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Freezing Eggs May Reduce A Woman's Odds Of Success With IVF

Fri, 08/28/2015 - 12:06pm

Eggs may be more vulnerable to freezing than embryos, but that's just one factor that affects the odds of having a baby with frozen eggs.

Jean-Paul Chassenet/Science Source

With egg freezing being touted as a way for women to potentially expand future childbearing options, the viability of those eggs when they're defrosted is still relatively unknown. The latest bit of guardedly good news is a short report in JAMA indicating that frozen eggs do indeed lead to live births after IVF nearly half the time — but that the odds of a live birth are almost 20 percent higher for IVF using fresh eggs.

The report, by Vitaly Kushnir and his colleagues at the Center for Human Reproduction in New York, is based on a retrospective analysis of success rates that U.S. fertility clinics send to the Society for Assisted Reproductive Technology. In 2013, donated eggs (as opposed to eggs from the would-be mother herself) were used in 11,148 IVF cycles. Most were fertilized and implanted as soon as they were retrieved, while 20 percent had been frozen after donation and were then thawed and fertilized. Kushnir and his colleagues looked at IVF success rates in terms of eventual live births and compared the rates for those using fresh donor eggs with those using frozen donor eggs.

The live birthrates per embryo transferred were 56.1 percent for embryos made with fresh donor eggs and 47.1 percent for those made with frozen donor eggs. In other words, a live birth was 19.1 percent more likely using fresh donor eggs rather than frozen.

It's hard to say what might account for this difference, Kushnir said. "The quality of the eggs could be somehow diminished by freezing and thawing." Or it could be explained by the fact that women who use frozen donor eggs get fewer eggs altogether, since they're split among a couple of recipients — and fewer eggs means fewer potential embryos.

In most clinics, a woman who uses a donor gets all the fresh eggs the donor produces — which, according to Dr. James Toner, president of SART, is usually about 15 to 20 mature eggs. But if she has to turn to frozen eggs from the egg bank, which he said are typically sold in batches of about half a dozen, she will usually have to share that batch with another woman.

Since fertility clinics these days implant just one or two embryos per cycle, "I think the difference in initial egg numbers in fresh versus frozen largely explains the difference in pregnancy rate," said Toner, who works at the Center for Reproductive Medicine in Atlanta.

So if you're using donor eggs, why opt for frozen instead of fresh? Two reasons, according to SART and the American Society of Reproductive Medicine, which issued a joint statement in response to the JAMA report. The first is cost: A cycle of IVF using donor eggs costs roughly half as much if the eggs are frozen — generally about $15,000 to $17,000 for frozen donor eggs, compared with $25,000 to $30,000 for fresh.

The second is convenience. As the SART/ASRM statement points out, using frozen donor eggs gives women "access to a wider field of donors and provides greater flexibility for both donors' and recipients' scheduling and coordination." These considerations, the group said, "may outweigh slightly lower success rates for some patients."

Unfortunately, it's hard to draw too many conclusions from this study about egg freezing as it's most commonly used these days: on eggs that are about a decade older than typical donor eggs, frozen by women in their late 30s who want to extend their fertility by a few more years.

Donor eggs generally come from young women; most fertility clinics look for egg donors in their 20s. Younger donors are preferred because their eggs are more likely to become fertilized in the first place, and once they're fertilized the resulting embryos are more likely to be successfully implanted in a recipient's uterus.

Currently, though, the typical cryopreserver is much older — a single woman in her late 30s (one study put the average age of elective egg freezing at 37.4). Does the JAMA report say anything about how likely it is for that woman to have a child once she decides she's ready — which might not be until her 40s?

"That's the same question every other journalist asks," Kushnir told me.

And what do you tell them?

"Well, we can extrapolate from the data," he said, "but there's no direct evidence in this study" of how older eggs will fare when they are frozen and then thawed. All he can really say is that the odds of success are lower for frozen eggs than they are for fresh, which is probably as true for older eggs as it is for younger.

Older women can improve their chances of getting pregnant post-freezing, Kushnir added, by freezing an embryo instead of an egg, since embryos allow for a greater margin of error when they're defrosted.

"They're approximately the same size," he said, "but an egg is just one big huge cell. If you thaw it and it doesn't thaw well, you lose the whole cell." But an embryo is a group of cells, usually eight. "When you thaw the embryo, if some of those cells die — say, if only six of the eight survive the thaw — those cells are pluripotent and can continue to divide and grow and still produce a pregnancy."

But while freezing embryos might be a better option biologically, socially it's pretty much a nonstarter. A 37-year-old woman considering egg freezing generally doesn't have a partner whose sperm she wants to use to create an embryo; if she did, she might be choosing to get pregnant instead. And once you start thinking about using donor sperm to make an embryo to put in the deep freeze, thinking about using a donor egg when you're finally ready to have a baby might not be that far a leap.

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Poll Finds Most Women Believe Mammograms Should Be Done Annually

Fri, 08/28/2015 - 9:40am

Most women 40 and older believe they should have mammograms every year to screen for breast cancer, the latest NPR-Truven Health Analytics health poll finds.

The finding is at odds with current recommendations by the U.S. Preventive Services Task Force that women with typical risks for breast cancer have screening mammograms every two years starting at age 50 and until they turn 75.

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The decision about mammograms for women in their 40s is a personal one. The task force found a small net benefit for biennial screening of women ages 40 to 49. The guidelines say women should take into account their health situation as well as their views on the benefits of early cancer detection and potential harms, such as unnecessary biopsies and surgery.

The USPSTF said there wasn't enough evidence about the benefits from mammograms for women age 75 and up to make a recommendation.

The task force is working on an update to the mammography guidelines, which have sparked controversy since they were last revised in 2009. The thrust of the draft advice is pretty much the same as it has been, but there's more nuanced discussion of the benefits and potential harms for women in their 40s.

The NPR-Truven Health poll found almost two-thirds of women ages 50 to 74 believe that they should have a mammogram annually. For women 40 to 49, the number drops to 56 percent. For women under 40, about 45 percent believe they should have a mammogram every year. Overall, 57 percent of women believe an annual mammogram is appropriate.

"The Task Force is happy to see that women are making informed decisions with their doctor about breast cancer screening and continue to have access to mammography screening," Dr. Kirsten Bibbins-Domingo, vice chair of the USPSTF, told Shots in a statement emailed after she reviewed the poll's findings. "Mammograms are an important tool in helping women avoid deaths from breast cancer. The value of mammography screening increases with age, with women ages 50 to 74 benefitting most from screening. In this age group, the evidence indicates that women get the best balance of benefits to harms when screening is done every 2 years."

She added, "The decision to start regular mammography screening for women in their forties should be an individual one that women make in consultation with their doctors and after consideration of their health history, preferences, and how they value the potential benefits and harms of screening."

The task force's advice is influential, but its guidelines aren't the only ones around. The American Cancer Society, for instance, recommends that women 40 and older "have a mammogram every year and should continue to do so for as long as they are in good health."

After reviewing the poll's findings, Dr. Michael Taylor, Truven's chief medical officer, told Shots: "There needs to be more education about the problem of false positives. If you do mammography every year starting at 40, you're going to find a lot of things that don't matter." There may be benefits for some women, but many will also be subjected to unnecessary biopsies and surgeries, he said. "We don't think enough about the harms of interventions" triggered by mammography, he said.

As for the belief that annual mammograms are best, Dr. A. Mark Fendrick, a professor of internal medicine at the University of Michigan Medical School, says, "It's much much harder to take away something that you're already doing than it is to start a behavior from time zero."

"More isn't always better," Fendrick says about screening tests, including mammograms. But there are some people with family histories of disease or who have specific genetic risk factors who should be screened more often, he says.

Overall, 48 percent of respondents were aware that the Affordable Care Act requires insurers to cover mammograms without any out-of-pocket costs.

The NPR-Truven Health Analytics Health Poll on mammograms was conducted in June. More than 3,000 women across the country were interviewed. The margin for error is plus or minus 1.8 percentage points. You can find the questions and full results of the latest poll here. For previous polls, click here.

Copyright 2015 NPR. To see more, visit http://www.npr.org/.
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FDA Warns Tobacco Companies Advertising 'Natural' Cigarettes

Thu, 08/27/2015 - 2:20pm

American Spirit is one of three brands that have gained unwanted attention from the FDA for marketing cigarettes as "natural" or "additive-free."

Lynne Sladky/AP

The Food and Drug Administration on Thursday ordered three tobacco companies to stop claiming their cigarettes are "additive-free" or "natural."

The agency said those claims could mislead smokers into thinking those cigarettes are safer than others.

The move marks the first time the FDA has taken this kind of step since it got expanded powers to regulate tobacco products in 2009. That included the authority to require that any claims suggesting a product is safer than regular cigarettes must be proven to be true.

"The FDA's job is to ensure tobacco products are not marketed in a way that leads consumers to believe cigarettes with descriptors like 'additive-free' and 'natural' pose fewer health risks than other cigarettes, unless the claims have been scientifically supported," said Mitch Zeller, director of the FDA's Center for Tobacco Products, in a written statement. "This action is a milestone, and a reminder of how we use the tools of science-based regulation to protect the U.S. public from the harmful effects of tobacco use."

The letters were sent to ITG Brands LLC, which sells Winston cigarettes, Santa Fe Natural Tobacco Co. Inc., which sells the American Spirit brand, and Sherman's 1400 Broadway N.Y.C. Ltd, which markets Nat Sherman cigarettes.

The agency gave the companies 15 days to respond.

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Help Wanted: Last Pediatrician On Mendocino Coast Retires

Thu, 08/27/2015 - 1:23pm

Dr. Bill Mahon says a gorgeous coast and the chance to practice a more personal style of community medicine lured him to remote Fort Bragg, Calif., 35 years ago.

Farida Jhabvala Romero/KQED

Dr. Bill Mahon was a young pediatrician in the early 1970s when he fell in love with the rugged coast and majestic redwoods of Mendocino County, Calif. Like other people who have moved to Mendocino from around the country, settling here for him was a personal choice that prioritized lifestyle over money.

The prospect of practicing medicine in a small community also called to him. In 1977 he left his well-paying job at Kaiser Sacramento to join a practice with two other pediatricians in Fort Bragg.

Still, the move was a risk.

"There were no guarantees coming to the coast. This was a practice that started from scratch, and I just trusted the fact that it would increase and everything would be fine," Mahon, now 68, says. "My first month of work here I made $200. That was it."

Over time, the private practice grew to include any patient regardless of ability to pay, says Mahon. Some patients were not insured. Many had Medi-Cal, the state's health insurance program for lower-income residents, which — until Mahon's office gained rural health clinic status in the 1990s — provided reimbursements that were "pretty meager."

"Early on we actually did trades at the practice," says Mahon, with a chuckle. "We would trade a visit for a salmon or pottery or some other commodity, which, in the end, felt good from both sides."

The Mendocino Coast District Hospital in Fort Bragg, Calif., now has pediatricians on call for emergencies only.

Farida Jhabvala Romero/KQED

For more than 35 years, Mahon examined patients day in and day out at his small clinic, next to Mendocino Coast District Hospital, the only hospital for miles. He handled everything from regular checkups to broken bones to very sick kids who might need a spinal taps or IV treatment. He got to know families closely. Going anywhere in town almost certainly involved bumping into a former patient.

"It really is the personal aspects of practice here," says Mahon. "The connection with the parents, the connection with the kids and then how that connection spilled over into the larger community."

Sometimes, he was roused out of bed in the middle of the night to attend to a newborn after a complicated delivery or speak with a distressed parent with an urgent question. Then those kids grew up — and many had kids of their own and brought them to see Mahon.

"I frequently tell people that I had a dream practice," he says. "I took care of at least two generations of children. I wouldn't trade a minute of it."

Now Mahon is mostly retired. He only works at the hospital on call a few days a month. Families in most of the Mendocino Coast region no longer have access to a pediatrician who lives there permanently. The doctors that Mahon joined in the '70s have long since retired, and other pediatricians have come and gone.

Until recently, a nurse practitioner and physician's assistant at the clinic handled most cases. But with no pediatrician in the office, if a patient showed up very sick or with a complicated case, the clinic's staff sent him to the hospital's emergency department, which has on-call access to a pediatrician.

"This community deserves better," says Mahon. "For me it's rather sad. For all these years there have been resident pediatricians and now for the first time in 40 years, there is none."

Mendocino Coast Clinics, which absorbed Mahon's practice a few years ago, contracted an outside agency to bring in a temporary pediatrician for three months. He started last week.

"This is a stopgap measure," says Paula Cohen, executive director at Mendocino Coast Clinics. "We would love to find someone who wants to move to this community and make it their home."

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Their search to find someone permanent has a few leads. Cohen says she interviewed an out-of-state doctor last weekend, and her staff is reviewing resumes. However, it's hard for tiny Fort Bragg — population 7,300 — to compete with metropolitan areas when recruiting physicians.

Cohen says many physicians prefer the amenities — cultural activities, department stores, even supermarkets — of bigger cities. A physician who is married might need to look in areas that offer career opportunities for a spouse — who, if he or she works in financial services or tech, say, might not want to move to Fort Bragg.

The practice of medicine has also changed since Mahon came to the coast. Today, many young doctors don't want to practice by themselves and independently treat the wide range of diseases and behavioral disorders in babies and children that Mahon did.

Most new physicians are educated in metropolitan areas, with a large suite of specialists available, says Janet Coffman, associate professor at the Institute for Health Policy Studies at the University of California, San Francisco.

"If you are in a rural area and the only pediatrician," says Coffman, "people are expecting you to do a wider scope of practice. New physicians might not be prepared for that kind of medicine."

Another big challenge is that most new doctors are looking for higher salaries to help them repay their debt from medical school. Graduates of public medical schools owed a median debt of $170,000, while private medical school graduates owed a median debt of $200,000, according to 2014 figures from the Association of American Medical Colleges. Poorer, rural areas, where many patients are on Medicaid, might not offer competitive salaries.

California could help rural communities recruit new physicians, Coffman says, by expanding programs that help doctors repay their debt if they practice in a medically underserved area. One such program in the state, the Steven M. Thompson Physician Corps Loan Repayment, offers up to $105,000 in financial assistance. Medical schools could also expand programs that train physicians for the daily challenges of practicing in a rural setting.

Shots - Health News How One Hospital Entices Doctors To Work In Rural America

The issue is pressing in Mendocino County and other nearby Northern California counties, where more than half of all doctors practicing are 56 or older and nearing retirement age, according to a 2009 report by the California HealthCare Foundation. Statewide, the physician workforce is one of the oldest in the nation, with only New Mexico having a greater proportion of active physicians over 60.

Meanwhile, families in Fort Bragg say they greatly miss having a regular pediatrician they trust nearby.

Cassandra and Milo Young now drive their three children 60 winding miles inland to a pediatric practice in Ukiah. The trips usually take an entire day and represent additional costs in gas and time off work.

"It's definitely a downfall to the area," says Cassandra Young. She moved to the coast after working as a creative director at a large advertising firm in New York City.

"We made certain concessions to give this lifestyle to our children. We gave up the big career and department stores," Young says. "But giving up good quality pediatric care doesn't feel like something we should have to give up."

She likes the pediatric practice in Ukiah well enough, she says, but misses Mahon.

"He's just wonderful, the kind of doctor we all wish our kids could have," Young says. "It would be amazing to get another Dr. Mahon to move out here and be our country doctor."

This story was produced by State of Health, KQED's health blog.

Copyright 2015 KQED Public Media. To see more, visit http://www.kqed.org.
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Abortion Foes Scour Clinics' Trash For Discarded Records

Thu, 08/27/2015 - 8:03am

Medical records are supposed to be disposed of securely. Anti-abortion activists say some clinics fail to do that.

iStockphoto

The scene in front of clinics where abortions are performed is often tense, with clinic workers escorting patients past activists waving signs and taking photographs.

But increasingly, another drama is unfolding out back. There, abortion opponents dig through the trash in search of patient information.

Using garbage as their ammunition, anti-abortion activists — who have sometimes been accused of violating abortion seekers' privacy — are turning the tables. They claim it's the clinics that are violating patients' privacy by discarding medical records in unsecured ways.

"Everybody acts like the abortion clinics are this bastion of protection for women's privacy, and they're like the chief offenders of just dumping this stuff willy-nilly," said Cheryl Sullenger, senior policy adviser at Operation Rescue, an anti-abortion group based in Wichita, Kan. "It's so hypocritical."

Abortion rights groups counter that while a small number of clinics have improperly disposed of records, the vast majority take strict precautions to protect patient privacy. It's far more common, they say, for abortion opponents to trespass on private property or try to break into locked dumpsters.

"Oftentimes, the dumpsters are not on public property," said Vicki Saporta, chief executive officer of the National Abortion Federation, the professional association for abortion providers. "These people trespass, their trespasses get reported, and law enforcement doesn't end up prosecuting that level of criminal activity."

Trash is at the center of several disputes involving patient privacy and abortion.

In Kansas City, Operation Rescue says a now-closed clinic improperly discarded records for at least 86 patients. In 2012, the group said it had received files from an informant, some of which included names and phone numbers. The group posted examples on its website.

Jeff Pederson, the former manager of the clinic, said the dumpster was located on private property and was locked. He later learned, however, that his waste company used a common key for all of its locked containers, which may have allowed an outsider to open it.

Pederson said he filed a complaint with local police about trespassing, which was caught on a low-resolution camera on the property, but it went nowhere. The state's investigation into Operation Rescue's complaint against the clinic and its physician remains open, Pederson said.

Cheryl Sullenger of Operation Rescue in Wichita, Kan., says clinics have failed to protect women's privacy rights.

Travis Heying for The Washington Post/Getty Images

At least some cases involving clinic dumpster dives have resulted in complaints to the Office for Civil Rights within the Department of Health and Human Services. The office is charged with enforcing the Health Insurance Portability and Accountability Act, or HIPAA, which prohibits patients' medical information from being shared without their consent.

The office cited three Michigan clinics in 2010 after abortion opponents said they found records including intake forms, drivers' licenses and recovery room reports, as well as fetal remains, in dumpster bins. One clinic blamed a janitorial service, but all subsequently took steps to comply with the law. Separately, Michigan prosecutors charged that one clinic with illegally disposing of patient records. Its corporate owner pleaded guilty to one count, which was dismissed six months later.

Since HIPAA only covers clinics if they transmit health information electronically, the Office for Civil Rights has been unable to pursue some complaints related to abortion records, spokeswoman Rachel Seeger said in an email. A Louisiana abortion clinic that was the subject of a 2014 privacy complaint fell outside the office's jurisdiction for that reason, she said.

Sullenger said groups like hers began rummaging through clinics' trash in part because they were having difficulty getting regulators interested in investigating abortion providers.

Activists see plenty of potential evidence in the material that clinics throw away, which has sometimes fallen into the hands of random passersby.

In 2012, for example, a Kansas woman found more than 1,000 abortion records dumped in a recycling bin outside an elementary school. The clinic had shut down. "I was under the impression that these would not be seen by anyone," its former owner told the Kansas City Star. "I thought that these would be recycled away just like any other papers."

Abortion opponents are as entitled as anyone else to help themselves to clinics' discards, Sullenger said.

"If it's lying out on the curb, it's a free-for-all, you know what I'm saying? That's the way we look at it," she said.

Operation Rescue filed complaints with Texas regulators based on material found by volunteers in the dumpsters of several Texas clinics in 2010 and 2011.

The group collected medical waste, as well as sonograms and documents containing patient names, the names of escorts, dates of abortion, whether the patient had been to the clinic before and the patient's referral source, among other things.

Operation Rescue posted a couple of examples on its website, redacting patient names. "All of your information will be kept very confidential," the clinic documents say. An investigation by the Texas Commission on Environmental Quality found that at least two clinics had improperly disposed of aborted fetuses.

Sometimes authorities are reluctant to act even when they are provided with evidence, anti-abortion activists say.

This year, Lynn Mills, a leader of Pro-Life Detroit, went to a shuttered medical clinic near Flint, Mich., run by the same doctor who had operated the clinic cited in 2010 by the Office for Civil Rights. At the Flint facility, she said, she discovered rows of boxes containing patient records from clinics the doctor had owned, as well as piles of syringes on the floor.

She called the authorities, but dispatch recordings show local law enforcement was unsure what to do about her discovery.

Mills was left frustrated. "You would think they'd say, 'Thank you, Lynn,' " she said. "Basically, nothing happened."

Michigan health regulators said they "immediately" dispatched an inspector in the area to verify the building was secured and did so again after receiving a second call. They also contacted the Flint police department to see if they had sent a person out too, which they had.

"In short, the building was being used as a warehouse and secured," wrote Michael Loepp, a spokesman for Michigan's Department of Licensing and Regulatory Affairs, in an email.

The records were removed within days, Mills said, and the doctor is no longer licensed to practice in Michigan. The doctor did not return telephone calls seeking comment.

Occasionally, activists' complaints about privacy violations have alerted authorities to broader problems involving abortion providers.

Last year, Operation Rescue filed a complaint against an Oklahoma City abortion doctor, saying an "anonymous source" had provided the group with medical records that had been thrown away in unsecured garbage bins.

The group said the records had been discarded before the seven-year period required by law had expired, and that "sensitive documents were placed in the common trash where any person or animal poking through garbage could easily find and uncover such personal and confidential paperwork."

The Oklahoma attorney general's office investigated and found wrongdoing that went well beyond record keeping. The doctor was charged with felonies for providing abortion drugs to undercover agents who were not pregnant. He also agreed to stop practicing medicine.

The doctor's attorney, Mack Martin, said his client was never charged with any privacy violations but has pleaded not guilty to the other charges against him. "Their allegation was that by not having shred the evidence [records], he violated HIPAA," Martin said. "I guess maybe from the strictest technicality that may be true, but normal citizens don't dumpster dive."

Sullenger said she recognizes that sifting through garbage appears unsavory, but she said it won't stop anytime soon.

"Is it a little bit on the sketchy side? Yeah, maybe. Who wants to dig through trash? But if we can find evidence of wrongdoing, we'll dig through trash all day long."

Charles Ornstein is a senior reporter at ProPublica, a nonprofit news organization based in New York.

Has your medical privacy been compromised? Help ProPublica investigate by filling out a short questionnaire. You can also read other stories in our Policing Patient Privacy series.

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How The Prescription Painkiller Fentanyl Became A Street Drug

Wed, 08/26/2015 - 2:43pm

Fentanyl, a synthetic opioid, has been used for decades as a painkiller in the operating room.

Joe Amon/The Denver Post/Getty Images

If you've ever had surgery, you may have been given an analgesic named fentanyl.

Fentanyl is a favored painkiller because it acts fast. But it's also 80 to 100 times more potent than morphine. The powerful drug has made its way to the streets and increasingly is being used to cut heroin — resulting in a deadly combination.

Fentanyl abuse first became a problem some 25 to 30 years ago, way before it started being mixed with heroin, says Dr. Neil Capretto, an addiction physician at the Gateway Rehabilitation Center in Aliquippa, Pa.

Fentanyl, Capretto explains, was originally invented to relieve pain and is often injected in patients prior to surgical procedures. The synthetic opioid can also be prescribed in a lozenge or patch to treat the severe pain associated with metastatic, colon and pancreatic cancer.

"Patterns of abuse actually began with hospital workers, anesthesiologists and nurses," Capretto says. "There were a rash of [health specialists] dying from overdose. You'd hear of them getting it in the operating rooms by drawing out fentanyl from vials and putting saline in its place."

Later, when take-home fentanyl patches were invented, patients began abusing the painkiller, too.

"There were occasional cases of people eating [the patches] or steeping them like tea," he says. "And because fentanyl is so powerful, we started seeing more drug overdoses and death."

In the 1980s, synthetic fentanyl became infamous as a street drug sold as China White, says Capretto. (The name was originally used as a brand for heroin.) That was pretty bad, he says, but even more dangerous is mixing heroin and fentanyl.

Today, drug dealers are addig fentanyl to heroin because it creates an intense high. Between 2005 and 2007, more than 1,000 U.S. deaths were caused by fentanyl-heroin overdoses, according to the Drug Enforcement Administration. Seizures of drugs containing the painkiller jumped from 942 to 3,334 between 2013 and 2014. In March, the DEA issued a warning on fentanyl as a "threat to public health and safety."

The combination of the two drugs makes users feel drowsy, nauseated and confused, but also euphoric.

The euphoria probably hits a lot faster when fentanyl is mixed with heroin, says Dr. J.P. Abenstein, president of the American Society of Anesthesiologists. It's that super-quick potency of fentanyl that makes it dangerous; a little can go a long way.

"What happens is that people stop breathing on it," Abenstein explains. "The more narcotic you take, the less your body has an urge to breathe. And it makes sense that a lot of people are overdosing on it because they aren't sure how much to take."

Capretto agrees. The rehab physician recently treated a heroin addict who tried fentanyl for the first time and overdosed. "Before he even took the needle out of his arm, he was unconscious."

Paramedics administered Naloxone, a drug that can reverse opioids overdoses, just in time to save the man's life.

Illegal drug labs are concocting fentanyl from scratch, according to the National Institute on Drug Abuse. Authorities have raided several labs in Mexico that were receiving chemicals from China and Japan to create the drug, according to the DEA.

But Capretto thinks there are labs in the U.S. making fentanyl, too.

"Drug dealers are in the business of making money and I've heard it's very easy to make, so that means they can save money [by doing it themselves]," he says. "I wouldn't be surprised if there were real Walter Whites out there. Chemists and pharmacologists can turn to the dark side, just like in Breaking Bad."

Nadia Whitehead is a freelance journalist based in El Paso, Texas.

Copyright 2015 NPR. To see more, visit http://www.npr.org/.
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Illicit Version Of Painkiller Fentanyl Makes Heroin Deadlier

Wed, 08/26/2015 - 2:41pm
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Heroin sold in the U.S., like this dose confiscated in Alabama last fall, is often cut with other drugs.

Tamika Moore/AL.com/Landov

Angelo Alonzo, a resident of Portland, Maine, says he nearly died last month after injecting what he believed to be a safe dose of heroin — the same amount he's taken before. But this time, he says, the drug knocked him to his knees.

"An amount that usually gives me a good mellow high was just way too much," he says, "and I woke up in the shower and I was cold. And I didn't put myself there."

Alonzo was lucky: A friend quickly treated him with Naloxone, an emergency antidote, and he entered a rehab program. While it would take a toxicology workup to discover exactly what was in the "heroin" that floored him, Alonzo says he suspects some form of fentanyl — a drug that's making a big showing in Maine.

All around North America, U.S. drug officials warn, some drug dealers are lacing heroin with an illicit version of the potent anesthesia drug fentanyl. The dangerous combination is quickly killing unsuspecting users — and worsening the nation's epidemic of deaths from heroin overdose.

According to the U.S. Drug Enforcement Administration, fentanyl is 30 to 50 times more potent than heroin, and 80 to 100 times more potent than morphine.

Regional drug dealers add the illicit form of fentanyl to the heroin they sell in hopes of restoring the potency of a product that's been diluted by dealers higher up the distribution chain.

"If you make that right mix, everyone loves your stuff," Alonzo explains. "But, you know, that right mix might kill some people, too."

Pharmaceutical-grade fentanyl is useful during surgery as an anesthesia drug and, in carefully titrated amounts. It also can be a blessing for patients in severe pain. But in the past two years, according to federal drug agents, Mexican cartels have ramped up production of a variant called acetyl fentanyl in clandestine labs. They are smuggling this version into the United States.

According to the DEA, acetyl fentanyl may be slightly less potent than fentanyl, but is still quite powerful. It is not yet included in many screens for toxic drugs, the DEA says. And this variant of fentanyl is also not approved for medical use in the United States.

Acetyl fentanyl's street price is slightly higher than heroin's, according to the DEA. But drug dealers apparently think the drug's stunning potency makes it a good deal, nonetheless. The flip side? Two milligrams or less — a dose the size of a few grains of salt — can kill.

"Heroin is bad enough, but when you lace it with fentanyl, it's like dropping a nuclear bomb on the situation," says Mary Lou Leary, a deputy director in the White House's office of National Drug Control Policy. "It's so, so much more dangerous."

There were at least 700 fentanyl-related deaths nationwide in a period from late 2013 through 2014, say federal officials. And many states, as well as Canadian provinces, are reporting a sudden wildfire of overdose deaths.

Two years ago, for example, Maine authorities documented just seven deaths related to illicit fentanyl. A year later the number of deaths jumped to 43, and Maine Attorney General Janet Mills says the problem is getting worse.

"In July alone, we suspect that approximately one death a day in Maine was due to a drug overdose of some sort," she says. "We are confirming this with laboratory testing, but a substantial number of those involved fentanyl."

Law enforcement officers and policymakers are struggling to react to the problem's fast-moving spread. Only a handful of states have added acetyl fentanyl to their lists of banned substances. And the DEA added it to the federal list just this year.

Mills says prosecutors should seek the ability to make felony charges in fentanyl cases. That would not only facilitate dealmaking with users to get better information about drug networks, she says, but would also be useful leverage in getting more heroin users into drug treatment.

"We want to have a significant sentence hanging over them, Mills says, "so that we can encourage them — force them, if you will — into treatment."

Federal and state authorities are trying to boost public awareness about fentanyl and have tried to get out the word locally when they discover a particularly dangerous batch of heroin on the streets.

But there's a terrible irony in all this: For some heroin users, as Angelo Alonzo says, danger is magnetic.

"Usually when someone hears that people are dropping or dying out there — that's usually when an addict wants that specific stuff," Alonzo says. "They think that the high is unbelievable and they want it. You can understand why. But that's a tough call. You're playing with your life. "

It's unclear what Alonzo's next call may be in his own difficult road toward recovery. He recently checked out of the local rehab shelter — against medical advice.

Fred Bever is a freelance reporter in Portland, Maine.

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

Texting Helps Low-Income Diabetes Patients Manage Insulin Dosing

Wed, 08/26/2015 - 12:52pm

Text messages helped remind diabetes patients to check their blood sugar and report in.

iStockphoto

People whose diabetes requires insulin injections usually have to make a series of visits to the doctor's office to fine-tune their daily dosage. But many low-income patients can't afford to take those few hours off to see the doctor. As a result, they often live with chronically elevated blood sugars for weeks or months until they can find time to get to the clinic.

But mobile technology can help patients with the process of titrating their dosage without them having to see a doctor, according to a study from New York's Bellevue Hospital.

For people with chronic conditions, mobile technology can provide crucial support and lower costs. Doctors have used mobile messaging to prompt hypertensive patients to measure their blood pressure and to remind HIV-positive people to return for regular lab testing. For people tracking their overall health, Apple's new HealthKit makes it easier for different health and fitness apps to exchange data.

So Natalie Levy, an assistant professor at the New York University School of Medicine and head of Bellevue Hospital's Diabetes Program, decided to try mobile technology to help her low-income diabetes patients adjust their insulin doses remotely.

When diabetics initially start taking insulin shots, they need to check their blood sugar at least once a day to make sure their dosage is correct.

Bellevue, which has traditionally served New York's poor, sees about 5,000 diabetes patients a year. In a survey Levy conducted, one patient reported that it often took three to four months to return for each followup visit during the titration phase.

"Many [diabetic patients] have jobs that don't provide sick leave, or they have young children or grandchildren in their care," she says.

Wearables like Fitbit or Jawbone cost far too much for most of Levy's patients, and less than half of this population owns a smartphone. Nearly all of Bellevue's diabetics, though, have mobile phones with a text-messaging feature.

Levy's team designed a pilot study called Mobile Insulin Titration Intervention, or MITI. A small subset of Bellevue's insulin-dependent diabetics, 33 patients, got a daily reminder to take a morning blood sugar reading and text that value back. Nurses reviewed the information daily online to check for values that were too high or too low, indicating the insulin dose needed to be adjusted.

Once a week, the patients spoke by phone to the diabetes nurse to adjust dosage as needed. This routine lasted 12 weeks. A control group of 27 patients got the usual kind of care and titrated their insulin with in-person office visits.

The differences between the two groups were stark.

Of the group that got daily text messages and weekly phone calls, 88 percent were able to get their blood sugars within an acceptable range. Only 37 percent of the comparison group managed to control their blood sugars. The results of the study were published in the Journal of Medical Internet Research in July.

Levy and her team also estimated that the remote titration group saved about two hours of time, plus the $15 copays that many other participants paid for office visits. The intervention appears feasible, too, since patients sent blood glucose values back more than 80 percent of the time, indicating that the daily task wasn't too arduous.

Moreover, Levy says the mobile titration patients reported feeling more in control of their illness and more accountable for complying with medical advice.

"I was actually checking my finger sticks every day," one participant noted in a post-study survey. Said another, "It got my head in the game."

Bellevue is the oldest public hospital in the United States. The majority of its patients come from underserved communities in New York.

Levy says mobile tech offers a new avenue for helping patients manage their chronic diseases.

Dominick Frosch, a patient-care researcher at the Gordon and Betty Moore Foundation in Palo Alto, Calif., echoes Levy's sentiments. He advocates for making patients with chronic diseases the primary managers of their illness. The clinician, he says, is a "consultant" for developing a day-to-day management plan.

If doctors don't take stock of what patients are realistically capable of, Frosch says, "they end up prescribing treatments patients can't fit into their lives."

Often, minor modifications can make a huge impact. And the more flexible doctors can be at using various media, Frosch says, like phone, email and patient portals, the better they can be at getting patients to manage their own illnesses.

MITI may soon become a hospitalwide program at Bellevue. The Health and Hospitals Corp. that runs Bellevue and other public hospitals in New York City is now looking into improving the system for sending secure private health information over text messages. Levy is looking forward to crossing that hurdle so that the MITI protocol can be provided on an ongoing basis to a much larger pool of diabetic patients.

Rina Shaikh-Lesko reported this story for KQED's Future of You blog, which explores the intersection of emerging technologies, medicine and health care.

Copyright 2015 KQED Public Media. To see more, visit http://www.kqed.org.
Categories: NPR Blogs

Wildfire Smoke Becomes The Health Threat That Won't Go Away

Tue, 08/25/2015 - 4:35pm

Smoke rises from a wildfire approaching Twisp, Wash., on Aug. 19. Smoke can damage the health of people hundreds of miles downwind.

Ted S. Warren/AP

I stepped out my parents' front door last Thursday, expecting a typically glorious summer day in southern Oregon. Instead, I was hit with acrid wood smoke that stung my eyes and throat. The air was thick with haze that obscured the mountains. I quickly retreated inside.

Health departments across the West are mobilizing to protect residents from smoke generated by dozens of fires that have sent smoke as far east as the Midwest.

"It's really bad," says Janice Nolan, assistant vice president for national policy at the American Lung Association. "I hadn't seen 'code maroon' days, which is the most hazardous air quality, in years."

A screenshot of fire conditions on AirNow.gov, with orange icons showing fires and gray representing smoke.

via AirNow

Lewiston, Idaho, is stewing under "very unhealthy" smoke, with older people, people with heart and lung disease and children urged to "avoid all physical activity outdoors."

And it's hardly the only city affected. Last weekend, Portland, Ore., which typically enjoys crystalline summer skies, was swathed in unhealthy levels of smoke that resembled wintry fog. It had drifted in from fires in Washington state.

"Unfortunately, this may be the new normal for us," says Jim Vannoy, program manager for environmental health programs at the Idaho Division of Public Health. "Not just for a day or two, but for weeks on end."

An extended drought and climate change mean more fires that burn longer, Vannoy says. The public health department is trying to get the word out through the state's smoke blog and social media, so people can learn how to protect themselves.

For schools, that means indoor recess and no outdoor sports practice when air quality levels are unhealthy, according to an advisory the public health department sent to Idaho schools.

Tiny particulates in smoke travel deep into the lungs, where they evade the body's defense systems, Nolen says. That poses an especially big threat to people with asthma, cardiovascular disease or lung diseases. Children are susceptible even if they're healthy, she says, because their lungs are still developing.

Staying inside is the best defense, Nolen says, with air conditioning set to recirculate air. Check the local air quality index before heading out. "If it's anything above a code green, people will be affected."

Face masks don't help, according to both Nolen and Vannoy. Lightweight masks used to fend off germs don't keep out fine particulates, and N95 masks that do are uncomfortable to wear all day. "We really hesitate to recommend face masks," Vannoy says. "We really want people to stay indoors."

The state may also consider establishing clean air shelters where people can get away from the smoke, he says.

If there's any silver lining, it's Vannoy's final recommendation: "We recommend not vacuuming." Most home vacuums don't have HEPA filters that catch tiny particles, he says. So if you're smoke afflicted, ditch the vac for the sake of public health.

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

Why Your Doctor Won't Friend You On Facebook

Tue, 08/25/2015 - 12:35pm

Patients of the Minnesota-based St. Cloud Medical Group can follow a public page on Facebook.

Meredith Rizzo/NPR

Doctors' practices are increasingly trying to reach their patients online. But don't expect your doctor to "friend" you on Facebook – at least, not just yet.

Physicians generally draw a line: Public professional pages – focused on medicine, similar to those other businesses offer – are catching on. Some might email with patients. But doctors aren't ready to share vacation photos and other more intimate details with patients, or even to advise them on medication or treatment options via private chats. They're hesitant to blur the lines between personal lives and professional work and nervous about the privacy issues that could arise in discussing specific medical concerns on most Internet platforms.

Some of that may eventually change. One group, the American College of Obstetricians and Gynecologists, broke new ground this year in its latest social media guidelines. It declined to advise members against becoming Facebook friends, instead leaving it to physicians to decide.

"If the physician or health care provider trusts the relationships enough ... we didn't feel like it was appropriate to really try to outlaw that," said Nathaniel DeNicola, an OB-GYN and clinical associate at the University of Pennsylvania, who helped write the ACOG guidelines.

But even the use of these professional pages raises questions: How secure are these forums for talking about often sensitive health information? When does using one complicate the doctor-patient relationship? Where should boundaries be drawn?

For patients, connecting with a physician's office or group practice on Facebook can be a simple way to keep up with basic health news. It's not unlike following a favorite sports team, your child's middle school or the local grocery store.

One Texas-based obstetrics and gynecology practice, for instance, uses a public Facebook page to share tips about pregnancy and childcare, with posts ranging from suggestions on how to stay cool in the summer to new research on effective exercise for post-birth weight gain. Practices have also been known to share healthy recipes, medical research news, and scheduling details for the flu shot season.

"I have people come up to me and say, 'I follow you on Facebook — thank you for posting this particular article. It helped me and my husband and my family,' " said Lisa Shaver, a primary care physician based in Portland, Ore.

But unless they're already friends, she won't add patients to her personal account, where, she said, she posts less health information and more cat videos.

Historically, professional groups including the American College of Physicians and American Academy of Family Physicians have advised against communicating through personal Facebook pages. The American Medical Association notes social media can be a valuable way to spread health information, but urged doctors in its 2010 guidelines to separate their personal and professional online identities to "maintain professional boundaries."

Finding ways to use Facebook and other forms of social media to connect with patients — even if it may just be through professional pages — fits a trend in which patients seek more equal footing with their doctors, said Zack Berger, an assistant professor of medicine at the Johns Hopkins School of Medicine who studies patient-doctor relationships and social media.

It also follows what James Colbert, a hospitalist at Massachusetts-based Newton Wellesley Hospital, described as the growing consumer approach to medicine, including the notion that patients should be able to reach their physicians at all hours. Colbert is also an instructor at Harvard Medical School who researches how patients want to fit social technology into their health care.

Email can be a particularly convenient method, though it isn't without concerns. Eva Schweber, 44, emails her doctor from a personal account and sends messages through an online portal — a more digitally secure system that is being adopted by a growing number of practices. The portal, she said, is for discussing complex, specific information. She'll email her doctor from her personal email for less private concerns: scheduling, filling prescriptions and asking if certain symptoms might warrant a checkup.

"The unsecure email is easier, in that I can do it from my phone, my tablet, whatever," said Schweber, of Portland, Ore.

In a recent study published in the Journal of General Internal Medicine, almost 20 percent of patient respondents reported trying to contact doctors through Facebook, and almost 40 percent through email. "Patients want to communicate with doctors [in whatever way] is convenient," said Joy Lee, a postdoctoral research fellow at the Johns Hopkins Bloomberg School of Public Health, and the study's lead author.

Doctors don't yet seem to share that enthusiasm, Colbert said.

Meanwhile, security questions persist.

Social networking platforms aren't usually digitally encrypted, increasing the odds they could get hacked or shared with third parties. The same worries hold true for other, casual forms of online communication such as email and text-messaging.

That means doctors who discuss specific health concerns with patients through those could break the Health Insurance Portability and Accountability Act, the patient privacy law.

"Those concerns are always going to be there," said David Fleming, past president of the American College of Physicians. "How private is it when we share, when we talk to people? ... Once I've written it or once I've emailed it, it's gone, and I have no control."

But because HIPAA was written before email and social media's ascent, it may not address patient preferences or behavior, Colbert said. With more patients becoming comfortable using personal accounts for health needs, he said, the law perhaps deserves another look.

"Should we allow patients to be able to share or send messages without going through these privacy safeguards if they're willing to do so? Or do we say that that's not safe and even if patients don't care about privacy we need to protect them," he said. "That's an open question."

That public nature is a real worry for patients like Katie Cardenas, 45, who lives in Garner, N.C. She doesn't think Facebook is secure enough for personal medical details. For sensitive information, she'll usually send messages through a patient portal, the more secure website her doctor's practice has set up.

Doctors could address that, several said, by using social media in other ways. These include maintaining active Twitter presences and professional Facebook pages for less-tailored health tips. That way, patients can get useful information and a sense of their doctors as people, but privacy stays intact and physicians maintain distance.

At the Minnesota-based St. Cloud Medical Group, patients can follow a public page. Doctors who are part of the practice post updates with safety tips and seasonal health reminders, or use the page to coordinate and publicize small projects, such as a week-long initiative geared to reducing children's screen time.

Julie Anderson, a family physician who is also part of the practice, sees the value in this option, but doesn't personally befriend patients on Facebook. Beyond patient privacy, she said, she fears blurring her personal and professional lives, or patients using that access to seek extra care when she's off the clock.

"I've known colleagues that have friended somebody and have had inappropriate questions asked online, in terms of kind of abusing service," she said. "Or abusing that ... Facebook friendship, where they're asking medical advice and you're not even their physician."

Copyright 2015 Kaiser Health News. To see more, visit http://www.kaiserhealthnews.org/.
Categories: NPR Blogs

Katrina Shut Down Charity Hospital But Led To More Primary Care

Mon, 08/24/2015 - 12:40pm
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Attorney Ermence Parent stands on the porch of her New Orleans home. Two hip replacements eased Parent's pain and got her exercising again, she says. A doctor at one of the city's newly renovated clinics made the diagnosis.

Edmund D. Fountain for NPR

Five years ago, New Orleans attorney Ermence Parent was struggling to find out what was wrong with her leg. She was 58 years old, and her right leg hurt so much that she needed a cane. That was not only painful, but frustrating for a woman who routinely exercised and enjoyed it. Parent sought advice from several doctors and a chiropractor, but got no diagnosis.

Shots - Health News Katrina's Emotional Legacy Includes Pain, Grief And Resilience

Then she made an appointment at the newly renovated St. Thomas Community Health Center, a primary care clinic dedicated to providing quality care for people regardless of insurance status. Most patients, including Parent, are on Medicaid or Medicare. Some pay on a sliding scale. Parent saw internist Dr. Mary Abell, who is now medical director of the clinic.

Abell took a careful medical history, looked at Parent's X-rays and watched as she walked up and down the hallway

"'Baby, your hips are going,' " the doctor told Parent. The attorney had "bone-on-bone" arthritis. Without surgery, the doctor said, "'in about six months you're going to be in a wheelchair.' "

Instead, about a month later, Parent received her first hip replacement, and nine months later, her second.

Today, she's back to exercising, has lost weight and sleeps more soundly. "You know, changing those two hips just rejuvenated me; it gave me years back on my life," Parent says.

When Katrina hit in 2005, many health facilities were destroyed or otherwise shut down, including urgent care centers, nursing homes, pharmacies and hospitals. The renowned and beloved Charity Hospital, a public facility that had served the city's poor for centuries, was forced to close.

Many said the loss of the hospital was devastating. Charity represented a precious connection to health from childhood through old age.

But the attachment people felt to the old institution may have been based more in sentiment than fact, says Abell, especially when it came to primary care. She says patients had to rely on a trip to the emergency room if they didn't have health insurance and had ongoing chronic problems.

"Before Katrina, there was no primary care or preventive medicine — really, truthfully — for patients," Abell says. "None. Zero."

Back then, a patient with a medical problem that wasn't acute often had to wait months to schedule an appointment, she says. And once they showed up for the appointment, they might have to wait all day — or even end up with the wrong clinic or with the wrong physician. Abell says the situation was "very disrespectful" to patients.

Today is a "different day," Abell says. In recent years, a network of renovated and newly built primary care health clinics has opened, which she and New Orleans residents hope will bring a new degree of stability to the health care that the city's low-income residents get.

Katrina was devastating, Abell says, but after its ruin, New Orleans received a dramatic infusion of cash from the state and federal governments, and from private foundations. The funds resulted in new hospitals, new clinics and an enormous state-of-the-art facility that replaced the old Charity Hospital.

University Medical Center New Orleans on Aug. 1, when the $1 billion facility welcomed its first patients.

Brett Duke/The Times-Picayune/Landov

University Medical Center New Orleans, which opened this month, is just a few blocks from the shuttered hospital. The new facility's gleaming buildings, hundreds of patient beds and high-tech specialty care, stand in startling contrast to the old institution.

Abell has high hopes the new medical center will provide timely, excellent care for both acute and chronic needs. And her biggest praise is for the new network of primary care clinics.

"Today, a patient can call and get same-day primary care," Abell says, an improvement that Ermence Parent attests to, as well. A few months ago, when Parent's leg became swollen, she called the clinic and was seen right away.

In a recent poll of New Orleans residents by NPR and the Kaiser Family Foundation, 72 percent of adults agreed that progress has been made in the availability of medical facilities and services in the city. But the majority of residents — 64 percent — also said more needs to be done to provide care for people who are uninsured and have low incomes.

And among African-Americans, nearly half said they're very worried that health care services may not be available when they need them. Only 13 percent of white adults said they are very worried in that way.

According to Abell, one of the biggest remaining weaknesses in the current system in New Orleans is timely access to specialty care like orthopedics, neurology and cardiology.

It's a problem, she says, "when you can't get your patient in to be seen for an issue that's evolving, and you know that some specialty advice would be helpful." She says she's had to rely on personal connections ­— and 30-plus years of experience working in the city — to help her poorer patients gain timely access to specialty care. She's anticipating that the new University Medical Center will help remedy that.

That hope extends to mental health care, as well. Rashain Carriere-Williams, who directs program operations at Boys Town Louisiana, a community organization that helps troubled families and children, says the need for mental health treatment in the city is huge.

After Katrina, psychiatrists fled New Orleans, along with many other people. Unfortunately, Carriere-Williams says, most psychiatrists never came back. In the entire city, there are now only two or three psychiatrists who accept Medicaid and are willing to see her patients and their families, Carriere-Williams says.

"A lot of times it's easier to get them in to see a psychologist, because there are more of those," she says. But psychologists can't prescribe the medication some patients need.

Although the new hospital has some beds dedicated to patients in need of mental health treatment, the number of beds isn't nearly high enough, she says.

She's been faced with heartbreaking situations — including one New Orleans boy who recently threatened suicide and had to be placed on suicide watch. The only facility with an inpatient bed was a six-hour drive from the city. The family drove their child there for a 72-hour hold, and the child temporarily got the needed care, says Carriere-Williams. But the experience was grueling, at a time when the family was extremely fragile.

Carriere-Williams says she's hopeful the new clinics and hospitals will begin to fill the big gaps in the community's mental health needs. But, based on Louisiana's and New Orleans' history in that regard, she says, she's skeptical.

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

Snooze Alert: A Sleep Disorder May Be Harming Your Body And Brain

Mon, 08/24/2015 - 4:39am
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It's time for consumers to wake up to the risks of sleep disorders, scientists say.

More than 50 million adults in the U.S. have a disorder such as insomnia, restless leg syndrome or sleep apnea, according to an Institute of Medicine report. And it's now clear that a lack of sleep "not only increases the risk of errors and accidents, it also has adverse effects on the body and brain," according to Charles Czeisler, chief of the division of sleep and circadian disorders at Brigham and Women's Hospital in Boston.

Research in the past couple of decades has shown that a lack of sleep increases a person's risk for cardiovascular disease, diabetes, infections and maybe even Alzheimer's disease. Yet most sleep disorders go untreated.

Michael Arnott, of Cambridge, Mass., says he used to have trouble staying awake on long drives. Sleep specialists discovered he has obstructive sleep apnea, though not for the most common reasons — he isn't overweight, and doesn't smoke or take sedatives.

M. Scott Brauer for NPR

Michael Arnott, who is now 67, began having sleep problems in his 50s, he says. As a result, he often found himself having trouble staying awake during long drives on the Massachusetts Turnpike.

"I would get groggy and feel like I've got to keep talking, open the window," Arnott says.

His wife, Mary White, says being a passenger on those drives could be scary.

"All of a sudden there'd be a change in the speed and I'd look over, and his eyes would be starting to close," she remembers.

White thought her husband might have sleep apnea, which interferes with breathing. But Arnott was in denial. He figured he was free of most risk factors for apnea. He wasn't overweight, he didn't smoke or take sedatives, and he has always stayed in great shape.

"I'm a runner. I've run for more than 40 years," he says. "I used to do marathons. Now I just do 5- and 10-kilometer road races."

So his wife took the initiative. "I asked him to see a doctor and he wouldn't," she says. In 2012, though, White persuaded him to take part in a sleep research study that paid for his participation, and took place at a sleep lab in Boston, not too far from the couple's home in Cambridge.

Doctors found a couple of problems. "I've got what they call moderate obstructive sleep apnea," Arnott says. He also has a form of restless leg syndrome that causes him to kick during sleep.

Those conditions, along with his tendency to stay up late and wake up early, meant he wasn't getting enough quality sleep. And research in the past couple of decades has shown that's a problem even if you're not nodding off on the Massachusetts Turnpike.

Much of that research was done in the same sleep lab at Brigham and Women's Hospital where Arnott was diagnosed. The lab includes rooms that are completely isolated from the light, sounds and even vibrations of the outside world. As study participants sleep in these rooms, their brain waves, respiration, oxygen levels and other signs can be monitored from a central control room.

In highly controlled environments like this one, Czeisler and other researchers have shown that sleep affects everything from blood pressure to memory to metabolism.

"Within 2 1/2 weeks we can take someone who is young, healthy and fit and put them in a pre-diabetic state just by putting them on an irregular schedule," Czeisler says.

Research also has shown a strong connection between sleep and the immune system, Czeisler says. "People who are not getting sleep, if they're exposed to a virus like the adenovirus — that causes the common cold — they will have a 200 to 300 percent increased risk of actually catching a cold," he says.

Many studies suggest that a lack of sleep raises the risk of a heart attack or stroke. And most recently, Czeisler says, scientists have found evidence that the brain actually needs sleep to stay healthy.

"It's during sleep that we clear out many of the toxins that build up during wakefulness," Czeisler says. Among those toxins is beta-amyloid, which produces the sticky plaques that appear in the brains of people with Alzheimer's disease.

Most sleep disorders can be treated, but often they aren't. Arnott, the sleepy driver from Cambridge, didn't address his symptoms until his wife pushed him to take part in a sleep study.

When worn at night, the mask of a CPAP (continuous positive airway pressure) machine delivers enough air pressure to keep the upper airway passages open. Blocked passages are behind the poor sleep and other symptoms associated with obstructive sleep apnea.

Dr. P. Marazzi/Science Source

"My whole clinic is full of patients who are brought in by their spouses," says Dr. Andrew Wellman, a sleep specialist at Harvard and Brigham and Women's who has cared for Arnott.

When Wellman is assessing a new patient, he asks a simple question: "Do your eyelids get heavy when you'd prefer to be awake?" If the answer is yes, that is a very specific indication that someone isn't getting enough sleep. Symptoms such as fatigue or feeling tired are less specific, and can have other causes, he says.

Much of Wellman's practice is devoted to sleep apnea, which affects about 1 in 3 adult men and becomes more common with age.

Wellman says a sleep apnea diagnosis usually requires an overnight sleep study to measure the flow of air in and out of the lungs. "If that flow is diminished, then that is the primary measurement that we use to detect these sleep apnea events," he says.

The problem can be in the brain — a condition called central apnea. But more often the airway is getting blocked repeatedly during sleep, a disorder called obstructive sleep apnea.

Arnott has an unusual variant of obstructive sleep apnea, Wellman says. "His airway actually collapses at the epiglottis, which is a structure just below the base of the tongue that prevents food from going down in the airway."

Regardless of the cause, the go-to treatment for sleep apnea is a continuous positive airway pressure (CPAP) machine. Arnott tried one for three months and hated it.

Instead of relying on forced air to keep his airway open when he sleeps, Arnott now wears this soft oral appliance at night. The device is more comfortable than CPAP, he says, and has decreased his apnea symptoms to "negligible" or "mild."

M. Scott Brauer for NPR

"You have to have a mask on your face; you have a machine making noise all night, and you have to have electricity," he says. "We hike. We go to places in the White Mountains of New Hampshire and Maine, where electricity is not always there."

Complaints like those are pretty common among people using CPAP machines, Wellman says. "Somewhere around 50 percent of patients don't adhere to their therapy. Probably there are many people that don't even come to the sleep lab because they know they might get that breathing machine, and they don't want it."

One alternative is surgery to help keep the airway open. Another is an oral appliance that moves the lower jaw forward.

Arnott eventually switched to an oral appliance and has made a series of other changes. He sleeps on his side, which reduces apnea. He tries to get to bed at the same time each night. And he has begun doing yoga before bedtime, which he says helps with his restless leg syndrome.

Those steps have made a big difference, Arnott says. For one thing, he no longer falls asleep at the wheel. And now, he says, "There are times on long trips when Mary actually says, 'I'm getting groggy. You drive.' "

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

After A Divorce, What Happens To A Couple's Frozen Embryos?

Sat, 08/22/2015 - 7:29am
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Frozen sperm straws and embryos are stored in liquid nitrogen, in a process known as cryopreservation. One question confronting the courts: Should embryos such as these be treated as property, or as children subject to custody action?

Veronique Burger/Science Source

Soon after their wedding, Dr. Mimi Lee and Stephen Findley decided to create five embryos. Lee had just been diagnosed with breast cancer, and she worried that treatment would leave her infertile. Now that they're divorced, Lee wants to use them; Findley, however, does not.

Those embryos are at the heart of a court case that will soon decide a very modern problem: Which member of a divorced couple gets control of their frozen embryos?

For this San Francisco couple, at least, it would seem to be an open-and-shut case. Findley points to a clinic consent form the two of them signed, which stipulates that if the pair divorced, their embryos would be destroyed.

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But while a signed document might help, Judith Daar of Whittier Law School says it's not necessarily decisive. She says that courts have been all over the map on this issue — and points to one Massachusetts case in particular.

"There were seven contracts in that case, because the couple had seven rounds of IVF [In Vitro Fertilization], and all of them provided that she would get the embryos," Daar says. "But in the end, the court said that it would violate the public policy of that state to force the man to become a parent against his wishes."

That reasoning would favor Findley's argument — and Daar says that overall, courts have tended to side with the party who wants to avoid procreation. But Lee in this case has her own compelling argument.

"My client at this point in time is 46 years old, and just simply as a matter of her age she is virtually infertile," says Peter Skinner, the attorney for Lee. "She really doesn't have any other realistic option to have a biologically related child, other than to use the embryos that she created for that very purpose."

Skinner says no court has ruled against someone in that position. He also maintains that what Lee and her ex-husband signed is not a legally binding contract.

Shots - Health News Fertility Clinic Courts Controversy With Treatment That Recharges Eggs

The fertility clinic the couple used disagrees; it has sided with the ex-husband, whose attorneys did not respond to an interview request for this article.

And there's another difficult question at work here: Is an embryo a child? Judy Sperling-Newton, the director of the American Academy of Assisted Reproductive Technology Attorneys, says that courts have struggled to provide an answer.

"Whether an embryo belongs to the people who created it, as property would, as something else they would divide in a divorce," Sperling-Newton explains. "Or whether they're living beings and should be considered the way children would be considered in a custody action."

Daar, the law professor, offers another solution.

"The fact that technology got us into this problem is also suggestive of the fact that technology will eventually get us out of this problem," she says, suggesting that a breakthrough could spare couples the legal wrangling. It's now become possible to freeze unfertilized eggs — so, as with bank accounts, loving couples could choose to keep their gametes separate.

"And if they break up," she adds, "he can have his sperm, she can have her eggs, and they can dispute other matters in the relationship."

In other words, it might make matters not quite so emotionally — or legally — messy.

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

Kansas Town Takes Dental Care To School

Fri, 08/21/2015 - 10:38am

To make dental care more accessible, some schools are bringing dentists to students.

iStockphoto

Weeks before school started in Olathe, Kan., earlier this month, the town's school district began its annual effort to get low-income students signed up for dental checkups.

When parents register at the elementary schools that serve the district's poorest students, they are asked whether their children have a dentist. "And if they say no, we say, 'We have a program in our school — a dentist is coming to our school this year,' " says health services director Cynthia Galemore.

The goal is to make dental care more accessible for low-income families. The obstacles to care aren't limited to cost.

"A lot of times in these families dental care is not a priority," says Galemore. "It's not that the parents wouldn't want to provide it, but they maybe can't miss work to take their child to the dentist, [or] they may not have transportation."

A lack of preventive dental care for poor children is a national problem. Medicaid and the Children's Health Insurance Program, which cover children from low-income families, both pay for dental services. But fewer than half of children and teens enrolled in those programs received a preventive dental service last year, according to Stacey Chazin, a public health specialist with the Center for Health Care Strategies.

The participating schools in Olathe, a suburb of Kansas City, Mo., are among a few hundred across the country that offer oral health care. "What's nice about the schools is [they're] a place where students already go on a regular basis, whether it's back to school night, or it's a meet-the-teacher, or to pick up or drop off their kids," says Chazin. In some schools, dentists provide care. In others, dental hygienists perform preventive services.

In a recent policy brief, Chazin recommends school-based oral health care as an important children's health strategy. And, as it turns out, the federal government set goals to increase the proportion of children enrolled in Medicaid and the Children's Health Insurance Program receiving any preventive dental service by 10 percent between 2011 and 2015.

Tooth decay is the most common chronic disease among American children, according to the American Academy of Pediatrics.

Some 25 percent of children ages 5 to 19 who live at or below the federal poverty level had untreated tooth decay, according to data from the Centers for Disease Control and Prevention. Only 12 percent of children with family incomes double that of poverty level had untreated tooth decay.

According to Chazin most school-based oral health programs focus on preventive services like cleanings, fluoride varnish and sealants – protective coatings placed over molars to prevent cavities. "The hope in all of it is that they're referred to, and begin to get care from a dentist, where they would subsequently go for regular preventive visits and any needed treatment," says Chazin. Medicaid and CHIP keep tallies of services performed at schools, when they are billed.

But it's difficult to know if parents are scheduling those follow-up dentist visits. That data are hard to track, and to Chazin's knowledge, no insurers or state health departments are taking the time to do it.

Olathe however, does have data on follow-ups. And that helped push the district to take the idea of in-school dental care one step further than most schools. At the start in 2009, the district tracked the number of follow-up appointments scheduled with dentists. The results weren't good. Of the 339 children treated in school by dental hygiene students from the University of Missouri-Kansas City, 63 percent had tooth decay and were referred to a dentist. By the end of the school year, only 11 percent of those referred had had their parents contact a dentist's office to schedule an appointment.

But when a clinic in town became a federally qualified health center in 2013, it opened up a new opportunity. The district now works with the clinic—which receives federal funds to provide free or low-cost care to the underserved— to bring dentists to the schools. These dentists perform the full array of services on site. It's a win-win for the school district: Nurses no longer have to worry about parents scheduling follow-up visits, because they are scheduled at school. And the clinic provides a steady source of funding for the district's growing number of immigrant students, some of whom don't qualify for insurance because of their undocumented status. If a student has no insurance, the service is free.

"We used to think, 'Oh, schools shouldn't do this.' We thought our job was to provide the education for the kids," Galemore says. "We didn't used to feed breakfast to kids at school either. Funding has been cut and cut and cut for schools, but it's part of focusing on the whole child. We know if we have better health for that child there's better learning."

For this school year, the oral health program in Olathe is expanding from 10 to 12 elementary schools, and adding two high schools.

This piece comes from Side Effects Public Media, a public radio reporting collaborative that explores the impacts of place, policy and economics on health. Follow Side Effects on social media here.

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

Can Health Care Be Cured Of Racial Bias?

Thu, 08/20/2015 - 4:14pm
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Katherine Streeter for NPR

Jane Lazarre was pacing the hospital waiting room. Her son Khary, 18, had just had knee surgery, but the nurses weren't letting her in to see him.

"They told us he would be out of anesthesia in a few minutes," she remembers. "The minutes became an hour, the hour became two hours."

She and her husband called the surgeon in a panic. He said that Khary had come out of anesthesia violently — thrashing and flailing about. He told Lazarre that with most young people Khary's age, there wouldn't have been a problem. The doctors and nurses would have gently held him down.

"But with our son, since he was so 'large and powerful,' they were worried he might injure the medical staff," Lazarre says. "So they had to keep sending him back under the anesthesia."

Khary was 6 feet tall. But he was slim.

"He wasn't the giant they were describing him as," Lazarre says.

Lazarre is white. Her husband is black. Lazarre says there's no doubt in her mind that the medical team's fear of Khary was because of race.

"I understood, certainly not for the first time, that my son — and my sons both — were viewed as being dangerous, being potentially frightening to people who were white," she says.

She's also sure the surgeon didn't see it that way.

"Like most white people, I don't think he was conscious of it at all," Lazarre says.

She and her husband insisted on seeing Khary. They saw right away that he wasn't angry or violent.

"He was scared," Lazarre says. She and her husband leaned over and whispered in Khary's ear: "'It's going to be OK, you can calm down.' And he began coming out of the anesthesia more normally."

Lazarre first wrote about this experience in her book Beyond the Whiteness of Whiteness: Memoir of a White Mother of Black Sons. Though it's been years since Khary's surgery, Lazarre says there's still so much that hasn't changed.

Racial Disparity In Medical Treatment Persists

Even as the health of Americans has improved, the disparities in treatment and outcomes between white patients and black and Latino patients are almost as big as they were 50 years ago.

A growing body of research suggests that doctors' unconscious behavior plays a role in these statistics, and the Institute of Medicine of the National Academy of Sciences has called for more studies looking at discrimination and prejudice in health care.

For example, several studies show that African-American patients are often prescribed less pain medication than white patients with the same complaints. Black patients with chest pain are referred for advanced cardiac care less often than white patients with identical symptoms.

Doctors, nurses and other health workers don't mean to treat people differently, says Howard Ross, founder of management consulting firm Cook Ross, who has worked with many groups on diversity issues. But all these professionals harbor stereotypes that they're not aware they have, he says. Everybody does.

"This is normal human behavior," Ross says. "We can no more stop having bias than we can stop breathing."

Unconscious bias often surfaces when we're multitasking or when we're stressed, research shows. It comes up in tense situations where we don't have time to think – which can happen frequently in a hospital.

"You're dealing with people who are frightened, they're reactive," Ross says. "If you're doing triage in the emergency room, for example, you don't have time to sit back and contemplate, 'Why am I thinking about this?' You have to instantaneously react."

Shots - Health News Medical Schools Reboot For 21st Century

Doctors are trained to think fast, and to be confident in their decisions. "There's almost a trained arrogance," Ross says.

But some medical schools are now training budding physicians and other health professionals to be a bit more reflective — more alert to their own prejudice.

Places like the University of Texas Medical School at Houston, the University of Massachusetts, and the University of California, San Francisco now include formal lessons on unconscious bias as part of the curriculum.

New Approach Teaches Students To Recognize Bias — And Slow Down

At UCSF, all first year medical school students take a workshop led by Dr. Rene Salazar, who coaches other members of the medical team, too.

"A lot of folks come to San Francisco thinking, 'Oh it's such an open-minded place, there are no biases here,' " he tells a class of newly arrived pharmacy residents. "That's not true. You're going to see this in every hospital. It's going to be an issue."

What Salazar wants these students to talk about isn't other people's biases, but their own. And not just the biases they know they have. But the ones they don't know — or don't believe — they have.

"Like it or not, all of us hold unconscious beliefs about various social and identity groups," he says. "Many times we think about bias and unconscious bias — they are incompatible with our conscious values, right?"

Before the class, students were asked to take an implicit association test, a series of timed computer tests that measure unconscious attitudes around race, gender, age, weight and other categories. Salazar asks who wants to share their results.

The students study their fingernails.

Salazar clears his throat.

"Well, I can share with you my story," he says.

When he took the test for the first time, it showed that he had a preference for whites — or a bias against African-Americans. Research shows that 75 percent of people who take the race test show an automatic preference for whites.

"I was struck," he tells the students. "Particularly being in the health professions and wanting to serve diverse communities, to learn that I had these biases — it was a bit disheartening."

So he began to explore where these biases came from.

"I grew up in south Texas — 99 percent Mexican-American. Mostly Latino. In my high school, we had one black student," he tells the pharmacy residents. "And so, up until age 18, you can imagine, a lot of my ideas — a lot of my attitudes, a lot of my beliefs — about folks who were black came from what? The media."

Shots - Health News Medical School Hopefuls Grapple With Overhauled Entrance Exam

A student named Amanda raises her hand. She asks that we not use her last name because she's afraid that what she learned about herself could harm her career.

Amanda explains to the class that her parents made their way to the U.S. from Iran, and settled in Marin County, north of San Francisco. She took the version of the test that measures bias against Muslims, and another on light and dark skin tone.

"I kind of went in thinking that these are two areas that I would probably not have a bias, and that's kind of why I chose them," she says.

But the results were not what she expected.

"It was like, actually, 'You're biased and you don't like brown people and you don't like Muslims,' " she says. "Which is interesting for me — because that's, kind of, the two things that I am."

Traditional Diversity Training Didn't Work — And Sometimes Backfired

The UCSF curriculum is based on a training program designed by Howard Ross, the diversity consultant. He says he developed the new "unconscious bias" approach to sensitizing people to their own predjudices after realizing that the traditional diversity training he was doing in the '80s and '90s wasn't working.

"People who seemed to have transformative responses to those [earlier] trainings, to have that kind of 'aha' moment — particularly people in the dominant group, [of] whites, men, heterosexuals — often, if you talk to them a month or two later, they actually felt quite wounded by the experience," Ross says. In some cases, he adds, participants seemed to become more defensive and hardened in their biases after those early trainings, not less prejudiced.

A 2007 study described in the Harvard Business Review examined diversity training programs at more than 800 companies over 30 years, and the results underscore Ross's point. Overall, such programs seemed to do nothing to change people's prejudices or improve diversity. Instead, in some cases, they reinforced bias.

"What happens is, ultimately, we feel bad about ourselves, or bad about the person that made us feel that way," Ross says.

So rather than making people feel bad or awkward, Ross and Salazar say that, more than anything, they want people to accept that having biases is part of being human.

"You know we all have them," Salazar tells his class in San Francisco. "It's important to pause for a second and normalize this. And be OK with this."

Salazar emphasizes that unconscious bias can't be eliminated, but it can be managed.

"So how do we address our bias? What do we do?"

One student says, "Slow down."

"Yeah," Salazar responds. "A trick that I use is that I pause before I walk in, take 10 seconds even, 15 seconds, just to try to clear your mind and go in with that clean slate."

It's too early to know if these new types of trainings that explore unconscious bias are actually having any effect on what goes on in the exam room. Participants fill out evaluation forms after the class, and these anecdotal self-reports are often positive. But, so far, there have been no formal studies to measure if anything in patient care has actually changed.

"What happens when that door closes? What happens in the interaction when I can't see the patient and the doctor talking?" Salazar says. "That's a little hard to capture."

Still, UCSF is betting the technique will help. Salazar and other leaders believe the younger generation of health care providers could help shift medicine — by learning early how to keep their own biases in check.

Copyright 2015 KQED Public Media. To see more, visit http://www.kqed.org.
Categories: NPR Blogs

Does This Phylum Make Me Look Fat?

Thu, 08/20/2015 - 10:35am

Bacillus subtilis may look like pasta under the microscope, but the bacteria are common in the gut of humans. Could the microbes be contributing to our belly fat? Too soon to tell, scientists say.

BSIP/UIG via Getty Images

We would all love a simple weight-loss plan. Beyond carbs and fats, some studies have hinted that a key group of gut microbes — from the phylum Firmicutes — might be more common among people who are overweight.

Thinner people, these studies suggest, might have more bacteria from the phylum known as Bacteroidetes. Maybe we just need to reestablish a Bacteroidetes-favoring gut to more easily lose weight, some people have said. A stack of diet books has already jumped on the notion.

But a computer analysis led by Katherine Pollard, a biostatistics professor at the University of California, San Francisco and a senior investigator at the Gladstone Institute, recently sifted through an ocean's worth of detailed data that's been collected on gut bacteria. Her analysis found no link between Firmicutes and obesity, after all.

If there's any real link between gut microbes and the size of your gut, it's not just the phylum of bacteria that matters, or maybe even the species, according to Pollard's results. A host of other factors that scientists are only beginning to understand probably contribute, too, she says.

Pollard discussed her team's analysis this month at a meeting of scientists in Seattle.

The technology for investigating the microbiome has been improving fast. Researchers can now detect and identify many of the different species of bacteria in your gut — not just phylum, class, order, family or genus.

But, that's created a new problem, Pollard says. It's one thing to identify the whole cast of microbial characters, and quite another to figure out what the microbes are actually doing in there. The same species of bacteria might act differently in my gut than in yours and the technology used in these big studies doesn't detect that level of detail.

"What matters to the human host," Pollard says, "is not the Latin names of the microbes" but what each microbe produces — whether that's anti-inflammatory molecules, vitamins, or factors that speed the conversion of extra calories we eat into body fat. (The scientists published a formal description of some of their data-crunching finds late last year in the journal PLOS ONE.)

"Individual microbial species can have widely variable genomes," says William Anton Walters, a researcher in molecular biology and genetics at Cornell University. Any given bacterium may share less than half of its genes with another member of the same species. These genetic differences, rather than phylum or even species designations, Walters says, "could explain the differences between the obese and lean gut microbiota."

Greg Gloor, a professor of biochemistry at the University of Western Ontario, agrees that Pollard and her team are on the right track, as they analyze massive amounts of data of all sorts, looking for trends. The results indicate "that there is more strain-level variation in the microbiome than we have appreciated," Gloor tells Shots in an email.

We know, for example, that some strains of E. coli can be harmless to humans, but that others can sicken or even kill us. Why should we expect other strains of gut bugs to be more uniform? "Bacteria are very diverse," Gloor says.

Gut bacteria may yet be found to play an important role in the extra pounds that plague some people, the scientists say. Walters points to work from studies of fecal transplants that have shown there are meaningful differences "in the gut microbiome of lean and obese individuals." The trick, he says, will be in figuring out more precisely what those differences are.

Katherine Harmon Courage is a contributing editor for Scientific American and a freelance journalist. Her next book, about the microbiome and diet, will be published by Random House in 2016. Follow her on Twitter: @KHCourage

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

Price Rises For Ticket To A Quicker Drug Review By FDA

Wed, 08/19/2015 - 3:20pm
Drew Kilb/Duke University's Fuqua School of Business

A deal struck between drugmakers AbbVie and United Therapeutics Wednesday set a record price for a voucher that can be redeemed for a fast-track review of a new medicine by the Food and Drug Administration.

AbbVie, marketer of Humira and AndroGel, has agreed to pay $350 million to United Therapeutics, a company specializing in treatments for rare diseases, for a ticket to the regulatory fast lane.

The tickets, or priority review vouchers as they're known, were created by Congress in 2007 to encourage the development of drugs for neglected tropical disease and rare illnesses affecting children.

Drugs like those aren't usually lucrative for companies. The priority review voucher was conceived of as a prize that would be given to companies that brought medicines for certain overlooked diseases to market.

The voucher entitles its holder to move a drug through the review line faster. FDA has to make a decision about a voucher drug in about six months rather than the 10 or so for a drug submitted without one.

There's no guarantee the FDA's decision will be an approval; the agency could just reject a drug faster.

Oh, there's one other important feature of the vouchers: They can be kept by the companies that won them or they can be sold to the highest bidder.

United Therapeutics got its voucher in March when the FDA approved a drug called Unituxin to treat pediatric neuroblastoma, a rare cancer in kids. Rather than keep the ticket, the company sold it. "We are very pleased to monetize our [voucher], and hope that this transaction will encourage others to join us in focusing development efforts on rare pediatric diseases," Roger Jeffs, president and co-CEO of United Therapeutics, said in a statement.

AbbVie, for its part, confirmed the terms of the deal in an email to Shots but declined to say what the company's plans are for the voucher.

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Duke University's David Ridley, whose academic work with two colleagues helped lay the foundation for the vouchers, told Shots in an email that the prices fetched by vouchers in 2015 "were in line with our expectations." A 2006 paper co-authored by Ridley pegged the value of a voucher at more than $300 million for a drug with the potential for blockbuster sales.

In May, French drugmaker Sanofi paid $245 million for a voucher. Last November, Gilead Sciences paid $125 million to Knight Therapeutics for a voucher that was awarded for the approval of a drug to treat leishmaniasis. All told, four vouchers have been sold.

Ridley said that "while the value of some vouchers might be around $300 million, the price might be lower if there are many sellers." He added, "United Therapeutics was lucky and/or smart that it was the only seller at a time when a buyer was eager to have a voucher."

On a related note, the FDA is expanding the illnesses that can earn companies a voucher. Chagas' disease and neurocysticercosis, a parasitic infection that can lead to epilepsy, have been added to the list of eligible conditions.

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Scientists Create Vomiting Machine To Learn How Norovirus Spreads

Wed, 08/19/2015 - 2:04pm

The vomit machine.

Courtesy of Grace Tung-Thompson

Norovirus is a huge public health problem, sickening as many as 21 million people a year in the U.S. But for all the gastric distress it causes, there are still some basic, unanswered questions about the virus.

One biggie: When an ill person vomits, does norovirus become aerosolized? That is, can an ill person's vomiting launch tiny viral particles into the air, where they might waft into your mouth or onto surfaces that you would later touch?

If you're now grossed out, you have good reason. Studies of the infection patterns that occur in outbreaks suggest that norovirus can indeed be aerosolized. And now there's some experimental evidence to add to that.

Researchers at North Carolina State and Wake Forest universities wanted to know what happens to norovirus when it's vomited out. "We first talked to a gastroenterologist and looked through the literature about what's known about vomiting," says Lee-Ann Jaykus, a food microbiologist at N.C. State and an author of the study. Not as much as you might think, it turns out. So the researchers worked with a civil engineer to construct a one-quarter scale vomiting device based on what is known about pressure, volume and other vomit metrics.

The device allowed the researchers to control the volume, viscosity and pressure of the simulated vomiting incidents. Jell-O instant pudding was added to make the lab vomit thicker.

Then they ran a series of experiments, changing the variables to simulate a range of vomiting behavior. They even ran one series of incidents with post-vomit retches.

The vomit machine and vomit chamber.

Courtesy of Grace Tung-Thompson

Though they conducted the experiments in a sealed Plexiglas box under a biosafety hood, norovirus was still too dangerous to use. A person sick with norovirus can spread billions of infectious particles, and only 18 are enough to make another person ill, the Centers for Disease Control and Prevention says.

So the researchers enlisted a harmless stand-in, a bacteriophage that is often used in place of norovirus in experiments. Only a fraction of virus particles were aerosolized during a typical vomiting incident. But there were definitely enough to make you sick.

The results appear in the journal PLOS ONE.

Another recent study collected air samples from eight health care facilities during norovirus outbreaks and found viral particles outside patient rooms.

"Taken together, they start to paint a pretty good picture of why norovirus is so atrociously infectious," says Andrew Pavia, chief of the division of pediatric infectious diseases at the University of Utah and a spokesman for the Infectious Diseases Society of America.

Of course, though the researchers did their best to simulate human vomiting, they didn't do a complete mock-up of the human digestive system. (A robot named Vomiting Larry is more anatomically accurate, but is less precise with regard to pressure, says Pavia.) And while the bacteriophage was chosen because of its similarity to norovirus, it may not behave the same way when aerosolized, he says.

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

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FDA Approves First Drug To Boost Women's Sexual Desire

Tue, 08/18/2015 - 6:46pm
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A daily pill called Addyi is the first medicine to be approved for the purpose of boosting women's sexual desire.

Allen G. Breed/AP

The Food and Drug Administration approved the first drug designed to increase a woman's libido.

The controversial decision was hailed by some doctors and advocates as a long-sought victory for women's health, but was condemned by others as irresponsible and dangerous.

The little pink pill, known generically as flibanserin, will be sold under the brand name Addyi beginning Oct. 17, according to its maker, Sprout Pharmaceuticals. The medicine is to be taken daily to treat premenopausal women suffering from hypoactive sexual desire disorder, which is essentially a sudden, unexplained loss of any desire to have sex.

"Addyi is a game changer, in my opinion, for women's health," said Cynthia Whitehead, Sprout's CEO. "For decades, millions of women have been waiting for a medical solution to restore their sexual desire. And I'm thrilled that today the decision is finally being turned over to women and their health care providers regarding their sexual health."

The pill has long history of controversy. The company and its supporters had essentially accused the FDA of being sexist for rejecting the drug twice before while approving Viagra and other drugs to help men with their sexual problems.

"For far too long we've reduced all things in the bedroom for men to biology, as witnessed by countless treatment options, and we've reduced all things for women to psychology," Whitehead says.

In June, Sprout finally convinced an FDA advisory committee to recommend the drug's approval by providing new studies to show it can safely boost a woman's sex drive, enabling them to have more satisfying sexual experiences.

The decision was welcomed by some doctors and women's advocates, who said they hoped it would open to the door to more drugs to help women with sexual problems.

"Clearly we need more than just one medication — women need to have an array of choices that meets their specific medical needs," says Terry O'Neill of the National Organization for Women. "So with this success I think there will be more development of more medications. And that is all to the good."

But the FDA's approval was being denounced by critics. They say Addyi doesn't work very well, if at all, and can cause troubling side effects.

According to the documents released in conjunction with the advisory panel's June meeting, three studies that compared Addyi with a placebo found that women using the drug had a median of 0.5 or 1.0 more satisfying sexual events a month, depending on the study. The median number of satisfactory sexual experiences each month before the drug test was two or three.

Some women faint when they take it. Others wake up so groggy the morning after it could be dangerous for them to drive to work. And there could be long-term risks from taking a psychoactive drug daily for years. Addyi works by altering the levels of three important neurotransmitters — norepinephrine, serotonin and dopamine.

"To have any chance of benefit from this drug they're going to have to take it every day for months on end, years," says Cindy Pearson of the National Women's Health Network. "We just don't know what the long-term effects will be of changing brain chemistry in this way."

In addition, some say the campaign to win approval for the drug has oversimplified human sexuality. They say Addyi is just another example of the pharmaceutical industry making what is normal human behavior for some people something people need to take a pill to fix. Some women naturally lose interest in sex, they say, or may lose interest in sex for other reasons, such as being in a bad relationship.

"This decision to approve flibanserin is a triumph of marketing over science," Pearson says.

The FDA is requiring the company and doctors to warn women not to drink alcohol while taking Addyi, to cut the risk they'll faint or wake up woozy. Women should also avoid taking Addyi with certain other drugs, including some medications used to treat yeast infections.

As part of the approval, Sprout has also agreed to conduct additional safety studies.

The company hopes many insurance companies will cover the new drug to the same level they cover drugs like Viagra. If so, Whitehead estimated it would cost women between $30 and $75 a month in out-of-pocket costs. The company is also planning to offset the expenses for women who don't have insurance so it doesn't cost them more than that, she said.

Copyright 2015 NPR. To see more, visit http://www.npr.org/.
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High Cost Of Diabetes Drugs Often Goes Overlooked

Tue, 08/18/2015 - 12:51pm

After the blood sugar check, it may be time for a diabetes medicine whose price has jumped.

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When it comes to treating chronic conditions, diabetes drugs aren't nearly as sexy as say, Sovaldi, last year's breakthrough hepatitis C drug that offers a cure for the chronic liver infection at a price approaching six figures.

Yet an estimated 29 million people in the U.S. have diabetes — about 10 times the number of people with hepatitis C — and many of them will take diabetes drugs for the rest of their lives. Cost increases for both old and new drugs are forcing many to scramble to pay for them.

"Every week I see patients who can't afford their drugs," says Dr. Joel Zonszein, an endocrinologist who's director of the clinical diabetes center at Montefiore Medical Center in New York City.

Although some of the top-selling diabetes drugs like metformin are modestly priced generics, new brand-name drugs continue to be introduced that act in different ways to control blood sugar. They may be more effective and have fewer side effects, but the advances come at a price.

For the fourth year in a row, per person spending on diabetes drugs in 2014 was higher than it was for any other class of traditional drug, according to the Express Scripts 2014 drug trend report. Fewer than half of the prescriptions filled for diabetes treatments were generic.

"The cost of diabetes treatment has been increasing pretty rapidly," says Dr. Glen Stettin, senior vice president for clinical, research and new solutions at Express Scripts, which manages the pharmacy benefits for many companies.

An analysis of per capita health care spending in 2013 for people with diabetes found average costs were $14,999, roughly $10,000 higher than the average $4,305 in per capita spending for people without the disease. The study by the Health Care Cost Institute examined the health care claims of nearly 40 million people under age 65 who had employer-sponsored insurance with one of three large insurers.

Insurers and pharmacy benefit managers have increasingly devoted resources toward managing patients' prescription drugs. Requiring patients to try an older, cheaper drug before approving a newer one is common practice as are rules that require providers to get approval before prescribing pricey drugs.

Diabetes occurs when the body can't control the amount of sugar in the blood because of problems making or responding to the hormone insulin. High levels of blood sugar can cause damage to the heart and blood vessels, nerves, kidneys, eyes and feet, among other things.

About 90 percent of people who have diabetes have type 2 diabetes, which is linked to lifestyle factors such as obesity and inactivity. Type 1 diabetes, once called juvenile diabetes, commonly develops among children.

Insulin was considered a wonder drug when it was discovered in 1921. It remains a mainstay of treatment for millions of patients, and yet decades after its introduction there are still no generic forms of insulin available.

And while it's true that the lack of generic insulin has hindered price competition for the key diabetes medicine, some readers and listeners of an earlier NPR story on insulin prices pointed out that Wal-Mart pharmacies carry a house brand of insulin that costs about $25 a vial.

Kaiser Health News is an editorially independent program of the Kaiser Family Foundation.

Copyright 2015 Kaiser Health News. To see more, visit http://www.kaiserhealthnews.org/.
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