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Falls From Strollers And Baby Carriers Can Cause Serious Injuries

NPR Health Blog - Thu, 08/18/2016 - 12:55pm

Buckle up for safety in strollers, too.

Ghislain and Marie David de Lossy/Getty Images

When parents are trying to keep their children safe, one thing many of them do is transport their kids in a stroller or baby carrier.

While strollers and carriers are generally safe when used properly, a new study is a reminder that even these devices can be dangerous, especially when parents don't use them properly.

Almost 361,000 children ages 5 and younger were treated in U.S. emergency rooms between 1990 and 2010 for injuries they suffered in connection with a stroller or carrier, according to the study published in the journal Academic Pediatrics.

That works out to about two children every hour, or about 50 a day, according to the analysis of data collected by the National Electronic Injury Surveillance System.

Most of the injuries occurred when a child fell from the stroller or carrier or when the stroller or carrier tipped over.

"As parents we use these devices to transport our most precious cargo. And it's easy to look away just for a second. We want to encourage parents to always buckle their child into these devices and make sure they're properly restrained," says Kristin Roberts of the Center for Injury Research and Policy at the Nationwide Children's Hospital in Columbus, Ohio.

Most of the injuries involved the child's head and face. While many were just bumps and bruises, one-quarter of the stroller injuries — and more than one-third of carrier injuries — resulted in traumatic brain injuries or concussions, the researchers found.

The proportion of stroller-related brain injuries doubled during the study period, increasing from 19 percent to 42 percent. The proportion of carrier-related brain injuries tripled, rising from 18 percent to 53 percent.

The increases don't necessarily mean strollers and carriers are becoming less safe, the researchers cautioned. It could be that doctors are becoming more aware of the seriousness of head injuries.

"We know that traumatic brain injuries can lead to long-term consequences on cognitive development," Roberts says. "So we really want to make sure these injures are avoided."

The researchers also recommended that parents get a stroller or carrier that fits their child. Parents should never hang heavy items on a stroller's handles that can cause it to tip over.

And make sure to lock the stroller's wheels when it is parked. Carriers should be kept as close to the ground as possible to minimize injuries if falls do occur, researchers say.

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

Where Insurers' Exits Are Hurting Obamacare Exchanges — And Where They Aren't

NPR Health Blog - Thu, 08/18/2016 - 12:24pm

Alina Nurieva (right) sat with Gabriela Cisneros, an insurance agent from Sunshine Life and Health Advisors, and picked an insurance plan at the Mall of the Americas in Miami last November.

Joe Raedle/Getty Images

Some of the Affordable Care Act's insurance marketplaces are in turmoil as the fourth open enrollment season approaches this fall. What's ahead for consumers depends very much on where they live.

Competition on some exchanges will be diminished next year when three of the nation's largest health insurers — Aetna, UnitedHealthcare and Humana — will sell individual plans in many fewer markets. The departure of several Blue Cross and Blue Shield plans in various states will also hurt. These pullbacks also come on top of the closure of 16 nonprofit co-ops, another coverage option, since January 2015.

Aetna's exit announcement Monday that blamed financial losses on its marketplace plans gave Obamacare opponents who have from the start predicted the health law's failure a fresh chance to proclaim, "I told you so."

Shots - Health News Aetna CEO To Justice Department: Block Our Deal And We'll Drop Out Of Obamacare

That story line got more complicated Wednesday after the Huffington Post reported Aetna CEO Mark Bertolini sent a letter to the Justice Department on July 5 threatening to withdraw from the Obamacare marketplaces if the government sued to block his company's planned merger with Humana. The Justice Department did just that a couple weeks later.

Still, most marketplace consumers won't see any ill effects from insurers' withdrawals, say the health law's advocates and independent analysts.

"The effect on consumers is going to be mixed around the country," said Katherine Hempstead, a senior adviser at the Robert Wood Johnson Foundation. "Most of these marketplaces are not dependent on" the large national carriers.

Also, the big insurers' announcements apply generally only to the individual market. The much larger market of employer-sponsored insurance is not part of the health law exchanges.

Many major metropolitan areas, such as those in California, New York and Texas, will still have several insurers for individual health insurance consumers to choose from. In Texas, all major metro areas — including Austin, Dallas, Houston and San Antonio — will have at least three insurers after Aetna and UnitedHealthcare exit.

That's true also for most urban exchange customers living in the Northwest, the Midwest and New England.

Most hurt will be marketplace consumers in Arizona, North and South Carolina, Georgia and parts of Florida, where only one or two insurers will be left when open enrollment season begins Nov. 1.

Remaining insurers might raise their monthly premiums as a result, but more than 8 in 10 consumers on the marketplaces who get government subsidies would be insulated. Subsidies increase as premiums rise.

One concern is that with less competition, insurers may tighten their provider networks and give these consumers fewer choices of hospitals and doctors. That trend started several years ago, and some states have responded with regulations requiring insurers to provide customers with reasonable access to doctors and hospitals in each county where they sell plans.

Nearly 13 million people signed up for Obamacare marketplace policies for 2016. Aetna, UnitedHealthcare and Humana have 2 million members in total, but their exit from certain states is predicted to affect between 1 million and 1.5 million people who will have to choose new carriers.

While changing plans can force people to find new doctors, it's also the best way for consumers get the best deals on coverage.

Aetna will exit 11 of 15 states where it sells plans on the exchanges. UnitedHealthcare has said it will quit 22 of 34 states, and Humana will leave four of the 15 states where it operates.

In late May, the Kaiser Family Foundation estimated the number of rural counties at risk of having one insurer on the exchanges would triple in 2017. That was before Humana and Aetna detailed their plans. (Kaiser Health News is an editorially independent project of the foundation.)

"We could be looking at about 1 in 4 counties in the U.S. with just one exchange insurer next year, though this could change between now and open enrollment in November," said Cynthia Cox, associate director for the Kaiser Family Foundation Program for the Study of Health Reform and Private Insurance.

Overshadowed by the big insurers' withdrawals is the prospect that other carriers will enter markets the three giants are leaving. Smaller insurers Molina and Centene have said they're doing fine on the exchanges. And Cigna, a larger insurer, has said it will move into some North Carolina counties for 2017.

North Carolina will be left with just one or two plans in most of the state after it loses UnitedHealthcare and Aetna plans. Health insurance analysts say three insurers are needed for a healthy competitive market.

"We've had a very robust enrollment under the ACA and hope consumers will still see benefits of having coverage even if they have fewer options," said Ciara Zachary, health policy analyst for the North Carolina Justice Center's Health Access Coalition.

Rural Americans had few health insurers to choose from even before Obamacare, but some suburban and urban parts of the Southeast will be in the same fix next year. In southeast Florida, consumers in counties near Naples and Fort Myers will have only one marketplace insurer — Florida Blue — next year, unless other insurers step in.

"There are some headwinds, but it's not a question of whether the market will stabilize but how quickly and how well," said Hempstead.

Strong winds are already blowing with hurricane force toward Arizona's Pinal County, southeast of Phoenix, health care advocates say. Nearly 10,000 people enrolled in Obamacare marketplace policies this year and about 85 percent received a federal subsidy.

In 2017, Pinal stands to lose its only two insurers — UnitedHealthcare and Blue Cross and Blue Shield of Arizona. "Clearly this is a big concern for consumers," said Allen Gjersvig, director of navigator and enrollment services for the Arizona Alliance for Community Health Centers. He said he is hopeful another insurer will step in, but not confident.

Neighboring Maricopa County, which includes Phoenix, is expected to have just two relatively small insurers in the area left on its marketplace next year. Gjersvig questions whether those two — Cigna and Phoenix Health Plan — will have enough doctors and hospitals under contract to handle their new members after larger rival Blue Cross and Blue Shield of Arizona gives up its 40,000 customers.

At least a dozen other counties in Arizona will be left with just one health insurer, he said.

Arizona had eight insurers operating in various parts of the state this year, but four are leaving entirely — Aetna, UnitedHealthcare, Humana and Health Choice. Two more, Blue Cross Blue Shield and Health Net, are scaling back their participation.

Despite the problems with the marketplaces, Gjersvig said thousands of people have gained coverage through them and he is confident they will survive. "We do not see this as a death knell for the marketplace," he said.

Tammie King, an insurance agent in Columbia, S.C., is less sure how insurer departures will affect consumers in the Palmetto State. The pullouts by UnitedHealthcare and Aetna mean there will be only one carrier in the state in 2017 — Blue Cross and Blue Shield of South Carolina.

That's a particular concern in Columbia, she said, because the Blue Cross plan does not include one of the biggest hospitals, Lexington Medical Center, and its affiliated physicians. "People will be left unable to see the doctors they are now using," King said.

King said she worried the Blue Cross plan will use its monopoly power to further reduce the number of doctors and hospitals in its network and limit its choice of prescription drugs. "You can't blame them because ... they have to do something to control costs," she said.

Kaiser Health News is an editorially independent news service supported by the nonpartisan Kaiser Family Foundation.You can follow Phil Galewitz on Twitter: @PhilGalewitz.

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

To Fight Off Diabetes, Latina Women Find Power In A Group

NPR Health Blog - Thu, 08/18/2016 - 10:27am

The goal is to intervene early so that fewer Latino women develop Type 2 diabetes.

Hero Images/Getty Images

Beatrice Sanchez and Mariana Arias drive around their city, Winston-Salem, N.C., in search of a very specific population of residents: Latinos with prediabetes.

The two women, both bilingual and Hispanic, are recruiting participants for a Type 2 diabetes prevention study called "La Comunidad," a lower-cost local version of the landmark Diabetes Prevention Program trial that staved off diabetes through changes in diet and physical activity in about 50 percent of study participants.

The results of that study suggested it was possible to fight a disease that affects about 29 million Americans without drugs and their side effects. It was more effective than using a common diabetes drug called metformin, which cut that number by just 30 percent.

The Diabetes Prevention Program is "still the gold standard," says Mara Vitolins, an epidemiologist at Wake Forest University Medical Center in Winston-Salem who is leading La Comunidad.

When the results of the Diabetes Prevention Program were first published, Vitolins was eager to test this concept in her own city, but cost was a big challenge. The program required six months of one-on-one counseling with case managers trained in nutrition or fitness, followed by personal visits every month for another year and a half. The first two years of intervention amounted to more than $2,600 per person.

To reduce the cost, Vitolins decided to focus on a part of the earlier program that relied on group counseling for her two-year study, called Healthy Partnerships in Preventing Diabetes (HELP).

"The whole idea was to take something that was extremely expensive and find every way that we could to make it more community friendly and that it can be sustained," she says.

HELP replaced case managers with community health workers and group meetings to help participants lose weight and bring their blood sugar levels down. It worked. The two-year study, which was completed in 2011, met goals close to or the same as those reached by the DPP for about a third of the cost—$850 per person. But the study was small, with only 301 participants, so it was impossible to tell if it lowered participants' risk of developing diabetes.

And the HELP study had another shortcoming. Though it was designed to reach a high-risk, underserved population, it included very few Latinos, a group that makes up about 15 percent of Winston-Salem residents. Latinos are more susceptible to developing diabetes at a young age; according to CDC data from 2011, the average age for diabetes diagnosis among whites was 55, but 49 for Hispanics.

To reach the Latino population, Vitolins launched La Comunidad in 2014, translating the HELP program materials into Spanish.

But she knew she needed to do more than just change the language. So she hired Arias and Sanchez as recruiters and ambassadors to the city's Latino population, which includes undocumented immigrants. "We've got to establish communication," says Sanchez. "We're targeting a group of people that are very cautious."

The team determines whether the participants' blood-glucose levels are high enough to be classified as prediabetic. Some are turned away because they are pregnant or unknowingly already have full-blown diabetes. Pregnancy was not an issue in Vitolins' former study because the average HELP participant was 60 years old, says Vitolins. But most of the people joining La Comunidad are in their early 40s. "We're finding that the Latino community, especially the women, are qualifying at a younger age."

The project team is also finding that more Latino women than men qualify for the program. They speculate that Latino men may have more physically active lifestyles, keeping them from developing prediabetes.

After qualifying, La Comunidad participants meet with a registered dietician. They also visit an outpatient clinic for general health assessments and blood work every six months for two years. The first recruits finished in May.

But the bulk of the work happens during group meetings, which are held weekly for the first 24 weeks. After that, members gather once every other month for the rest of the study. Topics cover everything from basic nutrition to what kind of shoe is best for particular workouts.

Group members share their own advice and experiences. One woman could not afford to buy prepared food, says Carmen Vazquez, a health adviser who helps lead the group meetings. Despite limited resources, she still manages to eat healthy and exercise. So far, she's lost 40 pounds. "She has been an example to the rest," Vazquez says.

The meetings help participants become aware of how foods and activities affect their bodies. "One of the major emphases of the program is to be sure people take control of their own life," says Vazquez. Information may have been missed because of health disparities, language barriers or just lack of education, and "We are trying to fill that gap."

Vazquez is quick to point out that she and the other health advisers are laypeople — in fact, her background is in fashion. Vitolins says this is one of the keys to making the program affordable. "It didn't matter that the person leading it didn't have a high school degree. It's the fact that that person can communicate a message."

The ultimate goal of studies like La Comunidad, Vitolins says, is to determine whether group-based techniques are helpful from both a health and medical reimbursement perspective. In March, the Centers for Medicare and Medicaid Services (CMS) announced that Medicare would cover preventive programs that meet the Centers for Disease Control and Prevention's (CDC) requirements, such as data reporting.

Vitolins agrees that community-level programs must have good data to support their use. "We're testing before we say everyone who's in the Latino population should use this approach," she says. "We want it to be effective."

Not everyone shares Vitolins' enthusiasm. Richard Kahn, a professor of medicine at the University of North Carolina at Chapel Hill says it's too early for Medicare and health insurance companies to be covering such programs, since they delay diabetes rather than prevent it totally.

"The question which is unanswered is whether that delay actually makes a difference," Kahn says. Another question is whether weight loss in the first few years of a program makes a difference if participants just gain it back, which many do. "We need more studies about how the body regulates weight."

In the meantime, Vitolins focuses on getting the message of diabetes prevention out to people who may not know their risk. Estimates vary depending on how blood glucose is measured, but the CDC reports that 86 million Americans are prediabetic, and many don't know it.

"With the numbers that we think are out there, every single program that shows efficacy should be at the table," Vitolins says.

Amanda B. Keener is a freelance science journalist who writes for Nature, The Scientist and PBS.org.

Copyright 2016 NPR. To see more, visit NPR.
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Study Of Sudden Cardiac Death Exposes Limits Of Genetic Testing

NPR Health Blog - Wed, 08/17/2016 - 8:41pm

The condition known as hypertrophic cardiomyopathy, or HCM, is inherited and can be a killer. But some of the genetic mutations once thought linked to the illness are actually harmless, geneticists say.

Afton Almaraz/Getty Images

Scientists have discovered that a common cause of sudden heart death has been misunderstood because researchers didn't appropriately account for racial differences in their studies.

The findings, published online Wednesday in the New England Journal of Medicine, have implications far beyond this particular inherited disease, called hypertrophic cardiomyopathy, or HCM. Researchers say the results also sound a cautionary note for many other illnesses that have been identified through genetic markers.

HCM gained attention in the 1980s after several seemingly healthy athletes, including the rising basketball talent, Hank Gathers, suddenly died from it. Scientists had figured out that the propensity for developing HCM is passed along as a genetic trait; the condition affects about one in 500 Americans.

Tarika Mingo, a psychiatric social worker in New York City, first realized something was wrong with her own heart several years ago, when she became so short of breath during gentle activity that she nearly passed out. In 2014 her doctors accurately diagnosed her with HCM. They performed open-heart surgery and reduced her risk of sudden death. She still feels the effect of the disease, however.

"I have to see the cardiologist every three to six months," she tells Shots. "I have to take my medicine every day. The heat is not my best friend, so it limits my social activities. We just had a heat wave and I was stuck in the house."

The diagnosis also sent reverberations through her family. That's because the likelihood of developing HCM follows a simple, inherited pattern: If your parent has the disease, your likelihood of developing it is 50:50. So she urged her entire family to get checked out. Mingo's 16-year-old son shows no signs of having inherited the condition, but her 29-year-old sister has some ominous symptoms.

As part of the diagnosis, doctors turn to genetic testing. But, while the inheritance of this disease follows a simple pattern, the genes that control it reveal a much more complicated story than geneticists realized until very recently.

And that applies to many other genetic traits that are now commonly diagnosed in medical labs.

In HCM, it turns out, any one of about a dozen genes can be damaged in ways that lead to the illness, and there are many different possible mutations in each of these genes. So there are many ways the disease can be passed down.

What's more, some of the variants that researchers originally flagged as disease-causing mutations have actually turned out to be benign.

Dr. Isaac Kohane at Harvard Medical School says a postdoctoral fellow working with him, Arjun Manrai, came across this serious problem of misdiagnosis quite by accident.

They were studying the genetic variants related to HCM. While the disease is observed to occur in about one in 500 people, "we saw that the variants that were ostensibly causing disease seemed to add up to much more than one in 500," he says.

In fact, the supposedly risky gene variants appeared in one out of 10 or one out of 20 people of African descent — an impossibly high number.

"Something must be wrong," Kohane realized. "Something must have been awry."

Kohane and his colleagues think they now may have solved that mystery.

When scientists originally went looking for these genes, Kohane explains, they compared the genetics of families affected by the illness with a sample of healthy people.

But here's the catch: People in the healthy comparison groups in these studies were white; whereas some people in the studies with HCM apparently had some African ancestry. As a result, some of the gene variants flagged as being linked to the illness simply represented racial differences between the groups and had nothing to do with HCM.

That problem would likely have been avoided if the original scientists had added four or five African-Americans to the control group, Kohane says.

It turns out that two of these variants commonly identified in African-Americans actually don't pose a health risk at all. That means many people may have been inadvertently misled about their risk of developing this disease.

"I've had to evaluate a large number of athletes with borderline anatomical findings," suggesting they had the heart condition, said Dr. Barry Maron, a leading expert on hypertrophic cardiomyopathy at Tufts Medical Center. He has also served as a consultant for top college athletic departments.

"Could some be false positives, and [mistakenly] disqualified from sports?" Maron asks. "I don't know for sure, but it's possible."

Promising athletic careers may have come to an abrupt halt, based on the results of genetic tests that turned out to be misleading. On the other hand, Tarika Mingo worries that insurance companies and doctors won't be as committed to diagnosis and treatment of HCM patients if there is no clear genetic marker. So she's nervous about seeing any genetic marker reclassified as benign.

Meanwhile, it's not clear whether these misidentified traits are still being linked with the disease, Kohane says. Genetic testing labs work independently, so the test for HCM can vary from one company to the next.

"The leading laboratories that do genetic testing make sure that they update their findings as these results come in," he says. But other labs may just adopt a panel of tests and stick with it.

Maron and Kohane say this discovery has implications that go far beyond sudden cardiac death. It underscores the point that even diseases that appear to have simple genetics are in fact usually quite complicated.

"Is HCM one of these diseases you either have or you don't?" Kohane asks. "Or is it like almost everything else we're coming to learn about, where it's a matter of degree."

Genetic testing, he says, has lulled us all into thinking that diseases can be boiled down to yes or no questions. But, increasingly, that does not seem to be the case.

"It just turns out that the genome is as complicated and as unique as each one of us," Kohane says.

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

Scientists Engineer An Opioid That May Reduce Pain With Less Risk

NPR Health Blog - Wed, 08/17/2016 - 3:31pm
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August 17, 20163:31 PM ET Heard on Morning Edition TS Photography/Getty Images

Once people realized that opioid drugs could cause addiction and deadly overdoses, they tried to use newer forms of opioids to treat the addiction to its parent. Morphine, about 10 times the strength of opium, was used to curb opium cravings in the early 19th century. Codeine, too, was touted as a nonaddictive drug for pain relief, as was heroin.

Those attempts were doomed to failure because all opioid drugs interact with the brain in the same way. They dock to a specific neural receptor, the mu-opioid receptor, which controls the effects of pleasure, pain relief and need.

Now scientists are trying to create opioid painkillers that give relief from pain without triggering the euphoria, dependence and life-threatening respiratory suppression that causes deadly overdoses.

That wasn't thought possible until 2000, when a scientist named Laura Bohn found out something about a protein called beta-arrestin, which sticks to the opioid receptor when something like morphine activates it. When she gave morphine to mice that couldn't make beta-arrestin, they were still numb to pain, but a lot of the negative side effects of the drug were missing. They didn't build tolerance to the drug. At certain dosages, they had less withdrawal. Their breathing was more regular, and they weren't as constipated as normal mice on morphine.

Before that experiment, scientists thought the mu-opioid receptor was a simple switch that flicked all the effects of opioids on or off together. Now it seems they could be untied. "The hope is you'd have another molecule that looks like morphine and binds to the same receptor, but the way it turns the receptor on is slightly different," says Dr. Aashish Manglik, a researcher at Stanford University School of Medicine who studies opioid receptors.

After Bohn's discovery, a number of people, including a team that includes Manglik, started looking for a drug that could connect to the mu-opioid receptor in a way that avoids the negative effects of beta-arrestin.

To do that, they mapped the receptor's structure in a computer program and started looking for chemicals that would stick to it. "We tried to look for molecules that would still bind to this 3-D structure, but are as far away from morphine and codeine as possible," Manglik says.

The team ran 3 million possibilities through the computer and picked the 23 best candidates to test in a lab. One chemical, PZM21, seems to do what they hoped: Turn the opioid receptor on without using much beta-arrestin. They report their findings in Nature on Wednesday.

The scientists then tweaked the chemical to make it more potent and gave it to mice. The mice had pain reduction similar to that with morphine. But their breathing was more normal, and they didn't seem to get high.

"If you give a mouse a drug that activates its reward pathways like cocaine, amphetamine or morphine, the mice just run around more. In this compound, we saw very little of that," Manglik says. The mice also didn't seem to have a preference between the chemical and salt water.

That means it's possible that the compound is less lethal and has less potential for abuse compared to something like morphine, but it still might be as effective of a painkiller. If, of course, it turns out to work in humans. So far it's only been tested in mice.

And the role that beta-arrestin plays in opioids is just one hypothesis. It would be eerily convenient if only the negative effects of opiates are tied to this one protein. The mice that didn't have any beta-arrestin actually seemed to have a stronger preference for morphine over saline. So there may be other things going on that science hasn't teased out yet.

But the work that Manglik and his collaborators have done is encouraging in the search for the next generation of painkillers — ideally ones that are safer and non-addictive.

"I think this was really a tour de force," says Gavril Pasternak, a researcher at the Memorial Sloan Kettering Cancer Center who's also trying to develop new opioids but was not involved in this study. "They're new entities with totally different pharmacological profiles. These are great promise for opiates over the course of the next five to 10 years."

Bohn, now a professor at The Scripps Research Institute in Jupiter, Fla., is hopeful that a safer opioid may be coming to the clinic, too.

Manglik and some of his collaborators have founded a company that will try to bring these new drugs to market, and the pharmaceutical company Trevena is running a very similar molecule through clinical trials now.

But that safe, effective painkiller isn't here yet, Bohn says. "We have some really gorgeous compounds, and I think opiates are a terrible epidemic. But I would be careful of overselling this as the answer."

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

Aetna CEO To Justice Department: Block Our Deal And We'll Drop Out Of Obamacare

NPR Health Blog - Wed, 08/17/2016 - 1:08pm

Mark Bertolini, CEO of Aetna, told the Justice Department in July that the insurer would walk away from many health exchanges if the government opposed the company's proposed deal for Humana. On Tuesday, Aetna followed through.

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It's not often in the midst of an antitrust fight that the public gets a look at the gamesmanship that's happening behind the scenes.

But thanks to the Huffington Post's Jonathan Cohn and Jeff Young, we got a glimpse at how health insurer Aetna is making its case to acquire rival Humana — and new insight into Aetna's decision announced Tuesday to pull out of Obamcare exchanges in 11 states.

The reporters obtained a copy of a letter from Aetna CEO Mark Bertolini to the Justice Department on July 5. The letter was written while the government was still deciding whether to oppose the insurance companies' merger on the grounds that it (and another proposed deal between Anthem and Cigna) would hurt consumers and reduce competition.

The Bertolini letter was in answer to a Department of Justice request for information about how a decision on the Humana deal would affect Aetna's participation in the health insurance exchanges created by the Affordable Care Act.

The letter is pretty direct: If the government moved to block the merger, then Aetna would begin to pull out of the health insurance exchanges.

Here's the key paragraph (emphasis added):

"Our analysis to date makes clear that if the deal were challenged and/or blocked we would need to take immediate actions to mitigate public exchange and ACA small group losses. Specifically, if the DOJ sues to enjoin the transaction, we will immediately take action to reduce our 2017 exchange footprint. We currently plan, as part of our strategy following the acquisition, to expand from 15 states in 2016 to 20 states in 2017. However, if we are in the midst of litigation over the Humana transaction, given the risks described above, we will not be able to expand to the five additional states. In addition, we would also withdraw from at least five additional states where generating a market return would take too long for us to justify, given the costs associated with a potential breakup of the transaction. In other words, instead of expanding to 20 states next year, we would reduce our presence to no more than 10 states. We also would not be in a position to provide assistance to failing cooperative exchanges as we did in Iowa recently."

The Huffington Post reporters calls the letter "a clear threat."

A little more than two weeks later, on July 21, the Justice Department said it would sue to block the Aetna-Humana deal and the other proposed megamerger between Anthem and Cigna.

On Tuesday, Aetna said it would dramatically scale back its participation on the insurance exchanges in 2017. The company move would take it out of 546 counties in 11 states, leaving it active in 242 counties in four states: Delaware, Iowa, Nebraska and Virginia.

Additional Information: Related NPR Stories Aetna Joins Other Major Insurers In Pulling Back From Obamacare Aug. 16, 2016

Aetna said the pullback was a business decision stemming from a loss in the second quarter on individual plans and uncertainty about the policy outlook for the exchanges.

In the company's statement, Bertolini said, "As a strong supporter of public exchanges as a means to meet the needs of the uninsured, we regret having to make this decision."

The statement made no mention of the company's pending offer for Humana nor its recent correspondence with the government about how Aetna would likely respond if the feds moved to block the deal. Aetna didn't immediately respond to a request for comment on how to reconcile Tuesday's announcement with the July 5 letter made public by Huffington Post on Wednesday.

The change in tack for Aetna is also noteworthy because Bertolini was talking up the business potential of the exchanges as recently as April, when he said during a call with analysts and investors that the exchanges were "a good investment," despite the losses incurred.

At the time, Bertolini said that Aetna was "committed to working constructively with the administration and lawmakers to find solutions that can improve this program, stabilize the risk pool, and expand product flexibility, all with the goal of creating a sustainable program that makes health care more affordable and accessible for all consumers."

Now, the company appears to be taking its ball and going home.

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

Abuse In Childhood Raises The Risk Of Early Death For Women

NPR Health Blog - Wed, 08/17/2016 - 11:02am

Women may have different ways of coping with childhood stresses than men, which may increase their risk of health problems in adulthood.

Jutta Klee/Uppercut/Getty Images Shots - Health News Can Family Secrets Make You Sick?

It's increasingly clear that bad experiences during childhood are associated with long-lasting health effects, including higher rates of heart disease, diabetes and depression. And childhood abuse in particular has been associated with psychiatric problems and chronic diseases years down the line. But whether that translates to a higher risk of early death for abuse survivors isn't well studied.

According to research published Wednesday, there is an association between reports of childhood abuse and premature death, but only in women. And because of the nature of the study, the link isn't definitive.

Researchers looked at data from a government-funded study that tracks how adults' physical and mental health change over time. Study participants had filled out questionnaires in 1995 and 1996 on topics including their experience with emotional and physical abuse during childhood. (Sexual abuse was not assessed, but there is evidence that it can have health repercussions, too.)

Then the researchers collected mortality data for 20 years and looked at whether reported abuse was associated with death during that period. For men, it wasn't. But women who reported childhood emotional abuse were 22 percent more likely to die during the follow-up period than women who didn't report abuse. If they reported moderate physical abuse, they were 30 percent more likely to die. For severe physical abuse, the increased risk was 58 percent. The more types of abuse reported, the greater the risk of death during those 20 years.

"It's important to consider not just the psychological consequences of childhood abuse, but also the possibility that there may be physical consequences," Edith Chen, a professor of psychology at Northwestern University and an author of the study, wrote in an email. The results were reported Wednesday in JAMA Psychiatry.

Here's the big caveat: The link to early death was with self-reported abuse, not abuse confirmed by courts or independently documented in other ways. It's possible, according to Chen, "that some adults may recall their childhoods as more difficult than they would have been characterized by an outside observer, and this tendency itself may be associated with greater health risks." Or people might not feel comfortable disclosing abuse in a questionnaire, even if it did occur.

To nail down that link, you'd have to find children who had court-verified cases of abuse and then follow them over many years.

But let's assume for a minute that there is an actual association between women's childhood abuse and their risk of dying before their peers who were not abused. What could be going on? For one, the physical and psychiatric problems associated with abuse can lead to reduced longevity, points out an editorial accompanying the study. Or people who experience abuse may use drugs or engage in other unhealthy behaviors such as overeating as coping strategies. Terrible childhood experiences may also set up the body for chronic inflammation, which has been linked to a host of chronic diseases, such as heart disease and diabetes.

And there's a second obvious question: Why only in women? That's unclear, the researchers say, but might be related to hormonal differences in stress response. Or women and men may have different coping strategies, with different health impacts. The study recorded only the death itself, not the cause of death, so it's hard to tease too much out from the data.

Given the evidence suggesting adversity in early childhood is tied to poor health decades later, many researchers are trying to figure out how to break that link. Some pediatricians are using "adversity scores" to identify at-risk kids and help out the whole family. Even asking adults about their childhood experiences might offer a way to understand some of the possible roots of their medical problems. Curious? You can take the quiz online here.

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.
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Florida Keys Opposition Stalls Tests Of Genetically Altered Mosquitoes

NPR Health Blog - Wed, 08/17/2016 - 5:06am
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August 17, 20165:06 AM ET Heard on Morning Edition

Containers hold genetically modified Aedes aegypti mosquitoes before being released in Panama City, Panama, in September 2014.

Arnulfo Franco/AP

The fight against the Zika virus has a new weapon: the genetically engineered mosquito. It's recently been approved by federal regulators and may soon be available in parts of the U.S. that are confronting the virus, like Puerto Rico and Miami.

The Florida Keys do not have a Zika problem at the moment, but on Aug. 5 the Food and Drug Administration approved trial releases of these mosquitoes in the Keys.

But because of the vocal opposition of people there, the local mosquito control board hasn't yet approved the trials, instead putting it on the November ballot as a nonbinding referendum.

Mosquito control in the Florida Keys is serious business. The Florida Keys Mosquito Control District is one of the top mosquito control agencies in the world. Six years ago, the District began looking at new technology aimed at combating a mosquito that's a serious disease threat, the Aedes aegypti.

That mosquito was responsible for a dengue epidemic in Key West in 2009 and 2010 that infected more than 90 people. It's also the mosquito that carries the Zika virus. The problem is that Aedes aegypti mosquitoes have become resistant to some pesticides. Michael Doyle, the Keys Mosquito Control District director, says the genetically modified mosquitoes developed by a British company called Oxitec should get much better results than spraying with pesticides.

"What we're doing now kills probably 50, maybe 60 percent of the adult females that are the ones carrying diseases. [Oxitec] is getting 90-plus percent," Doyle says.

Oxitec's genetically modified male mosquitoes are intended to mate with wild females. The offspring die before reaching adulthood.

When the FDA gave Oxitec the go-ahead to test its genetically modified mosquitoes in the Keys, it seemed to be in the nick of time. Miami, just up the overseas highway from the Keys, already has 30 cases of locally acquired Zika, most in the Wynwood neighborhood.

Pregnant Women In Miami Take Extra Precautions Against Zika Listen · 5:10 5:10 Toggle more options
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Mosquito Control Board Commissioner Jill Cranney-Gage says Zika gives new urgency to the trials proposed for the Keys.

"Zika is here. It's coming. We see what's happening in Wynwood. This board has to do everything that they can to protect the health and safety of the residents and our tourism and our economy," Cranney-Gage says.

But vocal opponents of the genetically modified mosquitoes in the Keys say Zika is no reason for them to change their minds. Megan Hall, who lives on Sugarloaf Key, worries that it's unproven technology that could have negative unforeseen consequences for people and the environment.

"Personally, I'm not afraid of Zika. I know it's a huge problem in a lot of places, and I don't discount it," she says. "I know it's terrible what's going on in Brazil and all these places — Puerto Rico. But this is not an emergency."

Shots - Health News Zika Cases Surge In Puerto Rico As Mosquitoes Flourish

If the board decides ultimately to give the trials the green light, the earliest they would likely start would be next spring.

But Oxitec CEO Hadyn Parry says the company has asked the FDA to consider allowing a test release of the mosquitoes on an emergency basis elsewhere, perhaps in Miami.

"We could do that; we're ready to deploy," Parry says. "We could do that very quickly, within about a month."

On Tuesday, the Keys Mosquito Control Board agreed to allow Oxitec to use its facility on Marathon Key to breed adult males for release elsewhere. A spokesman for Miami-Dade County says there's been no discussion about using the mosquitoes there.

Another possibility is Puerto Rico, where the Obama administration on Friday declared Zika a public health emergency.

Copyright 2016 NPR. To see more, visit NPR.
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California Court Helps Kids By Healing Parents' Addictions

NPR Health Blog - Tue, 08/16/2016 - 4:00pm
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August 16, 20164:00 PM ET Heard on All Things Considered

From

Hearing Officer Jim Teal presides over a session of Early Intervention Family Drug Court in Sacramento, Calif., in March. The county program helps keep families together — and saves taxpayers $7 million annually, Sacramento County officials say.

Robert Durell for Kaiser Health News

At 10 a.m. on a recent Wednesday morning, a line of parents pushing strollers filed into a conference room at the Sacramento County Courthouse in California. They sat at rows of narrow plastic tables, shushing their babies and looking up at a man in a black robe.

Hearing Officer Jim Teal sounded his gavel. "This is the time and place set for Early Intervention Family Drug Court," he began, gazing sternly at the parents who sat before him. "Graduation from this court is considered a critical factor in determination that the children of participants will be safe from any further exposure to the danger and destructive impact of parental substance abuse."

There has been a surge recently, across the U.S., in the number of children entering the foster care system after years of decline. Nationally, roughly 265,000 kids entered foster care in 2015 — the highest number since 2008, according to a recent government report.

Substance abuse is a factor in up to 80 percent of cases where a child is removed from a home. And there are signs that the opioid epidemic may be to blame.

Parents who receive addiction treatment are much more likely to get their kids back, but 4 in 5 parents fail to complete their treatment regimen.

The Early Intervention Family Drug Court aims to change that by helping parents with substance abuse problems to complete treatment before their children enter the foster care system. If the parents fail, they'll be sent to a formal family drug court, where their children are taken away and given attorneys of their own.

But before that, the parents get this opportunity to enter recovery, through a mix of support, medication-assisted treatment and tough love.

Many parents participating in the early intervention drug court entered the system after having babies born dependent on opioids or other drugs. Others were reported to Child Protective Services by friends or family. All are at risk of losing custody of their children because of their drug abuse.

Emma, 20, a striking woman with long blond hair, approached Teal's podium holding a baby. NPR is withholding her last name because her case is active with Child Protective Services.

"Good morning," Teal said. "Who do you have with you there?"

"My daughter, Cailynn," Emma answered proudly, bouncing the cooing child on her hip.

Emma started using drugs when she was 16. At first it was methamphetamines, she said, but she quickly transitioned to heroin. Then she got pregnant.

Her daughter Cailynn tested positive for opioids at birth. Child Protective Services came to the hospital and took the baby into custody.

"I regret every moment of it," Emma said. "It's hard. But I've got to keep my head up and keep going." From the start, she wanted her daughter back.

A court booklet give parents inspiration to stay off drugs. They paste a photo of their child on the front and then write about their experiences inside.

Robert Durell for Kaiser Health News

Usually, Sacramento County has a three-month wait for people who need substance abuse treatment. But by volunteering to participate in the drug court, Emma was able to get treatment right away and her baby back.

"So Emma, it says here you're 63 days compliant," Teal said that day in court. "And 63 days in the program, so you've been good. You've been doing what you're told. Congratulations."

The other parents in the room burst into applause — this is a major accomplishment. The six-month program is rigorous. In addition to monthly sessions at the court, the parents must attend almost daily group meetings, submit to random drug tests and take parenting classes. Many, like Emma, go to inpatient rehab. Medication-assisted therapy for opioids is also available. And once or twice a week, they get a home visit from their social worker.

Emma attributed much of her success in the program so far to social worker Matthew Takamoto, whom she called "amazing."

Takamoto has been a social worker for 20 years and has been part of the EIFDC since the program began six years ago. The program, he said, is an important change in way the county handles addiction.

"In the olden days, we were quicker to send them to court," he said. Their approach was "more 'blaming the addict,' versus giving them the tools they need."

In the afternoon following the court meeting, Takamoto drove to the inpatient residential facility where Emma lives with her daughter. In the back is a grassy yard with a small jungle gym, where several mothers sat, watching their children play. Emma was there, too, holding Cailynn in her lap.

Matthew Takamoto has been been a social worker with the early intervention program in Sacramento County from its start, and is pleased with its success. The hardest part, he says, is realizing that not every parent will be be able to quit drugs for good.

Robert Durell for Kaiser Health News

Takamoto seemed happy with Emma's progress. "You take these clients from the very beginning, where they're broken and it's the worst day of their life," he said. "And to see them slowly get back up as they have days of clean time — it's been incredible."

The hardest part of his job, he said, is realizing that not all the parents are going to make it. In fact, just a third end up graduating from the county's program.

"If these parents aren't successful, it's the kids [who] pay the price," Takamoto said. "The parents are doing what they want to do, but the kids don't have a choice."

Just 5 to 10 percent of families in the United States who could use family drug courts have access to them, according to Children and Family Futures, an organization that advises and evaluates family drug courts. Sacramento's program is one of about 350 in the country; most of the rest work with families after their children have entered the foster system.

Sherri Z. Heller, director of Sacramento's Health and Human Services Department, described family drug courts as a success story.

"People can overcome addiction if the motivation is strong enough, and this is the most effective motivation I have ever seen," Heller said.

Just 10 percent of kids with families in the program end up being removed from their home, compared to 30 percent of children in families who do not participate. That represents a major savings to the county — about $21,000 dollars a year for every kid who doesn't have go into the court and foster system, for an annual total savings of $7 million.

"The rush that comes with getting high is pretty spectacular," Heller said. "And it's very hard physically, once the addiction happens, to overcome. But if there is one thing that matters to people more than the thrill of getting high, it's the thrill of doing the right thing for your children and keeping your family intact."

Kaiser Health News is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation. You can follow Jenny Gold on Twitter: @JennyAGold.

Copyright 2016 Kaiser Health News. To see more, visit Kaiser Health News.
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Olympic Athletes Prove That Older Doesn't Have To Mean Slower

NPR Health Blog - Tue, 08/16/2016 - 1:14pm
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August 16, 20161:14 PM ET Heard on All Things Considered

Kristin Armstrong won Olympic gold in the cycling time trial the day before she turned 43.

Tim de Waele/Corbis via Getty Images

When Kristin Armstrong pedaled across the Olympic finish line to win a cycling gold in Rio de Janeiro, her nose was bleeding and her 5-year-old son was waiting for her.

The 42-year-old told reporters that people constantly ask why she keeps competing despite her age and multiple hip surgeries.

Her response? "Because I can."

"I think that for so long, we've been told that we should be finished at a certain age, and I think that there's a lot of athletes out there that are actually showing that that's not true," said Armstrong, who turned 43 the next day.

Usain Bolt is still the world's fastest runner at age 29; swimmer Michael Phelps won five more gold medals at age 31. And Oksana Chusovitina, a 41-year-old gymnast from Uzbekistan, has been competing in Olympic gymnastics since before most of her competitors were born.

Oksana Chusovitina, 41, competed in the Olympics against gymnasts who are younger than her son.

Julio Cortez/AP

"We used to think that individuals over age 50 might potentially be too fragile to work out hard, and research is refuting that," says Mike Studer, a physical therapist and co-owner of Northwest Rehabilitation Associates in Salem, Ore., who often works with older athletes. "And gender does not seem to have any influence on the ability to perform well as we age," he adds.

Studer says older athletes tend to need longer recovery time and might need tweaks to their training, like running underwater rather than on a road. But they have better and better equipment and training techniques at their disposal.

Studer, who is 47 years old, is training for an Ironman triathlon and was pedaling on a stationary bike while we talked.

"I've got a 69-year-old patient who I helped to train to his first marathon, and in a month and a half he's getting ready to do his second," says Studer.

There are some things that will inevitably decline with age. Small studies in mostly sedentary people have found that skeletal muscle starts to decrease by about 1 percent a year after age 40, and about 2 percent per year after 50. Nerves fire a tiny bit more slowly. And the heart, which is a muscle, loses some power with age.

"And so the amount of work that we can do in any given minute — which is a factor of how much blood the heart can kick out and how fast it can kick it out — does reduce with age as well," says Studer.

But those effects tend to be more pronounced in sedentary people. Athletes can counteract them to some extent with consistent exercise.

"They can't postpone it forever, but they can impact the degree to which they change," says Wojtek Chodzko-Zajko, an exercise scientist at the University of Illinois, Urbana-Champaign.

"I think we have an incorrect idea about the rate and extent to which physiological aging occurs. It occurs in all of us. It's inescapable and inevitable," he says. But it happens at different rates in different people, especially active ones.

The Torch What Team USA Looks Like: A By-The-Numbers Look At America's Olympians

And in some cases, says Chodzko-Zajko, age can give athletes a crucial advantage — the wisdom that comes from experience. For starters, older athletes have had plenty of time to get to know their bodies and their limits.

"An older athlete may learn how to train smarter, which helps them to avoid injury," says Chodzko-Zajko. "They may show more wisdom in strategy and tactics, and those can actually help them with respect to performance."

He says that's particularly true for endurance sports like marathons, though Bolt and Phelps continue to excel in short-distance competition.

So, he says, don't underestimate the power of experience. And if you're watching the Olympics, consider doing so from a treadmill.

Copyright 2016 NPR. To see more, visit NPR.
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Aetna Joins Other Major Insurers In Pulling Back From Obamacare

NPR Health Blog - Tue, 08/16/2016 - 12:14pm
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August 16, 201612:14 PM ET Heard on All Things Considered

Aetna is the latest big health insurer to retreat from the exchanges established under the Affordable Care Act.

Jessica Hill/AP

Insurance giant Aetna will stop selling health insurance through most of the exchanges created by the Affordable Care Act in 2017 because the company said it is losing money in many of those markets.

On Monday, Aetna said it will sell individual insurance policies in only 242 counties in four states, down almost 70 percent from the 778 counties in 15 states where the company markets Obamacare plans this year.

The decision is a blow to President Obama's signature health care law. Most insurers selling plans through the exchanges have been losing money because the people getting insurance under Obamacare have been sicker than forecast.

But Aetna, which lost $430 million on the Obamacare plans in the first half of the year, said it may re-enter the markets in the future.

"We will continue to evaluate our participation in individual public exchanges while gaining additional insight from the counties where we will maintain our presence, and may expand our footprint in the future should there be meaningful exchange-related policy improvements," CEO Mark Bertolini said in a statement.

Aetna, which covers about 900,000 people through the exchanges, is the third major insurer to pull back from the Obamacare marketplaces. UnitedHealth Group said in April it planned to pull out of ACA marketplaces in most states, and just last month Humana, which covers about 800,000 people, said it will cut back its offerings to just a handful of counties.

All the companies said they are losing money on the plans. The Department of Health and Human Services has argued that companies have themselves to blame because they set premiums too low. The companies will be able to adjust the premiums in the future.

"Aetna's decision to alter its Marketplace participation does not change the fundamental fact that the Health Insurance Marketplace will continue to bring quality coverage to millions of Americans next year and every year after that," said Kevin Counihan, CEO of HealthCare.gov, the federal insurance exchange.

In all, about 11 million people have bought insurance through the exchanges.

A spokesman for HHS said Aetna's decision was an about-face from its earlier statements about the Obamacare exchanges.

In April, Bertolini called the marketplace plans "a good investment" because it would have cost the company far more than $430 million to try to attract that many customers.

"If we were to build out 15 markets, it would cost us somewhere between $600 million to $750 million to enter those markets and build out the capabilities necessary to grow that membership," he said on the company's April earnings conference call with analysts.

Aetna's announcement comes less than a month after the Justice Department sued to stop the company's planned merger with Humana, arguing that the combination would hurt competition. At the same time, the government also sued to block Anthem from purchasing Cigna.

Sen. Elizabeth Warren, a Massachusetts Democrat, suggested Aetna's change of heart was in response to the Justice Department's action. In a post on her Facebook page last week, Warren questioned the company's motives after it first hinted that it was considering cutting its participation in Obamacare.

"The health of the American people should not be used as a bargaining chip to force the government to bend to one giant company's will," she said.

Aetna spokesman T.J. Crawford didn't immediately respond to a request for comment on Warren's statement.

HHS said last week that the per-member health care costs for people covered through the exchanges remained stable from 2014-2015. If that trend continues, insurers should be able to set premiums that better reflect the actual costs of covering people under Obamacare.

"The next ACA open enrollment is key," tweeted Larry Levitt, a senior vice president at the Kaiser Family Foundation. If insurance sign-ups increase, then deeper concerns about Obamacare will fade. "If not, expect a debate about fixes to the law," he wrote.

Copyright 2016 NPR. To see more, visit NPR.
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Insurers' Fine Print May Exclude Health Care Important To Women

NPR Health Blog - Tue, 08/16/2016 - 5:00am

Health insurance plans may exclude coverage for many types of genetic testing that aren't required by law.

Andrew Brookes/Getty Images

Buried in the fine print of many marketplace health plan documents is language that allows them to refuse to cover a range of services that are used more often by women, a study finds.

It's unclear if these exclusions have prevented patients from getting needed treatments. An insurance industry representative says patients are generally able to get care if it's appropriate for them. Yet some women with a family history of hereditary breast and ovarian cancer, for instance, may have gaps in care because of the exclusions.

More broadly, advocates say, the report suggests coverage issues that may still need to be addressed, despite significant improvements in coverage of women's health needs following passage of the Affordable Care Act.

The study by researchers at the National Women's Law Center, an advocacy group based in Washington, D.C., examined exclusions in marketplace plans offered by 109 insurers in 16 states in 2014 and 2015.

The health law requires insurers to explain whether they cover 13 services, including acupuncture, bariatric surgery and infertility treatment, in a plan's easy-to-read general summary of benefits. But other services that aren't required to be listed there may also be excluded. And those exclusions may be hard to find in the more detailed plan coverage materials, which can be quite technical and run dozens of pages.

The researchers reviewed plans' detailed documents and identified six types of excluded services that could have a disproportionate impact on women's health care, although many of them also are used by men. The excluded services included:

  • Treatment for conditions that result from noncovered services, such as an infection following cosmetic surgery. They were excluded by 42 percent of plans.
  • Maintenance therapy for a chronic disease or other care that prevents regression of a stable condition (27 percent of plans).
  • Genetic testing, except as required by law (15 percent).
  • Fetal reduction surgery, which is sometimes recommended when a woman is carrying multiple fetuses in order to protect the woman's health or improve the odds of a successful pregnancy (14 percent).
  • Treatment for self-inflicted conditions, such as a suicide attempt (11 percent).
  • Preventive services not required by law (10 percent).

"We wanted to highlight issues that would have a particular impact on women as well as show how broad some of the exclusions are," says Dania Palanker, who co-authored the study and is now an assistant research professor at Georgetown University's Center on Health Insurance Reforms.

It's not uncommon for women who have a family history of breast or ovarian cancer to run into this type of roadblock when they need genetic testing or preventive services, says Lisa Schlager, vice president of community affairs and public policy at Force, an advocacy group for people affected by hereditary breast, ovarian and related cancers.

The Affordable Care Act requires insurers to cover services that are recommended by the U.S. Preventive Services Task Force, an independent panel of medical experts, without requiring consumers to pay anything out of pocket. The task force recommends that women with a family history of breast or ovarian cancers receive genetic counseling and, if necessary, testing for a mutation in the BRCA1 or BRCA2 genes that are known to increase the risk of developing those cancers.

However, insurers aren't required to cover testing for the 40 or so other genetic mutations that are also recognized as increasing women's risk of breast or ovarian cancer, Schlager says, and many don't do so.

If a woman does test positive for a BRCA mutation, insurers may not cover earlier or more frequent screening or other preventive care she may need, Schlager says.

"We are in this strange scenario where insurers are paying for the testing and then not paying for the breast MRIs or prophylactic mastectomies," she adds.

Clare Krusing, a spokeswoman for America's Health Insurance Plans, a trade group, calls the report "overblown." She says it fails to address whether treatments are safe and effective for all patients; whether other effective treatments are covered; and whether there are processes to help patients get access to excluded treatments.

"If a patient has a medically necessary reason for this care, it will likely be covered," Krusing says.

Kirsten Sloan, senior policy director at the American Cancer Society Cancer Action Network, says people who use the society's call center aren't generally complaining about plan coverage exclusions. Still, coverage distinctions may be confusing for patients, Sloan says, and highlight the need for better transparency in communicating coverage information.

Copyright 2016 Kaiser Health News. To see more, visit Kaiser Health News.
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Study Says FluMist Vaccine Does Indeed Work, Contradicting CDC

NPR Health Blog - Mon, 08/15/2016 - 5:01pm

FluMist is a live attenuated vaccine, which should make it more effective than the inactivated virus in flu shots.

Joe Raedle/Getty Images

It came as a surprise this June when the Centers for Disease Control and Prevention recommended against using the nasal flu vaccine for the 2016-2017 flu season, citing a lack of evidence that it works.

Now, findings from a Canadian study appear at first blush to contradict the research that led the Advisory Committee on Immunization Practices to recommend against that live attenuated vaccine.

But things aren't so simple. In fact, the conflicting evidence about the live nasal flu vaccine offers an excellent case study on how complex the task of analyzing flu vaccine data and making recommendations really is.

"Sometimes the public wants a very simple message, and unfortunately life's not like that," Mark Loeb, the new study's lead author and director of the division of infectious diseases at McMaster University in Ontario, tells Shots. "Things change as the evidence grows and we understand more. Unfortunately, that's how science and clinical medicine work. The challenge is to be able to help the public understand the shades of gray here."

Loeb's study focused on 52 Hutterite communities in rural Canada, because their relative isolation makes for an environment with fewer confounding factors. Researchers randomly assigned 1,186 children, ages 3 to 15, to receive either the live attenuated nasal flu vaccine or the inactivated flu vaccine by injection.

During the three flu seasons from 2012 to 2015, 5.3 percent of the children in the live nasal vaccine group and 5.2 percent of the children in the inactivated vaccine group had lab-confirmed influenza, revealing that the two vaccines were equally effective.

The study lacked a control group of children who did not get a vaccine, but previous studies showed a flu infection rate of about 10 percent among unvaccinated children and of 4 to 5 percent in vaccinated children in these communities, Loeb says. Rates of antibiotic prescriptions, ER visits, respiratory illnesses, hospital admissions and school or work absences were also similar across the two groups.

These findings, published Monday in Annals of Internal Medicine, parallel the early evidence for the live nasal vaccine in the U.S. which led ACIP to preferentially recommend it for children for the 2014-2015 season. CDC data consistently showed the live nasal vaccine to be very effective in children until 2013, when the vaccine went from including three strains (trivalent) to including four strains (quadrivalent).

And therein lies the rub: The new Canadian study used the trivalent vaccine, while ACIP analyzed data using the quadrivalent vaccine, and among U.S. children.

"Many of us felt very strongly that the [live attenuated influenza vaccine] was a better vaccine than the inactivated for children, and the data supported that," says Pedro Piedra, a professor of virology and microbiology at Baylor College of Medicine and one of the investigators involved in the nasal vaccine clinical trials in the late 1980s. "But something happened when it became a quadrivalent vaccine."

The CDC decision in June relied primarily on data from the U.S. Flu Vaccine Effectiveness Network, which assesses the health of people who have an acute respiratory illness with cough for at least a week during flu season and are at least 6 months old. Researchers compare the odds of vaccination among those testing positive or negative for flu to determine vaccine effectiveness.

From November 2015 through April 2016, CDC data from more than 7,500 individuals, including nearly 2,300 children, showed the inactivated flu shot was 49 percent effective against any flu strain that season. But the live nasal flu vaccine showed almost no effectiveness at all that season or during the two previous ones. The inactivated flu shot outperformed the nasal vaccine for all flu strains in the CDC study, as well as in a smaller Department of Defense study.

Experts disagree on how much, if at all, ACIP should consider this evidence when they meet again Oct. 19-20. The flu working group communicates throughout the year between meetings, but recommendations are made only at the thrice-yearly meetings of the full committee. Would they even consider changing the 2016-2017 recommendations well after flu season has started?

For one thing, comparing the trivalent and quadrivalent vaccines is like "comparing oranges and tangerines," says Kawsar R. Talaat, an assistant scientist at the Center For Immunization Research at Johns Hopkins Bloomberg School of Public Health. In fact, comparing any two flu vaccines involves a "quagmire of issues," partly because every year, vaccines act a little differently, Talaat tells Shots.

"It was not an easy decision, but ACIP did what was in the public's interest given the U.S. epidemiological data," she said. Her supervisor, Ruth Karron, is head of the ACIP flu vaccine working group. "The flu vaccine is different every single year, so they do their best to make the recommendation for that particular season based on the data that's available." She adds: "Given three years' worth of data showing this vaccine didn't work, do they wait to get more data? You're spending time and effort, and you're vaccinating children with a vaccine that is basically no better than giving them salt water."

At the same time, the Canadian study is a randomized controlled trial, which should produce higher-quality evidence than observational data collected by the CDC. These Canadian data also corroborate findings presented to ACIP from a small United Kingdom study, a large Finnish study and a moderately sized study from Astra Zeneca, the pharmaceutical company that manufactures FluMist, showing the quadrivalent nasal vaccine's effectiveness in children ranges from 46 to 58 percent.

"Personally, I could argue it both ways," says Litjen Tan, chief strategy officer for the Immunization Action Coalition. He says a Food and Drug Administration statement following the CDC recommendation noted that the vaccine's benefits outweighed its potential risks. The FDA sharply rebuked the ACIP decision, Tan says, by suggesting it didn't consider the "totality of the evidence" in making the decision.

But while ACIP looks at global data, it must prioritize data from the U.S., Piedra says.

"Data outside the U.S. cannot be used to drive your decision at this time," he says. "Something is different between what we see in Canada and what we see in the U.S., and we need to be able to understand that because a public health body like the CDC would be criticized pretty severely if they recommended a vaccine that has very little evidence of benefit."

Several phenomena may contribute to the incongruity in the data. Going from the trivalent to the quadrivalent vaccines, for example, could have introduced more vaccine interference. Each vaccine strain competes to infect enough cells so that the virus can replicate and induce an immune response in those cells. More strains means more competition among the strains to infect cells, so multistrain flu vaccines include higher doses of each virus.

Shots - Health News Bad News For Kids Who Don't Like Flu Shots

But that alone would not explain lower U.S. effectiveness, because the U.K., Finland and Astra Zeneca studies showed higher effectiveness with the quadrivalent vaccine. Another factor could be that U.S. children have been vaccinated regularly enough since the first universal flu vaccine recommendation in 2007 that they've built up an underlying immunity. That underlying immunity could interfere with responses to new doses, progressively lessening the vaccine's apparent effectiveness each year. (This is more likely with live nasal vaccines than with the shot because they induce different types of immune responses.) Bias in the study or other as-yet-unidentified factors could play a role too.

"Like all things in life, it is never very clean, and there may be more than one reason we may not see an optimal immune response," Piedra says.

All the experts agree that better flu vaccines are needed, but influenza is a tricky virus to combat, and current inactivated vaccines are effective. With a public health concern as serious as the flu, which kills thousands of people in the U.S. every year, public health officials can't afford to send the wrong message to the public.

"What happens is that public health makes a message that's too simple and the public doesn't buy it, and that leads to vaccine hesitancy," Loeb says. Public health officials must therefore balance complexity and accessibility in describing evidence on the flu vaccine.

The question now is how much consideration ACIP gives this new evidence at their October meeting.

"Now they're in a rock and a hard place," Tan says. "In light of this data, are they going to come back and revisit this recommendation before flu season starts — even though it's already starting?"

If the live nasal vaccine isn't recommended for this flu season, that means the CDC will have far fewer U.S. data next year on the live vaccine's effectiveness, Tan says. "If the CDC says we're only to trust the data from the CDC, where's the data going to come from?"

Copyright 2016 NPR. To see more, visit NPR.
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How Big A Risk Is Acetaminophen During Pregnancy?

NPR Health Blog - Mon, 08/15/2016 - 1:15pm

Acetaminophen, which is sold under the brand name Tylenol, may carry underappreciated risks. But teasing out their magnitude is a challenge.

Scott Olson/Getty Images

Dozens of journal articles cross our desks at NPR each week and, like nurses in the emergency room, we need to do rapid triage.

First we scan for those in critical need of attention (they aren't all that frequent). Next we look for studies that are interesting but not essential. Finally, we ask ourselves whether articles that are iffy need some attention anyway, since other news organizations are going to run with them. We figure Shots readers would like to see our take.

One study now caught in that eddy is a report reporting behavioral problems in children born to women who took acetaminophen (popular brand name: Tylenol) during pregnancy. Evie Stergiakouli and George Davey Smith at the University of Bristol published it Monday in JAMA Pediatrics. They studied about 7,800 women and their children over the course of more than seven years.

There's no question the study addresses an important topic. About half of all pregnant women take acetaminophen during pregnancy because it's considered safer than other painkillers. And hyperactivity and other behavioral problems in childhood are common and potentially disruptive.

Shots - Health News When Pregnant Women Need Medicine, They Encounter A Void

The study reports that these behavioral problems were about 20 to 45 percent more common among the children of women who took acetaminophen during pregnancy.

So it sounds like a pretty important finding, right?

Well, it's not quite so simple.

On the one hand, two previous studies have shown similar results. So this finding isn't out of the blue. One advantage of this study is it asked women –while they were pregnant — whether they took acetaminophen, so the findings weren't as prone to faulty memories, which can be a problem in studies like this.

On the other hand, the researchers didn't ask women how much of the drug they took, and they didn't ask why they took it. The women who took acetaminophen were somewhat more likely to report that they smoked during their pregnancies, that they drank alcohol and that they suffered from psychiatric illness. When the researchers mathematically factored out those confounding observations, the effect disappeared entirely for some subgroups and was diminished in the others.

So is this finding significant? Remember, the researchers said they saw increases ranging from about 20 to 45 percent in behavioral issues among the children whose mothers took acetaminophen (measured at the age of 7 with a test called the Strengths and Difficulties Questionnaire). But what do those percentages really mean?

It turns out you can't answer that question fully by reading the paper alone. You have to dig into the supplementary data tables posted online. The 20 percent to 45 percent increase is actually a small change. To pick one representative endpoint: Among women who had not taken the drug, 4.3 percent of their children registered an elevated score on the "SDQ total difficulties" test. Compare that with 6.3 percent of children born to women who did take the drug.

So, the risk went from a small percentage to a slightly less small percentage of these children.

That's a key point.

First of all, a change that small is never easy to measure. The study concludes it's unlikely to be a statistical fluke, but that's not the only kind of uncertainty that can creep into a study like this. Scientists always have to worry about whether their findings are biased by some factor they hadn't even considered. And for findings this small, bias is always a worry.

The small increase in absolute risk could be reassuring to women who need to take a painkiller during pregnancy. If the drug is indeed tipping the scale, it's not tilting it very much. And remember, the risk in this study generally faded — or even disappeared entirely, depending on the subtype of the SDQ test — when adjusted for smoking, drinking and reported psychiatric problems.

On the other hand, because many women use acetaminophen during pregnancy, even a small effect can matter across the entire population. It's a public health issue worth understanding.

Last year the Food and Drug Administration weighed in on the previous studies of pain medication during pregnancy: "We found all of the studies we reviewed to have potential limitations in their designs; sometimes the accumulated studies on a topic contained conflicting results that prevented us from drawing reliable conclusions."

The agency's advice was: Ask your doctor. That advice still stands.

Copyright 2016 NPR. To see more, visit NPR.
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Will Your Prescription Meds Be Covered Next Year? Better Check!

NPR Health Blog - Mon, 08/15/2016 - 4:32am
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August 15, 20164:32 AM ET Heard on Morning Edition

Express Scripts assures patients it has a policy of not putting cancer medicine or mental health drugs on the list of products it excludes from its formulary.

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The battle continues to rage between drug companies that are trying to make as much money as possible and insurers trying to drive down drug prices. And consumers are squarely in the middle.

That's because, increasingly, prescription insurers are threatening to kick drugs off their lists of approved medications if the manufacturers won't give them big discounts.

CVS Caremark and Express Scripts, the biggest prescription insurers, released their 2017 lists of approved drugs this month, and each also has long lists of excluded medications. Some of the drugs newly excluded are prescribed to treat diabetes and hepatitis. The CVS list also excludes some cancer drugs, along with Proventil and Ventolin, commonly prescribed brands of asthma inhalers, while Express Scripts has dropped Orencia, a drug for rheumatoid arthritis.

Such exclusions can take customers by surprise, says Lisa Gill, an editor at Consumer Reports' "Best Buy Drugs."

"We've talked to dozens and dozens of people who find themselves at the pharmacy counter, shocked to find out that the drug is no longer covered," she tells Shots. Patients can appeal the decision in individual cases, but that process can be arduous.

CVS Caremark has been the more aggressive of the two prescription insurers, listing roughly 130 drugs on its "we won't pay" list. Express Scripts lists 85 and has a policy of not banning cancer drugs or mental health medications.

The threat of kicking drugs off their covered lists — which are known as formularies — is a powerful way to drive discounts, says Adam Fein, CEO of the Drug Channels Institute and author of a blog on prescription drug markets.

"Exclusions are one reason why discounts have been growing," he tells Shots.

Express Scripts and CVS Caremark only started actively using their lists this way in 2012. Both firms claim they've already extracted huge savings for their customers: the health insurance companies and private corporations who hire them to manage their prescription drug plans.

CVS says its formulary management will save its customers $9 billion over the next five years.

For 2017, the company has excluded nine drugs that it deems "hyper-inflationary" — defined as "products with egregious cost inflation that have readily available, clinically appropriate and more cost-effective alternatives," says Carolyn Castel, a spokeswoman for CVS Caremark.

The company specifically looks at drugs whose prices more than triple over three years, Castel says.

Those drugs include three skin creams that combine an over-the-counter ingredient, such as hydrocortisone or aloe, with a generic prescription drug to make a new and expensive brand name medication.

CVS manages prescription coverage for about 75 million people. For the first time in 2017 it is dropping from its list two so-called biologic drugs — the diabetes drug Lantus and Neupogen, a medicine commonly given to patients undergoing chemotherapy to help boost white blood cells and immunity. Instead, the company will pay for alternatives known as biosimilars. It was an important move; because of the way these drugs are made, biosimilars aren't exact equivalents of the medications they replace.

But that's part of the strategy of formulary exclusions. The managers of pharmacy benefits pit brand-name drugs that treat the same condition against each other, rather than waiting for generic drugs to come on the market and drive prices down.

Express Scripts covers about 85 million people, according to a recent investor presentation. Spokesman David Whitrap says the company tried to avoid excluding drugs; he recognizes the exclusions are an inconvenience to patients.

"Express Scripts will only ask members to switch their medication if there is a clinically equivalent alternative," he tells Shots, "and only if that switch delivers a significant cost savings for their employer."

For patients, the inconvenience can be minor, or it can be a real medical issue.

"From a consumer standpoint, you can wind up with a much bigger headache, with a lot more time invested in trying to sort out your prescriptions," says Gill.

That's because when the excluded medications don't have generic alternatives that pharmacists can substitute automatically, patients have to go back to their doctor to get a prescription for a new drug.

"It's a tricky trade-off," says Jack Hoadley, a professor and researcher at Georgetown University's Institute for Health Policy. "Am I getting enough of a discount to offset the inconvenience?"

Sometimes the drug on the approved list doesn't work as well for some patients as the one that's been kicked off.

"You end up having to switch to a drug that your prescriber thinks is less than optimal for treating your particular health condition," Hoadley says.

Copyright 2016 NPR. To see more, visit NPR.
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How The Placebo Effect Could Boost An Olympic Performance

NPR Health Blog - Sun, 08/14/2016 - 6:00am

Alexander Naddour, of the U.S. men's gymnastics team, bears the circular mark of cupping on his right arm as he prepares to compete on the pommel horse at the Rio de Janeiro Olympics on August 6.

Alex Livesey/Getty Images

Olympic medals are won by margins of tenths or even hundredths of a second. So, it's no surprise that athletes want any edge they can get — even methods not backed by a lot of scientific evidence.

The alternative practice du jour in Rio, so far, has been cupping. In years past it was special, stretchy tape, said to support sore muscles and improve range of motion. And dietary supplements are an ever-popular option.

Like every other treatment or intervention, though, these purported performance-enhancers are subject to the placebo effect — benefits due to the recipient's belief in a treatment. Not only can placebos improve medical indicators, like pain in people who are sick, they can help athletes go faster, higher and stronger.

"The idea that the placebo effect is manifest in sports performance should not be any surprise at all," says Chris Beedie, a reader in Applied Sport and Exercise Science at Canterbury Christ Church University in the U.K. Even very powerful drugs like morphine work better in people who know they're taking them rather than those who don't, he says. So in the case of illicit drugs like EPO, banned for use in athletes, there's likely some small incremental placebo boost on top of the very real physiological effects.

On the other end of the spectrum, he says, are treatments whose benefits are likely to be entirely or almost entirely due to the placebo effect.

Caffeine falls in the middle of that spectrum — proven to be helpful, but also subject to an extra boost that's based on the belief that it is helpful.

For example, in one small study Beedie and his colleagues published in 2006, cyclists who were told they'd received large doses of caffeine generated a bigger increase in power (relative to their baseline performance) than cyclists who thought they'd received small doses. And those who were told they got a placebo did worse than they did in a baseline test. In fact, none of the cyclists in the study had been given caffeine.

On average, Beedie says, the performance boost from a placebo is in the 2 to 3 percent range. But he cautions that the response will vary depending, on the context. For example, a placebo is likely to work better if you know and trust the person who recommends it.

Katrin Holtwick, of Germany's 2012 beach volleyball team, prepares to serve at the 2012 Olympics in London. Holtwick is bedecked in a stretchy cotton tape widely used by some athletes because they think it supports sore muscles, or improves range of motion.

Alexander Hassenstein/Getty Images

It's not clear how placebos improve performance. It might be that they reduce anxiety, which decreases muscle tension and makes movements more efficient and fluid, Beedie says. Or they could reduce perceived pain or effort.

They may simply motivate you to push yourself more, though Beedie says his lab research has found that indicators of effort — like heart rate — don't go up the way you might expect if the person taking the placebo were working harder.

What's particularly interesting about cupping, he says, is that because it leaves visible signs, it might also put a damper on the performance of competitors who see the marks and suddenly feel they're at a disadvantage.

"I don't know who the first person was to pull off their sweats and show a red blotch, but the race is so often won or lost in that pre-event time," Beedie says, when everyone is focusing and psyching each other out. (Just look at what went on in the ready room before the swimming semifinal featuring rivals Michael Phelps and South Africa's Chad le Clos, when Le Clos' "get loose" dance provoked a steady scowl from Phelps.)

"It's a fantastic example of how sport, despite all the science and technology, is still at heart a very ritualistic thing," says Beedie.

So assuming that a treatment has no proof of actual benefit but isn't likely to hurt an athlete, is there anything wrong with benefiting from the placebo effect?

For individual competitors, maybe not, says Timothy Caulfield, a professor in the faculty of law and school of public health at the University of Alberta and the author of Is Gwyneth Paltrow Wrong About Everything? When Celebrity Culture and Science Clash. He recently compiled a list of performance aids that, though popular, have little or no evidence to back up their use.

Caulfield says he is concerned that seeing big-name Olympians advocating unproven treatments "has the potential to legitimize the pseudoscience." And that could influence how we mortals spend our limited resources – pushing us to buy things that aren't actually helping us solve our own problems.

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.
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Psychiatrists Reminded To Refrain From Armchair Analysis Of Public Figures

NPR Health Blog - Sat, 08/13/2016 - 6:00am

A poll of psychiatrists about the mental fitness of Barry Goldwater, Republican nominee for president in 1964, led to the creation of a rule that discourages doctors from public diagnoses.

William Lovelace/Hulton Archive/Getty Images

Earlier this week the American Psychiatric Association cautioned psychiatrists against taking part in a feverish new national hobby.

Catching Pokémon wasn't mentioned. Psychoanalyzing Donald Trump was.

On the organization's website, APA President Maria A. Oquendo wrote: "The unique atmosphere of this year's election cycle may lead some to want to psychoanalyze the candidates, but to do so would not only be unethical, it would be irresponsible."

Oquendo was referring to the "Goldwater Rule," a guideline adopted by the APA after a 1964 survey of psychiatrists found that nearly half of those polled felt that GOP presidential candidate Barry Goldwater was psychologically unfit to be president.

The rule states that despite the shiny diagnostic T-ball Trump has propped in front of them — his volatility, his grandiosity, his entitlement — professional code holds that if they haven't performed an in-person evaluation, psychiatrists should keep quiet on the mental character of public figures (unless of course they have that person's permission to speak out).

The professionalism is sound. But what happens when, in the minds of many, a candidate crosses the line?

The Goldwater Rule

On occasion psychiatrists are asked for an opinion about an individual who is in the light of public attention or who has disclosed information about himself/herself through public media. In such circumstances, a psychiatrist may share with the public his or her expertise about psychiatric issues in general. However, it is unethical for a psychiatrist to offer a professional opinion unless he or she has conducted an examination and has been granted proper authorization for such a statement.

Principles of Medical Ethics with Annotations Especially Applicable to Psychiatry

On Tuesday of this week, at rally in Wilmington, N.C., Trump suggested that perhaps there is something gun owners — or, "the Second Amendment people" — can do if Hillary Clinton is elected and appoints judges who oppose gun rights. Though he didn't specify just what they could do, the implication was ominous.

A few months ago, speaking about nuclear weapons, he reportedly asked a senior foreign policy adviser, "If we have them, why can't we use them?"

One could argue that a presidential candidate casually evoking the possibility of nuclear war — even if joking — could be seen as crossing a line.

Many mental health specialists feel that short of saddling politicians with formal diagnoses, we still need a realistic way to assess and discuss their mental states. In his recent cover story for The Atlantic, Dan McAdams, a psychology professor at Northwestern, did just that.

McAdams used scientifically backed personality and social psychology research to develop what he calls a "psychological commentary" on the life and the personality of Trump. It's a reasoned, rational account of a hulking persona: careful to avoid a specific diagnosis. McAdams simply concludes that the Republican candidate has "narcissistic motivations and a complementary personal narrative about winning at any cost."

"These constructs give you a richer understanding of his life and personality than you might get from, say, offering a clinical diagnosis," McAdams told me in an email.

Tufts psychiatrist Nassir Ghaemi agrees that mental assessments can be important, whether by psychiatrists, psychologists or other mental health professionals: "I think in principle [this] kind of detailed psychological analysis can be legitimate, and certainly shouldn't be verboten for being unethical." Yet, he says, objectivity and a scientific rationale are key, as opposed to what he considers catchphrases rooted in Freudian jargon. The media's frequent verdict on Trump's "narcissism" especially bugs him.

Ghaemi also proposes a few amendments to the Goldwater Rule. He believes that the in-person examination requirement should be nixed — assessing psychiatric patients often requires outside input: from colleagues; from family; from friends — and he also feels that psychiatrists should be able to weigh in when a candidate poses a societal threat that overtakes professional oath.

Still, Ghaemi, McAdams and the other mental health experts I interviewed in reporting this piece all staunchly advise against diagnosing public figures from afar — armchair psychiatry, they feel, is a great irresponsibility.

But many also feel that even in the absence of a diagnosis, the more general psychological interpretations common to cable news and other media outlets — not under the rubric of the Goldwater Rule, psychologists show up with exceptional frequency as talking heads — can be ethically dubious.

After a series of statements by Donald Trump drew fire, the president of the American Psychiatric Association cautioned members that publicly psychoanalyzing candidates is unethical and irresponsible.

Evan Vucci/AP

"I think offering semi-psychological interpretations is a poor idea for psychologists and psychiatrists," said Arthur Caplan, a bioethicist at New York University's Langone Medical Center. "How can anyone give an in-depth character analysis on psychological or mental health grounds without knowing or examining the person at all?"

Caplan feels doing so not only stirs up gossip — gossip that demeans those suffering from diagnosed mental illness — but risks pathologizing what could be normal, if off-putting, personality traits. "Positions or attitudes that are outside of the mainstream or outside the pale can be ascribed to mental illness, when in fact there are plenty of racist, sexist, classist bigots all over the place who are not mentally ill," he said.

Insight into the health of our politicians has been a campaign concern, well, probably forever.

But a few recent examples come to mind. FDR had a deal with the press corps to cover up the extent of his paralysis. John F. Kennedy's Addison's disease, a disorder of the adrenal glands, was cleverly concealed until after he was elected. President Eisenhower, after being hospitalized for a heart attack, was red-faced when his doctors publicly applauded his first "good bowel movement."

The voluntary release of select physical health data has since become commonplace among presidential candidates. President Obama's enviable blood pressure is one thing. Unfortunately, mental health is another. Stigma still runs deep.

In her statement on behalf of the APA, Oquendo makes clear her strong support for the Goldwater Rule. She — and Caplan for that matter — also feel the guidance should apply not just to psychiatrists but to psychologists and other mental health practitioners as well.

One reason that Oquendo is resolute in pointing this out is that plenty of people with mental illness attain great success: CEOs, performers and even psychiatrists.

"Whether we like it or not, many have the notion that an individual with a psychiatric condition is less capable than others," she laments. "The fact is that's simply not true."

Ghaemi has written extensively on how mental illness can positively contribute to character and success in many ways, whether it's the empathy and realism sometimes imparted by depression (Lincoln, Gandhi and Martin Luther King Jr. come to mind) or the ambition and creativity brought on by mania. A 2006 study out of Duke University reviewed the historical records of 37 presidents and concluded that 18 of them met criteria of psychiatric diagnoses.

One idea occasionally floated through the psychiatry community is instituting a mandatory mental and physical health screen for aspiring presidents, the results of which would be made public.

In 2008, for example, a panel of high-level health experts recommended that both presidential and vice presidential candidates be required to undergo a health screen by an independent team of doctors. To this end, Ghaemi argues that if someone is in a position to send our sons and daughters into war, we deserve a more in-depth glimpse into his or her psyche — one interpreted and presented to the public by mental health experts.

"I've been arguing for a presidential health screen for over 20 years!" said Caplan, laughing. "But I see it as a panel that simply provides information for the public to assess, not one that qualifies or disqualifies anyone. If you want to vote for FDR with polio or Reagan with incipient Alzheimer's, you should be able to."

However, much like the 2008 recommendation, Caplan's efforts, he admits, have gone nowhere.

Oquendo is not sold on a standardized mental health screen, pointing out that upwards of 20 percent of the population experiences mental illness in a given year — and also that a public screen could bolster the erroneous notion that having a psychiatric condition renders someone an unfit candidate.

So assuming no screening process is implemented anytime soon — and also that asserting psychiatric absolutes remotely is probably irresponsible and ultimately unhelpful — how are we to assess the mental character and capacities of our candidates?

According to Oquendo, the answer is simple: behavior.

"So many factors can influence behavior. And, for example, not everyone with bipolar will be overly creative or ambitious, so you can't predict somebody's behavior just based on diagnosis," she explains. "But how someone acts is right there for people to see; voters can then decide if a particular behavior is acceptable or not."

In other words, the cause of someone's conduct — whether mental illness or not — is beside the point.

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

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Why Doctors Want A Computerized Assistant For Cancer Care

NPR Health Blog - Fri, 08/12/2016 - 12:35pm

Researchers at the New York Genome Center are working with IBM Watson to make better treatment plans for cancer patients.

Courtesy of New York Genome Center

A computer may soon be able to offer highly personalized treatment suggestions for cancer patients based on the specifics of their cases and the full sweep of the most relevant scientific research.

IBM and the New York Genome Center, a consortium of medical research institutions in New York City, are collaborating on a project to speed up cancer diagnoses and treatment.

The work, which got underway in 2013, is exploring the use of computers to help analyze a wide range of genetic information and the scientific literature with the goal of quickly formulating precise treatment plans for cancer patients.

The line of research is being orchestrated by Robert Darnell, the founding director of the New York Genome Center and a neuro-oncologist at Rockefeller University. A project on brain tumors aims to bring cancer experts in New York City to bear on treatment plans that take advantage of the very latest scientific evidence.

An essential assistant on Darnell's team is supercomputer IBM Watson, which helps by comparing the genetic differences between healthy cells and tumor cells in patients, as well as fetching the newest treatment ideas from medical journals.

Watson wasn't always part of Darnell's lineup. When he started the project, he relied on the collective brainpower of a bunch of medical researchers in New York City. Fifteen of them, including Darnell, spent three weeks evaluating the case of the first patient of the project. But, he says, "by the time we got through with this patient, the patient died."

Speed matters, given how fast cancer can spread. Information overload is a particular challenge.

"Cancer is not giving you the luxury of time," says Ajay Royyuru, the director of IBM's Healthcare and Life Sciences Research. And, he adds, there are "more papers published in each year than cancer researchers can read and remember."

New York Genome Center Center has more DNA sequencing capacity than any other single institution in New York City.

Courtesy of New York Genome Center

In contrast, IBM's supercomputer Watson, famous for defeating former champions in Jeopardy! in 2011, is able to read "800 million pages per second ... from medical literature to patient records to doctors' notes," according to Christine Douglass at IBM Watson Health.

Upon learning about Watson's abilities, Darnell approached IBM. By 2014, a human-computer coalition to fight cancer was born.

"Compare what the genetics in the healthy cell looks like to what the genetics in the cancer cell looks like, you get the list of differences," says Steve Harvey, vice president of Watson Health at IBM. "Watson will first try to figure out what are the differences that could be causing cancer. For each of those potential genetic issues, it will go through databases and literature to find" known treatment options, he says.

With the help of Watson, Darnell's group studied 30 patients with glioblastoma, an aggressive form of brain cancer, and developed personalized treatment options for each patient "based on genetic mutations present in the tumor," according to Darnell. Darnell declined to comment on the specifics of the findings before they're published. But, he says, "there are patients who will benefit" from this study. A preliminary report on the findings has been submitted to The Journal of Clinical Oncology.

Both IBM and the New York Genome Center are moving on to find out whether Watson can apply what he learned from Darnell's research to a larger group of glioblastoma patients.

"We'll be working with the Veterans Health Administration," says Harvey. According to Harvey, "The VHA overseas the largest population of cancer patients — 3.5 percent of all cancer patients in the US are from the VHA."

According to Darnell, the paper his group submitted will "lay the groundwork for the larger, more comprehensive paper on the same study." Darnell says the current research project is not yet a clinical trial, and he hopes to execute a large-scale clinical trial in the future, recruiting "any cancer patient who is sick, not necessarily from glioblastoma."

"It's not going to be doable without the machines," says Darnell.

Copyright 2016 NPR. To see more, visit NPR.
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Where Lead Lurks And Why Even Small Amounts Matter

NPR Health Blog - Fri, 08/12/2016 - 4:40am
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August 12, 20164:40 AM ET Heard on Morning Edition Katherine Du for NPR

Lead problems with the water in Flint, Mich., have prompted people across the country to ask whether they or their families have been exposed to the toxic metal in their drinking water, too.

When it comes to assessing the risk, it's important to look in the right places.

Even when municipal water systems' lead levels are considered perfectly fine by federal standards, the metal can leach into tap water from lead plumbing.

Kate Gilles moved to Washington, D.C., from Rhode Island for a job in international public health six years ago. When she was pregnant with her son, now 3, and her daughter, who turned 1 in July, she says she paid close attention to her health.

She ate better. She exercised. She followed her doctor's orders. Gilles checked off every task on the long list of things that she was supposed to do to help protect her babies.

But that was before Flint, and it never occurred to her to test her drinking water for lead.

No one — not her pediatrician, not authorities at her local water utility and not the realtor who sold her the home she lives in — suggested that she might have a problem with lead.

In April, she learned that her home is one of more than an estimated 6 million in America that gets its water delivered through a lead service line.

When There's Lead Underground

When there is a problem with lead in drinking water, service lines are the most likely culprit. Service lines are like tiny straws that carry water from a utility's water main, usually running below the street, to each building.

In older cities, many of them in the Midwest and Northeast, these service lines can be made of pure lead.

Katherine Du for NPR

Wherever lead service lines are in place, there is a risk of water contamination. The toxic metal can leach into the water whenever something jostles the pipes, like nearby construction, a heavy truck coming down the road or when the water just sits still for too long.

Civil engineer Marc Edwards, the Virginia Tech professor who helped document the lead problems with water in Flint, calls lead service lines "ticking time bombs."

The Risks Of Low-Level Lead Exposure

Dr. Bruce Lanphear has spent decades researching low-level lead exposure, and his work is often cited by the Centers for Disease Control and Prevention. He says that while blood lead levels have been reduced drastically in recent decades, even levels as low as 5 micrograms per deciliter can lower IQs and increase the risk of attention and behavioral problems in children. For adults, lead exposure can cause kidney problems and high blood pressure.

Because it would be unethical to expose people to a known toxin, clear data are lacking on exactly how much lead a person must be exposed to before it shows up in the blood or triggers health and behavioral problems. Public health officials say that removing all lead from a person's environment is the best course of action.

Wherever lead service lines or other lead plumbing fixtures exist, there are precautions people can take to protect themselves — if they know they are at risk. They can flush their pipes every morning. They can purchase a filter certified for lead removal. Ultimately, they can replace lead service lines and lead plumbing in the house, though those replacements can be costly.

Still, there aren't any federal notification laws for the presence of lead plumbing as there are for lead paint. Checking the service line isn't part of typical home inspections. Landlords aren't required to warn tenants about lead pipes, and realtors don't need to tell potential buyers.

Gilles, who has a master's degree in public health, said she felt silly for not looking into lead risks from pipes. "But I also feel really angry that there's nothing that flags it for homeowners," she says.

Lead Regulations: 'Illusion Of Safety' Or Protection?

After learning that her house has lead pipes, she ordered a test kit from DC Water, the local authority. When she got the results, she was more confused than relieved. The test showed 0.7 parts per billion of lead in the water, far below the EPA's so-called action level, set at 15 parts per billion.

But what did the results mean? "I'm marveling at the total lack of lucidity of this letter," she says. "Because it doesn't say whether or not we need to be concerned. I'm guessing that the EPA decided that the margin of safety was this 15 parts per billion, and we're under that."

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Except that isn't at all what the EPA decided.

The EPA seeks to control lead in the drinking water with its Lead and Copper Rule, created in 1991. The rule says that, depending on factors like how big a city is and how long it has been since high lead levels were last detected, water utilities have to test the water in between 50 and 100 homes with lead service lines every six months to nine years.

If 90 percent of homes have lead below the 15 parts per billion action level, the water utility passes the test. Nothing has to change. If the utility fails the test, it has to take follow-up action, including more testing and possibly changing water treatment methods.

But, critics say, there are several problems with the EPA's rule. For one, the most severe cases are essentially tossed out of the utilities' reports.

Also, according to the EPA's own research, the current lead sampling protocol requires water be collected immediately after the water has been stagnant for six hours. That means they are likely capturing the water that has been sitting inside the house, rather than the water that has been sitting in the lead service line. In other words, the utilities aren't capturing the full extent of the problem.

In addition, critics say, the EPA's trigger for action — or so-called action level — is set too high, at 15 parts per billion of lead in the water. Too many test results above that threshold are a red flag for water utilities, a sign that they might have a lead problem.

The number is often cited as a threshold for public health, but no amount of lead is considered safe for human consumption.

Jeff Cohen helped develop the EPA's Lead and Copper Rule back in the late '80s. He says that the action level didn't come from medical research; it came from water utilities.

"It was based on the little data that was available at that time from water utilities in the U.S. that had installed different levels of corrosion control treatment," he says.

Cohen points to the goal written into the rule, which is zero lead in drinking water. The action level, he says, is "not really designed to identify a safe level of lead in drinking water. It's simply one of many pieces of data that should be used to determine whether corrosion control treatment is working or not."

In June, the American Academy of Pediatrics called on federal regulators to tighten lead oversight, including lowering the action level. The Academy claimed that lead thresholds are set too high, they aren't based on science, and they create an "illusion of safety." Dr. Lanphear was the lead author on the AAP policy.

"We've consistently said that no level of lead is safe," says Joel Beauvias, the deputy assistant administrator for the EPA's Office of Water. He said that the 15 parts per billion action level isn't meant to be a threshold for public health.

The Safe Drinking Water Act says that the rule has to be updated every six years. The agency has been discussing possible revisions since 2010 and is looking at making improvements to the rule. But an agency spokesperson said it is too early to speculate on exactly what the agency will propose or when.

While the ultimate fix would be to replace all lead service lines and lead plumbing, that's a daunting task. In the meantime, there is a call for greater transparency about where lead service lines are in use so that people can reduce their risks.

The EPA wrote governors in February across the country encouraging, but not requiring, disclosure.

After multiple inquiries from NPR, D.C.'s water utility published a map of the lead service lines it knows about. The map is incomplete; there are more than 13,000 homes on the map that may or may not have lead pipes. Still, the map gives residents — particularly renters — easier access to the utility's records. In most cities, the information is still considered private and available only to the person paying the water bill.

George Hawkins, the general manager for DC Water, said it is in everyone's best interest to make lead service line inventories public. The information helps homeowners manage risks in the short term and can encourage them to replace lead service lines.

Although lead levels have gone down significantly in D.C. since the 2004 crisis, the majority of homes the utility has tested in recent years have still shown small amounts of lead in the water — 1 or 2 parts per billion.

Hawkins says that might be a problem for certain households. "Were I [in] a household with a wife who was pregnant or small children, I'd want that number at zero or as close to zero as it can be," Hawkins said.

Gillis decided that even small amounts of sporadic lead release weren't OK for her two children. She and her husband decided to have their lead service line replaced in May. It cost them $1,400.

She's had both of her children tested for lead and is reassured by the results. But she's still angry that no one told her about the lead service line — or the potential risk — earlier.

"The argument can be made that the onus was on us," she says. "But we didn't even know to look at it. This should really be the duty, the responsibility of the government."

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Talk About An Ancient Mariner! Greenland Shark Is At Least 272 Years Old

NPR Health Blog - Thu, 08/11/2016 - 2:03pm
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August 11, 20162:03 PM ET Heard on All Things Considered

The long lifespan of the Greenland shark, shown here in the cold, deep waters of the Uummannaq Fjord, may only be surpassed by that of the ocean quahog, a clam known to live as long as 507 years.

Julius Nielsen/Science

Sharks can live to be at least 272 years old in the Arctic seas, and scientists say one recently caught shark may have lived as long as 512 years.

That's according to a study published Thursday in the journal Science that says Greenland sharks can live longer than any other known animal advanced enough to have a backbone. Until now, the record-holder for the oldest vertebrate was the bowhead whale, known to have lived up to 211 years.

The Greenland shark, a massive carnivore that can be more than 16 feet long, hasn't been studied much, and its life in the cold northern waters remains largely mysterious. Julius Nielsen, at the University of Copenhagen in Denmark, says there had been some hints that Greenland sharks grow very slowly, perhaps less than a centimeter per year. That suggested the huge sharks might be ancient.

"We only expected that the sharks might be very old," says Nielsen. "But we did not know in advance. And it was, of course, a very big surprise to learn that it was actually the oldest vertebrate animal."

He and some colleagues obtained 28 female Greenland sharks taken by research vessels as unintended bycatch from 2010 to 2013. The researchers then used radiocarbon dating techniques on the lenses of the sharks' eyes.

A Greenland shark caught as bycatch from research vessel Pâmiut in southwest Greenland.

Julius Nielsen/Science

There's a bit of uncertainty associated with the age estimates, but Nielsen says the most likely age for the oldest shark they found was about 390 years. "It was, with 95 percent certainty, between 272 and 512 years old," he says. The researchers believe these sharks reach sexual maturity at about the age of 150 years.

"It's a fascinating paper and certainly moves back the vertebrate longevity record by a substantial amount," says Steven Austad, who studies the biology of aging at the University of Alabama, Birmingham. "Even if you look at the low end of their estimate — 272 years — that's still substantially longer than any other documented vertebrate."

He says there are lots of anecdotal accounts of long-lived turtles and fish, but this beats those by a long shot.

The Greenland shark's lifespan may really only be surpassed by that of the ocean quahog. These clams have annual growth rings on their shell, and scientists have found that they can live as long as 507 years.

The Greenland shark, the bowhead whale and the oldest ocean quahogs spend their long lives in cold northern waters, notes Austad, suggesting that low temperatures might have something to do with their unusual longevity.

"I don't think that cold is the whole story," says Austad. "It's probably playing a role. But my guess is there are plenty of short-lived animals that are swimming around with this shark."

Still, he says, just imagine what it would be like to have muscles, like these sharks, that have been working nonstop since the time of the Pilgrims.

"There's something going on in those muscles that we'd very much like to know about," says Austad.

He notes that Greenland sharks would not be easy to study in the lab, but perhaps people could study shark cells grown in a dish.

"Probably whatever sort of physiological tricks the sharks have to live that long, and the quahogs have to live that long, they're probably something that humans don't have," says Austad. "But it's something that, if we discover what it is, we might be able to adapt it to human use."

He's been studying the quahog, which has a beating heart, and whenever doctors who specialize in geriatrics stop by, he likes to hand them a 200-and-something-year-old clam and tell them they're holding a beating heart that's older than any heart they'll encounter in their entire career.

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