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OxyContin Manufacturer Says It Will Stop Promoting Opioid Painkiller To Doctors

NPR’s Ari Shapiro talks with journalist Sam Quinones about Purdue Pharma’s announcement that it would stop promoting its blockbuster opioid painkiller OxyContin to doctors. Purdue’s move comes as it faces dozens of lawsuits.

ARI SHAPIRO, HOST:

Effective today, Purdue Pharma is no longer promoting its blockbuster painkiller OxyContin to doctors. In an open letter, the company has said it is doing more to fight the opioid crisis. The letter concludes, this is our fight too. Purdue faces lots of fights. States and cities across the U.S. have sued the drug company for contributing to the addiction epidemic. Sam Quinones has reported on Purdue Pharma for years. He’s author of the book “Dreamland: The True Tale Of America’s Opioid Epidemic.” Welcome.

SAM QUINONES: Thanks for having me.

SHAPIRO: Purdue Pharma used to market OxyContin really aggressively. It’s been less of that recently. What exactly is the change that’s starting today?

QUINONES: My impression is that they are simply not going to be promoting it to doctors at all. They have been promoting it as a reasonable painkiller. And my impression is now that they will be ceasing that, which would be a big step for them – considering that I think it’s one of the few drugs they actually have.

SHAPIRO: Why do you think they’re doing it right now?

QUINONES: I think they are seeing a groundswell of concern across the country and communities everywhere because this is a problem. Opiate addiction is a problem all across the country from coast to coast. They’re also seeing, of course, as you mentioned, dozens of lawsuits filed by states’ attorneys general, by counties, by towns alleging that several companies, Purdue foremost among them, lead a kind of a campaign to dupe the public into believing that their drug was not addictive. And these lawsuits, particularly in the last – I would say – year and a half, have really gained steam as local entities, counties and towns, have seen themselves buckling under the cost of paying for the consequences of this epidemic and having done nothing to really create it – are looking for ways of paying for the increase in foster care that they now have to provide, the full jails, the courts that are that are overwhelmed with new addicts.

SHAPIRO: So do you think this change is likely to affect those lawsuits?

QUINONES: I doubt it. The lawsuits were filed based on what has gone on up to now. A lawyer could tell you better. But my feeling is that these lawsuits were – are based on evidence or facts they say they have that show that the company did this in the past – not what’s going on today. I think it may be more a PR move, as a way of kind of softening feelings toward the company, because I can tell you in many parts of the country this company is very roundly hated.

SHAPIRO: Well, I was going to ask. Purdue Pharma is not ending sales of OxyContin. They just say they’re going to stop marketing oxy. How much of a difference will that make?

QUINONES: It’s hard to say because by now Purdue Pharma and OxyContin, they’re household names. In any doctor’s office, certainly everybody knows the drug. Most pain patients know the drug. It’s not clear to me how much more promoting they actually have to do to get this drug well-known. It’s also got a very bad reputation too. A lot of people are very wary of it. Doctors are very wary of it now, I think. And so what exactly is – how this will help? I’m not sure. They may have their own calculations as to what effect it will have.

SHAPIRO: How much money has this drug made for Purdue Pharma over the years?

QUINONES: Well, it’s a private company. I’m not sure exactly. But estimates that I have read – between $35 and $40 billion in sales since the drug came out in 1996. It’s basically the reason why the Sackler family, which owns Purdue, is one of the wealthiest families in America. Forbes magazine pegged it as one of the wealthiest families in America due almost entirely to the sales of OxyContin.

SHAPIRO: OxyContin is not the only addictive opioid out there. Other drug companies continue to sell addictive painkillers. How much of a difference does it make that this one company will no longer market this one drug? Do you think other drug companies will follow?

QUINONES: I suspect they may. I think it’s more of a – kind of a bellwether of where this issue is going because when you talk about how we got into this, really Purdue Pharma is the company that led the way. Their promotions and their sales and their aggressive marketing really led the way into all this. And so people are now looking to say, well, look. We are turning away from that. We have learned our lesson. We want to be part of the solution – I think as they said in that statement that you read. I’m not sure how much effect it will actually have. And I think time will tell that this is a problem that is not going away. It’s very deeply rooted now in American culture. And will this change in marketing and promotion mean much after the company’s gone to such lengths to root this in America? I don’t know. I guess we’ll see.

SHAPIRO: Journalist and author Sam Quinones, thanks a lot.

QUINONES: My pleasure.

Copyright © 2018 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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Can A Patient Gown Makeover Move Hospitals To Embrace Change?

The new hospital garment ties in the front, like a robe, allowing the patient more modesty than the standard gown.

Sophie Sahara Barkham/courtesy Care+Wear

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Sophie Sahara Barkham/courtesy Care+Wear

A medical company is trying to make hospital gowns less terrible — maybe even good. The company is called Care+Wear and it’s currently testing out the new gowns at MedStar Montgomery in Olney, Md.

You know the old gown, sometimes called a “johnny“: It’s got the flimsy ties and the exposed back.

The new gown from Care+Wear ties at the front like a robe. It’s got color coded ties and a pocket for your phone. Maybe most importantly, it covers the butt without sacrificing bedpan access for the bedridden.

A new hospital gown isn’t a completely original thought. Back in 1999, a hospital in Hackensack, N.J., asked designer Nicole Miller to make gowns, robes, and pajama bottoms. In 2010 The Cleveland Clinic recruited Diane Von Furstenberg to help design a new gown modeled after her famous wrap around dresses. In 2014, the Henry Ford Health System in Detroit teamed up with Carhartt to make a robe they dubbed the Model G. While these designs may have been successful on the small scale, none of them have usurped the johnny gown as the industry standard, say industry experts.

Why not? “Hospitals are not designed for patients,” says Dr. Bridget Duffy, the chief medical officer of Vocera, a hospital communications company. More importantly for this story, she was the chief experience officer at the Cleveland Clinic — the one with the Diane Von Furstenburg gown that they still use today — and she helped consult on the new Care+Wear gown. She says a big reason hospitals don’t move toward a more patient-friendly gown is due to your usual bureaucratic inertia, as well as a habit of focusing more on health care provider needs than patients’ needs.

“In the past we’ve never had patients in the room at the very beginning of the design process,” she says.

Instead of flimsy ties, the back of the new gown has a flap to cover the patient’s behind.

Sophie Sahara Barkham/courtesy Care+Wear

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Sophie Sahara Barkham/courtesy Care+Wear

Dr. Fredrick Finelli, surgeon and vice president at MedStar Montgomery, sums up the gown design conflict: “For me as a doctor, it would be best to have the patient naked,” he says. “Then I wouldn’t have to deal with any gowns or cloth in my way. But for the patient, they basically want the opposite. They’d like to be covered up.”

Care+Wear teamed up with a class at the Parsons School of Design to iron out the kinks of making a new robe that works for both patient and provider. Irene Lu was a student in the class who says they took each step of their design to both clinicians and patients.

“Working with these patients with different opinions on the gowns really helped inform our design,” she says. They took notes on how people felt about the neckline, the buttons, the ties, and how it fit on people of different sizes and mobility.

Jimena Ryan was a patient at MedStar Montgomery who was wearing the new gown when I spoke to her. She was into it. The gown works more or less like a robe, so it felt familiar to her.

“I have many dresses for work that come together the same way, so it’s intuitive to put it together,” she says. “And the fact that it’s not open in the back is a big relief, especially when you’re up and around,” she adds.

Part of Ryan’s recovery was walking around the halls of the hospital. With the old gown, “you’re always wondering what is open and what is flapping, what view am I giving,” she says.

Professor Traci Lamar is less optimistic about any robe overtaking the johnny gown. She teaches at North Carolina State University in the college of textiles, and had a hand in a hospital gown re-design herself back in 2009.

“There are number of pressures in the hospital environment that influence what they purchase and when they purchase. Cost management, inventory management, storage space, all of those kinds of things come into play as factors when they start looking at changing a garment that’s widely used,” she says.

To her, the cost-benefit analysis isn’t going to tip in favor of more hospitals changing gowns until the gowns have something more to offer than coverage.

“There’s more value coming with the apparel item if it also becomes something that replaces or enhances other equipment that’s used in the hospital environment,” she says. Like a gown that can also keep an eye on your blood pressure, or measure your heart rate.

Who knows when textiles can be smart enough to pull that off, so we might be stuck with the old johnny gown for a while.

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What The Budget Deal Means For Medicare Drug Prices

The new budget will likely lower the cost of expensive prescription drugs for Medicare patients. Elisabeth Rosenthal of Kaiser Health News talks with NPR’s Scott Simon.

SCOTT SIMON, HOST:

The new budget passed late this week includes changes for Medicare patients. It will require drug companies to give deeper discounts to Medicare on expensive prescriptions. That should reduce the cost of drugs for patients. The skyrocketing cost of prescription drugs is something followed closely by Elisabeth Rosenthal, a veteran healthcare reporter and editor-in-chief of Kaiser Health News, who joins us from her offices. Thanks so much for being with us.

ELISABETH ROSENTHAL: Thanks for having me.

SIMON: Will this and other features you see in the budget help reduce the cost of prescription drugs?

ROSENTHAL: Well, to a small number of people, it will. I mean, this really targets the Medicare-age population and Medicare plans. And for people who have very high drug costs within Medicare, it will definitely help them. But it, of course, doesn’t solve the much larger problem of the very high prescription drug prices that everyone pays in this country. And P.S., what we’re talking about for Medicare patients, even, are discounts on these very high initial prices. So, you know, a discount of a really high price still isn’t a very good deal.

SIMON: Why do we have a problem with this in the United States?

ROSENTHAL: Well, we’re the only country that doesn’t in some way directly negotiate prescription drug prices with manufacturers – the only developed country, that is. I mean, most other countries in some form either evaluate the cost-benefit ratio of a new drug and decide what they’re willing to pay or, you know, very aggressively negotiate with drug manufacturers, particularly for older drugs, as they age.

SIMON: Insulin in one form or another has been saving lives for – what? – 80 years.

ROSENTHAL: Yeah.

SIMON: Why has the price gone up in recent years?

ROSENTHAL: Prices will rise to whatever the market will bear, right? We see that uniquely in the U.S. One vial of insulin in the U.S. costs seven times what it does in Germany. So there’s a huge disparity there. Some of the reasons have to do with reformulations of insulin that are, in fact, better than some of the older ones. Although, when I’m talking about that 1 in 7 price comparison, that’s the same exact insulin.

In the U.S., what’s happened – and this is something that I know the Trump administration is looking at and many experts in the field have decried – the slow arrival of biosimilars or generic insulins onto the market, which are on the market in other countries. The problem in this country is the lowering of prices of insulin. And insulin patents have been held up in the courts for years now in suits and countersuits between the three big insulin drug makers, including by Eli Lilly, which is the former employer of our new HHS Secretary.

SIMON: That’s Alex Azar – has been appointed Secretary of Health and Human Services.

ROSENTHAL: Yes.

SIMON: Is he the kind of choice that gives you optimism that prescription drug prices will come down?

ROSENTHAL: Well, there’s a certain argument to be made that Alex Azar of all people on Earth understands how the games are played and how these suits and countersuits about making generics or making biosimilars have held up the arrival on the U.S. market and have raised prices for everyone. On the other hand, there’s ongoing concern about the revolving door between government and pharmaceutical companies such that you wonder, is their loyalty to the American people, or is their loyalty to the pharmaceutical world from which they came?

SIMON: I don’t think I can think of any politician who says, and if you elect me, I promise prescription drugs will cost more.

ROSENTHAL: (Laughter).

SIMON: I mean, on the contrary, every politician says, elect me, and I’ll do something to bring down the cost of prescription drugs. Why doesn’t that get done?

ROSENTHAL: Yeah. Everyone agrees that our prescription drug costs are too high – both right and left – you know, Democrat, Republican. It’s one of the few points of information, points of fact that everyone agrees on. The problem is everyone disagrees on how best to tackle that. And there are a lot of forces that are resisting any change at all.

The bipartisan solution which Senator Klobuchar and Senator John McCain have proposed is allowing prescription drug imports from other countries, so we allow for a global competition in the sense of, you know, if everyone else is getting a better deal than us, why can’t we buy our prescription drugs from there the same way we buy our, you know, refrigerators and cars?

SIMON: Elisabeth Rosenthal, editor-in-chief of Kaiser Health News and author of “An American Sickness: How Health Care Became Big Business And How You Can Take It Back.” Thanks so much for being with us.

ROSENTHAL: Thanks for having me.

(SOUNDBITE OF THE JAZZ MANDOLIN PROJECT’S “SPIDERS”)

Copyright © 2018 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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Spot Shortages Of Antiviral Drugs Seen As Flu Season Drags On

People 6 months and older should get vaccinated against the flu, says this government poster on display in a health center in Decatur, Ga.

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David Goldman/AP

The peak of the flu season could still be several weeks away, federal health officials cautioned Friday.

“We may be on track to break some recent records,” said Dr. Anne Schuchat, acting director of the Centers for Disease Control and Prevention. Nearly all states are still reporting widespread flu activity, with less severe reports only coming from Oregon and Hawaii.

“Flu is incredibly difficult to predict and we don’t know if we’ve hit the peak yet,” Schuchat said in a call with reporters. “We could still see several more weeks of increased activity.”

Health officials don’t directly count flu cases and deaths for the general population. They do track deaths among children, which climbed to a total of 63 for this season.

Another measure is the percentage of deaths attributed to flu or pneumonia, which often accompanies influenza. Last week, 1 in 10 of all deaths reported in the United States were caused by flu or pneumonia.

The rate of flu activity is similar to the rate in 2009, which was the last flu pandemic, “though that doesn’t mean we’re having a pandemic,” Schuchat said.

The strain of flu known as H3N2 remains the dominant form circulating in the United States. It’s a particularly severe strain that isn’t easily stopped by the current vaccine.

Two other strains are on the rise, however, and they generally cause milder symptoms. They’re also more likely to be blocked by the flu vaccine. So, Schuchat said, it’s still not too late to get vaccinated.

The CDC recommends antiviral medications, such as Tamiflu or the generic version called oseltamivir, for vulnerable populations hit by flu. Those groups include young children, pregnant women, the elderly and people with heart or lung disease.

There are spot shortages of the antiviral drugs, Schuchat said. People seeking them may need to call multiple pharmacies to fill their prescriptions.

The CDC has been working with insurers and pharmacies to alleviate those shortages and to make brand-name drugs available at a lower cost when generics aren’t available.

“I wish there were better news this week,” Schuchat said.

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Senate Budget Deal Would Give A Boost To Health Programs

“This bill represents a significant bipartisan step forward,” Senate Majority Leader Mitch McConnell said Wednesday.

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In a rare show of congressional cooperation, Republican and Democratic leaders in the Senate announced a two-year budget deal Wednesday that would increase federal spending for defense as well as key domestic priorities, including many health programs.

Not in the deal, for which the path to the president’s desk remains unclear, is any bipartisan legislation aimed at shoring up the Affordable Care Act’s individual health insurance marketplaces. Senate Majority Leader Mitch McConnell, R-Ky., promised Sen. Susan Collins, R-Maine, a vote on health legislation in exchange for her vote for the GOP tax bill in December. So far, that vote hasn’t materialized.

The deal does appear to include almost every other health priority Democrats have been pushing the past several months, including two years of renewed funding for community health centers and a series of other health programs Congress failed to provide for before they technically expired last year.

“I believe we have reached a budget deal that neither side loves but both sides can be proud of,” said Senate Minority Leader Chuck Schumer, D-N.Y., on the Senate floor. “That’s compromise. That’s governing.”

McConnell said, “This bill represents a significant bipartisan step forward.”

Senate leaders are still negotiating details of the accord, including the size of a cut to the Prevention and Public Health Fund, which would help offset the costs of this legislation.

According to documents circulating on Capitol Hill, the deal includes $6 billion in funding for treatment of mental health issues and opioid addiction, $2 billion in extra funding for the National Institutes of Health, and an additional four-year extension of the Children’s Health Insurance Program, which builds on the six years approved by Congress last month.

In the Medicare program, the deal would accelerate the closing of the “doughnut hole” in Medicare drug coverage that requires seniors to pay thousands of dollars out-of-pocket before catastrophic coverage kicks in. It would also repeal the controversial Medicare Independent Payment Advisory Board, which is charged with holding down Medicare spending for the federal government if it exceeds a certain level.

Members have never been appointed to the IPAB, however, and its use hasn’t so far been triggered by Medicare spending. Both the closure of the doughnut hole and creation of the IPAB were part of the Affordable Care Act.

The agreement would also fund a host of more limited health programs — some of which are known as “extenders” because they often ride along with other, larger health or spending bills.

Those programs include more than $7 billion in funding for the nation’s federally funded community health centers. The clinics serve 27 million low-income people and saw their funding lapse last fall — a delay advocates say had already complicated budgeting and staffing decisions for many clinics.

And in a victory for the physical therapy industry and patient advocates, the accord would permanently repeal a limit on Medicare’s coverage of physical therapy, speech-language pathology and outpatient treatment. Previously, the program capped coverage after $2,010 worth of occupational therapy and another $2,010 for speech-language therapy and physical therapy combined. But Congress had long taken action to delay those caps or provide exemptions — meaning they had never actually taken effect.

According to an analysis by the nonpartisan Congressional Budget Office, permanently repealing the caps would cost about $6.47 billion over the next decade.

Lawmakers would also forestall cuts mandated by the ACA to reduce the payments made to what are called Disproportionate Share Hospitals, which serve high rates of low-income patients. Those cuts have been delayed continuously since the law’s 2010 passage.

Limited programs are also affected. The deal would fund for five years the Maternal, Infant and Early Childhood Home Visiting Program, a program that helps guide low-income, at-risk mothers in parenting. It served about 160,000 families in fiscal year 2016.

“We are relieved that there is a deal for a 5-year reauthorization of MIECHV,” says Lori Freeman, CEO of advocacy group the Association of Maternal & Child Health Programs, in an emailed statement. “States, home visitors and families have been in limbo for the past several months, and this news will bring the stability they need to continue this successful program.”

And the budget deal funds programs that encourage doctors to practice in medically underserved areas, providing just under $500 million over the next two years for the National Health Service Corps and another $363 million over two years to the Teaching Health Center Graduate Medical Education program, which places medical residents in Community Health Centers.

Kaiser Health News correspondent Emmarie Huetteman contributed to this report.

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Trump Says He Will Focus On Opioid Law Enforcement, Not Treatment

On Jan. 10, President Trump signed into law the bipartisan Interdict Act, to give federal agents more tools to curtail opioid trafficking. But, after declaring the opioid crisis a public health emergency last fall, Trump has been slow to request money for treatment, critics note.

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More than three months after President Trump declared the nation’s opioid crisis a public health emergency, activists and healthcare providers say they’re still waiting for some other action.

The Trump administration quietly renewed the declaration recently. But it’s given no signs it’s developing a comprehensive strategy to address an epidemic that claims more than 115 lives every day. The President now says to combat opioids he’s focused on enforcement, not treatment.

Trump spent just over a minute of his 80-minute State of the Union address talking about opioids. In a speech this week in Cincinnati, he had a few more comments. The opioid epidemic, he said, “has never been worse. People form blue ribbon committees. They do everything they can. And frankly, I have a different take on it. My take is you have to get really, really tough, really mean with the drug pushers and the drug dealers.”

The President’s mention of “blue ribbon committees” sounds like a slam on one he convened last year, chaired by former New Jersey Governor Chris Christie — the President’s Commission on Combating Drug Addiction and the Opioid Crisis. The commission issued more than 50 recommendations. The administration has so far followed up on just a few of those recommendations.

Some officials and care providers who work on the frontlines of the opioid crisis, however, are scathing about what they see as a lack of action from the White House. Former Congressman Patrick Kennedy, who served on the White House opioid commission, says he’s “incredulous” that, after declaring a public health emergency in October, the President still hasn’t requested any money from Congress to combat the epidemic.

“I mean this is just a mental health crisis of the first order,” Kennedy says, “and this administration has done nothing.”

Here’s what the administration has done so far:

  • President Trump declared a public health emergency in October to deal with the opioid epidemic. The declaration brought no new money to fund the federal response.
  • In November, President Trump announced he’s donating his third-quarter salary — about $100,000 — to help the Department of Health and Human Services fight opioids.
  • The Centers for Medicare and Medicaid Services announced a policy change in November that allows states to apply for waivers allowing them to use Medicaid to pay for residential drug treatment at facilities that have more than 16 beds. Some states are already taking advantage of that policy change.
  • President Trump signed the INTERDICT Act in January giving federal agents additional tools for detecting fentanyl and other synthetic opioids at the border.
  • Also this month, Attorney General Jeff Sessions announced an operation using medical data to crack down on pharmacies and doctors that dispense suspicious amounts of opioids.

Here are things critics point out the administration hasn’t done:

  • There is still no head of the Office of National Drug Control Policy. In October, Trump’s nominee to the position, Rep. Tom Marino, R-Pa., withdrew his name after reports linked him with a bill that limited the DEA’s ability to investigate abuses by opioid manufacturers and distributors.
  • President Trump still hasn’t nominated anyone to head the Drug Enforcement Agency.
  • The administration hasn’t asked Congress for any new funding to address the opioid epidemic.

Roughly 64,000 people died from drug overdoses in 2016, and data from the CDC indicates deaths are rising. Kennedy says what’s needed is a coordinated federal response similar to the one in the mid-1990s — when the U.S. spent $24 billion a year to address the HIV/AIDS crisis.

“We’re talking about a major league crisis and they’re taking credit for little things, while the whole country is burning down,” Kennedy says.

Instead of a big boost in funding, the Trump administration is focused, in many cases, on cutting spending.

In the 2018 budget, the President recommended cutting the Office of National Drug Control Policy budget by 95 percent, and may do so again this year.

“It’s very hard to make sense of,” says Keith Humphreys, a professor of psychiatry at Stanford and former policy adviser to the drug czar’s office in the Obama administration. “I mean, it’s like closing a fire station in the middle of a wildfire.”

A law signed by President Obama that designated a billion dollars to help states combat opioids runs out of money this year. Humphreys has seen no sign President Trump intends to ask Congress to renew that funding.

“The 2018 budget had a $400 million cut to the Substance Abuse and Mental Health Services Administration which is the lead agency that funds treatment in the United States,” Humphreys says. “So, the administration’s impulse seems to be not to spend more — in fact to spend less.”

The White House is preparing to act on one of the recommendations of its opioid commission—that it launch a campaign to educate the public, especially young people, on the dangers of opioids. The campaign is being developed not by the Office of National Drug Control Policy, but by a team in the White House led by Kellyanne Conway.

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Black Lung Study Finds Biggest Cluster Ever Of Fatal Coal Miners' Disease

In this historical image, a doctor reviews an X-ray of a patient with black lung disease. Federal researchers say they’ve now identified the largest cluster ever recorded of the most advanced stage of the disease.

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Michael Sullivan/Getty Images/Science Source

Updated on Feb. 6 at 3:49 p.m. ET

Epidemiologists at the National Institute for Occupational Safety and Health say they’ve identified the largest cluster of advanced black lung disease ever reported, a cluster that was first uncovered by NPR 14 months ago.

In a research letter published Tuesday in the Journal of the American Medical Association, NIOSH confirms 416 cases of progressive massive fibrosis or complicated black lung in three clinics in central Appalachia from 2013 to 2017.

“This is the largest cluster of progressive massive fibrosis ever reported in the scientific literature,” says Scott Laney, a NIOSH epidemiologist involved in the study.

“We’ve gone from having nearly eradicated PMF in the mid-1990s to the highest concentration of cases that anyone has ever seen,” he said.

The clinics are operated by Stone Mountain Health Services and assess and treat coal miners mostly from Virginia, Kentucky and West Virginia, a region that includes what have historically been some of the most productive coalfields in the country.

“When I first implemented this clinic back in 1990, you would see … five [to] seven … PMF cases” a year, says Ron Carson, who directs Stone Mountain’s black lung program.

The clinics now see that many cases every two weeks, he says, and have had 154 new diagnoses of PMF since the fieldwork for the NIOSH study concluded a year ago.

“That’s an indication that it’s not slowing down,” Carson says. “We are seeing something that we haven’t seen before.”

A slide from a presentation by the National Institute for Occupational Safety and Health shows the progression from a healthy lung to advanced black lung disease.

NIOSH

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NIOSH

Laney acknowledges that the full scope of what he calls an epidemic is still unknown. “Even with this number, which is substantial and unacceptable, it’s still an underestimate.”

“Nobody looks forward to dying”

PMF, or complicated black lung, encompasses the worst stages of the disease, which is caused by inhalation of coal and silica dust at both underground and surface coal mines. Miners gradually lose the ability to breathe, as they wheeze and gasp for air.

Edward Brown is a 55-year-old former coal miner with progressive massive fibrosis, or complicated black lung disease.

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Adelina Lancianese/NPR

“I’ve seen it too many times,” said Charles Wayne Stanley, a Stone Mountain client with PMF, who spoke with NPR in 2016. “My wife’s grandpa … [I] watched him take his last breath. I watched my uncle die with black lung. You literally suffocate because you can’t get enough air.”

Lung transplants are the only cure, and they’re possible only when miners are healthy enough to qualify.

“[I] can’t breathe, you know. [I] can’t do nothing hardly like I used to,” says Edward Brown, a 55-year-old retired miner from Harlan, Ky., who was diagnosed with PMF at both Stone Mountain and another medical clinic.

“That’s all I got to look forward to is to get worser and worser,” Brown says, pausing for a deep sigh and nervous chuckle. “Nobody looks forward to dying, you know, but it’s a-comin’ and then that worries me.”

Brown’s age and disease fit another finding of the NIOSH study and a trend Carson first disclosed to NPR in December 2016.

“Miners are dying at a much younger age,” he says, noting that in the 1990s, the clinic’s PMF diagnoses typically involved miners in their 60s, 70s and 80s. Now the disease strikes miners in their 50s, 40s and even 30s with fewer years mining coal.

“A high proportion” of the miners in the NIOSH study had severely advanced disease and “coal mining tenure of less than 20 years, which are indications of exceptionally severe and rapidly progressive disease,” the study says.

The lung of deceased West Virginia coal miner Chester Fike was taken out during a double lung transplant when he was 60. He worked in the mines for 35 years.

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NIOSH

The Stone Mountain study follows a NIOSH review of cases at a small clinic in Coal Run Village, Ky., in 2016. NIOSH researchers confirmed 60 diagnoses of PMF there in 20 months. That alarmed them because NIOSH had earlier reported only 99 cases nationwide in five years.

At the same time, an NPR survey of 11 black lung clinics in Kentucky, Virginia, Pennsylvania and Ohio identified 962 cases, 10 times the original NIOSH count. Since then, NPR’s ongoing survey of clinics has counted nearly 1,000 more cases.

The NPR investigation also found that the likely cause of the epidemic is longer work shifts for miners and the mining of thinner coal seams. Massive mining machines must cut rock with coal and the resulting dust contains silica, which is far more toxic than coal dust.

The spike in PMF diagnoses is also due to layoffs and retirements brought on by the decline in coal mining. Miners who had put off getting checked for black lung earlier began streaming into clinics, especially if they needed the medical and wage replacement benefits provided by black lung compensation programs.

A public health emergency?

There is also concern for the 50,000 coal miners still working.

“They really need to declare this a public health emergency,” says Joe Wolfe, an attorney in Norton, Va., who helps miners file claims for black lung compensation.

“If you had 400 cases of E. coli, [NIOSH] would flood the area with technicians and doctors and nurses checking people’s health,” Wolfe adds. “There are people literally working in the mines right now … that have complicated black lung that do not have a clue.”

NIOSH doesn’t have that authority, according to David Weissman, who directs the agency’s respiratory health program in Morgantown, W.Va. Public health emergencies are declared by the secretary of the U.S. Department of Health and Human Services.

“But I will say that this is a very important problem. We’re very passionate about this problem,” Weissman says. “And we’re going to keep doing everything in our power to address it.”

Multiple NIOSH and independent studies are underway or planned to try to pinpoint the number of miners who have the disease, as well as the causes.

A mining disaster in slow motion

Jess Bishop, a black lung victim, takes his last breaths while his sons — also coal miners — keep vigil in Logan County, W.Va., in 1976. The disease spiked in the 1960s and ’70s but then plummeted with the passage of mine safety laws.

Courtesy of Earl Dotter

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Courtesy of Earl Dotter

Coincidentally, new federal regulations that are supposed to limit exposure to dangerous levels of coal and silica dust were fully implemented in 2016, a few months before NPR first reported the PMF epidemic. The Trump administration recently announced a “retrospective study” of the new regulations, a move that has mine safety advocates concerned, especially given the epidemic of the disease caused by mine dust.

“It would be outrageous for any undercutting of those regulations that puts miners [back] in harm’s way and subjects even more of them to this terrible disease,” says Joe Main, the former mine safety chief at the federal Mine Safety and Health Administration.

“When we think we know as much as we thought we should know about the disease, the next day [there’s] worse information,” says Main. “It shows that the depth of the disease is worse than what we knew the day before.”

Main pushed for the tougher mine dust exposure limits. His successor at MSHA is David Zatezalo, a former mining company executive.

“We are not proposing to weaken this rule,” Zatezalo tells NPR in a written statement. “We are planning to collect feedback on the rule from stakeholders, which was both a commitment previously made by MSHA, and a directive from President Trump, who strongly supports America’s miners.”

Zatezalo did not respond to requests for an interview. His agency’s formal notice for the “retrospective study” labels it a “deregulatory” action, which implies less regulation.

At a congressional hearing today in Washington, Zatezalo was asked directly about his agency’s “retrospective study” of the tougher mine dust limits imposed by the Obama administration.

“Do you plan to rollback any aspect of the 2014 respirable dust rule?” asked Rep. Bobby Scott, D-Va., the ranking Democrat on the House Committee on Education and the Workforce.

David Zatezalo, the Assistant Secretary of Labor for Mine Safety and Health, was asked about the advanced black lung epidemic at a congressional hearing in Washington, D.C., on Feb. 6, 2018.

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“I do not,” Zatezalo responded.

Zatezalo was also asked about his agency’s own description of the “retrospective study” of the new mine dust regulations as “deregulatory.”

“I can’t tell you why it was listed as a deregulatory item,” Zatezalo responded, unless, he added, that had something to do with the frequency of testing using new dust monitors.

“Each case of advanced black lung disease is an entirely preventable tragedy, and represents mine operators’ unwillingness to adequately control mine dust exposures, and safety regulators failure to set, monitor and enforce standards necessary to protect miners,” Scott said in a statement to NPR.

“MSHA should not bend to pressure from well-connected coal mine executives to roll back the regulations,” Scott added. “The Mine Safety and Health Administration (MSHA) cannot keep looking the other way while the burden of this preventable disease grows.”

The burden is clear on the walls of Ron Carson’s office at the Stone Mountain black lung clinic in St. Charles, Va. They’re lined with photographs and other mementos of clinic patients, some who died from the disease.

Carson describes a kind of mining disaster in slow motion, in which the disease takes years to develop, even though it strikes quicker now, and in which each death is solitary. He points to a half sheet of white paper tacked to his bulletin board. It shows a phrase he printed out from an article about black lung.

“Mining disasters get monuments,” Carson says, his voice softening. “Black lung deaths get tombstones. And I’ve seen many a tombstone in [the last] 28 years from black lung. And I’m seeing more now. A lot more now.”

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In The U.S. Virgin Islands, Health Care Remains In A Critical State

Patients seeking cancer treatment in the U.S. Virgin Islands must now go to the mainland. The Charlotte Kimelman Cancer Institute at Schneider Regional Medical Center on St. Thomas remains closed because of extensive damage to areas like the CAT scan suite.

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Health care in the U.S. Virgin Islands remains in a critical state, five months after Hurricane Irma and Hurricane Maria pummeled the region.

The only hospital on St. Thomas, the Schneider Regional Medical Center, serves some 55,000 residents between the islands of St. Thomas and St. John. Schneider’s facilities suffered major structural damage, forcing a decrease in its range of services, mass transfers of its patients, staff departures and significant losses in revenue. Only about one-third of the beds are currently available for patient care.

In early September, when Irma hit the Virgin Islands, most of Schneider’s staff members were on duty. At the height of the storm, a large window on the hospital’s top floor gave out. “You had winds of 175, 180 miles per hour whipping through here,” says the hospital’s Vice President Darryl Smalls.

The screws holding the window in place failed. The window itself, made from hurricane impact glass, remained intact. It’s here, leaning against a nursing station that’s now in shambles. Ceiling panels are gone, exposed pipes and ducts are damaged and sagging in places. A large plywood barrier covers the window opening.

When the window tore off, Smalls says the staff worked quickly to evacuate some 20 patients to a safer part of the hospital. They couldn’t use the elevator in the middle of the storm, so staff transported patients from the fourth floor to the third floor using the emergency stairwells. “We literally took the patients on the mattresses, slid them down the stairs, down to the third floor, across the building and up onto the other side,” Smalls says. “We have a surgical unit which was not compromised and capable of handling patient care.”

Eventually, all of the patients who were at Schneider during the storm were evacuated off of the island. But even as staff dealt with a host of problems, the hospital remained open. In the emergency room, which flooded badly from a leaky roof, Smalls says, “You probably had about 3 to 4 inches of water on the floor in here. I had pumps. I think we probably had 50 people in here at any given time just trying to evacuate as much water out of the facility.”

Today, the hospital continues to provide surgery, labor and delivery care, radiology and lab services. But its cancer center, a $28 million facility, remains closed because of extensive storm damage. The hospital can now only provide limited services for patients requiring dialysis.

Meanwhile, Schneider Medical’s sister center, the only hospital on St. Croix, the U.S. Virgin Islands’ other major island, suffered even more extensive damage to its operating rooms.

Without adequate medical services available, Schneider Regional CEO Bernard Wheatley says most patients who evacuated St. Thomas have not been able to return. “It’s over 400 that have been transferred off island,” Wheatley says. “And to this day, we’re still transferring some patients, especially the ones requiring extensive length of stay.”

High winds blew out ceiling panels and damaged ducts and pipes at Schneider Regional Medical Center, the only hospital on St. Thomas, when a window on the hospital’s top floor blew out.

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Along with the lack of facilities, another major problem is staffing. Wheatley says he’s lost 150 of the hospital’s 600 employees — many of whom left the island after the storms destroyed their homes. “The sad part of it, we’ve lost a lot of nurses,” he says. “If you ask me right now, what’s my key entity in terms of shortages, from a clinical standpoint it would be the nursing staff.”

Shanique Woods-Boschulte, who directs Schneider’s foundation says, “Every day we get one or two resignations.” After five months, Woods-Boschulte says, the daily struggle is wearing down many staff members. “The morale was really high after the storm because we saw what we were able to accomplish — no patients hurt,” she says. “But now things are trickling down and everyone is leaving a broken hospital and going home to a broken home.”

Adding to the woes, the hospital is in desperate financial straits. Revenues are half of what they were because there are far fewer patients. The government-supported hospital is projecting a $7 million loss.

With all the competing problems on the islands, CEO Bernard Wheatley says it’s not clear how much help the local government can provide. “The territory itself is projecting a $400 million loss,” he says. “They don’t have the hotel rooms, tourism is down. It’s just not the same island.”

The U.S. Virgin Islands is now looking to Congress to help decide what to do about its battered hospitals. The local government is in talks with FEMA and the Army Corps of Engineers to determine whether the hospitals can be rehabilitated, or if new facilities will be needed.

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Why A Cancer Patient Opposes The 'Right To Try' Experimental Cancer Drugs

Michael Becker is dying from cancer. But he tells NPR’s Scott Simon that he opposes the passage of the Right To Try Act, which gives terminally ill patients access to experimental drugs.

SCOTT SIMON, HOST:

Imagine you’ve been diagnosed with cancer. You’ve been told it’s terminal. Doctors have tried everything. The only option left may be experimental, unapproved drugs. You want these drugs no matter what the risk. This week, President Trump urged Congress to pass what’s called the Right To Try Act in his State of the Union address. But many doctors, scientists and those involved in research think it may be a bad idea. Michael Becker is the former CEO of two biotech firms working to develop cancer treatments. Mr. Becker also has terminal cancer. Michael Becker joins us from Bucks County, Pa. Thanks so much for being with us.

MICHAEL BECKER: My pleasure, Scott. Thanks for having me.

SIMON: And I have to begin by asking you, how are you?

BECKER: (Laughter) Feeling pretty good. The quality of life at the moment is not too bad. And I’m happy to still be here.

SIMON: Why are you suspicious of the Right To Try Act?

BECKER: You know, I agree with President Trump that patients like me that are facing a terminal illness should have an opportunity to access experimental drugs. Fortunately, we already do. It’s the Compassionate Use mechanism for the Food and Drug Administration.

SIMON: Having read about you, you just don’t believe that this would be redundant but could be dangerous.

BECKER: Yeah. If you put the two side by side, there’s only one difference. And that is the FDA. The FDA gets taken out of the equation with the proposed legislation. The FDA is in the equation with the existing regulations. Compassionate Use process is extremely easy. Basically, go to your doctor. Find one who will agree to administer the therapy. Contact the drug company. See if they’re also willing to agree. Fill out the paperwork. And then if the FDA doesn’t object, the patient can get the treatment. And the only difference with the new legislation is that last part. The FDA is taken out of the equation.

SIMON: With respect, why care so much about the FDA if a life is hanging in the balance?

BECKER: So as a terminal cancer patient, I would, you know, obviously love to try something that’s going to prolong my life or cure my cancer. The reality is that that’s a very, very small statistic in terms of drug development discovery. Only 5 percent of drugs that go through phase one development actually go on to be approved. So you’re talking about giving people medications that, in historical context, have only had a 5 percent chance of actually working at the end of the day. And then you’re exposing these patients to, potentially, additional toxicities that could accelerate their death or cause additional problems for them.

SIMON: I’m sure you’ve run all this through your mind. Why not – I was about to ask you, why not let the patient decide? Why not let you decide?

BECKER: Well, the problem becomes that you have a lot of false hope as a terminal cancer patient. You want to cling to anything that’s going to sound like it’s an opportunity to live longer or have a better quality of life. And that hope can sometimes cover up the realities of some of the more sinister aspects of getting a drug, which are things go wrong. So I could take a drug that was purported to help me, and it may actually make my condition worse. It could create other difficulties for me. And then my quality of life may be even worse than it was originally. That’s what I would fear as a – or what I do fear as a patient.

SIMON: Yeah. And would it potentially take advantage of people at their most vulnerable?

BECKER: Absolutely. I can’t tell you how many times I see miracle cures and herbal remedies and everything from unsolicited emails to Internet ads, you know, talking about cures and treatments for cancer. If you take the FDA as the policeman out of that equation, I’m scared to death as to what cancer patients or other patients facing terminal illnesses may be subjected to.

SIMON: Well, Mr. Becker, good luck to you. We are so grateful to speak with you. Thank you so much.

BECKER: Thank you, Scott.

Copyright © 2018 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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Indiana Adds Work Requirement To Medicaid, Will Block Coverage If Paperwork Is Late

Health and Human Services Secretary Alex Azar announced federal approval for changes to Indiana’s Medicaid program Friday in Indianapolis.

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Indiana on Friday became the second state to win federal approval to add a work requirement for adult Medicaid recipients who gained coverage under the Affordable Care Act. A less debated provision in the state’s new plan could lead to tens of thousands of people losing coverage if they fail to complete paperwork documenting their eligibility for the program.

The federal approval was announced by Health and Human Services Secretary Alex Azar in Indianapolis.

Medicaid participants who fail to promptly submit paperwork showing they still qualify for the program will be locked out of enrollment for three months, according to updated rules.

Since November 2015, more than 91,000 enrollees in Indiana have been kicked off Medicaid for failing to complete the eligibility redetermination process, according to state records. The process requires applicants to show proof of income and family size, among other things, to see whether they still qualify for the coverage.

Until now, these enrollees could simply reapply anytime. Although many of those people very likely weren’t eligible anymore, state officials estimate about half of those who failed to comply with its re-enrollment rules still qualified for Medicaid coverage.

Indiana expanded Medicaid starting in February 2015, providing coverage to 240,000 people who were previously uninsured. The change helped lower the state’s uninsured rate from 14 percent in 2013 to 8 percent last year.

The HHS approval of the state’s waiver extends the program, which was expiring this month, through 2020.

The new lockout builds on one Indiana already had in place for people who failed to pay monthly premiums and had annual incomes above the federal poverty level, or about $12,200 for an individual. Locked-out people are barred for six months from coverage. During the first two years of the experiment, about 10,000 Indiana Medicaid enrollees were subject to the lockout for failing to pay the premium for two months in a row, according to state data. In addition, more than 25,000 enrollees were dropped from the program when they failed to make the payments, although half of them found another source of coverage — usually through their jobs.

An additional 46,000 were blocked from coverage because they failed to make the initial payment.

“The ‘lockout’ is one of the worst policies to hit Medicaid in a long time,” says Joan Alker, executive director of the Georgetown University Center for Children and Families. “Forcing people to remain uninsured for months because they missed a paperwork deadline or missed a premium payment is too high a price to pay. From a health policy perspective it makes no sense because during that six-month period, chronic health conditions such as hypertension or diabetes are just likely to worsen.”

Indiana’s Medicaid expansion is being closely watched in part because it was spearheaded by then-Gov. Mike Pence, now vice president, and his top health consultant, Seema Verma, who heads the federal Centers for Medicare & Medicaid Services.

The expansion, known as Healthy Indiana, enabled nondisabled adults access to Medicaid. It has elicited criticism from patient advocates for complex and onerous rules that require these poor adults to make payments ranging from $1 to $27 per month into health savings accounts or risk losing their vision and dental benefits — or even all their coverage, depending on their income level.

Indiana Medicaid officials say they added the newest lockout provision in an effort to prompt enrollees to get their paperwork submitted on time. The state initially requested a six-month lockout.

“Enforcement may encourage better compliance,” the state officials wrote in their waiver application to CMS in July.

The new rule will lead to a 1 percent cut in Medicaid enrollment in the first year, state officials said. It will also lead to a $15 million reduction in Medicaid costs in 2018 and about $32 million in savings in 2019, the state estimated.

The number of Medicaid enrollees losing coverage for failing to comply with redetermining their eligibility has varied dramatically each quarter from a peak of 19,197 from February 2016-April 2017 to 1,165 from November 2015-January 2016, state reports show. In the latest state report, 12,470 enrollees lost coverage from August to October 2017.

The Kentucky Medicaid waiver approved by the Trump administration in January included a similar lockout provision for failing to pay the monthly premiums or providing paperwork on time. Penalties there are six months for both measures. But the provision was overshadowed because of the attention to the first federal approval for a Medicaid work requirement.

Like Kentucky’s, the Indiana Medicaid waiver work requirements, which mandate adult enrollees to work an average of 20 hours a month, go into effect in 2019. But Indiana’s waiver is more lenient. It exempts people age 60 and over and its work-hour requirements are gradually phased in over 18 months. For example, enrollees need to work only five hours per week until their 10th month in the program.

Most adult Medicaid enrollees do work or go to school or are too sick to work, studies show.

Indiana also has a long list of exemptions and alternatives to employment. This includes attending school or job training, volunteering, or caring for a dependent child or disabled parent. Nurses, doctors and physician assistants can give enrollees an exemption for illness or injury.

Three patient advocacy groups have filed suit in federal court seeking to block the work requirements.


Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation. Phil Galewitz is a senior correspondent for KHN.

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