Link between health care spending, quality unclear

NEW YORK (Reuters Health) – Whether states, hospitals and smaller practices that spend more money on health care provide better treatment is still an open question, according to a new review of past studies.

“This is really one of the central issues we’re grappling with today in health care,” said Peter Hussey from the RAND Corporation in Arlington, Virginia.

The topic is especially pressing because although the United States spends more of its budget on health care than any other wealthy nation – and is spending more each year – the World Health Organization ranks its health system 37th.

According to the Kaiser Family Foundation, the U.S. spent nearly $ 2.6 trillion on health in 2010 – equal to just under 18 percent of the country’s gross domestic product (GDP).

Hussey and his colleagues analyzed results from 61 studies that compared health care spending with outcomes on both small, hospital-wide scales and broader state-wide levels.

Some of those studies looked at whether hospitals that spent more money per patient had fewer in-hospital deaths, or if their doctors and nurses better followed guidelines. Others compared states’ Medicare spending with how well their older residents were treated for a range of conditions.

“The bottom line was that no matter how you drill down into the results, at every level the results are just all over the map,” Hussey told Reuters Health.

“It’s totally unclear what the real relationship is.”

Twenty-one of the 61 studies showed higher spending was tied to better outcomes for patients, such as fewer deaths. However, 18 studies found a link between more spending and worse outcomes, and 22 showed no difference or an unclear association based on spending, according to findings published in the Annals of Internal Medicine.

For example, in one 2010 study the one-quarter of hospitals with the highest spending per patient had better quality scores than the lowest-spending hospitals when it came to treating people with heart failure, but were worse at treating pneumonia patients.

Many of the studies compared certain types of spending with potentially unrelated outcomes, according to Hussey. Others didn’t take into account how sick patients were initially when looking at how they fared in different situations.

Hussey said there are likely some places in the health care system where spending can be cut without reducing quality – but so far, it’s unclear what those areas are.

GETTING DOCTORS INVOLVED

Although health spending is a hot-button issue, doctors are typically focused on getting their patients better and not on how much that might cost, according to Dr. Alyna Chien, from Harvard Medical School in Boston.

“Putting the two together – meaning you want to improve quality or maintain quality while decreasing costs – is even more complicated,” said Chien, who co-wrote an editorial accompanying the new study.

One hurdle is that most doctors don’t have any idea what the drugs they prescribe or the tests they order actually cost – for the patient or the health care system in general, she told Reuters Health.

“You need physicians to know some of that information because they also have to talk to the patient about what they care about,” Chien said.

“Sometimes patients just think more (treatment) is better,” without knowing that a cheaper option might be just as effective.

The researchers both said further studies are needed to help address overspending in the U.S. Researchers should look for links between specific types of spending and outcomes that are likely to be directly related, according to Hussey.

And cost analyses should be included in studies of new treatment options, Chien said.

“Having that price tag information would help people know which intervention is easier to implement or sustain,” she said.

SOURCE: http://bit.ly/U4xDkh Annals of Internal Medicine, online December 31, 2012.

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Brain image study: Fructose may spur overeating

This is your brain on sugar — for real. Scientists have used imaging tests to show for the first time that fructose, a sugar that saturates the American diet, can trigger brain changes that may lead to overeating.

After drinking a fructose beverage, the brain doesn’t register the feeling of being full as it does when simple glucose is consumed, researchers found.

It’s a small study and does not prove that fructose or its relative, high-fructose corn syrup, can cause obesity, but experts say it adds evidence they may play a role. These sugars often are added to processed foods and beverages, and consumption has risen dramatically since the 1970s along with obesity. A third of U.S. children and teens and more than two-thirds of adults are obese or overweight.

All sugars are not equal — even though they contain the same amount of calories — because they are metabolized differently in the body. Table sugar is sucrose, which is half fructose, half glucose. High-fructose corn syrup is 55 percent fructose and 45 percent glucose. Some nutrition experts say this sweetener may pose special risks, but others and the industry reject that claim. And doctors say we eat too much sugar in all forms.

For the study, scientists used magnetic resonance imaging, or MRI, scans to track blood flow in the brain in 20 young, normal-weight people before and after they had drinks containing glucose or fructose in two sessions several weeks apart.

Scans showed that drinking glucose “turns off or suppresses the activity of areas of the brain that are critical for reward and desire for food,” said one study leader, Yale University endocrinologist Dr. Robert Sherwin. With fructose, “we don’t see those changes,” he said. “As a result, the desire to eat continues — it isn’t turned off.”

What’s convincing, said Dr. Jonathan Purnell, an endocrinologist at Oregon Health & Science University, is that the imaging results mirrored how hungry the people said they felt, as well as what earlier studies found in animals.

“It implies that fructose, at least with regards to promoting food intake and weight gain, is a bad actor compared to glucose,” said Purnell. He wrote a commentary that appears with the federally funded study in Wednesday’s Journal of the American Medical Association.

Researchers now are testing obese people to see if they react the same way to fructose and glucose as the normal-weight people in this study did.

What to do? Cook more at home and limit processed foods containing fructose and high-fructose corn syrup, Purnell suggested. “Try to avoid the sugar-sweetened beverages. It doesn’t mean you can’t ever have them,” but control their size and how often they are consumed, he said.

A second study in the journal suggests that only severe obesity carries a high death risk — and that a few extra pounds might even provide a survival advantage. However, independent experts say the methods are too flawed to make those claims.

The study comes from a federal researcher who drew controversy in 2005 with a report that found thin and normal-weight people had a slightly higher risk of death than those who were overweight. Many experts criticized that work, saying the researcher — Katherine Flegal of the Centers for Disease Control and Prevention — painted a misleading picture by including smokers and people with health problems ranging from cancer to heart disease. Those people tend to weigh less and therefore make pudgy people look healthy by comparison.

Flegal’s new analysis bolsters her original one, by assessing nearly 100 other studies covering almost 2.9 million people around the world. She again concludes that very obese people had the highest risk of death but that overweight people had a 6 percent lower mortality rate than thinner people. She also concludes that mildly obese people had a death risk similar to that of normal-weight people.

Critics again have focused on her methods. This time, she included people too thin to fit what some consider to be normal weight, which could have taken in people emaciated by cancer or other diseases, as well as smokers with elevated risks of heart disease and cancer.

“Some portion of those thin people are actually sick, and sick people tend to die sooner,” said Donald Berry, a biostatistician at the University of Texas MD Anderson Cancer Center in Houston.

The problems created by the study’s inclusion of smokers and people with pre-existing illness “cannot be ignored,” said Susan Gapstur, vice president of epidemiology for the American Cancer Society.

A third critic, Dr. Walter Willett of the Harvard School of Public Health, was blunter: “This is an even greater pile of rubbish” than the 2005 study, he said. Willett and others have done research since the 2005 study that found higher death risks from being overweight or obese.

Flegal defended her work. She noted that she used standard categories for weight classes. She said statistical adjustments were made for smokers, who were included to give a more real-world sample. She also said study participants were not in hospitals or hospices, making it unlikely that large numbers of sick people skewed the results.

“We still have to learn about obesity, including how best to measure it,” Flegal’s boss, CDC Director Dr. Thomas Frieden, said in a written statement. “However, it’s clear that being obese is not healthy – it increases the risk of diabetes, heart disease, cancer, and many other health problems. Small, sustainable increases in physical activity and improvements in nutrition can lead to significant health improvements.”

___

Online:

Obesity info: http://www.cdc.gov/obesity/data/trends.html

___

Marilynn Marchione can be followed at http://twitter.com/MMarchioneAP

Mike Stobbe can be followed at http://twitter.com/MikeStobbe

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FDA approves Salix’s diarrhea drug for HIV/AIDS patients

(Reuters) – U.S. health regulators approved Salix Pharmaceuticals Ltd‘s drug to treat diarrhea in HIV/AIDS patients on antiretroviral therapy, a combination of medicines used to treat HIV infection.

Diarrhea is a common reason why HIV/AIDS patients discontinue or switch their antiretroviral therapies.

The drug, called Fulyzaq, is intended to be used in HIV/AIDS patients whose diarrhea is not caused by an infection from a virus, bacteria, or parasite.

Until now, there have been no therapies for HIV-associated diarrhea approved by the U.S. Food and Drug Administration.

(Reporting By Debra Sherman; Editing by David Gregorio)

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Democrats, Republicans apart on key “fiscal cliff” issues: Reid

WASHINGTON (Reuters) – Senate Majority Leader Harry Reid said on Sunday that Democrats and Republicans still had key differences in talks to avert a looming year-end “fiscal cliff,” and he had not been able to make a counteroffer to the latest Republican proposal.

“I’ve had a number of conversations with the president and at this stage we’re not able to make a counteroffer,” Reid said on the Senate floor.

He said that as the day wears on, Democrats may be able to make such an offer.

“I think that the Republican leader has shown absolutely good faith. It’s just that we’re apart on some pretty big issues,” Reid added. (Reporting By David Lawder; Editing by David Brunnstrom)

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Brazil president, cancer survivor, pronounced healthy

BRASILIA (Reuters) – Brazilian President Dilma Rousseff, who survived lymphoma cancer in 2009, was pronounced healthy by doctors after a routine exam on Friday.

Rousseff’s health was “within normal levels,” according to a statement released by her office following the check-up at the Sirio-Libanes Hospital in Sao Paulo, one of South America‘s leading cancer treatment centers.

Rousseff underwent chemotherapy in 2009 and briefly wore a wig, but the cancer went into remission and she appeared to be in good health by the time she staged her winning campaign for the presidency in 2010.

Concerns over her health have faded since then, although a bout with pneumonia and a lengthy recovery in 2011 have kept the issue on some investors’ radar screens.

(Reporting by Ana Flor, Writing by Brian Winter; Editing by Doina Chiacu)

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House sets Sunday session as “fiscal cliff” deadline nears

WASHINGTON (Reuters) – The House of Representatives will return to Washington on Sunday night, just over a day before income tax rates are set to spike higher, in a last-ditch chance to avert the year-end “fiscal cliff.”

Senior Republican aides confirmed that House Speaker John Boehner on Thursday told members to be back in Washington in time for a 6:30 p.m. EST (2330 GMT) legislative session on Sunday.

The House may then stay in session until January 2, the final day of the current Congress, according to a Twitter message from House Majority Leader Eric Cantor.

That is the day that another component of the “fiscal cliff” – $ 109 billion in automatic spending cuts to military and domestic programs – is set to start.

The House went on recess a week ago amid a deadlock over how to resolve ways to avoid the $ 600 billion in tax increases and spending cuts that could throw the U.S. economy back into recession.

Some media outlets reported that Obama would meet with congressional leaders on Friday, but several congressional aides said no such meeting had yet been arranged.

If a meeting occurs, Obama is not expected to offer a new “fiscal cliff” solution and he is instead likely to stick to the outline he set out a week ago for a stop-gap fix, according to a senior Democratic aide.

That would include legislation to shield most Americans from any income tax increase starting on January 1, except for those households with net incomes above $ 250,000 a year. Obama also wants an extension of expiring benefits for the long-term unemployed.

So far, the Republicans who control the House have refused to go along with any measure that would raise income taxes on anyone.

Meanwhile, House Republican leaders held an approximately 35-minute telephone conference call with rank-and-file members on Thursday, according to one Republican aide.

“There were a lot of different members who spoke on the call. All had questions. All had comments,” the aide said, refusing to elaborate.

(Reporting By Richard Cowan and David Lawder; Editing by Will Dunham)

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Web-based info may not increase cancer screening

NEW YORK (Reuters Health) – Offering women information on colon cancer screening via the web does not get them to take up screening any more effectively than printed materials, according to a new study.

“It’s disappointing that the web didn’t have more effect,” said Dr. David Weinberg of Fox Chase Cancer Center in Philadelphia, the report’s lead author.

Although the U.S. Preventive Services Task Force recommends that adults between ages 50 and 75 get screened regularly for colorectal cancer, about 40 percent of people don’t follow those guidelines.

To raise awareness of the recommendations and encourage people to go get screened, researchers have developed a variety of approaches, Weinberg said, including videos and printed materials. But none of these “have been tremendously successful,” he added.

Dr. Hamant Roy, director of gastroenterology research at NorthShore University HealthSystem in Evanston, Illinois, said one method that has been shown to be effective is simply having doctors spend time with their patients to talk about the cancer tests.

“But one of the issues is they have to see more and more people with less and less time, so it gets really hard to have these discussions with patients,” said Roy, who was not involved in the new study.

To see whether the web might provide an easily accessible and inexpensive alternative for getting people to comply with screening recommendations, Weinberg and his colleagues asked 865 women who were coming in for routine gynecology appointments to participate in the study.

Of those, 171 saw their doctor as normal, 349 also received printed materials about colon cancer screening at the time of their visit and 345 were offered access to a web site that contained the same information as the printed matter.

Included in the materials was information about the benefits of screening and harms of going unscreened, as well as background on the various types of colon cancer screen available: a stool test once a year, a sigmoidoscopy every five years or a colonoscopy every 10 years.

All the women were eligible to get screened for colon cancer based on their age and health status.

Four months after the doctor visit, however, roughly 12 percent of the women – regardless of whether they received the extra information or not – had gotten a colon cancer screen.

Roy called the numbers “dismal.”

“At the end of the day, something is better than nothing,” he said, but compared to screening rates for breast cancer, the uptake for colorectal cancer screening was quite low.

Among the women in the study, published in the Archives of Internal Medicine, 73 percent had received a mammogram in the past year.

On the other hand, Weinberg said, “you might argue their participation in the study did manage to raise their interest level enough” to get screened.

Not enough, however, to get most of the women to even access the website Weinberg’s group had developed.

Only 24 percent had logged on, according to the researchers’ records, and just 16 percent of the women remembered going to the website.

Weinberg still thinks there might be ways that the web could be helpful.

“I think that the web has great promise…the question is, how do you get people to look at it in the first place?” he said.

Perhaps following up with people to ask them about their experience on the website might improve their participation, he suggested.

Roy agreed that it would be premature to toss out the web as a potential tool for increasing screening rates.

“It seems like the energy to get people over the hump to get colorectal screening is higher than simply passively going to a website. I think the website is maybe helpful, but there needs to be more help to get them over the edge,” he said.

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

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Wife’s Garbled Text a Sign of Stroke

Dec 25, 2012 12:57pm

Sending garbled texts may be a sign of stroke. Image credit: Stone/Getty Images.

Smartphone autocorrect is famous for scrambling messages into unintelligible gibberish but when one man received this garbled text from his 11-week-pregnant wife, it alarmed him:

“every where thinging days nighing,” her text read. “Some is where!”

Though that may sound like every text you’ve ever received, the woman’s husband knew her autocorrect was turned off. Fearing some medical issue, he made sure his 25-year-old wife went immediately to the emergency room.

When she got there, doctors noted that she was disoriented, couldn’t use her right arm and leg properly and had some difficulty speaking. A magnetic resonance imaging scan — MRI — revealed that part of the woman’s brain wasn’t getting enough blood. The diagnosis was stroke.

Fortunately, the story has a happy ending. A short hospital stay and some low-dose blood thinners took care of the symptoms and the rest of her pregnancy was uneventful.

Click here to read about how texting pedestrians risk injuries

The three doctors from Boston’s Harvard Medical School, who reported the case study online in this week’s Archives of Neurology, claim this is the first instance they know of where an aberrant text message was used to help diagnose a stroke. In their report, they refer to the woman’s inability to text properly as “dystextia,” a word coined by medical experts in an earlier case.

Dystextia appears to be a new form of aphasia, a term that refers to any trouble processing language, be it spoken or written. The authors of the Archives paper said that at least theoretically, incoherent text messages will be used more often to flag strokes and other neurological abnormalities that lead to the condition.

“As the accessibility of electronic communication continues to advance, the growing digital record will likely become an increasingly important means of identifying neurologic disease, particularly in patient populations that rely more heavily on written rather than spoken communication,” they wrote.

Even though jumbled texts are so common, Dr. Larry Goldstein, a neurologist who is the director of the stroke center at Duke University, said he also believes it’s possible they can be used to sound the alarm on a person’s neurological state, especially in a case like this where the text consisted of complete words that amounted to nonsense rather than the usual autocorrected muddle.

“It would have been very easy to dismiss because of the normal problems with texting but this was a whole conversation that wasn’t making sense,” Goldstein said. “I might be concerned about a patient based on a text like this if they were telling me they hadn’t intended to send a disjointed jumble but they weren’t able to correct themselves.”

In diagnosing stroke, Goldstein said both patients and medical professionals tend to discount aphasic symptoms, even in speech, but they can often be the first clue something is up. In this woman’s case, other signs were there. Her obstetrician realized in retrospect that she’d had trouble filling out a form earlier in the day. She had difficulties speaking too which might also have been picked up sooner if a recent upper respiratory infection hadn’t reduced her voice to a whisper.

But unlike this woman, most people leave their autocorrect turned on. If we relied solely on maddeningly unintelligible text messages to determine neurological state, neurologists might have lines out the door.

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Truth About Santa Still Stings Adults

Emily Charlton, as a wide-eyed fourth grader, said she felt betrayed by her classmates on her elementary school playground during recess just before the holidays.

“It was a day or two before Christmas break so we were talking about what we had asked for and I remember saying at one point, ‘Well I asked Santa for…’ and everyone started laughing,” said Charlton, now a 29-year-old waitress from San Diego. “I think they thought I was making a joke.”

She stood her ground. “I remember feeling embarrassed and upset,” said Charlton. “My belief, however, was unchanged.”

But it got worse.

A few days later, she was at Toys “R” Us with her father and saw him pack a long, narrow box into the trunk. On Christmas morning, her younger sister opened up an electric keyboard from Santa in that same box.

Charlton ran to her mother for reassurance that what she suspected was wrong.

“I will never forget what came next,” she said. “She looked at me, and without skipping a beat said, ‘Don’t tell your brother and sister.’ I was devastated. … A huge bomb was dropped on me and as silly as it sounds, it really changed my life.

“The worst part of all was how unceremoniously it happened, it was like one minute I was a child full of wonderment, and in a flash was snapped into a world of non-believing, magic-less adults.”

Parents aren’t the only grinches this time of year.

In Ontario, Canada, this week a man walked along a Christmas parade route telling kids there is no Santa Claus, according to 24 Hours Vancouver. The 24-year-old, whose hair was gelled to look like horns, was arrested for intoxication and causing a disturbance.

And a news anchor in Chicago went on a rant against the jolly old man after a segment on holiday expectations and the bad economy, according to the Huffington Post.

“Stop trying to convince your kids that Santa is Santa,” said Robin Robinson of Fox Chicago. “That’s why they have these high expectations. They know you can’t afford it, so what do they do? Just ask some man in a red suit. There is no Santa.”

Robinson later apologized.

Of course the truth is inevitable, unless you are a logical middle-school child who has done a careful “cost-benefit analysis.”

“I was one of those kids who stretched a belief in Santa for as long as possible, probably well past a point of willful ignorance,” said Peter Dacey, a 27-year-old from Easton, Conn.

He had been the recipient of several “Christmas miracles.” One was the “coolest space Lego out there,” the working monorail, which he was convinced was too expensive for his parents to give him.

The other came right out of the “Miracle on 34th Street” playbook when his family was living in temporary housing, looking for a new home.

“All I wanted for Christmas was for us to find a house,” said Dacey. “Strangely, that year I found a little box in the tree left for me that contained some random key. But it didn’t seem so strange when I realized that it must be the key to our new home. I took it with me to the next few open houses we went to, and lo and behold, it fit in one.”

In the end, it was a question of what reaped the most rewards.

“If you don’t believe in Santa, no good comes of it, as either you’re correct or you’re not, in which case have fun forcing your parents to get you all your future Christmas gifts while Santa visits the believers,” said Dacey. “On the other hand, if you do believe, the worst that can happen is that you find out you were wrong, and what’s the harm there?”

To this day, Dacey said there is a part of him that “still believes,” at least in the messages of love and giving.

“I suppose I stopped believing in a living, breathing jolly-old-elf over a number of middle-school years, but have never stopped believing in Santa,” he said. “I hope the silver sleigh bell would still ring for me.”

Emily Charlton is still miffed that Mom spilled the beans.

“It was honestly the first time I can remember feeling heartbreak,” she said. “I don’t think it was just about the belief in Santa, but about the belief in magic and wonder and make believe, and everything that makes your childhood so great,” she said.

But one parent — now a grandmother who dresses up each year pretending to be an elf — defended herself for bringing a dose of reality to her household when she was raising a family.

She was outraged when her 6-year-old son was sent to the principal’s office for telling his first-grade class there was no Santa Claus.

“Man, was I mad about that,” said Martha Chabinsky, a 59-year-old yoga teacher from Amherst, N.H. “Punishing a kid for telling the truth.”

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Fear, finger-pointing mount over U.S. fiscal cliff

WASHINGTON (Reuters) – Top U.S. lawmakers voiced rising fear on Sunday that the country would go over “the fiscal cliff” in nine days, triggering harsh spending cuts and tax hikes, and some Republicans charged that was President Barack Obama‘s goal.

“It’s the first time that I feel it’s more likely that we will go over the cliff than not,” Senator Joe Lieberman, an independent from Connecticut, said on CNN’s “State of the Union.”

“If we allow that to happen it will be the most colossal consequential act of congressional irresponsibility in a long time, maybe ever in American history,” Lieberman added.

The Democratic president and Republican House of Representatives Speaker John Boehner, the two key negotiators, are not talking and are out of town for the Christmas holidays. Congress is in recess, and will have only a few days next week to act before January 1.

On the Sunday news shows, no one signaled a change of position that could form the basis for a short-term fix, despite a suggestion from Obama on Friday that he would favor one.

The focus was shifting instead to the days following January 1 when the lowered tax rates dating back to the George W. Bush administration will have expired, presenting Congress with a redefined and more welcome task that involves only cutting taxes, not raising them.

“I believe we are,” going over the cliff, said Republican Senator John Barrasso of Wyoming. “I think the president is eager to go over the cliff for political purposes. I think he sees a political victory at the bottom of the cliff,” Barrasso said on Fox News Sunday.

Some Republicans have said Obama would welcome the fiscal cliff’s tax increases and defense cuts, as well as the chance to blame Republicans for rejecting deal. Obama has rejected that assertion.

Congress started the clock ticking in August of 2011 on the cliff. The threat of about $ 600 billion of spending cuts and tax increases was intended to shock the Democratic-led White House and Senate and the Republican-led House into bridging their many differences to approve a plan to bring tax relief to most Americans and curb runaway federal spending.

Economists say the harsh tax increases and budget cuts from the fiscal cliff could thrust the world’s largest economy back into a recession, unless Congress acts quickly to ease the economic blow.

MARKETS COULD TUMBLE

The most immediate impact could come in financial markets, which have been relatively calm in recent weeks as Republicans and Democrats bickered, but could tumble without prospects for a deal.

Markets will be open for a half-day on Christmas Eve, when Congress will not be in session, and will be closed on Tuesday for Christmas.

Wall Street will resume regular stock trading on Wednesday, but volume is expected to be light throughout the week with scores of market participants away on a holiday break.

If Congress fails to reach any agreement, income tax rates will go up on just about everyone on January 1. Unemployment benefits, which Democrats had hoped to extend as part of a deal, will expire for many as well.

In the first week of January, Congress could scramble and get a quick deal on taxes and the $ 109 billion in automatic spending cuts for 2013 that most lawmakers want to avoid.

Once tax rates go up on January 1, it could be easier to keep those higher rates on wealthier taxpayers while reducing them for middle- and lower-income taxpayers. Lawmakers would not have to cast votes to raise taxes.

Some lawmakers expressed guarded hope that a short-term deal on deficit-reduction could be reached in the next week or so, with a longer more permanent deal hammered out next year.

But a short-term deal would need bipartisan support, as Obama has said he would veto a bill that does not raise taxes on the wealthiest Americans.

Democratic Senator Kent Conrad, chairman of the Budget Committee, said Obama and Boehner are not that far apart and that both sides should keep pushing for a long-term big deal.

“I would hope we would have one last attempt here to do what everyone knows needs to be done, which is the larger plan that really does stabilize the debt and get us moving in the right direction,” Conrad of North Dakota told Fox News Sunday.

(Reporting By Thomas Ferraro and Richard Cowan; Editing by Fred Barbash and Vicki Allen)

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Hepatitis C tests continue after NH tech’s arrest

CONCORD, N.H. (AP) — Hospitals across the country recommended hepatitis C testing for about 7,900 patients last summer after a traveling medical worker was accused of stealing drugs and infecting patients with tainted syringes in New Hampshire. But five months later, nearly half of those who were possibly exposed to the liver-destroying disease in other states have yet to be tested.

Described by prosecutors as a “serial infector,” David Kwiatkowski is accused of stealing syringes of the powerful painkiller fentanyl from the cardiac catheterization lab at New Hampshire’s Exeter Hospital and replacing them with saline-filled syringes tainted with his own blood. In jail since his arrest in July, he pleaded not guilty to 14 federal drug charges earlier this month and is expected to go to trial next fall.

Before April 2001, when he was hired in New Hampshire, Kwiatkowski worked as a traveling cardiac technologist in 18 hospitals in seven states, moving from job to job — despite being fired twice over allegations of drug use and theft.

Thirty-two people in New Hampshire have been diagnosed with the same strain of hepatitis C that Kwiatkowski carries, along with six in Kansas, five in Maryland and one in Pennsylvania. At least 3,700 people outside New Hampshire have yet to be tested, hospitals and public health officials told The Associated Press.

For example, in Michigan, where Kwiatkowski grew up and started his career, about 2,300 patients at five hospitals were notified that they may have been exposed to hepatitis C by Kwiatkowski. As of early December, only about 500 had gone in for testing, none of whom were diagnosed with a strain linked to the New Hampshire outbreak, according to the Michigan Department of Community Health.

In Pennsylvania, 2,280 patients at the University of Pittsburgh Medical Center Presbyterian were notified that they should get tested, but only 840 have, one of whom was diagnosed with a matching strain of hepatitis C.

Kwiatkowski was fired a few weeks into his temporary job at UPMC in 2008 after a co-worker accused him of swiping a fentanyl syringe from an operating room and sticking it down his pants. Citing a lack of evidence, hospital authorities didn’t call police, and neither the hospital nor the medical staffing agency that placed him in the job informed the national accreditation organization for radiological technicians. Within days, Kwiatkowski was starting a new job at the Baltimore VA Medical Center, where one patient also has since been diagnosed with hepatitis C linked to Kwiatkowski.

Though the VA center initially said it had identified 168 patients who may have been exposed, that number was later lowered, and 68 patients ultimately were tested. Two other Maryland hospitals where Kwiatkowski worked also have completed their testing, with no diagnosed cases of hepatitis C matching Kwiatkowski. But at the fourth, The Johns Hopkins Hospital in Baltimore, four patients have been diagnosed with the strain of disease linked to Kwiatkowski.

About 500 of the 1,567 patients notified by Johns Hopkins have yet to be tested, according to hospital spokeswoman Kim Hoppe. Kwiatkowski had been referred by a staffing agency that assured Johns Hopkins that it had followed a vigorous vetting process, Hoppe said. He worked there for two 13-week stints, from July 2009 to January 2010.

Saint Francis Hospital in Poughkeepsie, N.Y., where Kwiatkowski worked in late 2007 and early 2008, notified and tested 31 patients without finding any linked cases to Kwiatkowski. In Kansas, nearly all of the 416 patients who may have been exposed at Hays Medical Center have been tested and six have been diagnosed with infections linked to the New Hampshire outbreak.

There have been no cases linked to Kwiatkowski in Arizona, where about 300 patients from two hospitals have been asked to get tested and about 280 have done so. Kwiatkowski worked at Maryvale Hospital in Phoenix in 2009 and the Arizona Heart Hospital in 2010. He was fired from the latter job after 10 days after a co-worker found him passed out in a bathroom stall with a stolen fentanyl syringe floating in the toilet.

That incident was reported to police, Kwiatkowski’s staffing agency, a state regulatory board and the national accreditation organization, but the accreditation group dropped its inquiry after learning police hadn’t filed charges.

Days later, Kwiatkowski landed a new job filling in for striking technicians at Temple University Hospital in Philadelphia. That hospital has recommended testing for 312 patients but won’t say how many have followed through or have been diagnosed with hepatitis C. A hospital spokesman referred questions to the city health department, which did not return calls.

Testing also is still under way in the last place Kwiatkowski worked before heading to New Hampshire — Houston Medical Center in Warner Robins, Ga. According to the hospital, fewer than 100 people have yet to be tested, and there haven’t been any cases yet linked to Kwiatkowski.

In New Hampshire, where about 3,300 patients were tested, Kwiatkowski is charged with seven counts of illegally obtaining drugs and seven counts of tampering with a consumer product, though prosecutors have said further charges are possible. Although New Hampshire cannot charge him for possible violations in other states, it can use evidence gathered in those jurisdictions in its trial, U.S. Attorney John Kacavas said. Other states are waiting to see the outcome of New Hampshire’s case before deciding whether to file charges, he said.

“We continue to reach out to other states affected by this matter,” Kacavas said this week. “Other health organizations and departments continue to do their work in their states, but nothing has changed in the sense that our prosecution will go forward. At this point, we are the only prosecution in the country, and we’ll see how it rolls out.”

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Gilead A Strong Buy On New HIV Treatments

By Jordo Bivona – December 21, 2012 | Tickers: BMY, GILD, YMI | 0 Comments

Jordo is a member of The Motley Fool Blog Network — entries represent the personal opinions of our bloggers and are not formally edited.

Despite the expiration of some of its HIV patents in 2018, Gilead Sciences’ (NASDAQ: GILD) new HIV treatments will enable the company to extend its HIV-based profitability for the long-term.

Gilead has done well with fixed-dose combination pills Truvada and Atripla combining multiple HIV medications into a single pill. The company has been rewarded with an impressive market share in the HIV treatment market, and is now looking for the same success in the treatment of Hepatitis C. Sofosbuvir, a novel Hepatitis C drug, recently demonstrated promising results in the first of several phase 3 trials, with 78% of patients having an undetectable viral load 12 weeks following treatment.

There are two characteristics of sofosbuvir which make it a potential blockbuster. First, if approved by the FDA, it would be the first all-oral Hepatitis C treatment. Second, it avoids the use of interferon, a component of standard Hepatitis C treatments associated with unfavorable side effects. Half the patients that take interferon typically develop flu-like symptoms, and one-third develop psychiatric complications such as depression. These challenges in the current Hepatitis C treatment regiments have led to approximately one-third of patients discontinuing treatment. As an all-oral, low side-effect medication, sofosbuvir has the potential to sharply reduce this rate of non-compliance and, in doing so, establish itself as the dominant drug in the treatment of Hepatitis C in a market estimated at over $ 20 billion. Sofosbuvir is currently progressing through phase 3 trials.

Drug Pipeline

Gilead has also recently introduced another HIV drug, Stribild, that is poised to become a lead drug choice in HIV treatment. A four-drug combination pill that builds on the success of Gilead’s single-pill model, Stribild has been predicted to become the market leading HIV drug within the next decade. In addition, Gilead produces all of the component drugs within Stribild, and they would avoid the revenue sharing arrangements associated with their previous HIV medications.

Gilead has also ramped up its research into oncology drugs, with several drugs in its pipeline being tested as treatments for colorectal cancer, pancreatic cancer and a specific type of leukemia. In December, Gilead bought YM BioSciences (NYSEMKT: YMI), a Canadian company, for $ 510 million in cash, mainly to get access to the Canadian company’s research into treatments for a bone-marrow disorder. The Canadian company’s lead drug candidate, CYT387, is an orally-administered, once-daily, selective inhibitor of the Janus kinase (JAK) family, specifically JAK1 and JAK2 and combats myelofibrosis, a bone-marrow disease that can lead to anemia and an enlarged spleen. The acquisition provides Gilead with a promising treatment at a reasonable price.

Financials

Total revenues for the third quarter of 2012 increased 14% to $ 2.43 billion, from $ 2.12 billion for the third quarter of the previous year. Net income for the third quarter was $ 675.5 million, or $ 0.85 per diluted share compared to $ 741.1 million or $ 0.95 per diluted share for the third quarter of 2011. Non-GAAP net income for the third quarter of 2012, which excludes acquisition-related, restructuring and stock-based compensation expenses, was $ 788.9 million, or $ 1.00 per diluted share compared to $ 795.2 million, or $ 1.02 per diluted share for the third quarter of 2011.

As of Sept. 30, 2012, Gilead had $ 2.65 billion of cash, cash equivalents and marketable securities compared to $ 9.96 billion as of Dec. 31, 2011. The decrease was due to the acquisition of Pharmasset in the first quarter of 2012. Gilead generated $ 2.49 billion of operating cash flow during the first nine months of 2012 including $ 745.4 million generated in the third quarter of 2012.

Analyst Ratings

Zacks reiterated its neutral rating on Gilead with a price target of $ 78.00. Analysts at Guggenheim reiterated a “buy” rating on Gilead with a price target of $ 87. On Dec. 5, analysts at Oppenheimer reiterated an “outperform” rating on Gilead. On Dec. 4, 2012, Barclays Capital reaffirmed its “overweight” rating on Gilead with a price target of $ 76. On Nov. 30, Gilead had its “overweight” rating affirmed by Piper Jaffray with a price target of $ 85. On Nov. 13, analysts at Stifel Nicolaus raised their price target on Gilead from $ 80 to $ 85 with a “buy” rating. On the same date, Lazard also raised its price target on Gilead from $ 89 to $ 100 with a “buy” rating.

Competition

Gilead’s HCV candidate sofosbuvir, which was added to Gilead’s pipeline through its acquisition of Pharmasset, is now in phase 3 trials. The results put Gilead in the lead in what has become a two-horse race with Abbott Laboratories (ABT) to produce the first treatment for the disease that doesn’t include interferon with its negative side effects. In the case of CYT387 included in the recent YM BioSciences acquisition, potential rivals in the field are Incyte (INCY) and Novartis’ (NVS) JAK inhibitor Jakafi, which the FDA approved last year to combat myelofibrosis. Cell Therapeutics (CTIC) has its own midstage program focusing on the blood disease. 

Bristol-Myers Squibb (NYSE: BMY)is testing sofosbuvir plus their NS5A inhibitor daclatasvir (formerly BMS-790052). Bristol-Myers Squibb had a clinical collaboration with Pharmasset and started this trial before Gilead’s acquisition. It appears, though, that these two competing companies, notably Gilead, are not interested in conducting a phase3 study to evaluate this combination. Bristol-Myers Squibb is also evaluating multiple HCV drug candidates. The acquisition of Zymogenetics in 2010 for $ 885 million brought pegylated interferon lambda while the company acquired INX-189 (now called as BMS-986094) through the acquisition of Inhibitex in 2012 for $ 2.5 billion.

Conclusion

I have every reason to believe that Gilead is going to continue to be highly successful, and I have no hesitation in recommending this stock to investors.

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Spartan Bioscience Announces 6,000-Patient Study of Personalized Medicine for Cardiac Stents

Landmark clinical trial begins for rapid DNA testing and personalized anti-blood clotting drugs.

Ottawa, Ontario (PRWEB) December 20, 2012

Spartan Bioscience today announced the start of a 5,945-patient study of personalized medicine for cardiac stent patients. The study is sponsored by the Center for Individualized Medicine at Mayo Clinic and is entitled “Tailored Antiplatelet Initiation to Lessen Outcomes due to Clopidogrel Resistance after Percutaneous Coronary Intervention (TAILOR-PCI).”

This clinical trial will evaluate whether genotyping of cardiac stent patients at the time of angioplasty can help improve patient outcomes by informing providers about drug selection of either Brilinta® (ticagrelor) or Plavix® (clopidogrel). These antiplatelet drugs are prescribed after surgery to reduce clotting complications, such as heart attacks, strokes, and cardiovascular deaths. The drugs are thought to work differently in patients with specific variations in the CYP2C19 gene, and the Spartan RX CYP2C19 rapid DNA testing system will be used to identify these variations in some patients of the TAILOR-PCI study. The study will enroll patients over a 22-month period at 9 hospitals in Canada and the United States.

The principal investigator of the TAILOR-PCI study is Naveen Pereira, M.D., a Mayo Clinic cardiologist. Chiranjit Rihal, M.D., chairman of the Division of Cardiovascular Diseases at Mayo Clinic in Rochester, Minnesota, serves as chairman of the TAILOR-PCI steering committee. The Mayo Clinic sites are Rochester; Jacksonville, Florida; Phoenix, Arizona; and the Mayo Clinic Health Systems in La Crosse, Wisconsin; and Mankato, Minnesota. Canadian sites participating in this study are St. Michael’s Hospital, Toronto General Hospital, Sunnybrook Hospital, and the University of Ottawa Heart Institute.

“We are excited to work with Mayo Clinic on this landmark clinical trial,” said Paul Lem, M.D., CEO of Spartan Bioscience. “Rapid DNA testing means doctors and patients do not have to wait days or weeks for results from a central lab.”

About the Spartan RX CYP2C19

The Spartan RX CYP2C19 is the first point-of-care DNA test in medicine.(1) It identifies carriers of certain CYP2C19 genetic mutations in 1 hour. These mutations are carried by approximately 30 percent of the world’s population.(2) Genetic carriers who receive Plavix® following a cardiac stent insertion to open clogged arteries have a 42 percent higher risk of death, stroke, or heart attack in the first year compared to non-carriers.(3) Currently, genetic testing is performed in central labs and it takes up to seven days to get a test result back. A rapid test is needed because most of the complications for CYP2C19 carriers occur in the first 24 to 48 hours.(3,4) In March 2010, the FDA issued a warning for Plavix regarding CYP2C19 poor metabolizers. The Spartan RX CYP2C19 has CE IVD Mark regulatory approval for Europe and other countries recognizing the CE IVD Mark. Spartan Bioscience is working towards FDA 510(k) clearance in the United States. For more information, please visit our website at: http://www.spartanbio.com/products/spartan-rx

About Spartan Bioscience

Spartan Bioscience is the leader in point-of-care DNA testing. The Spartan RX is the first complete sample-to-result, point-of-care DNA testing system in medicine. It is a fully integrated DNA collection, extraction and analysis platform, with an intuitive interface that is easy to operate—no laboratory training required. For the first time, healthcare providers and their patients can get DNA results on demand. For more information, please visit our website at: http://www.spartanbio.com.

The Spartan logo is a registered trademark of Spartan Bioscience Inc.

Brilinta is a registered trademark of AstraZeneca.

Plavix is a registered trademark of Bristol-Myers Squibb/Sanofi Pharmaceuticals.

1. Roberts JD et al. (2012). Lancet. 379: 1705–1711.

2. Damani SB, Topol EJ. (2010). J Am Coll Cardiol. 56:109–111.

3. Mega JL et al. (2009). N Engl J Med. 360:354–362.

4. Wiviott SD et al. (2007). N Engl J Med. 357:2001–2015.

Paul Lem, M.D.
Spartan Bioscience Inc.
+1 (613) 228-7756 735
Email Information

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Court approves Amgen’s $762 million payment in drug case

NEW YORK (Reuters) – A federal judge on Wednesday approved a $ 762 million payment from Amgen Inc, the final step to resolve nearly a dozen criminal and civil cases stemming from the sale of its once-blockbuster anemia drug Aranesp and several others.

Prosecutors previously said in Brooklyn federal court on Tuesday the company had agreed to pay $ 612 million in a civil settlement, a $ 14 million criminal forfeiture payment, and a $ 136 million criminal fine. It is the single largest criminal and civil fraud settlement involving a biotechnology company in U.S. history, according to the U.S. attorney’s office in Brooklyn.

Amgen pleaded guilty on Tuesday to one misdemeanor criminal count that it promoted Aranesp for higher, less frequent doses than approved in the drug’s label by federal regulators. The company was also accused of marketing the drug to treat anemia caused by cancer, for which it was not approved, rather than to combat anemia as a side effect of chemotherapy treatments.

Amgen recorded a $ 780 million charge in the third quarter of 2011 to resolve civil and criminal litigation. In a recent regulatory filing with the U.S. Securities and Exchange Commission, Amgen said it had set aside $ 806 million related to the proposed settlement of charges arising out of the federal civil and criminal investigations.

U.S. District Judge Sterling Johnson accepted the company’s plea on Wednesday and approved its plea agreement with the government. The agreement includes a call for Amgen to abide by a five-year corporate integrity agreement, which imposes new compliance, transparency and accountability measures on the company’s top executives and directors.

The agreement resolves a more than five-year investigation by the U.S. attorney’s office in Brooklyn, as well as a related investigation by federal prosecutors in Washington state, according to court papers.

“Instead of working to extend and enhance human lives, Amgen illegally pursued corporate profits while jeopardizing the safety of vulnerable consumers suffering from disease,” acting U.S. attorney Marshall Miller of the Eastern District of New York said in a statement.

Details of the $ 612 million civil portion of the settlement were also unsealed Wednesday, encompassing a wider scope of allegations than the criminal case. The civil settlement resolves 10 whistleblower lawsuits from Brooklyn, Massachusetts and Washington federal courts, prosecutors said.

The civil settlement covers allegations that Amgen market Aranesp and two other drugs, Enbrel and Neulasta, for uses and doses that had not been approved. The company was also accused of offering illegal kickbacks to try to persuade health-care providers to prescribe their drugs, and engaged in false price reporting practices, federal prosecutors said.

Other Amgen drugs named in the civil suits include Epogen, Neupogen and Sensipar, according to court papers.

“The government raised important concerns in the criminal prosecution,” Amgen chief compliance officer Cynthia Patton said in a statement. “Amgen acknowledges that mistakes were made, and we did not live up to our standards.”

Amgen shares were down 53 cents to $ 88.76 in midafternoon trading.

(Reporting by Jessica Dye; Editing by Neil Stempleman)

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Watch: ‘Kings Park’: Stories From an American Mental Institution

Home > Video > Health > Health News

‘Kings Park’: Stories From an American Mental Institution

‘Kings Park’: Stories From an American Mental Institution

Documentary revisits shuttered state hospital on New York’s Long Island.

Quadriplegic Mom Uses Thoughts to Control Robotic Arm

Quadriplegic Mom Uses Thoughts to Control Robotic Arm

Jan Scheuermann, 52, can now feed herself thanks to technology from Pittsburgh researchers.

Tips to Stay Healthy at Holiday Parties

Tips to Stay Healthy at Holiday Parties

Dr. Jennifer Ashton explains how to enjoy holiday festivities without packing on the pounds.

Help for Parents Struggling With a Troubled Child

Help for Parents Struggling With a Troubled Child

Dr. Jamie Howard discusses ways parents can help children suffering from mental illness.

Hillary Clinton’s Concussion: Doctor Orders Rest

Hillary Clinton’s Concussion: Doctor Orders Rest

The secretary of state fainted while suffering from a stomach bug.

The Reality of Raising a Troubled Child

The Reality of Raising a Troubled Child

Parents speak out about the issues that can go with raising a mentally ill child.

Hillary Clinton Faints, Suffers Concussion

Hillary Clinton Faints, Suffers Concussion

Government says secretary of state fainted from dehydration caused by a stomach virus.

Alan T. Brown Power of We Campaign

Alan T. Brown Power of We Campaign

Effort to raise $ 250,000 for spinal cord research.

Dr. Timothy Johnson Retires from ABC News

Dr. Timothy Johnson Retires from ABC News

Johnson to step down from Boston affiliate WCVB after 40 years.

Obese Girl Loses 66 Pounds, Maintains Healthy Diet

Obese Girl Loses 66 Pounds, Maintains Healthy Diet

200 lb 9-year-old struggling with obesity transforms her body and her life.

Newborn Baby Mixup at Minneapolis Hospital

Newborn Baby Mixup at Minneapolis Hospital

Tammy Van Dyke’s child was breastfed by another mom due to the error at Abbott Northwestern.

Oregon Teen Loses Legs to Mystery Illness

Oregon Teen Loses Legs to Mystery Illness

Tabitha Schulke is in critical condition with infection that has her doctors baffled.

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Teva to enter Korean drugs market with Handok venture

JERUSALEM (Reuters) – Israel’s Teva Pharmaceutical Industries has entered into a joint venture with Handok Pharmaceuticals, aiming to gain a foothold in the $ 14 billion Korean market.

The agreement ends months of speculation that Teva was interested in making an acquisition in South Korea, where the Israeli company noted healthcare spending is expected to reach as much as 9 percent of gross domestic product by 2015.

The move comes after Jeremy Levin, new chief executive of the world’s largest generic drug company, last week set out a strategic plan, vowing to reshape Teva into “the most indispensable medicines company in the world” and provide significant value to its shareholders.

Levin said Teva’s growth centered on five areas: accelerating growth platforms, extending its global presence, engaging in strategic business development, protecting and expanding its core franchises and reduce its core cost base.

“Our business venture with Handok is a strategic fit for Teva in these growth areas and aligns with our commitment to address global medical, societal and consumer needs,” Levin told Reuters on Monday.

“Teva recognizes the importance of growing in east Asia, both for our shareholders and the patients who will benefit from having access to our medicines,” Levin said.

Teva shares, which have fallen sharply since the strategy was announced on December 11, were down 0.5 percent at 144.8 shekels by 0955 GMT, their lowest in 12 months.

Teva will hold 51 percent and Handok will own the rest, in a venture which will be Teva’s first in east Asia outside Japan and which is due to start operations in the next few months. Financial details were not disclosed.

Under terms of the deal, Teva will be responsible for manufacturing and supplying medicines, while Handok will handle sales and marketing, distribution and regulatory affairs.

Teva said the new company’s plans included selling its branded multiple sclerosis treatment Copaxone, which has started to face competition globally.

(Editing by David Holmes)

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Analysis: Boehner opens door to tax hikes, shifts U.S. fiscal cliff talks

WASHINGTON (Reuters) – U.S. House of Representatives Speaker John Boehner’s offer to accept a tax rate increase for the wealthiest Americans knocks down a key Republican road block to a deal resolving the year-end “fiscal cliff.”

The question now boils down to price – which income levels, what rates and what’s offered in return. Such major questions, still unanswered so close to the end of the year suggest, however, that no surge toward an agreement is immminent.

With just over two weeks before the fiscal cliff’s $ 600 billion in automatic tax hikes and spending cuts are triggered, threatening a new recession, there is little time to craft a comprehensive deal that will satisfy both Democrats and Republicans.

Until the latest offer, made on Friday, Boehner had insisted on extending all of the Bush era tax rates, resisting President Obama’s demand to let the marginal rates rise on income above $ 250,000. A rising chorus of business executives also had urged Republicans to agree to this.

Although the White House has not accepted Boehner’s gambit, which media reports have said includes a $ 1 million tax-hike threshold, it could push negotiations away from entrenched, ideological positions.

“Boehner has now accepted the premise of higher rates. So now we’re just arguing over details. I think it’s a significant step,” said Greg Valliere, chief political strategist at Potomac Research Group.

A framework deal spelling out tax revenue and spending cut targets to be finalized in the new year could be possible, Valliere said.

“Boehner’s offer to allow tax rates to go up for taxpayers earning over $ 1 million fundamentally transforms fiscal cliff negotiations,” added Sean West, U.S. policy analyst at Eurasia Group, a political risk consultancy.

In a note to clients, West wrote that it signals, significantly, that Boehner ultimately believes a deal to avoid the cliff is still possible.

“The political burden is now shifted back to the president, who must be willing to take on his party in order to get a deal Boehner can ultimately pass. We do not think the president will overreach: Obama will work with Boehner to get to a deal.”

There are still several critical elements to a deal besides a tax rate increase on the wealthy, including Republican demands to cut spending on entitlements.

Changes to the expensive Medicare and Medicaid health care programs for the elderly and the poor could be central to any deal, which must also include an increase in the federal debt limit needed by the end of February.

DEMANDS ENTITLEMENT CUTS

Boehner conditioned his tax rate increase offer on Obama agreeing to cuts in entitlement spending.

Many Republican lawmakers want to raise the eligibility age on Medicare from 65 to 67. They also want to add more means testing to Medicare, making wealthier retirees pay more for their care.

Currently, Medicare does have some means testing, charging higher premiums for coverage of doctors visits and prescription drugs to individuals earning more than $ 85,000 and married couples earning more than $ 170,000. Only about 5 percent of recipients pay these higher premiums.

Thus far, Obama has offered only about $ 400 billion in 10-year entitlement savings, mostly through small adjustments in reining in health care costs – not fundamental changes such as raising eligibility ages.

And just as Boehner faces opposition in his own party to raising any tax rates, Obama faces opposition to cuts to Medicare, Medicaid and Social Security from Democrats, who pledged in election campaigns they would protect these programs.

A major bloc of congressional Democrats has already signaled they will not accept major cutbacks in Medicare as part of any fiscal cliff deal.

House Minority Leader Nancy Pelosi of California and Maryland Representative Chris Van Hollen are among the high ranking Democrats in the House who in recent days have come out forcefully defending against raising the age for eligibility for Medicare from the current 65 to 67 years of age.

“Given the level of savings that is being talked about from Medicare, you can’t get it all from providers and drug makers,” said Paul Heldman, an analyst at Potomac Research, which tracks Washington policy for investors.

“So Opponents of raising the eligibility age have reason to believe beneficiaries will take some sort of hit if a mega-deal is cut,” he said.

If Republicans are not successful in securing entitlement program cuts in exchange for a tax-rate increase on the wealthy, they are adamant about using a debt-limit increase as leverage to overhaul Social Security and Medicare.

The U.S. Treasury expects to reach its $ 16.4 trillion statutory debt cap by year-end, and will exhaust its remaining borrowing capacity around mid-February, risking a potential default.

Louisiana Republican Representative John Fleming, a member of the conservative Tea Party caucus who has never voted to increase the debt ceiling, said he would support a debt limit hike if it were part of a deal to make Medicare and Social Security sustainable.

The pace of activity could pick up the coming week.

House Republicans were told to prepare for a possible weekend session next week, potentially interrupting travel plans for the long Christmas holiday weekend.

House Majority Leader Eric Cantor scheduled “possible legislation related to expiring provisions of law,” a reference to the expiring tax cuts, for the end of the week, portending a weekend session. Cantor has said the House would meet through the Christmas holidays and beyond.

(Additional reporting by Thomas Ferraro, Richard Cowan and Kim Dixon; editing by Fred Barbash and Todd Eastham)

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School murders silence “cliff” rhetoric as deadline nears

WASHINGTON (Reuters) – Mass murder in Connecticut silenced “fiscal cliff” talk on Saturday as the White House and Congress quietly got ready for a final scramble to avert the tax hikes and spending cuts set for the New Year, with sessions of the U.S. House of Representatives now scheduled just days before Christmas.

President Barack Obama canceled a trip he had planned to make next Wednesday to Portland, Maine to press his case for tax hikes for the wealthy. His weekly radio and Internet address on Saturday focused on Newtown, the site of Friday’s school shootings, in which a gunman killed 20 children and six adults before taking his own life.

House Speaker John Boehner of Ohio canceled the standard Republican radio response to Obama “so that President Obama can speak for the entire nation at this time of mourning,” he said in a statement issued late Friday.

The moratorium on cliff pronouncements masked a growing recognition that the two sides could remain deadlocked at the end of the year on the key sticking point – whether to leave low tax rates in place except for high earners, as Obama wants, or extend them for all taxpayers, as Boehner wants.

With multiple polls showing that the public supports Obama’s position, Republicans in the U.S. Senate prodded their counterparts in the House to make a face-saving retreat, in a fashion that would allow Obama’s proposal to pass the Republican-controlled House while simultaneously letting Republicans cast a vote against it.

Republicans could then shift the debate onto territory they consider more favorable to them, cutting government spending to reduce the deficit.

“Just about everyone is throwing stuff on the wall to see if anything sticks,” one Republican aide said with reference to various proposals being discussed on how to proceed. Alluding to public opinion polls, the aide added: “We know if there is no deal, we will get blamed.”

“We could win the argument on spending cuts,” said a Republican senator who asked not to be identified. “We aren’t winning the argument on taxes.”

However, Republican leaders in both chambers are leery about seeming to cave on taxes. “There’s concern that if we did that, Obama would simply declare victory and walk away and not address spending,” said one aide. “We don’t trust these guys.”

Some of the prodding was coming from Senate Minority Leader Mitch McConnell of Kentucky.

Don Stewart, a McConnell spokesman, said the minority leader in the Democratic-controlled Senate hasn’t embraced any single plan, but has discussed and circulated measures offered by fellow Senate Republicans.

“Senator McConnell does not advocate raising taxes on anybody or anything,” Stewart said.

“We’re focused on getting a balanced plan from the White House that will begin to solve the problem of our debt and deficit to improve the economy and create American jobs,” said Boehner spokesman Michael Steel.

“Right now, all the president is offering is massive tax hikes with little or no spending cuts and reforms,” Steel said.

House Majority Leader Eric Cantor scheduled “possible legislation related to expiring provisions of law,” a reference to the expiring tax cuts, for the end of the week, portending a weekend session.

Cantor has said the House would meet through the Christmas holidays and beyond.

Hopes expressed after the November6 general election of some “grand bargain” on deficit reduction have all but disappeared, at least for this year. This is partly because time is running out and partly result of growing warnings from Democrats in Congress that they would not support big changes in the Medicare program, the government-run health insurance program for seniors that is a major contributor to the government’s debt.

House Democratic Minority Leader Nancy Pelosi of California ruled out one frequently mentioned proposal – raising the age of eligibility for Medicare, in a December 12 CBS television interview.

Asked if she was drawing a “red line,” around that idea, Pelosi said her comments were “something that says, ‘don’t go there,’ because it doesn’t produce money.

(Reporting by Thomas Ferraro and Kim Dixon; Editing by Fred Barbash and David Brunnstrom)

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Menopause quality of life unchanged by soy supplements

NEW YORK (Reuters Health) – Menopausal women who took soy supplements during a two-year trial reported no differences in quality of life compared to their counterparts taking placebo pills, U.S. researchers report.

It’s possible that soy could still offer women some benefits through menopause, said the study’s lead author Dr. Paula Amato, from Oregon Health and Science University in Portland, “but I think if you are similar to the subjects in the study, then probably taking supplements isn’t going to make a huge impact on your quality of life.”

In light of health concerns attached to taking hormones, soy has been seen as an attractive alternative for relieving menopausal symptoms. But research on the effectiveness of soy extracts for hot flashes and other bothersome symptoms has yielded conflicting results so far.

In the new report, published in the medical journal Menopause, Amato and her colleagues looked not just at specific symptoms but overall quality of life measures among healthy women, mostly in their 50s and six years or more into menopause on average.

Several hundred women were asked to take supplement pills three times a day for two years. Among them, 126 took a fake supplement that contained no soy extract, while 135 women took tablets containing a total of 80 milligrams a day of soy protein and another 123 women took 120 mg each day.

At the start of the study and again one and two years into it, the women filled out a quality of life survey that asked about mental, physical and sexual health as well as about hot flashes.

In each of the surveys, the women in all three groups scored similarly on the main measures in the questionnaire.

“From our study and the good amount of the literature to date it appears that taking soy supplements after menopause does not improve quality of life,” said Amato. “We can’t really recommend it to our patients.”

Mark Messina, president Nutrition Matters and an adjunct professor at Loma Linda University in California, cautioned against concluding that the key ingredients in soy supplements, known as isoflavones, don’t have any effect on hot flashes, however.

“Unfortunately, because of the severe limitations of this study, very little if anything can be learned about isoflavones and hot flashes,” Messina wrote in an email to Reuters Health.

For one, he said, the levels of a particular type of isoflavone – called genistein – were lower than in other studies that have found benefits from soy extracts.

Additionally, the researchers originally set out to look at the effects of soy extracts on bone health, and did not recruit women specifically with hot flash or quality of life concerns in mind.

“So in my opinion, no useful information about isoflavones and hot flashes is provided by this study,” said Messina, who regularly consults for companies that make or sell soy foods and supplements.

Isoflavone companies market the supplements, sold for about $ 17 for 90 50-mg pills, as “potentially” easing the changes associated with menopause.

Amato agreed that the study has some limitations, and that the findings can’t be generalized to all forms of soy in all types of women.

For instance, “taking supplements just might not be the same as eating a high soy content diet your entire life,” she told Reuters Health.

But “if you look at this specific supplement for this particular group of women for this reason, quality of life, I’m convinced by this study it’s not terribly helpful,” she added.

SOURCE: http://bit.ly/UsyPIY Menopause, online December 3, 2012.

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U.S. faces task of running dozens of health exchanges

WASHINGTON (Reuters) – Fourteen U.S. states and the District of Columbia so far have told the federal government they plan to operate healthcare exchanges under President Barack Obama‘s reform law, leaving Washington with the daunting task of creating online marketplaces for at least two-thirds of the country.

On the eve of a federal deadline for states to say whether they will run their own exchanges, a top U.S. healthcare policy official told lawmakers that the exchanges will start enrolling eligible families starting on October 1, 2013.

“I am confident that states and the federal government will be ready in ten months, when consumers in all states can begin to apply,” Gary Cohen, director of the Center for Consumer Information and Insurance Oversight, told a health oversight panel in the U.S. House of Representatives.

Cohen, whose agency is part of the U.S. Department of Health and Human Services (HHS), was among federal officials who testified alongside state health authorities at a hearing of the House Energy and Commerce Subcommittee on Health.

In written testimony, Cohen said 15 states have told the administration they will operate their own exchanges. He later explained under questioning that the count comprises 14 states and the District of Columbia.

Separately, HHS officials confirmed the count of 14 states but could not immediately explain why Cohen’s written testimony contained a higher number.

Some experts say the number of states planning to operate their own exchanges could reach 18 by the time the deadline arrives Friday. Still, the nonpartisan Kaiser Family Foundation, which tracks healthcare issues, says only two states – Utah and Florida – remain undecided.

That would leave at least 30 states in which the administration would be required to run exchanges, a challenge that is raising questions about how successfully U.S. officials can implement a key provision of the healthcare reform law, known to opponents and advocates alike as “Obamacare”.

“I don’t envy them for the job that they have,” said Dennis Smith, a former federal healthcare official who now heads health services in Wisconsin, a state that has decided not to pursue its own exchange.

“At the end of the day, you’re trying to connect a buyer to a seller. And the fundamental things required to do that are not yet in place,” he said.

The Patient Protection and Affordable Care Act, which Obama signed into law more than 2-1/2 years ago, is expected to extend health coverage to more than 30 million uninsured Americans. Those who enroll starting in October would be covered by insurance from January 1, 2014.

POLITICAL THEATER

About half of those newly insured individuals would purchase private coverage from online exchanges at federally subsidized rates. Ultimately, the number of people finding coverage through exchanges is expected to reach 26 million, according to the nonpartisan Congressional Budget Office.

The remainder would be covered by expanding the Medicaid program for the poor to cover all adults earning up to 133 percent of the federal poverty level, or about $ 15,000 for individuals and $ 30,600 for a family of four.

Thursday’s hearing provided a political stage for partisan rhetoric about Obama’s health reforms, which have survived repeated Republican repeal efforts, a nail-biting consideration by the Supreme Court and the Presidential election campaign.

Republicans and state officials from Republican-led states complained about compliance costs and accused HHS of delaying the release of vital details and rules needed to move forward on the exchanges and on the planned Medicaid expansion.

“The uncertain regulatory environment and the overall lack of response from HHS are not encouraging the states or the health plans to move forward,” said Representative Michael Burgess, a Texas Republican.

In response, Congressional Democrats and their state allies stressed the law’s benefits for senior citizens, protections for young adults and the sick, and the prospective economic benefits from an expected influx of billions of dollars in federal money.

“The (Republican) move now is to delay implementation under the guise of lack of information,” said Representative Frank Pallone, a New Jersey Democrat.

“The world in fact is not coming to an end,” he added. “The nation will be better because of the Affordable Care Act.”

States that don’t run their own exchanges would opt for one of two alternatives: a federally facilitated exchange that requires minimal state participation, or a federal partnership exchange in which states help by performing certain duties.

Kaiser Family Foundation expects six states to choose the partnership option and two dozen to opt for federally facilitated exchanges. Cohen said the count so far is four partnerships and seven facilitated exchanges.

States have until February 15 to say whether they intend to seek a federal partnership exchange. Four have done so already, Cohen said.

The administration will have to engineer an information technology system capable of processing operations in a way that meet the needs of healthcare consumers in different states.

Experts say the biggest challenge will likely be providing adequate customer service to handle enrollment, as well as fielding a technology system capable of interfacing seamlessly with the system of each state government.

Cohen told the panel the administration is building a website with interactive capabilities and a call center and has begun testing a data services hub to determine eligibility.

(Reporting by David Morgan; Editing by Ros Krasny, Jilian Mincer, Nick Zieminski and David Gregorio)

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