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

Hillary Clinton leaves New York hospital with family, aide

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NEW YORK (Reuters) – Secretary of State Hillary Clinton left New York-Presbyterian hospital on Wednesday and was driven away with her husband, Bill, and daughter, Chelsea, and an aide, a Reuters photographer witnessed.


It was unclear where she was going or whether she had been discharged from the hospital, where she had been admitted for treatment of a blood clot behind her right ear.






A hospital spokeswoman directed all questions about Clinton, 65, to the State Department, which had no immediate comment.


Earlier Wednesday, a State Department spokeswoman said Clinton, who had not been seen in public since December 7, had been talking with her staff by telephone and receiving memos.


Clinton also spoke to two foreign officials – the U.N. envoy on Syria and the prime minister of Qatar – on Saturday, the day before the State Department disclosed the blood clot and her stay at New York-Presbyterian Hospital.


“She’s been quite active on the phone with staff and taking paper, etc.,” State Department spokeswoman Victoria Nuland said at the department’s daily briefing.


The State Department announced on Sunday that Clinton was in a New York hospital for treatment of a blood clot that stemmed from a concussion she suffered in mid-December.


The concussion was itself the result of an earlier illness, described by the State Department as a stomach virus she had picked up during a trip to Europe that led to dehydration and a fainting spell after she returned to the United States.


In a statement released by the State Department on Monday, Clinton’s doctors said they were confident that she would make a full recovery and that she would be released from the hospital once the correct dosage of blood thinners had been determined.


(Reporting by Joshua Lott in New York; Editing by Daniel Trotta and Jackie Frank)


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

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


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






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


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


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


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


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


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


FISCAL 2013 EFFECTS


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


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


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


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


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


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Naloxone reverses overdoses without hefty price tag

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NEW YORK (Reuters Health) – Distributing a drug that reverses drug overdoses in heroin users would save lives and be cost-effective, according to a new analysis.


U.S. researchers, who published their findings in the Annals of Internal Medicine on Monday, calculated that one death may be prevented for every 164 naloxone injection kits they distribute to heroin users.






That, the researchers say, works out to be a few hundred dollars for every year of healthy life gained.


“The great news here is these overdose deaths can be prevented, it’s cost effective to do so, and may even be cost saving,” said Dr. Phillip Coffin, the study’s lead author from the San Francisco Department of Public Health.


Naloxone is a drug that stops opioids such as heroin from reaching receptors in the brain, which may reverse an overdose. The drug is currently only approved by the U.S. Food and Drug Administration (FDA) to be injected into a person, but there are promising trials for an inhaled version of it.


The general idea, according to Coffin, is that giving heroin or opioid users naloxone injection kits gives them the chance to reverse another person’s overdose.


“Typically when someone has an overdose, they’re unconscious and they fall asleep quite quickly… So the idea that you would reverse your own overdose is not practical,” said Dr. Wilson Compton from the National Institute on Drug Abuse (NIDA) in Bethesda, Maryland.


Currently, an estimated 213,000 people in the U.S. use heroin each year. Over that population’s lifetime, more than one in 10 users may die of an overdose.


Compton, who co-authored an editorial accompanying the study, said naloxone has few side effects, except that high doses may send someone into withdrawal.


For the new study, Coffin and a colleague created a computer simulation that predicted what would happen if they distributed naloxone injection kits to 20 percent of U.S. heroin users, and compared the resulting deaths and costs to a simulation of users without kits.


In that scenario, the model found that in a population of 200,000 heroin users 6.5 percent of deaths that would have occurred could be prevented with distribution of the kits.


The simulation also found that almost 2 percent of heroin users eventually quit when the kits were distributed. That, however, also led to about a 1 percent increase in overdoses, because high-risk users were living longer.


The researchers calculated that the kits would cost about $ 400 for every year of healthy life gained.


That’s well below the $ 50,000 per healthy year of life gained threshold that policymakers typically think is worth paying for, the authors note.


Coffin told Reuters Health that distributing the kits may end up saving money because it might prevent aggressive attempts to revive a person who overdoses, which can be costly.


“This study helps us understand that providing naloxone is not only effective, but can also be a very cost effective approach to preventing overdose deaths in heroin addicts,” Compton said.


Coffin added that there may be additional benefits from distributing the kits based on real-world experiences in places such as New York City, Chicago, San Francisco and Scotland, where overdose deaths fell between 37 percent and 90 percent with naloxone distribution programs.


“It may be influencing behavior,” said Coffin. “That rides on the assumption that talking to people about overdoes and providing them with a tool to prevent overdoses makes them a little bit more careful.”


But Compton said these kits may only be part of an approach to curb the growing epidemic of opioid overdose deaths.


“Providing this intervention to address the overdose epidemic is one piece of it, but we think it must be part of a larger approach to prevent the abuse and misuse of prescription drugs,” he said.


According to Compton and his editorial co-authors, which include NIDA Director Dr. Nora Volkow and representatives from the FDA, total U.S. drug overdose deaths in 2010 reached almost 40,000 and outpaced deaths from motor vehicle accidents.


Overall, Coffin told Reuters Health he thinks the results are “fantastic,” because it shows “it’s a really excellent benefit for a modest amount of dollars.”


SOURCE: http://bit.ly/Ms1ZbQ Annals of Internal Medicine, online December 31, 2012.


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

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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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Hospitals, red tape may be limiting tubal ligations

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NEW YORK (Reuters Health) – Women in California and Texas have varying access to “getting their tubes tied” immediately after giving birth, according to a new study, but the reasons are still unclear researchers say.


Analyzing the records of nearly 890,000 mothers across 499 hospitals in both states, they found that more women in Texas got the voluntary sterilization procedure after delivery in 2009 than did women in California.






But the differences were not clearly linked to obvious factors – such as cost or religiously affiliated hospitals that refuse to do the surgery. Further, sterilization rates ranged from zero to 15 percent in California hospitals and between zero and 30 percent in Texas hospitals.


“This huge variation we’re seeing both between the two states and within facilities raises a red flag,” said study author Dr. Daniel Grossman, senior associate at Ibis Reproductive Health. “Our paper raises more questions than it answers,” he told Reuters Health.


Differences in federal funding could explain some of the discrepancies. Federal funds through Title X and Medicaid programs reach more women in California than Texas, Grossman said.


In his team’s report, published in the journal Obstetrics & Gynecology, the researchers suggest that Texas women have fewer low-cost family planning options, which may act as an incentive to get their tubes tied for contraceptive purposes.


Conversely, the more generous family planning funding in California might mean that women have access to low-cost options beyond sterilization after delivery.


Nonetheless, surgical sterilization remains very popular in the U.S. and nearly a third of women with children use it for family planning purposes, according to some estimates.


A 2011 study from the Centers for Disease Control and Prevention, for example, found that tubal sterilization was performed following every one in 13 births in the U.S. between 2001 and 2008, while insertion of a contraceptive IUD was done after one in every 37,000 births. (See Reuters Health story of August 26, 2011.)


In the new study, Grossman and his colleagues found that in California, one in every 15 women had her tubes tied after delivery, compared with Texas where one in 10 women was sterilized after delivery.


They looked at several factors that might explain the variation in rates, but none stood out as a clear cause. Variation was similar among private versus publicly insured patients and among mothers who delivered by cesarean section – a procedure that might make it easier to have elective sterilization right after delivery.


The age of the mothers also did not explain the disparities. The data did not include the number of previous children the women had.


Differences in accessibility might arise from several other sources, the researchers suggested. Catholic hospitals ban sterilization, but non-Catholic hospitals could also have policies that limit tube tying.


“It doesn’t matter if it’s at an institutional level or a state level, it’s always the least mobile, the poorest (women) who don’t have the choice,” said Dr. Cori Baill, a physician at The Menopause Center in Orlando, who has counseled mothers in family planning issues.


Baill, who was not involved in the current study, said poor women who lack prenatal care will not have sterilization as an option since Medicaid requires expectant mothers to sign consent forms 30 days before delivery. “It’s ridiculous that Medicaid rule still exists,” Baill told Reuters Health.


Night and weekend staffing could also affect the variation in tube tying since doctors may not be around to perform the elective surgery, Baill added.


Though the current study did not examine how many mothers requested their tubes tied after delivery, Grossman and colleagues are examining the demand for sterilization in an ongoing pilot study in El Paso, Texas.


“Women across the country should be able to access the form of contraception that they want,” Grossman said. “We need more information to determine what accounts for this variability.”


SOURCE: http://bit.ly/Uqx8hQ Obstetrics & Gynecology, online December 20, 2012.


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Senator McConnell says still time to avert “fiscal cliff”

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WASHINGTON (Reuters) – The top Republican in the U.S. Senate, Mitch McConnell, on Thursday said that there is still time to avert the “fiscal cliff” and a “wholly preventable economic crisis.”


In a speech on the Senate floor McConnell warned, however, that Senate Republicans “aren’t about to write a blank check for anything Senate Democrats put forward just because we find ourselves at the edge of the cliff.”






Lawmakers and President Barack Obama are up against a December 31 deadline for finding a way to stop $ 600 billion in potentially harmful tax hikes and spending cuts from taking effect with an alternative deficit-reduction formula.


(Reporting By Richard Cowan and David Lawder; Editing by Sandra Maler)


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Web-based info may not increase cancer screening

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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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One in 12 in military has clogged heart arteries

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NEW YORK (Reuters Health) – Just over one in 12 U.S. service members who died in the Iraq and Afghanistan wars had plaque buildup in the arteries around their hearts – an early sign of heart disease, according to a new study.


None of them had been diagnosed with heart disease before deployment, researchers said.






“This is a young, healthy, fit group,” said the study’s lead author, Dr. Bryant Webber, from the Uniformed Services University of the Health Sciences in Bethesda, Maryland.


“These are people who are asymptomatic, they feel fine, they’re deployed into combat,” he told Reuters Health.


“It just proves again the point that we know that this is a clinically silent disease, meaning people can go years without being diagnosed, having no signs or symptoms of the disease.”


Webber said the findings also show that although the U.S. has made progress in lowering the nationwide prevalence of heart disease, there’s more work that can be done to encourage people to adopt a healthy lifestyle and reduce their risks.


Heart disease accounts for about one in four deaths – or about 600,000 Americans each year, according to the Centers for Disease Control and Prevention.


The new data come from autopsies done on U.S. service members who died in October 2001 through August 2011 during combat or from unintentional injuries. Those autopsies were originally performed to provide a full account to service members’ families of how they died.


The study mirrors autopsy research on Korean and Vietnam war veterans, which found signs of heart disease in as many as three-quarters of deceased service members at the time.


“Earlier autopsy studies… were critical pieces of information that alerted the medical community to the lurking burden of coronary disease in our young people,” said Dr. Daniel Levy, director of the Framingham Heart Study and a senior investigator with the National Institutes of Health.


The findings are not directly comparable, in part because there was a draft in place during the earlier wars but not for Operations Enduring Freedom and Iraqi Freedom/New Dawn. When service is optional, healthier people might be more likely to sign up, researchers explained.


Still, Levy said the new study likely reflects declines in heart disease in the U.S. in general over that span.


Altogether the researchers had information on 3,832 service members who’d been killed at an average age of 26. Close to 9 percent had any buildup in their coronary arteries, according to the autopsies. And about a quarter of the soldiers with buildup in their arteries had severe blockage.


Service members who had been obese or had high cholesterol or high blood pressure when they entered the military were especially likely to have plaque buildup, Webber and his colleagues reported Tuesday in the Journal of the American Medical Association.


More than 98 percent of the service members included were men.


“This study bodes well for a lower burden of disease lurking in young people,” Levy, who wrote an editorial published with the report, told Reuters Health.


“Young, healthy people are likely to have a lower burden of disease today than their parents or grandparents had decades ago.”


That’s likely due, in part, to better control of blood pressure and cholesterol and lower rates of smoking in today’s service members – as well as the country in general, researchers said.


However, two risks for heart disease that haven’t declined are obesity and diabetes, which are closely linked.


“Obesity is the one that has not trended in the right direction,” Levy said.


“Those changes in obesity and diabetes threaten to reverse some of the dramatic improvements that we are seeing in heart disease death rates,” he added.


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


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Little change in overtreatment at doctors’ offices

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NEW YORK (Reuters Health) – Although some Americans are getting more of beneficial treatments that were underused in the past, including drugs for heart disease, others are still being overtested or overtreated for a range of conditions, according to a new study.


Researchers found U.S. doctors’ offices made progress on six of nine “quality indicators” for recommended and underused therapies but only scaled back on two of 11 unnecessary and potentially harmful health services.






Those findings reflect a growing concern over skyrocketing health care costs – and the realization that doctors and hospitals are going to have to find places where services can be scaled back.


“We all know that we need to do something about it, and one component of the high health care costs is the overuse and misuse of therapies and interventions,” said Dr. Amir Qaseem, director of clinical policy at the American College of Physicians.


It’s not about getting rid of services that are too expensive, he told Reuters Health, but evaluating what current tests and treatments may offer little value for certain patients.


For example, two overuse indicators included in the new analysis are screening men age 75 and up for prostate cancer and screening women 75 and older for breast cancer.


“For men who are getting screened over the age of 75, the likely benefit doesn’t happen within a patient’s lifetime,” Qaseem said, because prostate cancer is often very slow-growing. And that’s assuming prostate specific antigen (PSA) tests are beneficial at all.


Regardless of a man’s age, however, the tests can still lead to invasive biopsies that come with side effects such as a risk of incontinence and impotence.


“We really need to start looking at some of these services that may be harmful,” added Qaseem, who wasn’t involved in the new research.


The findings are based on nationally representative studies of adult care in outpatient offices, conducted by the Centers for Disease Control and Prevention. Data came from 79,083 office visits in 1998-1999 and 102,980 visits in 2008-2009.


During that span, the use of many recommended therapies improved. For example, 28 percent of people with coronary artery disease were given aspirin in 1998-1999, compared to almost 65 percent a decade later.


Likewise, the use of statins more than doubled in those same patients, from 27 percent to 59 percent. In people with diabetes, statin prescriptions increased from 12 percent to 36 percent.


However, there was little change in rates of unnecessary and overused services, including some types of cancer screening for older adults or x-rays and urine tests done as part of a general check-up.


Two of those overuse indicators improved: cervical cancer screening for women over 65 dropped from 3 percent to 2 percent, and unnecessary antibiotic prescribing for asthma flare-ups fell from 22 percent to 7 percent.


On the other hand, rates of prostate cancer screening for older men increased, from between 3 and 4 percent to almost 6 percent, according to findings published Monday in the Archives of Internal Medicine.


The lead author on the study from New York’s Mount Sinai School of Medicine, Dr. Minal Kale, said the set of quality indicators her team used doesn’t necessarily represent all tests and treatments provided in outpatient care.


And she added that the overuse of medical services is a complicated issue.


“Culturally, there’s a lot of resistance to limiting access to health care services because it quickly becomes politicized,” Kale told Reuters Health.


“The question about overuse really needs to come back to quality. It’s about quality of the care that we’re delivering to patients.”


The goal, she said, is to “increase the value and the quality of our health care system while also paying attention to the costs.”


SOURCE: http://bit.ly/LvmYaB Archives of Internal Medicine, online December 24, 2012.


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

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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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Federal appeals court rules against Hobby Lobby on contraception

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


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






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


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


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


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


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


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


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


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


(Editing by Corrie MacLaggan and Lisa Shumaker)


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Diagnostics Research Group Introduces Holiday Gift Ideas for Allergy Sufferers

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Diagnostics Research Group in San Antonio, Texas uses the knowledge and experience of its team of physicians to recommend holiday gift ideas for allergy sufferers. The clinic educates consumers about environmental irritants that exacerbate allergies and asthma and encourages participation in their current study of a product to relieve the symptoms of dust mite allergies.


San Antonio, TX (PRWEB) December 21, 2012






Diagnostics Research Group, a research clinic in San Antonio, Texas, is pleased to use their research to provide key information for allergy sufferers. The clinic says that the holidays are a great opportunity to purchase gifts that will be beneficial to those with allergies and asthma. Recommended gifts include new bedding, towels, pillows and other textiles that help alleviate the symptoms of dust mite allergies.


About 23 million people in the United States have asthma, and 70% of them have an allergy to an allergen that is known to trigger asthma. Dust mites are the most common triggers in our homes, along with mold, pollen and animal dander. Research has shown that high levels of exposure to dust mites are an important factor in the development of asthma in children and over seven million children have asthma, and many of them are undiagnosed.


Diagnostics Research Group is currently screening persons ages 12 and older who are allergic to dust mites. They are conducting a study for an investigational product to relieve the symptoms of dust mite allergies. Diagnostics Research Group is offering free testing, and, for participants who qualify for the study, free medical care by physicians, study product and compensation for time and travel.


“There are more warning signs that your child might be allergic to dust mites,” said Dr. Charles Andrews of Diagnostics Research Group. ” In addition to the asthma associated with dust allergy, young persons may also have chronic fatigue, recurrent ear infections and interrupted sleep.”


Diagnostic Research Group is owned by local physicians who are board certified in Internal Medicine, Pulmonary Medicine and Sleep Medicine. The research facility strives to perform research studies with integrity and competence, follow good clinical practices, offer quality studies to diverse subject populations and invest in the development and maintenance of competencies and productivity by all members of their team. Those interested in participating in the dust mite allergy study should call (210) 692-7157.


About the company:



Diagnostics Research Group, located in the South Texas Medical Center in San Antonio, Texas, is an independent clinical research site that performs clinical trials to test the safety and effectiveness of new drugs, treatments, and medical devices.


Those interested in volunteering for clinical trials can expect quality care from the staff at Diagnostics Research Group. Currently, there are 10 staff members certified by the Association of Clinical Research Professionals. Diagnostics Research Group has research experience with more than 200 studies in several therapeutic areas such as: allergies, respiratory diseases, internal medicine, women’s health, vaccines, and sleep disorders. For more information visit their website at http://www.dxrg.com.


Cristi Morales
Diagnositics Research Group
210-692-7157
Email Information


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The eye-opening costs of America’s insomnia

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By Quentin Fottrell


In yet another sign Americans are sleeping less, the number of sleep clinics has reached an all-time high. And while sleeplessness is big business, worth over $ 32 billion, it’s an even bigger economic problem — costing nearly twice that in lost productivity.






More Americans are seeking help for sleep-related conditions like insomnia and sleep apnea. On Wednesday, the American Academy of Sleep Medicine accredited its 2,500th sleep center, reporting that the number of sleep centers has doubled over the past five years and increased fivefold over the past decade.


The economic costs now run into billions of dollars a year. Nearly a quarter of all workers are affected by sleeplessness, according to a 2011 study by Harvard Medical School. And insomnia costs an average of $ 2,280 per worker in reduced productivity every year — a total cost of $ 63.2 billion to the economy, the study says. That equates to 11 working days lost annually for each worker, says Ronald C. Kessler, lead author of the study and McNeil Family Professor of Health Care Policy at Harvard Medical School.



The prescription drug epidemic


More Americans now die each year from prescription drug overdoses than from cocaine, heroin and other illegal drugs.



So why are Americans losing sleep? Since the 2008 recession, more people are lying awake at night worrying about their financial situation and job security, says Nathaniel F. Watson, president of the American Board of Sleep Medicine. (In fact, one-third of Americans lose sleep over the economy, according to one 2009 poll by the National Sleep Foundation.) The rise in U.S. obesity rates is another major factor, Watson says. But others are less certain. “There are lots of pop-psychology theories,” Kessler says. “One thing we do know — it’s pervasive through all sections of society.”


Whatever the causes, consumers are spending billions of dollars to get some shut-eye. The “sleep market” industry is currently worth over $ 32 billion, up from nearly $ 24 billion four years ago, according to John LaRosa, research director at MarketData Enterprises, a market research company in Tampa. Some 70 million Americans suffer from sleeplessness. Desperate for the perfect night’s sleep, they’re buying sleeping pills, premium mattresses, white noise machines, sleeping masks, mobile phone apps and other sleep-related paraphernalia.


But people need help staying awake too, which is compounding the problem. “There’s an enormous amount of self-medication for sleeplessness in America,” Kessler says. “That’s one reason why the sales of supercaffeinated energy drinks are skyrocketing.” Sales of energy drinks in the U.S. grew by around 16% last year to $ 8.9 billion, according to “Beverage Digest,” an industry publication. There are better ways of dealing with insomnia, Kessler says, like cutting down on caffeine and not playing on your smartphone or watching TV in bed late at night.


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24HR HomeCare Now Offers All Services in Walnut Creek

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24-Hour Care announced to day that they now offer all in-home care services in Walnut Creek.


Walnut Creek, Ca (PRWEB) December 19, 2012






24-Hour Care announced to day that they now offer all in-home care services in Walnut Creek. 24-Hour Care is a leading provider of in-home services to those in need.


On July 21, the Walnut Creek office opened its doors at 1399 Ygnacio Valley Road, Walnut Creek, California. 24-Hour Home Care is a quality in-home care service for disease specific clients and those in need. They provide care for a few hours a day or round-the-clock.


The client’s needs are reviewed in an in-home consultation process that results in a customized care plan, an on-call emergency guide, client health information, and a caregiver profile. 24-Hour Care develops a profile of a caregiver for a client. Disease specific care includes cancer, Alzheimer’s/dementia, heart disease, hospice and diabetes.


24-Hour Care list of services includes personal care, light housekeeping, meal preparation, medication reminders, companionship, transportation and emergency response system. Personal care includes assistance with bathing, dressing and grooming, and with mobility. Light housekeeping includes cleaning the house, taking out the trash, washing dishes and doing laundry. Meal preparation includes preparing nutritional and proper food. Medication reminders include keeping daily logs and giving right dosages. Companionship includes socialization, walking and playing stimulating games. Transportation includes accompanying the client on trips to the doctor, the hospital, on errands and on long trips to provide companionship. The emergency response system includes the installation of a system that alerts emergency personnel and family of an emergency. A simple push of a button takes care of all the necessary emergency communications.


24-Hour Care thoroughly vets their caregiver candidates for positions with local, state and national background checks in a 24 point screening process. They check candidates against the national criminal child sex offender listings with the Dru Sjodin Registry. Candidates are matched with those in need in a process that guarantees a good pairing.


24-Hour Care stresses punctuality with their employees and ensures they arrive at a client’s home on time with employee phone check-ins. They bond and insure their employees and cover them with worker’s comp insurance. An injury occurring in a client’s home is covered by worker’s comp, according to representatives. Employees are also protected with criminal bonding insurance. According to 24-Hour Care, their liability insurance covers clients from general, non-auto owned, professional, physical and sexual misconduct. They will provide proof of insurance during the client consultation upon request.


24-Hour Care has a quality assurance program that guarantees standards of high quality and service for every client. Along with the newly opened office in Walnut Creek, they serve Culver City, Encino, Irvine and Torrance. In Walnut Creek, contact them by phone at (925) 322-8627 or by visiting their website: 24hrcares.com/caregivers-walnut-creek


David Allerby
24Hr HomeCare
(800) 522-1516
Email Information


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Many have ovary surgery even with negative gene test

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


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






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


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


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


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


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


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


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


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


OVARIAN CANCER SCREENING


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


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


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


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


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


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


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


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


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


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


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


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


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


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Workplace Bullying Common, Could Lead to Medication Use

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Dec 16, 2012 7:00am



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






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


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


The study was published Thursday in the journal BMJ.


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


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


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


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



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First Responders Face Haunting Memories

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Police and paramedics who descended on the scene of the massacre at a Connecticut grade school face haunting memories and nightmares in the days and weeks to come, particularly if they have children of their own, experts say.


Twenty children and seven adults were killed Friday after a gunman opened fire at Sandy Hook Elementary School in Newtown, Conn. The shooter, identified as 20-year-old Adam Lanza, then killed himself.






“How the first responders react depends on how closely they identify with the victims,” said Dr. Charles Marmar, chair of psychiatry at NYU Langone Medical Center in New York City. “Let’s say somebody has a son or a daughter the same age as the victims — we know that makes a big difference.”


CLICK HERE for full coverage of the tragedy at the elementary school.


After the initial shock of such a violent attack fades, first responders sometimes struggle with flashbacks and sleep disturbances that can take a personal and professional toll.


Neal Schwieterman, a first responder at the 1999 Columbine massacre, still struggles with memories of what he saw there.


“Part of me is still missing from that day,” said Schwieterman, who was a sheriff’s deputy in his last week with the Jefferson County Police Department at the time. “I will never be the same.”





Alex von Kleydorff/AP Photo







Newtown Teacher Kept 1st Graders Calm During Massacre Watch Video





Newtown School Shooting: What to Tell Your Kids Watch Video



Schwieterman rushed to the scene where he evacuated eight carloads of wounded students.


“It’s a grieving process for everyone after this kind of thing, including first responders,” said Schwieterman, who sought counseling to cope with the harrowing day. “It took a complete toll on me, and rightfully so.”


Schwieterman was not a father at the time, but now has a 10-year-old daughter.


“I just can’t imagine,” he said of the Newtown shooting. “It rips your heart out.”


CLICK HERE for live updates on the Connecticut school shooting.


Experts say first responders are surprisingly resilient, with the vast majority recovering from the stress of a horrific scene within days or weeks.


“But some will continue to have symptoms, and those people will probably benefit from some form of counseling,” said Dr. Spencer Eth, a professor of clinical psychiatry at the University of Miami. “Unfortunately, when it comes to police, they sometimes try to act tough even when they’re feeling badly, and that’s an obstacle to getting the help they need to recover.”


The fact that most of the victims in Newtown were children, Eth said, could mean more first responders will need counseling.


“The shock and horror of seeing children killed is more personally distressing than almost any other situation they have to deal with,” he said, adding that first responders in many cases are also responsible for notifying families of the deceased. “Having to notify parents of their child’s death is among the most difficult things they have to do in their professional lives.”


With help, first responders can learn to cope. But they can never forget. Schwieterman, who is now the mayor of Paonia, Colo., still speaks of Columbine with a shaky voice, pausing often to gather himself. And when he heard about the Newtown shooting, he knew his phone would be ringing.


“I’ve had several family members call and ask if I’m doing OK,” he said. “That kind of support helps you through these things.”


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Confused by medication guides? You’re not alone

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NEW YORK (Reuters Health) – The information sheets that come stapled to certain prescriptions picked up at the pharmacy are too complex and difficult for people to understand, according to a new study.


“Anyone who’s seen these are not going to be surprised by the fact that they’re difficult to read,” said Michael Wolf, the study’s lead author and an associate professor at Northwestern University’s Feinberg School of Medicine in Chicago.






The U.S. Food and Drug Administration-approved medication guides are attached to drugs that the agency considers to have “serious and significant public health concerns,” according to the report.


Patients are supposed to read the guides before taking the drugs to learn about risks, side effects, potential interactions with other drugs and why the medication should be taken as prescribed.


“You want to make sure that message is effective. Otherwise it can do major harm,” Wolf told Reuters Health.


In previous studies, Wolf and his colleagues found several problems with the guides, including patients not understanding their content and – in many cases – not even receiving them along with their medication.


The number of drugs required to be accompanied by a so-called med guide increased from 40 in 2006 to 305 last year. That led the researchers to look into whether the guides had gotten easier to understand.


For the new study, the researchers first analyzed 185 medication guides in April 2010, which represented the majority of those available on the FDA’s website at the time.


On average, the guides were about 2,000 words long, none of the guides had a review section or brief summary and only one met “suitability” guidelines frequently used as the standard for medical education materials.


Then, Wolf and his colleagues asked 449 adults at two Chicago clinics to read three medication guides then answer a series of questions about the drugs, including how they should be stored and their possible side effects. The participants were allowed to refer back to the guides during the test and were not rushed to answer the questions.


On average, the participants were only able to correctly answer half of the questions.


People with the lowest literacy level did the worst, answering only about a quarter of all the questions correctly. That compared to people with the highest level of literacy, who answered about 65 percent of the questions correctly.


The researchers add, however, that the results are limited, because they only tested three medication guides and people may not pay as close attention to the material if they’re not actually taking the drugs.


But, Wolf said, in general people failed the test.


“It was highly educated and lowly educated people. It didn’t make a difference. Everyone struggled,” said Wolf.


In their analysis, Wolf and his colleagues found the guides were typically written for someone at an 11th or 10th grade reading level.


They write in the Journal of General Internal Medicine that the Plain Writing Act of 2010 requires federal agencies to make information available to the public in a clear and understandable way. The Act, however, does not provide a way to measure what is understandable.


Some researchers have suggested that materials be written for people with a 4th to 8th grade reading level.


“If you’ve ever tried to create things at a 4th grade reading level, it’s incredibly difficult. And I don’t know if the evidence is clear as to what grade level is the target,” said Wolf.


There are a few possible solutions to the problem, including creating a uniform guide, which the researchers say is something the pharmaceutical industry and a private institution are working together to develop.


Wolf told Reuters Health that his team is also working with the U.S. Agency for Healthcare Research and Quality to create a how-to guide for medical organizations to make educational materials easy to understand.


He added that they’re also testing a new medication guide prototype in a clinical trial.


Until better guides become available, Wolf said patients should not be afraid to ask their doctors and pharmacists questions.


“Have that conversation when they’re getting it prescribed to them, but understand the pharmacist is available,” he said.


The FDA did not respond to a request for comment.


SOURCE: http://bit.ly/Y19pZ0 Journal of General Internal Medicine, online December 2012.


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More pressure to justify cost of cancer drugs versus benefits

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(Reuters) – Medical providers have begun to think more about cost, as well as safety and effectiveness, when they decide on cancer treatments.


In the past, pharmaceutical companies could launch a high-priced drug with little push back. But now, there is more pressure from insurers as well as doctors to justify using drugs that provide only incremental benefits. Products that offer clear-cut advances in treatment, however, still command premium prices.






The pressure on costs is likely to accelerate. The U.S. Affordable Care Act includes several provisions aimed at improving the value of healthcare, including paying hospitals for the quality of care rather than the quantity.


“It’s a sign of the times,” said Mark Mynhier, partner, healthcare industries advisory at PricewaterhouseCoopers PwC. “We are in fact in a significantly financially challenging environment.”


Four-fifths of U.S. health insurers recently polled by PwC now require evidence of cost savings or a clear clinical benefit to include new products on their lists of covered drugs.


Doctors at New York’s Memorial Sloan-Kettering Cancer Center decided in November not to use Zaltrap, a new $ 11,000 a month colon cancer drug, because it has a “modest” impact on survival, works no better than Avastin, a similar but cheaper competitor, and has worse side effects.


Sanofi SA, according to the hospital, responded by offering the drug to all health providers at a 50 percent discount to its wholesale price.


The Manhattan cancer center still does not include Zaltrap on its list of available drugs. Sanofi and Regeneron, which helped develop and also sells the drug, both declined to comment.


“In order to warrant the price, you are going to have to have better overall survival,” said Rhonda Greenapple, chief executive at Reimbursement Intelligence, a consulting firm specializing in medical reimbursement.


Linking value to patient outcomes – mainly a drug’s impact on survival – is particularly important in oncology, where treatment costs can total tens of thousands of dollars a year.


“In cases where there are co-pays, they really do effect the consumer,” Mynhier said. “Patients are saying ‘I can’t afford to pay 10 or 20 percent of a $ 100,000 therapy.’”


WellPoint Inc, the second-largest U.S. health insurer by market value, said it is increasing the amount it pays for less expensive generic cancer drugs as an incentive for doctors to use them.


PROFIT OPPORTUNITY FOR DOCTORS


Infused cancer medications are first purchased by doctors, who then bill insurers for reimbursement. That is different from pills and other oral drugs for which doctors typically write a prescription filled at a pharmacy.


The offer of a 50-percent discount to Zaltrap’s list price is a potential windfall for doctors. Patients, health insurers, the government or anyone else who pays healthcare bills would not see a benefit.


“At the very least it is an incentive for doctors to use the drug,” said Dr Leonard Saltz, chief of Memorial Sloan-Kettering’s gastrointestinal oncology service. “And I find that concerning.”


He noted that rebates and discounts for cancer drugs are not uncommon, but said this is the first time he is aware of a verbal across-the-board offer for a half-price discount.


The average U.S. oncologist, according to the Journal of Oncology Practice, generated revenue of nearly $ 5 million last year, of which drug costs accounted for nearly $ 3 million.


To combat the temptation of wider profit margins, health plans in recent years began reimbursing doctors for cancer drugs based on average sales prices, rather than wholesale prices. But for a new drug such as Zaltrap, reimbursement is based on the full list price until a sales track record is established.


WellPoint said it is raising reimbursements to independent oncologist on a range of generic chemotherapy drugs by as much as 140 percent.


“These drugs are the backbone of many therapies recommended by the National Comprehensive Cancer Network (NCCN) … and typically much less expensive than their brand counterparts,” said Jennifer Malin, WellPoint’s medical director oncology.


She said the goal is to shift the system away from what has been a largely drug-revenue based practice model, to one where oncologists are paid for providing good patient-centered care.


“The payers are looking at the quality data and demanding incremental value over existing products,” said Dan Mendelson, chief executive officer of consulting firm Avalere Health.


“COKE DIDN’T WORK, SO LET’S TRY PEPSI”


Zaltrap was approved in August by the Food and Drug Administration after a study found it improved survival, in combination with chemotherapy, by 1.4 months in colon cancer patients who had stopped responding to chemo.


That is the same benefit seen with Avastin, sold by Roche Holding AG for around $ 5,000 a month, or about half the price of Zaltrap.


NCCN guidelines say either one or the other drug should be used, not both, but Dr Saltz said most Zaltrap use is likely in patients who were already treated with Avastin – a practice that insurers will eventually stop.


“It’s like saying Coke didn’t work so let’s try Pepsi,” he said.


As scientists unravel the biological underpinnings of cancer cells, new targeted therapies are being developed, but the process is expensive.


Dr. Saltz said the solution might just be to walk away from drugs with small, incremental benefits.


“We simply can’t afford to pay these very, very large amounts for drugs that offer most people very small benefit,” Dr Saltz said. “We haven’t figured out how to rein it in.”


(Reporting By Deena Beasley in Los Angeles. Editing by Andre Grenon)


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Lilly plans another study for Alzheimer’s drug

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INDIANAPOLIS (AP) — Eli Lilly‘s experimental Alzheimer’s drug has flashed potential to help with mild cases of the disease, but patients and doctors will have to wait a few more years to learn whether regulators will allow the drugmaker to sell it.


Lilly said Wednesday that it will launch another late-stage study of the drug, solanezumab, no later than next year’s third quarter. The company’s stock slipped in midday trading.






The Indianapolis drugmaker said in August that the intravenous treatment failed to slow memory decline in two late-stage studies of about 1,000 patients each. But scientists saw a statistically significant slowing when they combined trial data. Pooled results found 34 percent less mental decline in mild Alzheimer’s patients compared with those on a fake treatment for 18 months.


Researchers also saw a statistically significant result when they examined a subgroup of patients with mild cases of Alzheimer’s disease.


Lilly will attempt to confirm that benefit in the new trial before it seeks U.S. regulatory approval, something analysts widely expected the drugmaker to do after it announced the initial results.


The additional study could help Lilly build a better case with U.S. regulators. But it will likely take a few years to learn the results. Researchers will have to measure over time a patient’s rate of cognitive decline, which involves the ability remember things.


Citi analyst Andrew Baum said in a research note the study will likely be completed by the second half of 2015. He expects the drug, if approved, to launch in 2017.


Eli Lilly and Co.’s share price fell $ 1.60, or 3.2 percent, to close at $ 49. It’s still up 16 percent since the company announced the initial results in August. Baum said Wednesday’s news helped shake out some of the “false hope” for a near-term approval of the drug that had inflated the stock price.


Drugmakers have tried and failed for years to develop successful treatments for Alzheimer’s, and patients and doctors are anxious for something that can slow its progression.


Solanezumab was one of three potential Alzheimer’s drugs in late-stage testing. Bapineuzumab, being developed by Pfizer Inc. and Johnson & Johnson’s Janssen Alzheimer Immunotherapy unit, gave disappointing results in two studies last summer.


A pivotal study of the third — Gammagard, by Baxter International Inc. — will wrap up at the end of this year. Results are expected in the first or second quarter next year.


Solanezumab binds to beta-amyloid protein, which scientists believe is a key component to sticky plaque that basically gums up the brain of a patient with Alzheimer’s disease. The drug is designed to help the body remove the protein from the brain before it can form that plaque.


Current treatments like Pfizer Inc.’s Aricept try to control symptoms of the disease. Analysts have said a treatment that does more than manage symptoms such as memory loss, confusion and agitation could be worth billions of dollars in annual sales. But drugmakers first have to spend a massive amount on testing and clinical development to produce such a drug.


“When you go for the blockbuster, you have to pay for the blockbuster, either in money or time,” WBB Securities analyst Steve Brozak said regarding Lilly’s announcement.


More than 35 million people worldwide have dementia, a term for brain disorders that affect memory, judgment and other mental functions. Alzheimer’s is the most common type. Many Alzheimer’s patients typically live four to eight years after diagnosis, as the disease gradually erodes their memory and ability to think or perform simple tasks.


In the United States, 5.4 million people have Alzheimer’s, which is the country’s sixth-leading cause of death. The number of Alzheimer’s patients in the U.S. is expected to jump to 16 million by 2050, and costs for care are expected to skyrocket.


___


AP Chief Medical Writer Marilynn Marchione in Milwaukee contributed to this report.


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