Showing posts with label Health. Show all posts
Showing posts with label Health. Show all posts

School Yoga Class Draws Religious Protest From Christians


T. Lynne Pixley for The New York Times


Miriam Ruiz during a yoga class last week at Paul Ecke Central Elementary School in Encinitas, Calif. A few dozen parents are protesting that the program amounts to religious indoctrination.







ENCINITAS, Calif. — By 9:30 a.m. at Paul Ecke Central Elementary School, tiny feet were shifting from downward dog pose to chair pose to warrior pose in surprisingly swift, accurate movements. A circle of 6- and 7-year-olds contorted their frames, making monkey noises and repeating confidence-boosting mantras.




Jackie Bergeron’s first-grade yoga class was in full swing.


“Inhale. Exhale. Peekaboo!” Ms. Bergeron said from the front of the class. “Now, warrior pose. I am strong! I am brave!”


Though the yoga class had a notably calming effect on the children, things were far from placid outside the gymnasium.


A small but vocal group of parents, spurred on by the head of a local conservative advocacy group, has likened these 30-minute yoga classes to religious indoctrination. They say the classes — part of a comprehensive program offered to all public school students in this affluent suburb north of San Diego — represent a violation of the First Amendment.


After the classes prompted discussion in local evangelical churches, parents said they were concerned that the exercises might nudge their children closer to ancient Hindu beliefs.


Mary Eady, the parent of a first grader, said the classes were rooted in the deeply religious practice of Ashtanga yoga, in which physical actions are inextricable from the spiritual beliefs underlying them.


“They’re not just teaching physical poses, they’re teaching children how to think and how to make decisions,” Ms. Eady said. “They’re teaching children how to meditate and how to look within for peace and for comfort. They’re using this as a tool for many things beyond just stretching.”


Ms. Eady and a few dozen other parents say a public school system should not be leading students down any particular religious path. Teaching children how to engage in spiritual exercises like meditation familiarizes young minds with certain religious viewpoints and practices, they say, and a public classroom is no place for that.


Underlying the controversy is the source of the program’s financing. The pilot project is supported by the Jois Foundation, a nonprofit organization founded in memory of Krishna Pattabhi Jois, who is considered the father of Ashtanga yoga.


Dean Broyles, the president and chief counsel of the National Center for Law and Policy, a nonprofit law firm that champions religious freedom and traditional marriage, according to its Web site, has dug up quotes from Jois Foundation leaders, who talk about the inseparability of the physical act of yoga from a broader spiritual quest. Mr. Broyles argued that such quotes betrayed the group’s broader evangelistic purpose.


“There is a transparent promotion of Hindu religious beliefs and practices in the public schools through this Ashtanga yoga program,” he said.


“The analog would be if we substituted for this program a charismatic Christian praise and worship physical education program,” he said.


The battle over yoga in schools has been raging for years across the country but has typically focused on charter schools, which receive public financing but set their own curriculums.


The move by the Encinitas Union School District to mandate yoga classes for all students who do not opt out has elevated the discussion. And it has split an already divided community.


The district serves the liberal beach neighborhoods of Encinitas, including Leucadia, where Paul Ecke Central Elementary is, as well as more conservative inland communities. On the coast, bumper stickers reading “Keep Leucadia Funky” are borne proudly. Farther inland, cars are more likely to feature the Christian fish symbol, and large evangelical congregations play an important role in shaping local philosophy.


Opponents of the yoga classes have started an online petition to remove the course from the district’s curriculum. They have shown up at school board meetings to denounce the program, and Mr. Broyles has threatened to sue if the board does not address their concerns.


The district has stood firm. Tim Baird, the schools superintendent, has defended the yoga classes as merely another element of a broader program designed to promote children’s physical and mental well-being. The notion that yoga teachers have designs on converting tender young minds to Hinduism is incorrect, he said.


“That’s why we have an opt-out clause,” Mr. Baird said. “If your faith is such that you believe that simply by doing the gorilla pose, you’re invoking the Hindu gods, then by all means your child can be doing something else.”


Ms. Eady is not convinced.


“Yoga poses are representative of Hindu deities and Hindu stories about the actions and interactions of those deities with humans,” she said. “There’s content even in the movement, just as with baptism there’s content in the movement.”


Russell Case, a representative of the Jois Foundation, said the parents’ fears were misguided.


“They’re concerned that we’re putting our God before their God,” Mr. Case said. “They’re worried about competition. But we’re much closer to them than they think. We’re good Christians that just like to do yoga because it helps us to be better people.”


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Life Expectancy Rises Around World, Study Finds





A sharp decline in deaths from malnutrition and infectious diseases like measles and tuberculosis has caused a shift in global mortality patterns over the past 20 years, according to a report published on Thursday, with far more of the world’s population now living into old age and dying from diseases mostly associated with rich countries, like cancer and heart disease.







Tony Karumba/Agence France-Presse — Getty Images

Children in Nairobi, Kenya. Sub-Saharan Africa lagged in mortality gains, compared with Latin America, Asia and North Africa.






The shift reflects improvements in sanitation, medical services and access to food throughout the developing world, as well as the success of broad public health efforts like vaccine programs. The results are striking: infant mortality declined by more than half from 1990 to 2010, and malnutrition, the No. 1 risk factor for death and years of life lost in 1990, has fallen to No. 8.


At the same time, chronic diseases like cancer now account for about two out of every three deaths worldwide, up from just over half in 1990. Eight million people died of cancer in 2010, 38 percent more than in 1990. Diabetes claimed 1.3 million lives in 2010, double the number in 1990.


“The growth of these rich-country diseases, like heart disease, stroke, cancer and diabetes, is in a strange way good news,” said Ezekiel Emanuel, chairman of the department of medical ethics and health policy at the University of Pennsylvania. “It shows that many parts of the globe have largely overcome infectious and communicable diseases as a pervasive threat, and that people on average are living longer.”


In 2010, 43 percent of deaths in the world occurred at age 70 and older, compared with 33 percent of deaths in 1990, the report said. And fewer child deaths have brought up the mean age of death, which in Brazil and Paraguay jumped to 63 in 2010, up from 30 in 1970, the report said. The measure, an average of all deaths in a given year, is different from life expectancy, and is lower when large numbers of children die.


But while developing countries made big strides the United States stagnated. American women registered the smallest gains in life expectancy of all high-income countries’ female populations between 1990 and 2010. American women gained just under two years of life, compared with women in Cyprus, who lived 2.3 years longer and Canadian women who gained 2.4 years. The slow increase caused American women to fall to 36th place in the report’s global ranking of life expectancy, down from 22nd in 1990. Life expectancy for American women was 80.5 in 2010, up from 78.6 in 1990.


“It’s alarming just how little progress there has been for women in the United States,” said Christopher Murray, director of the Institute for Health Metrics and Evaluation, a health research organization financed by the Bill and Melinda Gates Foundation at the University of Washington that coordinated the report. Rising rates of obesity among American women and the legacy of smoking, a habit women formed later than men, are among the factors contributing to the stagnation, he said. American men gained in life expectancy, to 75.9 years from 71.7 in 1990.


Health experts from more than 300 institutions contributed to the report, which provided estimates of disease and mortality for populations in more than 180 countries. It was published in The Lancet, a British medical journal.


The World Health Organization issued a statement on Thursday saying that some of the estimates in the report differed substantially from those done by United Nations agencies, though others were similar. All comprehensive estimates of global mortality rely heavily on statistical modeling because only 34 countries — representing about 15 percent of the world’s population — produce quality cause-of-death data.


Sub-Saharan Africa was an exception to the trend. Infectious diseases, childhood illnesses and maternity-related causes of death still account for about 70 percent of the region’s disease burden, a measure of years of life lost due to premature death and to time lived in less than full health. In contrast, they account for just one-third in South Asia, and less than a fifth in all other regions. Sub-Saharan Africa also lagged in mortality gains, with the average age of death rising by fewer than 10 years from 1970 to 2010, compared with a more than 25-year increase in Latin America, Asia and North Africa.


Globally, AIDS was an exception to the shift of deaths from infectious to noncommunicable diseases. The epidemic is believed to have peaked, but still results in 1.5 million deaths each year.


Over all, the change means people are living longer, but it also raises troubling questions. Behavior affects people’s risks of developing cancer, heart disease and diabetes, and public health experts say it is far harder to get people to change their ways than to administer a vaccine that protects children from an infectious disease like measles.


“Adult mortality is a much harder task for the public health systems in the world,” said Colin Mathers, a senior scientist at the World Health Organization.


Tobacco use is a rising threat, especially in developing countries, and is responsible for almost six million deaths a year globally. Illnesses like diabetes are also spreading fast.


Donald G. McNeil Jr. contributed reporting.



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World’s Population Living Longer, New Report Suggests


A sharp decline in deaths from malnutrition and diseases like measles and tuberculosis has caused a shift in global mortality patterns over the past 20 years, according to a new report, with far more of the world’s population now living into old age and dying from diseases more associated with rich countries, like cancer and heart disease.


The shift reflects improvements in sanitation, medical services and access to food throughout the developing world, as well as the success of broad public health efforts like vaccine programs. The results are dramatic: infant mortality has declined by more than half between 1990 and 2010, and malnutrition, the No. 1 risk factor for death and years of life lost in 1990, has fallen to No. 8.


At the same time, chronic diseases like cancer now account for about two out of every three deaths worldwide, up from just over half in 1990. Eight million people died of cancer in 2010, 38 percent more than in 1990. Diabetes claimed 1.3 million lives in 2010, double the number in 1990.


But while developing countries made big strides – the average age of death in Brazil and Paraguay, for example, jumped to 63 in 2010, up from 28 in 1970 – the United States stagnated. American women registered the smallest gains in life expectancy of all high-income countries between 1990 and 2010. The two years of life they gained was less than Cyprus, where women gained 2.3 years of life and Canada, where women gained 2.4 years. The slow increase caused American women to fall to 36th place in the report’s global ranking of life expectancy, down from 22nd in 1990.


“It’s alarming just how little progress there has been for women in the United States,” said Christopher Murray, director of the Institute for Health Metrics and Evaluation, a health research organizationfinanced by the Bill and Melinda Gates Foundation at the University of Washington that coordinated the report. Rising rates of obesity among American women and the legacy of smoking, a habit women in this country formed later than men, are among the factors contributing to the stagnation, he said.


The World Health Organization issued a statement Thursday saying that some of the estimates in the report differ substantially from those done by United Nations agencies, though others are similar. All comprehensive estimates of global mortality rely heavily on statistical modeling because only 34 countries – representing about 15 percent of the world’s population – produce quality cause-of-death data.


Health experts from more than 300 institutions contributed to the report, which measured disease and mortality for populations in more than 180 countries. It was published Thursday in the Lancet, a British health publication.


The one exception to the trend was sub-Saharan Africa, where infectious diseases, childhood illnesses and maternal causes of death still account for about 70 percent of all illness. In contrast, they account for just one-third in South Asia, and less than a fifth in all other regions. Sub-Saharan Africa also lagged in mortality gains, with the average age of death there rising by fewer than 10 years from 1970 to 2010, compared to a more than 25-year increase in Latin America, Asia and North Africa.


The change means that people are living longer, an outcome that public health experts praised. But it also raises troubling questions. Behavior affects people’s risks of developing noncommunicable diseases like cancer, heart disease and diabetes, and public health experts say it is far harder to get people to change their ways than to administer a vaccine that protects children from an infectious disease like measles.


“Adult mortality is a much harder task for the public health systems in the world,” said Colin Mathers, a senior scientist at the World Health Organization in Geneva. “It’s not something that medical services can address as easily.”


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Rate of Childhood Obesity Falls in Several Cities


Jessica Kourkounis for The New York Times


At William H. Ziegler Elementary in Northeast Philadelphia, students are getting acquainted with vegetables and healthy snacks.







PHILADELPHIA — After decades of rising childhood obesity rates, several American cities are reporting their first declines.




The trend has emerged in big cities like New York and Los Angeles, as well as smaller places like Anchorage, Alaska, and Kearney, Neb. The state of Mississippi has also registered a drop, but only among white students.


“It’s been nothing but bad news for 30 years, so the fact that we have any good news is a big story,” said Dr. Thomas Farley, the health commissioner in New York City, which reported a 5.5 percent decline in the number of obese schoolchildren from 2007 to 2011.


The drops are small, just 5 percent here in Philadelphia and 3 percent in Los Angeles. But experts say they are significant because they offer the first indication that the obesity epidemic, one of the nation’s most intractable health problems, may actually be reversing course.


The first dips — noted in a September report by the Robert Wood Johnson Foundation — were so surprising that some researchers did not believe them.


Deanna M. Hoelscher, a researcher at the University of Texas, who in 2010 recorded one of the earliest declines — among mostly poor Hispanic fourth graders in the El Paso area — did a double-take. “We reran the numbers a couple of times,” she said. “I kept saying, ‘Will you please check that again for me?’ ”


Researchers say they are not sure what is behind the declines. They may be an early sign of a national shift that is visible only in cities that routinely measure the height and weight of schoolchildren. The decline in Los Angeles, for instance, was for fifth, seventh and ninth graders — the grades that are measured each year — between 2005 and 2010. Nor is it clear whether the drops have more to do with fewer obese children entering school or currently enrolled children losing weight. But researchers note that declines occurred in cities that have had obesity reduction policies in place for a number of years.


Though obesity is now part of the national conversation, with aggressive advertising campaigns in major cities and a push by Michelle Obama, many scientists doubt that anti-obesity programs actually work. Individual efforts like one-time exercise programs have rarely produced results. Researchers say that it will take a broad set of policies applied systematically to effectively reverse the trend, a conclusion underscored by an Institute of Medicine report released in May.


Philadelphia has undertaken a broad assault on childhood obesity for years. Sugary drinks like sweetened iced tea, fruit punch and sports drinks started to disappear from school vending machines in 2004. A year later, new snack guidelines set calorie and fat limits, which reduced the size of snack foods like potato chips to single servings. By 2009, deep fryers were gone from cafeterias and whole milk had been replaced by one percent and skim.


Change has been slow. Schools made money on sugary drinks, and some set up rogue drink machines that had to be hunted down. Deep fat fryers, favored by school administrators who did not want to lose popular items like French fries, were unplugged only after Wayne T. Grasela, the head of food services for the school district, stopped buying oil to fill them.


But the message seems to be getting through, even if acting on it is daunting. Josh Monserrat, an eighth grader at John Welsh Elementary, uses words like “carbs,” and “portion size.” He is part of a student group that promotes healthy eating. He has even dressed as an orange to try to get other children to eat better. Still, he struggles with his own weight. He is 5-foot-3 but weighed nearly 200 pounds at his last doctor’s visit.


“I was thinking, ‘Wow, I’m obese for my age,’ ” said Josh, who is 13. “I set a goal for myself to lose 50 pounds.”


Nationally, about 17 percent of children under 20 are obese, or about 12.5 million people, according to the Centers for Disease Control and Prevention, which defines childhood obesity as a body mass index at or above the 95th percentile for children of the same age and sex. That rate, which has tripled since 1980, has leveled off in recent years but has remained at historical highs, and public health experts warn that it could bring long-term health risks.


Obese children are more likely to be obese as adults, creating a higher risk of heart disease and stroke. The American Cancer Society says that being overweight or obese is the culprit in one of seven cancer deaths. Diabetes in children is up by a fifth since 2000, according to federal data.


“I’m deeply worried about it,” said Francis S. Collins, the director of the National Institutes of Health, who added that obesity is “almost certain to result in a serious downturn in longevity based on the risks people are taking on.”


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A Breakthrough Against Leukemia Using Altered T-Cells





PHILIPSBURG, Pa. — Emma Whitehead has been bounding around the house lately, practicing somersaults and rugby-style tumbles that make her parents wince.




It is hard to believe, but last spring Emma, then 6, was near death from leukemia. She had relapsed twice after chemotherapy, and doctors had run out of options.


Desperate to save her, her parents sought an experimental treatment at the Children’s Hospital of Philadelphia, one that had never before been tried in a child, or in anyone with the type of leukemia Emma had. The experiment, in April, used a disabled form of the virus that causes AIDS to reprogram Emma’s immune system genetically to kill cancer cells.


The treatment very nearly killed her. But she emerged from it cancer-free, and about seven months later is still in complete remission. She is the first child and one of the first humans ever in whom new techniques have achieved a long-sought goal — giving a patient’s own immune system the lasting ability to fight cancer.


Emma had been ill with acute lymphoblastic leukemia since 2010, when she was 5, said her parents, Kari and Tom. She is their only child.


She is among just a dozen patients with advanced leukemia to have received the experimental treatment, which was developed at the University of Pennsylvania. Similar approaches are also being tried at other centers, including the National Cancer Institute and Memorial Sloan-Kettering Cancer Center in New York.


“Our goal is to have a cure, but we can’t say that word,” said Dr. Carl June, who leads the research team at the University of Pennsylvania. He hopes the new treatment will eventually replace bone-marrow transplantation, an even more arduous, risky and expensive procedure that is now the last hope when other treatments fail in leukemia and related diseases.


Three adults with chronic leukemia treated at the University of Pennsylvania have also had complete remissions, with no signs of disease; two of them have been well for more than two years, said Dr. David Porter. Four adults improved but did not have full remissions, and one was treated too recently to evaluate. A child improved and then relapsed. In two adults, the treatment did not work at all. The Pennsylvania researchers were presenting their results on Sunday and Monday in Atlanta at a meeting of the American Society of Hematology.


Despite the mixed results, cancer experts not involved with the research say it has tremendous promise, because even in this early phase of testing it has worked in seemingly hopeless cases. “I think this is a major breakthrough,” said Dr. Ivan Borrello, a cancer expert and associate professor of medicine at the Johns Hopkins University School of Medicine.


Dr. John Wagner, the director of pediatric blood and marrow transplantation at the University of Minnesota, called the Pennsylvania results “phenomenal” and said they were “what we’ve all been working and hoping for but not seeing to this extent.”


A major drug company, Novartis, is betting on the Pennsylvania team and has committed $20 million to building a research center on the university’s campus to bring the treatment to market.


Hervé Hoppenot, the president of Novartis Oncology, called the research “fantastic” and said it had the potential — if the early results held up — to revolutionize the treatment of leukemia and related blood cancers. Researchers say the same approach, reprogramming the patient’s immune system, may also eventually be used against tumors like breast and prostate cancer.


To perform the treatment, doctors remove millions of the patient’s T-cells — a type of white blood cell — and insert new genes that enable the T-cells to kill cancer cells. The technique employs a disabled form of H.I.V. because it is very good at carrying genetic material into T-cells. The new genes program the T-cells to attack B-cells, a normal part of the immune system that turn malignant in leukemia.


The altered T-cells — called chimeric antigen receptor cells — are then dripped back into the patient’s veins, and if all goes well they multiply and start destroying the cancer.


The T-cells home in on a protein called CD-19 that is found on the surface of most B-cells, whether they are healthy or malignant.


A sign that the treatment is working is that the patient becomes terribly ill, with raging fevers and chills — a reaction that oncologists call “shake and bake,” Dr. June said. Its medical name is cytokine-release syndrome, or cytokine storm, referring to the natural chemicals that pour out of cells in the immune system as they are being activated, causing fevers and other symptoms. The storm can also flood the lungs and cause perilous drops in blood pressure — effects that nearly killed Emma.


Steroids sometimes ease the reaction, but they did not help Emma. Her temperature hit 105. She wound up on a ventilator, unconscious and swollen almost beyond recognition, surrounded by friends and family who had come to say goodbye.


But at the 11th hour, a battery of blood tests gave the researchers a clue as to what might help save Emma: her level of one of the cytokines, interleukin-6 or IL-6, had shot up a thousandfold. Doctors had never seen such a spike before and thought it might be what was making her so sick.


Dr. June knew that a drug could lower IL-6 — his daughter takes it for rheumatoid arthritis. It had never been used for a crisis like Emma’s, but there was little to lose. Her oncologist, Dr. Stephan A. Grupp, ordered the drug. The response, he said, was “amazing.”


Within hours, Emma began to stabilize. She woke up a week later, on May 2, the day she turned 7; the intensive-care staff sang “Happy Birthday.”


Since then, the research team has used the same drug, tocilizumab, in several other patients.


In patients with lasting remissions after the treatment, the altered T-cells persist in the bloodstream, though in smaller numbers than when they were fighting the disease. Some patients have had the cells for years.


Dr. Michel Sadelain, who conducts similar studies at the Sloan-Kettering Institute, said: “These T-cells are living drugs. With a pill, you take it, it’s eliminated from your body and you have to take it again.” But T-cells, he said, “could potentially be given only once, maybe only once or twice or three times.”


The Pennsylvania researchers said they were surprised to find any big drug company interested in their work, because a new batch of T-cells must be created for each patient — a far cry from the familiar commercial strategy of developing products like Viagra or cholesterol medicines, in which millions of people take the same drug.


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New Taxes to Take Effect to Fund Health Care Law





WASHINGTON — For more than a year, politicians have been fighting over whether to raise taxes on high-income people. They rarely mention that affluent Americans will soon be hit with new taxes adopted as part of the 2010 health care law.




The new levies, which take effect in January, include an increase in the payroll tax on wages and a tax on investment income, including interest, dividends and capital gains. The Obama administration proposed rules to enforce both last week.


Affluent people are much more likely than low-income people to have health insurance, and now they will, in effect, help pay for coverage for many lower-income families. Among the most affluent fifth of households, those affected will see tax increases averaging $6,000 next year, economists estimate.


To help finance Medicare, employees and employers each now pay a hospital insurance tax equal to 1.45 percent on all wages. Starting in January, the health care law will require workers to pay an additional tax equal to 0.9 percent of any wages over $200,000 for single taxpayers and $250,000 for married couples filing jointly.


The new taxes on wages and investment income are expected to raise $318 billion over 10 years, or about half of all the new revenue collected under the health care law.


Ruth M. Wimer, a tax lawyer at McDermott Will & Emery, said the taxes came with “a shockingly inequitable marriage penalty.” If a single man and a single woman each earn $200,000, she said, neither would owe any additional Medicare payroll tax. But, she said, if they are married, they would owe $1,350. The extra tax is 0.9 percent of their earnings over the $250,000 threshold.


Since the creation of Social Security in the 1930s, payroll taxes have been levied on the wages of each worker as an individual. The new Medicare payroll is different. It will be imposed on the combined earnings of a married couple.


Employers are required to withhold Social Security and Medicare payroll taxes from wages paid to employees. But employers do not necessarily know how much a worker’s spouse earns and may not withhold enough to cover a couple’s Medicare tax liability. Indeed, the new rules say employers may disregard a spouse’s earnings in calculating how much to withhold.


Workers may thus owe more than the amounts withheld by their employers and may have to make up the difference when they file tax returns in April 2014. If they expect to owe additional tax, the government says, they should make estimated tax payments, starting in April 2013, or ask their employers to increase the amount withheld from each paycheck.


In the Affordable Care Act, the new tax on investment income is called an “unearned income Medicare contribution.” However, the law does not provide for the money to be deposited in a specific trust fund. It is added to the government’s general tax revenues and can be used for education, law enforcement, farm subsidies or other purposes.


Donald B. Marron Jr., the director of the Tax Policy Center, a joint venture of the Urban Institute and the Brookings Institution, said the burden of this tax would be borne by the most affluent taxpayers, with about 85 percent of the revenue coming from 1 percent of taxpayers. By contrast, the biggest potential beneficiaries of the law include people with modest incomes who will receive Medicaid coverage or federal subsidies to buy private insurance.


Wealthy people and their tax advisers are already looking for ways to minimize the impact of the investment tax — for example, by selling stocks and bonds this year to avoid the higher tax rates in 2013.


The new 3.8 percent tax applies to the net investment income of certain high-income taxpayers, those with modified adjusted gross incomes above $200,000 for single taxpayers and $250,000 for couples filing jointly.


David J. Kautter, the director of the Kogod Tax Center at American University, offered this example. In 2013, John earns $160,000, and his wife, Jane, earns $200,000. They have some investments, earn $5,000 in dividends and sell some long-held stock for a gain of $40,000, so their investment income is $45,000. They owe 3.8 percent of that amount, or $1,710, in the new investment tax. And they owe $990 in additional payroll tax.


The new tax on unearned income would come on top of other tax increases that might occur automatically next year if President Obama and Congress cannot reach an agreement in talks on the federal deficit and debt. If Congress does nothing, the tax rate on long-term capital gains, now 15 percent, will rise to 20 percent in January. Dividends will be treated as ordinary income and taxed at a maximum rate of 39.6 percent, up from the current 15 percent rate for most dividends.


Under another provision of the health care law, consumers may find it more difficult to obtain a tax break for medical expenses.


Taxpayers now can take an itemized deduction for unreimbursed medical expenses, to the extent that they exceed 7.5 percent of adjusted gross income. The health care law will increase the threshold for most taxpayers to 10 percent next year. The increase is delayed to 2017 for people 65 and older.


In addition, workers face a new $2,500 limit on the amount they can contribute to flexible spending accounts used to pay medical expenses. Such accounts can benefit workers by allowing them to pay out-of-pocket expenses with pretax money.


Taken together, this provision and the change in the medical expense deduction are expected to raise more than $40 billion of revenue over 10 years.


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Extended Use of Breast Cancer Drug Suggested


The widely prescribed drug tamoxifen already plays a major role in reducing the risk of death from breast cancer. But a new study suggests that women should be taking the drug for twice as long as is now customary, a finding that could upend the standard that has been in place for about 15 years.


In the study, patients who continued taking tamoxifen for 10 years were less likely to have the cancer come back or to die from the disease than women who took the drug for only five years, the current standard of care.


“Certainly, the advice to stop in five years should not stand,” said Prof. Richard Peto, a medical statistician at Oxford University and senior author of the study, which was published in The Lancet on Wednesday and presented at the San Antonio Breast Cancer Symposium.


Breast cancer specialists not involved in the study said the results could have the biggest impact on premenopausal women, who account for a fifth to a quarter of new breast cancer cases. Postmenopausal women tend to take different drugs, but some experts said the results suggest that those drugs might be taken for a longer duration as well.


“We’ve been waiting for this result,” said Dr. Robert W. Carlson, a professor of medicine at Stanford University. “I think it is especially practice-changing in premenopausal women because the results do favor a 10-year regimen.”


Dr. Eric P. Winer, chief of women’s cancers at the Dana-Farber Cancer Institute in Boston, said that even women who completed their five years of tamoxifen months or years ago might consider starting on the drug again.


Tamoxifen blocks the effect of the hormone estrogen, which fuels tumor growth in estrogen receptor-positive cancers that account for about 65 percent of cases in premenopausal women. Some small studies in the 1990s suggested that there was no benefit to using tamoxifen longer than five years, so that has been the standard.


About 227,000 cases of breast cancer are diagnosed each year in the United States, and an estimated 30,000 of them are in premenopausal women with estrogen receptor-positive cancer and prime candidates for tamoxifen. But postmenopausal women also take tamoxifen if they cannot tolerate the alternative drugs, known as aromatase inhibitors.


The new study, known as Atlas, included nearly 7,000 women with ER-positive disease who had completed five years of tamoxifen. They came from about three dozen countries. Half were chosen at random to take the drug another five years, while the others were told to stop.


In the group assigned to take tamoxifen for 10 years, 21.4 percent had a recurrence of breast cancer in the ensuing 10 years, meaning the period 5 to 14 years after their diagnoses. The recurrence rate for those who took only five years of tamoxifen was 25.1 percent.


About 12.2 percent of those in the 10-year treatment group died from breast cancer, compared with 15 percent for those in the control group.


There was virtually no difference in death and recurrence between the two groups during the five years of extra tamoxifen. The difference came in later years, suggesting that tamoxifen has a carry-over effect that lasts long after women stop taking it.


Whether these differences are big enough to cause women to take the drug for twice as long remains to be seen.


“The treatment effect is real, but it’s modest,” said Dr. Paul E. Goss, director of breast cancer research at the Massachusetts General Hospital.


Tamoxifen has side effects, including endometrial cancer, blood clots and hot flashes, which cause many women to stop taking the drug. In the Atlas trial, it appears that roughly 40 percent of the patients assigned to take tamoxifen for the additional five years stopped prematurely.


Some 3.1 percent of those taking the extra five years of tamoxifen got endometrial cancer versus 1.6 percent in the control group. However, only 0.6 percent of those in the longer treatment group died from endometrial cancer or pulmonary blood clots, compared with 0.4 percent in the control group.


“Over all, the benefits of extended tamoxifen seemed to outweigh the risks substantially,” Trevor J. Powles of the Cancer Center London, said in a commentary published by The Lancet.


Dr. Judy E. Garber, director of the Center for Cancer Genetics and Prevention at Dana-Farber, said many women have a love-hate relationship with hormone therapies.


“They don’t feel well on them, but it’s their safety net,” said Dr. Garber, who added that the news would be welcomed by many patients who would like to stay on the drug. “I have patients who agonize about this, people who are coming to the end of their tamoxifen.”


Emily Behrend, who is a few months from finishing her five years on tamoxifen, said she would definitely consider another five years. “If it can keep the cancer away, I’m all for it,” said Ms. Behrend, 39, a single mother in Tomball, Tex. She is taking the antidepressant Effexor to help control the night sweats and hot flashes caused by tamoxifen.


Cost is not considered a huge barrier to taking tamoxifen longer because the drug can be obtained for less than $200 a year.


The results, while answering one question, raise many new ones, including whether even more than 10 years of treatment would be better still.


Perhaps the most important question is what the results mean for postmenopausal women. Even many women who are premenopausal at the time of diagnosis will pass through menopause by the time they finish their first five years of tamoxifen, or will have been pushed into menopause by chemotherapy.


Postmenopausal patients tend to take aromatase inhibitors like anastrozole or letrozole, which are more effective than tamoxifen at preventing breast cancer recurrence, though they do not work for premenopausal women.


Mr. Peto said he thought the results of the Atlas study would “apply to endocrine therapy in general,” meaning that 10 years of an aromatase inhibitor would be better than five years. Other doctors were not so sure.


The Atlas study was paid for by various organizations including the United States Army, the British government and AstraZeneca, which makes the brand-name version of tamoxifen.


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Well: New Meaning and Drive in Life After Cancer

When people hear the words “You have cancer,” life is suddenly divided into distinct parts. There was their life before cancer, and then there is life after cancer.

The number of people in that second category continues to grow. In June, the National Cancer Institute reported that an estimated 13.7 million living Americans are cancer survivors, and the number will increase to almost 18 million over the next decade. More than half are younger than 70.

A new book, “Picture Your Life After Cancer,” (American Cancer Society) focuses on the living that goes on after a cancer diagnosis. It’s based on a multimedia project by The New York Times that asked readers to submit photos and their personal stories. So far, nearly 1,500 people have shared their experiences — the good, the bad, the challenging and the inspirational — creating a dramatic photo essay of the varied lives people live in the years after diagnosis.

For Susan Schwalb, a 68-year-old artist from Manhattan, a diagnosis of early-stage breast cancer at the age of 62 led to a lumpectomy, followed by a mastectomy and then failed reconstruction surgery. She discovered that cancer was not only a physical challenge but a mental one as well, and she turned to friends and support groups to cope with the emotional strain. When she saw the “Picture Your Life” project, she submitted a photo of herself wearing a paint-splattered artist’s apron.

“What cancer made me do in my own professional life is to pedal faster,” Ms. Schwalb said in an interview. “I’ve encountered some people who decide to enjoy life, retire, work in a garden. I decided I had to have more of what I wanted in life, and I better move fast because maybe I don’t have the long life I imagined I would have.”

Indeed, a common theme of the “Picture Your Life” project is that cancer spurs people to take long-delayed trips, seek out adventure and spend time with their families. Photos of mountain climbs, a ride on a camel, scuba diving excursions and bicycle trips are now part of the online collage.

Dr. David Posner, associate program director of pulmonary medicine at Lenox Hill Hospital in Manhattan, says a diagnosis of metastatic colon cancer at the age of 47 has helped him relate to his own patients with cancer. The past decade has included nine operations, six recurrences and three rounds of chemotherapy, but Dr. Posner said he never missed more than three weeks of work.

“My salvation has been my family and my work,” he said. “When I was at work I wasn’t thinking about myself, and it was very therapeutic. I see my share of cancer patients, and I motivate them and they motivate me.”

Dr. Posner said he decided to be part of “Picture Your Life” because he wants to get the word out that a cancer diagnosis — even a dire one like his — doesn’t have to define your life.

“I think about someone asking me, ‘So how was your last decade — was it wasted or was it a life filled with a lot of happiness and joy?’ ” he said. “The cancer thing was a pain, but for the most part I’ve had a pretty good time.”

The “Picture Your Life” collage includes photo after photo of survivors with their pets. Sandra Elliott, 59, of Claremont, Calif., submitted a picture of herself with her two golden retrievers, Buddy and Molly. They were just puppies when she received a diagnosis of Stage 2 breast cancer in 2003. During her recovery from surgery and chemotherapy treatments, she took the dogs to romp on the Pomona College campus, near her home, and one day a professional photographer snapped the picture.

“No matter how bad I felt that day, no matter how many chemo treatments or doctors appointments, those two little puppies with these big black eyes would look at me with their tails wagging as if to say, ‘It’s time. It’s time. It’s time to go out!’  ” Ms. Elliott recalled.

“I felt so physically horrible, and I’d look at them and the pure joy on their faces and in their bodies for just being out in nature and being able to smell the air, smell the trees, chase a squirrel — that sheer in-the-moment love of life they showed me really lifted my spirit on a daily basis.”

Ms. Elliott still lives with chronic pain as a result of nerve damage from her cancer treatment, and she can relate to others in the “Picture Your Life” project who worry that their cancer will recur or that they’ll never feel completely normal again. But she says a stronger theme runs through all the pictures and stories.

“We have all been forced to find the joy in the smallest things,” she said. “I’m sitting here looking at a geranium about to bloom. These things are out there — we just have to be reminded to look at them. And cancer is a big reminder.”

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Sign Language Researchers Broaden Science Lexicon





Imagine trying to learn biology without ever using the word “organism.” Or studying to become a botanist when the only way of referring to photosynthesis is to spell the word out, letter by painstaking letter.




For deaf students, this game of scientific Password has long been the daily classroom and laboratory experience. Words like “organism” and “photosynthesis” — to say nothing of more obscure and harder-to-spell terms — have no single widely accepted equivalent in sign language. This means that deaf students and their teachers and interpreters must improvise, making it that much harder for the students to excel in science and pursue careers in it.


“Often times, it would involve a lot of finger-spelling and a lot of improvisation,” said Matthew Schwerin, a physicist with the Food and Drug Administration who is deaf, of his years in school. “For the majority of scientific terms,” Mr. Schwerin and his interpreter for the day would “try to find a correct sign for the term, and if nothing was pre-existing, we would come up with a sign that was agreeable with both parties.”


Now thanks to the Internet — particularly the boom in online video — resources for deaf students seeking science-related signs are easier to find and share. Crowdsourcing projects in both American Sign Language and British Sign Language are under way at several universities, enabling people who are deaf to coalesce around signs for commonly used terms.


This year, one of those resources, the Scottish Sensory Centre’s British Sign Language Glossary Project, added 116 new signs for physics and engineering terms, including signs for “light-year,”  (hold one hand up and spread the fingers downward for “light,” then bring both hands together in front of your chest and slowly move them apart for “year”), “mass” and “X-ray” (form an X with your index fingers, then, with the index finger on the right hand, point outward). 


The signs were developed by a team of researchers at the center, a division of the University of Edinburgh in Scotland that develops learning tools for students with visual and auditory impairments. The researchers spent more than a year soliciting ideas from deaf science workers, circulating lists of potential signs and ultimately gathering for “an intense weekend” of final voting, said Audrey Cameron, science adviser for the project. (Dr. Cameron is also deaf, and like all non-hearing people interviewed for this article, answered questions via e-mail.)


Whether the Scottish Sensory Centre’s signs will take hold among its audience remains to be seen. “Some will be adopted, and some will probably never be accepted,” Dr. Cameron said. “We’ll have to wait and see what happens.”


Ideally, the standardization of signs will make it easier for deaf students to keep pace with their hearing classmates during lectures. “I can only choose to look at one thing at a time,” said Mr. Schwerin of the F.D.A., recalling his science education, “and it often meant choosing between the interpreter, the blackboard/screen/material, or taking notes. It was like, pick one, and lose out on the others.”


The problem doesn’t end at graduation. In fact, it only intensifies as new discoveries add unfamiliar terms to the scientific lexicon. “I’ve had numerous meetings where I couldn’t participate properly because the interpreters were not able to understand the jargon and they did not know any scientific signs,” Dr. Cameron said.


One general complaint about efforts to standardize signs for technical terms is the idea that, much like spoken language, sign language should be allowed to develop organically rather than be dictated from above.


“Signs that are developed naturally — i.e., that are tested and refined in everyday conversation — are more likely to be accepted quickly by the community,” said Derek Braun, director of the molecular genetics laboratory at Gallaudet University in Washington, D.C., which he said was the first biological laboratory designed and administered by deaf scientists.


Since at least the 1970s, deaf scientists have tried to address the lack of uniformity by gathering common signs for scientific terms in printed manuals and on videotapes. The problem has always been getting deaf students and their interpreters to adopt them.


Often, at science conferences, “local interpreters that we never met before would often use different signs for the same terms, leading to confusion,” said Caroline Solomon, a biology professor at Gallaudet University who is deaf.


This article has been revised to reflect the following correction:

Correction: December 4, 2012

An earlier version of this article misstated the origin of the ASL-STEM Forum.  It was developed by researchers at the University of Washington, not Gallaudet University.  Researchers at Gallaudet and the National Institute for the Deaf work with the University of Washington to provide content and help the forum grow.



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Call That Kept Nursing Home Patients in Sandy’s Path


Chang W. Lee/The New York Times


Workers were shocked that nursing and adult homes in areas like Rockaway Park, Queens, weren’t evacuated.







Hurricane Sandy was swirling northward, four days before landfall, and at the Sea Crest Health Care Center, a nursing home overlooking the Coney Island Boardwalk in Brooklyn, workers were gathering medicines and other supplies as they prepared to evacuate.




Then the call came from health officials: Mayor Michael R. Bloomberg, acting on the advice of his aides and those of Gov. Andrew M. Cuomo, recommended that nursing homes and adult homes stay put. The 305 residents would ride out the storm.


The same advisory also took administrators by surprise at the Ocean Promenade nursing home, which faces the Atlantic Ocean in Queens. They canceled plans to move 105 residents to safety.


“No one gets why we weren’t evacuated,” said a worker there, Yisroel Tabi. “We wouldn’t have exposed ourselves to dealing with that situation.”


The recommendation that thousands of elderly, disabled and mentally ill residents remain in more than 40 nursing homes and adult homes in flood-prone areas of New York City had calamitous consequences.


At least 29 facilities in Queens and Brooklyn were severely flooded. Generators failed or were absent. Buildings were plunged into a cold, wet darkness, with no access to power, water, heat and food.


While no immediate deaths were reported, it took at least three days for the Fire Department, the National Guard and ambulance crews from around the country to rescue over 4,000 nursing home and 1,500 adult home residents. Without working elevators, many had to be carried down slippery stairwells.


“I was shocked,” said Greg Levow, who works for an ambulance service and helped rescue residents at Queens. “I couldn’t understand why they were there in the first place.”


Many sat for hours in ambulances and buses before being transported to safety through sand drifts and debris-filled floodwaters. They went to crowded shelters and nursing homes as far away as Albany, where for days, they often lacked medical charts and medications. Families struggled to locate relatives.


The decision not to empty the nursing homes and adult homes in the mandatory evacuation area was one of the most questionable by the authorities during Hurricane Sandy. And an investigation by The New York Times found that the impact was worsened by missteps that officials made in not ensuring that these facilities could protect residents.


They did not require that nursing homes maintain backup generators that could withstand flooding. They did not ensure that health care administrators could adequately communicate with government agencies during and after a storm. And they discounted the more severe of the early predictions about Hurricane Sandy’s surge.


The Times’s investigation was based on interviews with officials, health care administrators, doctors, nurses, ambulance medics, residents, family members and disaster experts. It included a review of internal State Health Department status reports. The findings revealed the striking vulnerability of the city’s nursing and adult homes.


On Sunday, Oct. 28, the day before Hurricane Sandy arrived, Mr. Bloomberg ordered a mandatory evacuation in Zone A, the low-lying neighborhoods of the city. But by that point, Mr. Bloomberg, relying on the advice of the city and state health commissioners, had already determined that people in nursing homes and adult homes should not leave, officials said.


The mayor’s recommendations that health care facilities not evacuate startled residents of Surf Manor adult home in Coney Island, said one of them, Norman Bloomfield. He recalled that another resident exclaimed, “What about us! Why’s he telling us to stay?”


The commissioners made the recommendation to Mr. Bloomberg and Mr. Cuomo because they said they believed that the inherent risks of transporting the residents outweighed the potential dangers from the storm.


In interviews, senior Bloomberg and Cuomo aides did not express regret for keeping the residents in place.


“I would defend all the decisions and the actions” by the health authorities involving the storm, said Linda I. Gibbs, a deputy mayor. “I feel like I’m describing something that was a remarkable, lifesaving event.”


Dr. Nirav R. Shah, the state health commissioner, who regulates nursing homes, said: “I’m not even thinking of second-guessing the decisions.”


Still, officials in New Jersey and in Nassau County adopted a different policy, evacuating nursing homes in coastal areas well before the storm.


Contradictory Forecasts


The city’s experience with Tropical Storm Irene last year weighed heavily on state and city health officials and contributed to their underestimating the impact of Hurricane Sandy, according to records and interviews.


Before Tropical Storm Irene, the officials ordered nursing homes and adult homes to evacuate. The storm caused relatively minor damage, but the evacuation led to millions of dollars in health care, transportation, housing and other costs, and took a toll on residents.


As a result, when Hurricane Sandy loomed, the officials were acutely aware that they could come under criticism if they ordered another evacuation that proved unnecessary.


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Opinion: A Health Insurance Detective Story





I’VE had a long career as a business journalist, beginning at Forbes and including eight years as the editor of Money, a personal finance magazine. But I’ve never faced a more confounding reporting challenge than the one I’m engaged in now: What will I pay next year for the pill that controls my blood cancer?




After making more than 70 phone calls to 16 organizations over the past few weeks, I’m still not totally sure what I will owe for my Revlimid, a derivative of thalidomide that is keeping my multiple myeloma in check. The drug is extremely expensive — about $11,000 retail for a four-week supply, $132,000 a year, $524 a pill. Time Warner, my former employer, has covered me for years under its Supplementary Medicare Program, a plan for retirees that included a special Writers Guild benefit capping my out-of-pocket prescription costs at $1,000 a year. That out-of-pocket limit is scheduled to expire on Jan. 1. So what will my Revlimid cost me next year?


The answers I got ranged from $20 a month to $17,000 a year. One of the first people I phoned said that no matter what I heard, I wouldn’t know the cost until I filed a claim in January. Seventy phone calls later, that may still be the most reliable thing anyone has told me.


Like around 47 million other Medicare beneficiaries, I have until this Friday, Dec. 7, when open enrollment ends, to choose my 2013 Medicare coverage, either through traditional Medicare or a private insurer, as well as my drug coverage — or I will risk all sorts of complications and potential late penalties.


But if a seasoned personal-finance journalist can’t get a straight answer to a simple question, what chance do most people have of picking the right health insurance option?


A study published in the journal Health Affairs in October estimated that a mere 5.2 percent of Medicare Part D beneficiaries chose the cheapest coverage that met their needs. All in all, consumers appear to be wasting roughly $11 billion a year on their Part D coverage, partly, I think, because they don’t get reliable answers to straightforward questions.


Here’s a snapshot of my surreal experience:


NOV. 7 A packet from Time Warner informs me that the company’s new 2013 Retiree Health Care Plan has “no out-of-pocket limit on your expenses.” But Erin, the person who answers at the company’s Benefits Service Center, tells me that the new plan will have “no practical effect” on me. What about the $1,000-a-year cap on drug costs? Is that really being eliminated? “Yes,” she says, “there’s no limit on out-of-pocket expenses in 2013.” I tell her I think that could have a major effect on me.


Next I talk to David at CVS/Caremark, Time Warner’s new drug insurance provider. He thinks my out-of-pocket cost for Revlimid next year will be $6,900. He says, “I know I’m scaring you.”


I call back Erin at Time Warner. She mentions something about $10,000 and says she’ll get an estimate for me in two business days.


NOV. 8 I phone Medicare. Jay says that if I switch to Medicare’s Part D prescription coverage, with a new provider, Revlimid’s cost will drive me into Medicare’s “catastrophic coverage.” I’d pay $2,819 the first month, and 5 percent of the cost of the drug thereafter — $563 a month or maybe $561. Anyway, roughly $9,000 for the year. Jay says AARP’s Part D plan may be a good option.


NOV. 9 Erin at Time Warner tells me that the company’s policy bundles United Healthcare medical coverage with CVS/Caremark’s drug coverage. I can’t accept the medical plan and cherry-pick prescription coverage elsewhere. It’s take it or leave it. Then she puts CVS’s Michele on the line to get me a Revlimid quote. Michele says Time Warner hasn’t transferred my insurance information. She can’t give me a quote without it. Erin says she will not call me with an update. I’ll have to call her.


My oncologist’s assistant steers me to Celgene, Revlimid’s manufacturer. Jennifer in “patient support” says premium assistance grants can cut the cost of Revlimid to $20 or $30 a month. She says, “You’re going to be O.K.” If my income is low enough to qualify for assistance.


NOV. 12 I try CVS again. Christine says my insurance records still have not been transferred, but she thinks my Revlimid might cost $17,000 a year.


Adriana at Medicare warns me that AARP and other Part D providers will require “prior authorization” to cover my Revlimid, so it’s probably best to stick with Time Warner no matter what the cost.


But Brooke at AARP insists that I don’t need prior authorization for my Revlimid, and so does her supervisor Brian — until he spots a footnote. Then he assures me that it will be easy to get prior authorization. All I need is a doctor’s note. My out-of-pocket cost for 2013: roughly $7,000.


NOV. 13 Linda at CVS says her company still doesn’t have my file, but from what she can see about Time Warner’s insurance plans my cost will be $60 a month — $720 for the year.


CVS assigns my case to Rebecca. She says she’s “sure all will be fine.” Well, “pretty sure.” She’s excited. She’s been with the company only a few months. This will be her first quote.


NOV. 14 Giddens at Time Warner puts in an “emergency update request” to get my files transferred to CVS.


Frank Lalli is an editorial consultant on retirement issues and a former senior executive editor at Time Warner’s Time Inc.



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Hockey Coaches Defy Doctors on Concussions, Study Finds





Despite several years of intensive research, coverage and discussion about the dangers of concussions, the idea of playing through head injuries is so deeply rooted in hockey culture that two university teams kept concussed players on the ice even though they were taking part in a major concussion study.




The study, which will be published Friday in a series of articles in the journal Neurosurgical Focus, was conducted during the 2011-12 hockey season by researchers from the University of Western Ontario, the University of Montreal, Harvard and other institutions.


“This culture is entrenched at all levels of hockey, from peewee to university,” said Dr. Paul S. Echlin, a concussion specialist and researcher in Burlington, Ontario, and the lead author of the study. “Concussion is a significant public health issue that requires a generational shift. As with smoking or seat belts, it doesn’t just happen overnight — it takes a massive effort and collective movement.”


The study is believed to be among the most comprehensive analyses of concussions in hockey, which has a rate of head trauma approaching that of football. Researchers followed two Canadian university teams — a men’s team and a women’s team — and scanned every player’s brain before and after the season. Players who sustained head injuries also received scans at three intervals after the injuries, with researchers using advanced magnetic resonance imaging techniques.


The teams were not named in the study, in which an independent specialist physician was present at each game and was empowered to pull any player off the ice for examination if a potential concussion was observed.


The men’s team, with 25 players and an average age of 22, played a 28-game regular season and a 3-game postseason. The women’s team, with 20 players and an average age of 20, played 24 regular-season games and no playoff games. Over the course of the season, there were five observed or self-reported concussions on the men’s team and six on the women’s team.


Researchers noted several instances of coaches, trainers and players avoiding examinations, ignoring medical advice or otherwise obstructing the study, even though the players had signed consent forms to participate and university ethics officials had given institutional consent.


“Unless something is broken, I want them out playing,” one coach said, according to the study.


In one incident, a neurologist observing the men’s team pulled a defenseman during the first period of a game after the player took two hits and was skating slowly. During the intermission the player reported dizziness and was advised to sit out, but the coach suggested he play the second period and “skate it off.” The defenseman stumbled through the rest of the game.


“At the end of the third period, I spoke with the player and the trainer and said that he should not play until he was formally evaluated and underwent the formal return-to-play protocol,” the neurologist said, as reported in the study. “I was dismayed to see that he played the next evening.”


After the team returned from its trip, the neurologist questioned the trainer about overruling his advice and placing the defenseman at risk.


“The trainer responded that he and the player did not understand the decision and that most of the team did not trust the neurologist,” according to the study. “He requested that the physician no longer be used to cover any more games.”


In another episode, a physician observer assessed a minor concussion in a female player and recommended that she miss the next night’s game. Even though the coach’s own playing career had ended because of concussions, she overrode the medical advice and inserted the player the next evening.


According to the report, the coach refused to speak to another physician observer on the second evening. The trainer was reluctant to press the issue with the coach because, the trainer said, the coach did not want the study to interfere with the team.


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Cost of Brand-Name Prescription Medicines Soaring





The price of brand-name prescription medicines is rising far faster than the inflation rate, while the price of generic drugs has plummeted, creating the largest gap so far between the two, according to a report published Wednesday by the pharmacy benefits manager Express Scripts.




The report tracked an index of commonly used drugs and found that the price of brand-name medicines increased more than 13 percent from September 2011 to this September, which it said was more than six times the overall price inflation of consumer goods. Generic drug prices dipped by nearly 22 percent.


The drop in the price of generics “represents low-hanging fruit for the country to save money on health care,” said Dr. Steve Miller, the chief medical officer of Express Scripts, which manages the drug benefits for employers and insurers and also runs a mail-order pharmacy.


The report was based on a random sample of six million Express Scripts members with prescription drug coverage.


The Pharmaceutical Research and Manufacturers of America, the trade group representing brand-name manufacturers, criticized the report, saying it was skewed by a handful of high-priced specialty drugs that are used by a small number of patients and overlooked the crucial role of major drug makers.


“Without the development of new medicines by innovator companies, there would be neither the new treatments essential to progress against diseases nor generic copies,” Josephine Martin, executive vice president of the group, said in a statement.


The report cited the growth of specialty drugs, which treat diseases like cancer and multiple sclerosis, as a major reason for the increase in spending on branded drugs. Spending on specialty medicines increased nearly 23 percent during the first three quarters of 2012, compared with the same period in 2011. All but one of the new medicines approved in the third quarter of this year were specialty drugs, the report found, and many of them were approved to treat advanced cancers only when other drugs had failed.


Stephen W. Schondelmeyer, a professor of pharmaceutical economics at the University of Minnesota, said the potential benefits of many new drugs did not always match the lofty price tags. “Increasingly it’s going to be difficult for drug-benefit programs to make decisions about coverage and payment and which drugs to include,” said Mr. Schondelmeyer, who conducts a similar price report for AARP. He also helps manage the drug benefit program for the University of Minnesota.


“We’re going to be faced with the issue that any drug at any price will not be sustainable.”


Spending on traditional medicines — which treat common ailments like high cholesterol and blood pressure — actually declined by 0.6 percent during the period, the report found. That decline was mainly because of the patent expiration of several blockbuster drugs, like Lipitor and Plavix, which opened the market for generic competitors. But even as the entry of generic alternatives pushed down spending, drug companies continued to raise prices on their branded products, in part to squeeze as much revenue as possible out of an ever-shrinking portfolio, Dr. Miller said.


Drug makers are also being pushed by companies like Express Scripts and health insurers, which are increasingly looking for ways to cut costs, said C. Anthony Butler, a pharmaceuticals analyst at Barclays. “I think they’re pricing where they can but what they keep telling me is they’re under significant pressure” to keep prices low, he said.


Express Scripts earns higher profits from greater use of generic medicines than brand name drugs sold through their mail-order pharmacy, Mr. Butler said. “There’s no question that they would love for everybody to be on a generic,” he said.


Dr. Miller acknowledged that was true but said that ultimately, everyone wins. “When we save people money, that’s when we make money,” he said. “We don’t shy away from that.”


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Imaging Shows Progressive Damage by Parkinson’s





For the first time, researchers at the Massachusetts Institute of Technology report, brain imaging has been able to show in living patients the progressive damage Parkinson’s disease causes to two small structures deep in the brain.




The new technique confirms some ideas about the overall progress of the disease in the brain. But the effects of Parkinson’s vary in patients, the researchers said, and in the future, the refinement in imaging may help doctors monitor how the disease is affecting different people and adjust treatment accordingly.


The outward symptoms and progress of Parkinson’s disease — tremors, stiffness, weakness — have been well known since James Parkinson first described them in 1817. But its progress in the brain has been harder to document.


Some of the structures affected by the disease have been buried too deep to see clearly even with advances in brain imaging. An important recent hypothesis about how the disease progresses was based on the examinations of brains of patients who had died.


Now, a group of scientists at M.I.T. and Massachusetts General Hospital report that they have worked out a way to combine four different sorts of M.R.I. to get clear pictures of damage to two brain structures in people living with Parkinson’s. In doing so, they have added support to one part of the recent hypothesis, which is that the disease first strikes an area involved in movement and later progresses to a higher part of the brain more involved in memory and attention.


Suzanne Corkin, a professor emerita of behavioral neuroscience at M.I.T. and the senior author on the paper published online Monday in The Archives of Neurology, said that this progression was part of the hypothesis put forward in 2003 by Heiko Braak, a German neuroscientist, based on autopsies.


But, she said, because of the limits of brain imaging, “nobody could test this in living patients.”


David A. Ziegler, who was at M.I.T. when the research was done, and is now a postdoctoral researcher at the University of California, San Francisco, said that the study, of 29 patients with Parkinson’s and 27 healthy patients of roughly the same age, showed that the peanut-sized substantia nigra lost volume first, and another structure called the basal forebrain, involved in memory and attention, was struck later.


Glenda Halliday, a neuroscientist at Neuroscience Research Australia and the University of New South Wales, who was not involved in the study, said the paper confirmed “the progression of degeneration in two important affected brain regions in people with Parkinson’s.”


Dr. Corkin, Dr. Ziegler and their colleagues developed a way to use four different varieties of M.R.I. — each using different settings on the same machine — to come up with four different images that could be used to form one image that showed structures deep in the brain like the substantia nigra, long known to be important in Parkinson’s.


The disease kills brain cells, shrinking the parts of the brain that it affects, and the comparative study showed that the reduction in size of the substantia nigra showed up in early stage Parkinson’s patients, compared with a healthy group.


The reduction in size in the basal forebrain, compared with the healthy group, did not show up in the patients in the early stage, but was clear in patients in the later stage.


“This is a project we’ve been working on in our lab for years,” she said. A next step, already in progress, is to correlate damage to specific brain structures with symptoms.


Parkinson’s, she said, is a disease that shows the same broad outlines of development in most patients, but with considerable variation. Dementia may arrive early or may not appear. The M.R.I. technique described in the paper, she said, might help tease out what is going on in the brain in subgroups of Parkinson’s patients that show different symptoms and could influence treatment.


One important difference between the two brain structures is that damage to the substantia nigra decreases production of the neurotransmitter dopamine, while a smaller basal forebrain would reduce the production of a different chemical, acetylcholine.


The research is just one step, Dr. Ziegler said. One of the “big outstanding questions,” he said, is whether all patients will eventually get dementia.


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Chia Seeds Gain Popularity for Nutritional Benefits





First there were Chia Pets; now there are chia people.




Ubiquitous in television ads that began 30 years ago, Chia Pets were called “the pottery that grows.” Mixing chia seeds and water on the outside of an animal-shaped terra-cotta figurine produces a plant resembling green hair almost overnight.


Now, chia is having a second life as a nutritional “it” item. Whole and ground chia seeds are being added to fruit drinks, snack foods and cereals and sold on their own to be baked into cookies and sprinkled on yogurt. Grown primarily in Mexico and Bolivia, chia, like fish, is rich in omega-3 fatty acids, though of a different sort. It also has antioxidants, protein and fiber. Recognition of its nutritional value can be traced as far back as the Aztecs.


Companies like Dole and Nature’s Path have introduced chia products, which have begun showing up on shelves in mainstream grocery stores like Ralphs, Vons and Albertsons. Mintel, a market research firm, counted 100 products containing chia in a presentation it did in March on the potential of increasing the use of the seeds in dairy products.


“About two years ago, our retailers came to us and said, ‘We need you to be in this business everyone is talking about, the business of chia seeds,’ ” said Michael P. Hirsch, vice president of Joseph Enterprises, which sells Chia Pets and other novelty products and has now added chia seeds and milled chia called — what else? — Ch-Ch-Ch-Chia Omega.


Last spring, high demand collided with weather patterns that depressed production, raising prices and the awareness that chia had moved beyond the realm of health food stores into the broader market.


Janie Hoffman, founder of Mamma Chia fruit juices, was one of the first people to recognize chia’s potential as a food. She was complaining about flax seed — “I hate how you have to grind it and then it goes rancid” — to a friend, who asked why she wasn’t using chia instead. “She said it had no taste, it’s high in antioxidants, huge in omega-3, a far superior seed,” Ms. Hoffman said. “In short, she made me feel like an idiot — no one was using flax seed anymore.”


So she bought some chia seeds online and was quickly sold on their benefits. “I started incorporating it into everything I was eating,” she said. “Stir fries, yogurt, beverages — there really wasn’t anything in my kitchen that didn’t have chia in it.”


In 2009, Ms. Hoffman developed fruit juices with chia seeds suspended in them. (Exposure to liquid gives the seeds a sticky, gelatinous coating, which is how they bond to the terra-cotta pets.)


“My first sales call a year and a half later was to Whole Foods in the southern Pacific region,” she said. “I walked in to meet the buyer and presented this chia beverage and said I would like it to go into a few stores. She said, ‘No, I want you in all of them’ ” — about 40 stores — “and that was that.”


Within 11 months, Mamma Chia products were in Whole Foods stores across the nation, as well as in hundreds of bodegas and health and natural foods stores. They are now sold in Ralphs and Vons stores and will soon be in Albertsons.


“I personally think demand for it will grow for sure, though how big it will get is still a question,” said Brad C. Bartlett, president of Dole Food Company’s packaged foods business.


Dole chose chia as the first ingredient it would promote in its new Nutrition Plus line of products, which aim to provide a functional benefit to consumers. It won out over other candidates, Mr. Bartlett said, because of its long history as a source of nutrition — the Aztecs used it for many purposes — and because it does not require much processing to confer its benefits.


The company does independent clinical testing on each product in the Nutrition Plus line to back up claims it makes about their health benefits, and it was surprised by one finding: significantly more alpha-linolenic acid in omega-3 reached the bloodstream and was converted into eicosapentaenoic acid, a long-chain fatty acid considered good for the heart, when the seeds were milled rather than whole.


“That came as quite a surprise, and we stopped the rollout and reformulated our clusters to use milled chia instead of whole seeds,” Mr. Bartlett said, referring to Dole’s Chia & Fruit Clusters.


Nature’s Path, an organic cereal company, introduced its first chia-laced cereal, Apple Crumble Love Crunch, last December, and now has eight products that include the seed in some form. “Business has been great with these products — overwhelmingly positive and, perhaps surprisingly, not just in health food stores but also in regular grocery stores,” said Arjan Stephens, executive vice president of sales and marketing at Nature’s Path.


Mr. Stephens said chia’s nutritional attributes, along with its many uses in food processing, could turn it into a staple. “It can be used in gluten-free breads or waffles to add fluffiness or to replace eggs in vegan products,” he said. “It offers an alternative to those with nut allergies.”


Mr. Hirsch, the Joseph Enterprises vice president, was less certain that chia would be a blockbuster, even though his company is adding protein bars to its line of edible chia products, which are sold in Walgreens, CVS and other drugstores. He said he was concerned about the supply of chia seeds, which are harvested once a year and grown in rotation, usually with corn.


Australia has recently joined Mexico and Bolivia in the chia-production act with its own type of seed that is grown somewhat differently, Mr. Hirsch said. But it is a difficult crop to grow outside of the traditional areas, and the market is tiny, about $70 million.


“Everybody is looking at this because everybody is always looking for something new,” Mr. Hirsch said. “I also know from the sales at this point it’s a niche market still, and we don’t know how big the niche is yet.”


If that niche fails to expand, there will always be another Chia Pet. This year, Chia Hello Kitty is joining the lineup.


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Documents Show F.D.A.’s Failures in Meningitis Outbreak





Newly released documents add vivid detail to the emerging portrait of the Food and Drug Administration’s ineffective and halting efforts to regulate a Massachusetts company implicated in a national meningitis outbreak that has sickened nearly 500 people and killed 34.




In the documents, released on Tuesday in response to a Freedom of Information Act request, the agency would threaten to bring the full force of its authority down on the company, only to back away, citing lack of jurisdiction.


The company, the New England Compounding Center, at times cooperated with F.D.A. inspectors and promised to improve its procedures, and at other times challenged the agency’s legal authority to regulate it, refused to provide records and continued to ship a drug in defiance of the agency’s concerns.


Some of the documents were summarized last week by Congressional committees that held hearings on the meningitis outbreak. Republicans and Democrats criticized the F.D.A. for failing to act on information about unsafe practices at the company as far back as March 2002.


By law, compounding pharmacies are regulated primarily by the states, but the pharmacies have grown over the years into major suppliers of some of the country’s biggest hospitals. The F.D.A. is asking Congress for stronger, clearer authority to police them, but Republicans have said the agency already has enough power.


Records show that the agency was sometimes slow in pursuing its own inspection findings. In one case involving the labeling and marketing of drugs, the agency issued a warning letter to New England Compounding 684 days after an inspection, a delay that the company’s chief pharmacist complained was so long that some of the letter’s assertions no longer applied to its operations.


The agency said in a statement Wednesday that it “was not the timeline we strive for,” but that much of the delay was because of “our limited, unclear and contested authority in this area.” Because of litigation, it said, there was “significant internal discussion about how to regulate compounders.”


The agency first inspected the company in April 2002 after reports that two patients had become dizzy and short of breath after being injected with a steroid made by the company.


 On the first day of the inspection, Barry Cadden, the chief pharmacist, was cooperative, but the next day, the agency inspectors wrote, Mr. Cadden “had a complete change in attitude & basically would not provide any additional information either by responding to questions or providing records,” adding that he challenged their legal authority to be at his pharmacy at all.


The F.D.A. was back at New England Compounding in October 2002 because of possible contamination of another of its products, methylprednisolone acetate, the same drug involved in the current meningitis outbreak.


 While the F.D.A. had the right to seize an adulterated steroid, officials at the time said that action alone would not resolve the company’s poor compounding practices. In a meeting with Massachusetts regulators, F.D.A. officials left authority in the hands of the state, which “would be in a better position to gain compliance or take regulatory action,” according to a memo by an F.D.A. official summarizing the meeting.


 David Elder, compliance branch director for the F.D.A.’s New England District, warned at the meeting that there was the “potential for serious public health consequences if N.E.C.C.’s compounding practices, in particular those relating to sterile products, are not improved.”


 The company fought back hard, repeatedly questioning the F.D.A.’s jurisdiction. In a September 2004 inspection over concerns that the company was dispensing trypan blue, a dye used for some eye surgeries that had not been approved by the F.D.A., Mr. Cadden told the agency inspector that he had none in stock.


But in the clean room, the inspector noticed a drawer labeled “Trypan Blue,” which contained 189 vials of the medicine.


A few days later, Mr. Cadden was defiant. He told the agency that he was continuing to dispense trypan blue and that there was nothing in the law saying a compounder could not dispense unapproved products.


 The conversation turned testy. “Don’t answer any more questions!” Mr. Cadden told another pharmacy executive, according to the F.D.A.’s report.


Mr. Cadden rejected many of the assertions in the warning letter that finally came in December 2006. The next correspondence from the agency did not come until almost two years later, in October 2008, saying that the agency still had “serious concerns” about the company’s practices, and that failing to correct them could result in seizure of products and an injunction against the company and its principals.


It is not known whether any corrective actions were taken. The agency did not conduct another inspection until the recent meningitis outbreak.


Denise Grady contributed reporting.



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