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Does Some Birth Control Raise Depression Risk? That's Complicated

Sun, 10/09/2016 - 2:40pm

The study looked at the relationship between women who used hormonal birth control, and antidepressant use, and diagnoses of serious depression.

AJPhoto/Science Source

When the birth control pill debuted more than 50 years ago, women wanted to know: Is it safe? There wasn't much evidence to answer that question, but women embraced the Pill as a revolutionary improvement in contraception.

Today, millions of women around the world use hormonal contraceptives that have expanded beyond the Pill to patches, implants, injections and uterine devices. Decades of research support their safety, and serious but very rare side effects such as blood clots are finally much better understood. But other areas of research lag, and we still don't know as much as we'd like about how these medications affect women's mental health.

So when a study came out linking hormonal birth control and depression, the headlines went wild. The stories made for good clicks, but not so great science reporting. Insufficient skepticism about a single study makes it easy to imply birth control definitely causes depression when the study shows nothing of the sort.

The study, which was conducted in Denmark and published in JAMA Psychiatry, analyzed 14 years' worth of health data for more than 1 million women from national healthcare systems and databases not available in most other countries. It also measured depression two ways: diagnosis at a psychiatric hospital, which would be quite severe depression, or filling a prescription for antidepressants. Across the whole study, 2 percent of all women ages 15 to 34, were diagnosed with depression at a hospital and 13 percent began taking antidepressants.

Several news stories reported an 80 percent increase in risk of depression in some groups of women, but few noted that was relative risk, which is an expression of proportional increase. An 80 percent relative risk does not mean that 80 percent of women taking hormonal birth control develop depression. It means that if 10 women not taking hormonal birth control develop depression, then 18 women on the birth control will develop depression.

In this study, that 80 percent increase in relative risk referred specifically to the likelihood that those ages 15 to 19 taking combined oral contraceptives — the pill containing both progestin and estrogen — would begin taking antidepressants after going on birth control.

However, looking at absolute risks conveys a less dire interpretation. Among women not taking hormonal birth control, 1.7 percent took antidepressants and 0.28 percent received a depression diagnosis at a psychiatric hospital. By comparison, 2.2 percent of women who started birth control began taking antidepressants afterward, and 0.3 percent were diagnosed with depression at a hospital. Basically, about 0.5 percent of women who began hormonal contraception developed depression who might not have otherwise.

"Therefore for an individual woman, even one using a method of hormonal contraception, the overall probability of experiencing one of these outcomes in this study was still fairly low, particularly for diagnosis of depression," explains Chelsea Polis, a senior research scientist at the Guttmacher Institute.

Rates of those filling antidepressant prescriptions were higher for other forms of hormonal birth control: 4.1 percent for the patch and 3.2 percent for the vaginal ring in the first year, for example. Psychiatric depression diagnoses occurred in 0.7 percent of patch users and 0.6 percent of vaginal ring users.

Even in terms of relative risk, though, many of the risk increases were modest: Among all women taking the combined pill, the increased risk was 10 percent for depression diagnosis and 20 percent for using antidepressants after statistically adjusting for women's age, educational level, weight and history of endometriosis or polycystic ovary syndrome, all factors that could influence depression risk.

Other increased risks ranged from 20 to 70 percent for all women, depending on contraception type. The largest increases — up to triple the likelihood of starting antidepressants — occurred among teens using the ring or patch.

Another thing to consider is that these numbers represent correlations — two things occurring at the same time that may or may not be linked.

"Depression is common. Contraception use is common. So both of those things are commonly going to occur together," explains Jeffrey Jensen, a professor of reproductive & developmental sciences and director of the Women's Health Research Unit at Oregon Health & Science University in Portland.

The study used several methods to reduce the possibility that other things could be causing depression. Jensen pointed out that women who are more likely to take hormones for contraception would probably also be more likely to take antidepressants for depression, but the authors did a separate analysis to compare women to themselves before and after beginning contraception and still found a depression risk.

None of this means that birth control does not cause depression, but it doesn't mean it does, either. Since a half percent of millions of women taking birth control adds up, it's important to know whether such a large number of women could be more susceptible to depression, which can be a very serious illness, after starting hormonal contraception.

But it's complicated, and subtle.

For example, the study also found that depression risk peaked six months after women began using contraceptives, but then decreased to the point that women using hormonal contraception for four years actually had lower rates of depression than those not taking it. Though this likely resulted from many women with depression stopping their birth control, those findings match up with a previous large study finding a protective effect against depression with hormonal contraception. But the studies were done differently: The earlier study included only sexually active women, unlike the new study.

"Unfortunately, the analysis did not provide information on the frequency of depression diagnoses or antidepressant use among women using nonhormonal methods of contraception, such as copper IUDs," says Polis. "Such a comparison would help to clarify whether the associations were related to other factors common to women choosing to use contraception, rather than being specifically related to the hormonal content of certain contraceptive methods."

For example, those who become sexually active in adolescence have a higher risk for depression and anxiety, as previous research has shown. Even among women in their 20s and 30s, the decision to begin hormonal contraception may accompany various other circumstances in their lives that could potentially increase the risk of depression or anxiety — not a stretch when the study identifies just a half percent of women with the increased risk.

But the possibility that sexual initiation might come with mental health risks baffled study co-author Lidegaard. "Sexual relationships are a good experience for the majority of women, so I cannot see why women would get depressed by starting sexual relationships," Lidegaard said in an interview. He pointed out that women not in relationships may experience loneliness, a risk factor for depression, but when asked about single women having sex, he said he believes "the majority feel more happy by realizing how wonderful sexual experiences can be. Why should women get depressed from that?"

What this study does do is suggest that women may respond differently to hormones and medical treatments.

"Doctors should perhaps be more careful when they prescribe hormonal contraception to young women and get a history of previous depression first," Lidegaard says.

There's no question that women are going to respond differently to hormonal contraception. But those differences are not well understood.

"We're all very, very different, and we're moving in the direction of precision medicine," adds Catherine Monk, an associate professor of psychiatry and director of research at the Women's Program at Columbia University Medical Center. "There are some women who are just much more sensitive to these hormone changes."

The higher risk of depression found among teenage girls, both Monk and Lidegaard pointed out, might be biological, since teens may be more sensitive to the hormonal changes happening during puberty.

"You need to know yourself and be really informed," Monk says. "If I were of an age and reading this article right now, I would want to be thinking, 'Who am I? Am I sometimes who has moodiness around my periods?' " She notes the importance of each woman considering these findings in conjunction with what she knows about her own body and her own circumstances.

Philosophical differences about medicine may also influence how people interpret these findings in the absence of studies showing causation. Jensen, for example, pointed out that women in developed countries no longer see other women dying during childbirth, illegal, unsafe abortions or other devastating health effects of unplanned pregnancy, and have come to places less value the effectiveness of hormonal birth control.

"Women are more skeptical of using hormonal therapy than ever before," Jensen says. "It's a tragedy of the riches. If you really want to be depressed, have an unintended pregnancy."

Toward the other end of the spectrum, Monk believes we may have gone too far in using hormones to control contraception. "Getting away from barrier methods of contraception is getting away from our bodies," she says, and she would like to see a much larger range of options for contraception for men and women.

The fact that dissent rages over this issue points out a larger question about women's health research.

"Understanding women's health has been neglected, and there's not enough research into understanding our hormones," Monk says. "This is partially a story about women's health research and how we need more of it."

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

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

EpiPen-Maker Mylan Settles For $465 Million In Medicaid Dispute

Fri, 10/07/2016 - 6:33pm

The federal Medicaid program had accused Mylan of underpaying required rebates for the EpiPen, which is used to reverse serious allergic reactions.

Drew Angerer/Getty Images

Drugmaker Mylan N.V. announced Friday that it had reached a $465 million settlement with the U.S. Justice Department and other government agencies to resolve questions over rebates required by the Medicaid program.

The deal settles allegations by the Centers for Medicare and Medicaid Services that Mylan had misclassified the EpiPen as a generic drug and had not paid the appropriate rebates that are required by law.

Andrew Slavitt, the acting head of CMS, detailed the allegations in a letter to Sen. Ron Wyden, D-Ore., this week.

Slavitt told Wyden that Mylan had misclassified EpiPen as a "non-innovator" or generic drug, when it should have been classified as a brand-name product. Slavitt said the agency had informed Mylan multiple times of the misclassification.

Drugs companies pay rebates to the Medicaid program of 23.1 percent for brand-name drugs and 13 percent for generics. Mylan paid only the 13 percent for $1 billion worth of EpiPens that Medicaid bought between 2011 and 2015. That cost state and federal taxpayers $163 million, he said.

Mylan was facing potentially large penalties. Companies are required to report a drug or device's correct classification and can be fined up to $100,000 per violation under the terms of the Medicaid Drug Rebate Program.

Mylan has come under increasing scrutiny by lawmakers on Capitol Hill, federal agencies and state attorneys general after the company raised the price for the EpiPen more than 500 percent since 2008. The device is an auto-injector used to reverse serious allergic reactions.

Mylan said the settlement "did not provide for any finding of wrongdoing."

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

How California's 'Paid Family Leave' Law Buys Time For New Parents

Fri, 10/07/2016 - 4:33pm
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October 7, 20164:33 PM ET Heard on All Things Considered

Iris and Eli Fugate with their 6-month-old son Jack, at the family's home in San Diego. Thanks to California's paid family leave law, Iris was able to take six weeks off when Jack was born, and Eli took three weeks, with plans to take the remaining time over the next few months.

Sandy Huffaker for NPR

Back in 2002, California passed a law that provides paid family leave benefits to eligible workers. In many ways, the law mimicked paid parental leave policies that are in effect in nearly every other country in the world. But it was the first its kind in the U.S., and several other states have since followed suit.

Here's how California's law, part of of the state's disability insurance program, works: Most workers in the state have small deductions (less than one percent of their wages) withheld from each paycheck.

The program works sort of like the federal Social Security system, creating a pool of money employees can draw from if and when they need to take time off work to care for a seriously ill relative, or when they have a new baby.

New moms and dads get six weeks off at a little more than half their weekly pay — 55 percent, with a cap that's indexed to inflation each year.

Iris and Eli Fugate, who live in San Diego, say the paid leave gave them precious time to welcome their son Jack into the family. Iris took the full six weeks of leave after Jack was born five months ago. Eli took three weeks, and plans to spread the rest out over the next few months.

Iris Fugate says having the time with her husband, Eli, to jointly care for their baby in Jack's first weeks of life helped them learn how to parent together.

Sandy Huffaker for NPR

"We both got time to get to know him together," Iris says of that early time with baby Jack. "Really meaningful — I can't imagine it going any other way."

Eli agrees. "It was really important during that first week or two especially," he says. Being able to encourage one of his son's first milestones — turning over for the first time — and share the baby's delight, was priceless, he says.

Since the family leave law went into effect more than a decade ago, it's had a positive impact, says sociologist Ruth Milkman, a professor at City University of New York, who has studied the law and its history. Business interests initially opposed the law, Milkman says, claiming it would kill jobs and drive small business out of business.

But when she and a colleague surveyed large, midsize and small companies in California five years after the state's family leave law went into effect, they discovered those early fears hadn't played out.

More than 90 percent of businesses reported a neutral or even positive impact on their companies after the law. The positive impact had to do with improved employee productivity and morale.

That makes sense, Milkman says. "It's a new benefit and employees are happy about it."

Families too, have reported positive changes, she says. There's been a steady, significant increase in the number of new dads like Eli taking paternity leave to bond with their babies. And, since the law launched, the length of time new mothers like Iris breastfeed has doubled.

The law still requires sacrifice on the part of anyone taking the benefit. It doesn't provide a full paycheck — just 55 percent of an employee's weekly salary. The Fugates say living on a tighter budget each week wasn't easy, but the couple had enough saved to make that work. Eli works as a manager for a large grocery chain, and Iris is a lawyer.

But for many families, especially low-wage workers, living on half-pay is much tougher, or even impossible.

It was financially challenging to live on 55 percent of the family's income in the weeks after Jack was born, Iris Fugate says, but the couple had been able to save enough money to make it work.

Sandy Huffaker for NPR

Kitty Jensen and her husband Lasha Gabrichi, live in North Hollywood, where Jensen works as a personal assistant to a clothing designer. Her boss encouraged her to take maternity leave after her baby was born, Jensen says, and never pressured her to return to work early.

Still, in the end, she returned to work much earlier than she wanted to. At the time of their son Leo's birth, Gabrichi was out of work, which meant the new family was living on half of Jensen's moderate salary.

It was money, says Jensen, but it felt like "nothing!" The family still had to pay rent, utilities, telephone, food, health insurance, car insurance plus all the other new costs of having a baby — from medical bills to diapers.

"If you're if you're not in the upper middle class, I don't know how people survive on it," Jensen says. "We certainly didn't."

Jensen turned to her parents for help. They're not well off, she says, but contributed as much as they could. Jensen and Gabrichi also started selling possessions on Craig's list — "furniture and art stuff I had, vintage art pieces, chairs," Jensen says. "I just sold anything I possibly could — all year."

Despite the financial strain, Jensen says she's grateful for the time she was able take away from her job to spend with the baby. But many workers who are eligible for family leave don't take it because they are even more stretched, financially.

Beyond her survey of how companies were affected by the state law, Milkman also looked at whether Californians were able to take advantage of the family benefit. One third of those surveyed said they couldn't afford to take the leave.

The Fugates still make time to stroll their San Diego neighborhood together. In a survey of California companies, more than 90 percent of businesses reported a neutral or positive impact on their companies after the 2002 California family leave law was enacted.

Sandy Huffaker for NPR

Even worse, says Milkman, more than half of those surveyed weren't even aware the law exists, she says.

"And the people who need it most — immigrants, young workers, poor people, low wage workers — they are the least likely to know about it," Milkman found.

Service industry workers, like Claudia Chi-Ku, who lives in Los Angeles, are often among those who don't realize they have the option of paid leave. Chi-Ku's worked in numerous restaurants, and is now doing housecleaning at a healthcare facility. But when she got pregnant with her fourth child several years ago, she was working for a large car wash chain.

"At that time, to be honest with you I had no idea — none whatsoever — about the paid leave law and the benefits it came with," Chi-Ku says. Even half a paycheck would have been a godsend, she says.

"I would have used that money," Chi-Ku says. "I really needed it at that time."

Today Chi-Ku works with advocacy groups like the Restaurant Opportunities Centers United, to help other low-wage workers understand their rights under the paid leave law.

And changes are on the way. Come 2018, leave benefits in California will be boosted to 60 percent of an employee's salary, and 70 percent for low-wage workers like Chi-Ku. State lawmakers have also worked to put more job protections in place for people who opt to take the leave.

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

Rising Premiums Rankle People Paying Full Price For Health Insurance

Fri, 10/07/2016 - 2:16pm

Shela Bryan of Hull, Ga., is looking for a new health insurance policy but has been stunned by the prices.

Steven Bush/Courtesy of Shela Bryan

Shela Bryan, 63, has been comparing prices for individual health insurance plans since May, and she can't believe what she has been seeing.

"They cost a thousand, $1,200 [a month], and they have a deductible of $6,000," she said. "I don't know how they think anyone can afford that."

Bryan, who lives in Hull, Ga., a hamlet of about 200, was on her husband's insurance plan for decades. When he died in 2013, she continued his workplace coverage through COBRA, but she had to pay almost the full price of the insurance, or about $800 a month. But it was "the Cadillac of insurance," Bryan said, with low copays, prescription drug coverage and a $500 deductible.

That option will run out in a few months, so she is turning to the individual insurance market in what is shaping up to be the most expensive year for the 400,000 or so consumers in Georgia who buy their own policies but don't purchase them on the health law's marketplaces.

About 10 million Americans buy individual insurance coverage without cost-reducing federal subsidies on the marketplaces on the open market, according to the Congressional Budget Office.

In Georgia, consumers who don't get insurance through their employers or don't qualify for tax credits to help pay for policies they purchase are facing double-digit premium increases. Blue Cross Blue Shield of Georgia, the only insurer offering plans throughout the state, received an increase of more than 21 percent from the state insurance commissioner. Humana was awarded a 67.5 percent hike.

Prices are going up in other states, too. BlueCross BlueShield of Tennessee was granted a 62 percent rate hike, while state officials approved a 46 percent increase for Cigna. Florida authorities gave plans there an average 19 percent bump. And last week, Minnesota officials announced that premiums for the seven insurers on the individual market are rising 50 to 67 percent.

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The insurers are now adjusting for some miscalculations, said Graham Thompson, executive director of the Georgia Association of Health Plans. "The prices are up this year, but our hope is that things will settle down after this year," he said.

While consumers have faced sticker shock, the insurers have faced what might be called "sicker shock." They are raising premiums after finding that many of the customers buying plans on the individual market were sicker and more costly to insure than expected when the health law was implemented.

Federal and Georgia officials note that customers can change plans each year to find a better price, but the switches can result in higher deductibles and changes in doctors and hospitals available to the insured.

Bryan, who makes just over the $47,520 limit for a subsidy, finds herself on her own in the individual market now. "I've worked ... all my life," said Bryan, a maintenance supervisor.. "We're the ones entitled to something, because we've worked. They tear me up in taxes and then they say my income is too high for a subsidy?"

She could end up paying as much as $14,000 in premiums for a pared-back policy, she said, which is $4,400 more than she is paying for the COBRA plan. The deductible would also rise by $5,800, and she wouldn't have drug coverage. The cheapest policies would amount to more than a quarter of her yearly income, or double her mortgage.

Bryan said she feels like she is paying for other people's subsidies with her high premium.

But Linda Blumberg, a senior fellow at the Urban Institute, says that's not how subsidies work. "It is not the people paying full premiums who are paying for the lower-income person," she said. Federal dollars are already allocated to do that.

"For a lot of modest income people, this can still feel expensive to them. I actually think we've underinvested" in the amount set aside for subsidies, she said. "I sympathize with it enormously."

Bob Laszewski, a health policy consultant in Washington, D.C., said the Obama administration needs to listen to the complaints of people who aren't getting assistance.

"These people are invisible," Laszewski said. The Affordable Care Act "is working very well for lower income people, but the Obamacare supporters missed the fact that if you're raising a family of four on $100,000, you're not rich. This is the ... guy who remodeled your house, who drives a pickup truck and he's wearing a Trump hat."

This flaw in the law needs correcting, he said. A wider range of insurance options, he said, could help more middle-class people afford coverage.

Individual insurance brokers said they are calling their clients, bracing them for higher premiums.

Athens, Ga., broker Jim Carrow said he's starting to hate his job. He once thought he was helping people. Now, he's delivering bad news.

"It's a mess," Carrow said. "I had one gentleman call me and I had to tell him that because he made $5,000 more this year, he won't be eligible for a subsidy. And who knows what he'll end up paying. It's just one string of misery after another."

Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

Copyright 2016 Kaiser Health News. To see more, visit Kaiser Health News.
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Do You Need Extra Screening For Breast Cancer? The Picture Is Blurry

Fri, 10/07/2016 - 5:00am

Following up a mammogram with an ultrasound exam can find more cancers. But the additional test can also find more false positives that aren't cancer at all.

F. Astier/Centre Hospitalier Regional/Science Source

Mammography can prevent deaths from breast cancer, but it's not a perfect test.

It misses some cancers, especially in women with dense breast tissue, and flags abnormalities for follow-up tests that turn out to be benign, among other issues. So there's a lot of interest in additional tests that might make screening more accurate in women who have dense breasts.

Many of those women may be wondering about extra screening after receiving notification letters saying that their mammogram was clean, but that their dense breasts put them at higher risk of cancer.

But there is no clear path for those women, who make up about 45 percent of women ages 40 to 74. The goal with breast imaging technology is not only to detect more cancers earlier, but to actually prevent deaths from breast cancer, says Dr. Otis Brawley, chief medical officer for the American Cancer Society. "That's a very separate and different question," he says. And so far, only mammography has met that standard, he says.

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Investigating that question requires large, randomized clinical trials that follow women for many years to track whether the group screened with the extra technology has fewer deaths from breast cancer than the group screened with mammography alone. And that kind of trial is expensive and logistically tough.

Because cancer isn't as common as many people think, "the number of women you have to screen to achieve statistical significance is huge," says Barbara Monsees, a professor of radiology and women's health at the Washington University School of Medicine in St. Louis. The full effects won't be apparent for decades. "It's a long-term commitment, and it costs a lot of money," she says.

So researcher, clinicians and policymakers who evaluate tests have to rely on studies of shorter-term outcomes like cancer detection rates and stage at detection — which may or may not translate to saved lives. They also look at what those studies say about false positive findings, since those can lead to invasive biopsies to see if cancer is actually present.

The New England Comparative Effectiveness Public Advisory Council, whose members are from the fields of medicine, economics and policy, looked at the evidence supporting any kind of supplementary screening in women with dense breasts and a clear digital mammogram. Their conclusions, published in 2014, found that there's not a ton of evidence on long-term outcomes, but that the available research suggests a net benefit depending on a person's underlying cancer risk from additional factors, namely age and family history of the disease.

For otherwise low-risk women with dense breasts, the New England group determined that there wasn't enough evidence to recommend extra screening. They mentioned the potential of overdiagnosis and overtreatment, since some percentage of breast cancers — and there is much controversy over how many — would likely never have caused a woman harm had they been left undiscovered.

But for women with dense breasts who are at moderate or high risk of breast cancer according to family history and age, they voted that from the available evidence, the benefits of routine supplemental screening are more likely to outweigh the harms.

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If a woman and her doctor decide that supplemental screening is needed because of her risk factors, the next question is what kind of screening. There are pluses and minuses of each technology:

Hand-held ultrasound devices use sound waves to visualize breast tissue. Ultrasound is often used in women with dense breasts. And research suggests that it can pick up more cancers in these women, ones missed by mammograms. "But there's a price for that," says Debra Monticciolo, chair of the American College of Radiology's Commission on Breast Imaging and a professor of radiology at Texas A&M University College of Medicine. There are many, many more false positives, she says, which in turn can lead to unneeded biopsies.

And it's unclear how those benefits and harms balance out. "Does finding those cancers impact long-term outcomes? You can't really prove it, because all you know is that you found additional cancers," says Monsees. "Can you guess if those would translate into saved lives? Perhaps not all of them, but what percentage of them?"

Magnetic resonance imaging, or MRI, uses magnetic waves to produce images of the breast. MRI finds more cancers, but it also leads to more false positive results than mammography, although fewer than ultrasound. It requires an intravenous catheter for the contrast agent used in the test, and is more expensive than ultrasound.

Most of the members of the New England group said MRI was their first choice for women with dense breasts and a high risk of cancer, citing research on its utility among high-risk women in general. And despite the lack of direct evidence that it saves lives, the American Cancer Society recommends it be added to mammography for women at very high risk of breast cancer, including women who carry certain genetic mutations. That group says there's not enough evidence to say whether women who are moderate risk or who have dense breasts should get the test, and it recommends against its use in low-risk women.

Tomosynthesis is basically a souped-up mammogram; it uses the same X-rays to generate multiple images. It's sometimes called a 3-D mammogram. And unlike the other technologies, it's being suggested for use in all women, says Dr. Janie Lee, associate professor of radiology at the University of Washington and director of breast imaging at the Seattle Cancer Care Alliance. (Lee was one of the authors of the New England group's technology assessment but not a voting member.) It can be used along with a separate 2-D digital mammogram or a virtual 2-D image digital mammogram image can be derived from the 3-D one. (Using the latter technique keeps the radiation dose comparable to a standard digital mammogram.)

Studies suggest that tomosynthesis may improve the cancer detection rate, lower the proportion of women who are called back for follow-up tests, or both, says Monsees, which makes it attractive when performed with the method that produces the lower radiation dose. But it likely won't significantly improve the callback rate in experienced radiologists who already have low recall rates, says Brawley.

Molecular breast imaging involves injecting a radioactive tracer that circulates through the body and is attracted to cancer. Research suggests that it can pick up more tumors in women with dense breasts, and it's cheaper than MRI. But the doses of radiation administered are generally larger than with mammography, notes Monticciolo. And while mammography exposes just the breast to radiation, MBI exposes other organs such as the GI tract. That means that at this point, says Lee, it's more of a candidate for head-to-head studies against MRI for women with dense breasts who are also at high risk of the disease because of other factors.

Researchers are pushing ahead to see if screening methods can be more tailored to an individual woman's risk. So far, though, there's no proven ideal option — which means the best course of action is to know your risk, and talk to your physician about your options.

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

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

Teens' Penchant For Risk-Taking May Help Them Learn Faster

Thu, 10/06/2016 - 3:08pm

Sure, keeping a teenager's thoughts corralled may seem like lion taming. But that impulsivity may help them learn, too.

Luciano Lozano/Getty Images

The teenage brain has been characterized as a risk-taking machine, looking for quick rewards and thrills instead of acting responsibly. But these behaviors could actually make teens better than adults at certain kinds of learning.

"In neuroscience, we tend to think that if healthy brains act in a certain way, there should be a reason for it," says Juliet Davidow, a postdoctoral researcher at Harvard University in the Affective Neuroscience and Development Lab and the lead author of the study, which was published Wednesday in the journal Neuron.

But scientists and the public often focus on the negatives of teen behavior, so she and her colleagues set out to test the hypothesis that teenagers' drive for rewards, and the risk-taking that comes from it, exist for a reason.

When it comes to what drives reward-seeking in teens, fingers have always been pointed at the striatum, a lobster-claw-shape structure in the brain. When something surprising and good happens — say, you find $20 on the street — your body produces the pleasure-related hormone dopamine, and the striatum responds.

"Research shows that the teenage striatum is very active," says Davidow. This suggests that teens are hard-wired to seek immediate rewards. But, she adds, it's also shown that their prefrontal cortex, which helps with impulse control, isn't fully developed. Combined, these two things have given teens their risky rep.

But the striatum isn't just involved in reward-seeking. It's also involved in learning from rewards, explains Daphna Shohamy, a cognitive neuroscientist at the Zuckerman Mind Brain Behavior Institute at Columbia University who worked on the study. She wanted to see if teenagers would be better at this type of learning than adults would.

To test this, Shohamy and her colleagues used an fMRI scanner to watch brain activity in a group of adults and teenagers. They were looking at the striatum, but also in a different part of the brain called the hippocampus. The hippocampus (which looks like, and is named after, a seahorse) helps people remember things like dates and times: the who, what, when and where.

"Think back to the last time something really great and surprising happened," says Shohamy, "You might remember a lot of little irrelevant details, like the weather or the shirt you were wearing. That's your episodic memory."

As the adults and teens had their brains scanned, they played a game that rewarded players for guessing correctly. Between questions, participants saw random pictures of neutral objects. As expected, the reward-hungry teenagers figured out the game faster than the adults did. Surprisingly, the striatum was equally active in both teenagers and adults. But in teens, it also worked closely with their hippocampus.

To see if this cooperation changed how the teens learned, the adults and adolescents were given a memory test. They had to recall the random pictures that had flashed on the screen as they played the game.

Overall, teenagers and adults were equally good at remembering the pictures. But they were good in different ways. When the picture was associated with getting something right in the learning test, adolescents were more likely to remember it than adults were.

Adolescence is a time of growing, Shohamy says, when teenagers transition from dependence to independence. She thinks that being sensitive to rewards could help youth explore and leave the safety of their home, to try new things and learn from them. Having a sharp episodic memory could help with that.

"Too many people describe the teen brain like it's a defective car with no steering wheel or brakes, just an accelerator," says BJ Casey, a cognitive neuroscientist and professor of psychology at Yale who was not involved in the study. "What we need to understand in terms of the adolescent brain is that while there are circumstances get them into trouble, there are also ones in which they excel. This study shows that not only do teens have cognitive capabilities, they're even better in some situations!"

Casey likes how this study treats the teenage hunger for new, positive experiences as normal, not deviant. But it doesn't explain everything about how teenagers learn, not by a long shot.

"It's just one snapshot in time, and it's only one study," says Shohamy. To draw further conclusions, first they'd have to replicate their findings. Then, Shohamy would like to know if the hippocampus and striatum cooperate in other age groups, too. She wants to follow children as they grow up and find out when these two brain regions start talking to each other, and when they stop.

"This field of research is still in its adolescence," Shohamy adds. In other words, it's got a lot of growing to do.

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

Public Health Labs Hope Federal Funds Will Speed Zika Test Results

Thu, 10/06/2016 - 2:02pm

Florida Department of Health workers at a temporary clinic set up in Miami Beach in September package up a urine sample to be tested for the Zika virus. Pregnant women in Texas and Florida have complained it can take as long as a month or more to get their Zika test results.

Joe Raedle/Getty Images

Houston-based Legacy Community Health Services, a federally qualified health center, is trying hard to fight the Zika virus. It's screening pregnant women and following federal guidelines to test people at risk.

But despite best efforts, there's a problem, says Legacy's chief medical officer, Dr. Ann Barnes. Pregnant women (and, often, their sexual partners) who get tested for Zika frequently have to wait as long as a month to know if they are indeed infected, and the pregnancy is at risk. That's the turnaround time from the state public health lab, where blood samples are sent for testing.

"In that situation, the anxiety a pregnant woman has to live with is great," Barnes says. "Ideally, we'd be able to speed up the process."

Shots - Health News Reporter's Notebook: Pregnant And Caught In Zika Test Limbo

It's not just an issue in Houston. Florida radio reporter Sammy Mack, of WLRN, got tested for the Zika virus in August after realizing she had been in the suspected transmission zone in Miami while pregnant. The testing was free, she explained, in a recent Shots post, but more than four weeks later, she was still waiting to learn the results.

In all areas where Zika poses a threat, public health departments are struggling to meet the need to test patients for the mosquito-borne virus — even if the government has classified the patient as being "at risk" of facing serious complications, particularly with regard to pregnancy.

Doctors and infectious disease specialists say last month's approval by the U.S. Congress of $1.1 billion in emergency funding to fight the virus could help these women, by giving local labs the resources to efficiently determine if people have been infected.

Federal health officials this week gave a rough outline of how this funding will be distributed.

Specifically, Congress directed $394 million to the Centers for Disease Control and Prevention.The bulk of that funding will go to supporting state and local Zika response efforts — such as mosquito control and emergency response teams and public education campaigns — as well as to efforts to improve diagnostic tests, and research to track how the virus affects children long-term. The federal funds also include money for expanding lab capacity, though it is still unclear exactly how much.

The U.S. Department of Health and Human Services, which includes the CDC, has until the end of October to craft a spending plan.

"These funds will hopefully allow the infrastructure for testing to be expanded," says Andrew Pekosz, a professor of microbiology at Johns Hopkins University's Bloomberg School of Public Health.

Zika is already spreading in Florida. The CDC has recommended that pregnant women in particular get tested, since the virus can cause birth defects and other complications. About 80 percent of infected people don't show symptoms, so a test is the only way to know if they have contracted Zika.

"Especially for a pregnant woman, getting an answer quickly is a big deal," says Dr. Jesse Goodman, a professor of medicine and infectious diseases at Georgetown University Medical Center in Washington, D.C. "You're going to be very concerned. If that concern can be reduced, that's going to be good for you."

But the additional federal funding will not be an immediate fix.

Given how long processing and budgeting can take, public health labs aren't expecting the cash infusion until early 2017, said Peter Kyriacopoulos, senior director of public policy at the Association of Public Health Laboratories.

While the congressional funding is a promising start, more investment is necessary, said Chris Gould, senior director for federal government relations at the Association of State and Territorial Health Officials. Local health departments have been shrinking over the past six years, he says, and many don't have staffs large enough to operate laboratories at the level needed, given the volume of samples coming in.

These local health departments need to expand manpower, Gould says, especially since testing for Zika isn't their only responsibility.

Kyriacopoulos estimates that labs would need about $39 million to adequately meet the challenges. And public health officials expect the virus to return next summer, he points out, which could create a need for further funding down the line.

Meanwhile, the CDC has already tried to alleviate some of the strain on these laboratories. Last month, it purchased $2.5 million worth of diagnostic supplies for states that offer Zika testing. And laboratories have been working on their own to try to expand capacity — especially labs that serve regions such as Florida, Texas and California, where the warmer, mosquito-friendly climate heightens the risk that Zika could spread.

Still, local health departments offering Zika testing remain "understaffed and overwhelmed," says Dr. Martha Rac, a maternal-fetal medicine specialist at Texas Children's Pavilion for Women and at Baylor College of Medicine, in Houston.

The burden doesn't fall evenly, Rac notes. In urban centers such as Houston, women who may have been infected are more likely to get a Zika test than are women from a poorer, rural town in south Texas. Public health clinics or lab systems in rural areas may not be as well-resourced, so women have fewer options.

Predicting future need is also tricky. States have been encouraging pregnant women to get tested, along with men who may have been exposed and are showing the virus' flu-like symptoms. But that leaves out other groups — such as asymptomatic men who may have contracted Zika and could pass it on to female partners. If states start to push for that testing as well, it could exacerbate the strain on the labs.

Plus, it's difficult to gauge whether demand will dip in the coming months. Technically, mosquito season peaks in the summer. But in high-risk states like Florida or Texas, the insects carrying Zika can persist into December and even January, says Dr. Umair Shah, executive director of the public health department in Texas' Harris County, which encompasses Houston.

Beyond expanding the nation's capacity to test for Zika, HHS is also planning to invest some of its new funding into developing better tests to detect the virus. Currently, labs use one test that can find the virus within two weeks of exposure, and another that can detect it for up to three months. But the second test — which is more commonly used — is less precise and can, for instance, turn up false positives if someone's been exposed to other, similar diseases.

The investment in improving and then testing some better diagnostics is crucial, Rac says, especially given the magnitude of threat Zika still poses.

"There's still a lot we need to know we need to figure out," she says. "And who knows what's going to happen? ... This mosquito's pretty resilient to destruction. This is something we're going to see for some time."

Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

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

Long-Term, Reversible Contraception Gains Traction With Young Women

Thu, 10/06/2016 - 5:00am

A number of states recently have dedicated more money to educating women and health care providers about the 99 percent effectiveness of long-acting, reversible forms of contraception, like the intrauterine device, or IUD — shown here.

Michael Tomsic/WFAE

Nurse practitioner Kim Hamm talks in soothing tones to her 14-year-old patient as she inserts a form of long-acting contraception beneath the skin of the girl's upper arm.

"This is the numbing medicine, so you're going to feel me touch you here," she says, taking the teen's arm. "Little stick, one, two three, ouch. And then a little bit of burn."

Hamm works at the Gaston County Teen Wellness Center, in Gastonia, N.C., which provides counseling, education and medical care. The teenager has already talked through her birth control options with another health care provider and chosen the implant — a flexible rod, about the size of a matchstick, that slowly releases low levels of hormones to prevent pregnancy.

"You're going to feel tons of pressure here," Hamm says, using a small device to insert the implant. "That's it!"

And, in terms of preventing pregnancy, that will be it for the teen for the next several years.

Long-acting reversible contraception methods — including implant rods and intrauterine devices, or IUDs — are safe forms of birth control, and 99 percent effective, say specialists in reproductive medicine.They are endorsed by the American Academy of Pediatrics and the American Congress of Obstetricians and Gynecologists as a good line of defense against teen pregnancy.

But in the U.S., these long-acting, reversible devices are still not as frequently used by young women as elsewhere. They can be expensive, and problems with older versions of the devices — issues that have since been resolved — hurt their reputation. Only about 10 percent of American women use the devices, says Megan Kavanaugh a senior research scientist at the Guttmacher Institute, which studies reproductive issues.

"Some of the other developed countries that we look at are in the high teens, maybe low 20s in terms of percentage of use," she says.

Kavanaugh says better provider training and patient education should lead to higher usage of the long-term devices in the United States.

That's exactly what is happening in Gaston County, N.C., where clinics have seen usage rates climb to nearly 30 percent among teens. Since 2009, all providers in Gaston County clinics have been trained to insert the devices. The county uses federal funding to help cover the cost for the uninsured, which can be roughly $1,000 for an IUD.

Colorado is also subsidizing the cost of long-acting, reversible contraceptive methods, says Jody Camp of Colorado's public health department, and has seen higher usage and subsequent drops in teen pregnancy and abortion.

"While we are not claiming full responsibility for all the decreases in these public health indicators, we do believe that our LARC investment made a huge impact on those," Camp says.

Recently, the federal Department of Health and Human Services has started encouraging all states to make the methods more accessible through Medicaid, government insurance that covers many low-income women. The government is asking doctors to talk to their patients about long-acting, reversible contraception and allowing higher reimbursement rates for the devices.

By using effective contraception to space out their children, teens and other young women can help reduce the risk of delivering a premature or low-birth-weight baby, research shows. And preventing unplanned pregnancies can be "essential to a woman's long-term physical and emotional well-being," according to HHS.

There are versions of the implants that can be left in place to prevent pregnancy for five or 10 years at a stretch. But women can also choose to get them removed whenever they want, and restore their fertility. Kie'Ja Phillips is from Gastonia and 19-years-old. She had the three-year implant in her arm before heading to college last year.

"I do not want to have children until I'm done getting my education," she says. "I want to be able to provide for my children and give them a stable household — financially and emotionally and physically."

Phillips also teaches her friends and other teens about their options. She says a lot of them know about the contraceptive pill, but very few about IUDs or implants.

"They have a lot of misconceptions and myths about it," she says. "Like, 'how am I supposed to get it out?' You go to a doctor to get it out. You don't take it out yourself. It's just things like that — common misconceptions that people have."

Last year, nearly 30 percent of teens who got contraception at the Gaston County clinics chose the long-acting kind.

Gaston County Medical Director Dr. Velma Taormina says the increased use of long-term contraception is a key reason the county's teen pregnancy rate has been dropping faster than the state as a whole. Gaston County has also largely erased the disparity between African-Americans and whites in teen pregnancy rates.

"We feel very strongly that this is making a huge impact here," Dr. Taormina says.

Medicaid in the state next-door — South Carolina — has also seen an increase in the use of these long-acting, reversible contraceptives. In 2012, the state implemented a new way of paying hospitals so medical providers could offer and insert long-acting, reversible contraception right after a woman gives birth, which the nation's leading obstetrician's group says can be a "particularly favorable time."

The University of South Carolina School of Medicine takes this SimCOACH — outfitted with two simulated hospital delivery rooms — throughout the state to train health care providers in a variety of procedures. Among the topics: the insertion and removal of contraceptive implants and IUDs.

Michael Tomsic/WFAE

Staff with the Palmetto Health-USC School of Medicine in Columbia demonstrated the procedure to health care providers recently in its SimCOACH, which is basically a truck outfitted, for training purposes, with two hospital rooms and high-tech mannequins that can simulate a variety of birth outcomes. Palmetto Health drives the coach around the state to teach hospital staff about a variety of procedures and topics, including contraception.

"The IUD is inserted 10 minutes after delivery of the placenta when a patient has had a vaginal delivery," Dr. Judy Burgis says.

B.Z. Giese is director of the South Carolina Birth Outcomes Initiative, a project within the state's department of health and human services. Giese says the choice to have an IUD or implant inserted is always completely up to the woman, and only after she's consulted with a health care provider. But the reason obstetricians within her program started offering it immediately after birth is simple: About half of women on Medicaid who gave birth weren't showing up to their postpartum visit.

"We were missing a lot of moms who did not come back," Giese says. "And, actually, the next time the doctor saw them, they came back pregnant with another child."

Ana Walker, an 18-year-old in Columbia, S.C., chose to have an implant that lasts three years inserted in her arm. Walker got the implant after giving birth to her daughter Bella. She says she likes that she won't have to remember to take a pill every day.

"Right when I heard about it, I went for it," she says.

Breanna Martin, who is 20 and also lives in Columbia, recently chose an IUD after she had her baby. Martin says the device puts her in control of her fertility.

"That's the wonderful thing about it," she says. "If I want to wait five years, I'm protected for five years. And if I want to have kids sooner, then I can get it taken out."

Giese calls getting the device after childbirth a win-win for the baby and the mom. "It is a cost savings," she says. "It is a convenience for the mom. The satisfaction rate of the moms that we know leaving the hospital is extremely high."

Now, she says, at some hospitals in South Carolina, around a third of new mothers leave with an IUD or implant in place. That number, Giese says, was basically zero just a few years back.

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

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

Women Say Ginger Doesn't Tame Morning Sickness

Wed, 10/05/2016 - 4:05pm
elenaleonova/Getty Images

Women had a lot to say about what works — and what doesn't — for treating morning sickness, after we ran a post summarizing the evidence for home remedies and over-the-counter meds.

NPR's Facebook feed lit up with comments from women saying that ginger, acupressure and other home remedies, which were recommended for mild symptoms in a medical journal article published Tuesday, did nothing to tame their nausea and vomiting.

As one woman wrote in response to our post:

If you have severe morning sickness, like I do currently, these things do literally nothing. Don't perpetuate the common conception that morning sickness is a mild woman's ailment that needs ginger tea and an 'it'll pass.' For some it is; for many, it isn't.

Severe morning sickness, called hyperemesis gravidarum, can be debilitating, even life-threatening; it affects about 3 percent of women, according to the American College of Obstetricians and Gynecologists.

We checked in with Dr. Aaron Caughey, chair of the department of obstetrics and gynecology at Oregon Health Science University and an author of ACOG's guidelines on treatment of morning sickness, to ask why it's so hard find effective relief for morning sickness. He replied by email while traveling. (Thank you, airline Wi-Fi!).

One great thing about the conversation in NPR's Facebook feed is that women are sharing a lot of advice on what's worked for them, from specific medications to crackers. Are they on target?

This comment about never having an empty tummy being helpful is something I commonly recommend. It seems like hypoglycemia leads to nausea and then they can't keep anything down and get more hypoglycemic. So I recommend crackers (saltines, goldfish, graham) to be kept in one's purse, next to the bed, etc .... and to eat at least one or two every hour .... at night, when getting up to go to the bathroom, a cracker as well.

I'm wondering if OB-GYNs perhaps give morning sickness less attention because they believe that most women don't have serious problems with it.

I don't know that OB-GYNs are dismissive of these symptoms, as we hear them from many women. It may be that we know that not one approach works for all women, so we have to just cycle through a range of over-the-counter and then prescription approaches.

Then there's the issue of the poor quality of medical research on morning sickness. The JAMA reviewers found that just 35 studies out of 13,000 were strong enough to be included, and those 35 weren't all that great. I'd imagine you had similar experiences with your ACOG review. Why isn't there more good research on morning sickness, considering that most women experience it while pregnant?

There is not enough research on pregnancy, period. During the first trimester of pregnancy, when pregnancy nausea is often the worst, is also the time for embryogenesis. Thus if you want to study a medication that could treat nausea in pregnancy, you would need to do many animal studies first to show that the effect on embryogenesis was nonexistent.

Even by doing so, there still could be an effect on the developing human embryo. Thus this is one of the most challenging conditions to get the pharmaceutical industry to study. Of note, the nausea of pregnancy may have been protective as a species because it kept women from trying to eat potentially embryo-toxic or teratogenic substances.

Women understandably get frustrated when recommended treatments like ginger aren't helping with the nausea and vomiting. When should someone consider moving on to prescription medication to treat morning sickness?

The medications that are commonly used have been used for many years, so are incredibly unlikely to have a negative impact on the developing embryo. In terms of when, this is something to discuss with your obstetric provider. Certainly if hospitalization for fluid has been required, it is time to try medications, but for many women it should be before hospitalization is necessary in order to prevent that from happening.

As a follow-up to that: The ACOG guidelines backed off on recommending the medication Zofran because of concerns that it may be linked birth defects. Do we have enough data to really know what's safe?

The word safe is challenging. I think most of us generally think it is safe to drive in a car, but of course as we all know, it is actually more dangerous than flying. Flying is pretty safe, but of course, there is not a zero risk. So, what risk is one willing to take? With regards to the Zofran issue, recent evidence demonstrated an association with some birth defects as you noted, so while the evidence isn't conclusive, we are trying not to use it except in more extreme cases.

Ultimately, women want to get through the pregnancy and deliver a healthy baby. As awful as severe morning sickness can be, does it pose a risk to the baby?

[Hyperemesis gravidarum] can pose a risk in someone who becomes dangerously dehydrated or in someone who suffers malnutrition for a prolonged period of time. So for someone who is losing a large amount of weight during the first trimester, we would often place a feeding tube to provide nutrition to the pregnant women and ultimately to the fetus.

Fortunately, most women won't have to contend with life-threatening symptoms, but they still feel pretty miserable. What do you tell your patients to help them get though those tough months?

I think one thing is to make sure that they don't feel alone or that they are outliers. Nausea and vomiting are incredibly common, HG is pretty common, too. And it was labeled "morning sickness", but for many women it is all day long, and that isn't abnormal either.

Then it is that we will do things to make sure that this will not get in the way of them being able to nourish their baby, and that even in the worst cases I have seen, the babies grew just fine. It is that we will likely have to try multiple approaches to find a multidimensional one that will work. Thiss may include a range of OTC and prescription treatments.

Finally, this nausea and vomiting eventually goes away in all pregnant women, but rarely is at all at once; it is little by little over time.

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

Has The Human Life Span Hit The Ceiling?

Wed, 10/05/2016 - 1:01pm
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October 5, 20161:01 PM ET Heard on All Things Considered Gary Waters/Ikon Images/Getty Images

Human life spans have been increasing for decades thanks to advances in treating and preventing diseases and improved social conditions.

In fact, longevity has increased so much in recent decades that some researchers began to wonder: What is the upper limit on human aging?

"We never had so many centenarians as we have now," says Jan Vijg, who studies molecular genetics at the Albert Einstein College of Medicine in New York. "Maybe we can actually live much longer than 100. Maybe this goes on and on and on."

So Vijg decided to try to find out if that's the case. His conclusion, published online Wednesday in the journal Nature: The seemingly inexorable rise in the human life span may have hit a ceiling of about 115 years.

"We cannot break through that ceiling," Vijg says. "The take-home message essentially is this whole ever-increasing life expectancy of humans cannot go on."

Vijg and his colleagues are basing their conclusions on an analysis of decades of longevity records from around the world, including the Human Mortality Database and the International Database on Longevity.

"Every year we looked at who was the one who died in that year and was the oldest human in existence," Vijg says.

The researchers found that the age of the oldest people dying had indeed increased steadily between the 1960s and 1990s, according to their report.

But beginning in the 1990s, "you no longer see that," Vijg says. "You see that it stays the same."

The absolute maximum human life span may be as high as 125, the researchers calculated. But the chances of anyone actually living that long are less than 1 in 10,000.

"If we would have 10,000 worlds like ours, only one individual across all these 10,000 worlds would reach 125 in any given year," Vijg says.

But, he added, "the take-home lesson from what we found is that the human species most likely has a maximum life span of about 115 and we cannot break through that ceiling, at least not as far as we now know."

Other experts say it's not surprising that human longevity may have hit a ceiling.

"Right now, all we're doing is we're combating one disease at a time: heart disease, cancer, stroke," says S. Jay Olshansky, who studies aging at the University of Illinois and wrote a commentary article accompanying the report

"It's like a game of whack-a-mole. You know: One disease goes down another comes up," he says.

Shots - Health News Are We Reaching The End Of The Trend For Longer, Healthier Lives?

Olshansky says the only way that could change is if scientists figure out a way to fight the underlying cause of aging, not just individual diseases.

"That would be a game changer," he says.

Scientists are conducting a range of research to try to do that, including studying the genes of families that seem to have a lot of members who live unusually long lives. Some are also trying to identify beneficial substances in the blood of young people that might improve their chances of having a long life, he says.

But no one expects scientists to discover some kind of pharmaceutical fountain of youth anytime soon.

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

Company That Ran Fateful Drug Trial In France Opens Test Facility In U.S.

Wed, 10/05/2016 - 11:03am

Biotrial, a French company that runs clinical studies, has opened a facility in Newark, N.J.

Chris Cooper/Biotrial

One man died and four were injured in January after a clinical trial went awry in Rennes, France. Now, Biotrial, the company that ran that study, said it has opened a new research facility in Newark, N.J.

Biotrial conducts clinical trials on behalf of drugmakers and biotechnology companies. Most are phase 1 trials, in which an experimental drug is tried in a small group of volunteers to make a preliminary assessment of its safety before the drug moves on to larger human studies to further evaluate safety and also its effectiveness in treating an illness.

Biotrial's new facility in New Jersey has 110 beds for healthy volunteers participating in clinical trials.

Chris Cooper/Biotrial

An announcement Friday from the company said that the new facility would be able to conduct up to 50 phase 1 trials a year, involving as many as 2,000 volunteers. With 110 hospital beds, the facility is just slightly smaller than the company's phase 1 research center in Rennes, which Biotrial says is considered Europe's largest.

The company started conducting trials at the new $30 million facility a few months ago. François Peaucelle, managing director at Biotrial, says it has already completed four, and there are plans or discussions about 20 more.

Peaucelle says that about 55,000 people have participated in company trials since its founding in 1989. He says the tragedy in January was a freak accident. "I compare it to a plane crash. It's very rare, but it can happen," he says. "Medications are never risk free, but diseases are always a risk, so it's important to continue the research. And in drug development, phase 1 is a necessary step."

Shots - Health News Botched French Drug Trial Followed Rules But Lacked 'Common Sense'

But John LaMattina, former head of research and development at Pfizer, says the accident strikes him as an important warning. "I don't think the trial was badly done," he says, but it showed poor judgment. LaMattina says that if he were in his old position at Pfizer and someone suggested conducting a trial with Biotrial, "I'd have to say that my response would be 'No.' "

Jack Reynolds, a pathologist who worked for pharmaceutical companies including Pfizer, Bayer, and Bristol-Myers Squibb before founding a preclinical drug discovery company, agrees.

"How does a potential customer look at this?" asks Reynolds. "Not very well, that's for sure. In this business, credibility and reputation are really important."

Biotrial president Jean-Marc Gandon told a French publication that, after the botched trial, the company dropped from doing about 60 phase 1 trials a year to less than six. "The stakes are very high for us because the U.S. market represents 50 percent of global studies on healthy volunteers," he said.

The U.S. Food and Drug Administration said in August that the experimental medication that killed the healthy volunteer and injured four others in France has "a unique toxicity" and wasn't tested in U.S. subjects.

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

Under Health Law, Many Preventive Services For Men Are Covered, Too

Tue, 10/04/2016 - 12:38pm
Alberto Ruggieri/Illustration Works/Getty Images

A federal health list specifically guarantees some women's health coverage available without a copay or deductible, so what about men's health? And what options are available for coverage for people who travel frequently? Here are the answers to some recent questions from readers.

Why aren't there preventive health recommendations for men like there are for women under the health law? Women and breast cancer get so much attention by the health care community. Heart health, diabetes, prostate cancer and colon cancer are a few examples of opportunities for education and preventive screening for men.

There are many recommendations for men's preventive care in the health law, although most of the examples you mention apply to women as well. Under the law, services recommended by the U.S. Preventive Services Task Force have to be provided without charging people anything out of pocket. The independent panel of medical experts currently recommends that women and men be screened for high blood pressure, elevated cholesterol and blood sugar levels, and for colorectal cancer.

It advises against routinely screening men for prostate cancer, however, noting that research hasn't shown it reduces death from the disease. (Medicare covers an annual prostate cancer test, but you may owe a copayment.)

The drafters of the health law paid special attention to women's preventive health needs, creating additional recommendations tailored specifically for them. This was done in part to address recognized gaps in women's services, especially in the areas of sexual and reproductive health, said Adam Sonfield, senior policy manager at the Guttmacher Institute, a reproductive health research and policy organization.

The federal government is in the process of updating the women's preventive health guidelines. If it adopts the working group recommendations this fall, insurers will begin to cover condoms and vasectomies for men without charge. Adding this no-cost benefit would address an inequity in current coverage rules and help both women and men avoid unwanted pregnancies.

I am 74 years old and on Medicare. My mother died of ovarian cancer and two maternal aunts and my paternal grandmother had breast cancer. Does Medicare cover BRCA testing?

Medicare generally only covers genetic testing for the two BRCA mutations that are associated with an increased risk of breast and ovarian cancer if you've already been diagnosed with cancer and have a family history that indicates testing is appropriate.

Throughout its history, the Medicare program, which provides health benefits for older and disabled Americans, has focused on treating injury and illness, not preventing them. Although the program now covers some cancer screening tests such as mammograms and colonoscopies, those changes were specifically authorized by Congress.

It's a wrongheaded approach, said Dr. J. Leonard Lichtenfeld, deputy chief medical officer at the American Cancer Society. "I'm incensed that this is not covered."

The BRCA test results could be important not only to the woman but also to her siblings and children, Lichtenfeld said.

The U.S. Preventive Services Task Force recommends that women who have a family history of breast or ovarian cancers be screened to determine if they're at higher risk for potentially harmful genetic mutations and, if appropriate, referred for genetic counseling and BRCA testing. Under the health law, private insurers are required to cover such testing without charging women for it. But that provision does not apply to Medicare.

There are non-insurance options for testing, Lichtenfeld noted. Color Genomics, for example, offers a genetic test that analyzes 30 genes associated with hereditary cancers, including BRCA1 and BRCA2, for $249.

Are there any options available for people with marketplace plans who travel regularly? Emergency costs for an accident should be covered, but what about follow-up care after an accident or an illness while traveling? How does this work with increasingly narrow provider networks?

The situation you describe can be tough to manage. Under the health law, an insurer can't require you to pay more for care in an emergency department that's not in your provider network than it would have mandated for emergency care in network.

But once you leave the emergency department, you may get hit with out-of-network charges if you're admitted to the hospital, for example, or need other follow-up care and are far from home.

You have a few options. Individual Blue Cross Blue Shield plans that are sold on many marketplaces may offer access to BCBS providers nationwide and overseas.

Be sure to check with individual Blues plans before signing up if that type of coverage is important to you, said Paul Rooney, vice president of carrier relations at, an online insurance broker.

"Some of the local Blues are pulling [that coverage] from their offerings," he said.

You might consider buying an accident policy. These plans typically pay a fixed dollar amount to offset your costs if you're injured in an accident. But they can be tricky, said Nate Purpura, vice president of consumer affairs at The policies don't cover preexisting medical conditions, and the insurer might deny a claim that it considers related to an earlier medical problem, he said.

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

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

Home Remedies Can Help Relieve The Misery Of Morning Sickness

Tue, 10/04/2016 - 12:16pm

Those acupressure wristbands might not help for seasickness, but they could help for morning sickness.

Ruth Jenkinson/Dorling Kindersley/Getty Images

Morning sickness is a fact of life, or at least a fact of pregnancy, with more than three quarters of women enduring nausea or vomiting. There are tons of remedies touted, from ginger to acupuncture. But it can be hard to figure out what works.

And science isn't helping women much. When researchers combed through more than 13,000 studies that addressed morning sickness, they found that just 35 were robust enough to be relied upon. It's not surprising that there's no magic cure-all, especially since any treatment needs to be safe for the mother and the baby. But a few things stood out, especially when it comes to simple remedies for mild to moderate morning sickness. Here's the scoop on treatments you can try at home:

Ginger: Ginger enthusiasts rejoice! One of the oldest anti-nausea tricks in the book seems to work, at least a little bit. Four studies found that ginger was better at relieving morning sickness symptoms than a placebo.

Vitamin B6 (pyridoxine): One study found that vitamin B6 could help with nausea, but that it didn't reduce vomiting any more than a placebo. Another study found that higher doses of vitamin B6 helped reduce symptoms of morning sickness better than lower doses.

Acupressure: You know those wristbands people sometimes wear before going on a boat? They're supposed to put pressure on a certain spot on your wrist and help prevent seasickness. They jury's still out on whether acupressure can cure nautical nausea, but one study found that acupressure bands might help a bit with morning sickness. Others were inconclusive. Acupuncture and electrical nerve stimulation, however, failed to stand up to the jury of clinical trials.

Antihistamines: Some over-the-counter and prescription allergy medications seem to help with morning sickness. Although they are considered safe, they do have side effects like drowsiness and headache, so they're recommended as a second-tier offense. The combination of doxylamine (sold under the brand name Unisom) and vitamin B6 also helped.

What works best? A few studies directly compared the effectiveness of morning sickness treatments. Four compared ginger to Vitamin B6 and found that ginger was just as good, and in one case better, at reducing nausea. Another found that ginger, either in capsules or as syrup, worked better than the motion-sickness bands. And ginger is side-effect free, if you don't count ginger burps or acid reflux. So ginger for the win!

Unfortunately, none of these treatments have instant results.

"The evidence suggests that if these measures are going to be effective, they'll start to help within three to four days," says Amy O'Donnell, a public health researcher and fellow at the National Institute of Health Research School for Primary Care at Newcastle University in Newcastle, U.K., who was an author of the study.

She emphasized that if one at-home treatment doesn't help, women should try something else and consult their doctors.

Shots - Health News Women Say Ginger Doesn't Tame Morning Sickness

The study, which was published Tuesday in JAMA, the journal of the American Medical Association, also looked at prescription drugs for moderate and severe morning sickness. The review wasn't conclusive, but it showed that some drugs are effective, including antihistamines and medications that block serotonin and dopamine receptors.

There are other steps women can and should take at the first sign of nausea, says Dr. Laura Sirott, who was not involved in the study. Sirott is a practicing OB-GYN and the California chairman at the American Congress of Obstetricians and Gynecologists.

Dietary changes can help, she says, like eating smaller meals more often, or avoiding foods that are spicy and have strong odors. Some women find eating something solid, like crackers, before having any liquids can help control nausea.

And using simple remedies to control early symptoms of morning sickness can help avoid more severe problems down the line, Sirott says. Vomiting can lead to severe dehydration which can cause more problems, so being proactive can be a big help.

Sirott says the remedies described in the review have worked for some of her patients.

"The evidence isn't great for some of these treatments, but they're really low-risk. If it's not going to hurt, why not try it?" Sirott says. It's hard to evaluate the effectiveness of morning sickness treatments, she says, because morning sickness naturally improves as pregnancy progresses. "Some of these treatments might just be placebos, but if women say they work, that's what matters."

Given the poor quality of many of the studies on morning sickness, it might be a while before scientists can weed placebo from good practice.

"We need appropriately designed, multicenter clinical trials to compare the effectiveness of different treatments at different severities," says O'Donnell. And they need to take into account the outcomes that matter to women, like "improved quality of life and side effects."

While we wait for better research to come in, Sirott likes to remind her patients that morning sickness can be a good thing. "It's a normal part of pregnancy, and it usually means the pregnancy is going well. But that doesn't mean not getting sick is a bad thing, either."

Copyright 2016 NPR. To see more, visit NPR.
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Feds Say More People Should Try Dialysis At Home

Tue, 10/04/2016 - 5:00am

Nurses teach patients how to use equipment and do peritoneal dialysis at home.

Life in View/Science Source

About half a million Americans need dialysis, which cleans toxins from the body when the kidneys can't anymore. It can cost more than $50,000 a year, and takes hours each week at a dialysis center.

To meet the need, roughly 7,000 kidney dialysis centers have opened across the country. Patients go several times a week and spend half a day undergoing the life-sustaining procedure. Medicare is now taking steps to make it easier for people to do their own dialysis at home.

That sounds like great news to Dr. Robert LaClair, a nephrologist in Helena, Mont., who has an unusually high percentage of patients who do their dialysis at home: 40 percent versus the national rate of about 10 percent. That's largely because LaClair is no fan of how dialysis has traditionally been done in America. He says his patients do better if they're more active participants in their care, rather than passive receivers.

"The way we do dialysis in this country, no one would be saying, 'This is the way we should be doing things,' " LaClair says.

The traditional dialysis routine in a clinic setting is tough on patients, he says. "Often our patients will feel poorly for four, five, six hours, sometimes the rest of the day after a dialysis treatment [in the center]," LaClair says. "They only start feeling better by the next day. And then of course by the time they feel really well, they're back on dialysis again. So it's very hard on people, especially as they get older, to have to go through that kind of treatment."

Contrast that to LaClair's patient, 84-year-old Ward Shanahan. He's a retired attorney who was diagnosed with diabetes a year ago. LeClair prescribed a home dialysis machine that Shanahan uses every night at bedtime. More frequent dialysis means less recovery time, and patients can do it when it's convenient for them, not when centers have appointments available.

"It gives me a life again," Shanahan says.

He has a lakeside cabin he likes to visit in the summer. Being tied to a dialysis center's daytime hours "busts up the week," he says. "I like to be able to get up in the morning, take a shower and go around the world."

Shanahan says his home routine, using something called a peritoneal dialysis machine, isn't particularly difficult. "It's got this sweet-voiced lady telling me what to do," he says about the prerecorded voice from the machine on his nightstand that talks him through properly connecting several slender, clear plastic tubes to it. One plugs into a pre-mixed bag of sugar solution, another to a permanent catheter near his navel. The machine slowly pumps the fluid into his lower abdomen, where it circulates and absorbs bodily wastes through blood vessels in the abdominal lining called the peritoneum. The machine then draws it back out through the same catheter. Another tube snaking away from his machine carries the waste fluids into a toilet in the adjacent bathroom.

Ward Shanahan, 84, does dialysis at home every night while he sleeps.

Eric Whitney/MTPR

Peritoneal dialysis is less common than hemodialysis, in which a machine filters the blood itself. Most people who dialyze at home use the peritoneal technique, although it is possible for some patients to perform hemodialysis at home, too.

Shanahan says he often sleeps through most of the fluid cycling, getting about six hours of sleep a night. If there's a problem, he says, his machine, which is about the size of a toaster oven, "has a squawker on it, so I could be sleeping and this thing wakes me up and tells me I've got to fix the line."

But the routine he's now familiar with requires a lot of up-front training. Medicare is proposing to more than double the payment it offers dialysis providers to teach patients how to do it—from the current $50.16 for 1.5 hours of a nurse's time, to $95.57 for 2.66 hours.

Still, that may not be enough to cover actual training costs, says Dr. Frank Maddux, chief medical officer for Fresenius, a large dialysis company. He says the number of Fresenius' patients who dialyze at home has increased from 7 to 11 percent over the last five years.

"I don't know that [the increased payment] will create all the fundamental changes that need to occur, but I think it sets a good, clear direction," Maddux says.

Neither Medicare nor Maddux will say how many more dialysis patients should do the procedure at home. They say that is both a personal and medical choice that isn't right for everyone, and they don't want patients who are happy using dialysis centers to feel pressure to change.

Medicare officials declined to be interviewed for this story, but Maddux says he sees the agency's proposed bump in payment for in-home dialysis training as part of its bigger "triple aim" goal of improving patients' experience while also improving their health and lowering medical costs.

"There are many patients I think that could be much more engaged in their therapy," Maddux says, which he thinks would likely lead to them feeling better. At least one study found that patients who dialyze more frequently feel better and are hospitalized less than those who do it less frequently.

Nephrologist LaClair practices at St. Peter's Hospital in Helena, Mont. He says his patients who switch from the largely passive experience of a center to taking responsibility for their own care at home never want to go back, "even when we've had people having significant problems and issues" doing it themselves.

At St. Pete's, LaClair says, they have had the opportunity to "model dialysis the way think we would want dialysis if we were sick, and that's what we do."

Neither LaClair nor Maddux sees home dialysis as a threat to the viability of the thousands of dialysis centers nationwide. Providers get the same base-level payments for caring for patients whether they do their dialysis at home or in centers. LaClair says maintaining patients on in-home dialysis is cheaper long term, but requires a significant investment up front in training, and he says it's crucial that there is always medical staff on call to help with challenges, including infection control.

Information technology is improving the viability of home dialysis, too. Patients used to have to keep pen-and-paper logs of important health data about their treatments, logs that nurses say were notoriously inaccurate and that they only saw once a month. New machines track patients vital signs in real time and send the data back to providers via the Internet, allowing them to track and even adjust treatments on their computers or smart phones on the fly.

Medicare hopes to implement the payment increase by January 1, 2017.

This story is part of a reporting partnership with NPR, Montana Public Radio and Kaiser Health News.

Copyright 2016 Montana Public Radio. To see more, visit Montana Public Radio.
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Japanese Biologist Wins Nobel Prize In Physiology Or Medicine

Mon, 10/03/2016 - 5:54am
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October 3, 20165:54 AM ET Heard on Morning Edition

Yoshinori Ohsumi, a professor at the Tokyo Institute of Technology, smiles as he speaks with Japanese Prime Minister Shinzo Abe on a phone during a press conference in Tokyo today, after he was awarded the Nobel Medicine Prize.

Toru Yamanaka/AFP/Getty Images

Yoshinori Ohsumi of the Tokyo Institute of Technology has won the 2016 Nobel Prize in Physiology or Medicine for his discoveries about "autophagy" — a fundamental process cells use to degrade and recycle parts of themselves.

Ohsumi, 71, is a professor emeritus at the Tokyo Institute of Technology in Yokohama, Japan. As the sole winner, Ohsumi will receive more than $930,000.

Ohsumi's work opened the path to understanding how cells adapt to starvation and respond to infection, according to statement from the Nobel Assembly at the Karolinska Institute.

Mutations in the genes that control autophagy can lead to a variety of conditions, including cancer, type 2 diabetes and neurological diseases such as Parkinson's and Alzheimers, according to the announcement.

Autophagy, a term that comes from Greek words for "self-eating," is a basic process cells need to function properly.

"Without autophagy, our cells won't survive," says Juleen Zierath, who chaired the committee that selected Ohsumi. "We need autophagy to ward off invading molecules, for example, to deal with very large proteins that might be long-lived or defective. But we also need autophagy for renewal."

Scientists had known about autophagy since the 1960s, but the process had been very difficult to study, according to the Nobel announcement. So the exact machinery involved was unknown, as was how the system worked and whether it was involved in disease.

Before Ohsumi's work, scientists knew there was a structure inside cells that was considered the equivalent of a "waste dump," Zierath says.

"What he showed was that it wasn't a waste dump. It was a recycling plant. This was a really sophisticated machinery that recycled damaged or long-lived proteins," Zierath says.

Ohsumi showed this by conducting a series of "brilliant" experiments in the 1990s using chemically modified baker's yeast to identify key genes that are essential for autophagy, according to the Nobel announcement. These experiments enabled Ohsumi to decipher the complex series of chemical signals and events involved in the process. He then went on to show that similar sophisticated machinery is used in human cells.

"Ohsumi's discoveries led to a new paradigm in our understanding of how the cell recycles its content," according to the announcement. "Intense research is now ongoing to develop drugs that can target autophagy in various diseases."

Ohsumi and the winners of the remaining 2016 Nobel prizes will receive their awards at a ceremony in Stockholm Dec. 10.

"All I can say is, it's such an honor," Ohsumi told reporters at the Tokyo Institute of Technology, according to the Japanese broadcaster NHK. "I'd like to tell young people that not all can be successful in science, but it's important to rise to the challenge."

Copyright 2016 NPR. To see more, visit NPR.
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Doll Therapy May Help Calm People With Dementia, But It Has Critics

Mon, 10/03/2016 - 5:11am
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October 3, 20165:11 AM ET Heard on Morning Edition


Vivian Guzofsky, 88, holds a baby doll at Sunrise Senior Living in Beverly Hills, Calif. Guzofsky, who has Alzheimer's disease, is calm when taking care of the dolls.

Heidi de Marco/Kaiser Health News

Sitting beside a neatly made crib, 88-year-old Vivian Guzofsky holds up a baby doll dressed in puppy dog pajamas.

"Hello gorgeous," she says, laughing. "You're so cute."

Guzofsky, who has Alzheimer's disease, lives on a secure memory floor at a home for seniors in Beverly Hills, Calif. She visits the dolls in the home's pretend nursery nearly every day. Sometimes Guzofsky changes their clothes or lays them down for a nap. One morning in August, she sings to them: "You are my sunshine, my only sunshine. You make me happy when skies are gray."

No one knows whether she believes she is holding a doll or a real baby. What the staff at Sunrise Senior Living do know is that Guzofsky, who can get agitated and aggressive, is always calm when caring for the dolls.

Doll therapy is catching on at nursing homes and other senior facilities across the country. It's used to help ease anxiety among residents with dementia, who can experience personality changes, agitation and aggression. But the therapy is controversial.

Supporters say the dolls can lessen distress, improve communication and reduce the need for psychotropic medication. Critics say the dolls are demeaning and infantilize seniors.

Marilou Roos, 87, rarely speaks and sleeps much of the day. But caregiver Jessica Butler says Roos brightens up when caring for the dolls.

Heidi de Marco/Kaiser Health News

Typically, caregivers will give residents the option of holding, changing or dressing the dolls, without saying whether the dolls are babies or toys. Caregivers may also use the dolls to start conversations about the residents' own children or grandchildren.

Care providers who use the technique say the dolls help engage elderly people who are no longer able to participate in many activities.

"A lot of people with Alzheimer's are bored and may become depressed or agitated or unhappy because they aren't engaged," says Ruth Drew, director of family & information services at the Alzheimer's Association.

Caregivers aren't trying to make their charges believe the dolls are real infants, Drew says. They are just "trying to meet them where they are and communicate with them in a way that makes sense to them," she says.

But some care providers do not like the technique.

"They are adults and we want to treat them like adults," says Stephanie Zeverino, who works in community relations at a Belmont Village center in Los Angeles. "These are very well-educated residents."

Staff members there work with residents to play brain games that promote critical thinking, she says. And they use other types of therapy including art and music.

"We want to provide a sense of dignity," Zeverino says.

Studies on doll therapy are limited, but some research has shown it can reduce the need for medications and lessen agitation, aggression and wandering.

"Having the doll ... offers them an anchor or a sense of attachment in a time of uncertainty," says Gary Mitchell, a nurse specialist at Four Seasons Health Care facilities in Northern Ireland, and author of a new book: Doll Therapy in Dementia Care: Evidence and Practice.

"A lot of people associate the doll with their younger days and having people to care for," Mitchell says.

However, he acknowledges that doll therapy can perpetuate the stigma associated with dementia that care givers are trying to get away from.

Some families worry about their relatives being laughed at when they engage in doll therapy, Mitchell says. He had the same concerns when he worked at a senior residential center. But when one resident requested that he allow her to continue caring for a doll, he saw the positive impact of the therapy. Mitchell says doll therapy should be used cautiously and more studies are needed.

At Sunrise Beverly Hills, the nursery is set up like a baby's room. A stuffed bear rests inside the wooden crib. On a shelf above are framed photos of Guzofsky and a few other women who regularly interact with the dolls. A few bottles, a Dr. Seuss book and diapers sit on a nearby changing table.

The nursery is just one of several areas designed to engage residents, says Rita Altman, senior vice president of memory care for Sunrise, which has facilities in the U.S., Canada and the United Kingdom. There are also art centers, offices, gardens and kitchens where residents may find familiar objects from their past.

Altman says the nurseries tend to attract residents who have an instinct to care for babies. Some people may not be able to talk anymore, but still find a sense of security with a doll, she says. "You can read it in their body language when they pick up the doll."

When asked what she likes about the dolls, Guzofsky says, "I love babies."

Heidi de Marco/Kaiser Health News

Sunrise caregivers also use the dolls to spark conversations by asking questions: How many children do you have? Was your first baby a boy or a girl? What are the best things about being a mom?

The executive director of the Beverly Hills facility, Jason Malone, says he was skeptical about the use of dolls when he first heard about them.

"I almost felt like we were being deceitful," he says. "It didn't feel like it was real."

But he quickly changed his mind when he realized that staff could use the dolls respectfully.

"We don't want to confuse treating our seniors as children," Malone says. "That's not what this activity is truly about."

Guzofsky began caring for the dolls soon after moving into the facility. When asked what she likes about them, she says, "I love babies. I have some very nice ones back where I live now."

Guzofsky's daughter, Carol Mizel, says her mom raised three children and volunteered extensively in Colorado and Mexico before being diagnosed with Alzheimer's about five years ago. Mizel doesn't see any downside to her mother caring for the dolls.

It is a "creative way of dealing with her where she is now," she says.

For some residents, including 87-year-old Marilou Roos, holding the dolls is one of the only times they interact with the staff. Roos uses a wheelchair and rarely speaks. She sleeps much of the day.

"There is not much [Marilou] can participate in," says Vladimir Kaplun, former coordinator of the secure memory floor. "When she spends some time with the babies, she wakes up and she brightens up."

On a recent day, caregiver Jessica Butler sits next to Roos, who holds a doll against her chest and pats her on the back. She kisses the doll twice.

"The baby's beautiful like you," Butler says.

"It's a boy," Roos says. "Five months."

Caring for the dolls is second nature to Roos, who made a career of being a mom to five children, according to her daughter, Ellen Swarts.

It's been difficult for Swarts to watch the decline of her mother, who hasn't called her by name in over a year. Watching her with the dolls helps, Swarts says.

"To see the light in her eyes when she has a baby in her arms, I don't care if it's real or if it's pretending," she said. "If that gives her comfort, I am a-OK with it."

Kaiser Health News is an editorially independent program of the Henry J. Kaiser Family Foundation, a nonprofit, nonpartisan health policy research and communication organization not affiliated with Kaiser Permanente.

Copyright 2016 Kaiser Health News. To see more, visit Kaiser Health News.
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Brain Game Claims Fail A Big Scientific Test

Mon, 10/03/2016 - 12:02am
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October 3, 201612:02 AM ET Heard on Morning Edition Katherine Streeter for NPR

Want to be smarter? More focused? Free of memory problems as you age?

If so, don't count on brain games to help you.

That's the conclusion of an exhaustive evaluation of the scientific literature on brain training games and programs. It was published Monday in the journal Psychological Science in the Public Interest.

"It's disappointing that the evidence isn't stronger," says Daniel Simons, an author of the article and a psychology professor at the University of Illinois at Urbana-Champaign.

"It would be really nice if you could play some games and have it radically change your cognitive abilities," Simons says. "But the studies don't show that on objectively measured real-world outcomes."

The evaluation, done by a team of seven scientists, is a response to a very public disagreement about the effectiveness of brain games, Simons says.

In October 2014, more than 70 scientists published an open letter objecting to marketing claims made by brain training companies. Pretty soon, another group, with more than 100 scientists, published a rebuttal saying brain training has a solid scientific base.

"So you had two consensus statements, each signed by many, many people, that came to essentially opposite conclusions," Simons says.

In an effort to clarify the issue, Simons and six other scientists reviewed more than 130 studies of brain games and other forms of cognitive training. The evaluation included studies of products from industry giant Lumosity, which has been a prominent sponsor of NPR and other public radio programming.

"We went through each paper and tried to look at the kind of evidence it provided," Simons says.

That meant asking questions like: How big was the study? Did it have an appropriate control group? Do the results support the marketing claims made by companies?

The scientists found that "many of the studies did not really adhere to what we think of as the best practices," Simons says.

Some of the studies included only a few participants. Others lacked adequate control groups or failed to account for the placebo effect, which causes people to improve on a test simply because they are trying harder or are more confident.

There were some good studies, Simons says. And they showed that brain games do help people get better at a specific task.

"You can practice, for example, scanning baggage at an airport and looking for a knife," he says. "And you get really, really good at spotting that knife."

But there was less evidence that people got better at related tasks, like spotting other suspicious items, Simons says. And there was no strong evidence that practicing a narrow skill led to overall improvements in memory or thinking.

That's disappointing, Simons says, because "what you want to do is be better able to function at work or at school."

The evaluation got a warm reception from at least some of the scientists who had signed the 2014 letter defending the science behind brain training.

"The evaluation was very even-handed and raised many excellent points," says George Rebok, a psychologist at Johns Hopkins University who has been involved in brain training research for the past 20 years. "It really helped raise the bar in terms of the level of science that we must aspire to."

Rebok, who says he has no ties to brain training companies, remains optimistic that the right program of brain exercises can improve mental functioning and delay the effects of aging.

One reason brain games haven't shown a clear benefit so far, he says, may be that they don't work the brain hard enough or over a long enough time period.

"It takes mental effort and practice to be able to see results," Rebok says. "If we can implement that long range, I think that there will be a big dividend eventually."

In the meantime, the brain training industry is facing scrutiny from the Federal Trade Commission.

In January, the company behind Lumosity agreed to pay a $2 million fine to settle FTC charges that it made unfounded claims about its brain training program.

And in May, a smaller brain training company called LearningRx agreed to pay a $200,000 fine to settle similar charges. Even so, the Learning Rx website still promises "A better brain at any age."

Copyright 2016 NPR. To see more, visit NPR.
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A Bygone Era: When Bipartisanship Led To Health Care Transformation

Sun, 10/02/2016 - 6:00am

People might be forgiven for thinking that the Affordable Care Act is the federal government's boldest intrusion into the private business of health care.

But few know about a 70-year-old law that is responsible for the construction of much of our health system's infrastructure. The law's latest anniversary came and went without much notice in August.

The Hill-Burton Act was signed into law by President Harry S. Truman on August 13, 1946 — and its effect on health care in the U.S. was nothing short of monumental. Perhaps more importantly, it stands as an example, warts and all, of how a bipartisan Congress can forge compromises to bolster American infrastructure and boost the well-being of our people.

Known formally as the Hospital Survey and Construction Act, Hill-Burton started as a Truman initiative. In November 1945, only two months after the official end of World War II, he gave a speech to Congress outlining five goals to improve the nation's health. The first and least controversial of these called for constructing hospitals and clinics to serve a growing and rapidly demilitarizing population.

Hill-Burton provided construction grants and loans to communities that could demonstrate viability — based on their population and per capita income — in the building of health care facilities. The idea was to build hospitals where they were needed and where they would be sustainable once their doors were open.

Over the subsequent decades, new facilities sprang up all around the country, including many in the 40 percent of U.S. counties that lacked hospitals in 1945.

By 1975, Hill-Burton had been responsible for construction of nearly one-third of U.S. hospitals. That year Hill-Burton was rolled into bigger legislation known as the Public Health Service Act. By the turn of the century, about 6,800 facilities in 4,000 communities had in some part been financed by the law. These included not only hospitals and clinics, but also rehabilitation centers and long-term care facilities.

In 1997, this type of direct, community-based federal health care construction financing came to an end. However, numerous Hill-Burton clinics and hospitals still exist around the country, specifically financed by a part of law to provide care to those unable to afford it.

"After the passage of Medicare and Medicaid, Hill-Burton ranks right up there among the most important pieces of health legislation in the 20th century," physician and historian Howard Markel told Shots.

Hill-Burton introduced many ideas in health care financing that are still in use today. Chief among them is that hospitals receiving federal monies are obligated to provide free or subsidized care to a portion of their indigent patients. U.S. non-profit hospitals (still the vast majority) must demonstrate evidence of 'community benefit' to maintain tax-exempt status. Providing care to the uninsured is one of the most common ways to meet this obligation.

Grace Hospital in Morganton, N.C., was funded in part by the Hill-Burton Act. Construction began in 1969.

Courtesy of Blue Ridge Healthcare Foundation

Another idea rooted in Hill-Burton is federal-state matching, meaning that federal appropriations must be matched by dollars from states, which is how Medicaid is financed.

Hill-Burton also has a poorly remembered dark side: Because of its provenance as a bipartisan law named for a Northern Republican (Sen. Harold Burton of Ohio) and a Southern Democrat (Sen. Lister Hill of Alabama), the law codified the idea of "separate but equal" in hospitals and health care facilities.

In order to achieve compromise and the necessary Democratic votes for passage, Southern Democrat segregationists had to be appeased. When this aspect of the law was overturned in a federal court challenge in 1963, Hill-Burton went on to become a major driver of hospital desegregation.

It seems worth noting that Sen. Hill's surgeon father named him after Dr. Joseph Lister, a pioneer of antiseptic surgery.

A month after enactment of the law, Truman, a Democrat, appointed Republican Sen. Burton to the Supreme Court in a bipartisan gesture that doesn't seem imaginable in today's polarized political landscape. And consider this: Burton was unanimously approved by the entire Senate the same day he was appointed. With no committee hearings! He joined the court the very next day.

"Hill-Burton speaks to an earlier time in our history when the American people and those who represented them had confidence that government could do good things," Markel said. "And that makes it all the more phenomenal to me."

John Henning Schumann is a writer and doctor in Tulsa, Okla. He serves as president of the University of Oklahoma-Tulsa. He also hosts StudioTulsa: Medical Monday for KWGS - Public Radio Tulsa. You can follow him on Twitter: @GlassHospital.

Copyright 2016 KWGS-FM. To see more, visit KWGS-FM.
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How We Got Here: Treating Addiction In 28 Days

Sat, 10/01/2016 - 8:26am
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October 1, 20168:26 AM ET Heard on Weekend Edition Saturday


After a string of inpatient rehabilitation stays, Louis Casanova, who lives near Philadelphia, says he is still trying to break his addiction.

Ben Allen/WITF

Louis Casanova is playing cards with a friend on the back deck of a recovery house in Philadelphia's northern suburbs.

He's warm and open as he talks about his past few years. The guy everyone calls Louie started using drugs like Xanax and Valium during his freshman year of high school. At age 18, Casanova turned to heroin. About two years later, the rehab shuffle began.

"I relapsed and then I was just getting high. And then I went to treatment again in February of 2015," he says. "Then I relapsed again and went back to treatment."

He's 23 now. He's hurt people close to him and his criminal record, fueled by his drug addiction, is long. By Louie's count, he has been through eight inpatient rehabs. Louis says his stays have ranged from about 18 to 45 days.

"I did 30 days, and after that I came here," he concludes, talking about his latest visit.

A month's stay can be pretty typical among people who go to an inpatient facility.

But why?

"As far as I know, there's nothing magical about 28 days," says Kimberly Johnson, director of the Center for Substance Abuse Treatment at SAMHSA, the federal agency that studies treatment services.

Anne Fletcher, author of the book Inside Rehab, agrees.

"It certainly is not scientifically based," she says. "I live in Minnesota where the model was developed and a lot of treatment across the country really stemmed from that."

She says the late Daniel Anderson was one of the primary architects of the "Minnesota model," which became the prevailing treatment protocol for addiction specialists. At a state hospital in Minnesota in the 1950s, Anderson saw alcoholics living in locked wards, leaving only to be put to work on a farm.

To find a path for them to get sober and leave the hospital, he came up with the 28-day model.

Shots - Health News FDA Boosts Warning On Danger Of Combining Opioids And Anxiety Meds

Marvin Ventrell, executive director of the National Association of Addiction Treatment Providers, has studied the model's history. He says the month-long standard comes from the notion that when "someone is suffering from addiction — and in the days that this began, we're pretty much talking about alcoholism — it made sense to people that it took about four weeks to stabilize somebody."

And then, Ventrell says, "It became the norm because the insurance industry was willing to pay for that period of time."

Now the model has spread to treatment for opioid addiction, even though recovering from addiction to those powerful drugs may require a different method.

Ventrell admits there isn't enough research about the most effective length for an inpatient stay for opioid addiction.

"Treatment centers have to step up and say, 'Just like cancer or heart disease, we're going to measure our outcomes and show them to you,' " he says.

The federal government estimates spending on treatment for all substance abuse will hit a high of $42 billion by 2020. Some people pay tens of thousands of dollars, desperately hoping inpatient treatment will work.

But there's increasing evidence that medication assisted treatment with the synthetic opioids methadone or suboxone can help those addicted by helping to relieve symptoms of withdrawal and reduce craving, especially when paired with strong outpatient counseling and other support.

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Fletcher says it's important for treatment to move away from the default month-long model.

That may be enough for some people, she says, but it "isn't the case for most people. It's like any other chronic disorder, it waxes and wanes."

After his inpatient stays, Casanova is still trying to break his addiction. While he says recovery largely depends on the person, he preferred longer stays because it gave him more time to learn from other patients in a supportive environment. But Casanova is just one person; others prefer inpatient stays that are shorter than a month, followed by intensive outpatient programs.

Casanova relapsed in February, before I talked to him, and recently had to serve some jail time. But he's back in the recovery house, and hoping to soon make the leap to the next stage — a house with even more independence.

This story is part of a reporting partnership with NPR, WITF's Transforming Health and Kaiser Health News.

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

CDC Tells Men At Risk Of Zika To Put Off Procreation For 6 Months

Fri, 09/30/2016 - 1:40pm

Men who may have been exposed to the Zika virus should wait at least six months before trying to conceive a child with a partner, regardless of whether they ever had any symptoms, federal health officials are recommending.

The Centers for Disease Control and Prevention had previously recommended that only men with Zika symptoms had to wait that long. Those who may have been exposed to Zika but never developed any symptoms were told to hold off on trying to conceive for just eight weeks.

But on Friday the agency published revised recommendations based on new evidence indicating the Zika virus can remain in semen longer than had been thought and can be spread by men even if they don't have symptoms.

"The updated recommendations incorporate what's been learned since the previous guidance was released," the CDC said in a statement announcing the change.

"The new time period for couples to wait to attempt conception when the man has possible Zika exposure but no symptoms [is] expected to minimize the risk of sexual transmission around the time of conception and prevent possible early fetal exposure to the Zika virus," the CDC said.

The Zika virus can cause a variety of birth defects when women get infected while pregnant. The most serious birth defect that has been linked to Zika is microcephaly, which causes babies to be born with abnormally small heads and badly damaged brains.

For couples planning to conceive who do not live in a place where the virus is actively spreading, the CDC recommends that men who may have been exposed to the virus by traveling where the virus is being transmitted wait at least six months before trying to conceive.

The virus has spread through Latin America, especially Brazil, and the Caribbean, including Puerto Rico. It has also been spread by mosquitoes in Pacific islands such as Fiji.

For couples who live in a place where the virus is spreading, the CDC recommends that women and men should be tested if they develop any symptoms. Men who test positive should wait at least six months to try to conceive. Women who test positive should wait at least eight weeks. Those who test negative should talk to their doctor about what to do.

The guidelines are less specific for couples who live in a place experiencing an outbreak, such as Miami, but who don't have any reason to believe they may have been infected.

The guidelines recommend that those couples talk to their doctors about what they should do, weighing factors that "might influence pregnancy timing," such as their age, whether they had problems getting pregnant and their fertility.

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The agency stressed that its guidelines could continue to change as new information about Zika becomes available.

The virus has repeatedly surprised health authorities. At first they thought the virus was transmitted only by mosquitoes. Then researchers discovered men could spread Zika to women through sexual contact. The CDC was surprised again when doctors determined women could also spread the virus to men.

The Food and Drug Administration also recently recommended that all blood donations be screened for the virus to minimize the chances that pregnant women could get infected from a transfusion, or sex with someone who had a transfusion.

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