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EpiPen's Dominance Driven By Competitors' Stumbles And Tragic Deaths

Wed, 09/07/2016 - 12:52pm

Mylan lobbied state legislatures for laws that require schools to stock EpiPens.

Rich Pedroncelli/AP

Thirteen year-old Natalie Giorgi probably didn't know the name of the company that makes EpiPen. But the Sacramento, Calif., girl's death from a peanut-induced allergy attack in 2013 inspired passage of the California law that made the Mylan product a staple at every school in the state.

It was Giorgi's story, not industry lobbying, that state Senate Minority Leader Bob Huff says inspired him to usher through the requirement that public schools stock the injectors. He says he was also influenced by one of his staffers, who has a child with life-threatening allergies.

"It was just sort of organic," Huff says about carrying the bill. "It seemed like we ought to do better to protect these kids."

Mylan, the company that raked in $1 billion last year for the EpiPen, takes credit for passing legislation in 48 states to ensure schools have them. But its political maneuvering is only one reason the company has, in its own words, become "the number one dispensed epinephrine autoinjector."

High-profile deaths in several states, particularly among school-age children, have helped fuel demand for consumer-dispensed epinephrine. At the same time, no other company has been able to effectively compete with Mylan's drug-delivery device. Patent rules, and competitors' manufacturing foibles, also have helped the company reign over the consumer epinephrine market.

When someone with a severe allergy goes into anaphylactic shock and can't breathe, "seconds count," Mylan CEO Heather Bresch said in a recent CNBC interview about the EpiPen, which now has a sticker price of $608 per two-pack. That's why, she said, "they need to be everywhere."

Bresch said lobbying is just one way the company has spent hundreds of millions "developing" the EpiPen since it acquired the patent in 2007.

Indeed, Mylan's presence in statehouses across the country has grown exponentially. The company added lobbyists in 36 states between 2010 and 2014, according to the Center for Public Integrity, outpacing every other U.S. company. And it spent more than $1.3 million lobbying in 16 states since 2012, according to the National Institute on Money in State Politics (Those are not the exact states that passed the school requirements, however.)

Just in the past several years, 10 states have passed laws requiring epinephrine in schools. Another 38 states have passed laws permitting them, according to the Food Allergy Research and Education advocacy group (FARE).

Nebraska appears to have been the first state with a school epinephrine requirement. High asthma rates in the state, as well as a couple of school-based child fatalities due to the respiratory illness, created an emergency response protocol that became law in 2006.

In California's case, Huff said he had never even heard of Mylan until the recent uproar over the EpiPen price increases. But the company is listed as a supporter of his bill, and FARE, which is partially funded by Mylan, was an official sponsor.

Heather Bresch, CEO of Mylan, says that EpiPens "need to be everywhere."

Michael Nagle/Bloomberg via Getty Images

FARE asserts that Mylan's money goes toward its education work, not its advocacy. It didn't disclose exactly how much of its funding comes from Mylan, but says funding from corporate partners amounts to less than 10 percent of its budget. (On Wednesday, the organization said it would not take funding from companies selling the devices until there was "meaningful competition.")

"In some states, momentum has been garnered by a fatality," says Jennifer Jobrack, senior national director of Advocacy at FARE, who says local lawmakers and activists call them in for help to craft policy.

"Legislators are looking for something they know will have a positive impact," Jobrack says.

Virginia's law, passed in 2012, came after 7-year-old Amarria Johnson died at a Chesterfield County school from a reaction to peanuts. A Texas teenager's death from fire ant bites led to that state's law permitting epinephrine in schools.

The push to require EpiPens got a high-level boost in 2013, as President Obama disclosed his daughter Malia's peanut allergy when he signed off on the federal law, which gives financial incentives to states that require the medication in schools. Co-author of the federal legislation, Rep. Steny Hoyer, D-Md., cited his 11-year-old granddaughter's peanut allergy when the EpiPen law passed the House. FARE and Mylan supported that as well.

With the help of these laws, Mylan's EpiPens are at 63,000 schools nationwide. The company also has distributed 500,000 of them for free through EpiPens4Schools.

The school giveaway program brings visibility and credibility to the EpiPen brand, building a consumer base beyond schools.

"It's kind of like the first hit's for free," says Nicholson Price, an assistant professor at the University of Michigan Law School. "You want to start people off with your product, and getting these products in at schools is a great way."

New York State's attorney general announced Tuesday it will investigate Mylan to determine whether it introduced "anticompetitive terms" into school contracts. STAT recently reported that participants of Mylan's EpiPen4schools program had to agree not to purchase EpiPen-like products for 12 months in order to get a discount.

Mylan also has a virtual monopoly on epinephrine autoinjectors simply because there are almost no other products like it, either branded or generic.

Mylan has a patent on the drug-device combo until 2025. If companies want to make a generic EpiPen, they have to sue Mylan in court to try to invalidate its exclusive rights on the injector, according to Jacob Sherkow, an associate professor at New York Law School.

Trying to create an EpiPen generic is an expensive and risky endeavor, says Sherkow. Even if a company is successful in court, manufacturing the device, which must be identical to the EpiPen, is also challenging.

Copying a chemical compound, like ibuprofen, is easier than reproducing a piece of hardware like the iPhone, says Sherkow. Patents are publicly available, and can act as an "instruction manual," but a lot can go wrong in the actual production of EpiPen syringes.

"The drug inside can't degrade or leak; they need to withstand shipping; they need to work at a wide range of temperatures; they need to be handled safely — to not accidentally inject the user with the needle," says Sherkow.

Teva Pharmaceuticals took on these challenges. It sued to invalidate Mylan's patent in court so that it could make a generic version of EpiPen, and successfully got the green light to do so through a settlement agreement. But Teva has yet to win FDA approval to release the product.

Other companies have tried to make their own version of the epinephrine injector without attempting to copy the EpiPen. But their efforts haven't been very successful either.

Amedra pharmaceuticals makes Adrenaclick, which has an injector with two caps (EpiPen has only one.) But Amedra has limited manufacturing capabilities for the device and a barely visible market share, according to Price.

Auvi-Q, made by Sanofi, was taken off the market in October 2015 after concerns the device wasn't dispensing the proper dose of epinephrine.

More epinephrine products will be on the market in 2017. Teva's generic version of the EpiPen is expected to be reintroduced then, and Mylan will put out its own generic in the coming weeks.

It's too early to tell if more consumer choices will bring down EpiPen's price.

This story is part of a collaboration between NPR and Kaiser Health News. Former Kaiser Health News intern Zhai Yun Tan contributed to this report.

Copyright 2016 Kaiser Health News. To see more, visit Kaiser Health News.
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Facebook And Mortality: Why Your Incessant Joy Gives Me The Blues

Wed, 09/07/2016 - 11:48am
Mark Fiore/KQED

Clearly, researchers love Facebook, even if some of the rest of us are ambivalent.

A 2012 survey of social science papers related to the social network turned up 412 separate studies, and there have been even more since. Among the most popular questions: What effect does Facebook have on emotional states?

It does seem a reasonable question. After all, about 22 percent of the world's population uses Facebook regularly, according to the company, logging on for about 50 minutes a day. But is all this interconnectedness creating psychological benefits or global gloom?

The answer, it turns out, is complicated.

I experienced an emotional flip-flop myself around Thanksgiving of 2008, when I first joined up. For a week or so, I marveled at Facebook's ability to connect me to people who had long ago faded into the remotest recesses of memory. But by Christmas, I was in the midst of a full-fledged metaphysical breakdown.

Those scrolls down memory lane were killing me. Better to have left that kid from third grade, who now likes to post videos of his weightlifting triumphs, as I last remembered him — a skinny punk hitting a double off the schoolyard fence.

It was the collapse of that natural partition between past and present that I found upsetting, and a few months in, after noting the male-pattern baldness of yet another long-lost pal, I figured out why: Facebook punctured the intransigently juvenile aspect of my personality that had refused to recognize the passage of time.

And that, of course, provided yet another piece of evidence for the harshest reality of life: We are all going to die.

Nearly an hour a day

OK, that was my Facebook freak-out — how about yours?

Ask around. Lots of folks will volunteer one resentment or another. Maybe they don't like the time they spend on Facebook. Or they don't like the way people communicate on Facebook. Or they just don't like Facebook. As Laurence Scott wrote in his recent book on digital life, The Four-Dimensional Human, "Everyone knows someone perpetually on the brink of quitting" the site.

Yet, whatever gripes people have, they aren't hurting business. The amount of time we spend on Facebook and Instagram beats out our dedication to all leisure activities save one, James B Stewart recently noted in the New York Times. (Still the king: watching TV.)

Given the expanding role Facebook plays in a reported 1.65 billion lives or more, it's not surprising the site has been laden with a surfeit of social and political significance, credited with contributing to everything from a rise in adultery to the toppling of autocratic regimes.

Facebook and mental health

But what about contributing to depression?

Ethan Kross, the director of the Emotion & Self Control Lab at the University of Michigan, who has co-authored several papers about Facebook, says the early research was "all over the place" as to whether using the site boosted or depressed a person's mental state.

But it's the research finding a correlation between Facebook and feeling lousy that has drawn the attention of the media. A study making headlines in the spring looked at the relationship between social media use and depression. University of Pittsburgh researchers surveyed 1,787 U.S. adults, ages 19 through 32, and found three times the incidence of depression among the most active users of sites like Facebook, Twitter and Reddit than among those who used them the least.

Still, that doesn't mean use of the site is causing depression, the University of Pittsburgh researchers acknowledge. "It may be that people who already are depressed are turning to social media to fill a void," their study concludes.

A spokesperson for Facebook pointed me to a meta-analysis it collaborated on with two researchers, one who is a computational social psychologist now working on Facebook's data science team.

That analysis points out that most studies about Facebook and psychological well-being have been done using cross-sectional surveys — which means they derive data from research participants at a particular point in time, rather than looking longitudinally to see how someone's mood or mental health diagnosis shifts after heavy use of a social media site.

"You really can't draw any conclusions about what effects online communication in general or Facebook communication in particular has from cross-sectional data," said Carnegie Mellon University psychologist Robert Kraut, a co-author of the meta-analysis (he's consulted for Facebook but isn't on staff there).

A happiness deficit?

I asked Kraut about another study last year that caused a media stir; it came out of the Happiness Research Institute in Denmark (the happiest place on earth, apparently). The institute asked half of 1,095 people, most of whom were daily Facebook users, to abstain from using it for one week.

"People who had taken a break from Facebook felt happier and were less sad and lonely," an online presentation of the study said. Those on a Facebook "fast" also "reported a significantly higher level of satisfaction" and significantly less stress than those sentenced to remain on the site.

The study was limited — the behavioral change lasted only a week, and the work has yet to be published in a peer-reviewed journal. But Kraut thought it a "reasonable" approach for starting to get at the way we use Facebook, and how that might influence mood.

A small 2013 study also looked at whether Facebook use influences people's assessment of their own well-being over time. Researchers texted online surveys to 82 people every day for two weeks, asking them questions like "How do you feel right now?" Their answers were correlated with their use of Facebook.

The more people used Facebook the worse they subsequently felt, the paper reported. The researchers said "multiple types of evidence" showed there was no confounding of cause and effect in the study.

"Facebook use may constitute a unique form of social network interaction that predicts impoverished well-being," they wrote.

The big green 'E'

Some researchers have divided Facebook use into the categories of "active" and "passive." Active use includes those activities that facilitate direct communications, like commenting on posts or sending messages; passive use refers to the mere consumption of information — like scrolling through your news feed and glimpsing the lawn furniture your cousin just bought.

A handful of studies from different labs have now established links between passive Facebook use and envy or other negative mental states, said Kross, who has co-authored one such paper.

According to a 2013 research paper from Germany, for example, "upward social comparison and envy can be rampant" on Facebook and other social networks. The online environment promotes "narcissistic behavior," the researchers found, "with most users sharing only positive things about themselves." Among the 357 participants in the German studies, the researchers turned up a large number of what they called "envy-inducing incidents" — most frequently related to travel and leisure, social interactions and "happiness."

Furthermore, the researchers said, some Facebook users seem to engage in an "envy-coping plan" that involves "even greater self-promotion and impression management." And that can trigger what they called a "self-promotion-envy spiral."

A one-upmanship arms race.

Another couple of studies that Kross and his team published in 2015 managed to isolate envy as the culprit in bumming people out, as opposed to other characteristics like the number of "friends" a user has or self-esteem.

"Passive Facebook usage predicted envy, and envy predicted declines in affective well-being," the researchers concluded.

They included in the discussion section of their paper an anecdote from Randi Zuckerberg, the sister of Facebook founder Mark Zuckerberg. "I've had friends call me and say, 'Your life looks so amazing," Randi Zuckerberg told The New York Times in 2013. "And I tell them, 'I'm a marketer. I'm only posting the moments that are amazing.' "

'Do we have to see that?'

A friend of mine, who doesn't want to give her name (would you?) has been telling me for years that she gets genuinely depressed on Facebook, and it has everything to do with envy. She finds the serial posters particularly annoying.

"There's this woman I know and she is constantly posting, and she does some amazing things," my friend complained. "There's this jealous part of me, that's like, 'Do we have to see that?' Everyone seems like they're happy on Facebook."

Yes. After plodding through these studies, I felt the need to reassess my own Great Facebook Freakout of 2008. It wasn't hard to see that, just beneath the Proustian navel-gazing on time gone by, there was also a strong component of rivalry: If some of those losers from third grade had not exactly set the world on fire, they'd at least managed to get a few sparks going, while I still seemed to be gathering twigs for kindling.

Not that realizing that made me feel any better. But even if I'd done super-well in this status game, just the act of comparison might have been deflating. Contrary to some studies — and consistent with others (naturally) — research on Facebook and depression published in 2014 indicated "engaging in frequent social comparison of any kind may be deleterious to one's mental well-being."

The 'happy' studies

There are studies showing Facebook can enhance a sense of social connection. A 2007 study, for example, found that college students who were heavy Facebook users reported higher levels of "social capital," consisting of resources like emotional support and job opportunities that can arise from membership in a social network.

A 2012 study found that posting status updates decreased loneliness, even when those updates elicited no response. And a 2010 study recorded moment-by-moment physiological responses when using Facebook. The equipment logged indicators of pleasant emotion when users actively sought out information or directly communicated with their Facebook friends, but fewer such positive feelings when passively browsing.

Kraut and his team found the same sort of thing in a study published this week in the Journal of Computer-Mediated Communication. Receiving "likes" on something you post may offer a small boost in mood, but getting a positive comment on the post from someone important to you is likely to be much more satisfying, the researchers found.

It's up to you

Kraut, whose studies of the emotional effects of using the Internet go back to its early days, told me research generally shows that whether your Facebook experience will be good or bad depends on how you use it.

"In particular, having longer, more substantive communication with people you feel closer to seems to be associated with increases in psychological well-being," he said. "You don't get the same effects if the communication is with people who are weaker ties. What seems to be crucial is that these are effortful, targeted communications."

Kraut's advice: "Don't treat it as simple entertainment and consume everything that is put in front of you," he said. "Use it more proactively to communicate with people that you care about."

That sounds about right. Personally, I've made my peace with the site. It's true I sometimes find myself scanning that unceasing river of flattering photos, adorable babies and pronouncements of good fortune with a hollow sense of diminishment. Facebook offers a plethora of choices as to how I want to spend my time, and I don't always make the right one.

But in that, Facebook is a lot like life.

This story was produced by KQED's Future of You blog. Jon Brooks is a longtime KQED reporter and editor, and the blog's host.

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

Pediatricians Recommend Flu Vaccination, Just Not With The Spray

Tue, 09/06/2016 - 1:33pm

Fourth-grader Jasmine Johnson got a FluMist spray at her Annapolis, Md., elementary school in 2007. This year, the nasal spray vaccine isn't recommended.

Susan Biddle/Washington Post/Getty Images

Sorry, kids. Your pediatrician will probably give you the flu vaccine in the form of a shot this year.

The American Academy of Pediatrics said Tuesday that it doesn't recommend using the flu vaccine that comes as a nasal spray. That's because the federal Centers for Disease Control and Prevention looked at its performance last year and concluded it wasn't up to snuff.

The CDC's Advisory Committee on Immunization Practices found that FluMist was only 3 percent effective in children aged 2 through 17 during the previous flu season. "This 3 percent estimate means no protective benefit could be measured," the committee reported. In comparison, injected flu vaccines protected about two-thirds of the children in this age group.

The CDC officially accepted that committee's recommendation on August 26, but didn't go out of its way to announce the policy. It posted its recommendation on a website.

The American Academy of Pediatrics is now following suit, with recommendations that go out to doctors who tend to the nation's youngsters. "The AAP recommends annual seasonal influenza immunization for everyone 6 months and older, including children and adolescents," the statement reads.

The group notes that 85 children died from the flu in the United States during the recent season, based on CDC figures. Most had not been vaccinated.

The American Academy of Pediatrics says most children will need a single shot. But children new to flu vaccinations will need two doses, four weeks apart. So a double sorry to you.

The pediatricians also recommend flu vaccination for all health care workers and women who are pregnant, considering pregnancy or breastfeeding during the flu season.

The nasal spray vaccine has more fans than the inoculation that comes in a syringe, for obvious reasons. So this turn of events is not simply a disappointment to the manufacturer, AstraZeneca. In fact, the manufacturer took issue with the CDC committee's recommendation, to no avail.

In a statement emailed to Shots, AstraZeneca said it expects limited demand for FluMist in the U.S. but will make sure the vaccine is available in case some doctors request it.

Copyright 2016 NPR. To see more, visit NPR.
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The Difficulty Of Enforcing Laws Against Driving While High

Tue, 09/06/2016 - 1:03pm
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Abby McLean of Northglenn, Colo., stands near the stretch of U.S. 85 in Adams County where she was pulled over for a DUI check in September 2014.

Nathaniel Minor/CPR News

This story starts with a stay-at-home-mom from the Denver suburbs.

Her name is Abby McLean. She's 30 and lives in Northglenn, Colo. She was driving home from a late dinner with a friend two years ago when she came upon a DUI roadside checkpoint.

"I hadn't drank or smoked anything, so I was like, 'Let's go through the checkpoint,' " she recalls.

McLean is a regular marijuana user but she insists she never drives while high.

Still, the cop at the checkpoint tells her he smells marijuana and that her eyes are bloodshot. Eventually he whips out handcuffs and McClean freaks.

"Like, massive panic attack. And, 'Oh, my God, I have babies at home. I need to get home. I can't go to jail!' "

She didn't go to jail that night, but she got home hours late. A blood test later revealed McClean had 5 times the legal limit of THC, the mind-altering compound in marijuana.

Colorado's marijuana DUI law is modeled on the one for alcohol, which sets a number to determine when someone is too intoxicated to drive. For pot, that number is five nanograms of THC per milliliter of blood. Anything above that and the law says you shouldn't be driving.

It may sound like an open and shut case that could have resulted in any number of penalties. But McLean's attorney, Nadav Aschner, had a field day in court with Colorado's marijuana intoxication limit.

Shots - Health News Why Is It So Hard To Test Whether Drivers Are Stoned?

"Even the state's experts will say that number alone is something, but generally not enough, and we really hammered that home," he says.

Aschner got a hung jury and McLean pleaded to a lesser offense.

Still, McLean's trip through the criminal justice system is emblematic of numbers that suggest a sharp increase in marijuana DUI arrests in Colorado. So far this year, State Patrol data show that total DUI citations this year rose to 398 through early July, compared with 316 in for the same period 2015.

More states may come up with their own marijuana DUI guidelines. Voters in five states from California to Maine are deciding this November whether to legalize recreational marijuana. They're weighing the good, the bad and the still unknown. Issues like driving while stoned are still in the "unknown" category.

It turns out, measuring a person's THC is actually a poor indicator of intoxication. Unlike alcohol, THC gets stored in your fat cells, and isn't water-soluble like alcohol, says Thomas Marcotte, co-director of The Center for Medicinal Cannabis Research at the University of California, San Diego.

"Unlike alcohol, which has a generally linear relationship between the amount of alcohol you consume, your breath alcohol content and driving performance, the THC route of metabolism is very different," he explains.

That's why adapting drunk driving laws to marijuana makes for bad policy, says Mark Kleiman, a professor of public policy at New York University. "You can be positive for THC a week after the last time you used cannabis," he says. "Not subjectively impaired at all, not impaired at all by any objective measure, but still positive."

Still, Colorado and five other states have such laws on the books because pretty much everyone agrees that driving stoned can be dangerous, especially when combined with alcohol.

What cops really need is a simple roadside sobriety test. Scientists at UCSD are among researchers working on several apps that could measure how impaired one is behind the wheel. One has a person follow a square moving around a tablet screen with a finger, which measures something called "critical tracking." Another app measures time distortion, because things can slow way down when a person is high.

Those tests are still experimental.

Simulated marijuana smoke billows out of the windows of a car during a demonstration by the Colorado Department of Transportation.

David Zalubowski/AP

Denver District Attorney Mitch Morrissey says the uncertainty doesn't mean Colorado should throw out its THC limit. He says it may not be perfect, but it gives juries another piece of evidence to consider at trial.

"I think that putting in a nanogram level makes sense," says Morrissey. "I can't tell you what level it should be. I don't think Colorado's is right. I don't think it should be as high as it is. I think it should be lower."

Morrissey remembers trying alcohol DUI cases as a young prosecutor. The science wasn't settled then either, the blood alcohol standard was about twice as high as it is now, and it took years for it to be lowered.

"I think that has to do with better testing better technology," which Morrissey says will get improve for marijuana too.

In the meantime, some regular marijuana users, like Abby McLean, are scared to drive for fear of failed blood tests.

"I haven't gone out really since then, because I'm paranoid to run into the same surprise, 'Oh oh, there's a DUI checkpoint.' "

A checkpoint that could mean potentially thousands more dollars in attorneys fees to defend herself.

This story is part of a reporting partnership with NPR, local member stations and Kaiser Health News.

Copyright 2016 NPR. To see more, visit NPR.
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Saline Nose Spray Might Help Tame Severe Nosebleeds

Tue, 09/06/2016 - 12:32pm

Researchers tested a variety of medications to treat severe nosebleeds. But saline appears to work just as well.

Glow Wellness/Getty Images

Saline nose spray is becoming increasingly popular as a treatment for allergies and sinus problems. And a study suggests the cheap, simple solution helps with severe nosebleeds, too.

Two studies published Tuesday in JAMA, the journal of the American Medical Association, used saline nose spray as a control when testing medications to treat severe nosebleeds caused by a rare genetic condition.

None of the drugs were any better than the saline spray at preventing nosebleeds. But the participants in the U.S.-based study said their nosebleeds were much less severe — even if they were just using the saline.

The participants all have hereditary hemorrhagic telangiectasia, which causes blood vessel malformations. Pretty much everybody with HHT gets bloody noses, ranging from a minor occasional annoyance to several severe nosebleeds a day. Those can be so bad that people need blood transfusions to maintain blood volume and prevent anemia.

Researchers in the U.S. and France decided to test drugs that have been used for years to treat nosebleeds in people with HHT, but have never been properly evaluated in a clinical trial.

One was bevacizumab, commonly known as Avastin, which slows the growth of new blood vessels and is used to treat cancer and macular degeneration. The U.S. researchers also tested estriol, a form of the hormone estrogen, and tranexamic acid, which improves clotting.

None of the drugs, which were administered as nasal sprays, significantly reduced the number of nosebleeds. The French trial was stopped early because of that lack of benefit.

"It's frustrating that the medications didn't have the effect that the anecdotes suggest," says Dr. Kevin Whitehead, an associate professor of cardiovascular medicine at the University of Utah School of Medicine and co-director of the Utah HHT Center of Excellence. He has been treating patients HHT for years and is lead author on the U.S. study. "We had really hoped to see a real impact on the number of nosebleeds."

But there's a silver lining — Whitehead and his colleagues also asked people to track the severity of their nosebleeds. Two-third of the people said their nosebleeds weren't nearly as bad.

When the study was over and the researchers found out which drugs people had used, they were surprised to discover that the people using saline reported as much improvement as the people on meds.

"There was either a placebo effect or a real beneficial effect from the saline," Whitehead says. And though he can't prove it, he thinks the saline is actually doing something.

The most drastic treatment for severe nosebleeds from HHT is to sew the nose shut. That means that a person can no longer breathe through the nose, but it also means the nose doesn't get dried out. And the nosebleeds end.

After the 12-week study ended, the 106 participants in the U.S. trial were told they could continue on any of the medications. Some were interested in bevacizumab, Whitehead says, but reconsidered when they were told that each vial costs $500 to $800.

"At this point, now that we know what people were taking, we're really emphasizing that as a first-line treatment for nosebleed you should try saline nose spray," Whitehead says.

Dry air is a known cause of nosebleeds, so those of us with nosebleeds not caused by a rare genetic disorder can take heart that such a simple intervention has been endorsed by a randomized clinical trial published in a highfalutin medical journal.

It's not the first time that salty water has earned props from medical professionals. It's also increasingly recommended as a safe, simple treatment for colds, allergies and sinus infections.

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

California Now Requires Timely Updates For Insurers' Doctor Directories

Tue, 09/06/2016 - 11:32am

California State Sen. Ed Hernandez wrote a law to keep insurance directories up to date and to give consumers recourse when errors lead to surprise bills.

Rich Pedroncelli/AP

California State Sen. Ed Hernandez and his wife, Diane, are optometrists.

Diane handles some insurance matters for their practice, and she recently told him that a health plan had emailed to request more information: It wanted confirmation that they were both participating providers.

"I didn't say anything because I was afraid she'd be mad at me," says Hernandez, D-West Covina.

That's because the additional paperwork was probably his doing.

Hernandez, who chairs the California Senate Health Committee, is author of a newly enacted state law that aims to improve provider directories, long riddled with out-of-date and inaccurate information.

Under the law, insurance companies — and health care providers like the Hernandezes — must comply with new requirements to keep directories of in-network providers of care updated at least every quarter.

The law, which took effect July 1, also provides patients with some firepower to fight surprise medical bills that result from directory errors.

The law's reach is broad: It applies to Covered California and private market plans, as well as Medi-Cal managed care and most job-based insurance policies.

The inaccuracy of directories, Hernandez says, "has been and ... seems to continue to be a problem that needs to be rectified."

Several other states, from Georgia to Maryland, have passed similar legislation or are considering doing so, says Claire McAndrew, private insurance program director for Families USA, a national health care consumer advocacy group. In some states, insurance commissioners have adopted new rules through the regulatory process.

But California's law "is the most comprehensive," she says. "The level of detail in California goes beyond any other state." Federal officials also instituted a rule this year requiring directories be updated monthly for all plans sold on the 37 state marketplaces run by the federal government.

And they set new federal rules for Medicare Advantage plans, requiring that the companies contact doctors every three months and update their online directories within 30 days. A recent study in the journal Health Affairs found that provider directories for some health plans sold through Covered California and in the private market are so inaccurate that they create a "disheartening" situation for consumers trying to find doctors.

That finding was confirmed this month when California's Department of Managed Health Care announced that Anthem Blue Cross and Blue Shield of California — which were previously fined for inaccuracies in their Covered California provider directories — still had "disappointing" directory problems.

"We are optimistic and hopeful that the law ... will help," says DMHC director Shelley Rouillard.

Among the law's new rules:

  • Health plans must update their printed directories at least every quarter and their online directories at least every week if providers report changes.
  • Provider directories must be posted online and be available to anyone, not just enrollees. Print directories must be available upon request.
  • The directories must "prominently" display directions for consumers who want to report inaccuracies. Upon receiving complaints, plans have 30 business days to makes changes, if necessary.
  • Providers must inform plans within five business days if they are no longer accepting new patients — or, alternately, if they will start accepting them.
  • Health plans can delay payments to providers who fail to respond to attempts to verify information.

The California law also gives consumers recourse. Let's say you use a provider directory to find a doctor but you're billed the out-of-network price because the directory was wrong. In that case, health plans must reimburse you the amount beyond what you would have paid to see an in-network doctor.

If you find yourself in this situation, first take your complaint to your plan, advises DMHC's Rouillard. You will have at least 180 days from the date you received the bill to file a grievance.

"You'll probably have to make a case" to the plan, Rouillard says. "You should explain what you did, when you looked at the directory, and that you relied on that information."

Documentation could help your case.

That's something to consider when you're searching for a provider in the first place. It wouldn't hurt to save a screen shot from the online directory showing the doctor is in-network, or take detailed notes if you call your plan's customer service line.

"Keep copies of everything, and note the date, time and name of anyone you speak to," says Nancy Kincaid, spokeswoman for the state Department of Insurance.

Plans have 30 days to investigate and respond to your complaint. If the situation isn't resolved to your satisfaction, your next step is to take your grievance to your health plan's regulator.

Since the law went into effect, the DMHC has helped one consumer get reimbursed as a result of this law. "I'm hoping consumers don't have to go through process. I'm hoping the directories are accurate," Hernandez says.

It might take time to get there, as health plans implement the new requirements — as well as others that will take effect in the coming months — and work with providers to update the information.

"This is so early and there are so many errors," Rouillard says.

This story was produced by Kaiser Health News, which publishes California Healthline, a service of the California Health Care Foundation. Send questions for Emily Bazar to AskEmily@kff.org.

Copyright 2016 Kaiser Health News. To see more, visit Kaiser Health News.
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Marijuana's Mainstream Move Triggers Different Kinds Of Family Talks

Mon, 09/05/2016 - 4:29pm
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September 5, 20164:29 PM ET Heard on All Things Considered

Debbie Moak, of Phoenix, is against the legalization of marijuana for recreational use. She worries about the potential for people to move from marijuana to harder drugs.

Stina Sieg/KJZZ

If pot laws were colors, a map of the U.S. map would resemble a tie-dye T-shirt.

In some states, marijuana is illegal. In others, it's legal for medical purposes. And still in others, it is even legal for recreational use.

Recreational pot has been legal in Oregon now for a year, but it was a long time coming. Voters approved medicinal pot 20 years ago. Arizona is voting on it this fall – along with California, Nevada, Maine and Massachusetts. It was only six years ago that Arizona approved marijuana for medicinal use.

The Arizona measure is making some voters nervous. A group that includes two county attorneys even sued, unsuccessfully, to get it off the ballot.

Then there's 59-year-old Debbie Moak, who lives outside of Phoenix. She put her son in drug rehab when he was 20.

"A lot of these kids who are going to be impacted the most by this, they won't be voting in this election," she says. "This is where we need to be the adult in the room and protect the kids."

Moak says pot led her kid to use harder drugs. Cocaine became his drug of choice. He dropped out of college and eventually becoming homeless.

"It tears a family apart," she says. "Addiction becomes a disease of the family, and I've lived it, in the trenches. And I don't want to see this happen for any other family."

But Moak used to see that pretty much daily, back when she ran a nonprofit called Not My Kid that worked to keep young people off drugs. For nearly two decades, she spoke to parents in pain because they were unable to reach their children who were sinking deeper into drug dependency.

She opposed the approval of medical marijuana because she feared it would lead to more acceptance of the substance she views as tremendously harmful.

Coming at this from a completely different direction is 60-year-old food editor Martha Holmberg. She lives in Portland, Ore., and says she smoked a lot of marijuana in high school and college then didn't touch pot again until she finished bringing up her daughter. Now it's more a fabric of her social life.

"I don't do it with people that I don't know well," she says. "But if I'm hanging out with girlfriends or we're going over to a friend's house, I will usually bring weed and say, 'Hey, anybody want to get high?' "

Some do and some don't. "And it all flows very comfortably in that situation," she says. "It's not like the pot smokers have to go off to the corner."

Holmberg recently hosted two women writing a pot cookbook. And they needed somewhere legal to try out recipes. The main issue: How much weed to include in each dish?

The equivalent for alcohol would be to figure out whether you make a Moscow Mule with a finger of vodka or a pint. Holmberg says they proved to be a little too cautious.

"At the end of the evening people weren't really very high," she says. "I think some people were disappointed. We actually pulled out a vape pen for anybody who wanted to get high. But it was much better that way. People felt reassured."

Lisa Olson, of Mesa, Ariz., uses marijuana to ease the symptoms of multiple sclerosis.

Stina Sieg/KJZZ

For some people in Arizona, the scene Holmberg described would be shocking. But the introduction of medical marijuana here in 2010 made it a lot more palatable for others. Like Lisa Olson, a mother of five who lives in Mesa, Ariz., outside of Phoenix. She uses pot to help ease the symptoms of her multiple sclerosis.

How does her marijuana use fit in with family life? "Basically, the way we ended up handling it was a lot like alcohol," she says. "So my kids certainly see me drinking a glass of wine with most dinners. They know that's not for them. That's for the adults."

She thinks adults should be able to use pot recreationally, too. For someone like Olson, who had always abstained from drugs, that's quite a change. Once she saw how much good marijuana did for her, she felt it shouldn't only be reserved for people with a few specific ailments.

She's passed this newfound openness onto her children. Jake Olson, 20, says the "just say no" message he got from school wasn't necessarily true. He appreciates hearing that there are times when use in moderation is OK and shouldn't be equated with heavier drugs.

"It's really funny because, you know, most teenagers don't figure out things like that through their parents," he says. "But I am that exception. I am that person who learned that maybe not all bad things are bad, from my parents."

Acceptance is growing in Oregon. But it's been a gradual process. Patrick Caldwell has a Portland business selling pot containers. He is 29 and brings cannabis-infused sodas to parties. He says he might share one at, say, a bachelor party but not at a family picnic. Caldwell doesn't want pot to be taken lightly.

"I want my nephews to be able to make their own informed decision about cannabis without being influenced by the fact that I so regularly use it," he says.

He thinks people need to respect what they're getting into. But he hopes that in a few years, bringing pot to a family picnic will be no different than bringing a six-pack.

This story is part of a reporting collaboration with NPR, local member stations and Kaiser Health News.

Copyright 2016 NPR. To see more, visit NPR.
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Bariatric Surgery Can Help People Keep Weight Off Long Term

Mon, 09/05/2016 - 5:03am
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September 5, 20165:03 AM ET Heard on Morning Edition

A new study counters the presumption that bariatric surgery is just a short-term fix for severe obesity.

Hero Images/Getty Images

It really hit Terry White eight years ago when he was at the mall with his wife. He was out of breath every few minutes and had to sit down. "My wife told me I had to get to the gym and lose weight," he says.

He had dieted most of his life. "I've probably lost 1,000 pounds over the years," says White, a realtor in North Myrtle Beach, N.C. But he put most of it back on.

By age 59, he knew he was headed for disaster; he weighed 387 pounds at just 5 foot 6. With encouragement from a friend, he headed to Duke University Medical Center in Durham where he had gastric bypass surgery. It reduced his stomach to about the size of an egg so his body absorbed fewer calories and fat from food.

The weight just fell off, he says. He didn't feel deprived. He just didn't want to eat that much. In seven months he'd lost 200 pounds. That was eight years ago. He's gained back a bit, but not much. It turns out his success isn't unique.

Researchers with the Durham Veterans Affairs Medical Center in North Carolina recently tracked the progress of 1,787 veterans who underwent gastric bypass surgery. They found that one year after surgery patients lost 98 pounds on average. Ten years later they gained back only about 7 pounds.

Earlier studies have tracked gastric bypass patients for relatively short periods of time, about 1 to 3 years. That has led to the assumption that most people who have gastric bypass surgery will eventually regain the weight.

This study, published online on August 31 in JAMA Surgery, is one of the largest and longest to evaluate the surgery's effects on weight loss. It also did a better job than many studies at follow-up, with 82 percent of participants staying in the study for 10 years.

Researcher Matthew Maciejewski at the Duke University School of Medicine collaborated with Dr. David Arterburn, a senior investigator at Group Health Research Institute in Seattle, in analyzing the data. They expected to see gradual weight gain over 10 years, with some patients gaining back everything they lost.

But they were pleasantly surprised. Patients regained a small amount of weight in the first few years after surgery, but then they "actually plateaued and maintained their weight loss and even lost a little more weight over the next few years," says Arterburn. Just 3 percent of the study participants gained most or all of the weight back in 10 years.

He says the surgery likely interferes with the body's natural defense to less food: a slowdown in metabolism. This is what dooms so many dieters. The study compared the 1,787 veterans who had the surgery to 5,305 equally obese patients who did not have surgery. For the nonsurgical patients, their weight after 10 years essentially stayed the same.

Arterburn says bariatric surgery seems to change how the brain perceives hunger. "Even though they're taking in a whole lot less calories than they were before, they don't feel a constant urge to eat, and it's not just a reduction in the size of the stomach. They don't feel hungry in between meals."

This is exactly what happened to Terry White, who is now 67. He no longer falls asleep all the time. He walks and jogs about 5 miles daily. He and his wife Wanda are planning to charter a boat in the West Indies to celebrate their upcoming 50th anniversary. He says it's been an "unreal" and extraordinary change in his quality of life.

Researcher Maciejewski says the findings of the study provide evidence that bariatric surgery can be highly effective for severely obese patients. He says further research is needed to look at postsurgical complications and how the experience affects long term mental health.

Copyright 2016 NPR. To see more, visit NPR.
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Researchers Question Safety, Value Of Untested Stem Cell Treatments

Mon, 09/05/2016 - 5:03am
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September 5, 20165:03 AM ET Heard on Morning Edition Maria Fabrizio for NPR

Hundreds of clinics around the country are offering to treat a long list of health problems with stem cells.

The clinics claim that stem cells found in fat tissue, blood, bone marrow and even placentas can help people suffering from arthritic joints and torn tendons to more serious medical problems, including spinal cord injuries, Parkinson's disease and strokes. Some even claim the cells can help children with autism.

But leading stem cell researchers say there's not enough evidence to support the clinics' claims.

Doctors have long used stem cells from bone marrow and blood to treat some types of cancer, such as leukemia and lymphoma. And stem cells are being widely studied as potential treatments for other health problems. Researchers hope stem cells may someday make it possible to repair or replace damaged cells, tissues and even entire organs — but there are very few treatments currently available that have been proven safe and effective.

"There's a lot of sketchy stuff going on," says George Daley, a Harvard stem cell researcher.

"You've got clinics springing up, taking a patient's own cells and then injecting these cells into arthritic joints, into spinal cords, into the brain. And there's really no evidence this is going to work," says Daley. "In fact, there are major concerns about safety."

The treatments could cause life-threatening infections, create tumors or trigger dangerous reactions by a patient's immune system, says Daley and other stem cell researchers.

So far the Food and Drug Administration has not aggressively regulated stem cell clinics. The reason is the stem cells being used typically come from the patient's own body — an autologous transplant. And the clinics don't process the cells much before injecting them.

But now that the treatments are being offered so much more widely, the FDA is considering more aggressive regulation. As part of that process, the agency will hold a workshop this Thursday, followed by a two-day hearing next week.

Another issue is cost. Patients are paying thousands of dollars for these treatments, which are not covered by insurance.

"We're talking about really big bucks here," says Paul Knoepfler, a stem cell scientist at the University of California, Davis, who monitors health and safety issues with stem cell clinics in his blog.

The treatments can cost from $5,000 to as much as $100,000, Knoepfler reports in an article recently published in the journal Cell Stem Cell. He estimates that there are more than 500 stem cell clinics treating as many as 100,000 patients a year in the United States.

Knoepfler hopes the FDA will crack down on the clinics.

"The FDA needs to step up its game on this, because otherwise this could continue to grow as an industry, and it's just going to put more and more people at risk," he says.

The clinics defend what they're doing.

"Patients should have access to their own body tissue," says Kristin Comella, chief scientific officer at the U.S. Stem Cell clinic, which is based in Sunrise, Fla. Comella also serves as president of the Academy of Regenerative Practices, which represents the clinics.

If patients "are able to provide and give informed consent to move forward with these treatments, that is their right," Comella says. "In particular for diseases where they have not had much success with traditional medicine."

Comella acknowledges that two of her clinic's patients suffered detached retinas after getting stem cells injected into their eyes. As a result, the clinic has stopped treating eye conditions. But otherwise, Comella says, the clinic has had no serious problems. It offers stem cell treatments for a host of conditions including diabetes, spinal cord injuries and congestive heart failure.

"There are always risks no matter what you're doing. That being said, our group has treated more than 6,000 cases and we've had very few safety events associated with these treatments," she says.

The clinics point out that the cells they are using are not human embryonic stem cells, which are controversial because embryos are destroyed to get them. And they're not induced pluripotent stem cells, which scientists create in the lab.

The FDA has no timetable for when it expects to make any decisions on regulation. In the meantime, the FDA website suggests patients carefully research any stem cell treatment before going ahead with it.

Copyright 2016 NPR. To see more, visit NPR.
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'Ugly': A Memoir Of Childhood, Deformity And Learning To Love A Distinctive Face

Sun, 09/04/2016 - 8:45am
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September 4, 20168:45 AM ET Heard on Weekend Edition Sunday

A writer by profession, Robert Hoge was the first member of his family to go to college.

Matthew Warrell/Courtesy of Penguin Young Readers

Robert Hoge's new memoir is about his childhood — his first day of school, making friends and learning to ride a bike. But it's also about getting called "cripple," having multiple reconstructive surgeries and teaching himself how to play sports with two artificial limbs.

Hoge was born with deformed legs and a giant tumor between his eyes. "The tumor formed really early during my development," he tells NPR's Rachel Martin. "So it subsumed my nose and pushed my eyes to the side of my head, like a fish, and made a mess of my face, as you'd expect."

Hoge lives in Brisbane, Australia, with his wife and two daughters. His new book, for readers age 8 and up, is called Ugly.

Interview Highlights

On how his mother reacted when she learned about his deformities

I was born in the early 1970s, so before prenatal scans were commonplace, and I'm the youngest of five children. And my parents had four healthy kids before me. I'm not going to call my brothers and sisters normal, but they were certainly healthy. And so I think, you know, my parents had every right to expect the healthy, normal child they thought they were owed. But I turned up without any warning, with these deformities. And my mother didn't even see me before I was taken away to intensive care, and she knew something was wrong because it was a difficult labor. ...

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And so I went away to the nursery for a week and then eventually one of the doctors convinced her to come and see me, and when she saw me, she looked down the cot and decided that she couldn't take me home. And so she went back to her bed in the hospital and thought about that a bit more and talked to every person possible she thought may help her not bring me home: She talked to her sister, she talked to her [general practitioner], she talked to her priest, she talked to her local politician, she talked to the doctors there. But she was pretty adamant that she wasn't going to bring me home. And I genuinely think that she was in a form of shock. ...

Eventually, she processed it a bit better and she was really worried about what impact bringing me home would have on my brothers and sisters. So, the quick story is they decided to have a family discussion and they sat down one Saturday morning and talked through all of my problems and whether I should come home. And my parents one by one asked my brothers and sisters, "Should we bring Robert home?" And one by one they all, thankfully, said yes. My sister Catherine, who was only 4 at the time, reckons the only reason she said yes was because everyone else said yes before her, so maybe peer pressure is a good thing.

On how he learned the story of his birth

The reason I know all of that was because one of the doctors at the time encouraged my mother to keep a diary. And she kept this lovely blue diary with beautiful handwriting in it and that was never hidden away from me. It would sit on the couch beside her, or it would be on her bedside table. ... And every now and then I'd ask mum to read me a bit from her book. And so she was really open and honest in that book about her feelings about me, and she was really open and honest with me from a very young age about her feelings. And I think I had a few times where I was a bit concerned and a bit worried and couldn't quite understand, but I think then it just clicked one day that it was like a movie that has some sad parts in the middle but has a happy ending. I was finding all of that out after knowing that my parents had decided to bring me home. And that kind of honesty and that openness was really important to me growing up and I think has really enabled me to be pretty open and honest about all of my feelings in the book.

On how he explained his deformities to other kids growing up

Normally with one quick and short answer. So, you know, kids would ask me, "Why have you got bumps on your head?" or "Why have you got a squished nose?" or "Why don't you have any legs?" And I would simply say, "I was born that way." And probably nine times out of 10, the questions wouldn't go much further than that. ... That satisfied them, and it certainly satisfied me.

On deciding not to have a major reconstructive surgery that would diminish the appearance of the birth defects

I made that decision when I was 14. By then, I'd had 24 different operations, some quite small and some very, very large. And my parents ... they said, "Well, Robert, you're almost an adult so you get to choose." Pretty tough. Big choice for a dumb 14-year-old boy, too, I can tell you. ...

We ended up talking about some of the potential side effects of the operation, and because they were moving my eyes a little bit closer again, there was a chance — and a not insignificant chance — that I might go blind. And my brother, when he heard that, piped up and said, "Well, what use is it looking pretty if he can't even see himself?" So right then and there I decided no, I'm not going to have this operation.

But certainly, you know, when you ask a girl out and she says no, and you're thinking how terribly lonely life's going to be when you're 16 years old, you know, you have moments where you kick yourself and think, "I should have had that operation," or "Maybe I can still have it."

On going against his doctors' advice when he decided to opt out of the surgery

I have genuine love and affection for the massive changes all of the doctors and nurses who worked on me made to my life. But doctors are tinkerers. They're always in the back shed thinking, "If we moved that nose up half an inch, it'd look so much better." But I think, you know, thinking about it now, I'm never going to look like Brad Pitt or George Clooney, so I think I should just stick with my rather distinctive face and go from there.

Copyright 2016 NPR. To see more, visit NPR.
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Colorado Gun Shops Work Together To Prevent Suicides

Fri, 09/02/2016 - 2:02pm
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September 2, 20162:02 PM ET Heard on All Things Considered

From

Jacquelyn Clark, co-owner of Bristlecone Shooting, Training and Retail Center in Lakewood, Colo., holds a list of gun safety rules. One recommendation: Consider "off-site storage if a family member may be suicidal."

John Daley/Colorado Public Radio

It's ladies night at the Centennial Gun Club in a suburb of Denver. More than 80 women are here for safety instruction and target practice.

Tonight the club is offering more than shooting, though. The women rotate through the firing range, and in another large room, they hear a sobering presentation from emergency room doctor Emmy Betz. She's part of a collaboration between gun shops and public health leaders in the state to help prevent suicide.

"If you've been touched by suicide somehow, if you could, raise your hand," she asks. About half the hands go up.

Colorado has the nation's seventh-highest suicide rate. In a typical year, more than half involve guns. Research suggests suicide is often an impulsive act, Betz says, and attempts are much more likely to be lethal when a firearm is used. If people survive a suicide attempt, they are far less likely to eventually die from suicide.

"Unfortunately, with firearms typically there's not that second chance," she says.

Dr. Emmy Betz works in the Emergency Department at the University of Colorado Hospital and also is part of the Colorado Gun Shop Project.

John Daley/Colorado Public Radio

There's a new push in the national conversation about gun violence that is attempting to sidestep the political rancor, to find common ground on one thing — guns and suicide. The campaign in Colorado is called the Colorado Gun Shop Project.

Centennial Gun Club is one of 46 on board. The project formally started in the summer of 2014, modeled after a similar one by the New Hampshire Firearm Safety Coalition.

During Betz's talk, organizers hand out Life Savers candies to drive home the message. Gun owner Lily Richardson says she thinks the information could do just that: save lives. "I think those who are aware and taking the initiative to talk about it can help make the difference," she says.

Nancy Dibiaggio, a new gun owner, agrees. "It's a big issue, and I think it's great Colorado is jumping on the wagon with this."

Dick Abramson, Centennial's owner, says he welcomes the opportunity to facilitate the discussion. "The difficulty is that it's not a topic people want to just bring up and talk about over the cocktail table, right?"

He says workers at his store have refused to sell a gun to someone they're concerned about or feel is having an especially bad day. "My honest feeling is this is a nonpartisan issue," he says. "This is something that everybody can get behind. It should be a universal concern of everyone."

Shooters take aim on Monday Night Bowling Pin Shoot at the firing range of the Bristlecone Shooting, Training and Retail Center in Lakewood, Colo.

John Daley/Colorado Public Radio

In another Denver suburb, the Bristlecone Shooting, Training and Retail Center is also part of the project. At its range, shooters take target practice at bowling pins lined up on the far wall.

In the shop's showroom, store owner Jacquelyn Clark shows off literature on display "that talks about suicide prevention and what to do if somebody you know or you yourself are in crisis," she says.

A poster reads, Gun Owners Can Help! Under a photo of a lone elk in the mountains, it lists signs someone may be suicidal and a phone number for the National Suicide Prevention Lifeline.

Clark says there's now an 11th commandment on gun safety rules: Consider off-site storage — family, friends, some shooting clubs, police departments or gun shops — if a family member may be suicidal. Clark says most people don't realize that the majority of gun deaths are not homicides but suicide.

A survey of hospital emergency rooms by the Centers for Disease Control and Prevention in 2011 found an estimated 21,175 suicides involving firearms compared with 11,208 homicides involving guns.

"The gun community itself is more at risk than the regular community, not because gun owners tend to have more mental health issues but just because they have more access [to firearms]," Clark says.

Jarrod Hindman, director of the Suicide Prevention Resource Center in Colorado, says he appreciates that local gun advocates are taking the lead. "This is their project," he says. "We're just helping to facilitate the process."

More than 500 Coloradans took their own lives with a firearm in 2014, says Hindman, but talking about the role of guns is hard.

"Obviously this is a very contentious topic, and we've found a way to find middle ground in a topic where we didn't think there was a middle ground," he says.

And now, a large trade association for the firearms industry, the National Shooting Sports Foundation, is teaming up with the American Foundation for Suicide Prevention to develop a suicide prevention campaign for the gun group's 13,000 members. Their goal is to reduce the annual suicide rate by 20 percent in the next decade.

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

Copyright 2016 Colorado Public Radio. To see more, visit Colorado Public Radio.
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FDA Bans 19 Chemicals Used In Antibacterial Soaps

Fri, 09/02/2016 - 12:56pm

The FDA says there's no evidence that antibacterial soaps do a better job cleaning hands, and chemicals in them may pose health hazards. The FDA ban applies only to consumer products, not those used in hospitals and food service settings.

Mike Kemp/Blend Images/Getty Images

Consumers don't need to use antibacterial soaps, and some of them may even be dangerous, the Food and Drug Administration says.

On Friday, the FDA issued a rule banning the use of triclosan, triclocarban and 17 other chemicals in hand and body washes. which are marketed as being more effective than simple soap.

Companies have a year to take these ingredients out of their products or remove the products from the market, the agency said.

"If the product makes antibacterial claims, chances are pretty good that it contains one of these ingredients," Theresa Michele, director of the FDA's Division of Nonprescription Drug Products, said Friday in a conference call with reporters.

The ban applies only to consumer products, not to antibacterial soaps used in hospitals and food service settings.

Many companies have already started phasing out these ingredients, especially after the FDA issued a proposed rule in 2013 that required companies to provide data on products' safety and effectiveness.

But not all. On its website, Dial's "All Day Freshness" antibacterial soap, for one, lists triclocarban as an active ingredient.

The Henkels Co., which owns Dial, didn't respond to an email seeking comment.

Many companies have replaced triclosan with one of three other chemicals — benzalkonium chloride, benzethonium chloride or chloroxylenol (PCMX) — in their antibacterial products. The FDA has given companies another year to provide more data on their safety and effectiveness.

There is some evidence that triclosan, triclocarban and the other chemicals can disrupt hormone cycles and cause muscle weakness, says Mae Wu, a senior attorney at the Natural Resources Defense Council, which originally asked the FDA to ban the ingredients.

The rule is part of a broader effort by the FDA to encourage consumers to skip so-called antibacterial soaps and simply use regular soap and water.

"There's no data demonstrating that over-the-counter antibacterial soaps are better at preventing illness than washing with plain soap and water," the agency said in a press release issued shortly after the rule was announced.

But advocates for the soap industry dispute that.

"Washing the hands with an antiseptic soap can help reduce the risk of infection beyond that provided by washing with non-antibacterial soap and water," said Brian Sansoni, spokesman for the American Cleaning Institute, in an emailed statement.

The FDA statement said that data submitted by the companies about the 19 ingredients wasn't sufficient:

"For these ingredients, either no additional data were submitted or the data and information that were submitted were not sufficient for the agency to find that these ingredients are Generally Recognized as Safe and Effective."

Here is a list of the newly banned chemicals:

  • Cloflucarban
  • Fluorosalan
  • Hexachlorophene
  • Hexylresorcinol
  • Iodine complex (ammonium ether sulfate and polyoxyethylene sorbitan monolaurate)
  • Iodine complex (phosphate ester of alkylaryloxy polyethylene glycol)
  • Nonylphenoxypoly (ethyleneoxy) ethanoliodine
  • Poloxamer-iodine complex
  • Povidone-iodine 5 to 10 percent
  • Undecoylium chloride iodine complex
  • Methylbenzethonium chloride
  • Phenol (greater than 1.5 percent)
  • Phenol (less than 1.5 percent) 16
  • Secondary amyltricresols
  • Sodium oxychlorosene
  • Tribromsalan
  • Triclocarban
  • Triclosan
  • Triple dye
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An Even Deadlier Opioid, Carfentanil, Is Hitting The Streets

Fri, 09/02/2016 - 5:02am
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September 2, 20165:02 AM ET Heard on Morning Edition

First responders have found that standard doses of naloxone aren't always enough to counteract the powerful sedating effects of carfentanil.

Ted Horowitz/Getty Images

A powerful drug that's normally used to tranquilize elephants is being blamed for a record spike in drug overdoses in the Midwest. Officials in Ohio have declared a public health emergency, and the U.S. Drug Enforcement Administration says communities everywhere should be on alert for carfentanil.

The synthetic opioid is 100 times more potent than fentanyl, the prescription painkiller that led to the death earlier this year of the pop star Prince. Fentanyl itself can be up to 50 times more deadly than heroin.

In the past few years, traffickers in illegal drugs increasingly have substituted fentanyl for heroin and other opioids. Now carfentanil is being sold on American streets, either mixed with heroin or pressed into pills that look like prescription drugs. Many users don't realize that they're buying carfentanil. And that has deadly consequences.

"Instead of having four or five overdoses in a day, you're having these 20, 30, 40, maybe even 50 overdoses in a day," says Tom Synan, who directs the Hamilton County Heroin Coalition Task Force in Southwest Ohio. He's also the police chief in Newtown, Ohio.

Synan says carfentanil turned up in Cincinnati in July. At times, the number of overdoses has overwhelmed first responders.

"Their efforts are truly heroic, to be going from call to call to call," he says. "One district alone had seen 14 in one shift, so they were nonstop."

First responders and emergency room workers are being told to wear protective gloves and masks. That's because carfentanil is so potent, it can be dangerous to someone who simply touches or inhales it.

This was devastatingly clear back in 2002, after a hostage rescue operation in Moscow that went wrong. To overpower Chechen terrorists who'd seized control of a theater, Russian Special Forces sprayed a chemical aerosol into the building. More than 100 hostages were overcome and died. Laboratory tests by British investigators later revealed that the aerosol included carfentanil.

In Ohio, Hamilton County Health Commissioner Tim Ingram says it can take hours for the body to metabolize carfentanil, far longer than for other opiods. That means a longer-lasting high.

But it also means that when someone overdoses, it's more difficult to revive them — and save their life — with naloxone, the emergency medication used to block the effects of opioids.

"We've been getting lots of reports that they're using two or three doses to get people to come back," says Ingram. He's trying to distribute a more concentrated version of naloxone.

There is no approved human use for carfentanil. It's even highly restricted for veterinarians, who can use it lawfully to sedate large animals. The Drug Enforcement Administration says much of the carfentanil being sold on the streets is illicitly imported from China.

DEA spokesman Russ Baer says some of the illicit carfentanil is brought in by Mexican drug traffickers, then sold at huge profit since it only takes a granule or so to induce a high. He says carfentanil can also be bought online.

"You can go on the Internet and anybody can establish an anonymous account, and you can order carfentanil directly from China," he says.

Ingram foresees a turning point in illicit opioids. He wonders why anyone would go to the trouble of growing poppies in order to make heroin, when something much more powerful can be made in a lab.

"We may be seeing more and more synthetic opioids from this point forward," he says, "and we're going to have to prepare for it."

Synan thinks one shift should include tougher penalties. Generally, he says, selling drugs on the street is considered a nonviolent crime. But that may not make sense if the drug includes carfentanil.

"To me, that's just like pulling a gun out and shooting someone, because you know that a tiny bit can kill a person," Synan says. "To me, it's intentional. It's murder."

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

FDA Fees On Industry Haven't Fixed Delays In Generic Drug Approvals

Thu, 09/01/2016 - 2:04pm

Where are the generic alternatives to EpiPen and other expensive drugs that have lost patent protection?

Victor J. Blue/Bloomberg via Getty Images

Consumers and lawmakers pushing for cheaper alternatives to the EpiPen, an antidote for life-threatening allergic reactions, and other high-priced drugs are seeking answers about a stubborn backlog of generic drug applications at the Food and Drug Administration.

Even after the agency started levying user fees on drugmakers in 2012 to pay for more people to review the medicines, the backlog of decisions still stretches almost four years.

As of July 1, the FDA had 4,036 generic drug applications awaiting approval, and the median time it takes for the FDA to approve a generic is now 47 months, according to the Generic Pharmaceutical Association, a trade group. The FDA has approved more generics in the past few years, but a flood of applications has added to the problem.

By comparison, the European Medicines Agency, Europe's version of the FDA, has just 24 generics, including biologically based biosimilars awaiting approval. The FDA's generic count doesn't include biosimilars, which are more complicated medicines to review. The EMA along with the European Commission, which handles approval of marketing materials, are approving generics and brand-name drugs in about a year on average, according to the EMA.

Critics say getting generic alternatives to the U.S. market for products like EpiPen is still taking far too long. Other off-patent drugs with rising prices and no generic competition have also drawn scrutiny, including Turing Pharmaceuticals' Daraprim, for toxoplasmosis, and Valeant's cardiovascular drugs Isuprel and Nitropress.

Congress asks why generic version of EpiPens aren't available

"We are concerned that Mylan (maker of the EpiPen) has not faced much competition for its product," five U.S. senators wrote Aug. 24 to FDA Commissioner Dr. Robert Califf, adding that one of EpiPen's nongeneric competitors, Auvi-Q, was recalled in October, granting Mylan a near monopoly. "News reports indicate that generic versions of the EpiPen have been subject to additional questioning by the FDA and have yet to be approved."

On Monday, three members of the House Committee on Energy and Commerce wrote a similar letter to the FDA, seeking information about the EpiPen generic applications it has received and how they've been prioritized.

When asked whether the FDA bears any responsibility for the lack of EpiPen competition, FDA spokesman Kristofer Baumgartner said he couldn't comment on pending applications or confirm their existence, citing confidentiality rules. But he stressed that the FDA pushes pending applications for drugs with no current generics to the front of the line and approved 580 generics in 2015, a record for the agency and 40 percent more than in 2014.

"The FDA is confident that the overall trend in actions on generic drug applications will be one of continuing improvement," Baumgartner said.

Shots - Health News Maker Of EpiPen To Sell Generic Version For Half The Price

In March, generics giant Teva Pharmaceuticals told investors that its generic version of EpiPen was rejected by the FDA, and that it wouldn't be able to launch the generic until at least 2017. Adamis Pharmaceuticals reported a similar rejection from the FDA for its EpiPen generic in June.

Mylan has said it will offer a $300 generic in the coming weeks. Because Mylan also makes the brand-name product, it won't have to wait in line behind other pending generics.

Dr. James Baker, the CEO and chief medical officer of the advocacy group Food Allergy and Research Education, said Mylan's move may deter other generic manufacturers from seeking approval. Adrenaclick is the only other epinephrine auto-injector on the market, but it isn't an exact generic of EpiPen and can't be swapped automatically at the pharmacy if a doctor has written a prescription for EpiPen.

Adrenaclick also isn't widely available. "You call up 100 pharmacies, and maybe 10 have the device, from what we gather," Baker said of Adrenaclick.

He said several factors have allowed EpiPen's price tag to swell over the years. Many patients were in the dark about EpiPen price increases until insurers started shifting more of the cost onto consumers a few years ago, and getting approval for a generic that's both a drug and a device is more complicated than getting approval for a drug alone, he said.

Meanwhile, Mylan has aggressively marketed its product and raised doubts about alternatives.

And documents show that Mylan submitted a citizen petition to the FDA arguing that people trained to use EpiPens wouldn't be able to use Teva's pending generic epinephrine auto-injector because of design differences.

"Is Mylan doing anything illegal? No," Baker said. "It's taking advantage of all these things to take the market and basically push it to an extreme."

User fees levied to speed up the approval process

The FDA's generic backlog isn't a new problem. In 2012, it was so large that it prompted the government to start charging user fees to generic manufacturers to provide the funds for the FDA to speed the process. The fees built on the 20-year-old Prescription Drug User Fee Act, which required brand-name drugmakers to pay fees to expand FDA's capacity to review applications for those medicines. In the first three years, the FDA collected $1 billion from generic drug manufacturers.

The fees were used to hire an additional 1,000 employees, and put the Office of Generic Drugs on par with the Office of New Drugs by reorganizing it and moving it from four outlying buildings to the FDA's main campus in Silver Spring, Md.

The funds were also used to upgrade the office's information technology. The FDA says on its website: "Additional resources will enable the Agency to reduce a current backlog of pending applications, cut the average time required to review generic drug applications for safety, and increase risk-based inspections."

In October 2012, there was a backlog of 2,868 generic drugs awaiting approval, and the FDA said it would take a "first action" on 90 percent of these drugs by 2017. This summer, the agency met its goal a year early, but a first action isn't an approval. Instead, it stops the review clock and puts the applications back in industry's court.

Only 1,551 generics have been approved since the fees on drugmakers were initiated, and that total includes some extra applications that weren't considered part of the official backlog. So, all told, the agency has only approved about half of the backlogged generics that were awaiting approval in 2012.

"Most applications from the backlog will need to come back to FDA for additional review due to deficiencies in the submissions, before approval is possible," the agency said in a statement in responses to questions.

David Gaugh, senior vice president for science and regulatory affairs at the Generic Pharmaceuticals Association, said standards used to compile generic applications when they were submitted three or four years ago have changed while the applications were sitting in the backlog. So when the FDA got back to those companies, it said the applications were of "poor quality."

The applications for generic drugs have continued to pile up even as the FDA approved a record number of generics in 2015 and again in the first seven months of 2016. The number of generic drug applications tripled from 2002 to 2012, according to January congressional testimony from Janet Woodcock, who directs the FDA's Center for Drug Evaluation and Research.

Still, some see signs the agency is on the right track.

"I think that it is an optimistic picture overall ... at the FDA, there's been a lot of progress, and I think there is more to be made," said Dr. Aaron Kesselheim, an interdisciplinary drug researcher at Harvard Medical School and Brigham and Women's Hospital. "This is not something that people should think has been solved at this point. It's totally an ongoing process."

Kaiser Health News is an editorially independent news service that is part of the nonpartisan Henry J. Kaiser Family Foundation. Follow Sydney Lupkin on Twitter: @slupkin.

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

POLL: Most Americans Want Congress To Make Zika Funding A High Priority

Thu, 09/01/2016 - 3:05am
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September 1, 20163:05 AM ET Heard on Morning Edition

County mosquito control inspector Yasser "Jazz" Compagines sprays a storm drain in Miami Beach to thwart mosquitoes that spread Zika.

Alan Diaz/AP

Summer is winding down, but when members of Congress return to Washington from their vacations next week, many of their constituents want them to do something about the mosquitoes — the ones carrying Zika virus, to be specific.

A new survey shows that three quarters of Americans say Congress should make the allocation of more money to deal with the Zika outbreaks in Florida and Puerto Rico an "important" or "top priority" when they return to Washington.

"People generally do value spending money when there is sort of a public health emergency," says Mollyann Brodie, executive director of public opinion and survey research at the Kaiser Family Foundation, which conducted the survey.

About half those surveyed said they'd be uncomfortable traveling to the areas of Florida where people have been infected by Zika. And 77 percent said pregnant woman are not safe in those areas.

"It is something that the local officials have to take really seriously," Brodie says, "because in many of those areas the tourism industry is a big part of those communities."

President Obama asked for $1.9 billion in emergency federal funding back in February to fight Zika. So far, Congress hasn't allocated anything.

So the administration has been using money shifted from other accounts — including money that had been specified for studying and fighting Ebola, and for state-level emergency preparedness — to address the Zika threat, instead.

Dr. Tom Frieden, director of the Centers for Disease Control and Prevention, says his agency will be out of funds to fight Zika by the end of the month. Health and Human Services Secretary Sylvia Burwell issued a similar warning in August.

But Mark Harkins, a senior fellow at Georgetown University's Government Affairs Institute, says that — at least technically — the Obama administration could move even more money from other programs to fight Zika.

Even though lawmakers usually allocate money for specific purposes, the federal budget allows for some shifting of funds, Harkins says.

"As part of the appropriations bills themselves there's always a provision that says you may transfer money or reprogram money, based on certain levels," he says. "And then they put in a little out that says, you can move money at any point, at any amount, as long as you give 15 days notice."

Some lawmakers seem to be daring the administration to do just that.

Senators Charles Grassley, R-Iowa, and James Lankford, R-Oklahoma, wrote a letter to Burwell, dated Aug. 26, that pointed to $20 billion that is sitting unspent in the HHS and State Department budgets. It could be spent on Zika, the senators say.

Lankford's staff provided NPR with a list of the accounts the letter refers to. They included Food and Drug Administration salaries and expenses, the State Department's diplomatic and consular programs and programs in nonproliferation and anti-terrorism.

The Senators simply added up all the money that remains unspent in the accounts Obama specified as needing additional funds, Harkins says.

Grassley "doesn't care that that money is supposed to be used for multiple different things," says Harkins. "He's just saying, 'If you think money should come out of that account, take any money that's left in that account.'"

Meanwhile, as the White House and Congress debate the budget, state health officials are scrambling.

Frank Welch, the head of community preparedness at Louisiana's health department, says his federal grant to prepare for all kinds of health emergencies was cut, and replaced with money that can only be used for Zika.

"But none of those other threats or emergencies that are very real possibilities have gone away," he says, "and we took about a $700,000 dollar cut."

Louisiana is using the Zika money for mosquito control, to do public outreach and education about how to recognize and prevent infection. The state is also updating its lab to be able to do Zika testing.

Welch says they've done a good job with prevention and preparedness, but there just isn't enough money left to deal with a Zika response if there's an outbreak in that state.

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

Drop In Teen Pregnancies Is Due To More Contraceptives, Not Less Sex

Wed, 08/31/2016 - 4:39pm
Garo/Phanie/Science Source

Teen pregnancy is way down. And a study suggests that the reason is increased, and increasingly effective, use of contraceptives.

From 2007 to 2013, births to teens age 15 to 19 dropped by 36 percent; pregnancies fell by 25 percent from 2007 to 2011, according to federal data.

But that wasn't because teens were shunning sex. The amount of sex being had by teenagers during that time period was largely unchanged, says the study, which was published online in the Journal of Adolescent Health. And it wasn't because they were having more abortions. Abortion has been declining among all age groups, and particularly among teenagers.

Rather, the researchers from the Guttmacher Institute and Columbia University found that "improvement in contraceptive use" accounted for the entire reduced risk of pregnancy over the five-year period.

"By definition, if teens are having the same amount of sex but getting pregnant less often, it's because of contraception," says Laura Lindberg, the study's lead author and a Guttmacher researcher.

No single contraceptive method stood out as singularly effective, said the researchers. Instead, they found that teens were using contraceptives more often, combining methods more often, and using more effective methods, such as the birth control pill, IUDs and implants.

Also, the use of any contraceptive at all makes a big difference, said Lindberg. "If a teen uses no method they have an 85 percent chance of getting pregnant [within a year]. Using anything is way more effective than that 85 percent risk."

The downturn in teen births actually dates back to the early 1990s, the authors say, with the rate dropping by 57 percent between 1991 and 2013. The increase in contraceptive use dates to the mid-1990s, with the use of any contraceptive at the most recent sexual encounter rising from 66 to 86 percent from 1995 to 2012.

Valerie Huber, who advocates for programs that urge teens to wait to have sex rather than provide information about contraception, says the study is biased toward birth control.

"As public health experts and policymakers, we must normalize sexual delay more than we normalize teen sex, even with contraception," said a statement from Huber, president and CEO of Ascend, a group that promotes abstinence education. "We believe youth deserve the best opportunity for a healthy future."

More recent policy changes could help drop the teen pregnancy rate even more. One is the Affordable Care Act requirement that boosted insurance coverage for contraception, starting in 2012. The other is the 2014 recommendation from the American Academy of Pediatrics that sexually active teenagers be offered "long-acting reversible contraception" methods such as implants and intrauterine devices, which are highly effective and do not require any additional action, such as remembering to take a daily pill.

But Lindberg noted that just as for older women, teens should be offered a full choice of contraceptives. "In the end, the best method for anyone is one that they are willing and able to use."

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

FDA Boosts Warning On Danger Of Combining Opioids And Anxiety Meds

Wed, 08/31/2016 - 2:01pm

Diazepam, also known as Valium, is used to treat anxiety and insomnia. But when combined with opioids, it can suppress breathing and cause death.

Universal Images Group/Getty Images

The Food and Drug Administration is warning that patients and doctors should more fully understand the potentially life-threatening risks of combining anti-anxiety or sleep medications with prescription opioids.

To that end, the agency is requiring that nearly 400 products carry a "black box warning" highlighting the risks from combined use, it said in a press release Wednesday. The risks include extreme sleepiness, respiratory depression, coma and death.

The move comes after an extensive review of scientific evidence by the FDA showing that physicians have been increasingly prescribing these drugs together. There was also a request for action in February, when health officials in cities and states across the country petitioned the agency for the change to the drug labels, citing an increase in overdoses from simultaneous use of the drugs.

"As an emergency physician, I have seen so many patients who are prescribed opioids and benzodiazepines together," wrote Dr. Leana Wen, Baltimore's health commissioner and a leader of the effort, on Twitter Wednesday. "A black box warning is a powerful education tool and thank [you to the FDA] for taking action to help prevent deaths from this dangerous combination."

A black box warning is a powerful education tool and thank @US_FDA for taking action to help prevent deaths from this dangerous combination

— Leana Wen, M.D. (@DrLeanaWen) August 31, 2016

From 2004 to 2011, the FDA says, the rate of emergency department visits involving nonmedical use of both drug classes increased significantly. Overdose deaths from taking prescribed or greater-than-prescribed doses of both drug classes nearly tripled, according to the release.

"It is nothing short of a public health crisis when you see a substantial increase of avoidable overdose and death related to two widely used drug classes being taken together," said Dr. Robert Califf, the FDA commissioner.

The number of patients who were prescribed both an opioid painkiller and a benzodiazepine increased by 41 percent during the period studied, the FDA says, translating to an increase of more than 2.5 million opioid patients receiving benzodiazepines.

Shots - Health News Risks Of Popular Anxiety Drugs Often Overshadowed

Painkillers and cough treatments containing opioids that will be required to carry the new warning include oxycodone, hydrocodone and morphine, among other drugs. The benzodiazepines that will get the warning are sold under a variety of brand and generic names, including Xanax, Valium and lorazepam. They often called tranquilizers or sleeping pills for their ability to relieve anxiety, insomnia and seizures.

Both classes of drugs suppress the central nervous system.

Shots - Health News In Prince's Age Group, Risk Of Opioid Overdose Climbs

Opioids have legitimate medical uses in treating pain and cough, but they can also cause drowsiness, dizziness, nausea, vomiting, constipation and slowed or difficulty in breathing. Benzodiazepines also cause some of these same side effects, which is why using the two drugs together can be deadly.

There are some medical conditions for which the combined use of these drugs is desirable and effective, including some treatments for opioid addiction and dependence. The FDA says it is continuing to examine available evidence regarding these uses.

The agency has created guidance for people who are taking either of these drugs, so they can better understand the risks of taking them together. Health care providers are also receiving information that urges caution when prescribing them together, including being careful not to increase the dose or dosing frequency for either drug, the FDA says.

Copyright 2016 NPR. To see more, visit NPR.
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Test Of Experimental Alzheimer's Drug Finds Progress Against Brain Plaques

Wed, 08/31/2016 - 1:10pm
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August 31, 20161:10 PM ET Heard on All Things Considered

Experimental drugs that clear clumps of proteins from the brains of Alzheimer's patients haven't panned out yet.

Science Photo Library/Pasieka/Getty Images

An experimental drug dramatically reduced the toxic plaques found in the brains of patients with Alzheimer's disease, a team reports in the journal Nature.

Results from a small number of patients who received a high dose of the drug, called aducanumab, hint that it may also be able to slow the loss of memory and thinking.

"If that hint of a clinical benefit is confirmed, it would be a game changer in the fight against Alzheimer's disease," says Dr. Eric Reiman, executive director of the Banner Alzheimer's Institute in Phoenix. Reiman wrote a commentary that accompanies the study in Nature.

But it will take much larger studies to show for sure whether aducanumab really does slow down Alzheimer's disease, Reiman says.

Officials of Biogen, which is developing the drug, were also cautious about interpreting the results of the study, which included 165 patients in the early stages of Alzheimer's disease.

Shots - Health News Failure Of Lilly Drug Is Latest Alzheimer's Setback

"We think we have something important here," says Dr. Alfred Sandrock, chief medical officer for Biogen. "We hope we're right because if it's true it would benefit millions of patients. But we don't know we're right yet."

The results are encouraging for pharmaceutical companies that have spent billions of dollars on efforts to come up with the first drug to treat the underlying cause of Alzheimer's. Those efforts have failed to produce a single approved drug so far.

But last summer, Biogen began presenting its results with aducanumab at scientific meetings, including the Alzheimer's Association International Conference in July. These early reports suggested the drug had a remarkable ability to remove plaques in the brain.

"It was surprising, encouraging and thought-provoking to see such a striking reduction of existing plaques," Reiman says.

The publication in Nature on Wednesday provides details about those early reports.

Biogen has already begun two much larger studies of aducanumab. They will include a total of 2,700 patients, and results are still several years off.

But there are reasons to think aducanumab may succeed where other drugs have failed.

One is that the drug appears to ignore benign forms of amyloid protein while attacking the toxic forms thought to damage brain cells. Another is that aducanumab seems to enhance the ability of existing immune cells in the brain to devour toxins, including amyloid.

But there's a downside. The process of removing plaque sometimes causes fluid to build up in the brain. In rare cases, it can also cause bleeding. These side effects are known as amyloid-related imaging abnormalities, or ARIA.

"We were actually anticipating that we would see it," Sandrock says. And the researchers did. Twenty patients dropped out of the trial because of adverse effects.

If aducanumab works in larger studies, it could help settle a long-running debate about whether amyloid is really the root cause of Alzheimer's. This idea is known as the amyloid hypothesis.

And large studies showing that removing amyloid can preserve memory and thinking "would go a long way toward validating the amyloid hypothesis," Sandrock says.

Results like those could also lead to the first approved drug to treat the underlying cause of Alzheimer's rather than just the symptoms.

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

A Paralyzed Florida Surfer Finds His Own 'Perfect Wave'

Wed, 08/31/2016 - 5:00am

It took a team of delighted friends and family to help Florida engineer Matt Bellina (center) get back on his surfboard this summer after his severe spinal injury. The result? "I feel like I'm home," Bellina said.

Courtesy of Diane Wehrell-Grabowski

For engineer Matt Bellina, of Cocoa Beach, Fla., riding the perfect wave was a group mission.

More than 15 friends gathered on Florida's Cocoa Beach on a Saturday morning this summer. Their task? Get 40-year-old Bellina back into the water surfing.

It wasn't easy. On Memorial Day, 2014, Bellina broke his neck, as he slid head-first down a water slide and into an inflatable wall. Bellina broke his C4 vertebra and damaged his high-cervical nerve. He's one of an estimated 17,000 Americans each year who suffer a spinal cord injury and live. Bellina can't walk, and has limited arm movement.

But, despite the odds, he wanted to surf again, and his friends wanted to help. They hoisted Bellina from a beach wheelchair to a sailboard that had been modified with a kayak seat. With four people on each side, they paddled Bellina out into the Atlantic.

Longtime friends, coworkers and family positioned themselves strategically in the water to rescue Bellina if he lost his balance and fell off the board. Though he wore a life jacket, there was an element of danger: Because of his injury, Bellina can't hold his breath for long. If he slipped, they'd have to get his head above water fast.

WMFE/ YouTube

And that's exactly what happened on the first wave. As Bellina took off, sitting up in the kayak chair, he lost his balance and tumbled to one side — basically falling into the arms of a friend, but still getting dunked underwater.

The team quickly righted Bellina, and hoisted him up for another try. This time, the surfer tried lying flat on his back, and having his friends push him into a wave.

They let go — and it worked! Bellina was surfing again. He cruised through the water, grinning from ear to ear, as his crowd of friends cheered. He caught two more rides before taking a break.

Back on the sand, Bellina was hoisted back in the wheel chair and took a sip of fresh water. How did he feel?

"So good, so good," he said, with a smile. "That was killer."

Bellina lives in a condo on the beach, but being in the water is something else.

"I feel like I'm home," he said. "I've grown up here, but I've lived in several different places. And being in the ocean has always felt like returning to home. That's what it feels like. It feels like I finally get to be myself, even if for a few seconds."

Research evidence shows that physical activity comes with a host of benefits for those with spinal cord injuries, said Dr. Santhosh Thomas at the Cleveland Clinic Center for Spine Health. And as Bellina's experience demonstrates, the benefits go beyond any physical gains.

"It's always good to get ... people back to near-normal activities that they enjoy, Thomas said, adding that "with quadriplegia you need a pretty good support system to get to that level."

Physical pain from the injury can be treated, Thomas said. But emotional wounds can be harder to handle.

"A lot of young adults who are the victims of these spinal cord injuries are devastated," Thomas said. "And getting them back into activities they enjoyed before the injury almost certainly has positive effects."

It can build friendships, he said, and help with cardiac conditioning, prevent bone loss, boost energy and help with self-image. Regaining some physical mastery can help with the anxiety and depression that are common after spinal cord injuries.

Tracy Farrell, executive vice president for physical health and wellness at the Wounded Warrior project, said the joy that Bellina experienced in getting back on the water is the sort of thing she sees all the time among injured veterans who engage in adaptive sports.

"You can look at studies that say physical health and physical wellness impacts depression, impacts PTSD, impacts cognitive abilities," she said. "So any way we can get individuals moving again after an injury, the better their overall emotional health."

Being able to return to a much-loved activity can be motivating — and transforming — in other ways, too, she said.

"When people get struck into the mindset of 'this is what the rest of my life will look like,' if you can challenge them to attain some sort of physical mobility again, many will strive and reach that challenge," Farrell said. "And the water is a happy place for many."

Science reporters at NPR have been exploring all sorts of waves this summer — from gravitational to seismic and more. You can find all our favorites here.

Copyright 2016 WMFE-FM. To see more, visit WMFE-FM.
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In Philadelphia, Neighbors Learn How To Keep Shooting Victims Alive

Tue, 08/30/2016 - 3:46pm
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August 30, 20163:46 PM ET Heard on All Things Considered

From

Amanda McMacken, a registered nurse at Temple University Hospital, shows North Philadelphia residents how to slow bleeding in trauma victims.

Kimberly Paynter/WHYY

When a young African-American man dies in the city of Philadelphia, more than half the time there's one main reason why, says Scott Charles.

"It's because somebody pointed a gun at him and pulled that trigger. It's not because of cancer; it's not because of car accidents; it's not because of house fires. It's because somebody pointed a trigger," he says.

Charles is trauma outreach coordinator at Temple University Hospital. The medical center now offers bystander first-aid training, called Fighting Chance, to give friends and family something to do in the minutes before help arrives.

At 6 o'clock one evening, kids run around while their parents and neighbors gather in an elementary school cafeteria. There are training stations set up, and at the back a nurse is showing people how stop blood flow from a gunshot wound.

"The pressure point is located on the inside of the arm," he explains. "And basically, you're going to take your hand and get up underneath the inside of the arm and clamp it down."

Each person takes a turn, taking an old towel or T-shirt and wrapping it around the fake bloody arm tight until help arrives.

Registered nurse Danielle Vetter demonstrates use of a tourniquet.

Kimberly Paynter/WHYY

Everyone's talking, but emergency medicine doctor Tim Bryan's voice is the loudest. He's a Navy veteran, a former combat medic, and he's used to giving commands. A shooting scene is chaotic and frightening, but Bryan says in just two hours of training, people get enough of the basics so they will know how to respond.

"You have that 'aha' moment and people are like, 'Wow, I can do this. I can control the scene. I can remember to call 911 and tell the person to put direct pressure on even if I don't do anything else.' And it does make a difference," he says.

The topic is serious, but the mood isn't. Alice Kellam, 63, wears a camouflage tracksuit and rhinestone hoop earrings. She's chatty and laughs with friends all evening — except when she talks about her husband, who was murdered in 1990. She doesn't have a lot to say about that, except that it was senseless.

"They took his sneaks and his hat. That was it," she says.

Many people in this North Philadelphia neighborhood have a story about someone and remember a moment when they felt helpless.

Louise Smith ("Everybody calls me Miss Midge," she says) is a perpetual volunteer, and at the big summer block party at 12th and Cambria, she's the lady who hands out the flavored water ice.

"About a year ago, we seen a shooting around here," she says. "It was a shame the two boys died right on the sidewalk, there wasn't nobody there to help them."

A severely injured person can bleed to death in less than 10 minutes. But it can take much longer for police to arrive and calm the situation, so the trainers teach the class how to move a victim away from danger and flying bullets.

Registered nurse Maureen Quigg explains how to do a two-person lift-and-carry.

"The knee closest to the victim is down and the other knee is up, and that's what you stand up with, the power from your legs and not your back," she says.

Quigg reassures the smaller women that they indeed can help a 200-pound person.

"If it's someone you care about or in a situation where there's a lot of activity your adrenaline is going — you have all this extra energy, you have all this extra power," she says. "And if you focus on doing it and doing it the right way, you can lift someone you'd never think you could lift, and you can do it without hurting yourself."

Advocates say learning first-aid skills to stop bleeding is the essential step in bystander education, not unlike learning CPR or making sure a defibrillator is nearby to jump-start someone's heart. The federal Department of Homeland Security provides an introduction to these lifesaving techniques online in its Stop The Bleed program.

Neighbors learn how to move gunshot victims safely. Temple emergency department nurse Oscar Hankinson, Jr., acts as the victim, while emergency department nurse Kayne Puchon looks on.

Kimberly Paynter/WHYY

At the end of the evening, the trainers stage a minidrama to test the group.

Bryan sets the chaotic scene and calls out directions. One person is the victim. There's a pretend shooter.

"Remember, you can ask somebody: 'Help me control the scene.' That's good," he calls out.

Charles helped develop the first-aid education program after a local resident came to him to complain that he was sick and tired of hearing about young men who died before getting to the ER.

"As we wait for laws to be changed, many people are going to find themselves on the wrong end of a gun," Charles says. "While those things are certainly important, we have to put the power in people's hands to address this issue."

The goal is to saturate one neighborhood with people who have basic lifesaving skills. About 250 people have been trained so far.

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


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