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Simplified Study Aims To Quickly Test A Long-Shot ALS Treatment

NPR Health Blog - Tue, 10/25/2016 - 4:17pm
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October 25, 20164:17 PM ET Heard on All Things Considered

Karen Lorne, diagnosed with Lou Gehrig's disease in July, volunteers weekly with her certified therapy dog, Bailey, at the Ronald McDonald House in Chapel Hill, N.C.

Courtesy of Karen Lorne

Researchers have launched an innovative medical experiment that's designed to provide quick answers while meeting the needs of patients, rather than drug companies.

Traditional studies can cost hundreds of millions of dollars, and can take many years. But patients with amyotrophic lateral sclerosis, or Lou Gehrig's disease don't have the time to wait. This progressive muscle-wasting disease is usually fatal within a few years.

Scientists in an active online patient community identified a potential treatment and have started to gather data from the participants virtually rather than requiring many in-person doctor's visits.

How is that possible?

In this case, doctors and patients alike got interested in an extraordinary ALS patient whose symptoms actually got better, which rarely occurs. He'd been taking a dietary supplement called lunasin, "and lo and behold six months later, [his] speech [was] back to normal, swallowing back to normal, doesn't use his feeding tube, [and he was] significantly stronger as measured by his therapists," said Richard Bedlack, a neurologist who runs the ALS clinic at Duke University.

Of course, it could just be a coincidence that the man who got better happened to be taking these supplements. To find out, Bedlack teamed up to run a study with Paul Wicks, a neuropsychologist and vice president for innovation at a web-based patient organization called PatientsLikeMe.

The study they came up with dispensed with many of the standard features of research that make it so expensive, time-consuming and often so hard to recruit patients:

  • There's no comparison group taking a placebo; instead the researchers match each patient with three to five people whose disease was on a similar course.
  • The researchers could skip safety testing because the supplement is already on the market.
  • Most important, they aren't looking for subtle effects, like slower disease progression. That may be vital for a pharmaceutical company seeking approval for a new drug, but isn't necessarily what patients want.

"I think what people are really looking for is to regain some function," Wicks says. "So with limited time resources, limited patients available to take part in studies, perhaps we want to swing for the fences every now and then."

Chances are the dietary supplement won't help, but at least people will learn the outcome quickly and won't waste their time and money if lunasin fails.

"If we find just one patient that has a reversal the size of the initial patient, that in itself is incredible, because these reversals are once in a generation," Wicks said. He and Bedlack have identified just 24 patients, over many years, whose disease actually reversed course, at least temporarily.

The study recruited 50 volunteers at a record pace for ALS research, Bedlack said. That's partly because it only requires three doctor visits. Those appointments are frequently challenging for people with this debilitating disease.

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Most of the data are gathered virtually — patients post their own weekly assessments in a secure area of the PatientsLikeMe website.

Karen Lorne, a 58-year-old nurse practitioner from Chapel Hill, N.C., had cared for patients with ALS, so she knew about the inexorable nature of the disease. This spring, she noticed she could no longer hold medical instruments securely in her left hand, and her speech started to slur. She was diagnosed with ALS in July.

"I was pretty shocked that we know so little and that we have no idea how to fix it — because that's what we do in medicine," she says.

After considering her options, Lorne decided to sign up for the low-hassle trial with the supplement. She reports her own symptoms once a week, by typing them in on the PatientsLikeMe website. She can track her own progress, as well as that of the other patients in the study.

And it also serves as a support group. "You can type in, 'I'm having a bad day,' and somebody will give you a list of pointers to help you keep in the center, which is where you really want to live," she said.

And the study doesn't consume her precious days. She still can focus on her family and life's daily pleasures.

"We try to live in the present and enjoy every moment as thoroughly as possible," she says. "And actually, some of my friends who do not have the disease, seeing me having it has helped them shore up their lives and recognize what's important."

She is also helping advance knowledge about ALS, even if this trial doesn't end up helping her.

Patients are a valuable resource, yet only 10 percent ever end up in a study.

"If this infrastructure works, in two years could you imagine 20 trials like this run in parallel?" Wicks asks. "You know, I have a question for the field: Why isn't every patient in a study?"

One reason that's not the case is that very ill patients are not likely to recover under any circumstances, so they don't usually provide a lot of value in scientific studies, says Jeffrey Rothstein, a neurologist who runs ALS studies at the Johns Hopkins University School of Medicine. "That's why almost no trial is open to all-comers," as this one was, he says.

He agreed, though, that the study would show whether the supplement has a truly dramatic effect, which is the main purpose of the experiment. "The value of getting patients involved is fantastic," he says.

If a virtual study like this identifies a promising lead, scientists could quickly pursue that through laboratory studies and more traditional studies with volunteers. Clearly that approach, of starting with animal studies and building on that knowledge, has been a huge disappointment so far with ALS.

And if the approach is successful, it could apply to other diseases as well.

Copyright 2016 NPR. To see more, visit NPR.
Categories: NPR Blogs

Applying A Silicon Valley Approach To Jumpstart Medical Research

NPR Health Blog - Tue, 10/25/2016 - 4:14pm
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October 25, 20164:14 PM ET Heard on All Things Considered

Cori Bargmann is applying her training as a neuroscientist to shaping the Chan Zuckerberg Initiative's ambitious agenda.

Chan Zuckerberg Initiative

Cori Bargmann's new job description includes "to help cure, prevent or manage all diseases by the end of the century." That's quite a lofty goal.

Bargmann is a neuroscientist and president of science for the Chan Zuckerberg Initiative, the joint venture of pediatrician Priscilla Chan and Facebook co-founder Mark Zuckerberg. The couple pledged $3 billion to solve major medical problems by helping scientists and engineers collaborate long term, over 25, 50, even 80 years.

All Things Considered host Robert Siegel spoke with Bargmann about what it's like to start a project you might not live to see the end of, and why the complexity of science today demands collaboration. Here are some highlights of the interview, edited for length and clarity.

On why medical researchers need to collaborate with engineers

As a neuroscientist, I see tremendous unmet needs in neurodegenerative diseases like Alzheimer's disease and Parkinson's disease and ALS. [Also] diseases that affect young adults like schizophrenia, and learning disorders and autism that affect children. So I can look across the whole field and think of ways that we would like to be able to address these problems.

The problem with studying the brain is that it's really complicated. There are 86 billion neurons in your brain, and all of these nerve cells are processing information and sending and receiving that information 10 times a second.

You really need a computer and the patience and boredom tolerance that a computer and an engineer can bring to the problem to try to map out the flow of information through such an incredibly complex structure.

On the foundation's project to create an atlas of cells in the human body

We know that there are trillions of cells in the human body, but we don't know what kinds they are, how many of each kind they are, exactly where they all are. We have a general view, sort of like an old Rand McNally Atlas. What we want is the kind of high-resolution house-to-house map you would get off of Google Maps these days.

If the Chan Zuckerberg Initiative were doing this alone, it might take a very long time to make a human cell atlas. But fortunately there's momentum around this idea in the world. With that, I think we might realistically accomplish it within 10 years. We'll then have that framework for everyone to build on, just like everyone now builds on the Human Genome Project.

On the pace of science and what can be accomplished in 80 years

Science is an enterprise where we build on the progress of the past, and hope that, in the future, people will build on our accomplishments. It's like a great medieval cathedral that may have been started in 1,000 AD and not been finished for 500 years. The original architects and the people who built the foundations were dead by the time the last Gothic spire was up or the last gargoyle was carved.

The great thing about science is that there might be individual moments of fantastic discovery — the equivalent of some beautiful stained glass window. But every brick in the foundation is important, and we hope that as we learn things, we're creating the foundation for future knowledge as well.

Eighty years ago, the first antibiotic was developed. Before then, the four major killers in the world were infectious disease. Today, none of them are even in the top 10 because of those antibiotics. 50 years ago, when Eisenhower had a heart attack he was put on bed rest. Today we know about controlling blood pressure, have statins to keep cholesterol down, have bypass surgery, and even heart transplants. We can keep people alive and healthy for a much longer time.

Copyright 2016 NPR. To see more, visit NPR.
Categories: NPR Blogs

For Babies On A Plane, Hot Drinks And Co-Sleeping Pose A Risk

NPR Health Blog - Tue, 10/25/2016 - 11:46am

The window seat may be a safer spot for small children than along the aisle. Plus there's the view.

Todd Burandt/Getty Images

When parents think of the risks of flying, they usually think of turbulence, emergency landings or horrific crashes. Hot coffee probably doesn't top the list. But when children are injured on airlines, they're most likely to get hurt the same ways they do on the ground.

The most likely cause of injury is burns from hot drinks, according to data presented Monday at the American Academy of Pediatrics conference. That accounted for 39 percent of injuries. Meal service was the most likely time. Sometimes the drinks splashed while they were being passed from person to person. Other times, rambunctious kids bumped tray tables, spilling scalding coffee everywhere.

Other injuries reflect ones seen at home, too. Children were hurt tripping and falling, or hit when objects fell out of overhead bins or when laptops slid off tray tables.

In conjunction with doctors at MedAire, a company that provides medical services for passengers on planes, Dr. Alexandre Rotta, chief of pediatric and critical care medicine at University Hospital Rainbow Babies and Children's Hospital in Cleveland, examined MedAire's database of in-flight medical emergencies from January 2009 to January 2014. They looked at 114,222 emergencies, 12,226 of which involved people under age 18. Most of the time, the child needed medical help because of a health problem he or she had before boarding the plane like a stomach bug or the flu. All told, they found 400 cases where a child was injured in-flight.

Younger children were much more likely to be injured than older children, according to Rotta. Infants held on laps were the most likely to be hurt — they made up 35.8 percent of the cases. Some of the injuries happened during turbulence, but some happened when babies simply fell off their parents' laps.

"People who have children are very much in tune with the fact that you cannot hold your child in your lap in a car," Rotta says. "Somehow, that wisdom doesn't apply to planes. Nobody thinks twice about it."

Alarmingly, five infants in the dataset died with symptoms consistent with sudden infant death syndrome. Co-sleeping, when parents let children sleep on top of them or with them, can put a baby at risk for SIDS or suffocation if there is soft bedding or an adult rolls over or changes positions. The American Academy of Pediatrics recommends that parents avoid sleeping with infants, particularly in chairs and couches. This study shows that "the dangers of co-sleeping are present on airplanes, too," says Rotta.

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Rotta suggests booking an extra seat for infants under age 2 if parents can afford it, and putting them in a bassinet or a car seat approved by the Federal Aviation Administration.

Dr. Benjamin Hoffman, a pediatric injury-prevention specialist, says the injuries reflect ones he sees in emergency rooms.

"I think this is a really important reminder that the same things you need to worry about at home, you should worry about on a plane," says Hoffman, who is the medical director of the Tom Sargent Safety Center at Doernbecher Children's Hospital in Portland, Ore. "Kids have things fall on them. They're burned with hot liquids. And if they sleep somewhere unsafe, we know it puts them at risk."

More than three-quarters of the injuries occurred on international flights and flights longer than six hours. Hoffman thinks this could be because kids get antsy on long flights or because parents get tired.

Overall, many of these injuries can be easily prevented, says Rotta. Putting a child in a window seat rather than an aisle or middle seat can make a big difference.

If infants and children are in the window seat, the odds of having a hot beverage spilled on them go way down, since drinks aren't being passed overhead. They're also protected from things that could fall from overhead compartments, their fingers and arms can't get crushed by passing food service carts and they can't wriggle their way off a parent's lap and into the aisle.

"Also," adds Rotta, "the window seat is more entertaining." Keeping kids entertained can make the flight more enjoyable for everyone, and help stop toddlers from escaping travel-weary parents and getting into trouble.

Although it's important for parents to be aware on airplanes, Rotta thinks kids should keep flying. After all, he notes, other modes of transport are much more dangerous. "There are about 100 children injured on airplanes each year. It's not a big number, but it's not negligible," he says.

And since so many of these injuries are preventable, he hopes the number will be even lower in the future.

Copyright 2016 NPR. To see more, visit NPR.
Categories: NPR Blogs

New Guidelines Acknowledge The Reality: Babies Do Sleep In Mom's Bed

NPR Health Blog - Tue, 10/25/2016 - 10:40am

This happens, pediatricians acknowledge. So they're offering advice on how to reduce the risk of bed sharing with infants, which includes removing loose bedding that could lead to suffocation.

PhotoAlto/Anne-Sophie Bost/Getty Images

It's a familiar scene for sleep-deprived parents everywhere: They put down the baby in the bassinet to sleep, and those tiny eyes flutter shut. Then they flutter back open and the crying starts. The only thing perhaps more harrowing than those long wakeful nights of a baby's first year is the fear that one day the child won't wake up.

A notable, if subtle, change in sleep guidelines released Monday from the American Academy of Pediatrics acknowledges the reality of those long nights and what parents should do if they can't always follow the guidelines to the letter. The goal is to reduce the risk of sleep deaths in babies.

"We recognize the fact that not only do mothers often inadvertently fall asleep with the infant in their bed, but many mothers choose to bed share," says Lori Feldman-Winter, a co-author of the new guidelines and a professor of pediatrics at Cooper University Health Care in Camden, N.J. "We thought it was prudent to provide guidance on making the bed-sharing arrangement as safe as possible and provide guidance on what populations are most at risk when bed sharing."

An estimated 3,500 infants die each year from deaths related to sleep. Together, these are called sudden unexpected infant deaths, which includes both sudden infant death syndrome (SIDS) and deaths from suffocation, asphyxiation, strangulation and other preventable deaths.

As before, relying on years of strong evidence about the risk factors for these deaths, the AAP recommends that infants be placed to sleep on their backs on a firm mattress in their own crib or bassinet, with no blankets, sheets, pillows, stuffed animals, crib bumpers, positioners or other items. The group recommends against parents and infants sharing a bed, sometimes called co-sleeping, because of a significantly increased risk of death from suffocation or other causes.

Bed sharing has been an area of controversy because some parents insist, contrary to the evidence, that it's safer than having an infant sleeping on a separate surface. Other parents feel they simply cannot get sleep without bed sharing.

The issue has been complicated by an incomplete and sometimes contradictory evidence base, making it difficult to tease out the risks of bed sharing compared to other risk factors. So the AAP hired an independent statistician to review studies that looked at similar data and came to slightly different conclusions.

"Upon further review of the available evidence, it is clear that we cannot safely recommend bed sharing because of the hazard," Lori Feldman-Winter says. "The hazards are particularly in infants under 4 months of age."

But she noted that several studies conducted since the last AAP recommendations have highlighted bed sharing's popularity both in the U.S. and abroad.

"I am pleased to see an acknowledgement that despite the clear, elevated, independent risk of bed-sharing with an infant, a high proportion of parents — even the most well-educated ones — end up bed-sharing with their babies, whether they intend to or not," says Daniel Flanders, a pediatrician in Toronto. "This doesn't make them bad parents; it simply reflects the fact that some medical recommendations are easier to follow than others."

The populations at greatest risk are those under 4 months old and those born premature or with a low birth weight. Putting a baby to sleep on his or her back as well as breast-feeding, routine immunizations and using a pacifier all reduce the risk of both SIDS and death during bed sharing, though none of those can eliminate the risk. Similarly, prenatal and postpartum smoking and parental use of alcohol, illicit drugs or medications causing drowsiness all increase the risk of infant sleep death, but abstaining from these cannot eliminate bed sharing risks.

"We hear a lot of myths — 'I'm not overweight, I'm not drunk, I'm not high, I'm breast-feeding, and therefore nothing bad is going to happen me,' " explains Elizabeth Murray, a pediatrician in emergency medicine at Golisano Children's Hospital in Rochester, N.Y.. Of the many resuscitations of infants she has attempted over the years, she says she hears the same thing from every parent: "We didn't think it was going to happen to us."

While the AAP continues to recommend against bed sharing, the statement also points out that the risks of sleeping together on a sofa or couch are far greater.

"When feeding occurs during the night, we recognize that mothers might be sleepy when they're feeding their baby, but if they fall asleep and the baby falls asleep with them, it's much more hazardous if they're feeding in the couch or an armchair than in the adult bed," Feldman-Winter says.

Previous studies have shown some sleep deaths occurred when parents took their baby to the living room to avoid bed sharing when they fed or calmed them, and then they fell asleep with the baby.

The updated recommendation, then, is that mothers feed their babies in bed and then place the baby on its own sleep surface afterward. If the mother falls asleep by accident, it's not as hazardous as it would be on a couch. When she wakes again, she should immediately place the baby back on its own bed, since the risk of death increases with the duration of bed sharing.

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Mothers who choose to bed share or who may accidentally fall asleep should also make sure they have a firm mattress — no pillow top, water bed or other non-firm surface — and remove pillows, comforters, blankets, loose sheets and anything from the infant's sleep area that could lead to suffocation or difficulty breathing. The bed should also be moved away from the wall so the infant cannot become trapped.

"Previous iterations of SIDS reduction guidelines have not really acknowledged the reality that for some families, it is virtually impossible to make it through the night without bringing baby into bed," Flanders says. This has led to a situation where parents feel ashamed or frustrated discussing their baby's sleep arrangements with their primary care doctors — and a missed opportunity to reduce risk.

"We make the statement for the first time that health care providers should first and foremost have open and nonjudgmental conversations with families about their individual preferences, sleep patterns, sleep environment and be able to have a dialogue about doing the best they can do," Feldman-Winter says.

Jaime Friedman, a pediatrician and partner at Children's Primary Care Medical Group, San Diego, Calif., is among the pediatricians welcoming this change.

"I think it's a sign, like they did with the media guidelines, that the AAP is more in tune with what's happening with parents," Friedman says. "You can look at the data and say this is the best thing to do, but if you're in the home, things are very different."

In addition to recommendations for those who end up bed sharing, the revised guidelines emphasize the importance of breast-feeding and skin-to-skin contact in reducing SIDS risk. A period of neurodevelopmental vulnerability is thought to be a major factor in SIDS, and skin-to-skin contact and breast-feeding both contribute to neurodevelopmental maturity and normal respiratory breathing patterns, Feldman-Winter explained.

In addition, breast-feeding reduces the risk of infections, and breast-feeding babies have different feeding patterns, sleeping patterns and sleep states, which may explain the reduced risk.

Another change in the guidelines is the recommendation that babies sleep in their own bed in their parents' room for at least their first six months, preferably up to one year. That recommendation comes from evidence that room-sharing reduces the risk of SIDS, but Friedman questions how realistic that is in practice.

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"I see families where they can't get the kid to go into the bassinet next to the bed because the baby wants to be in the bed with the parent," she says. "Sometimes that doesn't improve until they get the kid into their own room."

The recommendations reiterate that baby sleep monitors do not reduce the risk of SIDS. By contrast, regular prenatal care does reduce risk. They also emphasize that commercial devices sold in stores, including crib bumpers, are not recommended if they do not adhere to the safe sleep guidelines.

The most significant change, however, appears to be the shift in tone toward understanding parents who may not feel they can follow every recommendation.

"When parents feel comfortable and safe to discuss their baby's sleep environment with their physician, the chances of successfully catalyzing risk-reducing behaviors are maximized," Flanders says.

Tara Haelle is the co-author of The Informed Parent: A Science-Based Resource for Your Child's First Four Years. She's on Twitter: @tarahaelle

Copyright 2016 NPR. To see more, visit NPR.
Categories: NPR Blogs

A Noninvasive Colon Cancer Test That's FIT To Be Tried

NPR Health Blog - Mon, 10/24/2016 - 6:10pm

It would look pretty darned cute if you didn't know it's a colon cancer screening test.

Nancy Shute/NPR

Not so very long ago, colonoscopy was the gold standard for colon cancer screening. But times are a-changing. Last month when I went in for a checkup, my primary care doctor handed me a FIT test, a colon cancer test you can do at home without the unpleasantness and risk that turn people off to colonoscopy.

The FIT test, or fecal immunochemical blood test, is a newer and more accurate way to test for blood in stool, which can be a symptom of colon cancer.

In June, the U.S. Preventive Services Task Force, an influential independent panel, endorsed the FIT test along with two other forms of fecal blood tests, as well as virtual colonoscopy and two invasive tests, colonoscopy and sigmoidoscopy, as good ways to screen for colon cancer.

The task force didn't play favorites; rather, it emphasized that the goal was to get more people tested, since one-third of adults between 50 and 75 have never been screened for colon cancer. It's the third most common cancer in the U.S., killing about 50,000 people a year.

"The idea behind most guidelines is to promote all of the screening tests equally, with the idea that within reason patients prefer a choice," says Dr. David Weinberg, chairman of the department of medicine at Fox Chase Cancer Center and lead author of an opinion article published Monday in Annals of Internal Medicine.

Last week, a task force from three professional societies of gastroenterologists evaluated the evidence for the FIT test, which is used in Canada and many countries in Europe and Asia as the primary form of screening.

They looked at 19 studies and found that FIT identified people with cancer 79 percent of the time and those without cancer 94 percent of the time. The results were published in the American Journal of Gastroenterology.

They pointed out that the FIT test is better at detecting cancer than the older guaic fecal occult blood test, or gFOBT, which requires samples from three different bowel movements.

I can testify to the simplicity of the FIT test; if you like arts and crafts kits, you'll probably like the minute bottle with collection wand, which goes into a padded plastic bag, then an envelope and into the mail. Trust me, your hand will never touch poop.

A few weeks later I got a letter back from my doctor, saying I had passed the test. Woohoo!

But that's where the question of simpler, less invasive cancer screening gets complicated.

For FIT testing to be successful, you have to repeat it every year. And that means that you need a doctor who will give you the test every year, and who will make sure that if you test positive, you go get a colonoscopy to see what's up.

"It's the first step," says Dr. Douglas Robertson, chief of gastroenterology at the VA Medical Center in White River Junction, Vt., and a professor of medicine at Dartmouth's Geisel School of Medicine. "It really is important to realize that when the test is positive it does need a follow-up test."

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Integrated care systems like the VA and Kaiser Permanente are embracing FIT testing, in part because those systems are good at repeat testing and follow-up. It's easy to let screening fall through the cracks.

"If you're going to choose a noninvasive test like FIT you need to be committed to doing it annually," says Robertson, who was a lead author of the new gastroenterology guidelines.

And that circles back to one reason why American gastroenterologists liked colonoscopies in the first place: "It's one-stop shopping," Weinberg says. "If you have a precancerous polyp it almost always can be removed, and the interval between colonoscopies when appropriately selected is typically long."

The current recommendation for people of average risk is to have a colonoscopy every 10 years, from age 50 to about age 75. "You devote essentially 24 hours of your life to one every 10 years," Weinberg says. "That's a pretty good deal."

The FIT test is a good test, Weinberg says, and it should be offered enthusiastically. "But at least at the primary care level, some challenges exist."

So is FIT as good as colonoscopy? "That's a really important question that doesn't have a definitive answer," Robertson says. He's a leader of the CONFIRM trial, which will compare FIT tests to colonoscopy in 50,000 people in the VA health care system. "The good news is we're underway with the trial," he says. "The bad news is the result won't be available for over a decade.

So for now the FIT-vs.-scope decision will be, like so many decisions in health care, a complex question of access, cost, convenience and personal preference. In this case, at least, the options look pretty good.

Copyright 2016 NPR. To see more, visit NPR.
Categories: NPR Blogs

Rates Up 22 Percent For Obamacare Plans, But Subsidies Rise, Too

NPR Health Blog - Mon, 10/24/2016 - 5:01pm
Rates Up 22 Percent For Obamacare Plans, But Subsidies Rise, Too Listen · 3:56 3:56 Toggle more options
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October 24, 20165:01 PM ET Heard on All Things Considered

You can check for health insurance options and prices.

Andrew Harnik/AP

The cost of health insurance under the Affordable Care Act is expected to rise an average of 22 percent in 2017, according to information released by the Obama administration Monday afternoon.

Still, federal subsidies will also rise, meaning that few people are likely to have to pay the full cost after the rate increases to get insurance coverage.

"We think they will ultimately be surprised by the affordability of the premiums, because the tax credits track with the increases in premiums," said Kevin Griffis, assistant secretary for public affairs at the Department of Health and Human Services.

The 22 percent rise reflects the average for all insurance marketplaces, both federal and state-based exchanges for which data are available. For insurance purchased through the federal exchange the rise will average 25 percent.

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During a media briefing Monday, Griffis said the 2017 rates are roughly at the level the Congressional Budget Office forecast when the law was proposed. "The initial marketplace rates came in below costs," he said. "Many companies set prices that turned out to be too low."

Enrollment opens Nov. 1. For coverage effective Jan. 1, people need to pick a plan by Dec. 15. With a few exceptions, the last day to sign up for Obamacare is Jan. 31, 2017. Plans are available on and state-run exchanges.

While the average premiums on the benchmark health plans are increasing, the government says more than 70 percent of people buying insurance on the marketplaces created by the law could get a health plan for less than $75 a month for 2017. To get the best deal, people would have to pick a low-cost plan with limited benefits and take advantage of all the subsidies available.

People who already have coverage through the exchanges can often save money by switching plans, the administration said. More than three-quarters of people could save money by switching to the lowest-cost plan within the level of coverage, such as bronze or silver, that they've previously selected.

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The Obamacare insurance exchanges are under strain after three major insurers pulled back from offering coverage in markets across the U.S. The administration says about 1 in 5 people buying insurance through the marketplaces will have only one company offering coverage.

It's in places like that where consumers will feel the most pain. "Where it really matters is where a big insurance company has exited and where that's going to leave just one company remaining," said Cynthia Cox, associate director of health reform and private insurance at the Kaiser Family Foundation. "For those people who live in that area, many people may have to switch plans. And they won't have much choice if they want to receive financial assistance and purchase through the exchanges."

Copyright 2016 NPR. To see more, visit NPR.
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Manic And Depressed, 'I Didn't Like Who I Was,' Says Comic Chris Gethard

NPR Health Blog - Mon, 10/24/2016 - 1:38pm
Manic And Depressed, 'I Didn't Like Who I Was,' Says Comic Chris Gethard Listen · 43:31 43:31 Toggle more options
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October 24, 20161:38 PM ET Heard on Fresh Air

Chris Gethard co-stars in Comedy Central's Broad City and in Mike Birbiglia's film Don't Think Twice. His one-man show, Career Suicide, details his experiences with depression.

Atisha Paulson/Chris Gethard

Comic Chris Gethard knows what it's like to feel hopeless and alone. He tells Fresh Air's Terry Gross that he has experienced depression so severe that it led to suicidal thoughts. "I didn't like who I was," he says. "I spent a lot of my life regretting who I was, which is a sad thing to say."

Gethard relives some of his darkest moments in the one-man show, Career Suicide, which is billed as "a new comedy about suicide, depression, alcoholism, and all the other funniest parts of life."

The show was inspired by a conversation about depression with his friend comic and filmmaker Mike Birbiglia, during which Gethard admitted to once crashing a car on purpose. "I thought [Birbiglia] was going to be really sad, and he goes, ... 'If you can get up on stage and make that funny, you've got something really special on your hands,' " Gethard says. "And I'm kind of driven by having a chip on my shoulder, so I was like, 'All right, I'll do it!' "

Career Suicide opened off-Broadway in early October, and Gethard says his stories of hitting rock bottom have resonated with audiences. "A lot of people ... tell me they identified with them or knew people in their family who dealt with that stuff," he says.

Interview Highlights

On what being suicidal and depressed felt like

I can only speak to my experience, but ... for me, when things were ... worst, I truly felt like I was broken in some way. Also, [I] could not figure out how to explain that to anyone in a way that made sense, and that any effort I ever made to try to help myself or reach out to other people who could help me made it more isolating.

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It was very, like, quicksand-feeling, of like, This is only getting worse, I don't know how to stop it. I feel totally alone, I wake up feeling not just sad but a profound level of isolated sadness and the more I try to climb out of it, the worse it gets.

In a certain way an analogy would be like a spotlight just getting smaller and smaller and smaller and [having] less room to breathe, less places to go, just less light in general. I know that's a little bit of a fanciful answer, but I think the other thing to keep in mind is the inability to explain it is also one of the things that's so terrifying and isolating in its own right.

On how thinking about his parents kept him from hurting himself

Having dealt with depression since a young age, there's been a handful of things like that where I've found something to hold on to and protecting my parents was actually a really big one. ... [I thought] about people like my parents and a handful of friends, girlfriends along the way, where you think about how's it going to affect those other people.

That was something that kept me hanging on from time to time. Ultimately though, being largely on the other side of it now, I needed to, I think, stop hanging that on other people and eventually learn how to kind of deal with myself and fix things for myself.

On how medication helped his creative work

Gethard says that therapy and medication help him cope with his depression.

Clay Anderson/Chris Gethard

It really helped. The whole romanticized "sad clown" thing, we gotta get rid of that. That has to go! That's just getting sick people to voluntarily stay sicker and sadder than they have to be.

For me, I took medication and there's a few things. A: My ideas weren't born out of mania anymore. I very classically would go into manic phases, which were as dangerous, if not more so, than the depressed phases, and I think I'd come up with the best ideas I ever had and then the next day I'd look at them and be like, "This is nonsense," because it was born out of a manic episode. What a waste of time.

And then on top of that, being medicated means that I can get out of bed consistently, I can do second drafts, I can keep things organized. I'm not giving into all sorts of impulsive behavior, like I can sit down and work and get things done. Both creatively and organizationally, being medicated has helped me immensely.

My career did not start until I was medicated. I can track the years I was off medication things dipped, and the years I went back on medication is when things started to get good for me again careerwise. It is 100 percent, in my case, undeniable that being medicated helped my creativity.

On learning that some of his family members suffered from mental illness

I'm so flummoxed that this stuff is so stigmatized and viewed as so shameful that we hide it, and then what happens is that cycle perpetuates. In my case it did. I think if I knew my grandfather had been sick I think maybe I would've been able to say to somebody sooner, "Hey, I want to know what happened to my grandpa, because I think it's happening to me." I didn't even know that was a sentence I had the option of saying until after things had hit rock bottom. ...

Shots - Health News Sarah Silverman Opens Up About Depression, Comedy And Troublemaking

The amount of times I was told to "toughen up" or "stop being a baby," when in reality what I needed was years of therapy and a litany of antidepressants, I think, yes, knowing there's a genetic component would've maybe helped me feel less like a baby and more like a sick person.

On the manic episodes he experienced

Depression — people know what that looks like, at the very least, even if they're not comfortable talking about it. When you see somebody who can't get off a couch and can't stop crying or is just visibly dismal, at least that's identifiable.

The manic side of things, I'd be the life of the party! Let's stay up all night! Let's do crazy things! Let's wind up in a different city than we started in! A lot of things like that that seem really fun but ... I'd wind up hanging out with a lot of strangers, because the people closest to me would always smell a rat and say, "What is going on? This is not you."

And then you come out on the other side of that and you've invariably made some decisions you're not proud of, and have some rebuilding to do. For me, the manic side [is] much scarier, because it can be really fun. People like being around it, but that doesn't mean it's healthy.

On The Chris Gethard Show on Fusion TV, which shows more of his manic side

I get to just be who I am. I get to be like the king of the Island of Misfit Toys on that show. ... The Chris Gethard Show is a very conscious environment where I go, "I'm not going to try to fit in. Instead, I'm going to be this manic oddball and see what happens with that."

The very cool thing about that show is it attracted all the other manic, oddball kids from blue-collar areas who felt like they don't have a right to be creative and it built a community of all those people.

On a temporary writing gig at Saturday Night Live and how it didn't make him happy, even though it was his dream

The trap I fell into was that I spent so many years convincing myself that career success was going to be the validation that would change me, and that was never going to happen.

At the time I was living in a room in Woodside, Queens, with no closet and the gas was disconnected, because I forgot to pay the bill, and no job is going to change the fact that I don't have it together. ...

No amount of money or validation or other people's perceptions of your success is going to change the fact that I didn't have it together, I couldn't live a totally functioning life at the time, because I was a messed up guy and I really regret how much time I wasted thinking achievements that other people can see are going to heal me. No, they were never going to heal me. I needed to buckle down and get into therapy and do the work.

Copyright 2016 Fresh Air. To see more, visit Fresh Air.
Categories: NPR Blogs

Getting Dental Care Can Be A Challenge For People With Disabilities

NPR Health Blog - Mon, 10/24/2016 - 4:37am
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October 24, 20164:37 AM ET Heard on Morning Edition

Beth Rown (right), a dental hygenist who cares for patients with special needs, cleans Lindsay Klecker's teeth.

Alison Kodjak/NPR

At the Marshfield Clinic dental center in Chippewa Falls, Wis., hygienist Karen Eslinger is getting her room ready. It's all quite routine — covering the chair's headrest with plastic, opening instruments, wiping down trays.

But then she starts getting creative.

"My next patient is pretty tiny and frail, so I like to go to oral surgery and get a heated blanket. I wrap her up, and I think it soothes her," Eslinger says.

The patient is 16-year-old Kathy Falk. She has Rett syndrome, which is a genetic disorder with a constellation of symptoms that look like cerebral palsy, Parkinson's, anxiety and autism all wrapped up together. She uses a wheelchair, can't speak and would find it difficult holding her mouth open for long stretches.

Kathy's parents lift her from her wheelchair into the dental chair. Eslinger swaddles her in the warmed blanket and fits her with tiger-striped sunglasses to block the glaring light. She narrates the entire cleaning, telling Kathy everything she's about to do, interspersed with words of encouragement.

"She's challenging to get the toothbrush in here and we can only ask so much, you know; whatever she tolerates," Eslinger says as she's bent over Kathy with an electric toothbrush. "You're doing the best you can."

For someone with severe disabilities like Kathy, Eslinger and this clinic are quite a find. They welcome patients with all kinds of physical and behavioral disabilities.

People with disabilities are often insured through Medicaid, the federal health care program for the poor and disabled. The program doesn't always pay for dental care, and when it does, those payments often fall short of the costs.

That means it can be hard to find a dentist willing and able to do the work.

Dentists and hygienists at the Marshfield Clinic take people with Medicaid and people without any insurance. They specialize in caring for people with disabilities who need extra help to get through a checkup and cleaning. Some patients with autism may be afraid of lights, sounds or touch. Some with physical disabilities may be unable to hold their head in place.

"I have a patient who comes in, and before she gets in the chair we read some books, and then she gets a little calmer and stops crying and we can do a little more of the cleaning," Eslinger says. The patient is in her 30s.

A patient with Down syndrome was so frightened that Eslinger started off cleaning his teeth in the lobby. Each appointment moved closer to the treatment room, until finally she persuaded him to get into the chair.

The work is also quite physical, says Beth Rowan, another hygienist at the clinic who cares for special needs patients.

She's down the hall from Eslinger, cleaning the teeth of Lindsay Klecker, a 31-year-old woman with cerebral palsy and a seizure disorder. Lindsay is blind and uses a wheelchair. Her mother says she functions at the level of a toddler.

Rowan leans over Lindsay, working to floss her teeth while her mother stands at her head, singing to her throughout the cleaning.

Sandra Klecker sings to her daughter Lindsay to help her stay calm through the cleaning.

Alison Kodjak/NPR

"It's hard on your body; they're strong," Rowan says. "They're pulling and tugging, their head is strong, their lips are strong, their tongue is strong."

For invasive procedures like fillings or root canals, the dentists at the Marshfield Clinic go across the street to St. Joseph's Hospital, where patients can be treated in an operating room under full anesthesia.

"There's a certain percentage of the population that absolutely requires having anesthesia for their dental care to be safe," says John Morgan, a professor in the division of special care at Tufts University School of Dental Medicine. Tufts runs a chain of clinics across Massachusetts that cares for people with disabilities.

Morgan is lead author of a 2012 study published in the Journal of the American Dental Association that shows that people with disabilities have worse oral health than the general population.

"Access to dental care is one part of the issue, but there's also the issue of what happens at home; what can be done to help improve maintenance of oral health in the home environment," Morgan says.

Kathy's mother, Arla Falk, says they tried several dentists before finding the clinic in Chippewa Falls. It's 45 minutes from their home, and they come four times a year.

"To have a dentist who would be willing to take medical assistance is a challenge," she says. "We've been to several with her. One of them didn't even want to take her on or keep her as a patient."

Three of the Marshfield clinics specialize in serving people with disabilities, and they serve more than 1,700 patients with disabilities a year.

"We do have patients that come as far as three, four hours away for a cleaning appointment or for their initial appointment," Rowan, the hygienist, says. "Then they'll have their one to two hours of care and they'll have to drive back, because there isn't anything in their surrounding area."

Two years ago, the only clinic in Madison, Wisconsin's capital, that provided dental care under anesthesia shut down because the hospital, Meriter UnityPoint Health, said it was losing more than $600,000 annually on providing dental care. It reopened this month under an agreement with two other hospitals in the city to share costs.

While the clinic was closed, Meriter officials referred the patients to the University of Minnesota, four hours away.

Jeffrey Karp, a professor at the University of Minnesota School of Dentistry who cares for children with disabilities, says he's not surprised.

"We do receive patients who come to us from Wisconsin; also from the Dakotas and parts of Iowa as well," Karp says. "There are not a lot of resources and obviously, you do need to travel larger distances to find those resources."

Karp has a grant to identify hospitals, clinics and dentists across the country that care for people with disabilities. The goal is to create networks of providers who have a commitment to providing dental care to people with disabilities despite the cost.

Greg Nycz, executive director of the dental clinics in the Marshfield Clinic network, says they get most of their costs reimbursed by Medicaid through a special provision that allows clinics that cater only to the poor to get bigger reimbursements than regular dentists.

But St. Joseph's Hospital and two others that Marshfield works with don't benefit from that. "Because we only have poor patients and patients on public assistance, this is a sacrifice for these hospitals," Nycz says. He says he's angry that large for-profit hospitals often won't make the same commitment.

Back at the clinic in Chippewa Falls, Kathy Falk has had enough. She's becoming agitated and gurgles a bit. Eslinger finishes up.

"We are all done with the cleaning," Eslinger says. "Ah, we got toothpaste everywhere, didn't we?"

Down the hall, Rowan compliments Lindsay Klecker's mother, Sandra.

"You are doing such a great job caring for her teeth," she says. "She's lucky to have had them as long as she has."

Copyright 2016 NPR. To see more, visit NPR.
Categories: NPR Blogs

Can Mental Illness Be Prevented In The Womb?

NPR Health Blog - Sat, 10/22/2016 - 6:00am
Katherine Streeter for NPR

Every day in the United States, millions of expectant mothers take a prenatal vitamin on the advice of their doctor.

The counsel typically comes with physical health in mind: folic acid to help avoid fetal spinal cord problems; iodine to spur healthy brain development; calcium to be bound like molecular Legos into diminutive baby bones.

But what about a child's future mental health? Questions about whether ADHD might arise a few years down the road or whether schizophrenia could crop up in young adulthood tend to be overshadowed by more immediate parental anxieties. As a friend with a newborn daughter recently fretted over lunch, "I'm just trying not to drop her!"

Yet much as pediatricians administer childhood vaccines to guard against future infections, some psychiatrists now are thinking about how to shift their treatment-centric discipline toward one that also deals in early prevention.

In 2013, University of Colorado psychiatrist Robert Freedman and colleagues recruited 100 healthy, pregnant women from greater Denver to study whether giving the B vitamin choline during pregnancy would enhance brain growth in the developing fetus.

The moms-to-be were randomly given either a placebo or a form of choline called phosphatidylcholine. Choline itself is broken down by bacteria in the gut; by giving it in this related form the supplement can more effectively be absorbed into the bloodstream.

Those in the treatment group received 3,600 milligrams of phosphatidylcholine in the morning and 2,700 milligrams at night. Since phosphatidylcholine is roughly 13-15 percent choline, the amount the women received was about 900 milligrams of choline a day, twice that recommended by the Health and Medicine Division of the National Academies (and about the same amount contained in three large eggs).

The Salt Can Mom's Pregnancy Diet Rewire Baby's Brain For Obesity?

After birth, infants were given either 100 milligrams of liquid phosphatidylcholine or placebo once a day for approximately three months. Given that both groups were also getting choline from regular feeding, the dose ensured that those supplemented received well over the Institute of Medicine's guideline that infants receive at least 125 milligrams a day.

At 5 weeks old, the children were exposed to a series of clicking sounds in the lab while their brain activity was monitored by electroencephalogram, or EEG, a method for recording electrical brain activity via electrodes placed on the scalp. Normally, when exposed to the same sound successively, both infant and adult brains will exhibit "inhibition," or a far weaker pulse of activity in response to the second sound. We realize that the now familiar tone is insignificant; our brains are unmoved.

However, in some kids this inhibition doesn't occur — a finding linked with an increased risk for attention problems, social withdrawal and, later in life, schizophrenia.

The results published in 2013 in the American Journal of Psychiatry by Freedman's group show that 76 percent of newborns whose mothers received choline supplements had normal inhibition to the sound stimuli. The proportion fell to 43 percent in those born to mothers who didn't get them. It appeared that choline might steer the infant brain away from a developmental course that predicted mental health problems.

A follow-up study at 40 months found that the children who had received choline supplements in utero and after birth had fewer attention problems and less social withdrawal.

Excessive choline consumption — or that over 7,500 milligrams a day — has been associated with drops in blood pressure, sweating, gastrointestinal side effects and a "fishy" body odor. Most American diets contain a significant amount of choline, and supplementation to optimal levels poses no known side effects or risk to fetal development, Freedman says.

A genetic theory

One of the first genes to be linked to schizophrenia goes by the catchy name "CHRNA7." Normally it encodes for a receptor on neurons in the brain that respond to the neurotransmitter acetylcholine as well as nicotine, a transmission essential to normal brain function and cognition. Genetic mutations in the CHRNA7 gene cause decreased levels of the neuronal receptor to be produced in people with schizophrenia.

A light bulb glowed for Freedman.

And the idea, he admits, is rather simple when you think about it: Choline is known to be essential to brain development and function and is also frequently deficient in pregnant women.

Couple these facts with animal and human research by Freedman and his colleagues showing that choline in the amniotic fluid also activates the CHRNA7 receptor in the developing fetal brain.

"It occurred to us that just as folic acid can help overcome defects in brain and spinal cord development, perhaps supplementing mothers with choline could help prevent mental illness," Freedman recalls. "And now that the children in our study are over 4 years old, we can see that those given the supplement appear to be on a different developmental track, one with fewer mental problems."

Moreover, though experimental psychosis treatments targeting the CHRNA7 gene and the receptor it codes for are being explored by other researchers, Freedman explains that levels of the receptor peak in the fetal brain and diminish after birth. "We realized the optimal time to try this intervention is during pregnancy," he says.

Though choline is available in a number of foods — eggs, seafood and liver are particularly rich in the nutrient — Freedman's work suggests that for many women, dietary sources may be inadequate during pregnancy. Also, prenatal supplements tend not to include it.

The Salt Nutrition In 'The First 1,000 Days' Of Life Can Shape A Child's Future

Two past observational studies — conducted with diet questionnaires rather than the more rigorous placebo-controlled supplementation Freedman's group tried — also found beneficial effects associated with higher maternal choline intake during pregnancy. At 7 years of age, children of moms consuming over 400 milligrams of choline a day performed better on memory and intelligence tests. At 18 months, infants whose mothers had higher blood levels of choline had significantly higher cognitive test scores.

Dr. Steve Zeisel of the University of North Carolina was one of the first doctors to strongly advocate for choline supplementation in pregnancy. In 2012, Zeisel published the only other placebo-controlled trial of the vitamin in pregnant moms. While he did not assess for future mental health risks, the findings suggested that choline supplementation did not enhance infant cognitive function at 1 year of age. However, Freedman point outs that all of the women included in the trial were highly educated and were found to have blood metabolites reflecting diets high in healthful, choline-containing foods.

The prospects of choline supplementation in pregnancy have piqued medical interest, but also notes of caution. "I think the choline research is really intriguing, and we're starting to investigate maternal choline levels as well," says Catherine Monk, an associate professor in psychiatry and obstetrics and gynecology at Columbia University Medical Center. "Some prenatal vitamins do contain it and foods rich in choline are readily available. But we have a lot more research to do before we start recommending it widely."

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In general, evidence-based interventions during pregnancy and early childhood to prevent mental illness are scant. Yet there are some modifiable risk factors that might make a difference, many of which focus on improving maternal wellbeing.

Monk's own research explores on the impact of an expecting mother's emotional state on the developing fetus. She and others have shown that stress, depression and anxiety during pregnancy increase a child's risk for ADHD, conduct disorders and depression later in life. At Columbia, Monk and her colleagues employ a program Practical Resources for Effective Postpartum Parenting, or PREPP, in which pregnant women who are distressed and at high-risk for postpartum depression are counseled and taught coping skills to make pregnancy and parenting more manageable emotionally.

Optimal nutrition, including choline and adequate amounts of zinc and omega-3 fatty acids, may also have developmental and mental health benefits as might avoiding smoking.

The future of funding

Despite incomplete data on choline supplementation, Freedman's research colleague Dr. Camille Hoffman-Shuler, an obstetrician, sees it as a promising intervention that should continue to be explored.

"Obstetricians and midwives are not widely aware of choline supplementation," she says. "But I do recommend it to pregnant women, especially if they have other mental health vulnerabilities. And I'd personally want it with a future pregnancy based on existing data."

Both Freedman and Hoffman-Shuler hope to continue choline research, yet decry the obstacles to securing the money to do it.

"The NIH is currently funding no trials of any intervention in humans during pregnancy to prevent mental illness," says Freedman, "yet ideally we'd follow these children for another 20 to 25 years to see if they develop mental illness. This is beyond the scope of most imaginable — and fundable — experiments."

Hoffman-Shuler is prepared to do what it takes. "The hardest part is getting this across to the funding agencies and the public," she says. But this is a serious public health issue in which prevention during pregnancy is far more preferable to the loss of health and consequences that come with mental illness!"

Bret Stetka is a writer based in New York and an editorial director at Medscape. His work has appeared in Wired, Scientific American and on The He graduated from University of Virginia School of Medicine in 2005. You can follow him on Twitter: @BretStetka.

Copyright 2016 NPR. To see more, visit NPR.
Categories: NPR Blogs

No Snapchat In The Bedroom? An Online Tool To Manage Kids' Media Use

NPR Health Blog - Fri, 10/21/2016 - 12:03am
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October 21, 201612:03 AM ET Heard on All Things Considered

Pediatricians realize parents need strategies beyond "Put down that phone!"

Jiangang Wang/Moment Editorial/Getty Images

Whether your kid is 3 and obsessed with Daniel Tiger videos or 15 and spending half her conscious hours on Snapchat, you are probably somewhat conflicted about how to think about their media habits.

How much time? What kind of media? What should our family's rules be?

When the American Academy of Pediatrics released its latest recommendations on these burning questions Friday, it also did something pretty cool: it launched an online tool that parents can use to create their own family media plan.

The interactive tool lets you set guidelines for each child, with suggested items based on the AAP's age-specific recommendations and space to add or substitute your own family's rules. At the end, you can print out a document that lays out your family's own media policy.

I went through the process for my 4-year-old daughter a few days ago. It took about five minutes to indicate the screen-free areas and times in our household, specify our device curfews and where they will recharge, how we will watch media with our daughter, what kind of media we'll avoid (unboxing videos) and answer other questions.

We've certainly had some of these rules in vague form floating around in our heads, but it helps to have something concrete to remind us that there are no screens allowed at the dining room table, in my daughter's bedroom, in the stroller or in the bathroom (No iPotty for us, thanks.)

Our plan also includes a list of things we can do more of by decreasing time spent with media, like coloring, going to the library and playing outside. It reminds us about digital safety rules, like reviewing privacy settings on sites our kid may use. And by making these the family's rules, it reminds my husband and me that we need to set a good example ourselves by putting our devices aside at the agreed-upon times and places. (I haven't had a chance to run it by my kid yet, but that's on my list for the weekend.)

It's not that a printout is going to automatically change behavior, says Jenny Radesky, a developmental pediatrician at the University of Michigan's C.S. Mott Children's Hospital and lead author of the AAP's policy statement on media use for young children. But it helps parents lay out their values in advance rather than simply reacting to the latest app or platform.

The AAP's updated recommendations are more nuanced than in the past, when the group discouraged any digital media use for children under 2 and recommended limiting screen time to two hours or less for those older than that.

Those lines in the sand are "too simplistic," says Ari Brown, a pediatrician in private practice in Austin, Texas, and a former member of the AAP's Council on Communications and Media. (She wasn't involved in writing these latest guidelines.)

NPR Ed American Academy Of Pediatrics Lifts 'No Screens Under 2' Rule

(NPR Ed lead education blogger Anya Kamenetz explains what we know about media use and learning in very young children here.)

In fact, the recommendations for elementary school-aged kids and teens don't set any specific time limit. The AAP says that's a decision that depends on the type of media being used and the child using them.

But they do say that children and teens' priority should be getting enough physical activity (one hour per day), and sleep (8-12 hours). They recommend that kids not sleep with devices in their room, and that they avoid exposure for one hour before bedtime, since that can disrupt sleep.

And they make it clear that parents have a huge role in their children' media use, even when they're teenagers. Parents should talk about online citizenship and safety, form a network of trusted adults their kids can engage with on social media, and take an active role in selecting and watching media with their children.

So-called "co-viewing" is crucial for younger children. "It should be like reading a book together," says Georgene Troseth, an associate professor of psychology at Vanderbilt University. "You should be talking about what you're watching." As with books, the goal is to help children compare what they're watching to the real world. That's a valuable skill to work on, since "that's how adults use media: we use it to get information or to be entertained," she says.

Shots - Health News Trying To Get The Kids To Put Down Those Phones? Here's Help

Still, the AAP says that parents shouldn't feel pressured to buy apps or gadgets because they think kids will be left behind. (They're intuitive enough so that they'll pick them up quickly whenever they start.) "Your kid doesn't know how to do a Google search when they enter kindergarten," says Brown.

The bottom line: Your family's media policy should be informed by your own values and intuition as well as what the science says.

"I want parents to trust their gut," says Radesky. "If they're sitting with a child [using media] and the child is liking it and seeming to be learning something, that kind of a test is totally great." And if you decide you'd rather ditch all devices in your house, that's fine too. "We support that 100 percent," she says. "Your child is not missing out on anything."

Katherine Hobson is a freelance health and science writer based in Brooklyn, N.Y. She's on Twitter: @katherinehobson.

Copyright 2016 NPR. To see more, visit NPR.
Categories: NPR Blogs

Will A Study Save Victims Of Violence, Or Gamble With Their Lives?

NPR Health Blog - Thu, 10/20/2016 - 4:14pm
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October 20, 20164:14 PM ET Heard on All Things Considered


An ambulance pulls out of the emergency entrance at Temple University Hospital in North Philadelphia.

Brad Larrison for NewsWorks

Dr. Zoe Maher has never been busier. In addition to being a trauma surgeon and a new mom, she's spent the last year and half talking to hospital patients and community groups across Philadelphia about a study she's confident will save more adult gunshot and stab wound victims.

On a recent Saturday morning, Maher stood before a dozen members of a North Philadelphia neighborhood association to walk them through the specifics of the Philadelphia Immediate Transport in Penetrating Trauma Trial. At the heart of the study is a simple but counterintuitive idea. For patients who are potentially bleeding to death, Maher and her colleagues say, just basic care is better until they reach the hospital.

To test this, patients in the study would get different medical attention based on the dispatch number city paramedics receive – what's called a randomized study.

"It's like the flip of a coin if patients are getting advanced or basic," said Maher, who works at Temple University Hospital.

Odd numbers will get what's called advanced care, which is what the majority of patients transported by paramedics get now. It includes inserting a breathing tube or supplying intravenous fluids.

Even numbers will get what's known as basic care, which can include hemorrhage control, breathing assistance with a bag-valve mask, dressing wounds and aligning bones. They would then be immediately transported to the hospital.

But the idea of assigning types of care randomly got mixed reviews at the community meeting in North Philadelphia.

Joanne Taylor was wary, but, like nearly everyone in the room, she has first-hand experience with gun violence. She said she is mourning a husband, son, grandson and cousin, so she's willing to support anything that may save more lives.

"It shakes me up a little bit, but I know something has to be done somewhere," said a teary-eyed Taylor afterwards.

Dr. Zoe Maher interviews a shooting victim at Temple University Hospital for a citywide study of care of violent trauma victims.

Emma Lee/WHYY

Others had more trepidation.

"In the interim, you're still sacrificing people, somebody," said Charles Lanier.

Yanitza Gonzalez, a staffer with City Councilwoman Maria Quinones-Sanchez, nodded from across the room.

"It almost seems like we'll be gambling with people's lives," said Gonzalez.

Community buy-in is key for Maher. She wants to tell as many people about the study before patients are enrolled, potentially this fall, and she told them residents can opt out.

Maher has heard the gambling response before, but she's convinced that her study is closer to a sure thing. She said previous research has proven as much, and that her trial is just about confirming those results.

The study would look only at use of IV fluids and breathing tubes, explained Maher.

That's because if someone is shot or stabbed and bleeding to death, the body instinctively tries save itself by constricting blood vessels and forming clots. For those clots to stick, the body needs to maintain a lower-than-normal blood pressure. IV fluids can raise a patient's blood pressure and potentially cause more internal bleeding.

Maher said a breathing tube could also be problematic and cardiopulmonary resuscitation or CPR is a better option because it keeps more blood moving from the heart to the rest of the body.

On average, about 30 percent of patients who would qualify for this study die. If basic care becomes the norm for paramedics in Philadelphia, Maher says the rate could get down to roughly 20 percent. In a city that routinely records 250-plus murders each year, that could potentially mean a lot of lives being saved.

Dr. Brent Myers, president-elect of the National Association of EMS Physicians, said that would be a big deal for medical professionals, especially paramedics.

"This has been one of the great questions, is how much advanced life support is beneficial for victims of penetrating trauma. You could probably go to any paramedic in any city in the United States and engage in a debate, because we just don't have the appropriate evidence to guide the decision," said Myers.

It's part of why Myers said he wouldn't expect a lot of grousing from paramedics, even though it will effectively dictate what they do in the field.

Dr. Amy McGuire, a medical ethicist at Baylor College of Medicine in Texas, said while the study does carry some risk for patients, there's nothing inherently unethical it.

"The only way to really know whether this is better or not is to do a randomized trial and to compare it to what is currently the standard of care," McGuire said.

Where she does see some moral gray area is in the community outreach piece of the trial. It's impossible for everyone in the city to know about the study before it gets underway.

"They'll be enrolled in the study, and they may not have wanted to have participated," said McGuire.

Every resident in Philadelphia is a potential enrollee in the study, all 1.5 million people. But residents can choose to not participate. They would get a wristband that they'd have to wear for the duration of the study, which is expected to last five years, maybe more.

Researchers hope to enroll roughly 1,000 patients, half of whom would get advanced care, half would get basic care. Anyone who is under 18, pregnant or a prisoner will be excluded.

Maher said the study would end early if it's clear that one kind of care is doing more harm than good.

"All of the evidence points to us being right, but if we are wrong, we will not complete the study," said Maher. "We surely don't want to hurt anyone."

Every trauma center in the city is participating. That includes: Temple University Hospital, Hospital of the University of Pennsylvania, Hahnemann University Hospital, Thomas Jefferson University Hospital, Albert Einstein Medical Center, Aria Health Torresdale, and City of Philadelphia Fire Rescue.

This story is part of a reporting partnership with NPR, WHYY's health show The Pulse and Kaiser Health News.

Copyright 2016 WHYY, Inc.. To see more, visit WHYY, Inc..
Categories: NPR Blogs

STD Infections Rise To New Highs After States Close Health Clinics

NPR Health Blog - Thu, 10/20/2016 - 3:33pm

The bacteria that causes gonorrhea can cause infertility in women and men.

BSIP/UIG via Getty Images

The number of people infected with three major sexually transmitted diseases is at an all-time high, according to a CDC report released Wednesday. And the increase in reported cases of chlamydia, gonorrhea and syphilis is hitting teenagers and young adults hardest.

Over half of gonorrhea and chlamydia cases are in people under the age of 25, says Dr. Jonathan Mermin, director of the National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention for the CDC.

These STDs can have serious long term health consequences, including chronic pain and fertility problems. Pregnant women can pass syphilis on to their children, leading to stillbirth or birth defects.

State and local budget cuts to STD care and prevention programs are major drivers in the surge in STDs, Mermin says. "Our ability to prevent STDs is only as strong as the public health infrastructure to support it," he says. "More than half of state and local STD programs have experienced budget cuts. In 2012, 20 health departments reported having to close their STD clinics."

Syphilis infections have been increasing at a particularly troubling rate, according to the report. In 2015, 23,872 cases were reported, a 19 percent increase since 2014. Syphilis cases have been going up over the past decade, while the spike in cases of chlamydia and gonorrhea is more recent. There were 395,216 cases of gonorrhea in 2015, for an increase of 13 percent, and 1.5 million cases of chlamydia, for an increase of 6 percent.

All three infections can be treated with antibiotics, though gonorrhea is becoming increasingly resistant to antibiotics.

"This basically tells us we have to do a better job of reach out to some of these communities that are disproportionately affected by these infections," says Dr. Jose Bazan, a medical director for an STD clinic at Columbus Public Health and an assistant professor of internal medicine at Ohio State University who was not involved with the report.

Shots - Health News More Babies In The U.S. Are Dying Because Of Congenital Syphilis

Men who have sex with men face a greater risk of being infected with syphilis. Over 80 percent of male syphilis cases were reported among gay and bisexual males, and over 90 percent of all syphilis cases were in men. People in racial and sexual minority groups can have more than the usual trouble finding care for preventing and treating STDs.

According to a congressional briefing last April by Dr. Gail Bolan, the director for the CDC Division of STD Prevention, over 40 percent of health departments reduced clinic hours, screening, or tracing people who may have been infected. "If that infrastructure gets eroded, people are more likely to have their STDs for a longer period of time, and that can lead to increased transmission," Mermin says.

The federal government also helps fund state and local STD programs through the CDC, but federal funds have not helped make up for some of the budget cuts on the local level, according to David Harvey, the executive director for the National Coalition of STD Directors. "We believe there's a direct relationship between budget cuts and increases in STDs in the United States. There has been no federal increases for STD programs in this country since 2003," he says.

If the trend is to be reversed, Mermin says there needs to be a real investment in STD prevention so that clinics can monitor these diseases and quickly diagnose and treat people who are infected. "We've seen success in the past where investments have paid off," he says. "We know what we need to do. We just need to do it more effectively than we've been able to do with this eroding infrastructure."

Copyright 2016 NPR. To see more, visit NPR.
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When A Fainting Spell Is Caused By A Serious Blood Clot

NPR Health Blog - Thu, 10/20/2016 - 1:43pm

A fainting episode, though usually no big deal, can sometimes be caused by a blood clot.

Whisson/Jordan/Getty Images

Unexplained fainting episodes may be caused by a dangerous blood clot in the lung more frequently than many doctors suspect, according to an Italian study.

Episodes of fainting (known as syncope) are quite common in elderly people. About half the time, doctors identify an underlying heart condition. Other cases are caused by shock or some other passing cause. But many cases remain mysterious.

Doctors in Italy decided to see how often these fainting spells were caused by blood clots in the lung, known as pulmonary embolisms. These clots usually dislodge from a leg and get jammed in the lung, with potentially deadly consequences.

Blood clots are on the list of conditions that doctors are supposed to consider when figuring out the cause of a fainting spell, but physicians don't routinely do full work-ups to look for them. So Dr. Paolo Prandoni and colleagues asked doctors at 11 hospitals to take those extra steps.

The doctors screened for blood clots among 560 elderly patients (average age 76). And they report in the latest issue of the New England Journal of Medicine that 17 percent of the patients with fainting spells also had blood clots in the lung. That's a surprisingly high figure — about 1 in 6 patients who had syncope serious enough to require hospitalization.

Prandoni and his colleagues note that current international guidelines for evaluating unexplained fainting "pay little attention" to the possibility it could be caused by a blood clot in the lung. "Hence, when a patient is admitted to a hospital for an episode of syncope, pulmonary embolism — a potentially fatal disease that can be effectively treated — is rarely considered as a possible cause," they wrote.

"It's a very important study," Dr. S. Adam Strickberger told Shots. A cardiologist at Inova hospitals in the Washington, D.C., area, Strickberger co-authored the American Heart Association's 2006 guidelines for evaluating syncope. Those make only passing reference to blood clots in the lung as a possible cause.

"If you don't think of [a blood clot] all the time, you're going to miss it," he said. "And once you think about it, you have to rule it out." Doctors evaluating patients with fainting spells should add blood clots to the list, he said.

That can be an expensive proposition. A blood test called a D-dimer assay can sometimes rule out a blood clot in the lung. But in the Italian study, that only eliminated about 60 percent of patients. The rest underwent an expensive CT scan of the blood vessels (called CTA).

And that triggered chatter among emergency room doctors on Twitter that the number of CTA scans could go through the roof if doctors fully embrace the results from Italy. On Twitter, University of California, San Francisco cardiologist Ethan Weiss quipped: "I expect all patients with syncope will have CTA from this point and forever."

A colleague in Texas cautioned that procedures in Italy for evaluating syncope differ from those in the United States, so the European findings might not translate directly.

Copyright 2016 NPR. To see more, visit NPR.
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Breathing Less Oxygen Reduces Jet Lag, At Least In Mice

NPR Health Blog - Thu, 10/20/2016 - 12:38pm
Nanette Hoogslag/Ikon Images/Getty Images

Whether it's jet lag, a new work schedule, daylight saving time or just a Monday morning, shifting sleep schedules takes a toll. But scientists think they might have found a way to reset our internal timers that's more than hot air.

At least, it works if you're a mouse. The solution, it seems, is thin air. A study published Thursday in the journal Cell Metabolism found that decreasing oxygen levels for a short period of time helped mice recover from jet lag faster.

According to Dr. Gad Asher, a clinician and assistant professor at the Weizmann Institute of Science in Rehovot and lead researcher on the study, this is because of our circadian clocks, molecular pathways that tell us when to sleep, move and eat. Scientists think these clocks are present in almost every cell in our body.

"If there are so many clocks, how do they all show the same time?" Asher wanted to know. Researchers had already identified a few universal clock resetting cues, including temperature. When we sleep, our body temperature drops. Because all the cells in our body use oxygen, Asher thought oxygen levels might be another cue.

First, Asher and his team put a bunch of mice in special cages designed to measure oxygen consumption and used a monitor to track their blood oxygen level. They found that the amount of oxygen the mice used rose and fell over the course of the day.

Then, they gave a bunch of mice jet lag — not by putting them on an airplane, but by moving their light-dark cycle up by six hours to throw off the brain's clock. When they exposed some of the mice to 12 hours of decreased oxygen before the shift, or two hours after, the mice adapted to their new light-dark cycle much faster.

Asher also wanted to identify which proteins helped these circadian clocks sense the changes in oxygen levels. He chose HIF1α, a protein that helps cells know when and how to use oxygen. The researchers knocked out one set of HIF1α genes in a group of mice and repeated the experiment. Low oxygen didn't help cure jet lag in the mice without HIF1α.

"It's not shocking, exactly, that oxygen is involved in circadian rhythm. But I don't think it was ever established before now," says John Hogenesch, a professor of pediatrics at Cincinnati Children's Hospital Medical Center and circadian rhythm researcher who was not involved in the study. "And it's great that they show HIF1α is involved, though I think we'll find there's more to it than that."

Because HIF1α is involved in a lot of different cell processes, Hogenesch hopes this research could help scientists understand some of the negative consequences of long-term fatigue and working night shifts. But there's still a lot more work to do first.

"One big question is: Is this oxygen-resetting mechanism unique to mice? To mammals? Or is it present in all organisms?" says Asher.

Assuming the results of this study hold true in humans, there are still more things Asher would like to know. For example, does changing the oxygen level work best before, during or after a flight? Would you need to be exposed multiple times, or is once enough to treat the tired? Does raising oxygen have the same effect as lowering it?

Still, Asher imagines a future where passengers might step off an airplane and into an oxygen bar, sipping O2 while they wait for their bags to be unloaded. Or, perhaps, oxygen masks will drop as a plane descends (in first and business class only — coach can caffeinate their way through circadian delay like they always have) and people will disembark bright-eyed and well-adjusted to their new time zone.

And there are other, more practical applications of this research, Hogenesch points out. Jet-lagged jet-setters aren't the only people whose internal clocks are out of whack.

According to the Bureau of Labor Statistics, 21 million Americans work night shifts, evening shifts, or have shifting work schedules that sometimes include evenings or nights.

Working an irregular schedule doesn't just make someone sleepy, says Hogenesch. Fatigue from shift work is associated with a suite of health impacts, including heart disease, obesity and diabetes. And working while fatigued can increase the risk of on-the-job injury.

There's still a long way to go to find out whether manipulating oxygen levels could ever become a treatment for the impacts of shifting circadian rhythms in humans.

But mouse and rat sightings on airplanes are pretty common, so frequent-flying rodents can rejoice! A cure for their jet lag, at least, may be on the way.

Copyright 2016 NPR. To see more, visit NPR.
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Fall Enrollment Efforts Could Be Pivotal For Federal Health Law

NPR Health Blog - Wed, 10/19/2016 - 8:35pm

Secretary of Health and Human Services Sylvia Burwell at a Senate hearing in 2014. "We expect this to be a transition period for the marketplace," she told reporters Wednesday. "Issuers are adjusting their prices, bringing them in line with actual data on costs."

Alex Wong/Getty Images

Rate hikes are likely on the way for insurance plans issued under the Affordable Care Act, health policy analysts say. Consumers' out-of-pocket costs are expected to climb in 2017 and some major insurers have signaled they are pulling out of the health insurance exchanges in a number of states.

In a meeting Wednesday with reporters and representatives of groups working to increase enrollment in the health plans, Department of Health and Human Services Secretary Sylvia Burwell acknowledged that the Affordable Care Act's fourth enrollment season — scheduled to begin Nov. 1 and run until Jan. 31 — is a pivotal time for the federal health law.

"Building a new market is never easy," she told the group at HHS headquarters. "We expect this to be a transition period for the marketplace. Issuers are adjusting their prices, bringing them in line with actual data on costs."

Burwell's comments foreshadow the higher premiums expected when federal officials release details on the health plans to be offered on for 2017. Those details are likely to come just days before a presidential election that could determine whether the ACA is repealed or revamped.

While the health law hasn't been a central issue in the current election season, it has been at the center of a bitter battle between political parties since it was passed in 2010. The House of Representatives has voted more than 60 times to repeal all or part of the measure. The law has survived some court challenges and faces others.

Burwell noted those fights Wednesday when talking about issues that arose in the law's implementation. "It also hasn't helped," she said, "that at nearly every turn, we've had to overcome partisan attempts to repeal and undermine the law through legislation and litigation."

Enrollment in the state and federal marketplaces is expected to grow by about a million people next year — from about 12.7 million to 13.8 million, according to federal estimates released Wednesday. The number of consumers who actually pay premiums and stay in the market is expected to average about 10.5 million per month in 2016 and about 11.4 million per month in 2017.

Consumers flow in and out of ACA plans because they change jobs, get coverage from other sources and face other factors that affect where and how they enroll in health insurance, including affordability. About 9.2 million of the 13.8 million people who now have ACA coverage are expected to reenroll, according to HHS.

This year, Burwell said, health officials working to increase insurance coverage among the uninsured are intent on making the enrollment process faster and simpler, and will particularly focus on signing up healthier consumers – including people between the ages of 18 and 34, who tend to have fewer ailments. They will also remind consumers of the penalty for not having coverage, which for adults in 2016 is $695 or 2.5 percent of income, whichever is higher. The flat penalty will be adjusted for inflation in 2017.

Federal officials are also focusing enrollment efforts on the 5.1 million Americans who are eligible to purchase health care coverage on the exchanges but buy it elsewhere, according to HHS figures. Of that group, 2.5 million people could be eligible for the law's financial assistance if they sign up for coverage during open enrollment, which ends Jan. 31.

The outcome of the November elections may well determine the future of the ACA. Republican presidential nominee Donald Trump has promised to repeal and replace the law, while Democratic nominee Hillary Clinton has said she wants to fix the law, making it more affordable for consumers who don't qualify for subsidies, yet struggle to afford coverage.

Burwell called on Congress to work with her and the Obama administration to make needed changes to the law. "To make more substantial changes — like a public option to encourage competition — we'll need cooperation from Congress," she said. "And we are hopeful that soon, we'll see more bipartisan efforts to make improvement."

Bipartisan cooperation isn't likely to happen until the next Congress meets, if then. Much will depend on the outcome of the presidential and congressional elections – on who is in power and whether GOP leaders think the ACA is still a potent political issue, as well as on how willing Democrats are to make changes that appeal to Republicans.

Mary Agnes Carey reports for Kaiser Health News, an editorially independent news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

Copyright 2016 Kaiser Health News. To see more, visit Kaiser Health News.
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Emergency Room Use Stays High In Oregon Medicaid Study

NPR Health Blog - Wed, 10/19/2016 - 5:45pm
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October 19, 20165:45 PM ET Heard on All Things Considered


Although expanding Medicaid in Oregon didn't drive down the recipients' overall use of hospital emergency rooms, the state has seen a decline in avoidable use of ERs by 4 percent in the past two years, according to state statistics.

Paul Burns/Getty Images

Will Medicaid expansion save the country money as people stop using expensive emergency rooms for primary care?

Not yet, suggest the latest findings from a landmark study published online Wednesday in the New England Journal of Medicine.

The study of Medicaid patients in Oregon who got Medicaid in 2008 found their ER use stayed high two years after they gained the health insurance coverage — even as they also increased their visits to doctors' offices.

All eyes have been on Oregon to answer this question about ER use because, eight years ago, the state tried an experiment. It wanted to expand Medicaid, but it didn't have the money to cover every eligible resident.

So it held a lottery to give coverage to as many people as possible, in the fairest way possible. The result was something of a gift to researchers like Bill Wright, director of the Providence Center for Outcomes Research and Education.

Bill Wright, one of the authors of the study, called the results "a surprise to a lot of folks."

Kristian Foden-Vencil/Oregon Public Broadcasting

"You couldn't do this as a researcher," Wright says. You couldn't design a study that randomly gave some people insurance, but not others. It wouldn't be ethical to leave some people without coverage just to have a control group.

"As a researcher," Wright says, "you don't want to put someone in that position, just to study it."

But, since Oregon was already conducting the insurance lottery, that offered an invaluable chance to study the differences between people who have Medicaid insurance and similar people who don't.

It was the first randomized study on the impacts of health insurance, and it's one of the largest, surveying about 25,000 people.

The study's first findings, published a few years ago, showed that Medicaid was beneficial in many ways. It improved people's financial security. They went to the doctor when they were sick. And having the insurance correlated with a drop in rates of depression.

"These are all things that are really important benefits of Medicaid expansion," says Wright.

But the study also found Medicaid enrollees increased their emergency room visits by 40 percent over the first 15 months.

"That was a surprise to a lot of folks," says Wright.

It was widely believed that having insurance would encourage people to get routine medical care in doctors' offices or clinics, instead of waiting until they have more serious symptoms and have to head to the ER, where care is most expensive.

After those early findings were published, health care analysts scrambled to explain why the number of ER visits didn't decline. Some thought it was a reflection of pent-up demand from people who hadn't seen a doctor in years because they didn't have insurance.

Others thought some of these newly insured patients simply hadn't yet had time in that first 15 months to establish a relationship with a primary care doctor. As more time passed, that theory suggested, and more patients had primary care providers, their reliance on emergency rooms would drop.

But Wright, one of the study's authors, says he and his colleagues have now studied two years of data — and that's not what they're finding.

"There was no sign that this [ER] use went down," he says. "So this idea of pent-up demand sort of fading away — at least in the first couple of years, it didn't happen."

Quite the opposite.

"If your hope is that, in the short term — the first couple of years — you're going to see savings that come out of reduced [ER] use from Medicaid expansion alone, I don't think I'd be super optimistic about that," Wright says. "I think that it is going to cost money in the short term."

However, there may be savings in other areas, he says, like an increased use of preventive services that could stave off problems that would become more expensive later.

And, Leslie Clement, with the Oregon Health Authority, says over the past two years, Oregon has seen avoidable use of emergency rooms drop by 4 percent.

That's because the state is now coordinating care better, she says, by doing things like helping people get to their doctors' appointments and take their medication.

"It is not just a 'open up coverage and let people used health care services as they have done historically,' " she says. "It's reforming that system."

The researchers won't be able to tease much more information out of what's come to be known as the Oregon Health Insurance Experiment — the experiment had to stop once the state expanded Medicaid fully under the Affordable Care Act.

This story is part of NPR's reporting partnership with Oregon Public Broadcasting and Kaiser Health News.

Copyright 2016 Oregon Public Broadcasting. To see more, visit Oregon Public Broadcasting.
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Small Savings For Drugs Made To Mimic Biotech Blockbusters

NPR Health Blog - Wed, 10/19/2016 - 3:48pm

A patient with Crohn's disease receives an IV infusion of Remicade, or infliximab.

Dr P. Marazzi/Science Source

Generic drugs generally cost 80 percent less than brand-name drugs, so hopes were high when a law enacted in 2010 paved the way for competition among the highest-priced drugs of all, known as biologics.

But, as these competing drugs start to appear on the market, consumers aren't reaping a windfall.

On Monday, Pfizer said it would start selling Inflectra, its version of the blockbuster rheumatoid arthritis drug Remicade, in late November. But Inflectra, the second so-called biosimilar set to hit the market, isn't exactly a steal.

Note: Chart shows the highest annual price, according to wholesale acquisition cost, for a vial containing 100 milligrams of powder for preparing an intravenous solution.

Truven Health Analytics

The wholesale acquisition cost (a benchmark price in the drug industry) for Inflectra is $946 a vial, only 15 percent off $1,113 for a comparable vial of Johnson & Johnson's Remicade, according to data from Truven Health Analytics. (The WAC price doesn't reflect rebates drugmakers typically offer.)

Early indications are that the prices for these substitute medications will only lop 15 or 20 percent off the price, said Dr. Mark McClellan, director of the Duke-Margolis Center for Health Policy, at a Tuesday meeting in Washington, D.C.

That discount is a far cry from the one for standard generic drugs, McClellan said at a forum hosted by Duke and Friends of Cancer Research. "On the other hand, 15 to 20 percent of a very big price – a very large number — is still a big number."

Steady price increases for Remicade mean that Inflectra, even at a 15 percent discount, will cost about what Remicade did in 2014.

Pricing this new class of drugs is just one challenge. Drugmakers will also have to persuade consumers and physicians that they are every bit as good as the drugs they would replace. Because these biotech drugs are similar but not identical to the brand-name medicines they mimic, pharmacists generally are restricted from substituting one for the other automatically, unlike most traditional generics.

The case for biosimilars as these new medicines are sometimes called isn't quite as straightforward as it is for standard generics. Typical drugs are simple molecules, so generic versions can be built atom by atom to be identical with the original.

These new "biologic" drugs are complex biological molecules. These drugs are produced in living cells. As a result, even the brand-name drugs vary a bit from batch to batch. The generic versions of these drugs, known as biosimilars, also vary. The Food and Drug Administration considers them essentially the same as the original drug, as long as their variations fall into the same range as the brand-name biologics.

So far, scientists have found no meaningful differences between these drugs and their mimics. Europe, which is a decade ahead of the United States in developing these drugs, has gathered 400 million patient life-years of data (which, for example, would be studies of 40 million people for 10 years), and hasn't identified any safety issues, said Lisa Bell, senior vice president of regulatory affairs for Coherus Biosciences.

The latest reassuring data, announced at a meeting Tuesday in Vienna, Austria, come from a government-funded study in Norway of 481 patients, half of whom switched from brand-name Remicade to another biosimilar called Remsima. After a year of follow-up, there was no meaningful differences between the two groups (though there were nonsignificant findings that provided potential fodder for skeptics).

In Europe, governments have a big hand in deciding which drugs are made available to patients in government-sponsored health systems. The system in the United States is a much more complicated picture, involving patients, doctors, insurance companies, middlemen and government providers such as Medicare. Doctors, in particular, have a big voice and will need to be convinced that the substitutes are just as good as the original drugs.

For example, doctors routinely prescribe Herceptin to treat certain forms of breast cancer. Dr. Richard Schilsky, senior vice president and chief medical officer of the American Society of Clinical Oncology, said a competitive product was shown to be at least as good as the original drug in a study that measured the likelihood that a woman taking the drug would suffer a relapse. But Herceptin has a 25-year-history that looks not only at relapse rates, but at long-term survival and other significant endpoints.

"At what point does the doctor and the patient have the confidence to make that switch" to the substitute brand, Schilsky asked at the meeting in Washington.

A patient may or may not see any savings, given the convoluted system of insurance and medical reimbursement in this country.

And the doctor may have a financial incentive to opt for the more expensive drug, including some cancer drugs. Currently, Medicare bases some payments to doctors on the price of chemotherapy drugs, so doctors make more when they prescribe more expensive drugs, Schilsky noted. (He said his organization is trying to change that payment system).

Time is running short to sort out all these issues. Leah Christl, at the FDA's Center for Drug Evaluation and Research, says that as of Oct. 5, the agency is processing 66 projects involving biosimilar drugs, which are potentially substitutes for 20 existing medications. Four products have already been licensed, though only one, Sandoz's Zarxio, is currently on the market, she said. Inflectra will be the second.

These applications all result from the 2010 law called the Biologics Price Competition and Innovation Act. It remains to be seen whether the hoped-for price competition will make a significant dent in American health care costs.

Copyright 2016 NPR. To see more, visit NPR.
Categories: NPR Blogs

Don't Look Now! How Your Devices Hurt Your Productivity

NPR Health Blog - Wed, 10/19/2016 - 10:32am
Nick Shepherd/Ikon Images/Getty Images

I'll admit it. I even take my phone with me when I head to the restroom, to fire off a few texts. Or I'll scroll through my email when I leave the office for lunch. My eyes are often glued to my phone from the moment I wake up, but I often reach the end of my days wondering what I've accomplished.

My productivity mystery was solved after reading The Distracted Mind: Ancient Brains in a High Tech World, by Dr. Adam Gazzaley, a neuroscientist at the University of California, San Francisco, and Larry Rosen, a research psychologist and professor emeritus at California State University, Dominguez Hills. Their book explains why the brain can't multitask, and why my near-obsessive efforts to keep up with email are likely lowering my productive output.

How the digital age zaps productivity

I visited Gazzaley in his UCSF laboratory to learn more about the science. On a video screen, he pulled up a 3-D image created from an MRI scan of a human brain. He pointed to different sections to explain what's going on when our attention flits between tasks.

How To Boost Productivity

Feeling chronically distracted? Dr. Adam Gazzaley has been there, too, and says these tricks can help you buckle down and think!

• Clear your work space. Remove mobile devices and extraneous papers.
• Use one computer screen. Shut down all unnecessary programs and apps.
• Open one browser, and use only one tab.
• Turn off email.
• Set expectations. Tell your boss you're going offline for a while. Or, set an auto response for texts and emails, explaining that you'll be offline for a set period of time.
• Work in a quiet environment. If you must work in a coffee shop use noise-canceling headphones.
• Display a "no interruption zone" sign at your desk or on your office door.
• Check out helpful apps like SelfControl, Freedom or FocusMe.

"The prefrontal cortex is the area most challenged," Gazzaley said. "And then visual areas, auditory areas, and the hippocampus — these networks are really what's challenged when we are constantly switching between multiple tasks that our technological world might throw at us."

When you engage in one task at a time, the prefrontal cortex works in harmony with other parts of the brain, he explained, but when you toss in another task it forces the left and right sides of the brain to work independently. It's this process of splitting your attention that usually leads to mistakes.

In other words, each time our eyes glance away from our computer monitor to sneak a peek at a text message, the brain takes in new information, which reduces our primary focus. We think the mind can juggle two or three activities successfully at once, but Gazzaley thinks we woefully overestimate that ability.

Skeptical? Try checking your email on a conference call.

"The act of doing that makes it so incredibly obvious how you can't really parallel process two attention-demanding tasks," he said. "You either have to catch up, and ask what happened in the conversation, or you have to read over the email before you send it — if you're wise!"

Answering an email takes much longer than you think

Our tendency to respond immediately to emails and texts gets in the way of high-level thinking, he said. If you're in the middle of a project and stop to answer somebody's note, it could take you nearly a half-hour to get back on task, some studies suggest.

"When a focused stream of thought is interrupted, it needs to be reset," explained Gazzaley. "You can't just press a button and switch back to it. You have to re-engage those thought processes, and re-create all the elements of what you were engaged in. That takes time, and frequently one interruption leads to another."

And that can make you less productive.

Based on his research, when UCSF neuroscientist Adam Gazzaley needs to focus on a big project he now clears his desk, works on one screen and turns off his phone.

Sierra Niblett/Courtesy of UCSF

Plus, mounting evidence shows a heavy diet of multitasking with multiple media could be hurting the brain's ability to think, in important ways — and that's true even for tech-native young people. Stanford researchers in 2009 studied the minds of students and others who regularly engage in several digital communication streams at once and found that, in general, high-tech jugglers struggle to pay attention, recall information or complete one task at a time.

"When they're in situations where there are multiple sources of information coming from the external world or emerging out of memory, they're not able to filter out what's not relevant to their current goal," said Stanford neuroscientist Anthony Wagner. "That failure to filter means they're slowed down by that irrelevant information."

The researchers are still studying what's causing multitaskers to perform poorly on cognitive tests. It could be that they are born with an inability to concentrate, or digital distractions are taking a toll. In any case, the researchers believe the minds of multitaskers are not performing optimally.

Create digital boundaries

But, take heart, Gazzaley said. You don't have to opt out of technology to get some of that brainpower back. In fact, there's a time and place for multitasking. If you're in the midst of a mundane task that just has to get done, for example, it's probably not detrimental to have your phone nearby or a bunch of tabs open. The distractions may reduce boredom and help you stay engaged.

Still, if you're finishing a business plan or a high-level writing project and need to focus, there are some steps you can take that should help. Check out Gazzaley's tips for turning off distractions in the sidebar above.

Then, get back to work!

This story was produced by KQED's health and technology blog, Future of You. The blog's host and editor is Jon Brooks.

Copyright 2016 KQED Public Media. To see more, visit KQED Public Media.
Categories: NPR Blogs

7 Insurers Alleged To Have Discriminated Against HIV Patients

NPR Health Blog - Tue, 10/18/2016 - 4:20pm

Once-a-day HIV pills that combine multiple medicines, such as Truvada, are easier to take, but they can be more expensive than pills that contain only one active ingredient.

Justin Sullivan/Getty Images

The Affordable Care Act prohibits insurers from discriminating against people with serious illnesses, but some marketplace plans sidestep that taboo by making the drugs that people with HIV need unavailable or unaffordable, complaints filed recently with the Department of Health and Human Services' Office for Civil Rights allege.

The effect may be to discourage people with HIV from buying a particular health plan or getting the treatment they need, according to the complaints.

The complaints – brought by Harvard Law School's Center for Health Law and Policy Innovation – charge that plans offered by seven insurers in eight states are discriminatory because they don't cover drugs that are essential to the treatment of HIV or require high out-of-pocket spending by patients for covered drugs.

The center filed complaints against Humana plans in six states: Alabama, Georgia, Illinois, Louisiana, Tennessee and Texas. Cigna plans were targeted in three states: Georgia, Tennessee and Texas. The group filed complaints against five other insurers: three in Pennsylvania, including Highmark, Independence Blue Cross and UPMC Health Plan; a complaint against Community Health Choice in Texas and a complaint against Anthem Blue Cross Blue Shield in Wisconsin.

"What's most important to us is that there's a robust enforcement mechanism around the promises ... in the [Affordable Care Act] and its regulations, especially the anti-discrimination provisions," said Kevin Costello, director of litigation at the health law center.

Shots - Health News Complaint Says Insurance Plans Discriminate Against HIV Patients

Although the center's focus is on HIV drugs, the complaints may help people with other chronic illnesses who may face similar hurdles on access to drugs, Costello said.

The HHS Office for Civil Rights investigates and enforces violations of civil rights and health information privacy. The Harvard center complaints were filed in September.

Federal rules prohibit marketplace plans from adopting benefit designs — such as coverage rules or reimbursement rates — that discriminate based on age, illness, race, gender or sexual orientation, among other things. But federal regulators have declined to define discriminatory plan design, noting that they will examine the facts on a case-by-case basis.

They've hinted, however, at some specifics in the regulations. They say, for example, that refusing to cover a single-tablet drug regimen, which is often associated with better compliance because a number of different drugs are combined in one pill, or placing most or all of the drugs that treat a specific condition in the highest cost tiers are examples of "potentially discriminatory practices."

Working with local AIDS groups in several states, the Harvard center examined hundreds of silver-level plans sold on the marketplaces to gauge whether their formularies would allow access to six treatment regimens that are the current standard of care for treating people who are newly diagnosed with HIV. In addition, they looked at the plans' cost-sharing requirements, Costello said.

They found, for example, that this year Anthem silver plans in Wisconsin cover only four of the 16 drugs or combination products that are recommended to meet the current standard of care, and they fail to cover any single-tablet regimens. In Illinois, the center charged that Humana's silver plans place 16 of the 24 most commonly prescribed HIV drugs in the highest cost-sharing tier, which requires patients to pay 50 percent of the cost. With estimated monthly costs ranging from $377 to $684 for different drug regimens, enrollees in the Illinois Humana plans would have to pony up between 8 and 14 percent of their average monthly income, according to the complaint.

"All Humana health insurance plans offered through the Health Insurance Marketplace fully comply with state and federal laws and regulations," said Alex Kepnes, Humana's director of corporate communications. He added, "Humana shares the concerns of HIV/AIDS organizations regarding the high cost of HIV/AIDS drugs and we are committed to working with them to lower prescription drug costs."

Similarly, Anthem spokesman Scott Larrivee said, "Anthem Blue Cross and Blue Shield is committed to providing all of our members with access to the care and services they need, including appropriate coverage of medications for the treatment of HIV/AIDS. Anthem Blue Cross and Blue Shield in Wisconsin covers more than a dozen medications for the treatment of HIV/AIDS and all required therapeutic drug categories are included on our formulary/drug list which is compliant with (marketplace) requirements."

Cigna spokesman Mark Slitt said his company doesn't comment on pending legal matters.

The center's work builds on an earlier discrimination complaint filed in 2014 with the Office for Civil Rights by two advocacy groups, the AIDS Institute and the National Health Law Program, against four Florida insurers that were selling marketplace plans. That complaint, against some of the same insurers highlighted by the Harvard center, charged that the insurers placed all the HIV drugs in the highest cost-sharing tier. The Florida insurance commissioner reached agreements with the four plans to move the HIV drugs to generic tiers and reduce cost sharing, and the same arrangement will continue in 2017, said Carl Schmid, deputy executive director of the AIDS Institute.

"We've been talking about these issues for years now," Schmid said. "These things need to be addressed, and it could be through enforcement" by the Office for Civil Rights.

Marketplace coverage of drugs to treat HIV and other serious conditions have improved somewhat in recent years, according to research by Avalere Health, a consulting company. An analysis found that in the case of five classes of drugs that treat cancer, HIV and multiple sclerosis, fewer silver plans in 2016 placed all the drugs in the class in the top tier with the highest cost sharing or charged patients more than 40 percent of the cost for each drug in the class.

Speaking about HIV drugs, Caroline Pearson, a senior vice president at Avalere, said that while access and costs in marketplace plans are improving, they vary widely from plan to plan. Employer plans tend to offer better coverage, she said.

The new complaints may put more pressure on the Office for Civil Rights to address this issue, said Katie Keith, a steering committee member for Out2Enroll, a health insurance advocacy group for the lesbian, gay, bisexual and transgender community.

"It's smart to do this in multiple states," she said. "People are really pushing for more concrete guidance."

Kaiser Health News is an editorially independent news service that is part of the nonpartisan Henry J. Kaiser Family Foundation. Michelle Andrews is on Twitter:@mandrews110.

Copyright 2016 Kaiser Health News. To see more, visit Kaiser Health News.
Categories: NPR Blogs

WEBCAST: The Cost And Quality Conundrum Of Child Care

NPR Health Blog - Tue, 10/18/2016 - 10:05am
Harvard T.H. Chan School of Public Health YouTube

There's a major gap between what parents view as quality child care and what developmental psychologists and other specialists define as good care. That's according to a poll released this week by NPR, the Robert Wood Johnson Foundation and the Harvard T.H. Chan School of Public Health.

Nearly 90 percent of parents say the quality of their child care is very good or excellent. But a major study in the field of child development has suggested that most child care is of only fair quality.

What's a parent to do? Quality care in a child's early years can help that young person develop lasting social, emotional and learning skills and can promote healthful eating and play.

But high-quality care, whether it comes from a nanny, a sitter, a day care or a preschool, can be difficult to find — and to afford.

There are solutions out there. A lively forum discussion at the Harvard Chan School covered the issues. We streamed the webcast, where specialists in child care and health will talk more about the findings, and what they mean for today's kids. (When the archived video becomes available, we'll add it to this post.)

Some of the issues that were discussed: How do parents find and select child care, and how does that care influence the health and well-being of families? How can child care be made accessible, high quality and affordable? How do we even measure quality in a meaningful and accountable way? The forum panelists discussed ways to equip parents with better information about child care and explained policy changes they thought could help children thrive.

Joe Neel, deputy senior supervising editor on NPR's Science Desk, moderated the discussion with:

Susan Hibbard, executive director of the BUILD Initiative

Kristin Schubert, managing director, Robert Wood Johnson Foundation

Rachel Schumacher, director, Office of Child Care, U.S. Department of Health and Human Services

Gillian SteelFisher, senior research scientist and deputy director of the Harvard Opinion Research Program, Harvard T.H. Chan School of Public Health

Copyright 2016 NPR. To see more, visit NPR.
Categories: NPR Blogs
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