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Health & Fitness (233)
There's fresh evidence that a lot of young people could be headed for heart trouble. A large study of preteens in Texas found that about one-third of them had borderline or high cholesterol when tested during routine physical exams.
The results seem to support recent guidelines that call for every child to have a cholesterol test between 9 and 11 - the ages of the 13,000 youths in this study. Many doctors and adults have balked at screening all children that young, but researchers say studies like this may convince them it's worthwhile.
"A concerning number of children" are at risk of heart problems later in life, and more needs to be done to prevent this at an earlier age, said Dr. Thomas Seery of Texas Children's Hospital and Baylor College of Medicine.
He led the study, which will be presented at an American College of Cardiology conference in Washington this weekend.
Estimates are that by the fourth grade, 10 to 13 percent of U.S. children will have high cholesterol. Half of them will go on to have it as adults, raising their risk for heart attacks, strokes and other problems.
High cholesterol rarely causes symptoms in kids. Many genes and inherited conditions also cause high cholesterol but not obesity, so it can be missed especially in youths who are slim or athletic.
The new study involved children having routine physicals from January 2010 to July 2011 at the largest pediatric primary care network in the nation, more than 45 clinics in the Houston area. One-third were Hispanic, about one-third were white, and 18 percent were black. About one-third were obese.
Unhealthy total cholesterol levels were found in 34 percent. LDL or "bad cholesterol" was borderline or too high in 46 percent, and HDL or "good" cholesterol was borderline or too low in 44 percent. Just over half had normal triglycerides, another type of fat in the blood.
Boys were more likely than girls to have higher total cholesterol, LDL and triglycerides, Seery said. Hispanics were more likely to have higher cholesterol and triglycerides.
"I would hope that data like these would get the attention of general pediatricians," because many cases of disease are being missed now, said Dr. Elaine Urbina, director of preventive cardiology at Cincinnati Children's Hospital Medical Center.
She was on the expert panel appointed by the National Heart, Lung and Blood Institute that wrote the screening guidelines issued in 2011 and endorsed by the American Academy of Pediatrics. They call for screening everyone between age 9 to 11 and again 17 to 21.
"Very few people know their entire family history," and many forms of high cholesterol occur in people who are not obese, so screening is needed to catch more cases, she said.
High cholesterol doesn't necessarily mean the child needs medicines like statin drugs, she said. The guidelines stress diet and lifestyle changes as the first step.
Screening guidelines: HTTP://WWW.NHLBI.NIH.GOV/GUIDELINES/CVD-PED/INDEX.HTM
Cholesterol info: HTTP://TINYURL.COM/23DTXVO
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WASHINGTON (AP) -- People who've started applying for health insurance but aren't able to finish before the March 31 enrollment deadline will get extra time, the Obama administration has announced.
"We are experiencing a surge in demand and are making sure that we will be ready to help consumers who may be in line by the deadline to complete enrollment, either online or over the phone," Health and Human Services spokesman Aaron Albright said Tuesday.
The White House is scrambling to meet a goal of 6 million signed up through new online markets that offer subsidized private health insurance to people without access to coverage on the job. The HealthCare.gov website got more that 1 million visitors Monday, and the administration also wants to prevent a repeat of website problems that soured consumers last fall.
Officials said the grace period will be available to people on the honor system, meaning applicants will have to attest that special circumstances or complex cases prevented them from finishing by March 31.
It's unclear how long the extension will last. Some have urged the administration to allow until April 15, the tax filing deadline. People who are due refunds may be willing to put some of that money toward health care premiums.
The latest tweak to the health care rollout is certain to infuriate Republican critics of President Barack Obama's signature law. It follows delays of the law's requirements that medium-sized to large employers provide coverage or face fines. The GOP is making repeal of the health care law its rallying cry in the fall congressional elections.
The White House had signaled last week that a grace period of some sort was in the works. Spokesman Jay Carney said Friday that people in line by the deadline would be able to complete their applications. Administration officials argue that's not extending the deadline. They compare it to the Election Day practice of allowing people to vote if they are in line when the polls close.
The decision to grant extra time was first reported late Tuesday by The Washington Post.
The administration's decision affects the 36 states where the federal government is taking the lead on sign-ups. The 14 states running their own websites are likely to follow, since some had been pressing for an extension on account of their own technical problems.
Brian Haile, senior vice president for health policy at the Jackson Hewitt tax preparation firm, welcomed the move.
"The disbursement of tax refunds appears to be making a substantial difference in the willingness and ability of uninsured Americans to sign up for ... coverage," Haile said.
Jackson Hewitt projects the administration can meet the goal of 6 million only if it allows people to keep signing up through April 15.
Enrollment has already crossed the 5 million mark.
LITTLE ROCK, Ark. (AP) -- The Arkansas Supreme Court tossed out a $1.2 billion judgment against Johnson & Johnson on Thursday, reversing a lower court verdict that found the drug maker engaged in fraudulent tactics when marketing the antipsychotic drug Risperdal.
The high court ruled the state's Medicaid fraud law, which formed the basis of Arkansas' lawsuit, regulates health care facilities and that drug manufacturers, including Johnson & Johnson and its subsidiary, Janssen Pharmaceutical Inc., don't fall under its scope.
The state alleged that the companies didn't properly communicate Risperdal's risks and marketed it for off-label use, calling the practices fraudulent.
Johnson & Johnson said there was no fraud and Arkansas' Medicaid program wasn't harmed.
Attorney General Dustin McDaniel said Thursday that he believes the Legislature intended for the Medicaid fraud law to allow lawsuits like the one against Johnson & Johnson.
"I am disappointed that the Court viewed the law differently. Nevertheless, I will keep working to protect consumers against fraud and the kinds of irresponsible and greedy actions shown by Johnson & Johnson and Janssen Pharmaceuticals in their marketing of the drug Risperdal," McDaniel said in a statement released by his office.
Johnson & Johnson issued a statement that included a defense of how Risperdal is used.
"We are pleased that the Arkansas Supreme Court has ruled in our favor, reversing and dismissing the state's claims brought under the Medicaid Fraud False Claims Act, and has also reversed the Deceptive Trade Practices Act claim, remanding it to the court below.
"Janssen remains strongly committed to ethical business practices. Risperdal continues to help patients around the world who suffer from the debilitating effects of schizophrenia and bipolar mania," the companies said in the release.
McDaniel's office said it can't refile the major component of the lawsuit by alleging the companies broke some other law, but it intends to pursue a lesser aspect of it that the state Supreme Court sent back to the lower court. That part of the lawsuit, for which the state was awarded $11 million, claimed that the companies broke the state's deceptive trade practices law.
In a separate ruling, the justices threw out $181 million in fees and costs awarded to the state. Johnson & Johnson argued, among other things, that the award was premature. The high court agreed and sent the fee issue back to Fox's court.
Risperdal and similar antipsychotic drugs have been linked to increased risk of strokes and death in elderly patients, along with seizures, weight gain and diabetes.
Risperdal was introduced in 1994 as a "second-generation" antipsychotic drug - and it earned Johnson & Johnson billions of dollars in sales before generic versions became available. The drug is used to treat schizophrenia, bipolar disorder and irritability in autism patients.
An Arkansas jury found the New Jersey-based companies liable in 2012. Pulaski County Circuit Judge Tim Fox then ordered the companies to pay $5,000 for each of the 240,000 Risperdal prescriptions for which Arkansas' Medicaid program paid during a 3 1/2-year span.
The lawsuit accused the companies of deceptive trade practices and Medicaid fraud and sought repayment for millions paid out by the state's Medicaid program for unnecessary prescriptions. The original lawsuit identified more than 597,000 prescriptions over a 13-year period, but that number was whittled down after challenges from the drug companies during pretrial proceedings.
Fox also fined the companies $2,500 for each of the more than 4,500 letters that Janssen sent to Arkansas doctors that the state said downplayed Risperdal's side effects. That's where the $11 million award was made under the state deceptive trade practices law.
In a separate action brought by the U.S. Department of Justice, Johnson & Johnson agreed in November to pay more than $2.2 billion to federal and state governments and in penalties to resolve criminal and civil allegations that the company promoted powerful psychiatric drugs, including Risperdal, for unapproved uses in children, seniors and disabled patients.
The agreement was the third-largest settlement with a drug maker in U.S. history.
Johnson & Johnson and Janssen are also awaiting a ruling by the South Carolina Supreme Court, where the companies have an appeal pending of a $327 million judgment in a similar case. A $330 million verdict against both companies in Louisiana was overturned in January.
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WASHINGTON (AP) -- Sitting in a tub of warm water can relieve a mom-to-be's pain during the early stages of labor, but actually giving birth under water has no proven benefit and may be risky, say recommendations for the nation's obstetricians.
There's no count of how many babies in the U.S. are delivered in water, but it is increasingly common for hospitals to offer birthing pools or tubs to help pregnant women relax during labor.
In a report released Thursday, a distinction is made between the two uses, saying that early on immersion may be helpful, as long as some basic precautions are taken.
But there has been little scientific study of underwater delivery, along with a handful of reports over the past decade or so of near-drownings and other risks to the infant, said the joint opinion from the American College of Obstetricians and Gynecologists and the American Academy of Pediatrics.
Although complications appear to be rare, the report urges that underwater deliveries be performed only in research studies to settle the questions.
"Laboring in water is not the same as delivering under water," said co-author Dr. Jeffrey Ecker of Harvard University, adding that he's cared for numerous women comforted by immersion during labor.
As for delivery, "We want people to do more research," added ACOG committee member Dr. Aaron Caughey of Oregon Health & Science University.
In fact, midwives at Caughey's hospital perform several dozen underwater deliveries a year and are collecting data on how mothers and babies fare, said Cathy Emeis, a certified nurse-midwife at the Oregon university. She cautioned that the numbers are small but so far don't show increased risks.
Pregnant women interested in a water birth at the Oregon facility are required to take a special class and sign a consent form, Emeis said.
"We always acknowledge to our patients that there is not a lot of high-quality evidence that shows there's a benefit to birthing under water," she said.
Thursday's recommendations aren't binding. Birthing in warm water, which proponents say simulates the uterine environment, has been an option for several decades, although more women use it for early labor than delivery, said Tina Johnson of the American College of Nurse-Midwives.
"I don't know that this statement will necessarily change women's desire for that option," said Johnson, whose organization is drafting its own guidelines.
The report recommends that hospitals or birth centers choose low-risk candidates for immersion during labor, keep tubs clean, monitor women appropriately and be able to move them out of the water quickly if a problem occurs.
It says potential risks of underwater delivery include infection, difficulty regulating the baby's body temperature and respiratory distress if the baby inhales water.
Almost half of Americans ages 40 to 75 and nearly all men over 60 qualify to consider cholesterol-lowering statin drugs under new heart disease prevention guidelines, an analysis concludes.
It's the first independent look at the impact of the guidelines issued in November and shows how dramatically they shift more people toward treatment. Supporters say they reveal the true scope of heart risks in America. Critics have said the guidelines overreach by suggesting medications such as Zocor and Lipitor for such a broad swath of the population.
"We wanted to be really objective and just quantify what the guidelines do, and not get into a discussion about whether they are correct," said Michael Pencina, the Duke University biostatistician who led the analysis. It was published online Wednesday by the New England Journal of Medicine.
Under the new guidelines, 56 million Americans ages 40 to 75 are eligible to consider a statin; 43 million were under the old advice. Both numbers include 25 million people taking statins now.
"That is striking ... eye-opening," Dr. Daniel Rader of the University of Pennsylvania said of the new estimate.
But since too few people use statins now, the advice "has the potential to do much more good than harm," said Rader, a cardiologist who had no role in writing the guidelines.
Nearly half a million additional heart attacks and strokes could be prevented over 10 years if statin use was expanded as the guidelines recommend, the study estimates.
The guidelines, developed by the American Heart Association and American College of Cardiology at the request of the federal government, were a big change. They give a new formula for estimating risk that includes blood pressure, smoking status and many factors besides the level of LDL or "bad" cholesterol, the main focus in the past.
For the first time, the guidelines are personalized for men and women and blacks and whites, and they take aim at strokes, not just heart attacks. Partly because of that, they set a lower threshold for using statins to reduce risk.
The guidelines say statins do the most good for people who already have heart disease, those with very high LDL of 190 or more, and people over 40 with Type 2 diabetes.
They also recommend considering statins for anyone 40 to 75 who has an estimated 10-year risk of heart disease of 7.5 percent or higher, based on the new formula. (This means that for every 100 people with a similar risk profile, seven or eight would have a heart attack or stroke within 10 years.)
Under this more nuanced approach, many people who previously would not have qualified for a statin based on LDL alone now would, while others with a somewhat high LDL but no other heart risk factors would not.
The Duke researchers gauged the impact of these changes by using cholesterol, weight and other measurements from health surveys by the Centers for Disease Control and Prevention. They looked at how nearly 4,000 people in these surveys would have been classified under the new and old guidelines, and projected the results to the whole country.
The biggest effect was on people 60 and older, researchers found. Under the new guidelines, 87 percent of such men not already taking a statin are eligible to consider one; only 30 percent were under the old guidelines. For women, the numbers are 54 percent and 21 percent, respectively.
Dr. Paul Ridker and Nancy Cook of Brigham and Women's Hospital in Boston have criticized the risk formula in the guidelines. Ridker declined to be interviewed, but in a statement, he and Cook noted that most people newly suggested for statins do not have high cholesterol but smoke or have high blood pressure. Those problems and lifestyle changes should be addressed before trying medications - which the guidelines recommend - they write.
Dr. Neil Stone, the Northwestern University doctor who helped lead the guidelines work, stressed that the guidelines just say who should consider a statin, and they recommend people discuss that carefully with a doctor.
"We think we're focusing the attention for statins on those who would benefit the most," Stone said.
Dr. Harlan Krumholz, a Yale University cardiologist who has long advocated this approach, agreed.
"The guidelines provide a recommendation, not a mandate" for statin use, he said.
Pencina, the leader of the Duke study, said his own situation motivated him to look at the guidelines more closely. His LDL was nearing a threshold to consider a statin under the old guidelines, but under the new formula for gauging risk, "I'm fine," he said.
Cholesterol info: HTTP://TINYURL.COM/2DTC5VY
Risk formula: HTTP://MY.AMERICANHEART.ORG/CVRISKCALCULATOR
Heart facts: HTTP://CIRC.AHAJOURNALS.ORG/CONTENT/127/1/E6
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It won't be nearly as much fun as eating candy bars, but a big study is being launched to see if pills containing the nutrients in dark chocolate can help prevent heart attacks and strokes.
The pills are so packed with nutrients that you'd have to eat a gazillion candy bars to get the amount being tested in this study, which will enroll 18,000 men and women nationwide.
"People eat chocolate because they enjoy it," not because they think it's good for them, and the idea of the study is to see whether there are health benefits from chocolate's ingredients minus the sugar and fat, said Dr. JoAnn Manson, preventive medicine chief at Harvard-affiliated Brigham and Women's Hospital in Boston.
The study will be the first large test of cocoa flavanols, which in previous smaller studies improved blood pressure, cholesterol, the body's use of insulin, artery health and other heart-related factors.
A second part of the study will test multivitamins to help prevent cancer. Earlier research suggested this benefit but involved just older, unusually healthy men. Researchers want to see if multivitamins lower cancer risk in a broader population.
The study will be sponsored by the National Heart, Lung and Blood Institute and Mars Inc., maker of M&M's and Snickers bars. The candy company has patented a way to extract flavanols from cocoa in high concentration and put them in capsules. Mars and some other companies sell cocoa extract capsules, but with less active ingredient than those that will be tested in the study; candy contains even less.
"You're not going to get these protective flavanols in most of the candy on the market. Cocoa flavanols are often destroyed by the processing," said Manson, who will lead the study with Howard Sesso at Brigham and others at Fred Hutchinson Cancer Research Center in Seattle.
Participants will get dummy pills or two capsules a day of cocoa flavanols for four years, and neither they nor the study leaders will know who is taking what during the study. The flavanol capsules are coated and have no taste, said Manson, who tried them herself.
In the other part of the study, participants will get dummy pills or daily multivitamins containing a broad range of nutrients.
Participants will be recruited from existing studies, which saves money and lets the study proceed much more quickly, Manson said, although some additional people with a strong interest in the research may be allowed to enroll. The women will come from the Women's Health Initiative study, the long-running research project best known for showing that menopause hormone pills might raise heart risks rather than lower them as had long been thought. Men will be recruited from other large studies.
Manson also is leading a government-funded study testing vitamin D pills in 26,000 men and women. Results are expected in three years.
People love vitamin supplements but "it's important not to jump on the bandwagon" and take pills before they are rigorously tested, she warned.
"More is not necessarily better," and research has shown surprising harm from some nutrients that once looked promising, she said.
Marilynn Marchione can be followed at HTTP://TWITTER.COM/MMARCHIONEAP