Amgen pagará 762 millones por vender un medicamento para usos no autorizados

Nueva York, 19 dic (EFE).- El gigante estadounidense de la biotecnología Amgen pagará una sanción de 762 millones de dólares tras declararse culpable de introducir en el mercado un medicamento para usos no permitidos por las autoridades federales.
La compañía aceptó hoy en un tribunal federal de Brooklyn (Nueva York) un acuerdo para declararse culpable, clausurar el caso y pagar 150 millones en sanciones criminales y 612 millones para cubrir las solicitudes de compensación a programas públicos de seguro médico, como Medicare o Medicaid.
El caso se refiere al "Aranesp", un medicamento aprobado por la Administración de Fármacos y Alimentos (FDA, por sus siglas en inglés) para favorecer la formación de glóbulos rojos en los tratamientos de anemias.
"A fin de incrementar las ventas de Aranesp y lograr más beneficios, Amgen ilegalmente vendió el medicamento con la intención de que se usara con dosis que la FDA había estudiado y rechazado, y para tratamientos que la FDA nunca aprobó", señaló el tribunal federal en un comunicado.
El acuerdo supone la mayor sanción por fraude a una compañía de biotecnología en la historia de Estados Unidos.
El fiscal federal Marshall Miller señaló que "en lugar de trabajar para alargar y mejorar la vida humana, Amgen buscó ilegalmente los beneficios empresariales mientras ponía en peligro la seguridad de consumidores vulnerables que sufrían enfermedades". EFE

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"Fiscal cliff" talks turn sour, Obama threatens veto

 Talks to avoid a fiscal crisis appeared to stall on Wednesday as President Barack Obama accused Republicans of digging in their heels due to a personal grudge against him, while a top Republican called the president "irrational."
As the clock ticks toward a year-end deadline, Obama and House of Representatives Speaker John Boehner, the top Republican in Congress, are trying to reach a deal to avert harsh tax hikes and spending cuts that could trigger a recession.
Obama said he was puzzled over what was holding up the talks and told Republicans to stop worrying about scoring "a point against the president" or forcing him into concessions "just for the heck of it."
"It is very hard for them to say yes to me," he told a news conference in the White House. "At some point, you know, they've got to take me out of it."
The rise in tensions threatens to unravel significant progress made over the last week in the so-called fiscal cliff talks.
Boehner and Obama have each offered substantial concessions that have made a deal look within reach. Obama has agreed to cuts in benefits for seniors, while Boehner has conceded to Obama's demand that taxes rise for the richest Americans.
However, the climate of goodwill has evaporated since Republicans announced plans on Tuesday to put an alternative tax plan to a vote in the House this week that would largely disregard the progress made so far in negotiations.
Obama threatened to veto the Republican measure, known as "Plan B," if Congress approved it.
Boehner's office slammed Obama for opposing their plan, which would raise taxes on households making more than $1 million a year and is a concession from longstanding Republican opposition to increasing any tax rates.
"The White House's opposition to a backup plan ... is growing more bizarre and irrational by the day," Boehner said through his spokesman, Brendan Buck.
Boehner expressed confidence the House would pass the legislation, known as "Plan B," on Thursday. He urged Obama to "get serious" about a balanced deficit reduction plan.
Global investors are on edge over the talks, and U.S. stocks fell on Wednesday following Boehner's comments.
An acrimonious presidential campaign that culminated in Obama's re-election on November 6 has added to the bad blood in Washington between Obama and congressional Republicans.
The two sides also clashed bitterly last year over the government's limit on borrowing - known as the debt ceiling - an episode that nearly led the nation to default on its debt.
On Wednesday, Obama said the fiscal cliff must not get bogged down with negotiations over the debt ceiling, an issue that must be dealt with again early next year.
LITMUS TEST
Voting on Plan B will be a litmus test for Republicans on Boehner's concession to raise tax rates. In a sign conservatives are coming around to Boehner's position, anti-tax activist Grover Norquist gave his blessing to the bill.
Obama and Boehner appear to have bridged their biggest ideological difference but remain hung up on the mix of tax hikes and spending cuts meant to narrow the budget gap.
"What separates us is probably a few hundred billion dollars," Obama said.
The White House wants taxes to rise on incomes above $400,000 a year, a concession from Obama's opening proposal for a $250,000 income threshold.
If a deal is not reached soon, some $600 billion in tax hikes and spending cuts are set to begin next month.
Senior administration officials described negotiations as at a standstill and Obama warned he would ask everyone involved in the talks, "what it is that's holding it up?"
Still, the top Republican in the Senate said resolution could come by the end of the week.
"There's still enough time for us to finish all of our work before this weekend, if we're all willing to stay late and work hard," said Senate Republican leader Mitch McConnell.
Any deal by Obama and the Republican leadership would need the support of their parties' rank and file.
Many Democrats dislike the president's offer to reduce benefits to seniors, although some political allies of Obama have given signs they feel they could swallow this concession.
"I don't like these particular changes," said Democratic Representative Chris Van Hollen, a member of the House leadership from Maryland. But he added: "What people are seeing is the president willing to compromise in order to get things done.

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

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.

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Colorado Woman Billed Medicaid for Dead Father

A Colorado woman was convicted this week for felony forgery for submitting fraudulent documents to Medicaid regarding personal health care services provided to her father after he died. It was the second announcement of Medicaid fraud-related convictions made by the Colorado Attorney General's office in less than a week. Here are the details.
* According to the office of Colorado Attorney General John Suthers, 52-year-old Viola Kwong pleaded guilty to felony forgery in Denver District Court on Tuesday. She was sentenced to pay $16,000 in criminal restitution and perform 50 hours of public service. The restitution reflects all of the money illegally received by Kwong.
* Kwong will also be placed on supervised probation for four years, is responsible for all court costs and probation supervision fees associated with her case, and will pay a civil penalty of more than $37,000 to the Colorado Medicaid program, the Attorney General's Office stated.
* The Attorney General's Office stated that Kwong had requested services for her elderly father through a Medicaid program that allows the Medicaid client to direct his or her own home-based medical care.
* Because Kwong's father was too ill to manage his care, Kwong was authorized by the program as his personal representative, in charge of obtaining those services for her father.
* Kwong's father died on July 23, 2010, but Kwong continued to submit documents about personal health care services that were being provided to her father until Nov. 8, 2010.
* Suthers stated that the restitution ordered was "another significant recovery for Colorado's Medicaid program."
* Colorado Department of Health Care Policy and Financing initially referred the case to the Attorney General's Medicaid Fraud Control Unit.
* Last week, the Attorney General's Office announced the conviction of occupational therapist Cheryl Moss, 47, for felony theft and felony forgery. Moss pleaded guilty to forging treatment records and fraudulently billing the Colorado Medicaid program for services she did not perform.
* Moss agreed to repay the program $54,332, serve 60 days home detention and perform 300 hours of community service. She was also ordered to pay an additional $46,000 to resolve any potential civil issues and to report her conviction to the agency charged with licensing occupational therapists in Colorado.
* According to the Attorney General, Medicaid is health insurance for qualifying low-income, disabled individuals, and children and families. Covered services include hospital care, skilled nursing home care, residential adult family care services, hospice, mental health, dental and eyeglass services. Each state administers its own Medicaid program.

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U.S. teen smoking declines to record low in 2012: study

 Cigarette smoking among American teenagers dropped to a record low in 2012, a decline that may have been partly driven by a sharp hike in the federal tobacco tax, researchers said on Wednesday.
An annual survey of about 45,000 students in the eighth, 10th and 12th grades found that the overall proportion of those saying they had smoked in the prior 30 days fell by just over a percentage point to 10.6 percent.
"A one percentage point decline may not sound like a lot, but it represents about a 9 percent reduction in a single year in the number of teens currently smoking," Lloyd Johnston, the principal investigator in the study, said in a statement.
He said reductions on that scale can translate into the prevention of thousands of premature deaths and tens of thousands of cases of cancer and other serious disease.
More than 400,000 Americans are estimated to die prematurely each year as a result of cigarette smoking - the No. 1 cause of preventable U.S. deaths - and most smokers begin their habit as adolescents, experts say.
Healthcare advocates hailed Wednesday's findings as evidence that higher cigarette taxes were paying off, combined with federal curbs on youth-oriented tobacco marketing and sales and a sweeping anti-smoking media campaign.
The researchers also cited the increase in federal cigarette taxes, raised by 62 cents a pack in 2009, as a likely contributing factor. The findings were part of an annual survey by University of Michigan researchers released by the National Institute on Drug Abuse.
Smoking rates fell for each of the individual age groups surveyed, most notably among eighth graders - from 6.1 percent in 2011 to 4.9 percent in 2012, the survey found.
Longer-term trends showed teen smoking rates dropping by about three-fourths among eighth graders, two-thirds among 10th graders and by half among 12th graders since a peak in the mid-1990s, researchers said.
One reason cited by experts is that the proportion of students who have ever tried smoking has declined sharply. Whereas nearly half of all eighth graders had tried cigarettes in 1996, just 16 percent had done so this year.
Teen attitudes toward smoking also continued to become more negative. For example, 80 percent of teens said they preferred to date nonsmokers in 2012.
But anti-tobacco advocates said their battle to stamp out teen smoking was far from over, noting that 17 percent of high school seniors still graduate as smokers.
Researchers singled out concerns over new forms of smokeless tobacco, including dissolvable products like Camel-branded "Orbs" and "Strips," and a fine, moist form of snuff called snus (rhymes with "loose"), which users place under their upper lip.
They said a significant portion of older teens have experimented with small cigars and water pipes called hookahs, which are becoming popular among young adults.
"We cannot let our guard down when the tobacco industry still spends $8.5 billion a year - nearly $1 million ever hour - to market its deadly and addictive products and is pushing new products ... that entice youth," said Susan Liss, executive director for the Campaign for Tobacco-Free Kids.

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Americans Living Longer, Report Finds

WEDNESDAY, Jan. 11 (HealthDay News) -- Americans are living longer, a new report shows, with the average life expectancy going from 78.6 years in 2009 to 78.7 years in 2010.

Meanwhile, U.S. death rates dropped half a percent between 2009 and 2010, and hit the lowest rate ever, at 746.2 deaths per 100,000 people, according to the latest set of data from the U.S. Centers for Disease Control and Prevention's National Center for Health Statistics.

And while both heart disease and cancer stubbornly remain in place as the nation's leading killers (together accounting for 47 percent of deaths in 2010), death rates here declined as well. Mortality from heart disease went down 2.4 percent, while it dropped 0.6 percent for cancer.

The report is based on 98 percent of death certificates from 50 states and the District of Columbia available to the NCHS.

"In many regards, I think the health of the nation is improving and people are living to an older age so that's good news," said Dr. David McClellan, acting regional chair of family and community medicine at Texas A&M Health Science Center College of Medicine. "But we are starting to see age-related diseases have more prominence."

For instance, pneumonitis (aspiration pneumonia) often happens when people get old enough and debilitated enough to where they can't swallow. This could be due to dementia or as the aftermath of a stroke, he explained.

There's also "a long way to go in terms of combating the epidemic of smoking, obesity, poor diet and exercise," he said. "If we could get the smoking epidemic under control, we'd probably see the numbers improve even more."

Another expert was more optimistic.

"This is good news. We're making major progression in cancer and heart disease through decreases in smoking," said Dr. Jay Brooks, chairman of hematology/oncology at Ochsner Health System in Baton Rouge, La.

Statins are also playing a part in reducing the death toll from heart disease, while cancer screening is also helping to save lives, Brooks added.

There were slight shuffles in the rankings of other causes of death.

Homicide fell out of the top 15 category for the first time since 1965, replaced by pneumonitis.

Kidney disease and pneumonia/influenza switched places, with the former now 8th and the latter now 9th.

"Pneumonia and influenza have really dropped a lot. Several years ago, they were the sixth leading cause of death," said Dr. Michael Niederman, chairman of medicine at Winthrop University Hospital in Mineola, N.Y. "To me, this is very encouraging because we're dealing with older populations where many patients frequently have pneumonia, but this affirms the national priority on immunization, both influenza and pneumococcal."

The other leading causes of death (in order) were: chronic lower respiratory diseases, cerebrovascular disease (stroke), accidents, Alzheimer's disease, diabetes, kidney disease, suicide, septicemia, liver disease, hypertension and Parkinson's.

Many of these are clearly diseases related to the aging population, Brooks noted.

Death rates also declined for influenza and pneumonia (by 8.5 percent), septicemia (3.6 percent), stroke (1.5 percent), respiratory diseases (1.4 percent) and accidents (1.1 percent).

Meanwhile, death rates increased for five of the top 15: Parkinson's disease (4.6 percent), pneumonitis (4.1 percent), liver disease and cirrhosis (3.3 percent), Alzheimer's disease (3.3 percent) and kidney disease (1.3 percent).

The death rate for HIV/AIDS (which was not among the 15 leading causes of death) declined 13.3 percent between 2009 and 2010. But the virus remains a significant concern, especially for people aged 15 through 64.

There was also good news in infant mortality, with rates in 2010 down 3.9 percent from 2009.

But Dr. Suzanne Steinbaum, a preventive cardiologist with Lenox Hill Hospital in New York City cautioned against getting too excited over the findings.

"This is good news. I don't think it's great news," she said. "With the increased incidence in obesity, diabetes, high blood pressure, high cholesterol, we're going to start seeing people getting sicker younger."

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Glam Slam: The Friday Five -- Ways To Get Even Sexier

The number one hit "Sexy and I Know It" makes me laugh (I work ouuut!) and with Valentine's Day just around the corner, you may be looking for a little "get sexy" inspiration.

InStyle magazine shares five ways we can all get even sexier!!!!

PLAY IT NOW: 2012 People's Choice Awards Fashion Report Card

Apply Bold Color There's power in your pout. One study showed that both red and pink lipstick hold a man's attention for five seconds longer than a neutral lip. But a high-impact hue has to feel right--to you. Experiment with different shades of crimson and fuchsia and combine it with a subtle, smoky eye.

Master the "Bed-Head Bardot" For touchable waves (like J.Lo's!), start with a volumizing spray or powder. Loosely gather hair into two low ponytails and secure with rubber bands. Twist each pony around its base; pin and leave in for two hours. Shake out and voila--goddess bed head. Create waves on shorter 'dos by wrapping strand vertically around a 1-inch curling iron; begin at the top of your ears and continue down to the ends.

VIEW THE PHOTOS: Hollywood Stars Who Take The Plunge!

Customize Your Curves When it comes to turning up the heat, a tailor can be a miracle worker. Alterations to the bust, waist and hips of a sheath dress can highlight your shape easily giving you a day-to-night look. Add definition with a thin or wide belt.

Work on Your Wink Fluttery fringe on the red carpet (like Eva Longoria's) is often achieved with false eyelashes or extensions, say pros. For DIY lashes at home, use these tips. Begin with a primer and secure your lashes to the bottom of your eyelid. Gently heat your lash curler with a blow-dryer before crimping. Finally, brush on waterproof mascara to seal the lash.

Embrace Lace A lacy stocking shows off your seductive legs in a seductive way that's not edgy or overt. Pair with an LBD and platform pumps for a saucy retro vibe.

VIEW THE PHOTOS: Kristen Stewart's Best Red Carpet Looks

For more beauty tips, pick up a February issue of InStyle on newsstands today.

Instyle is also hosting its annual Beauty Lounge today and tomorrow at the Four Seasons Hotel in Beverly Hills.

VIEW THE PHOTOS: Stars Step Out For GQ's 2011 'Men Of The Year' Party

To celebrate the 2012 Awards Season, stars like Malin Ackerman will get pampered at the lounge's complimentary hair and makeup touch ups by L'Oréal Paris and mini manicures by OPI! Good times!

Copyright 2012 by NBC Universal, Inc. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

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9 Things You Shouldn't Buy at Grocery Stores

Grocery stores offer plenty of conveniences to make food-buying as simple as possible. Most of us head to the grocery store  to pick up fresh produce, meats, cheeses, snacks, and other convenience foods, and you can pick from dozens of brands and generic items that fit your budget. Still, there are a few things you don't want to pick up at your local supermarket. Certain types of produce are full of pesticides and you'll be better off heading to the local farmers market or buying organic. Buying non-grocery items at the supermarket usually means you'll spend much more than the average price in your area.

Here are nine items you shouldn't pick up from the grocery store:

[See 50 Ways to Improve Your Finances in 2012.]

1. Cosmetics and skin care items. Even though many grocery stores are stocked with popular brands of cosmetics and skin care products, you'll probably pay a premium for every item. Head to your nearest chain drugstore, Wal-Mart, or Super Target if you want to stock up on or sample makeup, moisturizer, cleansers, and scrubs.

2. Pre-ground coffee. Some grocery stores offer great prices on coffee beans that you can grind right in the store, but buying pre-ground coffee could put a dent in your grocery budget. The mark-up on pre-ground coffee is relatively high and you could get a much better deal on large coffee cans at your neighborhood big-box store. Remember you can also track down coupons and vouchers for certain brands.

3. Party supplies. As convenient as it is to pick up candles, balloons, and other party supplies for that last-minute get together, you'll end up paying a high price solely out of convenience. Plan to make a pit stop at the local dollar store or party supply store to take advantage of lower prices.

4. Kitchen appliances. Whether you're in the market for a new toaster, blender, or food processor, do your homework and track down a great price on kitchen appliances online. Grocery stores typically carry a very small stock of these items and you probably won't even find a quality brand. Stick with big-box stores and online merchants for your kitchen appliances and other small electronics.

[See 10 Kitchen Tools That Will Save You Money.]

5. Hardware. Light bulbs, extension cords, nails, and small tools don't come cheap at the grocery store. Again, these are considered to be specialty goods at a grocery store and most will only have a very small inventory of hardware items. Stick with big-box retailers, the dollar store, or even your local hardware store when you need to stock up.

6. Cookware and bakeware. If you're suddenly inspired to cook a banquet-style meal when shopping at the grocery store, make sure you pick up your basic supplies elsewhere. Cookware and bakeware items are usually heavily marked up at the grocery store and you could end up paying almost double the price for your items. Make a list of what you need then head out to a store that has a larger inventory of these specialty items.

7. Some fruits and veggies. PBS put together two lists of fruits and vegetables that are worth buying-and not buying-at the grocery store, based on the level of pesticides and chemicals present in each items. The recommendation is to stick with organic varieties of apples, bell peppers, peaches, strawberries and potatoes. Grocery stores are your best bet for fruits and vegetables like asparagus, sweet peas, eggplant, cantaloupe, sweet potatoes, and onions.

[See 5 Ways to Stretch Your Grocery Budget.]

8. Gourmet cheese. The deli section of most grocery stores is stocked with pricey items that also have a very short shelf life. If you're looking for cheese, head to the dairy section where you'll find processed varieties for a fraction of the price of the fresh, gourmet options. If it's gourmet cheese you're after, keep an eye out for deals on offerings from daily deal sites at local wine and cheese stores in your area. You can also get better pricing on cheese at your local warehouse club.

9. Name-brand spices. Fresh spices are another gourmet food item that you're probably paying a premium for at the grocery store. Your best bet? The ethnic food markets and local ethnic food stores. Some big-box stores also tend to stock a large spice inventory and will price these at lower price points than your neighborhood grocery store. Consider buying in bulk from the ethnic market to save even more.

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65-and-Older Population Soars

There are now more Americans age 65 and older than at any other time in U.S. history. According to a new Census Bureau report, there were 40.3 million people age 65 and older on April 1, 2010, up 5.3 percent from 35 million in 2010 (and just 3.1 million in 1900).

"The population age 65 and older has increased notably over time," says Carrie Werner, a Census Bureau statistician and author of the report. "It is expected to increase more rapidly over the next decade as more baby boomers start to turn 65 in 2011."

[See 10 Cities With the Most People Over 65.]

The 65-and-older population jumped 15.1 percent between 2000 and 2010, compared with a 9.7 percent increase for the total U.S. population. People age 65 and older now make up 13 percent of the total population, compared with 12.4 percent in 2000 and 4.1 percent in 1900.

Females significantly outnumber males at older ages, but the gap is narrowing. In 2010, there were 90.5 males for every 100 females among people age 65 and older, up from 88.1 males per 100 females the same age in 2000. "Women outnumber men in the older population at every single year of age," says Werner. "Males showed more rapid growth in the older population than females over the past decade." In the 2010 Census, there were approximately twice as many women as men beginning at age 89. This point occurred about four years older than it did in 2000, and six years older than in 1990.

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Why Some People Live to 110

SUNDAY, Jan. 8 (HealthDay News) -- People who live 110 years or longer have as many disease-associated genes as those in the general population, but they may also be blessed with protective genes that help them live so long, researchers report.

The team of U.S. scientists noted that supercentenarians, as they are called, are extremely rare, with only one per 5 million people in developed nations. There is growing evidence that genetics play a major role in living to such an old age.

In what they describe as a first-of-a-kind study, the researchers analyzed the whole genome sequences of a man and a woman who lived past the age of 114 and found that they had as many disease-associated genes as other people.

For example, the man had 37 genetic mutations associated with increased risk for colon cancer.

"In fact, he had presented with an obstructing colon cancer earlier in his life that had not metastasized and was cured with surgery. He was in phenomenal cognitive and physical shape near the time of his death," study senior author Dr. Thomas Perls, director of the New England Centenarian Study, said in a Boston University Medical Center news release.

The woman had numerous genetic variations associated with age-related disease, such as heart disease, cancer and Alzheimer's disease. She did develop congestive heart failure and mild cognitive impairment, but these conditions didn't become evident until she was more than 108 years old.

"The presence of these disease-associated variants is consistent with our and other researchers' findings that centenarians carry as many disease-associated genes as the general population," Perls said. "The difference may be that the centenarians likely have longevity-associated variants that cancel out the disease genes. That effect may extend to the point that the diseases don't occur -- or, if they do, are much less pathogenic or markedly delayed towards the end of life, in these individuals who are practically living to the limit of the human lifespan."

The study was published Jan. 3 in the journal Frontiers in Genetics, and researchers will be able to access the information at the U.S. National Institutes of Health data repository.

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