contended that Novartis promised rebates and discounts to 20 or more pharmacies if they would persuade doctors to switch patients to Myfortic from CellCept, or to keep patients on Myfortic after the cheaper generic versions of CellCept reached the market.

Novartis said in a statement that it disputed the government's claim and would defend itself.

In filing the suit, the federal government is intervening in a whistle-blower lawsuit that remains under seal, as does the identity of the whistle-blower.

Pharmacies can profit if the amount they are paid for a drug by patients, or their insurers, including Medicare and Medicaid, exceeds what they pay to buy the drug. Getting a discount on the drug from a manufacturer can increase a pharmacy's profit.

Prosecutors say in their lawsuit that Medicare and Medicaid paid tens of millions of dollars in claims for Myfortic that were "tainted" by the kickbacks.

That does not mean, however, that Medicare and Medicaid lost that much. CellCept and Myfortic cost about the same, according to the lawsuit, so switches from the brand name CellCept to Myfortic would not have appreciably raised federal costs.

Moreover, the suit notes, there are hundreds of pharmacies that prescribe Myfortic and the purported kickback scheme involved only about 20 of them, affecting just "hundreds, possibly thousands" of patients.

The suit says, however, that Novartis chose particularly influential pharmacies which could earn tens or hundreds of thousands of dollars in rebates.

The suit says that pharmacies couched their advice to doctors to use Myfortic as professional recommendations, concealing any mention of the financial inducement the pharmacy was receiving from Novartis.

While the contracts between Novartis and the pharmacies mentioned the discounts, the commitments Novartis received in return were left out of the contracts, the suit says.

In one example, the suit says that Novartis directed more than $650,000 in kickbacks to Bryant's Pharmacy in Batesville, Ark., which submitted 8,300 Myfortic claims to Medicare Part B alone, receiving more than $3.2 million in reimbursement.

The suit, citing an internal memo by a Novartis account manager, says Bryant's drove its annual Myfortic sales to more than $1 million a year from $100,000. And when the generic version of CellCept arrived in 2009, the pharmacy argued to doctors that patients doing well on Myfortic should not be switched.

Steve Bryant, owner of Bryant's Pharmacy, said doctors made the decisions on which drug to use. He said the discounts were given by Novartis to make it affordable for the pharmacy to dispense Myfortic without losing money from inadequate Medicare reimbursement.

None of the pharmacies was named as a defendant in the lawsuit.

Myfortic is one of Novartis's top 20 drugs, though not a star. Sales in the United States were $239 million in 2012, up 20 percent from 2011. Global sales were $579 million.


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‘Accountable Care’ Helping Hospitals Keep Medical Costs Down

Nathan Weber for The New York Times

Noraine Scarpelli, at an Advocate Health Care hospital.

CHICAGO — On a stormy evening this spring, nurses at Dr. Gary Stuck's family practice were on the phone with patients with heart ailments, asking them not to shovel snow. The idea was to keep them out of the hospital, and that effort — combined with dozens more like it — is starting to make a difference: across the city, doctors are providing less, but not worse, health care.

Nathan Weber for The New York Times

Dr. Karen O'Mara monitoring intensive care patients, ready to alert a doctor if they need help.

For most health care providers, that would be cause for alarm. But not for Advocate Health Care, based in Oak Brook, Ill., a pioneer in an approach known as "accountable care" that offers financial incentives for doctors and hospitals to cut costs rather than funnel patients through an ever-greater volume of costly medical services. Under the agreement, hospital admissions are down 6 percent. Days spent in the hospital are down nearly 9 percent. The average length of a stay has declined, and many other measures show doctors providing less care, too.

This approach is one small part of a growing effort by providers to hold down costs without restricting needed care. Nationwide, health care spending has grown over the last three years at the slowest rate since the federal government started keeping data more than 50 years ago. While the bulk of that is related to the poor economy, changes among insurers and health care providers have contributed as well. If the trend continues, even at a reduced pace, it could help alleviate Washington's long-term deficit problems and ease the strain on family budgets.

"The part that's not driven by the economy, that's the part we can theoretically control," said Drew Altman, president of the Henry J. Kaiser Family Foundation. "If we can shave even a small percentage off of it, it has a huge impact on public programs, a huge impact on premiums, a huge impact on employers."

But even as more health systems seek to replicate Advocate's early success, its experience shows just how hard it may be to expand the approach and keep medical costs from resuming their relentless rise.

"It's hard to imagine that you could start from scratch and do this and be successful in three years, said Dr. Lee Sacks, Advocate's chief medical officer, noting that other systems may find it far harder to flip the traditional fee-for-services system on its head. "We had a running head-start going back to 1995."

Nonetheless, the Affordable Care Act, President Obama's health care law, has helped encourage a shift to Advocate's payment model. Such agreements were merely a theory four years ago. But an estimated 428 accountable-care organizations now cover four million Medicare enrollees and millions more people with private insurance.

Under Advocate's deal with Blue Cross Blue Shield, certain patients are assigned to the accountable care framework — about 380,000 — and their health costs are projected. If Advocate achieves savings below that amount while meeting explicit quality targets, it splits the money with the insurer. If not, its revenue is at risk.

In some ways, accountable care resembles earlier efforts to control medical spending, including the health maintenance organizations that proliferated in the 1980s but fell out of favor, in part because they severely limited patients' choices. But accountable care differs by giving doctors and hospitals a direct financial stake in saving money and a reason to invest in various programs of preventive care rather than relying exclusively on the fees they would normally earn from providing services.

"There's an enormous amount at stake in getting these reforms to work," said Alan Krueger, the chairman of President Obama's Council of Economic Advisers.

To help control costs, Advocate has hired scores of workers to coordinate care and keep an eye on the highest-cost patients, like those who are obese or have diabetes. It started providing doctors' offices with report cards on their performance. Dozens of quality-control measures cover items as varied as blood pressure, rehospitalizations for asthma attacks or the use of expensive imaging machines.

On a blustery spring morning, those changes were visible in Advocate care centers across the metropolitan area. Sumera Khan, a clinical pharmacy specialist, popped into the hospital room of Noraine Scarpelli, an elderly woman with congestive heart failure, to check her prescription drug levels, an additional level of scrutiny that can help prevent complications. In another building, Dr. Karen O'Mara flicked between eight computer screens, peering at intensive care patients miles away, ready to alert a doctor if they looked in distress.

Advocate, a faith-based nonprofit, has an advantage over other health systems just jumping into what is more broadly known as "value-based care." In the late 1990s, well before it forged its contract with Blue Cross Blue Shield, Advocate began taking steps to control costs and improve quality. A decade ago it adopted a "clinical integration" program, requiring doctors to work together on patients in common. It was also a pioneer in the use of electronic health records.


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Well: Do We Have to Cool Down After Exercise?

Phys Ed

Gretchen Reynolds on the science of fitness.

Do you often, if guiltily, skip cooling down after exercise? A small but soothing body of new research suggests that you aren't missing out on much.

Most of us were taught in elementary school gym classes that the body requires a formal period of cooling down after a workout or competition. Instructors told us that by slowing to a jog or otherwise lessening the intensity of the workout, followed by stretching or otherwise transitioning out of physical activity, we would prevent muscle soreness, improve limberness and speed physiological recovery. All of this would allow us to perform better physically the next day than if we hadn't cooled down.

But under scientific scrutiny, none of those beliefs stand up well.

In a representative study published last year in The Journal of Human Kinetics, a group of 36 active adults undertook a strenuous, one-time program of forward lunges while holding barbells, an exercise almost guaranteed to make untrained people extremely sore the next day. Some of the volunteers warmed up beforehand by pedaling a stationary bicycle at a very gentle pace for 20 minutes. Others didn't warm up but cooled down after the exercise with the same 20 minutes of easy cycling. The rest just lunged, neither warming up nor cooling down.

The next day, all of the volunteers submitted to a pain threshold test, in which their muscles were prodded until they reported discomfort. The volunteers who'd warmed up before exercising had the highest pain threshold, meaning their muscles were relatively pain-free.

Those who'd cooled down, on the other hand, had a much lower pain threshold; their muscles hurt. The cool-down group's pain threshold was, in fact, the same as among the control group. Cooling down had bought the exercisers nothing in terms of pain relief.

Similarly, in two other studies published last year, one in The Journal of Human Kinetics and the other in The Journal of Strength and Conditioning Research, professional soccer players in Spain underwent a series of physical tests to benchmark their vertical leap, sprinting speed, agility and leg muscle flexibility, and then completed a normal soccer practice. Afterward, some of the players simply stopped exercising and sat quietly on a bench for 20 minutes, while others formally cooled down with 12 minutes of jogging and 8 minutes of stretching.

The next day, the players repeated the physical tests and also told the scientists how sore their legs felt, an assessment with which professional athletes tend to be familiar.

It turned out that there were almost no differences between the two groups of players. The cool-down group could, on average, leap a little higher the next day than those who'd sat around for 20 minutes, but the difference was slight. And on all of the other measures of performance, flexibility and muscle soreness, the groups were the same.

The available data "quite strongly suggest a cool-down does not reduce postexercise soreness," says Rob Herbert, a senior research fellow at Neuroscience Research Australia and senior author of what is probably the foundational study of cooling down, from 2007. In that experiment, healthy adults walked backward downhill on a treadmill for 30 minutes, courting sore muscles and curious stares from fellow gymgoers. Some of the volunteers first walked forward for 10 minutes as a warm-up; others did the same afterward, to cool down. Others didn't warm up or cool down.

Two days later, the group that had cooled down was every bit as sore as the control group.

Given all of these findings, then, is there any valid reason to cool down?

Yes, says Andrea Fradkin, an associate professor of exercise science at Bloomsburg University in Pennsylvania. "A cool-down has been shown to prevent venous pooling after exercise," or the buildup of blood in the veins, she says. During prolonged, vigorous exercise, the blood vessels in your legs expand, meaning that more blood moves through them. Stop exercising abruptly, and that blood pools in your lower body, which can lead to dizziness or even fainting.

The condition is easy to combat, though. Just walk for a few minutes at the end of a workout and you'll maintain normal circulation to the brain, says Ross Tucker, a South African physiologist and a founder of the estimable Web site The Science of Sport. "And that's not really a cool-down," as most of us would define the procedure, he says.

Still, if a formal cool-down provides few confirmed physiological benefits, it may have a scientifically squishy, but nevertheless worthwhile psychological effect. "If you've done a very hard track session, it's nice to end with some light jogging," Dr. Tucker says, just to restore a subjective "sense of normality to your legs."

A cool-down, in other words, feels nice.

And it's important to note that "none of the scientific research shows any negative effects due to performing a cool-down," Dr. Fradkin says.

So, in essence, the available science suggests that whatever you're doing now at the end of a workout is probably fine.

"My feeling is that" unless future science shows otherwise, "people shouldn't worry about it," Dr. Herbert says. "If they like to cool down, then it's not going to hurt them. But if they don't feel like it, then they shouldn't feel a need to do it."


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New York Proposes Raising Minimum Age for Cigarette Purchases

Written By Unknown on Selasa, 23 April 2013 | 13.57

Victor J. Blue for The New York Times

A store in Bushwick, Brooklyn, that sells cigarettes. The legal age for buying them should be raised to 21, some city leaders say.

The age to legally buy cigarettes in New York City would rise to 21 from 18 under a proposal that officials unveiled on Monday, a measure that would give New York the strictest limits of any major American city.

The proposal would make the age for buying cigarettes and other tobacco products the same as for purchasing liquor, but it would not prohibit people under 21 from possessing or even smoking cigarettes.

It is the latest effort in a persistent campaign to curb smoking that began soon after Mayor Michael R. Bloomberg took office, with bans on smoking in restaurants and bars that expanded more recently to parks, beaches, plazas and other public places.

But this latest proposal, announced by Dr. Thomas A. Farley, the city's health commissioner, and Christine C. Quinn, the City Council speaker and a mayoral candidate, puts New York squarely into the middle of a debate over the rights and responsibilities of young people, and it drew much skepticism. At 18, New Yorkers are old enough to fight in wars, to drive and to vote, but if the smoking restriction passed they would be prohibited from deciding whether to take the risk of smoking.

Ms. Quinn and Dr. Farley defended the proposal, saying that people typically make the transition from experimental smoking to regular smoking around age 20, and that by making cigarettes harder to obtain at a young age the city would make it less likely that people would become lifelong addicts.

"With this legislation, we'll be targeting the age group at which the overwhelming majority of smokers start," Ms. Quinn said in announcing the legislation at a City Hall news conference.

While officials focused on the public health aspect of the age limitation, the announcement was also infused with political overtones. In the past, Mr. Bloomberg had always been on hand, standing in front of television cameras to boldly promote public health initiatives. But on Monday he was nowhere to be seen, allowing Dr. Farley to represent the administration and seemingly ceding the spotlight to Ms. Quinn, who initiated the proposal.

By proposing the legislation, Ms. Quinn, a Democrat who polls show is a leading candidate to succeed Mr. Bloomberg, appeared to be positioning herself to follow in his footsteps as a mayor who would make public health a top priority.

Mr. Bloomberg, in fact, had opposed a similar measure in 2006, arguing that raising the age to buy cigarettes would actually make smoking more enticing to teenagers. But he now believes differently, a spokeswoman said, because the city's youth smoking rate has plateaued and recent research has suggested a correlation between a higher smoking age and lower smoking rates.

In interviews, many New Yorkers were largely critical of the proposal, viewing it as an attack on the maturity and self-determination of young people.

"By 18, people are responsible enough to make their own decisions," said Erik Malave, 23, a music production student at City College. "Forcing people to make themselves healthy tends not to work."

Mr. Malave, from Yonkers, has been smoking for about three years, and he breaks for a cigarette four or five times a day. He also said that he thought the law would be a waste of time, and that young people would easily acquire cigarettes if they wanted them. "When I turned 18, I bought cigarettes for all my friends who weren't 18," he said.

Jessette Bautista, 21, began smoking when she was 17 and had no problem getting cigarettes from friends who would buy packs for her. She was surprised to hear about a proposal to change the legal age to purchase cigarettes. "What happened to freedom?" she said.

While alcohol may impair a person's judgment and so warrants a law that requires partakers to be 21 or older, Ms. Bautista said, cigarettes do not alter a person's state of mind. "Cigarettes will not intoxicate you the same way as alcohol," she said. "It will not put you under any influence."

Sheelagh McNeill and Julie Turkewitz contributed reporting.Sheelagh McNeill and Julie Turkewitz contributed reporting.


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Day Centers Lure Fit Elders and Bill Medicaid

Ozier Muhammad/The New York Times

Clients of R & G Social Adult Day Care Center in Brooklyn can get takeout lunch. Some travel to the center by bicycle.

Scores of elderly Russian immigrants played bingo under the chandeliers of a former funeral parlor in Brooklyn on a recent Monday, with a free dinner and door-to-door transportation from anywhere in the city.

Nearby, older people speaking Chinese filled a supermarket-size storefront with vigorous games of table tennis, billiards and mah-jongg, and ordered free lunch from a takeout menu featuring minced pork, beef and salty fish.

In Bensonhurst, Brooklyn, at the new R & G Social Adult Day Care Center, known locally among elderly immigrants for luring clients with cash and grocery vouchers, most people there for lunch did not stay to eat. Instead, many walked briskly toward the subway carrying bags stuffed with takeout containers, and two elderly men rode away on bicycles with the free food.

Not a wheelchair or walker was in sight at these so-called social adult day care centers. Yet the cost of attendance was indirectly being paid by Medicaid, under Gov. Andrew M. Cuomo's sweeping redesign of $2 billion in spending on long-term care meant for the impaired elderly and those with disabilities.

Such centers have mushroomed, from storefronts and basements to a new development in the Bronx that recently figured in a corruption scandal. With little regulation and less oversight, they grew in two years from eight tiny programs for people with dementia to at least 192 businesses across the city.

Managed care companies, financed by Medicaid, pay the centers to provide services to members. But the door swings both ways: Centers also refer new clients to the companies.

Managed care became mandatory last year for people receiving home services who are eligible for both Medicaid and Medicare. The idea is to try to control spending, but about a third of the 92,000 people so far enrolled in the system statewide are newcomers to such services, many responding to aggressive marketing by social day care centers.

Centers collected over $25 million from managed care plans in the first nine months of 2012, at roughly $93 per person per session, according to state figures. The managed care companies are paid by Medicaid; in New York City, the rate is about $3,800 a month per member.

"The whole thing is going to end up costing the state much more money," said Valerie Bogart, a lawyer with New York Legal Assistance Group who specializes in advocacy for frail elderly and disabled people. "It's really up to the managed care plans to be the watchdogs now, and it's like the fox watching the chicken coop, because they have an incentive to make money from these centers, too."

It was not supposed to play out this way. The bold Medicaid overhaul, part of a grand bargain with the state's most politically powerful health care players, has been promoted as a national model for curbing costs and reversing the incentives for fraud. It transferred tens of thousands of recipients of long-term care from a system in which providers billed Medicaid for each service to managed care, in which a capped monthly rate must cover all services to a company's enrollees.

With the largest Medicaid budget in the country, $54 billion, New York is trying not only to rein in runaway spending, but also to "rebalance" it, away from costly institutional care, like nursing homes and medical models known for overbilling, to inexpensive supports that keep people safely in their communities.

In that context, Jason Helgerson, the state's Medicaid chief, defended the rapid expansion of social-model adult day care, saying that without a chance to socialize and connect with others, Medicaid clients would suffer a decline in health that would add costs. But when a reporter described some of the practices observed at centers, he expressed surprise and anger.

"The idea that people are bicycling home from managed long-term care is a complete misnomer," Mr. Helgerson said. "The idea that they're playing Ping-Pong — I guess they could be wheelchair-bound Ping-Pong players, but otherwise it's fraud and they are not eligible."

Beneficiaries are supposed to be impaired enough to need at least 120 days of help with tasks like walking, bathing or taking medication. But managed care companies, not government agencies, are now mainly in charge of determining eligibility, typically by using nurses to assess each potential member.

"It is being gamed," said an executive at a managed care company, speaking on the condition of anonymity. "There are just plums in the payment system. And the state will choose to be blind about this until something happens, which is what they did with nursing homes."

Mei-Yu Liu contributed reporting.


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Price of Recovery May Place Another Burden on Boston Victims

Stan Honda/Agence France-Presse — Getty Images

Victims of the Boston Marathon bombings waited to be treated on April 15 at Brigham and Women's Hospital in Boston. More Photos »

WASHINGTON — For victims of the Boston Marathon bombings, the terrible physical cost may come with a daunting financial cost as well.

Many of the wounded could face staggering bills not just for the trauma care they received in the days after the bombings, but for prosthetic limbs, lengthy rehabilitation and the equipment they will need to negotiate daily life with crippling injuries. Even those with health insurance may find that their plan places limits on specific services, like physical therapy or psychological counseling.

Kenneth R. Feinberg, the lawyer who has overseen compensation funds for victims of the Sept. 11 terrorist attacks, the shootings at Virginia Tech and other disasters, arrived in Boston on Monday to start the difficult work of deciding who will be eligible for payouts from a new compensation fund and how much each person wounded in the bombings and family of the dead deserves.

The One Fund Boston, which Mayor Thomas M. Menino of Boston and Gov. Deval Patrick of Massachusetts created a day after the bombings, has already raised more than $10 million for victims and their families. At the same time, friends and relatives have set up dozens of smaller funds for individual victims.

For at least 13 victims who lost limbs, including William White of Bolton, Mass., expenses may also include renovations to their homes that make it easier for them to get around.

"What if his stairs are at the wrong incline, or he needs a ramp, or the cobblestones in his backyard are uneven?" said Benjamin Coutu, a friend of the White family who helped create a donation page on a fund-raising Web site for Mr. White and his wife and son, who were also wounded in the blasts. "People who are insured in these situations think, 'Wow, I'm O.K., I'm covered.' It's not until a month or two later that they realize, 'I'm covered for the bare bones.' "

The overall medical costs are difficult to estimate, especially since it is not yet clear how much rehabilitation or future surgery the victims with the worst injuries will need. But as a basis for comparison, medical costs for shooting victims average about $50,000, said Ted Miller, a senior research scientist at the Pacific Institute for Research and Evaluation who studies the costs of injuries.

For Mr. Feinberg, whom city and state officials asked to administer the One Fund Boston, the first task is to determine how much money is going to be available through it. Most donations typically arrive in the first month after a disaster, he said, adding that the fund-raising window should ideally be brief. "I'm a big believer, in most of these programs, that the fund should be a very small duration," Mr. Feinberg said in a phone interview. "Because you've got to begin to get the money out the door to the people who really need it, and you've got to know how much you're going to distribute."

The thornier job, though, will be figuring out who qualifies for the funds and how much each victim who survived — as well as the families of the three who died — should receive. More than 170 people were wounded in the blasts, and more than 50 remain in the hospital.

Mr. Feinberg said that he would seek input from victims and their families before deciding on a formula. For victims of the Virginia Tech shooting, he said, compensation amounts were based on how long they were in the hospital. After the movie theater shooting in Aurora, Colo., victims who were paralyzed or suffered traumatic brain injuries received just as much as the families of those who died.

"You can't pay everyone the same if someone has a broken ankle versus a brain injury," he said. "There's got to be some sliding scale."

After the shootings in Aurora, some of the hospitals who treated victims agreed to limit what they charged and to waive charges entirely. Tim Gens, executive vice president of the Massachusetts Hospital Association, said that the hospitals treating the Boston victims had not yet discussed how to handle billing, but that it would be decided case by case.

For the uninsured, Mr. Gens said, Massachusetts has a charity care fund that covers all or part of their costs, depending on their income. Each hospital also has its own policies for waiving costs in certain situations, he said.

Meanwhile, Mr. Gens said, "For those who have insurance, there really shouldn't be an issue." Massachusetts requires most of its residents to have health insurance,  although a small number refuse to comply or get waivers. It is not yet clear how many of the wounded were visiting from other states, or how many were uninsured.


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Motherlode Blog: Study Links Autism With Antidepressant Use During Pregnancy

A cautiously worded study based on data collected in Sweden has found that "in utero exposure to both selective serotonin reuptake inhibitors (S.S.R.I.'s) and nonselective monoamine reuptake inhibitors (tricyclic antidepressants) was associated with an increased risk of autism spectrum disorders, particularly without intellectual disability."

The Swedish medical birth register (which contains data on current drug use reported by mothers early in their pregnancies), along with a system of publicly funded screenings for autism spectrum disorders and extensive national and regional registers of various health issues, make a detailed, population-based case-control study possible — one that controls for other variables like family income, parent educational level, maternal and paternal age and even maternal region of birth (all factors the authors note have been previously associated with autism).

This is the second study in two years to associate antidepressant use during pregnancy with an increased incidence of autism in exposed children. An earlier, smaller study in California also found a modest increase in risk. The Sweden-based study could not (and did not) exclude the possibility that it was the severe depression, rather than the use of antidepressants, that created the association, but the smaller California study (which considered only S.S.R.I.'s) found "no increase in risk" for mothers with a history of mental health treatment in the absence of prenatal exposure to S.S.R.I.'s.

The authors of the current study took a very cautious approach to their findings:

The results of the present study as well as the U.S. study present a major dilemma in relation to clinical advice to pregnant women with depression. If antidepressants increase the risk of autism spectrum disorder, it would be reasonable to warn women about this possibility. However, if the association actually reflects the risk of autism spectrum disorder related to the nongenetic effects of severe depression during pregnancy, treatment may reduce the risk. Informed decisions would also need to consider weighing the wider risks of untreated depression with the other adverse outcomes related to antidepressant use. With the current evidence, if the potential risk of autism were a consideration in the decision-making process, it may be reasonable to think about, wherever appropriate, nondrug approaches such as psychological treatments. However, their timely availability to pregnant women will need to be enhanced.

Others working in the field are more inclined to draw a line between the prenatal drug exposure and the increased risk of autism. "It really shouldn't come as that much of a surprise given that numerous animal studies have shown that exposure during development leads to changes in the brain and changes in behavior — often that mimic autism," said Dr. Adam C. Urato, assistant professor of obstetrics and gynecology at the Tufts University School of Medicine and chairman of the department of obstetrics and gynecology at MetroWest Medical Center in Framingham, Mass. (Dr. Urato obviously didn't speak in links, but you can find the animal studies he refers to here and here.)

"And why should it surprise us that medications that can change brain chemistry and function might alter the development of the brain and behavior?" Dr. Urato argues that the risks of antidepressant use during pregnancy outweigh what he sees as the limited benefits.

One conclusion that is simple to draw is that it's extraordinarily difficult for a pregnant woman with clinical depression to find some definitive answer about what's best for her in her situation. I've spoken to other researchers in the past who have described for me how difficult it is to put together a study that separates the risks of depression itself in pregnancy from the risks, if any, of the drugs used to treat it. As the researchers in Sweden note, it's unlikely that conclusive evidence on this issue will ever be available.

If you've been pregnant with clinical depression, where did you go to find the information and advice you needed?



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