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Screaming For Science: The Secrets Of Crying Babies And Car Alarms

Thu, 07/16/2015 - 12:04pm
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It's almost impossible to ignore a screaming baby. (Click here if you doubt that.) And now scientists think they know why.

"Screams occupy their own little patch of the soundscape that doesn't seem to be used for other things," says David Poeppel, a professor of psychology and neuroscience at New York University and director of the Department of Neuroscience at the Max Planck Institute in Frankfurt.

And when people hear the unique sound characteristics of a scream — from a baby or anyone else — it triggers fear circuits in the brain, Poeppel and a team of researchers report in Cell Biology. The team also found that certain artificial sounds, like alarms, trigger the same circuits. "That's why you want to throw your alarm clock on the floor," Poeppel says.

The researchers in Poeppel's lab decided to study screams in part because they are a primal form of communication found in every culture. And there was another reason.

"Many of the postdocs in my lab are in the middle of having kids and, of course, screams are very much on their mind," Poeppel says. "So it made perfect sense for them to be obsessed with this topic."

The team started by trying to figure out "what makes a scream a scream," Poeppel says. Answering that question required creating a large database of recorded screams — from movies, from the Internet and from volunteers who agreed to step into a sound booth.

A careful analysis of these screams found that they're not like any other sound that people make, including other loud, high-pitched vocalizations. The difference is something called the amplitude modulation rate, which is how often the loudness of a sound changes.

When someone is talking, the modulation rate is about four or five changes a second. But when someone is screaming, it can jump to more than 100 changes a second.

That gives the sound an acoustic quality called roughness.

So we hear the audio of the "rougher voice" clip you see below, instead of the high, loud, "smoother voice" clip below that one.

Rougher voice

Smoother voice

Screams are the only human sound with this sort of roughness, Poeppel says. But "car alarms, house alarms, sirens work exactly on the same principle and they have this roughness modulation," he says.

To find out how these sounds produce such an immediate and intense reaction, the team used functional MRI to monitor the brains of people as they listened to a variety of sounds, including screams.

The experiment showed that screams had a unique ability to cause activity in the amygdala, "the circuitry associated with generating fear responses," Poeppel says. And screams that had been rated as especially scary by listeners produced the highest levels of activation.

So why have humans have evolved to scream? Part of the answer probably involves babies, Poeppel says. He suspects that babies may be more likely to survive if they can instantly activate the amygdala of a parent or caregiver.

Copyright 2015 NPR. To see more, visit http://www.npr.org/.
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Webcast: Sports And Health In America

Thu, 07/16/2015 - 11:45am

The vast majority of kids in America play sports.

But while about three-quarters of adults played sports when they were younger, only 1 in 4 still plays sports today. Among them, men are more than twice as likely as women to play.

Why do we tend to give up sports as we grow older? A poll conducted by NPR, the Robert Wood Johnson Foundation and the Harvard T.H. Chan School of Public Health offers fresh insights into how and why adults and kids play sports, and also why they don't.

Shots - Health News A Look At Sports And Health In America

What are the obstacles that keep adults off the field? How can sports help keep kids and adults in good health? What are the best ways to encourage more widespread participation, particularly among women and lower-income adults? And what role do parents play in helping children become active and stay that way?

As part of our series "Sports and Health in America," Harvard presented a webcast Thursday in collaboration with NPR and the Robert Wood Johnson Foundation to explore these questions and more.

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

  • Robert Blendon, professor of health policy and political analysis, Harvard T.H. Chan School of Public Health and Harvard Kennedy School
  • Elizabeth Matzkin, chief of women's sports medicine, Brigham and Women's Hospital, Boston
  • Caitlin Cahow, former member of the U.S. Women's National Ice Hockey Team and current member of the President's Council on Fitness, Sports & Nutrition
  • Ed Foster-Simeon, president and CEO, U.S. Soccer Foundation
  • Cobi Jones, three-time World Cup U.S. men's soccer player

Update 1:35 ET: The webcast is over. We'll add an archived video when it becomes available.

Copyright 2015 NPR. To see more, visit http://www.npr.org/.
Categories: NPR Blogs

'Consumer Reports' Says Laundry Pods Are Too Risky To Recommend

Thu, 07/16/2015 - 11:15am

Can you spot the four laundry pods?

CR/John Powers and Ariana Salvato/Apotrophe/Courtesy of Consumer Reports

Consumer Reports, the granddaddy of advice-givers on what to buy, won't recommend laundry pods containing liquid detergent anymore. The risks to small kids are just too high, the magazine says.

In its latest tests, eight different single-use packets were rated very good at cleaning. That wasn't a strong enough showing to put any of them among the top three laundry detergents, which got the magazine's recommended check mark.

But the real problem is safety. Despite some changes in packaging and a heightened awareness of the risks to kids, the number of health incidents involving the pods continues to climb.

Through June, 6,046 incidents involving pods and kids younger than 6 have been reported to the American Association of Poison Control Centers. The exposures, as the AAPCC calls them, include ingestion, inhalation and contact with eyes and skin. Health problems after exposure include wheezing, gasping, extreme sleepiness, vomiting and corneal abrasions.

If the incidents continue to be reported at the current pace, they'll exceed the 11,714 that were registered by the poison control centers in 2014.

Reports to poison control centers of exposure of children 5 and younger to laundry detergent packets. Data for 2015 are through June 30.

NPR/American Association of Poison Control Centers

Procter & Gamble, maker of Tide pods, didn't immediately respond to a request for comment.

"Given the continued danger, we have made the decision to not include pods on our list of recommended products," says the article in the September issue of the magazine. "And we strongly urge households where children younger than 6 are ever present to skip them altogether." The magazine says its "new position doesn't apply to laundry (or dishwasher) pods that contain powder, because injuries associated with them are less frequent and less severe."

The AAPCC says households with children should take precautions with the pods. "Our official stance from a poison prevention and education standpoint is that single-use laundry packets should be kept up, away and out of sight of children," Krista Osterthaler, national director of outreach for AAPCC, tells Shots. The poison control centers would also like to see packaging improvements to make the products more child-resistant and additional labeling to tell consumers about the dangers.

"We would also support efforts in reformulation to make them less toxic," she says. "We just don't know what that looks like."

Update 2:35 p.m. ET: Procter & Gamble provided a statement by email:

"We take every incident of accidental exposure seriously and believe these accidents are preventable. Less than 1% of the calls to Poison Control centers were related to laundry pacs, and the vast majority of these calls to Poison Control centers resulted in minor or no medical treatment. Today, we are seeing encouraging signs that the rate of accidents relative to the number of P&G laundry pacs sold is declining at a rate of 28 percent."

Copyright 2015 NPR. To see more, visit http://www.npr.org/.
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Why We Play Sports: Winning Motivates, But Can Backfire, Too

Thu, 07/16/2015 - 5:02am
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Lorenzo Gritti for NPR

Playing sports has always been important to 31-year-old Erik Johanson, a city planner in Philadelphia. Johanson thrived in baseball and ice hockey as a kid, he says — "one of the best players on the team in high school."

Today, Johanson is married and expecting his first child but is still passionate about ice hockey — and about winning. He plays on a highly competitive team of guys who got together after college and still play weekly in an adult league; they hope to take the crown this year.

Shots - Health News Benefits Of Sports To A Child's Mind And Heart All Part Of The Game

"I think if you had that experience when you were younger — and that experience feels really good to win — I don't think you ever really lose that," he says. "I think, especially when life gets more complicated when you grow up, you still need it. You have fewer opportunities for it, because it's not such a key part of your life anymore, so you seek it out."

A recent poll NPR did with the Robert Wood Johnson Foundation and the Harvard T.H. Chan School of Public Health found that a solid majority of adults in the U.S. who play sports — 56 percent — say that winning is important to them, too. Fifty-four percent of adults who play sports say they always or often push themselves to their physical limits, and 85 percent say their performance is important to them.

Plus, victory in sport is just plain fun, says George Gmelch, an anthropologist at the University of San Francisco and at Union College in Schenectady, N.Y. Gmelch studies sports culture, and he played professional baseball in the minor leagues.

Shots - Health News A Look At Sports And Health In America

Even watching your team win feels good, Gmelch says; imagine how great people feel when "they've contributed to the team's success." But interestingly, he says, as we get older that need to compete and win in the sports we play seems to wane.

That may be one reason why interest in playing sports declines with age. Forty percent of U.S. adults between 18 and 25 say they play sports. But among those who are 26 to 29 years old, only one in four plays. As for the over-50 crowd, just 20 percent play sports.

For anyone who views participation in sports as one way to keep adults physically active as they age, that sharp drop-off in participation can be dismaying.

Respondents to our poll cite health problems and injuries among their reasons for not playing sports. But they also say they just don't have the time or the interest.

Sports psychology coach Greg Chertok, a member of the American College of Sports Medicine, says this drop in interest may stem in part from how today's adults viewed losing as kids, not just winning.

"Did we view losing as a blow to our self esteem?" Chertok says. "Did losing guarantee a verbally abusive car ride home with Dad? Did losing mean a 10-minute diatribe from the coach after the game?"

Those sorts of negative reactions to not winning can be demoralizing, says Chertok, and can lay the groundwork for a negative view of sports in childhood and teen years — or later in adulthood, when wins get even tougher to come by.

Shots - Health News Poll: Support For High School Football, Despite Concussion Risks

"Kids don't begin playing sports with the sole intention of winning," Chertok says. That's often an adult-imposed goal, he says, starting as early as Little League or youth soccer. "And often parents can be as demanding — and, detrimental — as coaches."

Learning early in life to feel pleasure in a win is great, Chertok says, but the main goals of youth sport should be exercise, fun, social interaction and personal growth and development — character building. Parents and coaches who put a "rigid, inflexible emphasis on winning," he says, not only put kids off, but risk turning them off sports — and its health benefits — for good.

Our sports and health series continues over the summer, based on the results of our poll with the Robert Wood Johnson Foundation and the Harvard T.H. Chan School of Public Health.

Copyright 2015 NPR. To see more, visit http://www.npr.org/.
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Should Women Be Able To Treat Bladder Infections Themselves?

Wed, 07/15/2015 - 5:21pm

If you know what a bladder infection feels like, should you have to go to the doctor every time?

iStockphoto

When you've got a bladder infection, the word "urgent" means right now.

Not urgent as in, wait two hours at the urgent care clinic. Not urgent as in, wait some more to get the prescription filled.

So when a doctor says that women should be able to self-prescribe antibiotics for simple urinary tract infections, that sounds like an idea whose time has come.

"In an era of ready access to information, increasing patient autonomy, and overstretched primary care services ... it would seem a good idea for women to be able to access safe and effective treatment without the costs and delays associated with consulting a clinician to write a prescription," Kyle Knox, a general practitioner at the Nuffield Department of Primary Health Care Services at the University of Oxford, wrote Tuesday in the BMJ.

Hear, hear, Dr. Knox. I realize you're in England, but couldn't this work in the U.S., too?

To find out, I connected with Tomas Griebling, a professor of urology at the University of Kansas School of Medicine. Here's an edited version of our conversation.

I'm all for Dr. Knox's idea of women self-prescribing antibiotics. What do you think?

I think it's actually a really interesting editorial. There are certainly parts I agree with, and there are other parts that are concerning.

Urinary tract infections are extremely common in women, particularly young women. They often respond really well to antibiotic therapy. He points out there's data to show that three to five days are often useful, and can be as effective as a longer course of antibiotics. The antibiotics he's talking about are also very safe in short courses.

Where it's more challenging is that there are often patients who develop symptoms that look like urinary tract infections, but are other conditions. The two that come to mind are interstitial cystitis, a chronic inflammation of the bladder that is common in young women. It causes urinary urgency and pelvic pain. The other is bladder cancer. The concern is that if people have those kinds of symptoms they may go a long time before being diagnosed.

Shots - Health News Common Test For Bladder Infections Misses Too Many Cases

So that's an argument against self-prescribing. But most women who have had a bladder infection will tell you they recognize the symptoms right away. What about letting them treat themselves?

If we know people are having true recurrent infections, then this kind of therapy could be very useful. [Knox] points out the data on self-start therapy. People are given instructions on how to evaluate and treat themselves and have a stock of antibiotics that the could keep on hand and treat themselves. That's been very effective.

So that's one way to speed up treatment. What are others?

There are a number of studies and a number of device companies that are trying to develop a rapid test. One of the challenges we have is that right now the diagnosis is based on urine cultures. It can take two to five days to get the results back.

If there was a way a person could give a urine sample and find out quickly if it was an infection, that would be very valuable. People are looking at things like PCR that would allow you to do an in-office test.

But that would still involve going to the doctor's. Should women ask their doctor if they're a good candidate for self-start?

The Salt Cranberry Juice For Urinary Tract Infections? It Really Can Help

Absolutely, especially for women who have been diagnosed with symptomatic urinary tract infections before. I see a lot of women who tend to have more issues with infection around the time of sexual activity. Taking prophylactic antibiotics for one or two days around that time can prevent that.

What about cranberry juice?

The scientific data on that is quite mixed. There's some cost utility analyses that suggest that it might not be useful in large population studies. The theory is that there's a chemical in cranberry that tends to make the bacteria not stick to the wall of the bladder.

I think probably the best thing is good hydration — drinking plenty of fluids, voiding on a regular basis, not holding urine too long.

Copyright 2015 NPR. To see more, visit http://www.npr.org/.
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Even Mild Mental Health Problems In Children Can Cause Trouble Later

Wed, 07/15/2015 - 1:24pm

It's not easy for a child who has had mental health issues to make a successful transition into adulthood. But even children who have symptoms that are mild enough that they wouldn't be diagnosed are more likely to struggle with life as adults, a study finds.

Children and teenagers with a psychiatric disorder had six times higher odds of having at health, legal, financial and social problems as adults, according to a study published Wednesday in JAMA Psychiatry. Those with milder symptoms were three times more likely to have problems as adults.

We already know from previous studies that most adults with mental health issues had a previous psychiatric disorder during childhood – it doesn't have to be the same exact condition. But this study shows mental health problems that occurred during childhood can make it more likely that someone will struggle as an adult, making it more likely that they won't graduate from high school or commit a felony, for instance.

The data comes from a population study that followed children starting at ages 9, 11 or 13 in 11 mostly rural counties in North Carolina from 1993 to 2010. Participants were interviewed every year until they turned 16, then again at 19, 21 and 25.

They were tested for symptoms of common childhood psychiatric disorders such as anxiety disorder, social phobia, depression and ADHD. Those affect 1 percent of the population at any given time.

The researchers wanted to know if a common mental illness is distressing and impairing to a child or teenager at the moment, does it continue to impact after they go into adulthood, Copeland tells Shots.

"Most common chronic conditions happen in middle adulthood, with the exception of mental illness," says William Copeland, lead author of the study and an associate professor of psychiatry at Duke University School of Medicine.

But for mental illness, symptoms usually first appear in childhood, and have the biggest impact in terms of financial cost, mortality and other indicators – a term known as disease burden – on youths from 10 to 24 globally.

But there are also a lot of people who report mental health problems that are significantly impairing their lives but don't count as having a psychiatric disorder under standardized criteria for diagnosis, according to Copeland. This is no small group – as many as half of the patients who go to a doctor for psychiatric disorders do not meet the established criteria, he says.

Shots - Health News Odds Of Abuse And Mistreatment Add Up Over Children's Lives

This is no minor problem, says Copeland, "the vast majority of them aren't getting help at all because they don't meet threshold, but [the impact] is still significant enough that they need help down the road," Copeland says.

Of course, a bad environment growing up doesn't help, so Copeland and team also took into account factors such as an unstable, dysfunctional or poor family background and retested the data. The results still hold true.

It's important to understand that the data from the study is not necessarily people who think they have mental disorders, but a random sample who were tested as part of the study and shown to have these symptoms, says Daniel Klein, professor of clinical psychology at Stony Brook University. In some cases the symptoms are very mild, and people don't see themselves as having a mental disorder.

And that's a problem.

"As a society we're prone to think of childhood as a relatively carefree life, obviously with exceptions, and most of the mental disorders you think about are in adults, except ADHD and autism, but the whole gambit are there in childhood," says Klein, who was not part of the study.

Shots - Health News Antipsychotics Too Often Prescribed For Aggression In Children

"People are coming around to the notion that these [mental health] problems are significant and can have long term affects," says Copeland. "Kids continue to have problems in adulthood even if it's not psychiatric problems."

It's important that we make treatment and prevention programs accessible in childhood, Klein say. On that, "we're doing a terrible job."

An editorial in the same issue of JAMA Psychiatry echoed that thought. Ben Lahey, a professor of epidemiology at the University of Chicago, believes that we as a society don't invest enough in mental health treatment, especially when it comes to children and adolescents, to reduce the burden later in adulthood.

Lahey also points out an important missing part of the puzzle: "The paper, and several papers before it, all they establish is childhood disorders predict adult disorders, they can't tell us why. Correlation does not imply causation."

Copeland agrees, saying, "We're talking about odds and relative risks." Copeland says of the study, But he also adds, "We want to do things that reduce the rate of mental health problems in general."

Copyright 2015 NPR. To see more, visit http://www.npr.org/.
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States Make Laws To Protect Patients From Hidden Medical Bills

Wed, 07/15/2015 - 10:19am

It's a situation that occurs all too often: Someone goes to the emergency room and doesn't learn until he gets a hefty bill that one of the doctors who treated him wasn't in his insurance network. Or a diligent consumer checks before scheduling surgery to make sure that the hospital she plans to use and the doctors who will perform the operation are all in her network. Then she learns later that an assistant surgeon she didn't know — and who wasn't in her network — scrubbed in on her operation, and charged her for it.

"If we're mandating that people buy insurance coverage it seems we should also protect them from surprise medical bills," says Mark Rukavina, founder of Community Health Advisors in Chestnut Hill, Mass.

Shots - Health News Opting Out Of Your Insurance Plan's Network Can Be Costly

If an out-of-network doctor or other provider doesn't have a contract with a health plan that determines how much they get paid for services, they may bill the patient for any charges not covered by insurance. In those instances, the consumer could be on the hook for the rest of the bill, a practice known as balance billing.

Although there's no federal restriction, about a quarter of states have laws on the books against balance billing by out-of-network hospitals, doctors or other providers, in at least certain circumstances such as emergency care.

New York recently took that sort of action. The state's law, which became effective for coverage that renewed after March 31, significantly expands consumer protections, and may be the most comprehensive legislation of its type, says Jack Hoadley, a research professor at Georgetown University's Health Policy Institute.

"If the pieces work like they set them up to, it feels like they've got all the bases covered," says Hoadley, who recently coauthored a study that examined protections in seven states against balance billing.

Under the New York law, patients are generally protected from owing more than their in-network copayment, coinsurance or deductible on bills they receive for out-of-network emergency services or on surprise bills.

A bill is considered a surprise if, for example, patients at a hospital or ambulatory surgical center that's in their network receive services from a doctor who, without their knowledge, is out-of-network. In addition, if consumers are referred to out-of-network providers but don't sign a written consent form saying they understand the services will be out-of-network and may result in higher out-of-pocket costs, it's considered a surprise bill.

"A key element that is really new is that for anyone who gets a surprise out-of-network service, or who doesn't get the right disclosure [beforehand] about it, there's a way for the consumer to step out of the middle of the transaction," says Mark Scherzer, legislative counsel for New Yorkers for Accessible Health Coverage, an advocacy group for people with chronic illnesses and disabilities.

Shots - Health News Can A Doctor Really Demand An Extra $75 Upfront?

Under the New York law, to get relief from a surprise bill a consumer first needs to complete an "assignment of benefits" form that allows the provider to pursue payment from the health plan. The patient then sends the form and the bill to her insurer and to the provider. As long as she's taken that step, she won't be responsible for any charges beyond her regular in-network cost sharing.

"Consumers basically say to the doctor or the hospital, 'I'm giving you my rights to reimbursement; you can duke it out with the insurance company,' " Scherzer says.

In situations involving out-of-network emergency care, patients should inform the insurance company if they receive a bill. The insurer will take it from there.

The law also sets up an independent dispute resolution process for providers and health insurers to settle disputes that arise regarding emergency services or surprise bills.

It's too soon to say how well the law will work, but consumers are already calling the hotline of the Community Service Society of New York to find out if they're eligible, says Elisabeth Benjamin, vice president of health initiatives there.

"So many times people just give up," Benjamin says. With the new law, they may not have to.

Copyright 2015 Kaiser Health News. To see more, visit http://www.kaiserhealthnews.org/.
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When To Start Taking A Cholesterol Pill? The Decision Is Yours

Wed, 07/15/2015 - 8:50am

You may be wondering what to do, if anything, about your cholesterol levels.

Many people, including health professionals, are still puzzling over a groundbreaking revision of cholesterol guidelines that was released almost two years ago. The guideline, from the American College of Cardiology and the American Heart Association, represented years of analyzing the medical literature to produce recommendations about who should be treated with cholesterol-lowering drugs.

The big change was moving the focus for the decision about treatment — from your cholesterol numbers to your overall risk of dying from coronary heart disease or having a heart attack or stroke. The idea is that the higher your risk, the more you have to gain from these drugs. Conversely, the lower your risk, the less likely you are to benefit.

A great ruckus followed the publication of these changes. After decades of focus on patients knowing their numbers and reaching cholesterol targets, the new approach took people by surprise. Even now, people, including doctors, are having trouble making the change in their thinking.

In this week's JAMA, the journal of the American Medical Association, two articles tackle issues with the new guideline. One article compared the new guideline with the old guideline for their ability to identify people who would benefit from statin therapy. Researchers studied people enrolled in the Framingham Heart Study, the granddaddy of our epidemiology studies of cardiovascular risk. The researchers found that the new guideline, with its emphasis on risks instead of targets, was more accurate and efficient in identifying people with an increased risk of cardiovascular disease.

Shots - Health News When A Cholesterol Test Becomes A Vice Instead Of A Virtue

In essence, they find that the new guideline identifies more people for treatment – but that they are people who are likely to benefit from treatment. This article strengthens the case for the wisdom of the change in approach to the decision to use statins.

The new guideline was also controversial because of its definition of what constitutes high risk among those individuals without known cardiovascular disease. It recommends statin treatment for people with cardiovascular diseases, such as having had a heart attack or stroke, or for those with diabetes even if they have not had prior heart disease. For others, they recommend treatment if a person's risk is greater than 7.5 percent in the next 10 years.

In the other JAMA study, scientists investigated the economic implications of various thresholds for treatment. Using an economic simulation model, they found that the 7.5 percent risk threshold was economically attractive compared with many other investments in health care. And, in fact, they found that even a risk as low as 4 percent was economically attractive for society.

For people contemplating statin therapy, the cost is quite low anyway. Most statins are generic now, and several can be bought for only a few dollars a month.

From my perspective, the researchers' findings give further support to the efforts to base the decision on the patient's preferences. It is not unreasonable from an economic perspective to support treatment decisions for even those who have a low risk of cardiovascular disease (lower than 0.5 percent a year), the researchers are saying.

The issue is the need to weigh known and unknown side effects, which are particularly important for those with low risk of heart disease and stroke and less likelihood of benefit.

The drugs are generally safe. But known side effects may involve muscle problems and diabetes, among other. The unknown side effects are, well, unknown, but there is always a possibility that lifelong therapy will involve some issue that we have yet to discover.

So what about your decision?

In the end, I don't believe the guidelines should dictate what people should do, but only suggest how they might think about their choices.

One of the new studies endorses the idea that treating based on cardiovascular disease risk is better than treating based on some target level. The other one suggests that treatment based on risk should be available to even low-risk people if they want treatment. We should also be clear that for them, the benefit is small and could easily be offset by any aversion to taking medications or concern about side effects.

For anyone, the decision should be about whether the potential benefit is big enough to you, based on your preferences, to make it worth taking a pill every day.

Harlan Krumholz is a cardiologist and the Harold H. Hines Jr. Professor of Medicine at Yale University School of Medicine. He directs the Yale-New Haven Hospital Center for Outcomes Research and Evaluation and is a director of the Robert Wood Johnson Clinical Scholars Program at Yale.

Copyright 2015 NPR. To see more, visit http://www.npr.org/.
Categories: NPR Blogs

Biohackers Aim To Make Homebrew Insulin, But Don't Try It Yet

Wed, 07/15/2015 - 7:33am

Glowing bacteria is part of a project on the open-source laboratory Arcturus BioCloud.

Courtesy of Arcturus BioCloud

Might people with diabetes someday be able to brew their own insulin for free at home, just as with beer? The answer may be yes, but whether it's a good idea is another question.

The home-brewed insulin concept is among the latest to emerge from the bio-hacking movement, in which people meet to tinker with biology in inexpensive do-it-yourself laboratories that have popped up in California, New York and a few other places in the United States and Europe.

The field is small so far — around six or seven real biohacker labs, with between five and 40 active members — but interest is growing.

"People wanted to do science outside of classical institutions like universities or big corporations, so we embraced it," says Ryan Bethencourt, an entrepreneur who co-founded San Francisco-based Indie.Bio, which provides seed funding for biotechnology startups. Bethancourt has also worked with several pharmaceutical companies in product development.

Ryan Bethencourt, who is leading the project to biohack insulin, speaks at Indie.Bio Demo Day in San Francisco.

Michael O'Donnell/Courtesy of Ryan Bethencourt

Beyond the creation of a glow-in-the-dark plant, few concrete products have thus far emerged from the biohacking movement. Bethencourt wants to change that.

The insulin idea came from speaking with a friend and fellow biohacker who has Type 1 diabetes and requires costly insulin to stay alive. Even with insurance coverage, a three-month supply can total hundreds of dollars out of pocket. Bethencourt says: "Anthony and I have discussed this for two years. Why is insulin so expensive?"

Indeed, while some of the older insulins are off patent or soon will be, in the United States there are currently no insulin biosimilars — the rough equivalent of "generic" for biological medicines — although one has been approved in Europe. Even with biosimilars, the cost isn't as comparatively low as it is for generic synthetic drugs versus brand names.

About 6 million people in the U.S. use insulin, including all of the 1 to 2 million with Type 1 diabetes and about 15 percent of those with Type 2 diabetes. In poor countries, children still die for lack of it.

Shots - Health News Why Is Insulin So Expensive In The U.S.?

"Insulin is the first medicine we're trying this with. It is probably the largest need of any biologic drug I know of," says Bethencourt.

In fact, biohacking it isn't that hard to do: Lab equipment costs have come down considerably in recent years, and the DNA sequences for recombinant human insulin and for the newer analogs are public information.

Bethencourt wants to use a cloud-based automated laboratory platform that would take DNA, insert it into bacteria and make insulin at a far lower cost than the commercial product.

He's planning to crowdfund about $2,000 for the equipment to get it going.

"We'll start by saying it's research only, and make it available to all the biohackers and any researchers who want open-source insulin," Bethencourt says. "Then we have to figure out how to increase the yield and how to purify it. Then people can start using it. They can brew it, like beer."

His ultimate goal is free insulin for everyone who needs it, in the U.S. and globally.

But Dr. Marcus Hompesch, president, CEO and a founder of the Profil Institute for Clinical Research, Inc. in San Diego, says the home-brewing idea is irresponsible and foolhardy. "Manufacturing insulin or any peptide or any biologic for that matter is a very complex affair. If you don't understand what it all entails, you could end up manufacturing something that is downright dangerous for patients."

Making recombinant human insulin is a multistep process, Hompesch explains, and "at any step of the way, things can go wrong .... It's highly regulated." Among the risks, he said, are that a protein sample that is either contaminated or isn't treated properly could trigger an immune response in the recipient that could then cross-react with and neutralize other insulins the patient might be receiving or, in the case of Type 2 diabetes patients, their remaining naturally-produced insulin.

Patients might have to make significant dose changes, which could adversely affect their diabetes control. Hompesch says. More significant immune reactions could happen as well.

Hompesch, who has published extensively on biosimilar insulins, says the discussion of biohacking insulin worries him because it is actually possible. "Practically, it can be done," he says. "The technological hurdle isn't one that couldn't be overcome." Getting it done right is not trivial, he adds. "As a clinician and researcher I wouldn't want to see a large biohacking experiment in patients even started."

But Bethencourt believes the biohacking community, which includes molecular biologists, is capable of addressing the challenges involved with making the protein consistently and safely. "At first, it will not be safe. That's why we have to make it available so other people can develop ways of ensuring that it's safe," he says. "We would get it at least to the same level of safety as current therapeutics. We'd want to use the same technology. We're just trying to make it cheaper."

For now, "The aim for me is more of a statement and concept piece." Bethencourt says. "I want to start a revolution in the way therapeutics are made, starting with insulin."

Miriam E. Tucker is a freelance journalist specializing in medicine and health. You can follower her on Twitter @MiriamETucker.

Copyright 2015 NPR. To see more, visit http://www.npr.org/.
Categories: NPR Blogs

Early Push To Require The HPV Vaccine May Have Backfired

Tue, 07/14/2015 - 3:58pm

HPV vaccine prevents cervical cancer and other cancers by fending off the virus that causes them. But it's been a tough sell with doctors and parents.

Joe Raedle/Getty Images

Nine years after it was first approved in June 2006, the HPV vaccine has had a far more sluggish entree into medical practice than other vaccines at a similar point in their history, according to a report in Tuesday's JAMA.

This might not surprise those who remember the early days of the human papillomavirus vaccine, which was targeted at girls aged 11 and 12 to prevent a sexually transmitted infection that causes cancer — but which opponents quickly branded as a vaccine that would promote teenage promiscuity.

Jason Schwartz, a health policy researcher at Princeton University's Center for Human Values, and his undergraduate research assistant Laurel Easterling compared state requirements for the HPV vaccine with those for three other vaccines introduced since 1990. That includes another used to prevent a sexually transmitted infection that causes cancer.

Eight years after the meningococcal vaccine was introduced, according to the JAMA report, it was required for middle school admission in 21 states and the District of Columbia. At the same point in its history, the vaccine against varicella, the virus that causes chickenpox, was required in 38 states and D.C. And 36 states and D.C. required the vaccine against hepatitis B — which, like HPV, is a sexually transmitted infection linked to cancer, in this case liver cancer (though, unlike HPV, it is given to infants, not preadolescents).

By comparison, eight years after it was introduced, just one state, Virginia, and D.C. required the HPV vaccine for middle school enrollment. And both have easy opt-out clauses for parents. Next month, it will also be required in Rhode Island.

The most widely used vaccine, sold under the brand name Gardasil, protects against nine strains of human papillomavirus (the original version protected against four strains) that together account for about 90 percent of cervical cancer in the U.S., as well as a large proportion of vulvar cancer, anal cancer and genital warts. But according to the CDC's most recent data from 2013, just 37.6 percent of American teenage girls have received all three doses of the HPV vaccine, and just 13.9 percent of American teenage boys.

Why such dismal acceptance rates for HPV? Part of the problem is that the original testing on the vaccine was done only on girls, and its 2006 approval was for girls only; approval for boys didn't come until 2009, and it wasn't added to the list of recommended vaccines for boys until 2011.

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So early lobbying for state mandates was easily twisted to language that cast the HPV vaccine as "a vaccine that would introduce sexual activity in young women, that would inappropriately introduce promiscuity," says Sarah Gollust, an assistant professor of health policy and management at the University of Minnesota School of Public Health.

"If they had waited until it was recommended for both boys and girls, that would have made a big difference," says Gollust, who was not involved in the study. "No other vaccine is required for just one gender, so it felt like there was something different about this one."

Another reason may be the early push to require the HPV vaccine, Schwartz says. "There was such an outcry for requirements, just days and weeks after [the HPV vaccine] was introduced," he says. "I think it backfired. Even if well intentioned, it wasn't the right time to talk about requirements. That should come at a particular time in a vaccination program, when all the foundational work has been in place" — work that he says includes making sure that questions of safety, supply and financing have been addressed, and that mechanisms of public health education are in place.

Instead, what HPV got was a rapid, possibly premature push toward legislation to mandate its use — an effort that turned out to be largely promoted by the manufacturer of Gardasil, the pharmaceutical giant Merck. "For state legislators and state health departments, there may be a reluctance to return to that heated and contentious atmosphere," Schwartz says.

The sense that the vaccine is controversial has stuck in the American mindset, Gollust says — even if the exact particulars of the controversy are forgotten. As a result, even pediatricians are hesitant to recommend the vaccine for 11-year-olds, fearful of bringing up a conversation with parents that could involve adolescent sexuality.

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"I think the biggest place to push here now is on the provider conversation, having providers disuses the vaccine with their patients as they would discuss any other vaccine," she says. According to Gollust, the single most important factor in whether a young person is vaccinated against HPV is whether his or her doctor recommends it.

The CDC is trying to do some catch-up to reframe the debate, focusing on that provider-initiated conversation. It has given grants to public health agencies in seven states to conduct campaigns targeting what Schwartz calls "HPV exceptionalism."

As Minneapolis physician Jon Hallberg, the narrator of the CDC-supported video from Minnesota's Department of Health, tells his peers: "We now have a way to prevent today's adolescents from developing certain forms of cancer tomorrow, and all we have to do is treat the HPV vaccine just like any other: take every opportunity to recommend it, give the doses on schedule and be prepared to answer any question, just as you would for any other vaccine. No drama needed."

Science writer Robin Marantz Henig is a contributing writer for The New York Times Magazine and the author of nine books.

Copyright 2015 NPR. To see more, visit http://www.npr.org/.
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When Weed Is The Cure: A Doctor's Case for Medical Marijuana

Tue, 07/14/2015 - 2:59pm
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Additional Information: Stoned

A Doctor's Case for Medical Marijuana

by David, M.d. Casarett

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A year and a half ago, Dr. David Casarett did not take medical marijuana very seriously. "When I first started this project, I really thought of medical marijuana as a joke," he tells Fresh Air's Terry Gross.

But then the palliative care specialist began to look seriously into the issue, and his mind began to change: "I've come to realize there really are medical benefits to medical marijuana. ... For many of the patients I spoke with, medical marijuana is not a joke. It's not funny. It's a treatment that they've come to rely on."

While researching his new book, Stoned: A Doctor's Case for Medical Marijuana, Casarett examined the limited medical studies related to the drug's use, traveled to places where it is being used legally and tested it on himself. He also spoke to patients who had used the drug to treat a variety of ailments, including seizures, post-traumatic stress disorder and neuropathic pain.

The book lays out the case for marijuana's medicinal use — as well as for more research into the drug's long-term effects. "There's a fair amount of science behind it," Casarett says. "Those are medical benefits that people in the medical marijuana world — including advocates and patients — really take seriously."

Interview Highlights

On the use of medical marijuana to treat neuropathic pain

It turns out that some of the best evidence for medical marijuana is actually for what's called neuropathic pain, which is pain that's caused by the nerves themselves. So unlike pain that's caused by arthritis or sometimes some kinds of cancer in which the nerve endings of pain fibers are stimulated, which causes pain, neuropathic pain is caused by disruption of or damage to the nerves themselves. ... That kind of pain can be really, really difficult to treat. ... In my experience as a palliative care physician, it doesn't respond nearly as well as more traditional nociceptive pain does to drugs like morphine. So there really is a need to find newer, better treatments for neuropathic pain. And so there have been a lot of trials focusing on medical marijuana for neuropathic pain, because other alternatives for treatment are really pretty limited.

On his own experience using medical marijuana for back pain

Dr. David Casarett directs the hospice and palliative care program at the University of Pennsylvania.

Joe Chielli/Church Street Studios

I was really hoping for any form of relief whatsoever, even just a few hours of relief from those muscle spasms, and I found it. I found it though, at least for me, at the cost of most of the most common side effects of acute use of medical marijuana — confusion, hallucinations. I think — mostly because the dose I gave myself, being relatively unfamiliar with marijuana and very unfamiliar with the strength of what I managed to obtain — [I] was really blindsided by some of the acute side effects like confusion and hallucinations, which I honestly should have expected, but didn't. ...

[I heard] air traffic controllers vectoring flights into and out of the Phoenix airport — those voices were coming from my living room, where there really weren't any air traffic controllers.

On the two main cannabinoids in medical marijuana

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There are actually a lot of cannabinoids out there. There are dozens that are present naturally in medical marijuana, and there are probably over 100 synthetic cannabinoids, so there's actually a fairly large family of these cannabinoids, of which most we have no idea what they do at all. Many of the synthetics, for instance, have never been tested in humans. The two that we know the most about are THC [tetrahydrocannabinol] and CBD [cannabidiol]. ...

So THC is most important and most popular because it's the cannabinoid that is responsible for the high feeling of euphoria. ... CBD is a bit more of a mystery because it doesn't have any of those really obvious effects that THC does. We know a little bit about what it does, because we know where those receptors are. We know that CBD binds to receptors in the brain but not on neurons; it binds to receptors on something called microglial cells which are the cells that wrap around neurons and are responsible for some of the neuron's structure, holding them together. But they also have an immune function. They're sort of the brain's immune cells. ... CBD also binds to cells in the immune system, so CBD receptors are fairly common in lymph nodes and also in areas of the body where there's a lot of immune activity like the [gastrointestinal] tract.

On using medical marijuana but avoiding the high

That's already happening in a couple of ways. There are strains of marijuana that have been tested, dispensaries sell these; so you can go into a dispensary where marijuana is legal and ask for a strain that is a low-THC high-CBD strain, for instance, if you're really interested in those effects. ...

An anesthesiologist and a pain researcher I spent some time with, researching this book, is very interested in the use of marijuana to treat neuropathic pain. And he's becoming increasingly convinced that it might actually be CBD and not THC that's responsible for some of the benefits for neuropathic pain. And he's doing clinical trials that are involving lower and lower amounts of THC and higher and higher amounts of CBD, and seeing some of the same effects on pain. Which is interesting, because again, CBD doesn't cause that high, euphoric feeling, but if it has therapeutic benefits, there are enormous opportunities for figuring out how to use that appropriately and productively for those people — and there are a lot of them — who really don't want to feel high. They don't want any of that recreational marijuana feeling. They really just want relief of pain or nausea.

On the problem with eating medical marijuana

There's no question that the war on drugs has set back medical marijuana research and cannabinoid research in general by probably decades.

The problems with eating [marijuana] are twofold: One is the absorption time can be widely variable, so you and I might eat a square of marijuana-infused chocolate at the same time but — because of differences in the way that our GI tracts work, differences in the degree that our livers metabolize the main forms of cannabinoids that are occurring in medical marijuana (CBD and THC) — you may feel the effects within 15 minutes, [and] I may not feel those effects for an hour or more. Or I may never feel those effects, or vice versa.

Also, in general, it takes a long time — long in terms of half an hour to an hour — before people begin to feel the full effects. And a common problem that many first-time users experience is eating a brownie or a square of chocolate or a gummy bear, waiting for 15, 20 minutes, not feeling any effect. And so they try another one and another one and another one, all the while those doses are stacking up, so when they begin to feel an effect in an hour [or] hour and a half, they've taken too much. ... So it's fairly easy to get the active ingredients of medical marijuana by eating, but it takes some care and some timing and some familiarity with what you're doing, how you're doing it and what the concentrations of THC and CBD are in that gummy bear or that square of chocolate.

On how the war on drugs has affected medical marijuana research

There's no question that the war on drugs has set back medical marijuana research and cannabinoid research in general by probably decades. Marijuana in the United States is classified as a Schedule 1 substance, which is reserved for those substances like heroin that have significant risks, including the risk of addiction, but, in theory, [have] no medical benefits. And that categorization really has slowed down the process of research. It's been hard to get medical marijuana; it's been hard to do clinical trials; it has left a lot of patients essentially to their own devices.

Copyright 2015 NPR. To see more, visit http://www.npr.org/.
Categories: NPR Blogs

Would Banning Headers In Soccer Solve The Concussion Problem?

Tue, 07/14/2015 - 11:12am

Heading the ball in soccer has been accused of causing most concussions. But the hazard may be more due to rough play than to one particular technique, researchers say.

The risks involved in heading — when a player uses their head to keep the ball in play — are not new. But Dawn Comstock, an injury epidemiologist at the University of Colorado's School of Public Health, wanted to know if headers are indeed the chief cause of concussions.

She became curious after learning of the Safer Soccer Campaign, a collaboration between the Sports Legacy Institute and several former U.S. Women's soccer stars that was formed to try to ban heading in youth players under age 14. Though she respected their motives, Comstock wanted to be sure the changes the group proposed would really make a difference. "I like to see kids kept safe," she says, "but I like to see that the evidence is data-driven."

To find out the cause and frequency of concussions in youth soccer, Comstock and her colleagues looked at nine years of data on high school soccer players. They found that although heading is the phase of play most frequently associated with concussions, accounting for 30 percent of concussions in boys and 25 percent in girls, many concussions weren't coming from the impact of the player's head with the ball. Instead, most concussions, including those that happened while heading the ball, resulted from athletes colliding.

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The study, published Monday in JAMA Pediatrics, showed that athlete-athlete contact was responsible for 69 percent of concussions in boys and 51 percent of concussions in girls.

"Our takeaway from that," Comstock says, "is yes, if you ban heading in soccer, you would prevent some concussions." But, she says, enforcing the rules of the game might make a bigger difference. "They're willing to completely eliminate a phase of play," she says, "But nobody is willing to address the elephant in the room, which is rough play."

A lot of the athlete-athlete contact is unnecessary and illegal, Comstock says, and can be controlled by playing by the rules. "Coach fair play, coach technique," she says, "And ensure officials enforce the rules of the game."

One problem is that this aggression plays out on the world stage—and on our TVs at home. Like that heart-stopping moment in the Women's World Cup semifinal game when Morgan Brian and Alexandra Popp collided in mid-air. Both women were attempting to head the ball; their heads cracked together and both crumpled to the ground. "Our children emulate what they see their sports stars do," Comstock says. "If they see the women in the World Cup playing so aggressively, they will translate that to the field." But we have the ability to stop it, she says. "We control the level of aggressiveness we see."

And if we are permissive about athlete-athlete contact, if we look the other way when the rules are broken, we foster an environment where players can get hurt, she says. In that case, a ban on heading would be better than nothing. "If we're not going to control the aggressive play, if we keep letting soccer evolve into a game that's starting to look like football, by all means ban heading," she says. "We will keep some kids safe."

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Other studies have found similar results, including one by John O'Kane, a sports physician and professor at the University of Washington Medical Center who was not involved in the study. He, too, thinks that banning heading might not solve the whole problem. "Heading is part of the sport and while there is risk involved, no sport is completely safe," he says via email. "The question is how to make heading and soccer in general safer, especially for kids."

O'Kane agrees with the call to reduce contact between players. "I believe that we place an emphasis on winning over learning proper technique at too young an age," he says, "The result is teams with big, fast aggressive players that win by running over people instead of playing good soccer."

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One concern O'Kane has with Comstock's study is that it relies on the players to report their own injuries to an athletic trainer, and not all players do. Comstock acknowledges that this is a limitation, but says concussions are tricky to diagnose conclusively. It's not like a broken bone, where a doctor can order an X-ray; most concussions are diagnosed based on self-reported symptoms. "This [study], we feel, is a reliable snapshot of what's actually happening to athletes in a high school setting across the U.S.," she says.

One thing Comstock doesn't want, she says, is for parents to see the results of her work and pull their kids out of sports. "I want more kids to play sports more often," she says. "I just want all adults around youth sports to keep them safe." And she thinks that controlling aggression might be the best way to do that.

"Every kid just wants to play," she says. "They'll play by whatever rules you tell them they have to."

Copyright 2015 NPR. To see more, visit http://www.npr.org/.
Categories: NPR Blogs

FDA To Take Another Look At Essure Contraceptive Device After Health Complaints

Tue, 07/14/2015 - 10:41am

Amanda Dykeman, 33, of Coal Valley, Ill., had Essure devices removed after having multiple health problems.

Tara Haelle for NPR

When Amanda Dykeman was certain she was done with having children, she had two options for permanent birth control: surgical sterilization, which typically involves general anesthesia and a laparoscopy, or Essure, the only nonsurgical permanent birth control option approved by the Food and Drug Administration.

She chose Essure. And she says her life has never been the same.

"Physically, it has permanently ruined my body inside and out," said Dykeman, now 33 years old, of Coal Valley, Ill. "Mentally I've never been stronger. You have to force yourself to be, or you'll never make it."

The Essure device is a permanent form of birth control that is implanted in the fallopian tubes.

Courtesy of Bayer HealthCare

Essure, approved by the FDA in 2002 for women ages 21 to 45, is a very soft, flexible metal spring made from a nickel-titanium alloy. OB-GYNs insert one Essure coil into each fallopian tube. Over the next several months, scar tissue grows around it, thereby blocking the tubes and preventing eggs from becoming fertilized or making their way to the uterus. Women must return three months after the procedure for a follow-up X-ray using dye to confirm that the tubes are fully blocked, at which point the method is considered 99.83 percent effective.

After undergoing the implantation of the device in September 2010, Dykeman experienced a range of symptoms: chronic fatigue, migraines, joint pain, digestive issues, back pain, heavy periods full of clots, difficulty concentrating, abdominal pain, hair loss, tooth deterioration, depression and such severe bloating she sometimes refused to go out in public because she feared being asked if she was pregnant.

She attributed most of these to simply aging until she missed a period in July 2012. She found her way to a Facebook group then of more than 18,000 women who have experienced similar problems and others, ranging from mild to serious, that they attribute to Essure.

Although Essure is designed to be permanent, many of the women, like Dykeman, have had it removed. The women call themselves "E-sisters," and they are frustrated that their doctors, the FDA and Bayer, the manufacturer of the device, have dismissed their concerns for years.

For its part, Bayer said the product passed a detailed analysis by the Food and Drug Administration before the company could sell it. "Essure was reviewed through the premarket approval process for Class III medical devices, the most stringent type of device marketing application, according to the FDA," said Tara DiFlumeri, a spokeswoman for Bayer.

"We don't understand," Dykeman said, "if all of these women are reporting the same symptoms, why aren't we being taken seriously?"

Now the FDA is taking them seriously. The agency updated the short- and long-term risks listed on its website, as well as adverse events reported through May. The FDA also scheduled a public advisory meeting of its Obstetrics and Gynecology Devices Panel on Sept. 24 that will bring together experts, physicians and patient and industry advocates to review the data and hear public comments from women.

It isn't yet clear what questions the committee will consider. Possibilities might include whether Bayer will need to amend labeling or whether additional studies are needed, among other possibilities, said FDA spokesman Eric Pahon.

"I'm anxious to attend the hearing and demonstrate everything we've learned about Essure and its safety and efficacy over the years," Dykeman said. "If the right people are in attendance and they really listen to what we have to say, I believe they will have no choice but to take some kind of disciplinary action."

One big question that will hang over the meeting is whether Essure actually causes many of the problems these women are experiencing, and how common these problems are.

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According to Elizabeth Micks, an OB-GYN and contraception specialist at the University of Washington Medical Center in Seattle, women commonly complain about various concerns that they attribute to their method of birth control, even if their method cannot feasibly cause some of those complaints.

"Some are valid, and some may not be valid, and it's hard to really know in some cases whether the method is causing the patient's complaints," Micks said. "I think it is very clear that some women have been harmed by the Essure device. Whether that means it should not be an approved method isn't clear."

Based on clinical trial data, approximately 9 percent of women experience mild to moderate pain during the procedure, and 13 percent experience it immediately afterward. Other known effects immediately after the procedure include cramping, vaginal bleeding, nausea, vomiting, fainting and pelvic or back pain for several days. Rarely, the body can expel a coil.

Long-term risks include rare cases of chronic pelvic pain; allergic reactions to the nickel; a coil that perforates the fallopian tube or uterus; or cases where the coil migrates through the tubes, requiring surgery. Women with Essure also have a higher risk of ectopic pregnancies.

A five-year study of the device after it went on the market didn't reveal any new safety concerns — such as extreme fatigue, depression or weight gain — or an increase in known ones, the company reports.

Insufficient data is among the primary complaints of the E-sisters, Dykeman said, especially since most research to date has been funded by Bayer or by Conceptus Inc., the company that developed the device and was then acquired by Bayer.

Micks also said she would like to see more data on long-term complications. The longest study currently available is a 10-year retrospective study, which primarily focused on pregnancies and the method's effectiveness. Another seven-year retrospective study found a low risk of complications.

"Most of the data we have are from the clinical trials, and you can't necessarily go by the clinical trial data in looking at complications because obviously some women in real life practice aren't following up, so we don't really know if they have a malposition of their coils," Micks said. "It's frustrating to be told we don't have the data, but I feel like the terrible cases I've seen are really people who were not properly informed about the risks and benefits ahead of time. I think the bigger problem is what physicians are communicating with patients."

Dykeman's pain and symptoms led her to request a hysterectomy in May 2013. Her surgical report included chronic inflammation of the cervix, several attached blood clots and a photo showing a coil outside her left fallopian tube. Although her symptoms improved after her hysterectomy, they have not all vanished. She still experiences chronic fatigue, back pain, digestive issues and bloating. "I was recently told my entire abdomen is full of adhesions that attach my organs together with bands of scar tissue, making it hard for my food to digest," she said.

According to Bayer spokeswoman Rosemarie Yancosek, the company has read the personal stories from women about their experiences with Essure. "These stories, while compelling, are not representative of the hundreds of thousands of women who have relied on Essure since its FDA approval in 2002," she said via email.

"Given there has been a great deal of interest in the safety of Essure among some patients, we welcome this open dialogue with health care providers, patients, researchers, representatives from professional societies and other members of the public to review and discuss available data regarding the benefits and risks associated with Essure," Bayer spokesperson Tara DiFlumeri said in another email.

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Micks said she has definitely seen complications from the device, including ones where the physicians clearly deviated from standard clinical practice. In one recent case, a woman's follow-up X-ray showed improper placement of the coils. But instead of laparoscopic surgery to address the issue as should happen, the patient — who ultimately became pregnant — underwent the Essure procedure a second time and was later found to have three coils perforating the uterus on one side.

"In medicine, anything that can go wrong will go wrong, so it's a matter of looking at numerators and denominators," said Dr. Jeffrey Jensen, director of the Women's Health Research Unit of the Center for Women's Health at Oregon Health and Science University in Portland. Jensen has consulted for Bayer HealthCare for many years, but not on Essure. He is also working with other researchers to make a better, cheaper alternative to Essure using grant funds from the Bill & Melinda Gates Foundation.

The denominator, in this case the number of people who have Essure, is well-established. Approximately 750,000 women have been implanted with the device, Bayer reports. It is the numerator, or the people who have problems with the device, where the numbers get fuzzier.

Patients and doctors can report problems that occur after implantation of a medical device to the FDA's Manufacturer and User Facility Device Experience database. However, the device surveillance system is passive, which means anyone can report anything that happens, whether it is related to the device or not. Further, some problems may be double- or triple-reported, while others may go unreported entirely.

Since Essure's approval, the FDA has received more than 5,000 reports of medical problems linked to Essure, primarily abdominal pain, headaches, fatigue and weight fluctuations, the agency said. In more than 400 accounts, patients or doctors have reported that Essure coils migrated from the fallopian tubes to other parts of the reproductive system. There have been five reported fetal deaths after Essure failed to prevent pregnancy. Again, however, it is unknown how many of those 5,000 reports are duplicates, and how many are problems caused by Essure.

Further, any problems associated with Essure would have to be compared against the risks of laparoscopy, pregnancy and other forms of birth control.

"Essure is not perfect, but no method is," Oregon Health and Science University's Jensen said. "It is an important option that should be available to women as an alternative to general anesthesia and laparoscopy." Jensen hopes the FDA will allow the product to continue being used, but whatever the agency decides, it should be based on data, not case reports, he said. "The individual who posts on the Internet or gets interviewed about her unique problem is one in the denominator of the hundreds of thousands of these procedures that have been completed safely worldwide."

What is clear is that women need good options for contraception, the University of Washington's Micks said. "We know that pregnancy exposes women to a whole host of medical problems and has a huge impact on their lives," she said. "Contraception is life and death for women."

Tara Haelle is a freelance health and science writer based in Peoria, Ill., and is on Twitter: @tarahaelle. She is also the medical studies core topic leader for the Association of Health Care Journalists.

Copyright 2015 NPR. To see more, visit http://www.npr.org/.
Categories: NPR Blogs

Administration Proposes Rules To Modernize Nursing Home Safety

Mon, 07/13/2015 - 11:23am

After nearly 30 years, the Obama administration wants to modernize the rules nursing homes must follow to qualify for Medicare and Medicaid payments.

The hundreds of pages of proposed changes cover everything from meal times to use of antipsychotic drugs to staffing. Some are required by the Affordable Care Act and other recent federal laws, as well as the president's executive order directing agencies to simplify regulations and minimize the costs of compliance.

"Today's measures set high standards for quality and safety in nursing homes and long-term care facilities," Health and Human Services Secretary Sylvia Burwell said in a statement. "When a family makes the decision for a loved one to be placed in a nursing home or long-term care facility, they need to know that their loved one's health and safety are priorities."

Officials unveiled the update as the White House Conference on Aging convenes Monday. The once-a-decade conclave sets the agenda for meeting the diverse needs of older Americans, including long-term care options. This month also marks the 50th anniversary of the Medicare and Medicaid programs, which cover almost 125 million older, disabled or low-income Americans. Medicare and Medicaid beneficiaries make up the majority of residents in the country's more than 15,000 long-term care facilities.

"The existing regulations don't even conceive of electronic communications the way they exist today," said Dr. Shari Ling, Medicare's deputy chief medical officer. "Also there have been significant advances in the science and delivery of health care that just weren't imagined at the time the rules were originally written. For example, the risks of antipsychotic medications and overuse of antibiotics are now clearly known, when previously they were thought to be harmless."

The proposed regulations include a section on electronic health records and measures to better ensure that patients or their families are involved in care planning and in the discharge process. The rules also would strengthen infection control, minimize the use of antibiotic and antipsychotic drugs and reduce hospital readmissions.

Revised rules would also promote more individualized care and help make nursing homes feel more like home. For example, facilities would be required to provide "suitable and nourishing alternative meals and snacks for residents who want to eat at non-traditional times or outside of scheduled meal times."

Residents should also be able to choose their roommates. "Nursing facilities not only provide medical care, but may also serve as a resident's home," the proposed rules say. "Our proposed provision would provide for a rooming arrangement that could include a same-sex couple, siblings, other relatives, long term friends or any other combination" as long as nursing home administrators "can reasonably accommodate the arrangement."

Consumer advocates are likely to be disappointed that officials are not including recommendations to set a federal nurse-to-resident ratio.

However, the proposed changes would require that nurses be trained in dementia care and preventing elder abuse to better meet residents' needs.

"We believe that the focus should be on the skill sets and specific competencies of assigned staff," officials wrote in the proposed rules, "to provide the nursing care a resident needs rather than a static number of staff or hours of nursing care that does not consider resident characteristics."

Nursing homes will be required to report staffing levels, which Medicare officials said they will review for adequacy.

"It's a competency approach that goes beyond a game of numbers," said Ling. "If residents appear agitated, figure out why, get at the cause of the problem," she said, instead of resorting to drugs to sedate residents.

Advocates for nursing home residents argue that because of inadequate staffing, residents with dementia are often inappropriately given antipsychotic drugs, even though that can be dangerous for them. The new rules would help control the use of these drugs by requiring the facility's pharmacist to monitor drugs that are prescribed for excessive periods of time or other irregularities and require the resident's physician to address the problem or explain in the resident's medical record why the medication is necessary.

"We don't have enough nursing staff," Toby Edelman, a senior policy attorney at the Center for Medicare Advocacy, said before the rules were released. Federal law requires only one registered nurse on the day shift for a 20-bed facility or as much as a 500-bed facility, licensed practical nurses around the clock and sufficient staff to meet residents' needs, she said.

"We don't look at the specific staffing positions per se," said Greg Crist, a spokesman for the American Health Care Association, which represents 11,000 skilled nursing facilities. "We look at the needs of the individuals when determining staff levels, and that is best addressed in the resident's care plan."

Although there are also no provisions addressing enforcement in the proposed rule, Ling said it "will permit detection of violations to enable enforcement by lessening the noise."

Additional Information: Web Resources Risk with blood thinners in nursing homes

"The biggest problem is that the rules we have now are not enforced," said Edelman. "We have a very weak and timid enforcement system that does everything it can to cajole facilities into compliance instead of imposing penalties for noncompliance."

A report by the Center for Medicare Advocacy last year found that some serious violations often were not penalized.

"Once the new rules are finalized, they will be added to the items nursing home inspectors check," Ling said.

Copyright 2015 Kaiser Health News. To see more, visit http://www.kaiserhealthnews.org/.
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Waiting To Pick Your Baby's Name Raises The Risk For Medical Mistakes

Mon, 07/13/2015 - 10:46am

Hands holding one week old baby boy.

Leanne Temme/Getty Images

Some parents pick out a name for their child as soon as the pregnancy test turns positive. For others, the choice of a name is a game-time decision, taking minutes, hours or even a day or two after birth.

My own baby went unnamed for about 20 minutes as my husband and I tried to figure out which of our top choices best fit her screamy little face.

Hospitals, however, have to put an identification bracelet on the baby ASAP. Most resort to generic names based on the mom's last name, like Babygirl Hobson. And once the infant is in the system with that name, it's often locked in until discharge, even after the parents pick a permanent one.

That convention, say the authors of a paper published Monday in the journal Pediatrics, is a problem.

The researchers believe that those widely used nondistinctive names increase the risk of mistakenly giving a treatment to the wrong patient. That's especially a fear if the newborn is one of the 12 percent that ends up in the neonatal intensive care unit, given the complexity and high stakes of that environment. "All neonatologists know this is a problem, but weren't able to quantify it," says Jason Adelman, an internist and patient safety officer at Montefiore Health System in New York and an author of the study.

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Adelman and his colleagues came up with a new naming convention that incorporates the mom's first name. Instead of Babygirl Hobson, my daughter would instead be tagged as Katherinesgirl Hobson. Twins would be called 1Katherinesgirl and 2Katherinesgirl, rather than the conventional BabygirlA and BabygirlB. (Another system using temporary names like CutiePie and BuggyBear was rejected, says Adelman.)

Researchers compared the rate of so-called retract-and-reorder events in the years before and after the intervention. Retract-and-reorder is a tool that uses the hospital's computer system to flag medical orders retracted by a health care worker and then placed by the same worker on a different patient within a short time period. There was a 36 percent decline in those RAR events in the year after the intervention compared to the earlier period.

The result isn't definitive proof that this new system beats the old one, but it might be enough for some hospitals to consider switching, says Adelman. (The study wasn't big enough to say whether the system specifically reduced RAR events in multiple births.)

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One caveat is that the RAR tool isn't measuring errors, but near misses. "Say I'm driving down the highway and I almost take the wrong exit but then swing back into the right lane and take the correct exit later," says Gautham Suresh, a neonatologist who is chief medical officer of Texas Children's Newborn Center in Houston. "RAR is catching those times when I almost took the wrong exit." RAR also slightly overidentifies wrong-patient errors because it includes some false positives, the authors note. "Ultimately, we want to prevent harm," says Suresh.

He calls the research innovative and says it moves the field forward, but that it's not yet clear whether this system should be recommended for use elsewhere. The issue, he says, merits attention. "The way we name babies in the hospital has to really be thought of very carefully," says Suresh.

Adelman says while this study looked only at computerized orders, the new naming system also has the potential to lower the rate of other kinds of errors, like grabbing the wrong container of pumped breast milk out of the refrigerator. And Suresh notes that other factors may play into wrong-patient mistakes, such as human distraction or poor lighting. "Patient identification errors are complex, and the name is only part of the puzzle," he says.

Copyright 2015 NPR. To see more, visit http://www.npr.org/.
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Engineering A Shingles Vaccine That Doesn't Wimp Out Over Time

Mon, 07/13/2015 - 5:04am
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The varicella zoster virus causes chickenpox in children, then lurks in the body for years and can cause painful shingles later in life.

James Cavallini/Science Source

If you had chickenpox as a child, then you're at risk for shingles. As you age, the risk increases, probably because the immune system weakens over time.

The varicella zoster virus can hide in the body over a lifetime and suddenly activate, causing a painful, blistery rash. Even when the rash disappears, pain can linger and worsen, causing a burning, shooting, stabbing pain so severe it can leave people unable to sleep, work or carry on other activities.

There is a vaccine on the market. The Centers for Disease Control and Prevention recommends it for people age 60 and older. But it's not very effective. It prevents shingles 64 percent of the time overall, but loses effectiveness as years go by, just when people are getting more susceptible. By the time people turn 70, the vaccine is only 38 percent effective.

A new vaccine that offers nearly complete protection against the painful shingles rash may be on the market as early as 2017.

The vaccine, developed by the pharmaceutical company GlaxoSmithKline, has proved to be effective more than 97 percent of the time regardless of age, says Dr. Leonard Friedland, GSK's director of scientific affairs and public health. That study involved more than 16,000 patients age 50 and older, with some patients well into their 80s. The high degree of efficacy was there for all ages, Friedland says.

What's different about this vaccine is something called an adjuvant — a chemical added to the vaccine with the sole job of "waking up" the immune system. The technology has been used in other vaccines, but not for shingles. Researchers are now looking at the potential for adjuvants in vaccines for older adults, says Dr. William Schaffner, an infectious disease specialist at Vanderbilt University Medical Center.

As people age, so does their immune system. Having something to help the body respond better to the vaccine and offer more protection, "that's dynamite," says Schaffner.

But the biggest challenge may be getting older people vaccinated in the first place, according to Dr. Susan Rehm, an infectious disease specialist at the Cleveland Clinic. Even though shingles vaccine is recommended for everyone over the age of 60, only 24 percent actually get the vaccine. "That is a low number," Rehm says. "Unfortunately it's typical of many adult vaccines; we find that adults are very much undervaccinated."

That's partly because adults, unlike children, don't have regularly scheduled doctor visits to receive vaccinations. Another barrier is cost. The current vaccine costs $200 or more. Medicare covers the cost for people over 65, but payment can be complicated. Most private plans cover it, but not all of them, so some patients may have to pay the full price themselves and hope for reimbursement.

And if you're between 50 and 59, when the risk of shingles begins to increase, you'll likely have to cover the full cost, even if you have insurance. That's because while the FDA has approved the vaccine for people over 50, the CDC only recommends it for people over 60, and that's the guideline most insurance companies use.

It's not clear what the new, more effective vaccine will cost. GSK officials expect to submit data to the FDA for approval sometime in 2016, with hopes of putting the vaccine on the market by 2017.

Copyright 2015 NPR. To see more, visit http://www.npr.org/.
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Should More Women Give Birth Outside The Hospital?

Mon, 07/13/2015 - 3:37am
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Katherine Streeter for NPR

A recent recommendation from doctors in the United Kingdom raised eyebrows in the United States: The British National Health Service says healthy women with straightforward pregnancies are better off staying out of the hospital to deliver their babies.

That's heresy, obstetrician Dr. Neel Shah first thought. In the United States, 99 percent of babies are born in hospitals.

"There's really only one way of having a baby in the U.S.," says Shah, who works at Harvard Medical School and Beth Israel Deaconess Hospital. Here, he says, delivering at home or at independent birthing centers is still not considered mainstream.

Shah was asked by the New England Journal of Medicine to respond to the British recommendation. He compared birth outcomes here in the U.S. and Britain, especially the cesarean rates, which average 33 percent in the U.S. compared with 26 percent in the U.K. And he started to think the British were on to something.

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"We're taking excellent care of high-risk women," he says, "and leaving low-risk, normal women behind. We're the only country on Earth with a rising maternal mortality rate."

There are lots of reasons for the rise — increased obesity, a lack of consistent prenatal care, older women having babies. Shah also blames hospital infections, and the rise in emergency and elective C-section deliveries.

Rather than rebut the British, Shah argues in his New England Journal editorial that the practice of giving birth outside a hospital with a midwife can be safer.

"Choose the right patients," he says. "And you need to be able to link those birth centers to hospitals, like mine, that have blood banks and three operating suites and everything else."

The American College of Obstetricians and Gynecologists has been supportive of midwife-led births. But it draws the line at home birth.

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"I don't recommend home birth, and as an organization ACOG suggests that a hospital or birth center is the safest option," says Dr. Jeffrey Ecker, an obstetrician at Massachusetts General Hospital and chairman of ACOG's committee on obstetrics practice.

Women and babies are in real danger, Ecker says, if something goes wrong during a home birth. Compared with births planned for delivery in a hospital or birthing center, planned home births have a significantly higher rate of infant mortality in the U.S., studies show, though the absolute risk of the baby dying is relatively low in both cases.

Also, Ecker says, the British and American health systems are simply too different for the British recommendation to make sense for the United States.

"The system that supports home birth in the U.K. is much different than the system that currently exists in the U.S.," Ecker says. "In fact, I would argue that there is no system in the U.S."

The U.K. has universal health care, and British women are generally referred to a midwife as soon as they know they're pregnant.

Though the percentage of American women who choose a midwife-led birth is still only about 9 percent, the total is on the rise, recent statistics suggest. Most midwives work in hospitals or birthing centers.

Yinka Sokunbi worked as a midwife in London until her husband's work transferred her to Dallas last year. She was stunned at the different attitudes toward childbirth in the U.S.

"A lot of people do not know what midwives do," she says. "They have this vision of old ladies with potions and herbs."

From her training and practice, Sokunbi says, she can handle a host of common childbirth scenarios.

"I am suitably trained to recognize when things aren't going as they should be going and what to do about it," she says.

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The bag Sokunbi takes to a home birth has no potions, but does have: a fetal Doppler device for monitoring the baby's heartbeat; certain medications; and oxygen for reviving a blue baby.

And at the first sign a delivery could be running into trouble, she sends her laboring patient to the nearest hospital, she says. That handoff to an obstetrician is one of the major differences between the U.S. and the U.K. It's very smooth in the United Kingdom, where doctors and midwives have a close partnership, Sokunbi says.

"In the States, the way I see it so far, it seems there are midwives on one side and obstetricians on the other — and there's this opposition," she says.

Shah warns against "thinking of midwifery as a silver bullet" aimed at fixing problems with childbirth in the United States. Rather, he hopes that obstetricians and midwives can work together, as they do in in the U.K., to give many women a cheaper, safer and more pleasant experience of labor and delivery.

Copyright 2015 NPR. To see more, visit http://www.npr.org/.
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Should Doctors And Drugmakers Keep Their Distance?

Sun, 07/12/2015 - 7:03am
Lorenzo Gritti for NPR

Doctors are obsessed with time.

It comes down to simple math. If I have four hours to see a dozen patients, there simply isn't much time to stray from the main agenda: What ails you?

Frequently harried, I avoid drug company salespeople. Their job is to get face time with me and convince me quickly of the merits of their products.

To sweeten the path in, they bring food for the staff along with free samples of prescription drugs for us to give to our patients.

A typical office visit goes like this: The sales rep catches me in the hallway between patient rooms, or ducks her head in my cubby when I'm furiously typing to keep up on chart notes. She greets me so warmly that human instinct kicks in, and I simply find myself unable to cut her off.

Boom. I'm trapped.

I get a four-minute spiel about her company's newest brand-name drug and why it's superior to similar medicines that have been on the market for years. I want to ask why I should prescribe the new drug when I know the older drug is safe, effective, and at this point cheap because it's generic.

But if I ask a question, I'll get another four-minute lecture. Forget it. I smile and stand to show how busy I am. The sales pitch ends.

The experience leaves me feeling tainted. Marketing isn't medical science, my mentors taught me. I've read the studies showing that drug detailing, as these sales calls are known, works in spite of doctors' skepticism that it influences our prescribing.

But let's be honest: Drugmakers wouldn't spend billions of dollars on sales and marketing without getting a return on their investment.

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When I was a medical resident, my training program prohibited drug detailers from calling on me and my colleagues. I understood the rationale. We were being taught to draw our own conclusions about medical science and steer clear of commercialism.

But a part of me felt the ban was too paternalistic – simply banishing industry folks from campus gave us no strategy for handling these inevitable interactions. Plus, I wondered, is there anything worthwhile in the sales pitches? I needed to find out for myself, so when I left the confines of residency and drug detailers came calling, I decided to let them pitch to me.

I quickly became more convinced of the merits of my residency's prohibition on detailers.

But roiling inside academe is a bigger philosophical question: Beyond sales and marketing, is there room for productive and ethical collaboration between doctors and industry in laboratory science, clinical trials and education?

For the most part, the doctrinaire position among many doctors has become one of mistrust toward those aligned with industry, on the basis of presumed conflicts of interest. That's why I was surprised to read a recent set of essays in the New England Journal of Medicine that questioned how our profession arrived at this state of affairs and suggested a re-examination is in order. The Journal has long been known for its stringent standards — both in terms of the science it publishes but also for helping make author disclosures standard operating procedure.

My initial reaction to these essays was similar to that of many critics: How could the Journal dare question this sacred cow? The series even sparked a highfalutin rejoinder from former Journal editors, who took their old home to task in the pages of a rival prestige journal.

This academic kerfuffle prompted me to read the essays more carefully. With enough time for reflection, the essays inspired me to think anew, taking me back to the days when I questioned orthodoxy.

Clearly there have been egregious examples of flawed collaborations with industry, such as the debacle over the painkiller Vioxx. Researchers both inside and outside the company were implicated in minimizing the drug's potential cardiovascular side effects in order to make it more marketable.

Examples like Vioxx understandably make us wary of pharmaceutical firms and those that collaborate with them. Nevertheless, it's wrong to simply assume that any doctor funded by or working with a drug company is corrupt. We should not simply read the number of industry collaborations that a doctor has as a litmus test for virtue.

I still have no interest in being hounded by pharmaceutical detailers, and I will still take note of how studies and researchers are funded. But I no longer will automatically dismiss clinical guidelines written by experts who have industry ties. Why, after all, would we want to automatically prevent the people most knowledgeable about a topic from being engaged with the public simply because industry helped pay for it?

As state and federal research budgets have become pinched, industry funding is a reality that we simply have to come to terms with if we are move to medical science forward.

Therefore it makes sense to me to re-examine how we handle these relationships and set up ground rules valuing transparency and the public good. A good starting point would be clarity on whether such industry funding is used for a researcher's lab and overhead costs — supporting the research effort — or simply funneled into their pocket, which I see as simply payment for marketing.

John Henning Schumann is a writer and doctor in Tulsa, Okla. He serves as interim president of the University of Oklahoma, Tulsa. He also hosts Public Radio Tulsa's Medical Matters. He's on Twitter: @GlassHospital

Copyright 2015 KWGS-FM. To see more, visit http://www.kwgs.org.
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Trying To Remember Multiple Things May Be The Best Way To Forget Them

Sat, 07/11/2015 - 8:11am
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Leigh Wells/Ikon Images/Getty Images

Our days are full of things to remember, and they don't always arrive in an orderly fashion. Perhaps you begin your commute home and remember that you need to pick up milk. But then immediately, another to-do springs to mind: You never called back your friend last week. You may try to hold both in your head, but in the end the milk, the phone call or both still sometimes fall away, forgotten.

A new scientific model of forgetting is taking shape, which suggests keeping multiple memories or tasks in mind simultaneously can actually erode them.

Neuroscientists already knew that memories can interfere with and weaken each other while they are locked away in the recesses of long-term memory. But this new model speaks to what happens when multiple memories are coexisting front and center in our minds, in a place called "working memory."

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It argues that when we let multiple memories come to mind simultaneously, those memories immediately lock into a fierce competition with each other. The milk and the phone call fight to each be remembered more than the other.

"When these memories are tightly competing for our attention the brain steps in and actually modifies those memories," says Jarrod Lewis-Peacock, a neuroscientist at UT Austin.

The brain crowns winners and losers. If you ended up remembering the milk and forgetting the phone call, your brain strengthens your memory for getting milk and weakens the one for phoning your friend back, so it will be easier to choose next time you're faced with that dilemma.

Previous research has demonstrated this competition-based weakening of memories over very short periods of time, but Lewis-Peacock and his colleagues recently put it to the test again, to see if it could cause long-term forgetting. They decided to force two memories to compete: pictures of human faces and pictures of scenes.

First they used an advanced type of MRI technology to get a window into the minds of the study's participants.

"We're starting to get to the point where we can pretty reliably sort of read out what a person is thinking about, seeing [and] trying to remember. And we're doing this on a moment-to-moment basis," says Lewis-Peacock. His team's MRI machine learned to recognize the unique pattern that emerges when each participant thinks of faces, scenes or both at the same time.

Then, while participants were loaded in the MRI, they were shown pictures of faces and scenes. They were then repeatedly asked to recall the pictures — in most cases just the images of scenes. "Most of the time, I'll show you both [then] test you on the scene. You can basically forget the face at that point," Lewis-Peacock told them.

The minds of participants were now presumably focusing on the memories of the scenes alone. "But occasionally I'm going to sort of trick you and say 'Aha, no: On this trial I'm actually going to test your memory for the face item,' " which forces your brain to quickly pull the face item back to mind, Lewis-Peacock says.

For many participants this meant suddenly both the scene and the face memories existed in their heads at once — competing with each other.

The research team used their MRI to verify that both memories were present at once, and 30 minutes later they did another test for memory of that scene. Indeed, in the trials where competition had taken place, memory for scenes weakened significantly. The upshot: people had more trouble recalling a memory when it had earlier been simultaneously active with another one.

Jarrod Lewis-Peacock cautions that more testing is required before researchers can strongly recommend certain memory-enhancing techniques. Still, he says one interpretation of this is that "switching between thoughts cleanly or efficiently is a good thing."

"When you're done thinking about something you totally pack it away. Don't let it sit in the back of your head," he says. "Because if you do, it might thrust it accidentally into competition with what you're moving on to think about."

Lewis-Peacock also says this competition theory of forgetting points to the limitations of our own minds.

"I think what this data is suggesting is that there might be these unintended consequences to the way that we're juggling thoughts in our head," he says. "Maybe it's not just a whole big free lunch that you can try to do as many things as you can try to without any repercussions."

Copyright 2015 NPR. To see more, visit http://www.npr.org/.
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In Florida, A Former Fast-Food Worker Lands In Medicaid Gap

Sat, 07/11/2015 - 7:40am
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Dr. Annelys Hernandez (left) checks out Cynthia Louis (right) in Florida International University's Mobile Health Center in Miami on March 3, 2015.

Courtesy of WLRN/Peter Andrew Bosch/Miami Herald

The Affordable Care Act got a big boost from the Supreme Court in June. But some states are still dealing with fallout from a previous Supreme Court decision that left it up to states to decide whether or not to expand Medicaid.

In Florida, which opted not to expand, about 850,000 people were left in health care limbo that some call the coverage gap.

Cynthia Louis, 58, is one of them. She worked for Burger King for most of her adult life, plus a year in high school.

"I worked for Burger King 25 years and loved every day of it, just coming, you know? Not because of the money, but just the people and working, just working," she says.

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A year-and-a-half ago, though, while working at a Burger King in the northern part of Miami, something felt off.

"All of a sudden I just started feeling sick. And I said, 'What's going on?' And then I started sweating." She says her stomach hurt and after sitting down for a while, she tried to stand up, but couldn't. Her knees hurt too much.

She left work early that day and hasn't been able to go back since.

"They miss me. I miss them, you know," she says. "I just hope and pray if I can come back when I get well, I'll be glad to come back,"

Louis is 58 and her joints still hurt all the time.

She used to have health insurance through Burger King, but after a while she dropped it because it was too expensive.

Now she needed insurance, but Medicaid wasn't an option for her in Florida.

"It's not right. Because it's a lot of people out here who don't work, and it's a lot of people out here sick and don't get Medicaid," she says. "So they can't go to the doctor, and they're getting sicker and sicker."

The popular description of Medicaid is that it's health insurance for the poor.

But in fact it's more complicated.

To qualify you usually have to also have meet another condition: be pregnant, have a dependent child or a disability. And within each of those groups, there's even more restrictions.

For example, in a family of four, the most the parents can make to qualify for Medicaid in Florida is just under $8,500. A single parent who makes $6,000 a year and has one kid earns too much to qualify for Medicaid. And if someone is single with no dependent kids and isn't disabled, no matter how little he or she makes, he or she can't get Medicaid in the state.

And that's Louis's situation.

So when enrollment started for Obamacare in 2013, she thought she had her answer.

"I called, I kept on calling because people kept telling me that I can get it," she recalls. "And I kept telling them, 'Well, they told me I can't get it.' And they said, 'No, you can get it!' So I called again."

In the end she tried three times.

"So you mean to tell me, I worked all my life, and I can't get Obamacare? Something wrong with that picture," she says.

The reason Louis didn't get Obamacare is that in Florida, only part of The Affordable Care Act ever went into effect.

The federal government helps some people pay for health insurance with subsidies if they make just above poverty level up to four times the poverty level.

For those making less, they were supposed to get Medicaid.

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But that second part never happened because Florida is one of 21 states that has chosen not to expand Medicaid after a Supreme Court decision opened that option.

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Florida's legislature discussed it seriously this time around but adjourned in late June without expanding Medicaid coverage.

That means Louis, and hundreds of thousands of others, fall into this gap where they don't get Medicaid and they don't qualify for subsidies.

She does qualify for charity care at Jackson Hospital along with a lot of other people.

"You go to Jackson, you see a million people down there. I see so many people at Jackson, it's ridiculous," she says.

And, charity care lacks some of the advantages of Medicaid, says Louis's Doctor, Katherine Chung-Bridges.

"It's being able to access specialist care. It's being able to access you know the appropriate labs the appropriate studies in a timely fashion," she says.

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With her Jackson charity care card, Louis can only go to certain primary care clinics and most of them don't have specialists on staff. She was referred to a rheumatologist at Jackson Memorial Hospital almost a year ago. Wait times there usually range from two weeks up to six months, says Ed Odell with Jackson Health.

"It depends on the specialties," he says. Urologist, pulmonary specialists and ear, nose and throat clinics have longest waits. Those clinics only see patients four hours a week since they're mostly teaching and academic clinics."

At the same time, the federal government is giving Florida less money for charity care because of the assumption that more people would have Medicaid.

In January, Louis was finally able to book an appointment with a rheumatologist.

That appointment is this month.

This story is part of a reporting partnership with NPR, WLRN and Kaiser Health News. Daniel Chang of the Miami Herald co-reported the story.

Copyright 2015 WLRN Public Radio. To see more, visit http://www.wlrn.org/.
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