Senate’s “fiscal cliff” bill adds $4 trillion to deficits: CBO

WASHINGTON (Reuters) – The Congressional Budget Office on Tuesday said Senate-passed legislation to avert the “fiscal cliff” would add nearly $ 4 trillion to federal deficits over a decade, largely because it would extend low tax rates for almost all Americans.

The congressional scorekeeper’s analysis was released as a number of Republicans in the House of Representatives voiced opposition to the bill, and considered amending it with deeper spending cuts.

House Majority Leader Eric Cantor and others complained the bill’s spending cuts would do little to curb trillion-dollar deficits.

Senate-passed plan extends decade-old Bush-era tax rates for individuals earning up to $ 400,000 and couples earning up to $ 450,000 – nearly 99 percent of U.S. taxpayers.

But the non-partisan CBO compared the Senate plan’s revenue and expenditure changes to laws that are currently in force, which call for $ 600 billion in tax hikes and automatic spending cuts in 2013 alone – effectively a dive off the fiscal cliff.

With Congress feverishly working to avoid the fiscal cliff in recent weeks, many Washington policymakers had viewed the current-law budget “baseline” as unlikely to be maintained.

Compared to an alternative CBO scenario in which Congress extends all expiring tax provisions and turns off automatic spending cuts slated to start taking effect this week, the Senate plan achieves minimal deficit reduction in the early years.

Over 10 years, deficits under the Senate plan would be $ 3.75 trillion less than permanently extending all of the tax and spending policies in the alternative scenario. That is largely because the CBO expects that remaining on an unsustainable fiscal path would severely constrict economic growth later in the decade, holding back revenue growth and keeping outlays higher.

FISCAL 2013 EFFECTS

By going over the fiscal cliff, the CBO had previously forecast that the higher taxes and lower spending would slash the fiscal 2013 U.S. budget deficit by more than half, to $ 641 billion from $ 1.1 trillion the prior year.

But in its analysis of the Senate-passed plan, the CBO said fiscal 2013 revenues would be $ 280 billion lower and spending $ 50 billion higher, resulting in a $ 330 billion deficit increase, for a total deficit of around $ 971 billion.

Under the CBO’s keep-taxes-unchanged scenario, the deficit would be $ 1.04 trillion for fiscal 2013.

None of the CBO’s analyses takes into consideration possible future spending cuts and reforms to federal health care and retirement programs that Congress might make in a new budget battle emerging around mid-February over the next increase in the U.S. debt limit.

(Reporting By Kim Dixon and David Lawder; Editing by David Gregorio and Vicki Allen)

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It’s a fight over fitness in Santa Monica’s parks

SANTA MONICA, Calif. (AP) — Physical fitness is a way of life on the beautiful beachfront oasis of Santa Monica. From sunrise to sunset, there’s huffing and puffing in the city’s parks as trainers put their students through the paces of every form of exercise imaginable.

All along the 420 acres of greenery paralleling the Pacific Ocean are groups of a dozen or more people furiously pumping iron, doing sit-ups, stepping on and off little benches and stretching on mats. Some flex their muscles with weight machines tied by big rubber bands to pretty much anything that’s anchored to the ground.

“It’s starting to look like a 24-Hour Fitness gym out there,” complained Johnny Gray, an assistant track coach at UCLA and former Olympic runner who says he’s often forced to navigate around weight machines, barbells and other exercise impediments as he runs.

In recent years, fitness classes have become as ubiquitous in Santa Monica’s signature Palisades Park as dog walkers and senior citizens playing shuffleboard.

Karen Ginsberg, the city’s director of community and cultural services, said other park users are complaining about fitness enthusiasts not only blocking pedestrian walkways but also making too much noise, killing the park’s grass with their weights and damaging its trees and benches with all the exercise gadgets they connect to them.

“Some people have also expressed concerns about people operating a business on city land and putting the city at risk of liability because they aren’t carrying insurance,” she said.

So now the City Council is considering requiring that fitness trainers who conduct workouts in Santa Monica’s parks and on its beaches pay an annual $ 100 fee and turn over 15 percent of their gross revenues to the city.

The council was to take up the issue of regulating fitness trainers this month, but that’s now been pushed back to at least March. Meantime, Ginsberg said city officials are looking at what restrictions they might put on the use of weights, bands and other equipment.

Although classes offering everything from fitness training to yoga to meditation can be found at several city parks and all over Santa Monica’s beaches, Palisades Park, with its stunning ocean views, is by far the most popular place.

As a result, city officials are considering limiting exercise class sizes there to no more than two students per trainer. Under the proposal being considered, other venues could still accommodate the larger groups as long as trainers pay the fees and provide proof of insurance.

The trainers respond that, like any responsible business operators, many already are insured and also know CPR. They also point out that they currently pay the city for business licenses and police-issued permits to hold their classes in the park. Although they don’t have to pay rent to anyone, they believe that’s enough overhead.

“I could easily go back indoors but that’s what I wanted to get away from,” said Ruben Lawrence, who has been offering boxing and fitness training classes at Palisades and other parks for six years. “I wanted to provide these programs to the masses at affordable rates to the community in a place people enjoy.”

Since the city began discussing the additional regulations, Lawrence said, he’s moved most of his classes to other parks in Santa Monica. If he has to pay the additional fees, however, he said he’ll likely just relocate to a gym.

Raisa Lilling, who offers vigorous exercise classes to the mothers of newborns, said she and other trainers have been working to keep their students quiet and out of the way of dog walkers, camera-toting tourists and others.

“I can absolutely see where they’re coming from, but a complete ban, I think, is a little extreme,” said Lilling, adding that the sides can always find a middle ground.

Lilling offers Stroller Strides classes in which mothers push kids in strollers across the park. As part of their workout, they’ll stop from time to time for vigorous bursts of cardio activity, including running up and down the park’s steep stairways to the beach while Lilling watch the kids.

“It’s not just a stroll in the park,” laughed the trainer, who is certified in CPR, carries insurance and also teaches yoga classes.

Ginsberg, emphasizing that planners are still fine-tuning the proposed regulations, agreed there should be a middle ground.

“I think we have to strike a balance between wanting an active community, which I think we do want, with the need to have some sort of ability for all users to enjoy our parks, particularly Palisades Park,” she said.

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Obama: “modestly optimistic” fiscal cliff deal can be reached

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Some cancer docs say their income tied to treatments

NEW YORK (Reuters Health) – A survey of cancer doctors finds that some believe they get paid more when they administer their patients’ chemotherapy and other drugs, raising concerns about conflict of interest and the potential for overtreatment.

Researchers found that oncologists, surgeons and other cancer specialists who get paid based on the number of services they provide were seven times more likely to say their pay increases when they oversee their patients’ chemotherapy treatments, compared to doctors who are paid a flat rate or salary.

“I think there is evidence out there that doctors are very responsive to financial incentives… So I think some patients should realize that doctors who are prescribing chemotherapy may be benefiting financially,” said Dr. Nancy Keating from Boston’s Harvard Medical School and Brigham and Women’s Hospital, the study’s senior author.

According to Keating and her colleagues, who published their study in the Journal of Clinical Oncology on Wednesday, some cancer doctors offer chemotherapy and other therapies in their offices.

Indeed, the researchers note, previous studies have found that as much as 65 percent of an oncologist office’s income typically comes from administering treatments. The rest comes from evaluating and managing patients’ cancers.

There are some advantages to patients in getting treatments at their doctors’ offices, such as not having to travel to a hospital, but some observers worry the practice gives doctors incentive to prescribe more chemotherapy or more expensive drugs because they’ll make more money.

In the last decade, the U.S. government tried to reduce the profit margin doctors were able to make by administering chemotherapy to their patients, but Keating told Reuters Health that didn’t solve the problem.

“I think there is some evidence out there that doctors just started prescribing more profitable drugs. So this is still an issue,” she said.

While the study could not determine whether patients received any unnecessary treatments, the researchers wanted to see whether doctors believe their pay is tied to their ability to give patients chemotherapy.

The researchers used a survey from 2005 through mid-2007 of 480 oncologists, who treated patients from across the country.

Overall, most participants said their income would be unaffected by prescribing chemotherapy or other drugs, or by referring patients to other specialists or hospices.

But 27 percent of the doctors said their pay would increase based on how much chemotherapy they administered and 25 percent said they’d get paid more if they administered more growth factors, such as so-called hormonal drugs, that regulate cell growth.

Doctors who were in some way paid based on how many services they provide – known as fee for service – were about seven times more likely to say their incomes would increase if they administered more chemotherapy or growth factors, compared to doctors who got a flat salary.

Doctors who had their own practices or were part of a smaller oncology group were about nine times more likely to say their income would increase if they administered their patients’ chemotherapy, compared to those who worked in a hospital.

“It really is pretty substantial differences. And often, I don’t think people pay that much attention to where their doctor works, but I think it does make a difference,” Keating said.

But Dr. Yu-Ning Wong of the Fox Chase Cancer Center in Philadelphia cautions that the new study only looks at whether the doctors believed their pay would increase if they could administer chemotherapy or other treatments.

“It didn’t say it actually did,” said Wong, who wrote a commentary accompanying the study.

She also told Reuters Health that she would not want cancer patients thinking they are receiving unnecessary care or treatments based on this study.

Still, Keating and her fellow researchers say, there needs to be a new way to pay doctors “to counter or eliminate these incentives to decrease unnecessary care and ensure that health care resources are used most effectively.”

Until then, Keating said patients should feel free to ask doctors whether they’ll benefit financially from their treatments.

“It’s certainly something I would want to know,” she said. “But I agree it’s not an easy thing to ask, but I do think it’s something to be aware of and I think it’s a fair question to ask.”

SOURCE: http://bit.ly/gPtMdm Journal of Clinical Oncology, online December 26, 2012.

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Obesity declining in young, poorer kids: study

NEW YORK (Reuters Health) – The number of low-income preschoolers who qualify as obese or “extremely obese” has dropped over the last decade, new data from the Centers for Disease Control and Prevention show.

Although the decline was only “modest” and may not apply to all children, researchers said it was still encouraging.

“It’s extremely important to make sure we’re monitoring obesity in this low-income group,” said the CDC‘s Heidi Blanck, who worked on the study.

Those kids are known to be at higher risk of obesity than their well-off peers, in part because access to healthy food is often limited in poorer neighborhoods.

The new results can’t prove what’s behind the progress, Blanck told Reuters Health – but two possible contributors are higher rates of breastfeeding and rising awareness of the importance of physical activity even for very young kids.

Blanck and her colleagues used data on routine clinic visits for about half of all U.S. kids eligible for federal nutrition programs – including 27.5 million children between age two and four.

They found 13 percent of those preschoolers were obese in 1998. That grew to just above 15 percent in 2003, but dropped slightly below 15 percent in 2010, the most recent study year included.

Similarly, the prevalence of extreme obesity increased from nearly 1.8 percent in 1998 to 2.2 percent in 2003, then dropped back to just below 2.1 percent in 2010, the research team reported Tuesday in the Journal of the American Medical Association.

Whether kids are obese is determined by their body mass index (BMI) – a measure of weight in relation to height – and by their age and sex.

For example, a four-year-old girl who is 40 inches tall would be obese if she was 42 pounds or heavier. A two-year-old boy who is 35 inches tall qualifies as obese at 34 pounds or above, according to the CDC’s child BMI calculator. (The CDC’s BMI calculator for children and teens is available here:.)

The new findings are the first national data to show obesity and extreme obesity may be declining in young children, Blanck said.

“This is very encouraging considering the recent effort made in the field including by several U.S. federal agencies to combat the childhood obesity epidemic,” said Dr. Youfa Wang, head of the Johns Hopkins Global Center on Childhood Obesity in Baltimore.

Blanck said between 2003 and 2010 researchers also saw an increase in breastfeeding of low-income infants. Breastfeeding has been tied to a healthier weight in early childhood.

Additionally, states and communities have started working with child care centers to make sure kids have time to run around and that healthy foods are on the lunch menu, she added.

Parents can encourage better eating by having fruits and vegetables available at snack time and allowing their young kids to help with meal preparation, Blanck said.

Her other recommendations include making sure preschoolers get at least one hour of activity every day and keeping television sets out of the bedroom.

“The prevalence of overweight and obesity in many countries including in the U.S. is still very high,” Wang, who wasn’t involved in the new study, told Reuters Health in an email.

“The recent level off should not be taken as a reason to reduce the effort to fight the obesity epidemic.”

SOURCE: http://bit.ly/JjFzqx Journal of the American Medical Association, online December, 25, 2012.

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Venezuela’s Chavez “improves slightly” after surgery: official

CARACAS (Reuters) – Venezuelan President Hugo Chavez‘s condition has “improved slightly” after a cancer operation in Cuba, the information minister said on Monday, amid doubts over whether the former soldier is in good enough health to continue governing.

“The patient has shown a slight improvement in his condition,” Venezuelan Information Minister Ernesto Villegas said during a terse televised statement, adding the president has maintained contact with family members.

Chavez has not been heard from in two weeks following a fourth operation for an unspecified type of cancer in the pelvic region. The government has said he suffered post-operatory complications including unexpected bleeding and a lung infection, but offered few details about his actual condition.

His death, or even his resignation for health reasons, would upend the politics of the South American OPEC nation where his personalized brand of oil-financed socialism has made him a hero to the poor but a pariah to critics who call him a dictator.

His allies are now openly discussing the possibility that he may not be back in time to be sworn in for his third six-year term on the constitutionally mandated date of January 10.

Opposition leaders say a delay to his taking power would be another signal that Chavez is not in condition to govern and that fresh elections should be called to choose his replacement.

They believe they have a better shot against Chavez’s anointed successor, Vice President Nicolas Maduro, than against the charismatic president who for 14 years has been nearly invincible at the ballot box.

But a constitutional dispute over succession could lead to a messy transition toward a post-Chavez era.

Maduro has become the government’s main figurehead in the president’s absence. His speeches have mimicked Chavez’s bombastic style that mixes historical references with acid insults of adversaries.

Opposition leader Henrique Capriles, who lost to Chavez in the October presidential vote, slammed Maduro in an interview published on Sunday for failing to seek dialogue with the opposition at a time of political uncertainty.

“Maduro is not the one that won the elections, nor is he the leader,” Capriles told the local El Universal newspaper. “Because Chavez is absent, this is precisely the time that (Maduro) needs help from people (in the opposition camp).”

Chavez has vastly expanded presidential powers and built a near-cult following among millions of poor Venezuelans, who love his feisty language and social welfare projects.

The opposition is smarting from this month’s governors elections in which Chavez allies won 20 of 23 states. They are trying to keep attention focused on day-to-day problems from rampant crime to power outages.

(Reporting by Brian Ellsworth; Editing by Sandra Maler)

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Few tests done at toxic sites after superstorm

OLD BRIDGE, N.J. (AP) — For more than a month, the U.S. Environmental Protection Agency has said that the recent superstorm didn’t cause significant problems at any of the 247 Superfund toxic waste sites it’s monitoring in New York and New Jersey.

But in many cases, no actual tests of soil or water are being conducted, just visual inspections.

The EPA conducted a handful of tests right after the storm, but couldn’t provide details or locations of any recent testing when asked last week. New Jersey officials point out that federally designated Superfund sites are EPA’s responsibility.

The 1980 Superfund law gave EPA the power to order cleanups of abandoned, spilled and illegally dumped hazardous wastes that threaten human health or the environment. The sites can involve long-term or short-term cleanups.

Jeff Tittel, executive director of the Sierra Club in New Jersey, says officials haven’t done enough to ensure there is no contamination from Superfund sites. He’s worried toxins could leach into groundwater and the ocean.

“It’s really serious and I think the EPA and the state of New Jersey have not done due diligence to make sure these sites have not created problems,” Tittel said.

The EPA said last month that none of the Superfund sites it monitors in New York or New Jersey sustained significant damage, but that it has done follow-up sampling at the Gowanus Canal site in Brooklyn, the Newtown Creek site on the border of Queens and Brooklyn, and the Raritan Bay Slag site, all of which flooded during the storm.

But last week, EPA spokeswoman Stacy Kika didn’t respond to questions about whether any soil or water tests have been done at the other 243 Superfund sites. The agency hasn’t said exactly how many of the sites flooded.

“Currently, we do not believe that any sites were impacted in ways that would pose a threat to nearby communities,” EPA said in a statement.

Politicians have been asking similar questions, too. On Nov. 29, U.S. Sen. Frank Lautenberg, D-N.J., wrote to the EPA to ask for “an additional assessment” of Sandy’s impact on Superfund sites in the state.

Elevated levels of lead, antimony, arsenic and copper have been found at the Raritan Bay Slag site, a Superfund site since 2009. Blast furnaces dumped lead at the site in the late 1960s and early 1970s, and lead slag was also used there to construct a seawall and jetty.

The EPA found lead levels as high as 142,000 parts per million were found at Raritan Bay in 2007. Natural soil levels for lead range from 50 to 400 parts per million.

The EPA took four samples from the site after Superstorm Sandy: two from a fenced-off beach area and two from a nearby public playground. One of the beach samples tested above the recreational limit for lead. In early November, the EPA said it was taking additional samples “to get a more detailed picture of how the material might have shifted” and will “take appropriate steps to prevent public exposure” at the site, according to a bulletin posted on its website. But six weeks later, the agency couldn’t provide more details of what has been found.

The Newtown Creek site, with pesticides, metals, PCBs and volatile organic compounds, and the Gowanus Canal site, heavily contaminated with PCBs, heavy metals, volatile organics and coal tar wastes, were added to the Superfund list in 2010.

Some say the lead at the Raritan Bay site can disperse easily.

Gabriel Fillippeli, director of the Center for Urban Health at Indiana University-Purdue University Indianapolis, said lead tends to stay in the soil once it is deposited but can be moved around by stormwaters or winds. Arsenic, which has been found in the surface water at the site, can leach into the water table, Fillippeli said.

“My concern is twofold. One is, a storm like that surely moved some of that material physically to other places, I would think,” Fillippeli said. “If they don’t cap that or seal it or clean it up, arsenic will continue to make its way slowly into groundwater and lead will be distributed around the neighborhood.”

The lack of testing has left some residents with lingering worries.

The Raritan Bay Slag site sits on the beach overlooking a placid harbor with a view of Staten Island. On a recent foggy morning, workers were hauling out debris, and some nearby residents wondered whether the superstorm increased or spread the amount of pollution at the site.

“I think it brought a lot of crud in from what’s out there,” said Elise Pelletier, whose small bungalow sits on a hill overlooking the Raritan Bay Slag site. “You don’t know what came in from the water.” Her street did not flood because it is up high, but she worries about a park below where people go fishing and walk their dogs. She would like to see more testing done.

Thomas Burke, an associate dean at the Johns Hopkins School of Public Health, says both federal and state officials generally have a good handle on the major Superfund sites, which often use caps and walls to contain pollution.

“They are designed to hold up,” Burke said of such structures, but added that “you always have to be concerned that an unusual event can spread things around in the environment.” Burke noted that the storm brought in a “tremendous amount” of water, raising the possibility that groundwater plumes could have changed.

“There really have to be evaluations” of communities near the Superfund sites, he said. “It’s important to take a look.”

Officials in both New York and New Jersey note they’ve also been monitoring less toxic sites known as brownfields and haven’t found major problems. The New York DEC said in a statement that brownfields in that state “were not significantly impacted” and that they don’t plan further tests for storm impacts.

Larry Ragonese, a spokesman for the New Jersey Department of Environmental Protection, said the agency has done visual inspections of major brownfield sites and also alerted towns and cities to be on the lookout for problems. Ragonese said they just aren’t getting calls voicing such concerns.

Back at the Raritan Bay slag site, some residents want more information. And they want the toxic soil, which has sat here for years, out.

Pat Churchill, who was walking her dog in the park along the water, said she’s still worried.

“There are unanswered questions. You can’t tell me this is all contained. It has to move around,” Churchill said.

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Federal appeals court rules against Hobby Lobby on contraception

OKLAHOMA CITY (Reuters) – A federal appeals court on Thursday rejected a claim by an arts and crafts chain that wants to be exempted from a requirement to provide emergency contraceptives to employees because it violates the religious principles of its owners.

The Court of Appeals in Denver ruled against family-owned Hobby Lobby‘s assertion that the religious beliefs of its owners should relieve them from providing the “morning after” and “week after” pills to their employees, as required under President Barack Obama‘s signature health care reforms.

Hobby Lobby vowed to appeal to the U.S. Supreme Court.

“The Green family is disappointed with this ruling,” said Kyle Duncan, general counsel for the Becket Fund for Religious Liberty, which is assisting Hobby Lobby in the legal case. “The Greens will continue to make their case on appeal that this unconstitutional mandate infringes their right to earn a living while remaining true to their faith.”

The medications at issue are classified as emergency contraceptives by the Food and Drug Administration, but the owners of Hobby Lobby call them “abortion-inducing drugs” because they are often taken after conception.

The lawsuit is among 42 legal actions that have been filed over the issue, according to the Becket Fund for Religious Liberty, a non-profit law firm in Washington, D.C.

The company faces fines of up to $ 1.3 million daily if it disobeys the mandate, which takes effect on January 1 for Hobby Lobby, a $ 3 billion chain, and its smaller sister operation, Mardel, a Christian-oriented bookstore and educational supply company.

Both companies are owned by the Green family of Oklahoma City, whose patriarch, David Green, is ranked 79th on Forbes Magazine’s list of the 400 richest Americans, with a net worth of $ 4.5 billion.

The family operates 514 Hobby Lobby stores in 41 states and employ 13,240 people. Inspirational Christian music is played in the stores, which are closed on Sundays.

U.S. District Judge Joe Heaton of the Western District of Oklahoma ruled on November 19 that the privately-owned companies are secular, for-profit enterprises that do not possess the same religious rights as the individual members of the family.

(Editing by Corrie MacLaggan and Lisa Shumaker)

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Alexza’s agitation drug gets FDA approval

(Reuters) – Alexza Pharmaceuticals Inc said the U.S. health regulators approved Adasuve, making it the first treatment for schizophrenia and bipolar disorder that can be inhaled.

Adasuve, which delivers an older antipsychotic drug called loxapine, passes through the lungs and into the bloodstream faster than a typical pill. Loxapine is available as an oral drug for schizophrenia.

The company said the product will include a boxed safety warning about potentially dangerous side effects including the potential for fatal bronchial spasms in people with asthma or chronic obstructive pulmonary disorder and a higher risk of death in elderly people with dementia-related psychosis.

Adasuve use will be restricted to mitigate the potential harm of bronchial spasms, Alexza said.

The FDA also required Alexza to conduct a large post- marketing clinical trial of patients to assess the real-world use of the drug.

“We believe that the ability to deliver medications rapidly and non-invasively will be important for patients and the professionals who care for them,” Chief Executive Thomas King said in the statement.

Three injectable drugs, Bristol-Myers Squibb’s Abilify, Eli Lilly’s Zyprexa and Pfizer Inc’s Geodon, are currently approved to calm patients with schizophrenia or bipolar disorder.

Adasuve, Alexza’s most advanced drug, will be available for commercial launch early in the third quarter of 2013, the company said.

Earlier this month, European health regulators recommended approval of Adasuve.

The FDA denied approval to Adasuve in May, after it found deficiencies at the company’s Mountain View, California manufacturing facility during an inspection.

The company’s shares fell 12 percent in the after market trading after the trade was halted at $ 5.79 before the drug- approval announcement.

(Reporting by Prateek Kumar; Editing by Sreejiraj Eluvangal)

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Sanofi to pay $109 million to settle U.S. kickback charges

(Reuters) – French drugmaker Sanofi has agreed to pay $ 109 million to settle charges that it violated the False Claims Act by providing free drugs as a form of kickbacks to physicians, the U.S. Justice Department announced on Wednesday.

The settlement resolves allegations that Sanofi submitted false average sales price reports for the drug Hyalgan, a knee injection to treat arthritis, that did not account for free units distributed contingent on future purchases.

Average sales prices are used to determine reimbursement rates by government health programs, such as Medicare. The Justice Dept said the practice caused government programs to pay inflated amounts for Hyalgan and a competing product.

Sanofi sales representatives were given thousands of free “sample” Hyalgan syringes and used the free drug as kickbacks with a promise to provide negotiated numbers of the syringes in order to lower Hyalgan’s effective price, the government claimed.

The drugmaker said it had taken “strong, proactive and effective steps” to address the issue and voluntarily halted the Hyalgan sampling program in 2009.

The settlement with the U.S. Attorney’s Office, District of Massachusetts, the U.S. Department of Justice and several states resolves all claims arising out of the investigation into sampling of Hyalgan, Sanofi said.

In addition to the $ 109 million payment, Sanofi said it expects to enter into a Corporate Integrity Agreement with the Office of the Inspector General of the United States Department of Health and Human Services that will place its operations under enhanced scrutiny.

There are no criminal charges against the company related to the Hyalgan allegations.

(Reporting by Bill Berkrot; Editing by M.D. Golan)

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Experts: Kids are resilient in coping with trauma

WASHINGTON (AP) — They might not want to talk about the gunshots or the screams. But their toys might start getting into imaginary shootouts.

Last week’s school shooting in Connecticut raises the question: What will be the psychological fallout for the children who survived?

For people of any age, regaining a sense of security after surviving violence can take a long time. They’re at risk for lingering anxiety, depression, post-traumatic stress disorder.

But after the grief and fear fades, psychiatrists say most of Newtown‘s young survivors probably will cope without long-term emotional problems.

“Kids do tend to be highly resilient,” said Dr. Matthew Biel, chief of child and adolescent psychiatry at MedStar Georgetown University Hospital.

And one way that younger children try to make sense of trauma is through play. Youngsters may pull out action figures or stuffed animals and re-enact what they witnessed, perhaps multiple times.

“That’s the way they gain mastery over a situation that’s overwhelming,” Biel explained, saying it becomes a concern only if the child is clearly distressed while playing.

Nor is it unusual for children to chase each other playing cops-and-robbers, but now parents might see some also pretending they’re dead, added Dr. Melissa Brymer of the UCLA-Duke National Center for Child Traumatic Stress.

Among the challenges will be spotting which children are struggling enough that they may need professional help.

Newtown’s tragedy is particularly heart-wrenching because of what such young children grappled with — like the six first-graders who apparently had to run past their teacher’s body to escape to safety.

There’s little scientific research specifically on PTSD, post-traumatic stress disorder, in children exposed to a burst of violence, and even less to tell if a younger child will have a harder time healing than an older one.

Overall, scientists say studies of natural disasters and wars suggest most children eventually recover from traumatic experiences while a smaller proportion develop long-term disorders such as PTSD. Brymer says in her studies of school shootings, that fraction can range from 10 percent to a quarter of survivors, depending on what they actually experienced. A broader 2007 study found 13 percent of U.S. children exposed to different types of trauma reported some symptoms of PTSD, although less than 1 percent had enough for an official diagnosis.

Violence isn’t all that rare in childhood. In many parts of the world — and in inner-city neighborhoods in the U.S., too — children witness it repeatedly. They don’t become inured to it, Biel said, and more exposure means a greater chance of lasting psychological harm.

In Newtown, most at risk for longer-term problems are those who saw someone killed, said Dr. Carol North of the University of Texas Southwestern Medical Center, who has researched survivors of mass shootings.

Friday’s shootings were mostly in two classrooms of Sandy Hook Elementary School, which has about 450 students through fourth-grade.

But those who weren’t as close to the danger may be at extra risk, too, if this wasn’t their first trauma or they already had problems such as anxiety disorders that increase their vulnerability, she said.

Right after a traumatic event, it’s normal to have nightmares or trouble sleeping, to stick close to loved ones, and to be nervous or moody, Biel said.

To help, parents will have to follow their child’s lead. Grilling a child about a traumatic experience isn’t good, he stressed. Some children will ask a lot of questions, seeking reassurance, he said. Others will be quiet, thinking about the experience and maybe drawing or writing about it, or acting it out at playtime. Younger children may regress, becoming clingy or having tantrums.

Before second grade, their brains also are at a developmental stage some refer to as magical thinking, when it’s difficult to distinguish reality and fantasy. Parents may have to help them understand that a friend who died isn’t in pain or lonely but also isn’t coming back, Brymer said.

When problem behaviors or signs of distress continue for several weeks, Brymer says it’s time for an evaluation by a counselor or pediatrician.

Besides a supportive family, what helps? North advises getting children back into routines, together with their friends, and easing them back into a school setting. Studies of survivors of the Sept. 11 terrorist attacks found “the power of the support of the people who went through it with you is huge,” she said.

Children as young as first-graders can benefit from cognitive-behavioral therapy, Georgetown’s Biel said. They can calm themselves with breathing techniques. They also can learn to identify and label their feelings — anger, frustration, worry — and how to balance, say, a worried thought with a brave one.

Finally, avoid watching TV coverage of the shooting, as children may think it’s happening all over again, Biel added. He found that children who watched the 9/11 clips of planes hitting the World Trade Center thought they were seeing dozens of separate attacks.

___

EDITOR’S NOTE — Lauran Neergaard covers health and medical issues for The Associated Press in Washington.

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Many have ovary surgery even with negative gene test

NEW YORK (Reuters Health) – Many women who test negative for gene mutations that heighten the risk of ovarian cancer still get their ovaries removed despite a lack of evidence that it reduces the risk of dying, says a new study.

“A higher number than expected went through with the surgery, and it probably has to do with doctors in the community not having enough information on their patients’ risk levels,” said Dr. Gabriel Mannis, the study’s lead author.

According to Mannis and his colleagues, who published their study in the Archives of Internal Medicine on Monday, the average woman’s risk of developing ovarian cancer is about 2 percent, but women with BRCA1 and BRCA2 gene mutations have a 40 percent and 20 percent risk, respectively.

For women that test positive for the gene mutations, the American Congress of Obstetricians and Gynecologists (ACOG) says, if they choose to have their ovaries removed, it should be when they are done having children and near 40 years old.

There are no guidelines, however, on ovary removal and screening for women whose blood tests don’t show the gene mutations but who may still be at an increased risk of cancer based on their family’s medical history.

“We don’t have a clear sense of what their risk level is, or what the role of screening should be,” said Mannis, of the division of oncology at the University of California, San Francisco.

For the new study, the researchers surveyed women at two hospitals about 4 years after they were tested for the gene mutations to see if they decided to be screened or have their ovaries removed.

Of 1,077 women surveyed, about 19 percent tested positive for a BRCA mutation, about 10 percent had no mutation, and the rest had unclear results.

The researchers found that about 70 percent of the women who tested positive for a mutation had their ovaries removed by the time they took the survey.

But, despite a lack of evidence that they should have their ovaries removed, about 12 percent of the women with unclear results still had the surgery.

OVARIAN CANCER SCREENING

The researchers also found that despite the U.S. Preventive Services Task Force recommending against screening for ovarian cancer in women without the gene mutations, about 20 percent of women whose test results didn’t clearly show the mutations still ended up getting screened in the year before taking the survey.

In a previously published study, women screened annually for ovarian cancer were no less likely to die from the disease than those who didn’t get regular screening (see Reuters Health article of Sep. 10, 2012. http://reut.rs/QAmMdk).

Aside from not being shown to help, the tests are also imperfect, said Dr. Jed Delmore, chair the Gynecologic Oncology Sub-committee for ACOG.

“I can simply say that as of today we don’t have a good screening,” said Delmore, of the University of Kansas School of Medicine in Wichita.

“At this point if doctors are going to proceed with screening in this group of women, there needs to be a conversation that we don’t really know if this will prevent you from dying sooner of ovarian cancer or that it may come back as a false positive,” said Mannis.

In that previous study, about one in ten screened women had a false positive result, and of those a third had one or both ovaries removed.

That means some women had both ovaries removed even though they were not at an increased risk for cancer, which needlessly put them in danger of a complication and forced them into menopause.

Plus, the removing an ovary can cost over $ 3,000.

Delmore told Reuters Health that it seems like an intermediate ground has been reached with a majority of BRCA-positive women having surgery to reduce their risk, and fewer BRCA-negative women having it.

He agreed with Mannis that doctors need to be honest with their patients about the limitations of today’s screenings and treatments.

“We have pretty solid information for women who are BRCA positive and clearly BRCA negative,” he said. “It’s just that group in the middle.”

Mannis told Reuters Health that the next step would be to identify that group’s risk levels, but both he and Delmore said that won’t be easy.

SOURCE: http://bit.ly/WiwDtv Archives of Internal Medicine, online December 17, 2012.

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Workplace Bullying Common, Could Lead to Medication Use

Dec 16, 2012 7:00am

If you’ve ever felt bullied at work, you’re not alone. A new study suggests workplace bullying is common, and so is the need for medical intervention.

The survey-based study of more than 6,000 Finns found that one in eight men and one in five women reported being bullied at work. And self-reported bullying victims were more likely to use of antidepressants, sleeping pills and sedatives.

“A potentially unexpected finding is that the results were somewhat stronger for men than women,” study author Dr. Tea Lalluka of the University of Hilsinki said, explaining that bullied men were slightly more likely to use medications than bullied women.

The study was published Thursday in the journal BMJ.

Even witnessing bullying can have health effects, according to the study. Men and women who observed workplace bullying were one and a half to two times as likely to need similar medications, reflecting true, medically confirmed mental problems.

“We’ve all seen it go on,” said Dr. Nadine Kaslow, vice chair of psychiatry at Emory University in Atlanta, who was not involved with the study. “It’s that bystander effect; nobody wants to do anything about it.”

The study was unable to examine the length or intensity of bullying among surveyed employees. But experts say preventing workplace bullying might help prevent serious mental health problems.

“There are employee assistance programs and wellness programs available to people,” Kaslow said. “I would encourage people to take advantage of those. Get support — social support, self care, exercise, eat well — whatever it is, make connections with people at work.”

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California home for developmentally disabled faces abuse inquiry

SAN FRANCISCO (Reuters) – California health officials have threatened to shut down part of the state’s oldest home for developmentally disabled adults due to evidence of physical abuse and neglect, in a move that could displace nearly 300 of its residents.

The state-run Sonoma Developmental Center could lose its license to run one unit if it does not fix the problems, according to a letter the state health department sent this week to the director of the sprawling facility in Eldridge.

Monitors this month and last “documented incidents of abuse constituting immediate jeopardy, as well as actual serious threats to the physical safety of female clients in certain units,” the California Department of Public Health letter said.

Among the incidents were physical abuse, a staff member exposing himself to a female client and inadequate monitoring of a patient who had propensity to swallow inedible items, leading to surgery, said Pam Dickfoss, assistant deputy director of the California Center for Health Care Quality.

The threat of sanctions against the board-and-care center in the heart of wine country represents a significant blow to a historic facility that opened at its current site in 1891 next to the bucolic town of Sonoma.

The center is northern California‘s only state-run residential facility for developmentally disabled adults and sits on 1,000 acres of land, including a petting zoo and sports fields.

Closure of the unit under scrutiny, the Intermediate Care Facility, could require moving 290 of the center’s more than 500 residents, officials said. It is unclear where they would be sent and officials say they hope that will not be necessary.

Administrators have vowed to correct deficiencies and said they plan to appeal the move to potentially strip them of federal funding and a state license for the unit under scrutiny.

“We are moving quickly to fix this center and protect our residents,” said Terri Delgadillo, director of the state Department of Developmental Services, which oversees the center.

She said the problems forced the removal of the center’s executive and clinical directors as well as other staff changes.

State monitors identified 57 deficiencies during a July visit, including four that posed an immediate danger to residents, and dozens of other threats to residents in more recent visits, the letter said.

The facility gets $ 117,000 a day in federal funding, said Nancy Lungren, a spokeswoman for the California Department of Developmental Services.

Most of the center’s residents suffer from cerebral palsy, epilepsy, autism, or a combination of those conditions. Many have lived their entire adult lives at the center.

Leslie Morrison, director of the investigations unit of Disability Rights California, a watchdog group, said she was troubled by reports from the facility over the past year.

“This has been developing for a long period,” Morrison said. “They have been trying to correct things, but it’s going to take a long time.”

(Editing by Alex Dobuzinskis and Eric Walsh)

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Alexza agitation drug gets EU recommendation, shares jump

(Reuters) – European health regulators recommended approval of Alexza Pharmaceuticals Inc‘s experimental drug Adasuve for controlling agitation in adults with schizophrenia and bipolar disorder, sending its shares up 19 percent.

Adasuve, Alexza’s most advanced drug in development, will be the first treatment for schizophrenia and bipolar disorder that can be inhaled.

“… The beautiful part of (the drug) is that the clinician can give (patients) almost instantaneous response, whereas possibly hours of waiting for any other kind of oral medication, and that is the critical key,” WBB Securities LLC analyst Steve Brozak told Reuters.

Three injectable drugs, Bristol-Myers Squibb’s Abilify, Eli Lilly’s Zyprexa and Pfizer Inc‘s Geodon, are currently approved to calm patients with schizophrenia or bipolar disorder.

The recommendation from the European Medicines Agency (EMA) will be forwarded to the European Commission, which normally endorses recommendations within two or three months.

Alexza estimates that as many as 8 million adults in the EU suffer from schizophrenia or bipolar disorder.

Adasuve is also under review by the U.S. Food and Drug Administration, with a decision expected by December 21.

“It’s simply a question of when it will get approved,” Brozak said.

The FDA denied approval to Adasuve in May, after it found deficiencies at the company’s Mountain View, California manufacturing facility during an inspection.

Adasuve, which delivers an older antipsychotic drug called loxapine, passes through the lungs and into the bloodstream faster than a typical pill. Loxapine is available as an oral drug for schizophrenia.

Adasuve, which the EMA said should be administered only in a hospital, is delivered using Alexza’s Staccato delivery device.

Two late-stage studies were conducted, and both demonstrated statistically significant reductions in agitation compared to a placebo, the company said. The study enrolled 344 adult patients with schizophrenia and 314 adult patients with bipolar disorder.

Alexza’s shares jumped 19 percent to $ 6.25 before easing back to $ 5.75 by mid-morning on the Nasdaq on Friday.

(Additional reporting by Ben Hirschler in London; Editing by Sriraj Kalluvila)

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Aetna plans to join 15 exchanges under U.S. healthcare reform

NEW YORK (Reuters) – Aetna Inc, the third largest U.S. health insurer, said on Wednesday that by 2014 it expects to be part of about 15 healthcare exchanges being established under government reforms.

Aetna, one of the companies on the front lines of healthcare changes in the United States, told analysts and investors that it believes an increase in the number of customers from the new market places will likely contribute to its growth.

An estimated 30 million more people are expected to join the insured over the next decade because of the U.S. Patient Protection and Affordable Care Act of 2010. Millions of those will seek their health insurance through the exchanges.

States have until December 14 to decide whether they will participate in a state-based, federal or partnership exchange. About 18 states have said they will create their own state-based exchanges and 18 others plan to default to a federal exchange, according to the Kaiser Family Foundation, a non-profit health policy group.

The shift to exchanges is fundamentally changing the managed care business, Aetna executives said during Wednesday’s meeting with analysts and investors.

“More and more consumers are going to be buying their healthcare, even if the employer-sponsored system survives,” Chief Executive Officer Mark Bertolini said. “A lot of things that we do today are no longer necessary to the end buyer.”

Aetna said profits will be helped by cost controls and growth of carefully managed care organizations — networks of doctors that work together — and expansion in government programs, such as Medicare for the elderly and Medicaid for the poor, and Aetna’s pending purchase of Coventry Health Care Inc..

Aetna expects earnings of $ 5.40 per share in 2013, below analyst estimates of $ 5.52 per share according to ThomsonReuters I/B/E/S. It sees revenue growth of 9 percent in 2013.

Competitors such as UnitedHealth Group Inc and Cigna Corp also gave weaker than expected 2013 earnings outlooks during their year-end meetings with analysts and investors. Aetna shares rose about $ 1.96 to $ 46.43 in midday New York Stock Exchange trading.

Aetna, whose $ 5.6 billion acquisition of regional insurer Coventry is being looked at by antitrust regulators, said that it still expects the deal to close in the middle of next year. It said it has not run into any issues that are beyond its expectations.

Aetna Chief Financial Officer Joe Zubretsky said in an interview that Aetna had not factored the possibility of the United States going over the so-called fiscal cliff into its 2013 outlook. The “fiscal cliff” is a combination of mandatory spending cuts and tax increases that will go into effect at the beginning of next year if a deficit cutting resolution is not reached by U.S. lawmakers.

Aetna’s outlook is based on a cautious view of the economy and one in which unemployment remains at about 7.5 percent and interest rate returns remain extremely low, the company said.

“We’re pretty much assuming the cliff gets solved,” Zubretsky said.

But he said the company is concerned and guarded against the possibility that it is not resolved. If that does happen, he said U.S. employees poised to lose their jobs and health insurance may increase use of medical services, or Aetna’s large employer business may decrease as companies cut back on employees, both of which would likely hurt profits.

(Editing by Bill Berkrot and Grant McCool)

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Health workers march in Spain’s capital against cuts, reforms

MADRID (Reuters) – Thousands of health workers, on strike since last month, marched on Sunday in Madrid to protest against budget cuts and plans from the Spanish capital’s regional government to privatize the management of public hospitals and medical centers.

It was the third time doctors, nurses and health workers have rallied since the local authorities put forward a plan in October to place six hospitals and dozens of medical practices under private management. The plan also calls for patients to be charged a fee of 1 euro for prescriptions.

Workers launched an indefinite strike last month against the plan, which has not been endorsed by the centre-right government of Prime Minister Mariano Rajoy. Health workers in the capital are striking Monday-Thursday each week and seeing patients only on Fridays, while also responding to emergencies.

Spain’s 17 autonomous regions control health and education policies and spending. They have all had to implement steep cuts this year as the country struggles to meet tough European Union-agreed deficit targets.

Dressed in white scrubs, the protesters shouted slogans such as “Health is not for sale” and “Health 100 percent public, no to privatizations”.

“Of course, privatization can be reversed. Actually the question is not if it can be reversed, because privatization should never have a future,” said Luis Alvarez, an unemployed man from Madrid attending the demonstration.

Belen Padilla, a doctor at Madrid’s hospital Gregorio Maranon, said one million citizens had already signed a petition rejecting the plan.

(Reporting by Reuters Television; Writing by Julien Toyer; Editing by Peter Graff)

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USDA to allow more meat, grains in school lunches

WASHINGTON (AP) — The Agriculture Department is responding to criticism over new school lunch rules by allowing more grains and meat in kids’ meals.

Agriculture Secretary Tom Vilsack told members of Congress in a letter Friday that the department will do away with daily and weekly limits of meats and grains. Several lawmakers wrote the department after the new rules went into effect in September saying kids aren’t getting enough to eat.

School administrators also complained, saying set maximums on grains and meats are too limiting as they try to plan daily meals.

“This flexibility is being provided to allow more time for the development of products that fit within the new standards while granting schools additional weekly menu planning options to help ensure that children receive a wholesome, nutritious meal every day of the week,” Vilsack said in a letter to Sen. John Hoeven, R-N.D.

The new guidelines were intended to address increasing childhood obesity levels. They set limits on calories and salt, and phase in more whole grains. Schools must offer at least one vegetable or fruit per meal. The department also dictated how much of certain food groups could be served.

While nutritionists and some parents have praised the new school lunch standards, others, including many conservative lawmakers, refer to them as government overreach. Yet many of those same lawmakers also have complained about hearing from constituents who say their kids are hungry at school.

Though broader calorie limits are still in place, the rules tweak will allow school lunch planners to use as many grains and as much meat as they want. In comments to USDA, many had said grains shouldn’t be limited because they are a part of so many meals, and that it was difficult to always find the right size of meat.

The new tweak doesn’t upset nutritionists who fought for the school lunch overhaul.

Margo Wootan, a nutrition lobbyist for the Center for Science in the Public Interest, says the change is minor and the new guidance shows that USDA will work with school nutrition officials and others who have concerns.

“It takes time to work out the kinks,” Wootan said. “This should show Congress that they don’t need to interfere legislatively.”

Congress has already interfered with the rules. Last year, after USDA first proposed the new guidelines, Congress prohibited USDA from limiting potatoes and French fries and allowed school lunchrooms to continue counting tomato paste on pizza as a vegetable.

The school lunch rules apply to federally subsidized lunches served to low-income children. Those meals have always been subject to nutritional guidelines because they are partially paid for by the federal government, but the new rules put broader restrictions on what could be served as childhood obesity rates have skyrocketed.

School kids can still buy additional foods in other parts of the lunchroom and the school. Congress two years ago directed USDA to regulate those foods as well, but the department has yet to issue those rules.

Sen. Hoeven, who had written Vilsack to express concern about the rules, said he will be supportive of the meals overhaul if the USDA continues to be flexible when problems arise.

“This is an important step,” he said. “They are responding and that’s what they need to do.”

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Should breast cancer patients skip the pre-op MRI?

NEW YORK (Reuters Health) – A new review of existing evidence suggests that using magnetic resonance imaging to “stage” a woman’s breast cancer before surgery might do more harm than good.

MRI produces a much clearer image than X-rays and ultrasound, and is recommended for detecting early tumors in women at increased risk for breast cancer. But routinely using the technology once any woman is diagnosed with a tumor may lead to more radical surgery without any benefits, says a team of Australian and U.S. researchers.

They found that about 26 percent of women who had a pre-operative MRI to help determine the extent and severity of their tumor ended up having their entire breast removed, compared to about 18 percent of those whose surgeons only used traditional methods of characterizing the cancer.

“I wasn’t surprised by the results at all. What I am surprised by was the strength of the data,” said Dr. Monica Morrow, the study’s senior author and the chief of breast service at Memorial Sloan-Kettering Cancer Center in New York.

Because MRIs are more sensitive than mammograms, some doctors think they are a good tool for identifying the precise outlines of cancerous tissue. Others, however, have begun to question whether the imaging led surgeons to remove more breast tissue than necessary.

Moreover, women who have MRIs before breast surgery seem to be no less likely to need a second surgery to remove additional cancerous tissue.

A study published in September, for instance, found that among more than 300 women who underwent breast cancer surgery, just as many of those who had an MRI before the first surgery ended up having a repeat operation. (see Reuters Health article of September 25, 2012 here: http://reut.rs/Oogm3c)

An MRI can also add more than $ 1,000 to a patient’s bill.

“I think more surgeons are starting to question this because they’re seeing the outcomes,” Morrow said.

For the new study, she and her colleagues pulled together data from nine previous studies to see if MRIs influenced the number of women who had their breast removed or who had a second surgery to remove additional cancer.

From the nine studies, the researchers had information on 3,112 women who had breast cancer surgery.

Overall, the team found that about 16 percent of the women who had an MRI ended up having the entire cancerous breast removed, known as a mastectomy, during their first surgery. That’s compared to about 8 percent of women who did not have an MRI.

They also found that having an MRI before surgery did not influence whether women would need additional surgery to remove more tissue. In each group, between 11 percent and 12 percent had to go back under the knife.

After taking into account the women’s initial surgery and the second operations, the researchers calculated that about 26 percent of those who had an MRI ended up having their entire breast removed, compared to 18 percent in the no-MRI group.

“It causes more mastectomies to start with, but it doesn’t decrease the number of women who started out wanting a lumpectomy and needing a mastectomy,” said Morrow of preoperative MRIs.

The study did not look at long term outcomes, including how many women survived beyond five years. Nor did it examine the use of MRI to screen the opposite breast for signs that cancer had spread, the researchers note in their report, which is published in the Annals of Surgery.

These results do not apply to certain subgroups of patients, they add, including women with genetic mutations that predispose them to cancer and those whose other diagnostic tests produced conflicting results.

But based on the short term measures of how many surgeries women got and how much tissue surgeons removed from them, Morrow told Reuters Health that MRIs do not seem to have a place in breast cancer surgery.

“There may be select circumstances where we’d use it to solve a problem, but for most women with breast cancer they don’t need an MRI for their evaluation,” she said.

SOURCE: http://bit.ly/RdZNIw Annals of Surgery, online November 26, 2012.

(This story was refiles to change “woman” to “women” in second paragraph.)

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Amarin raises $100 million to help launch heart drug

(Reuters) – Biopharmaceutical company Amarin Corp Plc said it raised $ 100 million in non-equity financing that will help it form a sales force to launch its heart drug Vascepa.

Amarin shares, however, fell 22 percent after the bell as the company did not announce a sale or a partnership to market the drug, as some investors had expected.

“This transaction provides Amarin with non-dilutive capital that will ensure our ability to fully execute on the Vascepa product launch while continuing our strategic partnership discussions,” CEO Joseph Zakrzewski said in a statement.

The company said it will hire 250 to 300 sales professional to launch Vascepa in the first quarter of 2013.

(Reporting By Vrinda Manocha in Bangalore; Editing by Don Sebastian)

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