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Opioids Can Derail The Lives Of Older People, Too

John Evard, 70, at the Las Vegas Recovery Center in Las Vegas last July. Evard, a retired tax attorney, checked into a rehabilitation program to help him quit the prescribed opioids that had left him depressed, groggy and dependent on the drugs. Heidi de Marco/Kaiser Health News hide caption

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Heidi de Marco/Kaiser Health News

It took a lot of convincing to get John Evard into rehab. He was reluctant to give up the medications that he was certain were keeping his pain at bay. But ultimately he agreed — and seven days into his stay at the Las Vegas Recovery Center, the nausea and aching muscles of opioid withdrawal are finally beginning to fade.

“Any sweats?” a nurse asks him as she adjusts his blood pressure cuff.

“Last night it was really bad,” he tells her, “but not since I got up.” Evard, who is 70, says he woke up several times in the night, his sheets drenched with sweat.

Evard says it is hard to understand, even for him, how he ended up 300 miles away from his home in Scottsdale, Ariz., at this bucolic facility in the suburbs of Las Vegas. “This is the absolute first time I ever had anything close to addiction,” he says. He prefers the term “complex dependence” to describe his situation.

“It was, shall we say, a big surprise when it happened to me,” he says.

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As the nation grapples with a devastating opioid epidemic, concerns have primarily focused on young people buying drugs on the street. But many elderly people in America also have a drug problem. Over the past several decades, physicians have increasingly prescribed older patients medication to address chronic pain from arthritis, cancer, neurological diseases and other illnesses that become more common in later life. And sometimes those opioids hurt more than they help.

A recent study of Medicare recipients found that in 2011, about 15 percent were prescribed an opioid when they were discharged from the hospital; three months later, 42 percent were still taking the pain medicine.

It’s perhaps no surprise, then, that some, like Evard, end up addicted.

John Evard, (left) participated in group therapy during his stay at the rehab center. He’d been prescribed increasing dosages of opioids to manage his pain, Evard says, but it hadn’t worked, and he was unable to quit the pills on his own. “I was effectively housebound,” he says. Heidi de Marco/Kaiser Health News hide caption

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Heidi de Marco/Kaiser Health News

Evard spent his life working as a corporate tax attorney. He’s lively and agile, with a contagious grin. A few years ago he and his wife retired to Arizona with their eyes on the golf course. But the dream didn’t last long. Just months into retirement, a virus infected Evard’s left ear. Overnight, he lost half his hearing and was left with chronic pain. In January, he had surgery to fix the problem.

“From the surgeon’s standpoint, the operation was successful,” Evard recalls. “The problem was, the pain didn’t go down. It went up.”

His doctors prescribed opioids, including Oxycontin. “They decreased the pain, particularly at first,” says Evard. “As time went on, [the pills] had less and less effect, and I had to take more and more.”

As the doctors increased his dosage, in hopes of managing the pain, Evard’s once active life fell apart. He was confused, depressed, and still in pain.

“I was effectively housebound,” he says. “I couldn’t play golf anymore. I couldn’t go to social events with my friends or my wife.”

He couldn’t think of anything except the pills, focusing on when he’d be able to take the next one. He knew he was in trouble — despite having taken them exactly as his doctor instructed.

“I was a rule-follower,” he says. “And I still ended up in a mess!”

In 2009, the American Geriatric Society came out strongly in favor of opioids, updating its guidelines on pain management to urge doctors to consider using opioids for older patients who have moderate to severe pain. The panel cited evidence that seniors were less likely than others to become addicted.

Dr. Bruce Ferrell,a geriatrician and pain specialist at the University of California, Los Angeles, served as chairman of the panel that issued the AGS guidelines.

“You don’t see people in this age group stealing a car to get their next dose,” Ferrell told the New York Times at the time.

Dr. Mel Pohl, medical director of the Las Vegas Recovery Center, calls that conclusion a “horrible misconception.”

“There’s no factual, scientific basis for that,” he says. “The drug takes over in the brain. It doesn’t matter how old the brain is.”

The problem is that there aren’t many good options to treat chronic pain as people age. Even aspirin and ibuprofen carry bleeding risks that can be serious.

The 2009 AGS guidelines are no longer in use, but opioid medications remain a crucial tool to treat pain in older people. And most people are able to take opioids in small doses for short periods of time without a problem.

“We really don’t use opioids necessarily as the first line of treatment, because we understand what the risks are,” says Dr. Sharon Brangman, past president of the AGS. “But we also don’t want to see our patients suffering needlessly if we can provide them with relief.” The trick, she said, is to first try non-pharmacological options such as acupuncture, and to use the smallest effective opioid dose possible.

Nonetheless, in the past 20 years, the rate of hospitalization among seniors that is related to opioid overuse has quintupled.

It took John Evard about a week to get over the vomiting and flu-like symptoms of detox, which can be particularly hard on older patients. He still has some of the chronic pain that first led him to seek help from a doctor, he says, but he takes Tylenol to deal with it. He’s speaking out now about opioids because he doesn’t want other seniors to fall into the same trap.

“Don’t just take the prescription because it’s part of the checkout process from the hospital,” he cautions. “It’s your body. Take charge of it, and push for alternatives at all costs. And if you do go on, get off them as fast as you can.”

Kaiser Health News is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation.

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Patients Cared For By Female Doctors Fare Better Than Those Treated By Men

Elderly hospitalized patients taken care of by female doctors had better results than those seen by male doctors. Julie Delton/Getty Images hide caption

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In a study that is sure to rile male doctors, Harvard researchers have found that female doctors who care for elderly hospitalized patients get better results. Patients cared for by women were less likely to die or return to the hospital after discharge.

Previous research has shown that female doctors are more likely to follow recommendations about prevention counseling and to order preventive tests like Pap smears and mammograms.

But the latest work, published Monday in JAMA Internal Medicine, is the first to show a big difference in the result that matters most to patients: life or death.

The study’s authors estimate “that approximately 32,000 fewer patients would die if male physicians could achieve the same outcomes as female physicians every year.”

“Of course! What did you expect?” replied the wife of Dr. Ashish Jha, the study’s senior author, when he shared his team’s findings with her. Jha said he expects a backlash over the study results. But his team’s methodology, successfully put through multiple analyses, makes this work noteworthy, he added.

But tens of thousands of fewer deaths per year if we just went with female doctors?

Whoa! To us, a man and woman who met as we were getting our start in medicine, them’s fightin’ words.

An editorial about the study urges doctors to remedy the gender disparities in care and the pay gap that favors male physicians over women.

Since half the patients we treat are women and girls, it makes sense that at least half the physician corps should reflect the population. We’ve achieved that in medical school rolls, but overall only a third of practicing doctors are female. And many specialties, including orthopedics, cardiology and neurosurgery, are still dominated by men.

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So why is there a gender-based difference in physicians’ care? The authors admit that they are “unable to identify exactly why female physicians have better outcomes than male physicians.”

We don’t pretend to know for sure, but as married doctors, we have our hunches. We talked it over and here are our thoughts about the research.

Dr. Sarah-Anne Henning Schumann: The actual effect reported in the study is small, but multiplied over a huge population it does add up to something significant.

Dr. John Henning Schumann: I like the Big Data aspect of it. The authors said, “Let’s look at more than a million Medicare patients over several years and see how they fared based on the gender of their doctor.” While many people may want to tear this study apart, I think the findings make intuitive sense.

Sarah-Anne: I’m assuming the difference is because of the way that women, in general, communicate. It’s about being better listeners, more nurturing and having emotional intelligence.

John: There are plenty of men who are good communicators.

Sarah-Anne: Yes, just as there are plenty of women who don’t really have those qualities. For female doctors, having worked their way through pre-med, med school and residency, they can have some of that nurturing communication skill beaten out of them.

John: That happens to men, too!

Sarah-Anne: That’s true. But this study shows us — just possibly — that if female doctors, on average, communicate better, their style might be more effective in treating disease and preventing death.

John: It’s interesting to me because I think about some of my older patients, who much prefer that I tell them what to do rather than to discuss options and share decision-making.

Sarah-Anne: I think that traditionally men were the doctors. People often assume men are more intelligent and so would be more likely to take their advice.

John: That has to change, as we get closer to parity with women in the profession.

Sarah-Anne: My mother has had many experiences with male doctors where she feels they haven’t listened to her. They aren’t warm or kind, but she feels reassured anyway. She thinks they’re smart, and what’s most important to her is their knowledge and technical skill, not their bedside manner.

John: Mom always knows best, if that’s what she values.

Sarah-Anne: Even in our family, we’re both doctors. I’m a family doctor, trained to see adults and kids. You’re an internist, trained to only see adults. And in both of our families, most of the time, our family members will reach out to you with their questions — even about kids. And my family, who attended my Harvard Medical School graduation, I’ll remind you, seems to value your opinion more. They seem to be looking for opinions more from men. That’s kind of an interesting thing.

John: I never really thought about that. I can see how that’s totally male privilege. It has to be frustrating to be taken less seriously.

Sarah-Anne: I’m in a Facebook group of physicians who are moms. While it’s not every doctor-mom in the country, there are over 60,000 of us in it. So many tell stories of being mistaken for nurses — and taking great offense at that. We have worked so hard to get where we are and want to be treated as equals to our male colleagues.

But I see the mix-up as a compliment rather than an insult. To be compared [to] a nurse says that patients are seeing me as someone who is caring for them and nurturing.

John: That’s a smart way to reframe it. Our colleague Jill used to get angry when people assumed she was a nurse. Instead, she decided to embrace it and use it as a call to service. Now she asks patients if they need an extra blanket or something to drink. And she believes that she provides better, more empathic care.

Sarah-Anne: Everyone is going to want to know what is it about women that leads to these better outcomes. I think it’s going to be hard to figure out exactly.

John: Do you think people that read or hear about this study will take home the message that they need to choose female doctors?

Sarah-Anne: Some will no doubt oversimplify it to that. What I take away is that if communication is the key, as I suspect, then we need to better select and train medical students and residents to exhibit these qualities.

John: Amen to that. What about equal pay for equal (or better!) outcomes? Paging Lilly Ledbetter!

Sarah-Anne: You’re not really asking me that, are you?

Sarah-Anne Henning Schumann is a family doctor and serves as medical director of Community Health Connection, a federally qualified community health center in Tulsa, Okla.

John Henning Schumann is an internal medicine doctor and serves as president of the University of Oklahoma’s Tulsa campus. He also hosts Studio Tulsa: Medical Monday on KWGS Public Radio Tulsa. He’s on Twitter: @GlassHospital

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Dolls With Disabilities Escape The Toy Hospital, Go Mainstream

Dominika Tamley and her doll “Isebelle” ride the train together in Chicago. Like Dominika, Isebelle has a hearing aid. “She’s like a mini-me,” Dominika says. Kevin Irvine hide caption

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Kevin Irvine

When Dominika Tamley chose “Isebelle,” her American Girl doll, she picked a toy whose hair and eye color matched her own. But the 10-year-old is quick to point out that’s not the only way the doll resembles the real child who plays with her.

“She’s like a mini-me,” Tamley explained with pride. “Because she has a hearing aid and I have a hearing aid.”

American Girl has for years offered a wide variety of accessories reflecting a range of disabilities. Arm crutches, leg braces, a sporty red wheelchair and allergy-free lunch sets. You can order a doll without hair — like a child with cancer — or one outfitted with a diabetes kit that includes insulin pumps, pens, glucose tablets and a blood sugar monitor.

“The designer who worked on that had Type 1 diabetes, and it was a really personal item for him to create,” said Stephanie Spanos, a public relations manager at American Girl. The designers developed the diabetes kit with the input of doctors, nurses and dietitians at American Family Children’s Hospital in Madison, Wis., Spanos added. “We introduced that at the very beginning of 2016 and it’s been in and out of stock all year.”

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The “Diabetes Care Kit,” designed to fit American Girl dolls, comes with insulin pumps, pens, glucose tablets and a blood sugar monitor. American Girl hide caption

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American Girl

American Girl dolls, which can cost more than $100, often come with a built-in back story, such as Nellie, the Irish immigrant orphan, or Cécile, the Creole girl growing up in 1850s New Orleans. Some activists remain irked that no American Girl comes with a built-in back story related to a disability. (A petition to add one last year, during the 25th anniversary of the Americans with Disabilities Act, was unsuccessful.)

Still, more and more mainstream companies are adding characters with disabilities to their roster of toys. Earlier this year, Lego introduced, for the first time, a figure of a little boy in a wheelchair. Significantly, he’s not in the hospital — instead, he’s part of a city park set, representing people with disabilities out in the world. And in 2013, Toys R Us added its Journey Girls line of dolls, with accessories including wheelchairs and crutches.

Is this good business? Or just good public relations?

“It’s not about PR for us,” said the chief merchandising officer of Toys R Us, Richard Barry. “Our job as a company is to make sure we have the best assortment for all kids.” Barry pointed out that Toys R Us catalog has also started including children with disabilities in its photos of kids playing with the company’s toys.

Representation of kids with disabilities was harder to find at a big-box store in the suburbs of Washington D.C., where Rebecca Cokley took me shopping. Cokley is executive director of the National Council on Disability, and the first female little person to have worked in the White House. She’s 4 feet 2 inches tall and white, with red hair and freckles. “My family is interracial and interspatial,” she said. “My husband’s average height and African American. And, so, our kids are biracial dwarf kids.”

There were all kinds of toys Cokely liked in the aisles — she’s a Lego nerd and a big fan of Batgirl, a character with her own deep connection to the disability community. But it was nearly impossible to find a single toy that represented disability. In the Barbie aisle, we found chef Barbies, vet Barbies and gymnast Barbies.

A Lego figure in a wheelchair was introduced at the 67th International Toy Fair in January 2016. He comes in the “City” set, a community of figures shown playing and working in an urban park setting. Daniel Karmann/AFP/Getty Images hide caption

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Daniel Karmann/AFP/Getty Images

“Why can’t one of these come with a hearing aid?” Cokely wondered. And Mattel has stopped making Becky, Barbie’s friend who uses a wheelchair (although you can still find Becky dolls to buy on secondary retail sites online.)

“And look — there’s Barbie’s inaccessible dream house!” Cokely said. “It’s got a working garage, but the elevator is too small for a wheelchair.” It would be tough for Becky to come over for a visit.

We had more luck in the Star Wars aisle. Cokely noticed a Luke Skywalker doll that comes with a prosthetic arm. “That counts!” she exclaimed, with a wry aside: “People do tend to claim Vader, but I don’t know if that’s a good thing or a bad thing.”

Aside from Luke, only one other toy (among many hundreds) explicitly represented a disability: Nemo. The friendly orange clownfish from the Pixar movie has one shortened fin, and the store sold a stuffed plush version.

“Both Finding Nemo and Finding Dory have been phenomenal resources for parents with disabilities,” she said. “Not only in terms of showing good examples of kids with disabilities, but also the challenges of being that overprotective helicopter parent.” She pointed out that some toys – such as My Little Pony — have been embraced by some disability activists, but that so much of the toy section represented missed opportunities.

“Why don’t we have any GI Joes that are disabled vets?” Cokely asked. “Think about that, what that would mean to a young boy whose dad’s a vet or whose mom’s a vet. To see their parents’ experience reflected in the toys — that would be massive.”

Research by social psychologist Sian Jones of Goldsmith University of London, as well as that of others, shows that all children benefit from playing with toys representing disability — it heightens empathy.

And activist Rebecca Atkinson, who runs the Toy Like Me website in the United Kingdom, told me she’d love it if every toybox included a wheelchair and a seeing-eye dog for children to play with. (Atkinson’s website points consumers towards toys that represent disability, and also creates playful images meant to inspire manufacturers, such as princesses with eye patches and scars, and superheros with tracheostomies.

This isn’t a niche market, Cokely added. One in four people will experience a disability at some point in their lives. “Everyone has a family member with a disability,” she said. “Everyone knows someone with a disability.”

And playing with toys in an imagined world where, just like in real life, people walk or use wheelchairs or have hearing aids is a world where kids can imagine other kids — disabled and otherwise — as friends.

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Study: Communities Most Affected By Opioid Epidemic Also Voted For Trump

Voting patterns show that areas where Donald Trump did well were also places where opiate overdoses and deaths occurred. NPR’s Scott Simon speaks with Shannon Monnat who led the study.

SCOTT SIMON, HOST:

Shannon Monnat was watching election returns last month when she thinks she noticed a pattern. Professor Monnat’s an assistant professor of rural sociology and demography at Penn State University, and she’s been studying drug and alcohol mortality rates. She joins us now from Lowville, N.Y. Thanks very much for being with us.

SHANNON MONNAT: Thanks, Scott.

SIMON: What did you look at, and what did you find?

MONNAT: Well, so this was part of a larger project where I’ve been trying to understand the common characteristics of places with high rates of mortality from drugs, alcohol and suicide – these kinds of deaths of despair. And as you mentioned, I was watching the returns come in on election night and sort of noticed that the states where Trump was performing more strongly than expected, like Pennsylvania and Ohio and Michigan, were states that have seen major upticks in drug overdoses and other deaths of despair over the past decade.

So I started looking at the data, especially within regions of the country where the opiate epidemic has received a lot of attention. And what I found was that Trump outperformed the previous Republican candidate Mitt Romney the most in counties with the highest drug, alcohol and suicide mortality rates.

SIMON: And to take the chance of getting you a little bit out of your area of academic expertise for a moment, do you infer a lot of people who live in these areas heard a message of hope in Mr. Trump?

MONNAT: You know, I think in many of the counties where he did the best, economic distress has really been building, and social and family networks have been breaking down for several decades. And so I think these findings reflect larger economic and social problems that sort of go beyond drug and alcohol abuse and suicide. It’s really about downward mobility and the dismantling of the American dream at a larger community level. And Trump really has sort of capitalized on and exploited the feelings of the people in these communities. In a lot of these places, good-paying jobs and the dignity that goes along with those good-paying jobs has been replaced by suffering and hopelessness and the belief that people in power don’t really care about them or their communities.

SIMON: So on top of everything else, those of us who report politics and live in a bubble – we missed the importance of the opioid epidemic?

MONNAT: I’m not so sure that it was missed, per se. I think it’s been there at the forefront of the news for a really long time. I just don’t think that we saw the potential that it would impact the election in the way that it did, insofar as it’s tied up in these other economic and social struggles that are occurring within the same communities.

SIMON: And to be clear again, you’re not saying that people that have a problem with opioids or drug or alcohol voted for Donald Trump so much as people who live in those communities that have been affected by it statistically in your study voted for Donald Trump.

MONNAT: Well, that’s right. And I can’t say necessarily who voted for Donald Trump, but we have to remember that addiction and depression and these diseases and deaths of despair go far beyond the individuals themselves who are affected by them. They affect friends and family members and coworkers and first responders and service providers and employers in communities who are dealing with the struggles of these and experience the same sort of frustration and anxiety that are associated or wrapped up within diseases and deaths of despair.

SIMON: You conclude your study by – I believe the quote is community level well-being played an important role in this election.

MONNAT: Yeah, that’s right. So I think what we’re seeing is the consequence of this perfect storm of decades of decline in these decent-paying jobs and benefits, especially for folks without a college degree, and little hope that those kinds of jobs will ever come back mixed with really easy access to pain pills and cheap and potent heroin. And on top of that, there’s a lack of comprehensive and affordable health care services, including mental health and substance abuse treatment.

SIMON: Professor Monnet, what do you hope a President Trump can do to help people who live in communities like this?

MONNAT: Well, it seems to me that the policies really need to reflect the economic and health challenges of rural and small city America in the same ways that they’ve tried to target large urban cities. And that includes good-paying stable jobs, especially for those without a college degree. That needs to be the staple of any economic policy. What people really want is to be able to support themselves and their families.

SIMON: Shannon Monnat, assistant professor of rural sociology and demographics at Penn State University, thanks so much for being with us.

MONNAT: Thanks for having me, Scott.

Copyright © 2016 NPR. All rights reserved. Visit our website terms of use and permissions pages at www.npr.org for further information.

NPR transcripts are created on a rush deadline by Verb8tm, Inc., an NPR contractor, and produced using a proprietary transcription process developed with NPR. This text may not be in its final form and may be updated or revised in the future. Accuracy and availability may vary. The authoritative record of NPR’s programming is the audio record.

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When Genetic Tests Disagree About Best Option For Cancer Treatment

Results from different genetic tests on samples from the same cancer patient can disagree about the best course of treatment. Clare McLean/University of Washington School of Medicine hide caption

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Clare McLean/University of Washington School of Medicine

Two widely used tests to analyze the genetics of tumors often don’t come to the same conclusions, according to head-to-head analyses.

Authors of two recent studies comparing these tests say doctors need to be careful not to assume that these tests are providing a complete picture of a tumor’s genetic variants, when using them to select treatments for cancer patients.

Dr. C. Anthony “Tony” Blau and colleagues at the University of Washington School of Medicine in Seattle compared results from two commonly used tests that are used to identify mutations in tumors. The FoundationOne test is used on tissue samples extracted from tumors. Guardant360 gathers traces of tumor DNA from blood samples.

Blau started out with a small sample of just nine patients, as he reported Thursday in JAMA Oncology. One had no mutations at all recognized by either test. Of the remaining eight, the two tests provided remarkably different results. Only 22 percent of the time (in 10 out of 45 instances) did both tests identify the same mutation.

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That’s not to say the tests themselves are technically flawed, Blau told Shots. But each test has its limitations, and so the results vary.

Tests of tumor tissue don’t sample the entire tumor. And tumor cells aren’t all the same, so a sample doesn’t give a complete picture of tumor genetics.

Blood tests sample free-floating cells that break loose from tumors. That’s a useful technology if a tumor is hard to sample directly, but again it provides an incomplete snapshot of the cancer’s genetic mutations. “They’re looking for a needle in a haystack,” Blau says.

Blood samples drawn at different times can produce different results, because different cells may be in the blood. And tumors evolve over time, so some of the difference could reflect that as well.

“The mutations you are looking for that might guide you to a particular drug can present in most or only a tiny fraction of cells,” Blau said. So either test can fail to detect a clinically important mutation.

These blood tests often include a list of cancer drugs for doctors to consider, based on the mutations detected. The recommendations also varied, because the tests often found different mutations. Only 25 percent of the time (in 9 of 36 cases) did these two tests recommend the same drug among the eight patients in the study.

These observations build on similar results of a somewhat larger study, published in August in the journal Oncotarget. In a sample of 28 patients, researchers found consistent results only about 17 percent of the time.

“It all boils down to a question of tumor biology,” says lead author of that study, Young Kwang Chae, an oncologist and a co-director of the Developmental Therapeutics Program of the Division of Hematology and Oncology at Northwestern University’s Feinberg School of Medicine.

“You can never say one test is the gold standard, or that one is better than the other,” he said. Because they are looking at different samples, it’s not surprising their results vary.

Many of the results from these tests are hard to interpret in the first place. In many instances, the presence of a particular mutation doesn’t tell a doctor exactly what form of therapy would work best.

But Chae says when he finds an “actionable genetic alteration” from either test, he uses that that to guide a patient’s therapy.

“Both tests are right,” argues Dr. Rick Lanman, chief medical officer at Guardant Health, which produces the blood-based Guardant360 test. If either test detects a particular mutation, there is high confidence that the particular mutation exists. And doctors can confidently base therapy on that positive detection, he says.

Doctors could get more complete results if they ran both tests on everybody, “but that’s not cost effective,” Lanman says.

His counterpart at Foundation Medicine, which makes the FoundationOne test, isn’t convinced that both tests are equally reliable. Dr. Vincent Miller says the blood tests can miss a lot more than tests run on tumor tissue.

He points to a recent study of pancreatic cancer. Gene variants very frequently found in pancreatic cancer were detected in 87 percent of tumor samples. But blood tests only found the mutations about 25 percent of the time.

Miller says his company has a blood test as well as the test for solid tumors, and they’re in the process of running a direct comparison, using the same genetic information. That could help clarify how much trust to put in blood tests, he says. “The technology may have gotten a little ahead of the clinical practice and the science,” he says.

Doctors may be lulled into thinking that these tests are providing definitive results, but they’re not. And that’s the overarching message for Blau at the University of Washington.

“You really have to be thoughtful about how you apply these to clinical decision making,” he says. “If you don’t understand these limitations, if you just treat the reports at face value, that could be leading to instances where oncologists use drugs that are unlikely to be effective.”

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States Accuse Generic Drugmakers Of Price Fixing

In an emailed statement, Mylan told NPR, “To date, we know of no evidence that Mylan participated in price fixing.” Jeff Swensen/Getty Images hide caption

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Twenty states are accusing a group of generic drug makers of conspiring to keep the prices on an antibiotic and a diabetes medication artificially high. And the state attorneys general say the lawsuit filed in federal court in Connecticut Thursday may be just the beginning of a much larger legal action.

The lawsuit alleges that the companies, led by New Jersey-based drug maker Heritage Pharmaceuticals, identified competitors and tried to reach agreements on how they could avoid competing for customers on price.

“While the principal architect of the conspiracies addressed in this lawsuit was Heritage Pharmaceuticals, we have evidence of widespread participation in illegal conspiracies across the generic drug industry,” Connecticut Attorney General George Jepsen said in a written release. “We intend to pursue this and other enforcement actions aggressively.”

The other companies accused of price-fixing were Aurobindo Pharma USA, Inc., Citron Pharma, LLC, Mayne Pharma (USA), Inc., Mylan Pharmaceuticals, Inc. and Teva Pharmaceuticals USA, Inc.

The complaint describes Heritage and other drug-company executives meeting at industry conferences and company-sponsored dinners where they would share information about the pricing. It also alleges that, to avoid having to lower prices, the companies would divvy up customers — such as pharmaceutical wholesalers, for example — rather than compete for the business.

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The two drugs — a delayed release version of the antibiotic doxycycline hyclate and the diabetes drug glyburide — saw enormous price increases during the time of the alleged conspiracy, the legal complaint says.

A separate congressional investigation into generic drug prices shows that the price of doxycycline rose more than 8,000 percent from October 2013 to April 2014.

The Centers for Disease Control and Prevention, as well as several industry trackers also noted shortages of various types of doxycycline during 2013.

The states’ lawsuit comes a day after the U.S. Justice Department filed criminal charges against Jeffrey Glazer, Heritage’s former CEO and Jason Malek, the company’s former president. It accuses the two men of conspiring with companies to manipulate drug prices.

Heritage fired the two men in August after an internal investigation, the company said in an email to NPR Thursday. The company also sued the men last month, accusing them of embezzlement.

A Heritage spokeswoman says the company is cooperating with both the federal and state investigations.

Mylan reported, in an emailed statement, “To date, we know of no evidence that Mylan participated in price fixing.” A Teva spokeswoman told NPR, “We have not found evidence that would give rise to any civil or criminal liability.”

In a filing Nov. 4 at the Securities and Exchange Commission, Mayne said it had received subpoenas from the Justice Department regarding doxycycline and potassium chloride powders, and said the company is cooperating with the investigation and “continues to believe these investigations will not have a material impact on its future earnings.” Mayne did not immediately comment on the states’ lawsuit.

Aurobindo and Citron did not immediately respond to requests from NPR for comment.

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Obama Administration Moves To Protect Planned Parenthood's Federal Funding

Planned Parenthood’s president, Cecile Richards, addresses the Democratic National Convention in July. Republicans in Congress have repeatedly threatened to cut off federal funding for Planned Parenthood because the family planning group performs abortions at some clinics. J. Scott Applewhite/AP hide caption

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J. Scott Applewhite/AP

The Obama administration is trying to protect Planned Parenthood’s federal funding before the president turns over the reins of government to Republicans who have historically been hostile to the family planning group.

The Department of Health and Human Services finalized a regulation Wednesday that says states that award federally funded grants for women’s health programs can’t discriminate against Planned Parenthood. The regulation doesn’t name Planned Parenthood, but it was clear the rule was written with the organization in mind.

Republicans in Congress have repeatedly threatened to cut off federal funding for Planned Parenthood because the family planning group performs abortions at some clinics.

“President Obama has cemented his legacy as a champion for women’s health,” said Planned Parenthood President Cecile Richards in a written release. “This rule protects birth control, cancer screenings, [sexually transmitted infection] testing and treatment and other health care for millions of people.”

Planned Parenthood and other clinics that provide family planning services to women get federal funding through the Public Health Service Act.

The group says 1.5 million of its patients benefit from the money provided by the federal government.

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Planned Parenthood gets more than $500 million a year from the federal government. About 75 percent of that comes from Medicaid, for medical care provided to patients with low incomes.

The new HHS rule reinforces federal law that says the agency cannot discriminate against qualified organizations in granting federal funds.

Still, the rule could be overturned in 2017 when President-elect Donald Trump takes office. Federal lawmakers are allowed to roll back regulations under the Congressional Review Act. Or they could go through a formal rule-making process to reverse Wednesday’s action.

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Sign Up For Health Coverage If You Need It, Despite GOP Repeal Plans

If you need to buy health insurance, don’t procrastinate. Pablo Martinez Monsivais/AP hide caption

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Pablo Martinez Monsivais/AP

Since Republicans have plans to repeal the federal health law, should consumers still sign up for next year’s coverage? And if the health law marketplaces disappear, might Medicare eligibility be expanded? Here are answers to some recent questions from readers.

It sounds like Republicans plan to repeal the health law in January once Donald Trump is sworn in. Since open enrollment goes until the end of January, should I just wait and see what happens before signing up?

No. Don’t wait. The future of the health law is murky, but some things are crystal clear. If you need marketplace coverage that starts Jan. 1, you have to pick a plan by Dec. 15, two days from now. So get cracking.

Republicans have pledged that if they repeal the law they’ll provide a transition period so that people won’t be stuck without coverage. But if you miss the enrollment period that ends on Jan. 31, you will be cutting yourself off from coverage for the year. After that date you can’t sign up for 2017 coverage on the exchange unless you qualify for a special enrollment period because you move to another state or lose your job-based coverage, for example.

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I’m 60 and I have coverage on the health insurance marketplace. If they do away with Obamacare, I’m not sure what I’ll do. I have diabetes and I had cancer when I was younger so I’m not an attractive insurance risk. Some people have proposed lowering the Medicare eligibility age so more people can qualify earlier. Is that really an option?

Beyond the political challenges there are also practical ones, said Dr. Ezekiel Emanuel, chair of the Department of Medical Ethics and Health Policy at the University of Pennsylvania and a former health policy adviser in the Obama administration. If policymakers simply reduced the eligibility age to 60, for example, “a lot of businesses would start sending their 60-year-old [employees] to Medicare and take the savings,” leading to a huge increase in costs for the program.

On the other hand, if individuals were able to buy into Medicare before age 65, even with subsidies it would probably be expensive to do so, Emanuel said. Those who would opt to buy in would likely be people with expensive health conditions like you who really need good coverage, a phenomenon called “adverse selection” that would make the program even more costly.

There is one possibility that could result in some sort of expanded Medicare in the longer term, Emanuel said. If the Republican Congress and Trump repeal Obamacare, millions of people may lose their health insurance. If that happens and current Republican proposals — state high-risk pools, for example, to provide coverage for people with expensive conditions — prove inadequate to the task, “there’s going to be a lot of pressure to do something,” he said.

I am 69 and have had Medicare Parts A and B since I turned 65. I also have a Medicare supplemental plan. I have recently been hired again and plan to take my employer’s insurance for 2017, and I will drop my supplemental plan and Medicare Part B because I won’t need them. When I start Medicare Part B again, will there be a penalty for stopping and then starting again?

In your case, you likely won’t be penalized, said David Lipschutz, senior policy attorney at the Center for Medicare Advocacy. As long as you’re actively employed and work for an employer with at least 20 employees, Medicare will consider your employer coverage your primary insurance and won’t penalize you for dropping and then re-enrolling in Part B, the medical insurance part of the program.

As you seem to be aware, the late-enrollment premium penalty for Medicare Part B can be hefty: 10 percent for every 12-month period when you could have signed up for Part B but didn’t.

Where people sometimes get tripped up is when they retire from a job and retain their employer coverage, Lipschutz said. Because they’re now retired and their coverage isn’t tied to their active employment, Medicare considers their employer insurance secondary to their Medicare coverage and will penalize people who don’t sign up for Part B when they become eligible.

Although you shouldn’t have any trouble re-enrolling in Part B when you leave your job, your Medicare supplemental plan, often called a Medigap plan, may be a different story. When you turn 65 and enroll in Part B, you are guaranteed the right to buy any Medigap plan in your state. But after that initial six-month enrollment window, insurers can evaluate your health and decide whether to offer you a plan.

That would apply to you when you return to the Medicare market. Some states provide additional rights to buy a Medigap plan; it’s worth checking to see if yours is one of them.

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

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Obamacare's Demise Could Be Quicker Than Republicans Intend

Senate Republicans will move “right after the first of the year” on a resolution to replace the Affordable Care Act, Senate Majority Leader Mitch McConnell told reporters Monday. Mark Wilson/Getty Images hide caption

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Mark Wilson/Getty Images

Republicans in Congress say they’ll vote to repeal much of the Affordable Care Act early next year — even though they don’t yet have a plan to replace it.

But they also insist that they don’t want to harm any of the millions of people who got their health insurance under the law.

The lawmakers’ strategy? Vote to repeal, and fulfill their top campaign pledge. But delay the changes, and keep running Obamacare for as long as two years while they figure out how to fill the hole they’ll create in the insurance market.

“We will move right after the first of the year on an Obamacare replacement resolution,” Senate Majority Leader Mitch McConnell told reporters Monday, using terminology that refers to the type of vote lawmakers will take to defund the health care law.

“Then we will work expeditiously to come up with a better proposal,” he added.

House Speaker Paul Ryan has said the plan will protect patients.

“There needs to be a reasonable transition period so that people don’t have the rug pulled out from under them,” he told reporters at a news briefing at the U.S. Capitol last week.

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But repealing the law that essentially created an entire market for health insurance that didn’t exist before — and then expecting that insurance market to remain healthy — may be fantasy, according to health insurance consultants.

“I don’t think the Republicans have come to grips yet that it’s going to be their responsibility to keep the wheels on Obamacare,” Robert Laszewski, president of Health Policy and Strategy Associates, told Shots.

Republicans keep saying the Obamacare exchanges are collapsing, Laszewski said. But by voting to kill the law, they may actually speed up that process.

“They’re arguing that the thing is in death throes; that the insurance companies are losing tons of money; and it’s not sustainable,” Laszewski said. “Why do they think the insurance companies are going to provide the insurance policies in that scenario?”

An estimated 20 million people have obtained health insurance over the last three years via provisions in the Affordable Care Act. Some get coverage through the insurance exchanges, but millions are covered because of the expansion of Medicaid in most states, and because the law allows young adults to stay on their parents’ insurance policies up to age 26.

Laszewski isn’t the only one who’s skeptical of the “repeal but delay replacement” strategy.

Last week America’s Health Insurance Plans — the trade group that represents health insurance companies — circulated a memo on Capitol Hill warning that a sudden repeal of Obamacare could threaten the expanded health coverage for those millions.

“Making sudden, significant changes now, or mid-year, will jeopardize the coverage they depend on,” the letter said.

AHIP asked lawmakers to keep in place many of the financial incentives that are central to the law — including the provision of subsidies for people to buy insurance and cover copayments, and the elimination of some taxes on insurers.

The American Academy of Actuaries also weighed in, warning in its own letter that a repeal of the ACA without replacing it would be dangerous to the long-term health of the insurance market.

“Insurers are in a situation right now where they’re trying to determine whether or not they’re going to participate in 2018,” said Cori Uccello, a senior fellow at the American Academy of Actuaries. “And part of that depends on whether, in the long run, it makes sense for them to participate in the market. And that long run depends on what’s going to happen, not just in 2018, but in the years after 2018.”

The big problem is that through Obamacare, the government plays a huge role in helping people pay for insurance on the individual market. Many insurance companies are already losing money on those policies, so if they think the government won’t keep offering subsidies, insurers may just stop selling individual policies altogether.

They won’t necessarily wait to find out what Congress is hoping to do at some point in the future.

Insurers “will have to see more than the repeal element,” Shubham Singhal, head of the health care practice at McKinsey, who consults with health insurance companies, told Shots. “They’ll have to see, if it’s delayed, then what’s the transition plan? That’s going to be quite important for them, to understand whether it creates a stable marketplace or not.”

Another complication is that Republicans won’t be able to repeal the law outright because — in order to pass a regular piece of legislation in the Senate — they would need the support of Democrats to overcome a filibuster.

So they will have to use a special legislative maneuver that allows them to pass any bill related to taxes or the budget with a simple majority. That means lawmakers can defund Obamacare, but leave some provisions in place, including a requirement that insurers cover people who have pre-existing medical conditions.

Most experts believe having that requirement in place with no mandate for healthy people to buy insurance will lead companies to quit writing individual insurance policies altogether.

So, even people who had insurance before the Affordable Care Act became law, and who pay for it without subsidies, could lose their coverage.

“I don’t think the Republicans are taking this anywhere seriously enough,” Leszewski says. “They could get themselves into a real hole.”

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Don't Skip Medicare Coverage For Doctor Visits, Even If You Have Other Insurance

When Cindy Hunter received her Medicare card in the mail last spring, she said she “didn’t know a lot about Medicare.” She and her husband, retired teachers who live in a Philadelphia suburb, decided she didn’t need it because she shared his retiree health insurance, which covered her treatment for ovarian cancer.

Cindy Hunter, who is battling ovarian cancer, says she mistakenly thought she didn’t need to enroll in Medicare because her husband’s retiree insurance would cover her. Steph Brecht/Courtesy of Cindy Hunter hide caption

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Steph Brecht/Courtesy of Cindy Hunter

“We were so thankful we had good insurance,” she said. So she sent back the card, telling officials she would keep Medicare Part A, which is free for most older or disabled Americans and covers hospitalization, some nursing home stays and home health care. But she turned down Part B, which covers doctor visits and other outpatient care and comes with a monthly premium charge. A new Medicare card arrived that says she only has Part A.

Her story isn’t unique.

When Stan Withers left a job at a medical device company to become vice president of a small start-up near Sacramento, Calif., he took his health insurance with him. Under a federal law known as COBRA, he paid the full cost to continue his coverage from his previous employer. A few years earlier, when he turned 65, he signed up for Medicare’s Part A. With the addition of a COBRA plan, he thought he didn’t need Medicare Part B.

Hunter and Withers now know they were wrong and are stuck with medical bills their insurance won’t cover. Hunter called it “an honest mistake” and said there was nothing in the written materials she and her husband received indicating that if they had Medicare Part A, his retiree coverage could not replace Medicare Part B. Withers had no idea he made a bad choice

Thousands of seniors unwittingly make similar mistakes every year, believing that because they have some type of health insurance they don’t have to worry about signing up for Medicare Part B. Generally, insurance other than that provided by a current employer will not exempt them from Medicare’s strict enrollment requirements.

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Advocates for seniors and some members of Congress want to fix the problem, backed by a broad, unlikely group of unions, health insurers, patient organizations, health care providers and even eight former Medicare administrators.

Medicare’s Part B enrollment rules haven’t changed since the program was created in 1965. Seniors can enroll only when they first become eligible — usually three months before and after the month they turn 65 — or when their job-based insurance ends. If they miss this chance, they have to wait until the months of January through March to enroll and then coverage only begins July 1. Most won’t be allowed to buy any other health insurance policy during that time.

If people delay signing up for 12 or more months after becoming eligible, many will be hit with a permanent penalty added to their Part B monthly premium. In 2014, about 750,000 beneficiaries paid late penalties, raising their Part B premiums an average of 29 percent, according to the Congressional Research Service.

“The rules have not changed, but our lives have,” said Joe Baker, president of the Medicare Rights Center, an advocacy group that is leading the effort to update the enrollment process. When Medicare began, the government wanted seniors, especially younger and healthier people, to sign up quickly and so the deadlines and late penalties were incentives to get them in the program.

But these days more seniors work past the Medicare eligibility age, get health insurance through their employer or their spouse’s, or have coverage through the health insurance marketplaces, Baker said. The problem isn’t that people are going without insurance. “The confusion that we really see is with how Medicare interacts with other insurance coverage,” he said.

Hunter, 62, became eligible for Medicare earlier than 65 because she gets Social Security disability benefits. She’s receiving two chemotherapy drugs to control a second reoccurrence of ovarian cancer. This fall her oncologist’s office told her there’s “something going on with your insurance,” she recalled. After many calls to her husband’s retiree plan, Social Security, Medicare and even her congressman, she learned that her insurance would only pay a share of the bills for her cancer treatment after deducting the amount the insurer said was Medicare’s responsibility. “But Medicare isn’t paying because I don’t have Part B,” she said. So Hunter is probably responsible for that portion.

Withers thought the health plan he purchased through his old employer would count as job-based coverage, but COBRA is not a substitute for Medicare Part B, a point no one mentioned when he submitted his paperwork. He should have signed up for Part B when he left his previous job.

“How could there be a rule that no one knows about?” Withers asked.

In addition, the private plan has refused to pay thousands of dollars in medical bills because the company argued that he should have had Part B and those are Medicare’s responsibility.

Confusion over COBRA is just one of many reasons that people miss their opportunity to enroll in Part B. Others think, incorrectly, that getting Veterans Health Administration benefits, job-based-health insurance from a company with less than 20 workers, retiree coverage from a former employer, or coverage from the health law’s insurance marketplace exempts them from Part B’s lifetime late penalties and waiting periods with no insurance.

To help seniors avoid such mistakes, bipartisan legislation has been introduced in both the House and Senate that would allow people who miss their initial Part B enrollment deadline to sign up in the fall, when millions of seniors already in Medicare are choosing private drug or medical policies. Part B coverage would begin the month after they enroll, said Stacy Sanders, federal policy director at the Medicare Rights Center. It would also allow most people who enroll late to apply for retroactive coverage to their initial eligibility date and request a waiver of the late penalties if they can prove they were misled by an employer, health plan, insurance broker or state official (currently, an exemption may be based only on misinformation from a federal government representative).

“Because I didn’t ask Social Security and they didn’t give me the wrong information, there was nothing they could do,” Hunter said. “They said if they had given me the wrong information, they might be able to do something.”

Seniors “shouldn’t face penalties or gaps in their Part B coverage simply due to bureaucratic snafu,” said Rep. Patrick Meehan, R-Pa., who co-sponsored the House bill. “I’ve had seniors contact my office and say they simply had no idea of existing deadlines — or that they faced penalties down the road for missing them.”

The legislation also would require Medicare officials to notify all Americans prior to their 65th birthday about signing up for Medicare. Currently, the federal government and some states notify only those 64-year-olds who have health insurance though the Affordable Care Act’s marketplaces.

Although the bill appears unlikely to see action before the end of the current congressional session, Meehan said he will reintroduce it in 2017.

Getting an official government notice before turning 65 explaining when to sign up for Part B would “absolutely” help, said Withers. “There should be something that tells people what they need to do.”

Kaiser Health News is an editorially independent news service that is part of the nonpartisan Henry J. Kaiser Family Foundation. You can follow Susan Jaffe on Twitter: @susanjaffe.

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