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A Fix For Gender-Bias In Animal Research Could Help Humans

NPR Health Blog - 5 hours 5 min ago
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There's been a male tilt to biomedical research for a long time.

The National Institutes of Health is trying to change that and is looking to bring gender balance all the way down to the earliest stages of research. As a condition of NIH funding, researchers will now have to include female and male animals in their biomedical studies.

As late as the 1990s, researchers worried that testing drugs in women who could be pregnant or become pregnant might lead to birth defects, so experimental drugs were mainly tested in men. Research in animals followed the same pattern.

"There was not the understanding that it really isn't scientifically appropriate to study men and apply your findings to women. We just didn't know that back then," says Dr. Janine Clayton, director of the Office of Research on Women's Health at the NIH.

When the drugs this way finally went to market and women took them, sometimes things went wrong. To try to fix the problem, the NIH and Congress required that women and men be included in research involving human subjects.

Now, there are more women than men participating in clinical trials, at least in studies funded by the NIH. But there's still a mystery: Why do women still report many more bad reactions to medications than men do?

"Men and women respond to medications differently. In fact, one study looked at the drugs that have been taken off the market and 8 of the 10 drugs taken off the market in that particular time period had more severe effects in women," says Clayton.

She thinks the problems that women experience when they take medications could stem from how biomedical research is conducted at the earliest stages – in animals.

"Eighty percent of drug studies that are done in mice are done in male mice," says Clayton.

Studies in mice are important because the results often inform what will be tested in humans.

It's not as if people are ignoring female animals because they're chauvinists. Some researchers say females have been excluded from studies because their hormone cycles can confound the experiments, though the actual variability that the estrus cycle introduces is debatable.

And in some cases, research has been skewed the other way. Male animals are sometimes excluded from studies because they fight with each other, which can complicate results, and because the males sometimes have to be caged separately, which can drive up costs in cash-strapped labs.

In other cases, studies are done on both male and female animals, but the data on each sex don't get reported separately.

All in all, Clayton says, researchers are missing indicators early on about how different bodies would respond to medications. "We're learning late," she says. "That's not the best way to do this. We need to study both sexes throughout the entire research spectrum."

So, Clayton and her colleagues drew up a policy starting Jan. 25 that applies to NIH-funded biomedical research starting January 25 on out involving animals with spines. "We're asking scientists to think about sex, to study both male and female animals in their preclinical research so that we can learn more about both male and female biology," says Clayton.

When the policy was first announced, people were pumped about it, says Sarah Richardson, a professor at Harvard who studies the history and philosophy of science. "People were like 'Absolutely, that's terrible. Why aren't they studying female mice?' That was my response, too," she says. "It was seen as just a straightforward obvious corrective that we have to do."

But she and other researchers maintain that if the goal is to address women's health inequities, the policy on animal research isn't likely to be effective by itself. Mice aren't people. Richardson also says the focus on animals could distract scientists from the big picture: what happens in real living humans.

"Women on average, in North America at least, take more prescription drugs than men do," she says. "Women also go to the doctor more. We all know this — we cannot get the men in our lives to go to the doctor. They are also for whatever reason more likely to be sensitive to and prone to report feelings of discomfort," she says. "So, what we thought when we reviewed this literature is, OK, if the NIH is really wanting to address this, we need tons more studies of just those kinds of factors," says Richardson.

The NIH put $10 million toward helping labs add sex and gender to their projects. But if they want to figure out health differences between men and women, Richardson says, they need to also put money towards understanding what drives differences in human behavior.

It's not always simple to account for sex and gender in research projects, says Stacey Ritz, an immunologist at McMaster University in Canada who wrote a guide on how to do so. "I've really struggled with it for many years," she says.

She says in most cases it's pretty straightforward to do a male-female comparison. But there's a danger in assuming that a difference noticed between male and female animals stems from a difference in their basic biology, rather than because of something else, like how the male animals might have been housed alone while the female animals were housed in groups.

"That's one of the things that concern me," says Ritz. "A lot of times the questions around social dynamics and gender get glossed over and it's assumed — especially with animals — that differences you see between male and female are purely biologically driven," says Ritz.

Neurologist Rhonda Voskuhl, at UCLA, agrees that mice aren't going to reveal all the intricacies of why human men and women can have different health outcomes. "There's no perfect model for the human except for the human," says Voskuhl.

But in many cases, she says, animal studies can uncover important findings that can make a difference for people.

Voskuhl has seen that firsthand. She directs UCLA's research program on multiple sclerosis. She says for quite a while, researchers didn't report the sex of animals they studied, though many studied mainly male rats. When they started looking more closely at female animals, they realized the disease progressed differently in them.

That knowledge has led to findings about how to treat multiple sclerosis in women, including the idea that a pregnancy hormone could relieve symptoms, an approach that's in clinical trials.

"The point of the story is, you may not think there's anything there until you study it," says Voskuhl.

She says research on animals and humans goes hand in hand. If researchers study and report data for both sexes, that may well dredge up new treatment possibilities in people.

A similar case came up in Jeff Mogil's work studying pain at McGill University in Canada. He says a few decades ago, people primarily studied male animals, which they'd order from a company. The lab he worked in studied both.

"And because of that I've been in a position to see sex differences where other people in my field haven't simply because they never had female mice lying around," says Mogil.

By studying both sexes, Mogil and his colleagues found that different cells communicate pain in female and male animals. "They experienced pain in the exact same way and to exactly the same degree, but the pain is produced and modulated using different circuits," Mogil says.

If the same is true in people, that difference could have big implications for a class of painkillers meant to work by blocking the cells that are more active in men. "The prediction would be those drugs simply won't work at all in women. It's not that they'll work better in women and worse in men. It's that they won't work in women period," he says.

And, he says, if people running clinical trials on that drug didn't know that it only worked in men, they might look at the trial data, see that it only worked in half the participants, and just ditch it entirely.

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

Zika Virus: What Happened When

NPR Health Blog - 12 hours 34 min ago

A lab worker exposes his arm to Aedes aegypti mosquitoes, which transmit Zika virus, during testing in the lab at Roosevelt Hospital in Guatemala City, Guatemala.

Saul Martinez/Bloomberg via Getty Images

Since it was first discovered in Uganda in 1947, Zika virus was known mostly as a short-lived and mild illness. In 2015, that all changed. An outbreak in Brazil is suspected of causing cases of a serious birth defect, microcephaly, and a potentially crippling disease, Guillain-Barre syndrome.

As the mosquito-borne illness spreads across the Americas, scientists are trying to figure out what illnesses the virus is truly responsible for and why more people are getting sick.

We've put together a timeline to track the global response to Zika virus and scientists' understanding of how it affects people, with the most recent events at the top. (Find NPR's ongoing coverage here.) Check back, as we're regularly updating this list.

Copyright 2016 NPR. To see more, visit NPR.
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Virus Profilers Race To Figure Out What Makes Zika Tick

NPR Health Blog - Tue, 02/09/2016 - 5:17pm
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While some scientists seek ways to stop the spread of Zika by mosquitoes, others have received new funding from the National Institutes of Health to track the genes and habits of the virus itself.

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When Carolyn Coyne's lab at the University of Pittsburgh recently tried to order a sample of Zika virus from a major laboratory supplier, they were told it was out of stock.

"They are actually back-ordered until July for the virus," Coyne says. "At least that's what we were told." She ended up obtaining Zika from another source, and it arrived at her lab Tuesday.

She's just one of a growing number of lab researchers who are racing to investigate Zika virus in the wake of reports that it may be linked to some cases of microcephaly, the birth defect that leaves babies with small heads and brains.

Zika virus was discovered back in 1947, but until recently, almost no one studied it. If you type "Zika" into a searchable database of grants from the National Institutes of Health, just one name pops up: Scott Weaver of the University of Texas Medical Branch in Galveston.

"I've been really working on Zika for a long time because in Africa it circulates with three other viruses that, until recently, were considered a lot more important," Weaver tells NPR.

He says really, though, those other viruses were his focus — his lab did very little with Zika, which was thought to cause a mild illness, if any. But everything changed last fall, when Weaver went to a conference and heard the shocking news that Zika might be linked to microcephaly.

"Most of our work now is on Zika," Weaver says. "We really shifted dramatically and ramped up our efforts."

His university has a collection of mosquito-borne viruses that it provides to other labs, on request — and he says requests for Zika are pouring in.

Scott Weaver, of the University of Texas Medical Branch, was one of only a few scientists studying Zika before the latest outbreak in Latin America.

Courtesy of University of Texas Medical Branch

"Probably a year ago, for Zika we would have gotten one or two requests in a whole year," says Weaver. "Now we're getting several each day." Every week, he and his colleagues have been shipping out dozens of Zika samples to labs around the world.

What's more, government officials have been reaching out to virologists who study pathogens that are closely related to Zika, offering extra funding and support for any work on Zika, says Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases.

Fauci explains they can do this by just supplementing researchers' existing grants. "There's a limited amount of money that you can do on a supplement," says Fauci, "but enough to get people started quickly."

One of the scientists contacted by the NIH is Dr. Michael Diamond, an infectious disease specialist at Washington University in St. Louis.

"This is one of the few times that I have been an investigator when the NIH has called me," says Diamond, noting that it usually works the other way around.

"We need vaccines, we need therapies, we need diagnostics," says Diamond. "We need to know how this virus works."

In addition to trying to create Zika-specific antibodies that could be used for better diagnostic tests or even potentially as a treatment, his lab has been trying to find a way to recreate in a lab animal the same signs and symptoms the virus produces in humans.

"There really hadn't been any work done in about 40 years on Zika virus in animals," says Diamond.

This story is part of NPR's ongoing coverage of Zika virus.

Typically, adult mice don't get sick from Zika, he says, but he and his colleagues are trying it in different kinds of mice, using different viral strains in different doses.

Scientists also have been looking at the Zika virus itself — to see if it has mutated in any way that could explain this large, unusual outbreak among people.

"The thing about working with Zika virus is that almost everything is a big unknown," says Helen Lazear, who studies Zika at the University of North Carolina at Chapel Hill.

Scientists in Brazil have sequenced the genes of Zika viruses circulating there, she says, so that they can be compared to Zika viruses collected earlier around the world.

"There are some differences in the sequence between the viruses," Lazear says, "but we don't know if that's just a chance variation in the sequence, or if this is something that impacts disease. We're working on having the systems in place to test that."

And then, of course, there's the big scientific question everyone wants answered: What exactly is the link between Zika and birth defects? After all, that's the main driver of all this attention and concern.

Epidemiologists in Brazil are still trying to nail down the nature of that link and consider other factors that might be involved, but lab researchers are on the case, too.

"This is one of those situations that we feel intrigued by the science, of course, but we really feel we have here a moral obligation to act as rapidly as possible," says Dr. Yoel Sadovsky, a physician-researcher at the Magee-Womens Research Institute in Pittsburgh.

Along with Coyne, he studies cells in the placenta that normally act as a first line of defense to protect the fetus from viruses in the mother's blood. The researchers want to study how those cells react to Zika.

They'll also explore the relationship between Zika and a closely related virus, dengue, which is common in Brazil, says Coyne. "It's possible that the pre-exposure to dengue virus in some way may alter the ability of Zika virus to infect these women and/or cross the placenta," she says.

Coyne is not the only one wondering what role, if any, dengue may play in these unusual manifestations of a Zika infection.

Doctors already know, Diamond says, that a person who has been infected with one dengue strain can later have a much more severe form of the disease if they get a second infection with a related, but not identical strain of dengue.

"Zika is actually not that far away from dengue in the genetic scheme of things" he says. "So the concept that immunity to Zika might influence dengue, or that immunity to dengue might influence Zika is certainly a possibility."

He says it's already clear that there are a lot of antibodies in dengue patients that cross-react to Zika, which can complicate the diagnosis with standard tests.

"Do those antibodies actually do anything?" he says. "We don't know."

Scientists are designing the lab experiments that could answer those questions, but Diamond says there's just no way to say how long it's going to take.

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

Why Is It So Hard To Test Whether Drivers Are Stoned?

NPR Health Blog - Tue, 02/09/2016 - 12:27pm

The psychoactive ingredient in marijuana is a fat-soluble compound called THC.

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Law enforcement officials would love to have a clear way to tell when a driver is too drugged to drive. But the decades of experience the country has in setting limits for alcohol have turned out to be rather useless so far because the mind-altering compound in cannabis, THC, dissolves in fat, whereas alcohol dissolves in water.

And that changes everything. "It's really difficult to document drugged driving in a relevant way," says Margaret Haney, a neurobiologist at Columbia University, "[because of] the simple fact that THC is fat soluble. That makes it absorbed in a very different way and much more difficult to relate behavior to, say, [blood] levels of THC or develop a breathalyzer."

When you drink, alcohol spreads through your saliva and breath. It evenly saturates your lungs and blood. Measuring the volume of alcohol in one part of your body can predictably tell you how much is in any other part of your body — like how much is affecting your brain at any given time.

That made it possible to do the science on alcohol and crash risk back in the mid-20th century. Eventually, decades of study helped formulate the 0.08 blood alcohol limit as too drunk to drive safely. "The 0.08 standard in alcohol is from decades of careful epidemiological research," says Andrea Roth, a professor of law at the University of California, Berkeley.

But marijuana isn't like that. The height of your intoxication isn't at the moment when blood THC levels peak, and the high doesn't rise and fall uniformly based on how much THC leaves and enters your bodily fluids, says Marilyn Huestis, who headed the chemistry and drug metabolism section at the National Institute on Drug Abuse.

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Because THC is fat soluble, it moves readily from water environments, like blood, to fatty environments. Fatty tissues act like sponges for the THC, Huestis says. "And the brain is a very fatty tissue. It's been proven you can still measure THC in the brain even if it's no longer measurable in the blood."

From her research, Huestis found that THC rapidly clears out of the blood in occasional users within a couple of hours. While they're still high, a trickle of THC leaches out of their brains and other fatty tissues back into the blood until it's all gone.

That means a lab test would only find a trace amount of THC in the blood of occasional smokers after a few hours. "You could have smoked a good amount, just waited two hours, still be pretty intoxicated and yet pass the drug test [for driving]," says Haney.

And if you eat the weed instead of smoking it, Haney says, your blood never carries that much THC. "With oral THC, it takes several hours for [blood THC] to peak, but it remains very low compared to the smoked route, even though they're very high. It's a hundredfold difference," she says.

But daily users are different. Huestis says that heavy smokers build up so much THC in their body fat that it could continue leaching out for weeks after they last smoked. These chronic, frequent users will also experience a rapid loss of THC from their blood after smoking, but they will also have a constant, moderate level of blood THC even when they're not high, Huestis says.

It gets trickier when you try to factor in the chronic effect of smoking weed, Huestis says. "We found [chronic, frequent smokers'] brains had changed and reduced the density of cannabinoid receptors," she says. They were cognitively impaired for up to 28 days after their last use, and their driving might also still be impaired for that long. "It's pretty scary," she says.

The attitude difference between stoned drivers and alcohol drivers seems clear, Huestis says. Pot smokers, she says, "tend to be more aware they're impaired than alcohol users." Drunk drivers are more aggressive, and high drivers are slower. But in her studies, she found that being blazed enough, as when a smoker's blood THC level peaks at 13 nanograms per milliliter, could be just as a dangerous as driving drunk. The marijuana advocacy group NORML emphasizes that driving high can be dangerous, and advises people to drive sober.

This all translates into a colossal headache for researchers and lawmakers alike. While scientists continue to bang their heads over how to draw up a biological measurement for marijuana intoxication, legislators want a way to quickly identify and penalize people who are too high to drive.

The instinct, Huestis says, is to come up with a law that parallels the 0.08 BAC standard for alcohol. "Everyone is looking for one number," she says. "And it's almost impossible to come up with one number. Occasional users can be very impaired at one microgram per liter, and chronic, frequent smokers will be over one microgram per liter maybe for weeks."

The shaky science around relating blood THC to driving impairment is unfair for people living in marijuana-legal states that have absolute blood THC limits for driving, says Andrea Roth, a professor of law at the University of California, Berkeley.

In states like Washington, if a driver is found to have over 5 nanograms of THC per milliliter in their blood, they automatically get a DUI-cannabis. "If we are going to criminalize DUI marijuana, we need to take information from scientific studies and use it to decide if that risk is sufficiently high to be so morally blameworthy that we call it a crime. But we don't, so picking 5 nanograms per milliliter is arbitrary," Roth says.

The complicated biology of THC makes current DUI cases very tricky.

"Blood isn't taken in the U.S. until 1.5 to four hours after the [traffic] incident," Huestis says. By then, THC levels would have fallen significantly, and these people might have been impaired but passed the test. At the same time, a heavy user living in a state like Washington would get a DUI even if she or he hadn't smoked in weeks.

As a result, it gets difficult to even understand how risky blazed driving is. Traffic studies that rely on blood THC measures could also be inaccurate if blood is drawn too late and THC has already left the system. And some state traffic databases, including Colorado's, according to state traffic officials, link accidents to 11-nor-9-carboxy-THC, a byproduct of marijuana metabolism that marks only recent exposure and not intoxication. That might result in an overestimation of marijuana-related accidents.

In the meantime, Haney says, the challenge shouldn't deter people from trying to find a marijuana DUI solution. People are working on breath tests, saliva, other blood markers and behavioral tests, just nothing that so far has stuck, she says. "We need something, because it's an important public health issue. But how we're going to get there? I just don't know."

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

How 401(k) Withdrawals Can Complicate Health Plan Subsidies

NPR Health Blog - Tue, 02/09/2016 - 11:32am

The IRS could be right behind you.

Oivind Hovland/Ikon Images/Corbis

There's never a shortage of questions about the twists and turns of health coverage. Here are answers to recent questions from readers about premium tax credit repayments for marketplace plans, out-of-network emergency care and nursing home bills.

While doing my taxes I discovered that I made more money in 2015 than I anticipated. I was forced to take money out of my 401(k) to make ends meet during the year and that raised my income level. Now I face having to pay back $1,500 for premium tax credits I received to subsidize my marketplace plan's premiums. What am I supposed to do?

It's not uncommon for people to fail to count one-time income bumps from retirement savings or other sources when they're estimating their annual income to qualify for advance premium tax credits for marketplace coverage, said Tara Straw, a senior policy analyst at the Center on Budget and Policy Priorities.

In the case of retirement savings, "they're not thinking of it as income because it's their own money," she said. But since retirement money is generally deposited on a pretax basis, it counts as income when it's withdrawn and can affect how much people qualify for in premium tax credits.

It's important to go back to the marketplace and report any income changes, including one-time changes, as soon as they occur to minimize repayment problems down the road, Straw said.

About half of people who received advance premium tax credits in 2014 got too much, the Internal Revenue Service reported, based on the tax forms people filed to reconcile how much they received against how much they should have gotten.

The amount that people have to repay is capped for those whose income is less than 400 percent of the federal poverty level (about $47,000 for one person).

"The repayment caps are really helpful in cases like this when something unexpected occurs or where an error was made," Straw said. However, taxpayers can still be on the hook for significant amounts, up to $1,250 for single taxpayers and $2,500 for couples and families, she said.

If you can't pay what you owe right away, the IRS will allow you to pay in installments, but there may be additional fees and interest charges.

I had an incident where a big metal trash can lid fell on my hand. I thought it was broken. I went to the nearest hospital emergency room, and they took an X-ray. I just had a bad bruise. They sent me home, and later I got a bill of more than $800. My insurance company had covered some of the costs but I was responsible for the rest because I was "out of network"! How can this happen with emergency care?

Federal law prohibits emergency departments from turning anyone away, but that doesn't mean your insurer will pick up the whole tab for your care, especially if the hospital isn't in your insurance network.

The health law helps prevent you from getting stuck with a big bill for out-of-network emergency care by prohibiting insurers from charging you higher copays or coinsurance for care received at an out-of-network emergency department than the rates you would pay for in-network emergency care.

But the law doesn't prohibit hospitals and doctors from billing patients for amounts that the insurer doesn't pay. These "balance bills" are not uncommon when people get out-of-network care because there's no contract in place that spells out how much the providers agree to accept as payment in full from the insurer.

If that's the case, you can ask the hospital to accept the amount that it's already been paid by the insurer as payment in full, said Dr. Jeffrey Bettinger, chair of the task force on alternative payment models at the American College of Emergency Physicians.

"Many hospitals or provider groups will make an allowance for something like that," Bettinger said.

That may not solve your problem, however. If your plan has a big deductible that you haven't met for the year, you may still have to pay up to that out of pocket.

"Whether it's in network or out of network, if you have a $3,000 deductible you may have to pay that bill," Bettinger said.

Should we receive a detailed list of services from our nursing home when we receive our bill each month? Or should we accept the flat fee we are charged without any itemized listing?

Private-pay nursing home patients typically pay a monthly charge, and if something is required outside that charge the resident may get an itemized bill, said Judi Lund Person, vice president for regulatory matters and compliance at the National Hospice And Palliative Care Organization.

If the nursing home charges a flat fee and you're unclear whether it includes ancillary services and equipment such as walkers or oxygen, check the agreement that you signed when you placed your parent or loved one in the facility, said Gary Kelso, president and CEO of Mission Health Services, a chain of eight nonprofit nursing homes in Utah and Wyoming. It should be spelled out there.

"Everyone signs an agreement that has a list of things that are included and those that are excluded," Kelso said.

If the facility provides an all-inclusive bill, you may not be able to get a break-out of specific services or supplies, Kelso said, because the nursing home may not track those items individually.

Kaiser Health News is an editorially independent news service that is part of the nonpartisan Henry J. Kaiser Family Foundation. Email questions for future columns: KHNHelp@KFF.org. Michelle Andrews is on Twitter: @mandrews110.

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

Farm Contractors Balk At Obamacare Requirements

NPR Health Blog - Tue, 02/09/2016 - 7:22am
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Contractors who supply workers to farmers say requirements of the Affordable Care Act and the immigration status of many of the workers create a Catch-22.

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Obamacare is putting the agricultural industry in a tizzy.

Many contractors who provide farm labor and must now offer workers health insurance are complaining loudly about the cost in their already low-margin business.

Some are also concerned that the forms they must file with the federal government under the Affordable Care Act will bring immigration problems to the fore. About half of the farm labor workforce in the U.S. is undocumented.

"There's definitely going to be some repercussions to it," says Jesse Sandoval, a farm labor contractor based in Stockton, Calif. "I think there's going to be some things that cannot be ignored."

Sandoval came to an educational conference for farm labor contractors — essentially staffing agencies for field workers — held at the San Joaquin County Agricultural Center in Stockton in the fall. Men with broad shoulders, wearing denim jackets and cowboy hats, sat in the audience, listening to lectures on a litany of laws and rules regulating their industry, including Obamacare's employer mandate.

Last year, employers with 100 or more full-time employees had to offer health insurance to their workers or pay a stiff penalty. This year, employers with 50 to 99 full-time employees must comply.

Sandoval has about 100 workers on his payroll. When farmers need a crew to pick cherries, pumpkins or asparagus, they call him to send the workers. He has to offer them insurance this year, and he's smarting over the price tag. At $300 a month per employee, he's looking at a $30,000 monthly bill.

Sandoval says he can't absorb the hit. "The numbers aren't there," he says. "My margin is 10 percent, and I have to increase expenses 10 percent? Well, that doesn't work."

So, like a lot of contractors, he's passing the bill on to the farmers, who in turn are passing the bill on to the farm workers. Under the Affordable Care Act, employees can be asked to contribute 9.5 percent of their income toward health premiums.

But for farm workers who pick oranges or peaches for $10 an hour, that's still too much. Agostin Garcia of Fresno, Calif., says the two contractors he works for near Fresno, Calif., offered him insurance directly. But when he saw the price tag, he turned them both down.

"For me, I'm the only one in my house who works," he says. "There's five of us in the family. It just wouldn't work. Either I pay for health insurance, or I pay the rent and utilities."

Garcia says only a fraction of his co-workers have signed up for coverage. He says when farm labor contractors hand out packets explaining the coverage, the page where workers reject it is right on top.

"I think they do it intentionally," Garcia says. "They comply with the laws by saying, 'I offered.' But they know that nobody's going to accept it, they know that nobody's going to pay those amounts."

The cost isn't the only thing about Obamacare stressing people out in the ag industry. Some are worried about immigration problems. Employers have to file new health care forms with the IRS for all their workers, whether or not they accept the insurance.

Attorney Kaya Bromley says this will make it harder for some contractors to turn a blind eye when workers give them fraudulent documents. "Now that there's more transparency because of all of the reporting, I think we're going to have a lot more data on how many illegal or undocumented workers we have," she says.

Bromley says among the contractors for whom she consults, she has seen a range of quasi-legal and even illegal strategies to sidestep the health law.

"I have heard of employees who are choosing to opt out because they want to fly under the radar. I have also heard of employers who are urging the opt-out or at least encouraging it," she says. "And I warn all of them that they are going to be in big trouble."

Farm labor contractors say they're stuck in a Catch-22. Technically, immigrants who are in the U.S. illegally aren't eligible for Obamacare benefits. But employers can't admit that any of their employees may be working illegally, so they have to offer the insurance or face stiff fines from the IRS, maybe even a discrimination claim.

"It's huge. And no one's talking about the enormity of it," Bromley says. "When it plays out, and the penalties start getting assessed, that's when people will start having religion about it."

Golinda Vela Chavez helps run a contracting company in Salinas, Calif. For her, talk of Obamacare mainly brings up frustration with the country's complicated immigration system. She says the U.S. doesn't enforce the borders, but then doesn't let people work. "And suddenly the employer is evil," she says.

Contractors wonder how they're supposed to comply with the health care law when there's still so much contradiction in the immigration system. "Our government, all they do is talk about it, they don't fix anything, they make everything worse," says Chavez.

The Affordable Care Act is a cookie cutter, she says, and the complexities of the farming industry just don't fit.

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

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

Sorry, Bogie, A Sigh Is Not Just A Sigh

NPR Health Blog - Mon, 02/08/2016 - 7:46pm

Emotion seemed to fuel plenty of sighs by Humphrey Bogart's character Rick (right) in the 1942 film classic Casablanca, and even Rick's good friend Sam, played by actor Dooley Wilson, couldn't console him.

Archive Photos/Getty Images

The sighs we notice usually accompany emotions like relief or discontent. But our brains are programmed to make us heave an unconscious sigh every five minutes or so — no matter how we feel.

"Sighing is vital to maintain lung function," says Jack Feldman, a brain scientist at UCLA. These periodic deep breaths reinflate tiny air sacs in the lungs that have gone flat. But the brain circuitry behind those reflexive sighs has been a mystery.

Now there's strong evidence from studies in rats that the neural wiring resides in a particular part of the brain stem that regulates breathing, Feldman and a team of researchers report in this week's issue of the journal Nature.

"We identified a very compact circuit consisting of about 400 neurons," Feldman says.

A few years ago, Feldman's lab showed that a substance called bombesin could increase sighing in rodents.

"Rats normally sigh about 40 times an hour," Feldman says. After bombesin was injected into the brain area that controls breathing rhythm, he says, "the sigh rate went to 400 times an hour, while the basic breathing pattern didn't change."

But it still wasn't clear precisely which cells in the brain were responding to bombesin. To find out, Feldman's lab teamed up with a lab at Stanford run by Mark Krasnow, a professor of biochemistry and investigator for the Howard Hughes Medical Institute.

Together, the researchers identified two clusters of cells in the brain stem that responded to bombesin. Each cluster consisted of about 200 brain cells. And each cluster responded to a different form of bombesin.

When the researchers blocked one form of bombesin in rats, the animals began to sigh half as often. And when the scientists blocked both forms, the rats didn't sigh at all.

It's pretty clear that a similar circuit controls sighing in people, Feldman says. And that means it might be possible to treat some human problems by inducing or suppressing sighs, he says.

People with anxiety disorders, for example, may sigh so often that it interferes with their lives. And people who have difficulty taking deep breaths on their own because of conditions such as heart failure or obesity might benefit from more sighing.

Of course, scientists still don't understand why certain emotions trigger sighing.

"It could be a way of communicating nonverbally," Feldman says. Another possibility is that it's a reflex that helps us calm down. That may be why we tell people who are tense to "just relax; take a deep breath," he says.

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

Scientists Discover A Second Bacterium That Causes Lyme Disease

NPR Health Blog - Mon, 02/08/2016 - 5:40pm

Until very recently it was thought that just one bacterium was to blame for causing Lyme disease in humans. But it turns out that a second, related bug can cause it too.

In 2013, during routine testing of bacterial DNA floating around in the blood samples of people suspected of having Lyme disease, researchers at the Mayo Clinic in Rochester, Minn., realized they were looking at something different.

"We detected this result which was positive, but it was clearly different from what we would have expected for Borrelia burgdorferi, which at that time was the only known cause of Lyme disease in the U.S.," says Dr. Bobbi Pritt, a microbiologist at the Mayo Clinic.

When they sequenced the genome of the bacterium, they realized it was different enough to be considered a new species. It's been dubbed Borrelia mayonii, after the Mayo Clinic. News of the new species was published this month in the journal The Lancet Infectious Diseases.

The new species hadn't appeared during routine tests on thousands of other samples over the course of a decade. Then, over the span of two years, it appeared in six patients out of about 9,000 tested for Lyme disease. They were all residents of Minnesota, Wisconsin or North Dakota.

The patients' symptoms were a little different from the usual Lyme disease cases. Instead of the telltale bull's-eye pattern associated with B. burgdorferi, rashes on these patients were diffuse or spotty. In addition to the fever, headache, rash and neck pain that accompanies the usual form of Lyme disease, patients who had contracted the new species of bacteria also experienced nausea and vomiting.

"This organism doesn't behave completely like the Lyme disease that we all know," says Pritt.

There were other odd symptoms. A child was nearly impossible to wake up from sleep. An adult had trouble with vision, and was seeing double. Two patients were hospitalized. Pritt says all have now recovered, except for one with continued arthritis.

Because the species had not been identified in the thousands of samples that were routinely tested before 2013, Pritt says, it's likely that it either recently emerged as a new organism through mutations of an existing bacterium, or it recently came into contact with people.

"Maybe it infected woodchucks and no one ever tested them," she says. "But what we can say is, it's a species that no one has ever described before, and it's clearly infecting patients."

The bacterium was isolated alive from the blood of two patients, and was subsequently found in black-legged ticks in two parts of Wisconsin.

Both species of Lyme-causing bacteria are carried by the tick Ixodes scapularis, also known as the black-legged or deer tick, which has continued to spread its range across the U.S.

"Lots of people are encountering ticks where they didn't encounter them 20 years ago," says Rebecca Eisen, a research biologist with the Centers for Disease Control and Prevention who published the latest map of tick populations in the U.S.

"It's a living organism, so the range of the tick changes, and so the likelihood of people encountering these ticks changes," says Eisen.

This new bacterium appears to be relatively rare so far. Entomologists found that of 600 ticks collected across Wisconsin, 3 percent tested positive for the new species of bacteria. The older bacterial species is typically found in 30 to 40 percent of black-legged ticks, says Pritt.

Doxycycline is used to kill both species of bacteria. The issue, Pritt says, is for patients and physicians to recognize the slightly different constellation of symptoms associated with this form of Lyme disease, so treatment can be started promptly.

It's also unclear what is behind the higher bacterial load detected in the blood samples of patients with B. mayonii, and if it's responsible for the more severe symptoms that the six patients experienced.

"It just seems like every time you turn around, there's a new tick-borne disease. So when people go outside, I think they have to think about protecting themselves from ticks," says Pritt.

The best way to avoid picking up an infection from a tick is to avoid tick-infested areas, use repellent and remove ticks as soon as they're spotted.

Copyright 2016 NPR. To see more, visit NPR.
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When Men Get Breast Cancer, They Enter A World Of Pink

NPR Health Blog - Mon, 02/08/2016 - 4:35am
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At 46 years old, Oliver Bogler's reaction to a suspicious lump in his chest might seem typical for a man. He ignored it for three to four months, maybe longer. "I couldn't really imagine I would have this disease," Bogler says. But when he finally "grew up" and went to the doctor, he was pretty quickly diagnosed with invasive breast cancer.

Now what's interesting here is that Bogler is a cancer biologist who regularly works with cancer cells, as senior vice president of academic affairs at the University of Texas MD Anderson Cancer Center in Houston. Even so, he figured the lump was a benign swelling of breast tissue.

He had good reason to think so. Breast cancer is rare among men. Only 1 percent of all breast cancer cases are in men. Still, that means about 2,600 men receive a diagnosis of breast cancer every year.

But men typically don't think they are at risk, says Dr. Sharon Giordano, an oncologist who also works at the MD Anderson Cancer Center. "Men don't think of themselves as having breasts," Giordano says. "They don't realize that all men have some residual breast tissue." So it's not unusual to see male patients like Bogler who come to her with more advanced breast cancer than the typical female patient.

This could be one reason why men have a lower life expectancy after a breast cancer diagnosis. According to a study published in 2012, in the Annals of Surgical Oncology, men with early breast cancer had a 74 percent survival rate five years after their diagnosis compared to women, whose survival rate was 83 percent.

And men not only can get breast cancer, they can also inherit the BRCA1 and 2 genetic mutations that place them at greater risk. Like women, they can pass that mutation on to their children, who have a 50 percent chance of inheriting a parent's mutation.

Once men are diagnosed, their treatment is pretty much the same as it is for women — typically surgery to remove the cancer followed by chemotherapy, radiation and hormone suppressing medication like tamoxifen.

That was the case for Bogler, but with one big difference — he had a mastectomy. Most women choose lumpectomies followed by radiation. This is often not an option for men, Giordano says, because their tumors are most commonly right behind the nipple, where there's not a lot of breast tissue to remove.

The markings on Oliver Bogler's chest are used to guide radiation therapy.

Courtesy of David Jay Photography

Unlike women, most men don't have reconstructive surgery. That's probably because they don't even know it's an option, says Giordano. A lot of male patients would probably be interested in having nipple reconstructive surgery, Giordano says, "So when they are out swimming, or playing basketball and have their shirt off, the surgical changes aren't quite so obvious."

And because breast cancer is so much more common among women, men with the disease can experience something of a "gender misfit." Bogler wrote about his experience in a personal blog he called Entering a World of Pink. Breast cancer clinics are often decorated in lots of pink, and support systems are designed with women in mind. Giordano recalls one male patient who, after a biopsy, was given a pink floral ice pack that came with instructions to "place it inside your bra."

When Edward Smith was diagnosed about four years ago, he went online to look for information and emotional support. The first couple of chat rooms he joined were not helpful, he says, when the participants found out he was a man. "They weren't outright nasty or anything, but you could just feel that they were pulling back in terms of the conversation that was going on at the time," he says.

Eventually Smith found a site that was welcoming — Living Beyond Breast Cancer. The women in this group were helpful, compassionate and willing to talk, Smith says. This was important because he was feeling a bit uncomfortable at work. Colleagues were just "stupefied," he says, "because most people have never encountered a male who had breast cancer."

The website recently published a guide for men, which Smith found particularly helpful. The medical information isn't so different from women, says Jean Sachs, executive director of Living Beyond Breast Cancer, but the experience is very different. "It's hard to get men to talk about it," she says. The guide provides a list of men, including Smith, who are willing to talk to other men about their experience.

It's also important, Sachs says, for men who test positive for the BRACA genetic mutations to understand that they can pass those mutations on to their children, which may encourage newly diagnosed patients to get tested.

The lack of awareness, even among doctors, oncologist Giordano says, means less money for needed research to figure out how breast cancer in men differs from women especially when it comes to life saving treatment. Treatments for men are based on evidence from research trials with women. Giordano's now heading up research to better understand the biology of the disease in men and to try to figure out the most effective hormone therapy for men with breast cancer.

Copyright 2016 NPR. To see more, visit NPR.
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A Voter's Guide To The Health Law Chatter

NPR Health Blog - Sat, 02/06/2016 - 7:00am

Republican presidential hopeful Ted Cruz initially claimed his private insurance had been canceled. It turned out his insurer had transferred him to a plan with a narrow network of providers.

Andrew Burton/Getty Images

Nearly six years after its enactment, the Affordable Care Act remains a hot issue in the presidential race — in both parties.

"Our health care is a horror show," said GOP candidate Donald Trump at the Republican debate in South Carolina in December. Texas Sen. Ted Cruz, winner of the Iowa caucuses, said at the debate in Des Moines that the health law has been "a disaster," adding it's "the biggest job-killer in our country."

Democrats largely support the law, but even they can't agree on how to fix its problems. Hillary Clinton said at the Jan. 25 town hall on CNN that she wants to "build on the ACA. Get costs down, but improve it, get to 100 percent coverage."

Clinton's rival for the nomination, Vermont Sen. Bernie Sanders, acknowledged that "the Affordable Care Act has done a lot of good things" but added that "the United States today is the only major country on Earth that doesn't guarantee health care to all people as a right." Sanders is pushing a government-run "Medicare for All" plan instead.

In some cases candidates are bending the truth. But praise and criticisms of the law can be accurate. That's because the health law is so big and sweeping that it has had effects both positive and negative.

Here is a brief guide to some things the health law has — and has not — accomplished since it was signed by President Obama in 2010.

CLAIM: The law has increased the number of people with health insurance coverage.

This is true, no matter what measure you use. The Census Bureau and polling firm Gallup both found substantial drops in the percentage of people without health insurance after the majority of the law's coverage expansions took effect in 2014.

COUNTERCLAIM: There are still millions of Americans who don't have insurance.

This is also true. Even though approximately 90 percent of Americans now have insurance, that remaining 10 percent amounts to more than 30 million people.

Millions aren't eligible for coverage under the law because they're not in the U.S. legally. An additional 3 million are in the so-called Medicaid gap, meaning they would be eligible for Medicaid under the ACA except their states opted not to accept the expansion after the Supreme Court effectively ruled the expansion optional.

Still others are eligible to purchase coverage on a health insurance exchange but either can't afford it, don't think the insurance available offers a good value, or don't know they are legally required to obtain it. An estimated 7.5 million Americans paid a fine to the IRS for failing to get covered in 2014; millions more were exempt from the requirement and didn't have coverage.

In recognition of the fact that enrollment has been smaller than expected, the Congressional Budget Office recently lowered its projections for those who will buy insurance under the law from 21 million to 13 million in 2016.

CLAIM: The ACA has fixed the dysfunctional individual insurance market.

Prior to the passage of the health law, millions of people who didn't have work-based or government coverage were shut out of buying their own insurance because they had been sick or because the coverage offered did not cover the services they needed.

The law aimed to address the problems in the individual market in several ways, including requiring insurers to sell to those with pre-existing conditions at the same price as healthier people; standardizing the benefits package; and limiting the size of deductibles. Tax credits were made available to help people afford coverage. And the law created insurance exchanges intended to help consumers compare, choose, sign up and pay for health insurance.

How well these changes succeeded in stabilizing the market isn't clear. What is clear is that more people are now insured through the market.

COUNTERCLAIM: The ACA has made the individual market worse.

All is not well in the individual market. Even with help paying premiums, many moderate-income Americans are finding that their deductibles and copayments are so high they cannot afford to use their insurance.

In other cases, individuals can get insurance they can afford to use, but it doesn't include their regular doctors and hospitals. In fact, plans that do offer coverage outside the insurer's network are becoming harder to find and more expensive.

That change affected Cruz, who initially claimed his private insurance had been canceled. In fact, his insurer had stopped offering his broad-choice plan and automatically transferred him to a narrow-network product.

CLAIM: The ACA has improved the Medicare program.

While most of the law was aimed at those without insurance, lawmakers also took the opportunity to beef up some benefits for the 55 million Americans in the Medicare program.

Medicare enrollees got new coverage for preventive services and annual checkups, and those with high prescription drug expenses got help to fill the "doughnut hole" gap left by the 2003 Medicare drug program.

Over the longer term, the law created several payment experiments intended to improve the quality of care Medicare patients receive and lower costs. These include efforts to prevent patients from going back to the hospital after they've been discharged.

COUNTERCLAIM: The ACA has not saved money for Medicare.

The rate of increase in Medicare spending has slowed since the health law was passed in 2010. But it's not clear how much of that can be attributed to the law, aside from some provisions that actually cut payments to hospitals and other health providers.

And some of the most highly anticipated projects, including accountable care organizations that are paid bonuses for keeping Medicare patients healthy and lowering spending, have not so far shown very good results.

CLAIM: The ACA has killed jobs.

One of Republicans' favorite talking points — that the health law would depress employment — has turned out not to be the case.

An analysis in 2015 by the Urban Institute found that the health law "had virtually no adverse effect on labor force participation; employment; the probability of part-time work; and hours worked per week by nonelderly adults."

While there would be fewer people in the workforce owing to the law, the Congressional Budget Office found in 2014 that "almost entirely" stems from voluntary actions by workers who could quit because they no longer depended on their jobs for insurance — now they could buy it on their own.

CLAIM: The ACA has slowed overall health spending.

The White House trumpeted the fact that health spending grew at its slowest rates ever between 2010 and 2013. But health policy analysts are still engaged in a lively debate about how much of the slowdown was attributable to the recession, to the health law and to other changes in the health care system.

Meanwhile, the rate of spending has begun to accelerate again, jumping from a 2.9 percent increase in 2013 to 5.3 percent in 2014. That has occurred as millions more Americans gained access to health care through the law.

Kaiser Health News is an editorially independent news service that is part of the nonpartisan Henry J. Kaiser Family Foundation. Julie Rovner is on Twitter: @jrovner

Copyright 2016 Kaiser Health News. To see more, visit Kaiser Health News.
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Families Near The Huge Gas Leak Wonder: Is Home A Safe Place To Be?

NPR Health Blog - Fri, 02/05/2016 - 7:21pm
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December brought storm clouds to the Porter Ranch neighborhood in Southern California's San Fernando Valley.

David McNew/AFP/Getty Images

A major natural gas storage well in Southern California is still leaking, though less so than back in late October, when the giant gas leak was first reported. More than 5,000 families and two schools have been relocated since then, and the local utility that operates the facility is now facing several legal actions.

The utility, Southern California Gas Co., now says the leak should be sealed by the end of the month, if not earlier, and also says the gases released will cause no long-term health effects. But some people who live near the leak worry that not enough research has been done to make that claim.

Christine Katz, for example, who has a home in Porter Ranch, a few miles downwind from the leak, remembers first smelling the gas in early October.

The Two-Way Calif. Official Says Leaking Gas Well Might Be Sealed As Soon As Next Week

"It would start off early in the morning, and then it would kind of dissipate," she says. "Then it continued on each day." She asked her husband if he might have accidentally left their barbecue on. He hadn't.

A couple weeks later, Katz's two-year-old daughter, Ava, got a cough and started wheezing. A doctor put her on an inhaler. That was still before the neighborhood was notified of the gas leak.

In November, Ava got sick again, this time for two weeks. She was extremely lethargic, Katz says — falling asleep in her high chair, or while playing on the grass. Katz's four other kids began having headaches and nosebleeds. Then, one day, Ava developed a high fever, and then had a seizure.

"She was rushed to the hospital, and they couldn't figure out what was wrong with her," Katz says. "So they transported her to Children's Hospital [Los Angeles] and she was in the ICU for four days."

Doctors tested Ava, but couldn't find anything wrong with her, beyond dehydration and respiratory problems, which they remedied.

California state health officials investigating the leak reported last week that "overall, the available air sample data does not indicate that an acute health hazard exists from any of the volatile organic chemicals measured," though it notes that the headaches, nausea and respiratory irritation that many residents have reported could be a response to the odorant the company adds to its natural gas supply.

Christine Katz says Ava's doctors found no evidence the gas leak was to blame for the little girl's fever or seizure. Some of her symptoms — like lethargy, wheezing, and rashes — have been commonly reported by other residents in Porter Ranch. Others, like the fever and seizure, haven't.

Still, Katz believes the gas leak was responsible for her daughter's illness.

So the family moved to a home about 30 miles away. SoCalGas, which was ordered by local officials to relocate residents who lived near the leak, has paid for three-months rent for the Katz's new house.

Porter Ranch residents lined up in December to lodge complaints and get information and help with housing at the community resource center that SoCalGas opened in the neighborhood.

Frederic J. Brown/AFP/Getty Images

Christine Katz says Ava is now fine.

"She's better and she's happy, and I'll do anything I can to keep her that way," Katz says.

Katz and her husband are now suing SoCalGas for damages, medical expenses and loss of value to their property. And she says she doesn't want to go back to their old house.

"Even though you can't see the gas, it's there," Katz says. "And that's the saddest part — people don't understand it. Because it's not a mudslide, it's not an earthquake. You just don't see the devastation, but it's there."

SoCalGas has set up a help center for local residents at a retail center in Porter Ranch. People who live within five miles of the leak can ask for relocation assistance, free air filters and air cleaning supplies.

Mike Mizrahi, a spokesman for SoCalGas, says the company brought him out of retirement to help handle public relations after the leak. Right now, he says, the utility's two priorities are to stop the leak and to serve the community.

"One of the key questions that folks continue to appropriately ask — it's one that I would ask — is, 'Is there anything I should be concerned about that might be long-term?" Mizrahi says. "And the answer is, 'No, according to public health, according to the air sampling they're doing.' "

The county health department of Los Angeles concurs that "exposures to these chemicals are generally not expected to lead to permanent or long-term health problems."

But Michael Jerrett, who heads the department of environmental health sciences at the University of California, Los Angeles, says such an assessment is "probably overly optimistic."

UCLA environmental health researcher Michael Jerrett checks one of the sensors he's placed throughout Porter Ranch. It's checking for a number of air contaminants, including benzene and hydrogen sulfide, as well as temperature and wind direction.

Becky Sullivan/NPR

Jerrett studies the effects of air quality and pollution on health. He agrees that methane — the main component of the natural gas that was leaked — is probably not harmful to people. And many of the symptoms reported, such as nausea, headaches or dizziness, can likely be traced to relatively innocuous, short-term effects of mercaptan — the smelly stuff that's added to methane so you can tell there's been a leak.

But some lesser components of natural gas have been shown to have health effects — at least at higher levels, Jerrett says. Benzene, for example, is carcinogenic, and n-hexane is a neurotoxin, he says, while hydrogen sulfide can irritate the lungs and skin.

There's been a good amount of research about the harmful effects of exposure to high amounts of benzene over a short period, like a matter of hours, Jerrett says. And there's some evidence of its effects over very long periods, such as a lifetime of occupational exposure, say. But there's not much data on exposures over a few months at levels that are higher than normal, but below what the government has deemed an acceptable standard. That's the sort of exposure, he says, that we're likely talking about with the leak at Porter Ranch.

"We're dealing with an area where, unfortunately, there's a gap in the science," Jerrett says. He says that if he were a resident of the area, he too would have relocated his family until the leak was fixed.

"And then," he tells NPR, "I would hope that there was going to be a very rigorous regulatory process that was going to be put in place to prevent this from ever happening again."

In late January, a board of the South Coast Air Quality Management District in Los Angeles ordered SoCalGas to — among other things — complete a study on the potential health effects of the leak.

In the meantime, many families from the area decided not to relocate — including Dhruv Sareen, who does stem cell research at Cedars-Sinai Medical Center in Los Angeles and lives just over a mile from the gas leak.

Sareen says he thinks the Porter Ranch gas leak has turned into a circus of lawyers and misinformation.

"As soon as that started happening — my degree being in chemical engineering and biochemistry — I started studying the numbers and the data," Sareen says. And that data didn't alarm him.

Along a public trail at the base of the large SoCalGas Aliso Canyon Storage Facility, one of the biggest natural gas storage areas in the country.

Becky Sullivan/NPR

One of his kids got sick soon after the gas leak, too, he says, but it was just the flu. He's not worried about the quality of the air.

"My parents live in New Delhi," Sareen says. "The particulate matter and the benzene levels and the sulphur compounds they are exposed to [are] probably 10 to 20 times more than here. I mean, we are breathing amazingly clean air compared to New Delhi."

There are risks to living anywhere, Sareen says.

"Should I leave my house, disrupt my life?" he asks. "Close the schools — close the preschools? And live somewhere else?" He doesn't think so.

SoCalGas says it hopes to have the leak fully stopped within the month, and will pay an additional week's rent after that for the families who did decide to relocate. After that, the utility says, residents should start moving back to the area.

But some people say they never will.

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Zika May Not Spread In Saliva Or Urine, Health Officials Say

NPR Health Blog - Fri, 02/05/2016 - 1:23pm

Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, says it's not clear whether Zika virus can spread through saliva.

Alex Brandon/AP

U.S. health experts cautioned Friday that the apparent discovery of the Zika virus in saliva and urine from people in Brazil does not necessarily mean the virus can be spread by more casual contact with infected people, such as through kissing.

"I think we need to be careful that don't we jump to any conclusions about transmissibility," Anthony Fauci, who leads the National Institute of Allergy and Infectious Diseases, said during an interview on NPR's Morning Edition.

"When you find a virus or fingerprints of a virus in a body secretion, it absolutely does not mean that it is transmitted that way," Fauci said.

The virus may be present in a form that is incapable of spreading, or in such low levels that transmission is impossible or unlikely, several scientists said. There also could be substances present in saliva that prevent the virus from spreading.

More research will be needed to determine what role, if any, the presence of the virus in saliva plays in the spread of the Zika virus, the scientists said.

"The important thing is now to determine whether the virus in saliva and urine can transmit the virus to others. We'll just have to wait and see," said William Schaffner, an infectious disease researcher at Vanderbilt University.

While other viruses can be found in saliva, such as the human immunodeficiency virus (HIV), it is not spread that way, Fauci noted.

Mosquitoes clearly remain the main way the Zika virus is transmitted, says Thomas Frieden, who heads the Centers for Disease Control and Prevention.

"I think it's important to step back and emphasize that Zika is a mosquito-borne virus and the overwhelming majority of cases are spread by mosquitoes," Frieden told reporters during a briefing Friday morning.

The CDC did, however, issue new guidelines for how pregnant women should protect themselves from getting infected, following a report out of Dallas this week that Zika had been spread through sexual contact in one case.

The CDC recommends that pregnant women whose sexual partners live in or have traveled to places where the virus is spreading should either abstain from sexual activity or "consistently and correctly" use condoms during vaginal, oral or anal sex.

This story is part of our ongoing coverage of Zika virus.

Women who are not pregnant should consider doing the same if they are "concerned about sexual transmission," according to the guidelines.

The Zika virus is spreading rapidly through many parts of Latin America and the Caribbean. Concern has spiked because the virus is apparently causing some babies in Brazil to be born with microcephaly, a condition marked by small heads and brains. It has also been linked to Guillain-Barre syndrome, which can cause paralysis.

Mosquitoes that can transmit the Zika virus are found in the U.S., but so far aside from the Dallas sexual transmission case all the infections reported in the continental United States have been among travelers who got infected elsewhere. The CDC said there have been 50 such cases so far.

While officials say mosquitoes could spread the virus in the U.S., they are optimistic there will not be widespread transmission because of several factors, most notably good mosquito-control efforts.

But Frieden stressed that there is a lot that remains unknown about Zika.

"The situation is evolving rapidly, and as we learn more we'll share more so Americans can best decide how to protect their health," Frieden says.

Copyright 2016 NPR. To see more, visit NPR.
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High Costs For Drugs Used By A Few Are Starting To Add Up

NPR Health Blog - Fri, 02/05/2016 - 1:13pm

The cystic fibrosis drug Orkambi can help people with specific genetic mutations breathe better, but treatment with the pill comes with a hefty sticker price — $259,000 a year.

Orkambi, which was approved by the Food and Drug Administration last July, is expected to take almost $36 million from California's general fund this fiscal year and next. That cost estimate doesn't include any discounts the state may receive from drug manufacturers.

Seventy-four Californians with health coverage under the Department of Health Care Services are expected to receive the drug in the current fiscal year. In the next one, 220 people are expected to get it, some of whom may be the same patients as this year.

Orkambi is listed on the specialty tier of drug categories in some private health plans. That category is typically reserved for high-cost drugs or, in the federal government's view, for drugs that cost more than $600 a month and are used by a small proportion of patients.

Specialty drugs are already proving to be a financial burden on one California agency, the California Public Employees' Retirement System, which purchases health benefits for active and retired state workers. CalPERS says that specialty drugs made up less than 1 percent of all prescriptions for its members but accounted for 30 percent of the total drug costs in 2014.

Drugmakers say the health benefits from specialty drugs justify their cost.
"Patients are gaining access to medicines that are better treating their diseases or frankly even curing them," said Priscilla VanderVeer, deputy vice president of communications at the Pharmaceutical Research and Manufacturers of America. "Patients are now healthier. They're more productive. They're functioning."

VanderVeer said companies price drugs not just on the cost of production, but on the value the industry believes the drug brings to the health care system, such as efficacy, improvements in quality of life or length of life and the extent to which the medical need for a drug has gone unmet.

The price of the drug also accounts for the cost of developing other drugs and the high risk that a particular drug won't make it to market, VanderVeer said. Only 12 percent of drugs that go through clinical trials get approved, according to PhRMA.

Finally, she said, the sticker price doesn't reflect the final price paid for the drug, which can be heavily discounted through negotiations or because of mandated rebates for Medicaid programs.

Drugmakers are following the money, said Joel Hay, professor of pharmaceutical economics and policy at University of Southern California. Companies invest in specialty drugs that target a small population because their high price tags can be spread over a large insurance pool, he said.

Even though specialty drugs are "ridiculously expensive per treatment episode," Hay said, the cost for each member in a health plan is "just a few cents." Raising the price 10 cents on a diabetes drug, for example, would have a bigger budget impact, he said, because more people have diabetes than cystic fibrosis.

Hay says manufacturers are now less inclined to invest in drugs that treat millions of people, because there is more pushback on price. "Drug companies are for-profit companies obligated to make money for their stockholders," Hay said. "They're not virtuous charitable organizations."

Drugmakers are also investing more in treating uncommon illnesses because there is less competition and therefore more opportunity for profit, said Dr. Helene Lipton, professor of health policy at the School of Pharmacy and Institute for Health Policy Studies at the University of California, San Francisco.

The high price of the drugs affects patients, she noted, because health plans put controls on the drugs so that they're used as a last resort.

"That may mean going through two or more rounds of care with other medications before being able to use the specialty drug," Lipton said.

Still, it's not just specialty drugs that are straining health plans' budgets, said Steve Miller, chief medical officer at Express Scripts, a pharmaceutical benefits manager that negotiates drug coverage for 7.5 million Californians.

"The price of drugs is just continuing to go up," said Miller, explaining that the trend is due to both new high-cost drugs coming on the market, and mark-ups of old drugs.

There has been an explosion of drugs costing $100,000 a year over the past decade, for things like cystic fibrosis and cancer, Miller said. And there was a 127 percent price increase of branded drugs that had been on the market between 2008 and 2014, he says.

A California ballot initiative scheduled to go before voters this November aims to rein in drug costs by limiting the amount the state pays for a drug to no more than the lowest price paid for the same drug by the U.S. Department of Veterans Affairs.

A version of this story appeared first on KQED's State of Health blog. CALmatters is a nonprofit journalism venture dedicated to explaining state policies and politics. Pauline Bartolone wrote this article while participating in the California Data Fellowship, a program of the Center for Health Journalism at USC's Annenberg School of Journalism.

Barolone will be exploring how the cost of specialty drugs' affects patient access. If you are a chronic disease patient who is either taking a specialty drug or having difficulty getting the right one, she would like to hear from you. Reach her on Twitter @pbartolone or pauline@calmatters.org.

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Is It Time To Stop Using Race In Medical Research?

NPR Health Blog - Fri, 02/05/2016 - 12:20pm
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Genetics researchers often discover certain snips and pieces of the human genome that are important for health and development, such as the genetic mutations that cause cystic fibrosis or sickle cell anemia. And scientists noticed that genetic variants are more common in some races, which makes it seem like race is important in genetics research.

But some researchers say that we've taken the concept too far. To find out what that means, we've talked to two of the authors of an article published Thursday in the journal Science. Sarah Tishkoff is a human population geneticist and a professor at the University of Pennsylvania. Dorothy Roberts is a legal scholar, sociologist and a professor at the University of Pennsylvania's Africana Studies department. This interview has been edited for length and clarity.

How do geneticists use race now, and how does that cause problems for science?

Sarah Tishkoff: We know people don't group according to so called races based purely on genetic data. Whenever the topic comes up, we have to address, how are we going to define race? I have never ever seen anybody come to a consensus at any of these human genetics meetings.

Dorothy Roberts: That's because race is based on cultural, legal, social and political determinations, and those groupings have changed over time. As a social scientist, looking at biologists treating these groupings as if they were determined by innate genetic distinctions, I'm dumbfounded. There's so much evidence that they're invented social categories. How you can say this is a biological race is just absurd. It's absurd. It violates the scientific evidence about human beings.

Tishkoff: But I as a human geneticist wouldn't want to imply that there are no differences — but among different ethnic groups, not racial classifications. For example, I'm Ashkenazi Jewish. I have a much higher risk of getting certain genetic diseases that are common in certain Ashkenazi Jewish populations. That was an important question when I was having children.

There was a drug, called BiDil, that somebody claimed is more effective with African-Americans than other races — which was not true. But there are genes that play a role in drug metabolism. So if a doctor was prescribing drug treatment based on her identification of race she'd say, "You should use drug A because that's better for people of European descent." But the patient might not carry the right gene. That might have negative consequences. That might be the wrong treatment for her.

Roberts: Race isn't a good category to use to understand those differences or the commonalities. It in many cases leads researchers down the wrong path and leads to harmful results for patients. For example, black patients who have the symptoms of cystic fibrosis aren't diagnosed because doctors see it as a white disease.

So part of the problem is that when we see a high frequency of a medically relevant gene in one racial population, we start to assume that all members of that race have that gene?

Tishkoff: Yeah, I think that's right.

Roberts: People take what's a difference in [gene] frequency and turn it into a categorical difference that interprets it as if one race has one gene and another race doesn't have the gene. You can't reach the conclusion that because you know someone's race you know what their genes are. It's not the case that there are populations where 100 percent, everyone, has those genes and nobody in other populations have those genes. It's a crude way and unhelpful way of figuring out what the disease risk is.

Tishkoff: That's not to say that genetic risk in disease isn't important. I do think geography is important, and I think that people historically during evolutionary history have adapted to different environments.

Is it that the science of genetics and the science of human populations are racist? Or is it that the numbers are there and, as a society, we're interpreting these things in a racist way?

Roberts: There is a long history of justifying the subordination of different groups and social groupings based on myths about their biologic or genetic predispositions. It's not only that there's scientific evidence that humans aren't divided into discrete biological categories we'd call races. But there's also evidence of the harm these biological meanings of race have caused for centuries. It's one of the reasons why it's difficult for human geneticists today to grapple with the meaning of race. You can't talk about race without also considering the history of racism.

Tishkoff: But modern human geneticists, we're not trying to say they have a racist agenda. It's a positive thing to try and increase studies of genetic diversity that may differ across different ethnicities or ancestries.

Roberts: Yes. I'm not trying to say anything about the motivations or what scientists are trying now to do. Our paper is a call for scientists to come up with better ways of understanding human genetic diversity without relying on this antiquated concept of race There is a failure of imagination for people to think, what is there something better that we can use? Let's develop that.

Is it that difficult, though? What are the things holding scientists back from developing something better?

Tishkoff: If I want a grant from the National Institutes of Health, I am required to check off the racial classification according to the U.S. government's census categories. I study very diverse people from all over Africa, but I believe the classification is African American or Black. I always feel awkward.

Roberts: The NIH guidelines require the use of race in recruiting research subjects. There's a history of advocating for that in order to increase the participation of minorities in clinical research. Then it gets confusing, because the researchers continue to use these categories in conducting the research. Scientists must conform their research to these admittedly social categories of race.

Tishkoff: One also has to take into account that you need a way to identify your study population. Ideally you want ethnically diverse populations, so obviously you have to have some way of identifying research subjects. And that's fine. But they don't need to say based on race. The language and terminology does matter.

Roberts: Except if the research question has to do with investigating the effects of racism — race as a social category that does affect people's lives and health and future because of the impact of social inequality. I often get the justification from doctors that "I know it's crude but it's the best we have given the limited resources."

Tishkoff: To some extent I think that's true. If a doctor doesn't have a readily available genetic test to look at ancestry or to look at individual genotypes of that person, race will be their best proxy. But the language matters. We need to move away from racial terminology, particularly in the field of medical genetics. That should just be eliminated. It reinforces the notion that there's a genetic basis to this classification system. We as scientists have to set an example.

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Florida Governor Ramps Up Mosquito Fight To Stay Ahead Of Zika

NPR Health Blog - Thu, 02/04/2016 - 6:42pm
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Sporadic dengue fever outbreaks in Florida in 2009 and 2010 spurred mosquito control efforts in Key West and Miami Beach, shown here. The same mosquito that carries dengue, Aedes aegypti, can transmit Zika.

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Florida is one of several U.S. states now reporting a few isolated cases of people infected with the Zika virus. In response, Florida's Gov. Rick Scott has declared a public health emergency in five counties in hopes of getting ahead of the virus's spread.

So far, just 12 cases of the mosquito-borne illness have been reported to health authorities in Florida, all of them among travelers who contracted the disease outside the U.S. But Scott figures it's only a matter of time before the virus starts showing up among mosquitoes in some regions of the state, too.

"We have to ensure that Florida's safe," he says. "Just like in a hurricane, we always say to ourselves, 'We'll prepare for the worst and hope for the best.' And we're going to do everything we can to stay ahead of the Zika virus."

Scott is calling for stepped-up monitoring, urging that special attention be paid to mosquito control in Miami-Dade and four other counties where Zika cases have been reported. He's also asked the Centers for Disease Control and Prevention to provide Florida with at least 1,000 antibody test kits so it can check people who traveled abroad and had symptoms of Zika — especially pregnant women.

So far, Florida's Zika cases have been restricted to people who recently returned from travel to Haiti, Venezuela, Colombia or El Salvador.

With its mild climate, Florida is susceptible to mosquito-borne diseases. Over the years, the state has experienced sporadic outbreaks of dengue and chikungunya — other tropical diseases carried by the Aedes aegypti mosquito, which is prevalent in Florida.

"I would like to bet money on the fact that we will see locally acquired cases," says Dr. Amy Vittor, an internist and public health researcher who studies tropical diseases at the University of Florida. Still, the state is unlikely to see the scale of the Zika outbreaks now sweeping through the Caribbean and Latin America, she and other health officials say, in part because residents of the Sunshine State have far less exposure to mosquitoes.

"We get in from our air-conditioned house into our air-conditioned car in the garage and drive to our air-conditioned office and then right back home," Vittor says. Contrast that, she says, to someone who lives in a dense urban setting, without air-conditioning or window screens, waste management or water sanitation.

"They have a very different exposure risk," Vittor says.

Only about 1 in 5 people infected with Zika becomes ill, according to the CDC. And, as tropical diseases go, the symptoms are usually mild: a fever, rash, headaches and joint pain. But because the virus has been correlated with a rise in microcephaly and other birth defects in other countries, Zika is especially worrisome. Those concerns may have played a role in Gov. Scott's decision to declare a public health emergency.

That wasn't done in 2009 and 2010 when Key West had nearly 90 cases of dengue fever, which can be lethal if it isn't promptly recognized and treated.

Key West, the southernmost city in the continental U.S., is a small, densely populated place in the subtropics. "We are the perfect climate for A. aegypti mosquitoes — and any mosquitoes," explains Beth Ranson, who represents the Florida Keys Mosquito Control District. "We are hot and we are humid."

Ranson says, so far, her agency isn't doing anything special to prepare for Zika. But day-to-day mosquito control in the Keys is already pretty intense, with a fleet of planes and helicopters and a couple of dozen inspectors ferreting out the places mosquitoes breed.

Even with its aggressive mosquito control effort, the Keys Mosquito Control District has only been able to cut its population of Aedes aegypti mosquitoes in half.

Ranson says that's why the district is looking at deploying genetically modified mosquitoes. A British company, Oxitec, has developed genetically modified A. aegypti mosquitoes that produce offspring that don't live to adulthood. In experimental trials in Brazil and other countries, Oxitec has shown it can reduce the A. aegypti population by 90 percent, says Derric Nimmo, a product development manager at the company.

"Now, of course, Zika has gained prominence in the past few months with this link to microcephaly," Nimmo says, "so there has been a much greater impetus in Brazil to look at how they can control this mosquito."

Oxitec is still waiting for the FDA to approve a trial release of the GMO mosquitoes in the Florida Keys. One obstacle has been a vocal group of opponents.

A local businesswoman in the Florida Keys, Mila de Mier, gathered more than 100,000 signatures a few years ago on a petition opposing the trials, which she hand-delivered to the FDA offices in Washington. She's worried about the risk of introducing genetically modified mosquitoes into the environment, she says, especially when there is no imminent risk of disease.

"We don't have dengue. We don't have chikungunya. We have no Zika," de Mier says. "And we are concerned. The Mosquito Control (District) is doing a really good job here. We don't see the need to jump into this."

But Ranson says the idea is to head off dengue, chikungunya and Zika outbreaks before they occur.

"Waiting until it's here before we have the ability to get the tools is not smart," Ranson says. Though it's been nearly six years, she notes, since her district and Oxitec began working toward conducting an experimental trial of the GMO mosquitoes in the Keys, approval to begin the test is still uncertain.

Other mosquito control districts in Florida have expressed interest in trying the GMO mosquitoes once the Keys trials are approved, Nimmo says. Meanwhile, Oxitec is expanding such tests in Brazil and hopes soon to receive permission there to begin marketing its GMO mosquitoes commercially.

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House Hearing Probes The Mystery Of High Drug Prices That 'Nobody Pays'

NPR Health Blog - Thu, 02/04/2016 - 5:57pm
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Nancy Retzlaff, chief commercial officer for Turing Pharmaceuticals, was asked how much the drug Daraprim costs at the House Oversight and Government Reform Committee on Capitol Hill on Thursday.

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Members of Congress at a Thursday hearing wrestled with questions about why the prices of some old drugs are rising so fast.

Much of the session held by the House Oversight and Government Reform Committee was dominated by Martin Shkreli, the bad-boy former CEO of Turing Pharmaceuticals who earned notoriety by raising the price 5,000 percent for the drug Daraprim, a treatment for toxoplasmosis.

Shkreli — who has been indicted on unrelated securities charges and pleaded not guilty — invoked his Fifth Amendment right against self-incrimination and refused to answer questions. As the hearing went on, he smirked, rolled his eyes and chuckled. Afterward, he insulted the committee members on Twitter.

Hard to accept that these imbeciles represent the people in our government.

— Martin Shkreli (@MartinShkreli) February 4, 2016

Committee member Rep. Ted Lieu, D-Calif., tweeted back.

You know what's sort of cool @MartinShkreli? That I represent the people and you are under federal indictment. https://t.co/acQvPEuPrT

— Ted Lieu (@tedlieu) February 4, 2016

Once Shkreli left Thursday's hearing, lawmakers grilled other witnesses about rising drug prices.

The seemingly simple question about how much Daraprim costs in the real world proved pretty tricky to pin down.

Listen for yourself as Rep. Peter Welch, D-Vt., asked Turing's Chief Commercial Officer Nancy Retzlaff how much Daraprim costs. The response is enough to make us feel like imbeciles.

Rep. Welch ask Turing's Nancy Retzlaff about Daraprim pricing

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Could Hospital ERs Provide Missing Data On Police Shootings?

NPR Health Blog - Thu, 02/04/2016 - 4:36pm

Criminologist Joseph Richardson is skeptical that the federal government alone can solve the data problem for police shootings. "There has to be a more pioneering, innovative approach to doing it," he says.

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For the past two years, Joseph Richardson has been trying to figure out how to keep young black men with knife and gunshot wounds from turning up again with similar injuries at Prince George's Hospital Trauma Center outside Washington, D.C.

Richardson is director of the Violence Intervention Research Project at the trauma center. When these men are admitted, he shows up at their rooms to ask them to take part in his ongoing study on risk factors for repeat violent injuries. Sometimes he finds them handcuffed to a hospital bed, guarded by a police officer or two. Richardson has to walk away. The patients are under arrest and off-limits to him.

Richardson is also a criminologist and associate professor at the University of Maryland. And recently, in the context of a national discussion about police violence, he got to thinking about the lack of access that kept him from asking these men what happened. How many of those handcuffed shooting victims had taken a bullet from a cop, he wondered?

With scant data on how many people are shot by police across the country every year, Richardson sees potential in hospital emergency departments. As a researcher he might not have direct access to patients under arrest, but the doctors and nurses certainly do. He's proposing that emergency departments step in and capitalize on that unique access to compile an alternative data source.

Doctors And Nurses Could Ask: 'Who Shot You?'

Richardson views police violence as a public health issue and believes health care providers have a role to play in addressing it. The concept seems simple: At some point during a patient's visit, emergency department staffers ask patients who shot them, record their answers and report the information to state health departments and the Centers for Disease Control and Prevention.

He's not suggesting doctors and nurses investigate their patients' claims, or that this self-reported data would even be completely accurate. After all, in quite a few cases it could be impossible to know who shot you.

Even so, Richardson says that some data are better than none. Hospital-reported numbers along with those recorded by police and media outlets could help define the true scope of police shootings.

In December, around the time Richardson floated his idea in the Journal of Urban Health, the FBI announced plans to expand its database on violent police encounters. For the first time, the agency will collect information on serious injuries, not just fatalities. But it will continue to lean on voluntary reports by local police departments.

Richardson is skeptical that the federal government can solve the data problem. "There has to be a more pioneering, innovative approach to doing it," he says. That's what he's trying to figure out. He notes that information about people who survive police shootings is especially elusive. "The only way we would know that is either the police would have to report that or the hospitals would have to," he says. "Up to this point, neither entity has done it."

Richardson points to a 2009 survey of academic emergency physicians that found that almost all of them believed they'd seen cases of excessive use of force by police but had largely failed to report them.

In interviews with the emergency department staff at Prince George's, he found that the overwhelming majority said the hospital has an ethical responsibility to record and report police-involved shootings. But doctors and nurses raised concerns about the logistics and consequences.

Some said it would be difficult to put into practice a standardized approach to collecting the information. Others felt patients weren't likely to open up to trauma staff — especially given the presence of police anytime a victim is under arrest. Still others worried they'd be dragged into court to testify if they implicated the police.

Can Hospitals Balance Care And Reporting On Shootings?

Logistics aside, what looms over Richardson's proposal is a philosophical divide over the role of the hospital and its staff.

As American College of Emergency Physicians board member James Augustine sees it, muddling a hospital's mission is bad for patients. "The hospital is not a good place for legal and law enforcement activities to infringe on people's rights for health care," says the veteran emergency medicine doctor. "In the emergency setting, this is not a priority."

But he doesn't dismiss the idea outright. The health care system plays a vital role in amassing data, he says. In fact, many trauma centers already collect reams of information and submit it to the National Trauma Data Bank. Stripped of names, it's used to track everything from auto accidents to clothing-related burns. It might be feasible to add information about violent police encounters to those data collection efforts, Augustine says.

David Livingston, chief of trauma at University Hospital in Newark, agrees that when it comes to collecting information, hospitals could help. "Emergency departments are the canary in the coal mine of health in our communities," he says. "They're a unique public health resource to gather data."

But there are serious limitations. Two years ago, Livingston and his colleagues analyzed more than 6,000 gunshot wounds treated at his hospital and found that his own trauma unit's database didn't account for nearly 20 percent of them. It turned out the emergency department, not trauma, had handled these relatively minor injuries and Livingston and his co-workers only discovered them when they scoured that department's billing records.

As for Richardson's proposal, Livingston says it could work in theory. "Is it economically and logistically feasible?" he asks. "We'd like to think it is, but I have my doubts." Getting detailed information would probably require dedicated staff, he says, and that's expensive. But he's quick to point out that similar data on cancer, heart disease, smoking, obesity and other conditions has been collected, with the National Institutes of Health or the National Science Foundation footing the bill. "In that respect," he says, "Dr. Richardson's contention to put this on trauma centers is shirking the government's responsibility."

Still, Richardson suggests a place to start: hospital-based violence intervention programs. Only about 30 hospitals in the U.S. have these special programs aimed at curbing readmission for violent crimes, but Richardson sees them as prime candidates for pilot projects.

For University of California, San Francisco trauma surgeon Rochelle Dicker, who heads up the violence intervention program at San Francisco General Hospital, keeping tabs on police violence seems like a natural extension of the work her team already does. "Part of our responsibility as physicians is to not just to do the traditional 'treat and street,' but to really get to the issues at hand and address violence in a more comprehensive way." In order to do that, she says, accurate information is key.

"The work is provocative," she says of Richardson's proposal, and it will get people talking. "I applaud the author for taking that first step and opening the door."

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Women Blast CDC's Advice To Use Birth Control If Drinking Alcohol

NPR Health Blog - Thu, 02/04/2016 - 4:20pm
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But first, birth control?

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New advice from the Centers for Disease Control and Prevention aimed at preventing fetal alcohol syndrome has created quite a stir.

The CDC estimates that about 3 million women "are at risk of exposing their developing baby to alcohol because they are drinking, sexually active and not using birth control to prevent pregnancy."

About half of all pregnancies are unplanned. And according to the CDC report issued Tuesday, about 3 in 4 women "who want to get pregnant as soon as possible do not stop drinking alcohol when they stop using birth control."

So the CDC is now advising women to stop drinking if they are trying to get pregnant or not using birth control with sex. That's right, abstain from drinking.

the #cdc is acting as if women aren't humans but rather just baby-making vessels

— hannah (@hantaloupe) February 4, 2016

The way this advice was communicated has struck many women as severe and condescending. "CDC to younger women: Better take your birth control before you drink that glass of wine," read one headline.

The Internet let forth a tsunami of derision. One columnist for The Washington Post quipped, "That's the last time I drink merlot alone in my apartment. I don't want herpes."

Indeed, the CDC did also point out that drinking can make a woman more vulnerable to injuries or violence and sexually transmitted diseases. But many commenters pointed out that there was no report warning men that drinking can lead to violent behavior and STDs.

#CDC releases study advising men not to drink alcohol citing high risk of abusing, sexually assaulting, raping women under the influence

— fran (@fran_says_hello) February 4, 2016

"The way [the CDC] stated this is very extreme," says Emily Oster, an economist at Brown University who wrote a book on the sometimes anxiety-producing advice that women are given during pregnancy.

Oster says the CDC has an important message to convey. Some women undoubtedly are unaware of the risks of alcohol during the early weeks of pregnancy when they may not even know they're pregnant.

But given the tone and the judgment woven into the messaging, Oster says, it touched a nerve.

The backlash also reignited the controversy about whether any amount of alcohol is safe during pregnancy.

Don't get me started. @CDCgov's rec nails the trifecta of impractical, sexist and alarmist. #cdc https://t.co/HX8l0REnf2

— Alla Lefkowitz (@LegalGal83) February 4, 2016

The American College of Obstetricians and Gynecologists released a statement Tuesday pointing to its policy that recommends women completely abstain from alcohol during pregnancy.

But this doesn't mean that having a few drinks in the early weeks of pregnancy — before a woman realizes she's pregnant — is harmful.

"I practiced for 30 years," says Hal Lawrence, an OB-GYN and CEO of ACOG. He says he would see women who'd had a glass of wine or two before they knew they were pregnant, "and generally you can reassure those [women] that it's not an issue."

But Lawrence does say the best advice is to avoid alcohol completely during pregnancy. "Alcohol exposure in any of the trimesters [of a pregnancy] can have some impacts on ... the fetus."

The CDC now appears to be extending that advice to thinking about getting pregnant, too.

"We really urge women, and their partners and friends — to be supportive of that idea: I'm not going to drink for a while because I'm thinking of getting pregnant," said the CDC's Anne Schuchat during a briefing announcing the new guidance.

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If BMI Is The Test Of Health, Many Pro Athletes Would Flunk

NPR Health Blog - Thu, 02/04/2016 - 12:36pm
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Sylvester Williams, a Denver Broncos nose guard, nabs Isaiah Crowell of the Cleveland Browns last October. If measured by BMI, Williams is obese.

AAron Ontiveroz/Denver Post via Getty Images

Employers are pushing workers to get in shape and become more fit through workplace wellness programs. But if employers use body mass index as a yardstick for health, then that could unfairly penalize millions of Americans, a study finds.

Doctors contend that BMI's usefulness ends at a rough indication that a patient should be checked for things like high blood pressure or cholesterol.

"It's a preliminary screening tool. Higher BMI is associated with higher health risk, but it's not a health state," says Dr. Deborah Burnet, a professor of medicine at the University of Chicago who didn't work on the study.

Pro athletes often have BMIs that could get them in trouble with a workplace wellness plan. Their muscle mass can boost them into the obese range, even though they're healthy and physically fit. Based on players' height and weight on the NFL website, there is no Denver Broncos player with a normal BMI, calculated at 18.5 to 24.9.

On average, the Broncos' BMIs fall into the obese range, at 30 or greater. Panthers players may want to avoid getting tackled by Sylvester Williams in the Super Bowl. At 6 foot 2 and 313 pounds, he has a BMI of 40.

And that mismatch between BMI and health is true not just for athletes, according to the study, published on Thursday in the International Journal of Obesity. It looked at the proportion of healthy individuals by BMI and six other heart and metabolic measures like blood pressure, cholesterol and insulin resistance.

Out of a national database of more than 40,000 people, about 70 percent of people with normal-weight BMIs were in the healthy range for all the other measures. So were 47 percent of people with an overweight BMI, 30 percent of those considered obese, and 16 percent of those labeled extremely obese.

Of course, if 30 percent of people considered obese are healthy, it also means that 70 percent of these individuals are not. Burnet says BMI is still useful as a quick and dirty way of giving doctors a heads-up on who might be at extra risk for health problems.

Indeed, the BMI was first invented in the early 19th century an an economic tool, not as individual health metric. Mathematics professor Keith Devlin, writing for NPR in 2009, called it "a 200-year-old hack."

Some provisions of the Affordable Care Act and rules proposed by the Equal Employment Opportunity Commission would allow employers to charge unhealthy employees up to 30 percent of health care costs based on conditions like being overweight or obese.

Doctors don't use BMI to determine healthiness, so the EEOC's proposed rules shouldn't either, says Janet Tomiyama, a health psychologist at the University of California, Los Angeles and lead author on the study. "We're finding a lot of people who are overweight or obese by BMI, 54 million Americans, who are healthy. They would be penalized unfairly."

Burnet agrees it would be foolish to use body weight as a metric for workplace wellness programs, and says it's also unethical. "[The rules] are a terrible idea. You're charging [people with a high BMI] more, like charging people with diabetes more, and that's wrong," Burnet says. "That's a significant misuse of BMI."

Across racial, ethnic and socioeconomic lines, the prevalence of overweight or obese individuals changes dramatically. "There are higher rates of obesity among African-Americans than among white people in the U.S. Some studies show that an African-American person may have less body fat than a white person of the same BMI," Burnet says. "[The rules] would disproportionately burden that group of people."

And rates of BMI-defined obesity are also higher among lower-income people, Burnet says. If the EEOC's proposal becomes codified, punitive workplace wellness programs based on BMI could financially drain an already financially stressed population. As the rules are currently written, Burnet says it would be up to the discretion of the employer to implement punitive incentives as it sees fit. "The guidelines should be written in a different way," she says. "It's bad for health insurance, for financial reasons and for stigma."

The EEOC says BMI as a health metric comes from language in the Affordable Care Act. "It's not really in our rule to say what is an appropriate health metric," says Chris Kuczynski, legal counsel for the EEOC. But he says the commission is discussing whether it will define what is medically and scientifically sound for a health program.

The solution, Tomiyama thinks, is simply follow science as closely as possible. Other measures, such as cholesterol level, blood pressure, or insulin resistance, are far more accurate indicators of poor health than BMI.

"We have this laser focus on weight, when this measure of body size doesn't get under the skin of what healthy markers are," she says. "We need to focus on actual health markers, rather than this outdated, very broad measure called BMI."

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Boosting Life Span By Clearing Out Cellular Clutter

NPR Health Blog - Wed, 02/03/2016 - 3:45pm
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When so-called senescent cells were removed from mice, they were healthier and lived longer than mice that still had the cells.

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Mice were much healthier and lived about 25 percent longer when scientists killed off a certain kind of cell that accumulates in the body with age.

What's more, the mice didn't seem to suffer any ill effects from losing their so-called senescent cells.

These are cells that have stopped dividing, though not necessarily because the cells themselves are old. "It's a normal cell that experienced an unusual amount of stress, and it decided to stop dividing," says Jan van Deursen, who studies senescent cells at the Mayo Clinic College of Medicine in Rochester, Minn.

Older creatures have a lot more of these cells than young 'uns. And even though the cells aren't dividing, they do keep busy — they secrete a mixture of chemicals that can trigger inflammation, which seems to be involved in just about every major age-related disease.

So van Deursen and his colleagues wanted to know: What would happen if you simply got rid of senescent cells? That's tough to do in humans, but possible in mice.

The researchers created mice that were genetically altered so that giving them a drug would trigger senescent cells to kill themselves. Then they waited until the mice reached middle age, and gave some of them the drug.

At first, wiping out the senescent cells didn't seem to make much difference. But as the mice got older, the research team could see that the treated mice looked healthier.

"And then when we started to record the life span of the animals, we saw that there was about a 25 percent extension in life span of animals that had their senescent cells removed from 1 year of age on," says van Deursen.

What's more, the treated mice had fewer cataracts, hearts with better stress tolerance, and improved kidney function. And losing the cells didn't seem to cause them any problems, the researchers report Wednesday in the journal Nature.

The bottom line, says van Deursen, is that "it seems like we're accumulating a cell type that we really don't need for anything and that makes us more unhealthy and reduces the length of our healthy lives."

Needless to say, the hunt is already on for drugs that could eliminate these cells in people. That's not going to happen tomorrow, of course, and useful drugs might never materialize. But the findings in mice provide researchers with a new place to look.

Van Deursen himself is working with a new company, Unity Biotechnology in San Francisco, that has some promising candidates.

A scientist named Judith Campisi, who studies senescent cells at the independent Buck Institute for Research on Aging, also works with Unity. She thinks the findings of the latest study are significant. "The impressive thing is those mice not only lived longer but they lived healthier," says Campisi.

But she cautions that removing these cells isn't going to be a magic bullet against aging.

"Obviously, even in the Nature paper, those mice got old and died," she points out.

And some research shows that these cells may have a useful role to play in our bodies. For example, there's evidence that senescent cells aid wound healing and that cellular senescence helps protect against cancer.

"One needs to move forward with care about trying to just kill off senescent cells with the anticipation that things will be wholly beneficial," says Dominic Withers, a researcher at the MRC Clinical Sciences Centre, Imperial College London.

He says it looks like these cells do contribute to aging, but it's too soon to say what to do with them.

"I think it's early days at the moment," Withers says. "There's still quite a lot to learn about whether you would want to try and kill senescent cells or do something to the senescent cells that exist, such as stop them secreting this cocktail of potentially bad molecules."

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