It’s The Go-To Drug To Treat Opioid Addiction. Why Won’t More Pharmacies Stock It?

A bus run by the organization Prevention Point parks at Kensington and Allegheny avenues in Philadelphia to offer harm-reduction services to drug users in the area. Louis Morano (center), who was visiting the Prevention Point bus for the second time, sits outside and waits to be seen by Dr. Ben Cocchiaro.

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Louis Morano knows what he needs, and he knows where to get it.

Morano, 29, has done seven stints in rehab for opioid addiction in the past 15 years. So, he has come to a mobile medical clinic parked on a corner of Philadelphia’s Kensington neighborhood, in the geographical heart of the city’s overdose crisis. People call the mobile clinic the “bupe bus.”

Buprenorphine is a drug, also known by its brand name, Suboxone, that curbs cravings and treats the symptoms of withdrawal from opioid addiction. Combined with cognitive behavioral therapy, it is one of the three FDA-approved medicines considered the gold standard for opioid-addiction treatment.

Morano has tried Suboxone before — he used to buy it from a street dealer to help him get through his workday when he couldn’t use heroin. It kept the sick feelings of withdrawal at bay. So he has a sense of how it will make him feel, though he has never been prescribed it. He used to think of it as a crutch. But now, he is committed to his recovery, and buprenorphine is key.

“I can’t do this anymore,” Morano says. He wants the medical support.

The bupe bus is a project of Prevention Point, Philadelphia’s only syringe-exchange program, and is part of the city’s efforts to expand access to this particular form of medication-assisted treatment for opioid addiction.

Morano is first in line. After a short time, the heavy doors of the bus heave open and Dr. Ben Cocchiaro waves Morano inside, where they squeeze into a tiny exam room. Together, Cocchiaro and Morano discuss how buprenorphine might help Morano’s recovery be more successful this time, as well as if he’s open to seeing a therapist. Cocchiaro gives Morano instructions on how to take the medication and then calls a pharmacy to authorize a prescription.

To date, much of the research on barriers to buprenorphine access has focused on the fact that there are too few medical providers available to write the prescriptions.

According to federal law, doctors must apply for a special waiver from the federal Substance Abuse and Mental Health Services Administration to prescribe buprenorphine. To get the waiver, a doctor must undergo eight hours of training — and, initially, can prescribe the drug to only a maximum of 30 patients at any one time. Given these constraints, many doctors don’t bother.

Inside the exam room on the “bupe bus,” as the mobile medical clinic is called, Dr. Ben Cocchiaro and Louis Morano talk over Morano’s options. Morano says he’s committed to his recovery this time and wants the support of buprenorphine to help him quit heroin.

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But, according to people active in addressing the opioid crisis, some pharmacists also prevent many opioid users who need buprenorphine from getting it.

“We can write a bunch of prescriptions for people,” says Dan Ventricelli of the Philadelphia College of Pharmacy. “But if they don’t have a pharmacy and a pharmacist that’s willing to fill that medication for them, fill it consistently and have an open conversation with that patient throughout that treatment process, then we may end up with a bottleneck at the community pharmacy.”

Pharmacists frustrated by remedy’s street use

There are a number of reasons some pharmacists say they are hesitant.

Just a few blocks away from the bupe bus in Kensington, for example, Richard Ost owns an independent pharmacy. He says his store was one of the first in the neighborhood to stock buprenorphine. But after a while, Ost started noticing that people were not using the medication as directed — they were selling it instead.

Richard Ost owns Philadelphia Pharmacy, in the city’s Kensington neighborhood. He says he has stopped carrying Suboxone, for the most part, because the illegal market for the drug brought unwanted traffic to his store.

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Buprenorphine acts as a partial opioid agonist, which means it’s a low-grade opioid, in a sense. When taken in pill or tablet form, bupe is unlikely to cause the same feelings of euphoria as heroin would, but it might if it were dissolved and injected. Many people buy it on the street for the same reason Morano did: to keep from going into withdrawal between injecting heroin or fentanyl. Others buy it to try to quit using opioids on their own.

“We started seeing people [sell the drug] in our store in front of us,” says Ost. He says it’s unethical to dispense a prescription if a patient turns around and sells the drug illegally, rather than uses it. “Once we saw that with a patient, we terminated them as a patient.”

Ost explains that the illegal market for Suboxone also means that customers trying to stay sober are continually targeted and tempted.

“So if we were having a lot of people in recovery coming out of our stores,” Ost says, “the people who were dealing illicit drugs knew that, and they would be there to talk to them. And they would say, ‘Well, I’ll give you this’ or ‘I’ll give you that’ or ‘I’ll buy your Suboxone’ or ‘I’ll trade you for this.’ “

Eventually, Ost’s staff didn’t feel safe, he says, and neither did the customers. He understands the value of bupe but says it just wasn’t worth it. He has mostly stopped carrying it.

Even pharmacies that aim to stock buprenorphine can have trouble doing so. Limits set by wholesalers require pharmacies to order the drug in small, frequent batches. Though pharmacies can apply for exemptions to order more at a time or have a higher percentage of their total stock be controlled substances, doing so invites a higher level of scrutiny from the wholesaler and, in turn, from the federal Drug Enforcement Administration.

Buprenorphine saves lives

Doctors and pharmacists also receive different education about how long buprenorphine should be prescribed before tapering a patient off the drug. Medical providers sometimes prescribe it for long-term treatment, based on recent SAMHSA guidelines, while pharmacists may view longer courses of treatment as intensifying the risk of long-term dependency.

“It’s not even that they’re on different pages,” says Ventricelli. “It’s that they’re reading completely different books.”

If a patient going through withdrawal can’t quickly get buprenorphine, the stakes are high, says Silvana Mazzella, associate executive director at Prevention Point — patients may be more likely to turn back to heroin or fentanyl.

“We’re in a situation where if you are in withdrawal, you’re sick — you need to get well,” she says. “You want help today, and you can’t get it through medication-assisted treatment. Unfortunately, you will find it a block away — very quickly and very cheaply.”

Doctors with Prevention Point have found a pharmacy near the bupe bus — the Pharmacy of America — that will reliably dispense buprenorphine to their Philadelphia patients.

The head pharmacist there, Anthony Shirley, says he’s comfortable filling the scripts because he trusts that the doctors at Prevention Point will write prescriptions only to patients who need the medication. He has heard firsthand from patients who say buprenorphine saved their lives.

“That’s something you can’t really put a price tag on,” Shirley says. For him, the calculation is simple: His store is in an area where lots of people need buprenorphine. That means it’s his job to get it to them.

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

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At ‘High Five’ Camp, Struggling With A Disability Is The Point

At Nashville’s “High Five” camp, 12-year-old Priceless Garinger (center), whose right side has been weakened by cerebral palsy, wears a full-length, bright pink cast on her left arm — though that arm’s strong and healthy. By using her weaker right arm and hand to decorate a cape, she hopes to gain a stronger grip and fine motor control.

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There’s a summer camp for kids with disabilities in Nashville that does things a little differently. Instead of accommodating the campers’ physical challenges, therapists make life a bit tougher, in hopes of ultimately strengthening the kids’ ability to navigate the world.

Priceless Garinger’s left arm is wrapped from shoulder to fingertips in a neon pink cast on the day I visit. The left is actually the 12-year-old’s strong hand. It’s her other arm and hand that’s been the problem since she was born with cerebral palsy. She can move her right arm but has difficulty grasping anything.

“Right there, where you bend your arm, it itches right there,” she says, using a plastic spoon to scratch her elbow, which is out of reach.

This day camp is organized by Vanderbilt Children’s Hospital. Some campers, like Priceless, have cerebral palsy; others have had a brain tumor removed, or had a stroke. All of them have a weak side of the body they rarely use. At High Five Constraint Camp the children are forced to try to strengthen that weak side.

“Yeah, there it is,” Priceless says as she bumps bare arms with a fellow camper — an improvised fist bump.

This kind of rehab is known as constraint-induced movement therapy. Similar camps are run by children’s hospitals all around the U.S. during the summer, based on research by Edward Taub at the University of Alabama at Birmingham. He hypothesized years ago that the affected limbs suffer from “learned nonuse.”

Priceless takes her turn on the indoor obstacle course at the hospital’s pediatric rehab facility, located at a Vanderbilt satellite campus on Nashville’s outskirts. She rides a modified zipline, wrapping her long legs around the swinging seat — swooping along and then dropping into a pit of overstuffed pillows.

The occupational therapists prompt her to climb out. They cheer her on but don’t immediately help. The struggle is the point.

Priceless finds her way out, and next plops down on a scooter. She grunts as she tries to propel herself with a hand that she can barely control.

“I’m not going anywhere,” she says.

Her therapist gives her a little boost toward the finish line, where Priceless hits a buzzer that sounds an alarm and draws cheers from the other campers.

Constraint-induced therapy

The restrictive rehab techniques are increasingly used with kids who have cerebral palsy, though there hasn’t been much research showing the approach is all that much better than traditional physical therapy. And some kids become overly frustrated or even refuse to cooperate.

To outsiders, the strategy can seem mean.

“If the families have never heard of it before, it’s kind of like, ‘What? You’re going to cast their good arm and take away their really functional hand?’ ” says occupational therapist Stephanie Frazer.

This particular day camp started a decade ago as part of a research project at Vanderbilt University. When the study concluded, the camp shut down. But Frazer revived it in recent years because she believes the approach, and the setting, are effective.

“Whenever we’re casting that good arm, the brain is like, ‘I have this other arm here.’ And they start using it more and it starts creating pathways,” she says. “They actually make a lot of progress in a short amount of time.”

The kids’ temporary casts end in a mitten shape to minimize any wiggle room and attempts to rely on that stronger hand while at camp.

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Even snacktime can be turned into a therapeutic experience. Playing with food is required at this camp. The kids take pretzels and stab them into blocks of cheese.

Some blow bubbles in their juice, partly out of frustration. Some resort to using the arm that’s in a cast to feed themselves.

Seeking independence

This is the third summer of camp for Priceless, who wasn’t exactly enthusiastic when she started. But she’s beginning to see how helpful it would be to be able to rely on both hands to do things like manipulate a remote control.

“I want to play with my iPad and watch TV,” she says.

The parents of the campers are even more motivated, because they understand how the use of two hands could make independence in adulthood much more feasible for their children.

“She talks about wanting to drive,” says Laura Garinger, Priceless’ mom.

From past experience, Garinger says she suspects that for the first few months after this camp session, Priceless will use her weak hand more often. But in past summers she has eventually reverted to relying on her strong side.

Still, Garinger says, she has witnessed lots of other, permanent successes.

Garinger, who is a special education teacher, met Priceless when the little girl was 3 years old; she adopted Priceless two years later. The preschooler needed to use a walker at the time. Now she walks on her own.

Being able to rely on both hands would go a long way toward helping Priceless achieve her dreams, her mom says.

“She hopes to be a police officer, so the sky’s the limit. We’ll see,” Garinger says, pausing as her voice shakes with emotion. “I mean, it’s probably not realistic, but I always tell her she can do what she wants when she grows up.”

Garinger says the first step for Priceless is strengthening her arm enough to give a high-five — and a two-arm hug.

This story is part of NPR’s reporting partnership with Nashville Public Radio and Kaiser Health News.

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Trump Team Hits Brakes On Law That Would Curb Unneeded Medicare CT Scans, MRIs

If a doctor is found to be ordering too many MRI or CT scans or other imaging tests for Medicare patients, a federal law is supposed to require the physician to get federal approval for all diagnostic imaging. But the Trump administration has stalled the law’s implementation.

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Five years after Congress passed a law to reduce unnecessary MRIs, CT scans and other expensive diagnostic imaging tests that could harm patients and waste money, federal officials have yet to implement it.

The law requires that doctors consult clinical guidelines set by the medical industry before Medicare will pay for many common medical scans for enrollees. Health care providers who go way beyond clinical guidelines in ordering these scans (the 5 percent who order the most tests that are inappropriate) will, under the law, be required after that to get prior approval from Medicare for their diagnostic imaging.

But after physicians argued the provision would interfere with their practices, the Trump administration delayed putting the 2014 law in place until January 2020 — two years later than originally planned.

And even then, the Centers for Medicare & Medicaid Services has slated next year as a “testing” period, which means even if a physician doesn’t check the guidelines, Medicare will still pay for the scan. CMS also said it won’t decide until 2022 or 2023 when exactly physician penalties will begin.

Critics worry the delays come at a steep cost: Medicare is continuing to pay for millions of unnecessary exams and patients are being subjected to radiation for no medical benefit.

A Harvard study published in 2011 in the Journal of Urology found “widespread overuse” of imaging tests for men on Medicare who were at low risk of getting prostate cancer. And a University of Washington study in the Journal of the American College of Radiology that reviewed 459 CT and MRI exams at a large academic medical center found 26% of the tests were inappropriate.

“These delays mean that many more inappropriate imaging procedures will be performed, wasting financial resources and subjecting patients to services they do not need,” says Gary Young, director of the Northeastern University Center for Health Policy and Healthcare Research in Boston. “If this program were implemented stringently, you would certainly reduce inappropriate imaging to some degree.”

Doctors order unnecessary tests for a variety of reasons: to seize a potential financial advantage for them or their health system, to ease fears of malpractice suits or to appease patients who insist on the tests.

The law applies to doctors treating patients who are enrolled in the traditional fee-for-service Medicare system. Health insurers, including those that operate the private Medicare Advantage plans, have for many years refused to pay for the exams unless doctors get authorization from them beforehand. That process can take days or weeks, which irks physicians and patients.

CMS Administrator Seema Verma has sought to reduce administrative burdens on doctors with her “patients over paperwork” initiative.

CMS would not make Verma or other officials available for an interview for this story, and answered questions only by email.

A spokeswoman says CMS has no idea how many unnecessary imaging tests are ordered for Medicare beneficiaries.

“CMS expects to learn more about the prevalence of imaging orders identified as ‘not appropriate’ under this program when we begin to identify outlier ordering professionals,” she says.

“It takes four clicks on a computer”

An influential congressional advisory board in 2011 cited the rapid growth of MRIs, CT scans and other imaging, and recommended requiring doctors who order more tests than their peers to be forced to get authorization from Medicare before sending patients for such exams. In the 2014 law, Congress tried to soften that recommendation’s effect by asking doctors billing Medicare to follow protocols to confirm that imaging would be appropriate for the patient.

Studies show a growing number of health systems have used clinical guidelines to better manage imaging services. The University of Virginia Health System found that unnecessary testing fell by between 5% and 11% after implementing such recommendations.

Virginia Mason Health System in Seattle in 2011 set up a system requiring its physicians — most of whom are on salary — to consult imaging guidelines. It would deny claims for any tests that did not meet appropriate criteria, except in rare circumstances. A study found the intervention led to a 23% drop in MRIs for lower back issues and headaches.

Dr. Craig Blackmore, a radiologist at Virginia Mason, says he worries that, unlike the efforts at his hospital, many doctors could be confused by the Medicare program because they have not received the proper training about the guidelines.

“My fear is that it will be a huge disruption in workflow and show no benefit,” he says.

In 2014, AtlantiCare, a large New Jersey hospital system, began grading physicians on whether they consult its guidelines.

“Some doctors see this tool as additional work, but it takes four clicks on a computer — or less than a minute,” says Ernesto Cerdena, director of radiology services at AtlantiCare.

Not all Medicare imaging tests will be subject to the requirements. Emergency patients are exempt, as well as patients admitted to hospitals. CMS has identified some of the most common conditions for which doctors will have to consult guidelines. Those include heart disease, headache and pain in the lower back, neck or shoulders.

Robert Tennant, director of health information technology for the Medical Group Management Association, which represents large physician groups, says the law will unfairly affect all doctors merely to identify the few who order inappropriately.

“For the most part, doctors are well trained and know exactly what tests to perform,” Tennant says.

The association is one of several medical groups pushing Congress to repeal the provision.

American College of Radiology’s role

The law required the federal government to designate health societies or health systems to develop guidelines and companies that would sell software to embed that guidance into doctors’ electronic health record systems.

Among the leaders in that effort is the American College of Radiology, which lobbied for the 2014 law and has been issuing imaging guidelines since the 1990s. It is one of about 20 medical organizations and health systems certified by CMS to publish separate guidelines for doctors.

The college wanted “to get ahead of the train and come up with a policy that was preferable to prior authorization,” says Cynthia Moran, an executive vice president of the radiology group. About 2,000 hospitals use the college’s licensed guidelines — more than any others, she says. And the college profits from that use.

Moran the licensing money helps the college mitigate the costs of developing the guidelines, which must be updated regularly, based on new research. She the college gives away the guidelines to individual doctors upon request and sells them only to large institutions, although she notes they are not as easy to access that way, compared with being embedded in a doctor’s medical records.

Kaiser Health News a nonprofit, editorially independent program of the Kaiser Family Foundation. KHN is not affiliated with Kaiser Permanente.

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How The CDC’s Reluctance To Use The ‘F-Word’ — Firearms — Hinders Suicide Prevention

In the U.S., firearms kill more people through suicide than homicide.

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The nation’s foremost public health agency shies away from discussing the important link in this country between suicide and access to guns.

That’s according to documents obtained by NPR that suggest the Centers for Disease Control and Prevention instead relies on vague language and messages about suicide that effectively downplay and obscure the risk posed by firearms.

Guns in the United States kill more people through suicide than homicide.

Almost 40,000 people died from guns in 2017 alone — 60% of those deaths were suicides. Guns are the most common method used for suicide.

If you or someone you know may be considering suicide, contact the National Suicide Prevention Lifeline at 1-800-273-8255 (En Español: 1-888-628-9454; Deaf and Hard of Hearing: 1-800-799-4889) or the Crisis Text Line by texting HOME to 741741.

Suicide rates are going up in nearly every state, even though research shows that suicide is preventable. Access to guns is such an important risk factor that any effective public education campaign to prevent suicide would surely need to address it.

The trouble is, the CDC is operating under something known as the Dickey Amendment, legislation passed by Congress in 1996 that prohibits the CDC from spending any of its funds to “advocate or promote gun control.”

A lot of attention has been paid to how this has stopped the CDC from funding certain kinds of gun violence research. The law also had another effect: It led the CDC to tiptoe around guns as it tries to tackle the increase in suicides.

“CDC staff do their best to provide the very latest science and evidence-based data to the public so they can protect their health,” a CDC spokesperson told NPR, declining to make any agency official available for an interview.

NPR reviewed early drafts and editing notes of a major 2018 CDC suicide report and a guide on suicide prevention, obtained through a Freedom of Information Act request, along with the agency’s public anti-suicide messages.

The internal documents reveal detailed staff deliberations over wording that resulted in the agency weakening language that might suggest restricting access to guns as a way to prevent suicides.

“Lethal means”

Guns get used in slightly more than half of all suicides. And people who try to kill themselves with a gun almost always die.

But the word “gun” is frequently absent when the CDC presents information on suicide prevention.

A CDC fact sheet published in 2018 on “Preventing Suicide” does not include the word “gun” or “firearm.” Instead, it advises people to “reduce access to lethal means among persons at risk of suicide.”

Where the CDC’s website lists the risk factors for suicide, it also does not include the word “gun.” It says instead “easy access to lethal methods.”

Internal texts exchanged between CDC suicide researchers show why a generic term like “lethal means” is preferred: It “is probably less likely to create issues compared to using the f-word,” which is firearms. A phrase like “access to firearms” would “raise a few red flags.”

Here is one text exchange:

LiKamWa, Wendy (CDC/CCEHIP/NCIPC) 2:56 PM:

haha one of the police articles I saw listed “access to firearms” and I was like, that would raise a few red flags!

Stone, Deborah (CDC/ONDIEH/NCIPC) 2:56 PM:

it’s ok. that’s fair territory!

that’s a big reason why their rates are so high.

we aren’t saying take away their guns!

at least not explicitly!

LiKamWa, Wendy (CDC/CCEHIP/NCIPC) 2:57 PM:

actually, the tiesman et al article (i.e. NIOSH) talks about firearms and access to firearms a lot

Stone, Deborah (CDC/ONDIEH/NCIPC) 2:59 PM:

yeah, it’s more of an issue if we are advocating for gun control. it’s a fact that access is a risk factor.

LiKamWa, Wendy (CDC/CCEHIP/NCIPC) 3:00 PM:

still, “lethal means” is probably less likely to create issues compared to using the F-word

Stone, Deborah (CDC/ONDIEH/NCIPC) 3:00 PM:

very true.

In the past, members of Congress have asked the CDC if agency staffers were told to avoid using the word “gun.” Here’s how the CDC replied:

“To ensure scientific integrity, technical accuracy, consistency with appropriations language, and usefulness to the intended audience, CDC has a standard agency review process for any manuscript or report produced by CDC scientists. … In the course of reviewing manuscripts or reports on firearm violence, CDC has asked employees to use correct terminology — for example, to say ‘died as a result of a firearm-related injury’ vs. ‘died from a firearm’ in the same way as one would write ‘died as a result of a motor-vehicle crash’ vs. ‘died from a car.’ “

But one former CDC official told NPR that of course employees know to censor themselves when it comes to guns.

“There were staff who would say you couldn’t even say the word ‘gun,’ ” recalls Linda Degutis, who used to serve as director of the CDC’s National Center for Injury Prevention and Control. “They would tell other people, or even new people sometimes, you can’t say the word ‘gun’ here.”

She says higher-ups would review documents, “because there would be a thought that if guns were mentioned too often, that would be violating this intent not to do any kind of research or work around guns.”

She says the problem with language like “lethal means” is that it doesn’t convey what people should actually be worried about and what actions they should take when it comes to suicide prevention, such as offering to remove guns from the home of a friend or relative who is going through a personal crisis.

“I think when you say ‘lethal means’ to the general public, they don’t know what you’re saying,” adds Degutis. “They don’t know that you might mean guns.”

“Safe storage” vs. “restricting access”

Another noticeable feature of the CDC’s suicide prevention messaging is the emphasis on “safe storage.”

By that, the agency means keeping guns and ammunition securely locked in a safe. Unlike other measures that could make it more difficult to obtain a gun, “safe storage” isn’t likely to be politically controversial.

Consider the edits made to one internal document prepared to help guide CDC staff in responding to questions about suicide.

The original answer included the words “restricting access to lethal means among those at risk for suicide has been proven effective for preventing suicide.”

One passage got edited to remove any reference to “restricting access.” Instead, the revised answer focused on “safe storage,” saying, “safe storage practices can help reduce the risk for suicide by separating vulnerable populations from easy access to lethal means.”

In a teleconference that the CDC held with reporters in June 2018, when the CDC released a report on rising suicide rates, CDC Principal Deputy Director Anne Schuchat said that “one of our recommendations is assuring safe storage of medications and firearms as one of the approaches to prevention. Very important to — you know, have safe storage.”

Research does show that locking up guns and ammunition can prevent suicidal adolescents from being able to access their parents’ guns.

But the “safe storage” approach doesn’t address the suicide risk that a gun poses to its owner, who presumably has the key or combination to a locked safe or cabinet.

And most gun suicides happen when the owner of the gun turns it on himself or herself.

“I’m a little bit dubious that safe storage will be relevant to the vast majority of suicides with firearms. Because the owners of those firearms are the ones storing the guns and locking the guns,” says Daniel Webster, director of the Johns Hopkins Center for Gun Research and Policy. “I certainly don’t know of any research that shows that safe storage of firearms reduces risks for adult suicide.”

David Gunnell, an epidemiologist at the University of Bristol, was perplexed by the CDC’s focus on safe storage.

“It was all about, if you like, putting the blame on the owners, making them store their firearms safely,” says Gunnell, “rather than seeing this large pool of firearms available in the community in the United States contributing to the heightened use of firearms for suicide.”

In his research on a common means of suicide in Sri Lanka, pesticide ingestion, Gunnell has found that providing locked storage boxes hasn’t been an effective form of prevention. Eventually, he says, families just stop bothering to use the secure box.

What has produced dramatic reductions in suicide rates, he says, has been regulatory bans that took the most dangerous pesticides off the market in certain places.

“So there’s a body of evidence that if you regulate, to make the environment safer by taking out of the broader environment the most toxic products, that results in a fall in deaths,” says Gunnell, because suicide research shows that people do not tend to substitute one suicide method for another.

In fact, Gunnell says, most international reviews of the research literature on suicide have found that the strongest evidence about how to bring down death rates “is around those interventions that restrict access to commonly used, high lethality suicide methods.”

In other countries, that approach has lowered suicide rates by as much as 30% to 50%.

These dramatic decreases are not mentioned in the CDC’s main guide to preventing suicide, described as “a resource to guide and inform prevention decision-making in communities and states.”

It does talk about the need to create “protective environments” and includes the example of “safe storage” of guns. But as the document got edited inside the CDC, its message about the importance of restricting access to “lethal means” got weakened. One early draft stated:

“The evidence for the effectiveness of means restriction and other ways to establish protective environments is some of the strongest in the field.”

The sentence got changed to:

“The evidence for the effectiveness of preventing suicide by reducing access to lethal means and otherwise establishing protective environments for individuals at risk of suicide is strong, particularly compared to existing evidence for other prevention strategies.”

Additional changes produced the final, published version, in which the evidence merely “suggests”:

“The evidence suggests that creating protective environments can reduce suicide and suicide attempts and increase protective behaviors.”

What’s missing?

It’s possible to read the CDC’s materials on suicide and come away not understanding what science shows about how to significantly reduce suicide rates, and the important connection between guns and suicide.

“Half of all suicide deaths in the states are from firearms,” says Gunnell, “and so, as a policymaker, my first step would be to say, ‘Well, what can we do to restrict access to firearms?’ ”

The CDC’s own research shows that simply having a gun in the home is associated with increased risk for suicide, but that isn’t highlighted in its public messages about suicide.

In addition, states that have higher gun ownership rates see higher rates for suicide, “even after you’ve controlled for a range of other factors known to be correlated with suicide risk,” says Webster. “Access to firearms does increase suicide risk. I recognize that is a conclusion that will make people uncomfortable. But that is simply what the facts are.”

When people are going through difficult times or grappling with substance use or mental health issues, says Webster, “it could be, at least temporarily, you can mitigate that risk by having someone else hold the firearms for them.”

Other possible measures might include waiting periods before purchasing guns, licensing processes for gun buyers, or laws that keep firearms from those who are deemed a risk to themselves or others (“red flag” laws).

None of those legislative options get mentioned in the CDC’s guide to strategies for suicide prevention for states and communities.

A spokesperson for the CDC told NPR that “some laws or policies to potentially reduce firearm suicides (e.g., red flag laws) have not been rigorously evaluated. CDC selected examples with ample evaluation using the criteria for inclusion in the front of the technical package. We are always reassessing the evidence and will update the evidence as it becomes available.”

She pointed to one CDC study of firearms and suicides in major metropolitan areas that does briefly mention “safely storing firearms or temporarily removing them from the home.” It also mentions policies to keep firearms away from people under a restraining order for domestic violence, as well as efforts to strengthen the background check system for gun purchases.

Draft documents of the CDC’s guide to suicide prevention show that some researchers at the agency feel that suicide prevention has been hindered by “hesitation to take up strategies known to be effective but perhaps unpopular”:

“Unfortunately, suicide prevention is impeded by barriers including: stigma related to help-seeking, mental illness, being a survivor, or someone with lived experience; fear related to asking about suicidal thought, hesitation to take up strategies known to be effective but perhaps unpopular; misinformation about suicide preventability, harmful messaging about suicide, and disproportionate funding given its public health burden.”

In the final version of that section that was published, some of those barriers to reducing suicide rates go unmentioned:

“There are a number of barriers that have impeded progress, including, for example, stigma related to help-seeking, mental illness, being a survivor and fear related to asking someone about suicidal thoughts.”

What’s actually allowed?

Webster believes that CDC officials have made the choice that it is safest for the agency to tread lightly when it comes to anything related to guns, since Congress controls the CDC’s funding.

“I think that’s a very unfortunate environment that they’ve had to operate in,” says Webster. “But I want people to understand that there is no law in place now that says that CDC can’t talk about the research and what’s been learned about the connection between firearms and suicide risk.”

The exact meaning of what the CDC is or is not allowed to do under the Dickey Amendment has been ambiguous ever since Congress passed the legislation decades ago.

Officials seem inclined to err on the side of caution. The minutes of one meeting to review a report on rising suicide rates showed that one CDC employee told researchers not to mention the often impulsive nature of suicides.

Apparently the official worried that mentioning this fact might turn “it into a removal of lethal means issue,” given that about half the people in the study who killed themselves were not previously known to have a mental health issue. She noted, “I don’t want it to be overly politicized.”

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Why Competition Hasn’t Brought Down The High Price Of Snakebite Treatment

The antivenin market for treating bites from rattlesnakes and other pit vipers might be considered a case study of why drugs prices are so high. Head-to-head competition between brand-name medicines may not meaningfully reduce prices.

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Dr. Steven Curry, a medical toxicologist and professor at the University of Arizona, has treated snakebites since the 1980s — long enough to remember when the treatment represented its own form of misery.

The first medication Curry used sometimes caused an immune reaction called serum sickness — patients broke out in a severe, itchy rash. Then, about 20 years ago, the snake antivenin CroFab entered the market and dramatically reduced the adverse reactions associated with treatment, he says.

But the drug came with a sky-high price tag. In one case reported by NPR and Kaiser Health News, an Indiana hospital last summer charged nearly $68,000 for four vials of CroFab.

Now, CroFab faces competition from a snake antivenin called Anavip. Curry says the health system he works for in Phoenix — Banner Health — is using the new drug as its first line of treatment. It is switching, he says, because Anavip could reduce readmissions by better controlling bleeding associated with a snakebite and lead to “substantial savings” for the hospital.

But few experts who study drug laws and drug prices expect this competition to reduce the cost for patients. Legal wrangling, the advantageous use of the patent system and the regulatory hurdles in creating cheaper alternative drugs stymie any serious price competition.

Indeed, the antivenin can be considered a case study of why drug prices are so high: Head-to-head competition between brand-name medicines may not meaningfully reduce prices.

“When we allow a system of perverse incentives to flourish, this is the result we get,” says Robin Feldman, a professor at University of California, Hastings College of the Law in San Francisco, who specializes in pharmacy law.

After being approved by the Food and Drug Administration in 2000, CroFab was the only commercially available snake antivenin in the United States.

That gave the drug’s British manufacturer, BTG, “a lot of latitude to determine what price it’s going sell its product at,” says Aaron Kesselheim, a faculty member at Brigham and Women’s Hospital in Boston, who studies pharmaceutical policy.

The Centers for Disease Control and Prevention reports that roughly 8,000 people in the U.S. each year are bitten by venomous snakes, which means there’s not a huge market for antivenin. But victims desperately need the remedy. Snake venom can cause tissue damage, hemorrhaging and respiratory arrest — in other words, a painful death.

Having had the market all to itself for years, CroFab has quadrupled in price since its launch, according to data from the health technology company Connecture. Today, the list price for wholesalers for the medicine is $3,198 a vial and the recommended starting dose for a patient is between four and six vials.

CroFab generated more than $132 million in revenue for its parent company, according to BTG’s 2019 annual report. The antivenin represented 14% of the firm’s total revenue.

Anavip, the competitor drug that was launched in October, is priced at $1,220 per vial for wholesalers, and the recommended initial dose is 10 vials.

That’s a “sustainable price that keeps us in business,” says Jude McNally, president of Rare Disease Therapeutics, a Tennessee-based company that markets Anavip in the U.S. (The drug is made by a Mexican company.) McNally says he has no plans to lower the price.

In practice, the prices for these drugs are closer than they appear.

Doctors need to use a higher starting dose of Anavip than of CroFab. Taking that into account, the difference in wholesale price from Anavip shrinks to about $500.

McNally says RDT “has done what we can to reduce initial and subsequent health care costs” with Anavip. He also noted that the package insert for CroFab recommends that patients receive additional doses on a timed schedule if needed to control the damage from the snakebite, making treatment more expensive.

In general, Kesselheim says, direct competition between two drugs can reduce prices for consumers by 15% to 20%. But “if you’re starting at a very high price,” he says, “it may not be helpful for patients.”

Cheaper, alternative versions of brand-name drugs can drive prices down. But an analysis by Kesselheim and his colleagues, described in the New England Journal of Medicine in 2017, found this tends to happen only after three or more generic drug manufacturers enter the market. At that point, the increased competition can offer generic drugs that are priced at 60% (or less) of the brand name’s initial price per dose.

That didn’t happen with antivenin. Manufacturers face bureaucratic challenges to making a cheaper, copycat drug to compete with CroFab and Anavip. These snake antivenins are biologic drugs — complex medicines made from live cells. Congress created a unique pathway for the FDA to greenlight cheaper equivalents to biologics, called biosimilars, in 2009.

As of July 23, the agency has approved 23 biosimilars. In contrast, European countries enjoy a larger, thriving market of biosimilars that are sold at a fraction of the U.S. cost.

In the U.S., even when the FDA approves another drug, the maker can manipulate the patent process to keep competitors out. A patent allows a drug manufacturer to claim ownership of certain product information and bar others from making, using or selling a drug based on the protected content for 20 years. This gives manufacturers a powerful edge – they can sue potential competitors for patent infringement.

“The most creative activity in the drug company should be in the lab, not in the legal department” says Hastings law professor Feldman, paraphrasing a former FDA commissioner.

Indeed, it was lawyers who helped BTG make even more money. When the makers of Anavip first wanted to enter the snake antivenin market in 2013, BTG sued them; the companies settled the case in 2014. In the agreement, Anavip promised to pay BTG royalties on its sales of antivenin until 2028.

BTG intends to maintain its market dominance, says spokesman Chris Sampson, by using strategies that include improving the CroFab formula. He also says the company doesn’t plan to lower the drug’s price.

“If your question is ‘Are we ready for the competition?’ ” Louise Makin, CEO of BTG, told investors in a May 2018 earnings call, “we are ready — we are absolutely ready.”

Kaiser Health News is a nonprofit, editorially independent program of the Kaiser Family Foundation. KHN is not affiliated with Kaiser Permanente.

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Coordinating Care Of Mind And Body Might Help Medicaid Save Money And Lives

John Poynter of Clarksville, Tenn., uses a wall calendar to keep track of all his appointments for both behavioral health and physical ailments. His mental health case manager, Valerie Klein, appears regularly on the calendar — and helps make sure he gets to his diabetes appointments.

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In modern medicine, the mind and body often stay on two separate tracks in terms of treatment and health insurance reimbursement. But it’s hard to maintain physical health while suffering from a psychological disorder.

So some Medicaid programs, which provide health coverage for people who have low incomes, have tried to blend the coordination of care for the physical and mental health of patients, with the hope that it might save the state and federal governments money while also improving the health of patients like John Poynter of Clarksville, Tenn.

Poynter has more health problems than he can even recall. “Memory is one of them,” he says, with a laugh that punctuates the end of nearly every sentence.

He is currently recovering from his second hip replacement, related to his dwarfism. Poynter is able to get around with the help of a walker — it’s covered in keychains from everywhere he’s been. He also has diabetes and is in a constant struggle to moderate his blood sugar.

But most of his challenges, he says, revolve around one destructive behavior — alcoholism.

“I stayed so drunk, I didn’t know what health was,” Poynter says, with his trademark chuckle.

Nevertheless, he used Tennessee’s health system a lot back when he was drinking heavily. Whether it was because of a car wreck or a glucose spike, he was a frequent flyer in hospital emergency rooms, where every bit of health care is more expensive.

The case for coordination of mind-body care

Tennessee’s Medicaid program, known as TennCare, has more than 100,000 patients who are in similar circumstances to Poynter. They’ve had a psychiatric inpatient or stabilization episode, along with an official mental health diagnosis — depression or bipolar disorder, maybe, or, as in Poynter’s case, alcohol addiction. And their mental or behavioral health condition might be manageable with medication and/or counseling, but without that treatment, their psychological condition is holding back their physical health — or vice versa.

“They’re high-use patients. They’re not necessarily high-need patients,” says Roger Kathol, a psychiatrist and internist with Cartesian Solutions in Minneapolis, who consults with hospitals and health plans that are trying to integrate mental and physical care.

As studies have shown, these dual-track patients end up consuming way more care than they would otherwise need.

“So, essentially, they don’t get better either behaviorally or medically,” Kathol says, “because their untreated behavioral health illness continues to prevent them from following through on the medical recommendations.”

For example, a patient’s high blood pressure will never be controlled if an active addiction keeps them from taking the necessary medication.

But coordinating mental and physical health care presents business challenges — because, usually, two different entities pay the bills, even within Medicaid programs. That’s why TennCare started offering incentives to reward teamwork.

Health Link

TennCare’s interdisciplinary program, known as Tennessee Health Link, was launched in December 2016. The first year, the agency paid out nearly $7 million in bonuses to mental health providers who guided patients in care related to their physical health.

TennCare has a five-star metric to gauge a care coordinator’s performance, measuring each patient’s inpatient hospital and psychiatric admissions as well as visits to emergency rooms. Providers are eligible for up to 25% of what’s calculated as the savings to the Medicaid program.

Studies show this sort of coordination and teamwork could end up saving TennCare hundreds of dollars per year, per patient. And a 2018 study from consulting firm Milliman finds most of the savings are on the medical side — not from trimming mental health treatment.

Savings from care coordination have been elusive at times for many efforts with varying patient populations around the U.S. A TennCare spokesperson says it’s too early to say whether its program is either improving health or saving money. But already, TennCare is seeing these patients visit the ER less often, which is a start.

While there’s a strong financial case for coordination, it could also save lives. Studies show patients who have both a chronic physical condition and a mental illness tend to die young.

“They’re not dying from behavioral health problems,” points out Mandi Ryan, director of health care innovation at Centerstone, a multistate mental health provider. “They’re dying from a lack of preventive care on the medical side.”

“So that’s where we really started to focus on how can we look at this whole person,” Ryan says.

But refocusing, she says, has required changing the way physicians practice medicine, and changing what’s expected of case managers, turning them into wellness coaches.

“We don’t really get taught about hypertension and hyperlipidemia,” says Valerie Klein, a care coordinator who studied psychology in school and is now an integrated care manager at Centerstone’s office in Clarksville, Tenn.

“But when we look at the big picture,” Klein says, “we realize that if we’re helping them improve their physical health, even if it’s just making sure they got to their appointments, then we’re helping them improve their emotional health as well.”

Klein now helps keep Poynter on track with his treatment. Her name appears regularly on a wall calendar where he writes down his appointments.

Poynter calls Klein his “backbone.” She helped schedule his recent hip surgery and knows the list of medications he takes better than he does.

Klein acknowledges it’s a concept that now seems like an obvious improvement over the way behavioral health patients have been handled in the past. “I don’t know why we didn’t ever realize that looking at the whole person made a difference,” she says.

This story is part of NPR’s reporting partnership with Nashville Public Radio and Kaiser Health News.

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Pain Rescue Team Helps Seriously Ill Kids Cope In Terrible Times

Robyn Adcock (left), a University of California, San Francisco pain relief specialist, gently guides Jessica Greenfield to acupressure points on her son’s foot and leg that have helped relieve his chronic pain.

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The Benioff Children’s Hospital at the University of California, San Francisco is a sleek new building with state-of-the-art facilities — a place where the sickest children go for leading-edge treatments.

Which is why it might be surprising to find Robyn Adcock, who practices acupuncture and acupressure walking the halls.

Though Adcock practices ancient arts of traditional Chinese medicine, she is an integral part of the hospital’s integrative pediatric pain and palliative care — or IP3 — team. It’s sort of an emergency response team for pain that combines traditional pharmaceutical pain care with other techniques to ease the suffering of the sick children who populate the rooms here.

The interdisciplinary team includes anesthesiologists and nurses, as you might expect. There’s also a clinical psychologist, a massage therapist and someone who practices hypnosis — as well as Adcock, who treats patients with both acupuncture and acupressure.

“We see cases in the hospital that are end-of-life or very chronic serious illness, or extreme pain cases — where their primary team maybe wants more support and managing the pain piece,” Adcock says.

Adcock (right) softly touches 11-year-old Miller, as she explains her pain relief plan to his parents. Miller has been heavily sedated because his rare neurological disorder periodicially forces all his muscles to clench at once — a painful, and life-threatening condition.

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On the day I visit, she’s headed to intensive care unit to see an 11-year-old boy named Miller. He is suffering with a severe neurological disorder called deafness dystonia syndrome, an exceedingly rare genetic condition that impairs his hearing and causes his muscles to contract uncontrollably.

The condition hits children at puberty, and it hit Miller hard earlier this year.

“We started to see some mild cognitive changes in the summer and fall,” says Jessica Greenfield, Miller’s mother. “And then, in January, we started to see significant dystonic movements.”

Today, she says, her son is in a painful and life-threatening state known as status dystonicus — which means all of his muscles are contracting at once.

“So, in the last the last 48 hours we’ve seen a significant ramp up in his symptoms,” Greenfield tells Adcock, as they stand over the bed where Miller lies, heavily sedated.

The medications her child is on are barely keeping his symptoms under control, Greenfield says, and he can’t tolerate any more painkillers. She tells Adcock that the acupressure techniques Adcock taught them a few days earlier have been helpful.

“It’s not that it stops it,” Greenfield says, “but it gives us these periods in there of interruption where we have something to offer him in between all of this medication that he’s getting.”

Adcock says she’s going to try some additional pressure points, and she leans over to greet the boy, who is almost unconscious.

“Hi, Miller,” she whispers. “I’m going to feel your pulses, and then we’re going to do some acupressure again today with you.”

Adcock quietly reaches for Miller’s wrists, then his legs and feet. She works silently for several minutes as Jessica and her husband John Greenfield look on, clutching paper coffee cups, their eyes clouded with sadness and exhaustion.

After working with Miller for about 15 minutes, Adcock beckons Jessica to the bedside to go over the pressure points they’ve already used and to show her some new points that she’s marked with tiny radish seeds.

Miller’s mom, Jessica Greenfield, says she knows the acupressure helps her son cope with his pain, because he requests it, when his medication isn’t enough. “It allows us a means of providing comfort for him,” Greenfield says.

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“So if you feel this side of the tibia … your four fingers will help you” Adcock says, gently guiding Greenfield’s hand. “You’ll feel a soft, deeper spot. And you can let your intuition find it as well.

“If you’re open and listening with your hands, you’ll be able to find the point,” she says quietly. “And you’re on it. Perfect.”

Jessica Greenfield says she knows the treatments help Miller, because he often asks her to touch his pressure points between Adcock’s visits.

Studies estimate that 20 percent of children worldwide have chronic pain. That could range from frequent stomachaches to debilitating pain from cancer.

And the majority of those children will grow into adults who also are in chronic pain, says Christine Chambers, the Canada research chair in children’s pain at the Centre for Pediatric Pain Research at Dalhousie University in Nova Scotia.

So, at a time when addiction to opioid painkillers is a crisis, finding alternative ways to manage pain and provide comfort is crucial, she says. Because not all pain can be taken away.

Chambers says research shows most children, even in hospitals, don’t get adequate pain care. And sometimes, doctors just can’t eliminate the pain.

“Every clinician who works with a child in pain hopes that we will be able to take away all the pain,” Chambers says. “That isn’t always possible.”

So this interdisciplinary approach, she says, helps kids manage their pain, ease it and live with it.

Research backs up many of the techniques, Chambers says, including physical therapy, hypnosis and even distraction.

“There’s a super strong evidence base in favor of distraction,” she says.

That’s where art and music therapy come in, because these can take kids’ minds off their pain.

Unfortunately, Chambers says, this type of pain care is rare, especially for children.

“Most children won’t be able to access these,” Chambers says. “There are specialized centers that offer these interdisciplinary treatment programs but there are not nearly enough of them.”

The team in San Francisco is one of only a handful across the U.S. And that’s particularly unfortunate, she says, because most children who suffer chronic pain will bring that into adulthood.

Tackling pain from many sides is crucial because different techniques target different kinds of pain, says Dr. Stephen Wilson, the Chief Medical Officer at UCSF Benioff who founded the IP3 team a decade ago and who has been building on it ever since.

Chemotherapy, for example, can cause many kinds of pain and discomfort in a child with cancer.

“They’re likely to have pain in their mouth and in their abdomen from the effects of the chemotherapy,” he says. “They’re likely to have pain in their hands and feet because the chemotherapy agents temporarily can affect nerves and give them what we call neuropathic pain.”

And then there’s the fear and sadness, which Wilson calls “existential pain.”

“It’s not the kind of pain that responds to pain medication, but it’s very real,” he says. “They’re suffering for sure.”

Wilson says the team still relies on traditional painkillers, including opioids, to help the children. But, he says, acupuncture may be more effective against nausea than a medication. And a massage therapist can ease muscle aches; a psychologist can help with the existential fear; and art or music therapy can distract children from their pain.

Together these interventions can make the experience of illness less awful.

“A lot of times, just walking in the room, you can sense that the child and their family are doing better with a terrible situation,” Wilson says. “The situation is still terrible, so I don’t want to paint a rosy picture that somehow everything is wonderful, but it makes a huge difference.”

Jessica Greenfield says the acupressure does just that for Miller and the whole family.

“There’s only so much medication he can have, and certainly only so much medication we would give him in a home setting,” she says. “So it allows us a means of providing comfort for him — which is really important for us as parents and for him as a patient.”

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Homeland Security’s Civil Rights Unit Lacks Power To Protect Migrant Kids

A Guatemalan teen asylum-seeker (left), who isn’t able to hear or speak, signs with his mom in Florida. He was brusquely separated from her and held in a shelter for nearly three months, unable to readily communicate, according to a civil rights complaint filed with the Department of Homeland Security.

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The children’s lawyer was incensed. Her two tiny clients — one of them blind — had been in a shelter for three months, separated from their mother.

The family had traveled from Mexico to the United States, reaching Nogales, Arizona, on March 1, 2018. Officials at the border found that the mother, Nadia Pulido, had “credible” reasons for seeking asylum from an ex-partner who, she says, beat her and stalked her after their relationship ended.

But U.S. Customs and Border Protection still sent Pulido into an adult detention center run by U.S. Immigration and Customs Enforcement. She had an hour to say goodbye and try to assure her blind daughter, 6, and sobbing 3-year-old son that she’d see them in a couple of hours.

“A couple of hours turned into months. Painful months,” Pulido recalled in an interview.

To help the children, pro bono attorney Maite Garcia turned to the U.S. Department of Homeland Security’s Office for Civil Rights and Civil Liberties. She filed a complaint with the office on June 7 of last year, explaining that Pulido’s daughter was “completely blind and requires assistance for daily living” and would be better off with her stepfather, a U.S. citizen.

Nearly two weeks went by before the civil rights office replied.

“The issues you raise are very important to us,” CRCL finally said in its emailed response. Then came a disclaimer: “Please be advised that our complaint process does not provide individuals with legal rights or remedies. … Instead, we use complaints like yours to find and address problems in DHS policy and its implementation.”

The Office for Civil Rights and Civil Liberties was created within the Department of Homeland Security in 2002. The office’s mission is to advise the department and prevent civil rights violations. But some insiders say the unit has always lacked teeth.

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That was the last Garcia heard from the nearly 100-person office in Washington, D.C.

The tepid response from the department’s civil rights office bolsters objections — not least from former staff — that the DHS watchdog is failing to stop rights abuses as they’re happening inside a detention system that’s expanding rapidly under the Trump administration.

The ineffectual handling of individual complaints adds to criticism that DHS leaders no longer heed recommendations from the agency’s own civil rights experts.

“Put yourself in the shoes of the person who’s sitting in the cell or who’s separated from their parent or who’s wondering where their child is,” former CRCL staff attorney and adviser Ellen Gallagher said.

A recent whistleblower, Gallagher has accused the civil rights office of failing to investigate multiple individual complaints alleging unjustified solitary confinement of detainees in ICE custody. Gallagher is now with DHS’ Office of Inspector General, a separate internal watchdog specializing in issuing reports after lengthy investigations.

“It seems to mislead the public, to invite complaints involving specific information about the individual or the family and the alleged violation, if Civil Rights and Civil Liberties had no intention of specifically investigating or resolving those individual complaints,” Gallagher said.

Acting Homeland Security Secretary Kevin McAleenan has insisted that DHS has “layers of oversight” to correct abuses. “We have good supervisory oversight, and we hold people accountable,” he said during a July 9 interview on CNN in response to questions about filthy conditions in CBP holding facilities.

Gallagher’s impression, however, is that the civil rights office “was actually fairly intimidated by ICE and CBP and did not want to engage in activity that might offend either. That is an odd and even disturbing posture for an oversight authority.”

Internal CRCL log: a flood of complaints

Some CRCL staff members say that individual employees contact CBP or ICE to try to informally resolve civil rights complaints. But they can only advise agencies, they say, because their office isn’t set up to halt abuses as they happen.

Cameron Quinn, chief of the civil rights office and an appointee of President Trump, declined a request for an interview. Another CRCL official responded in writing to questions, asking not to be quoted by name.

“CRCL does not have authority to remedy individual complaints but instead focuses on systemic issues” at DHS, the official wrote. The office does have authority, however, to seek “remedies” for people facing disability discrimination, the official said, declining to elaborate.

“With regard to family separations,” the official said, “CRCL investigated the issue from a policy and process standpoint.” The civil rights office then sent its recommendations to ICE and Customs and Border Protection in a memo. CRCL declined to release the memo, calling it a “deliberative” document.

CRCL, the official added, still has “open investigations” into the separations of children under age 5, the separations of children with disabilities and standards for separating families based on parental criminal history.

The Office for Civil Rights and Civil Liberties was created along with the Department of Homeland Security in 2002. The office’s mission is to advise the powerful federal department and prevent civil rights violations such as the post-Sept. 11 roundups of Muslims without due process. But some insiders say CRCL has always lacked teeth.

Last year, the civil rights office proved especially weak as complaints about due process concerns and family separations began pouring in — nearly 850 in the first half of 2018 alone, logged into a CRCL database. An independent journalist obtained a copy through a Freedom of Information Act request and then shared it with the Center for Public Integrity and NPR.

The complaints referenced more than 380 separated children 10 years old or younger, of which more than 120 children were age 5 or younger.

More than 140 complaints arrived before the Trump administration announced its “zero tolerance” policy on April 6, 2018. More than 160 cases of separation referenced in the log were carried out before that date. The zero-tolerance policy required separating families so that CBP could hold all adults for prosecution, even for a first-time misdemeanor illegal entry.

Former and current staff in the civil rights office say their colleagues were so upset by allegations in the complaints that they openly wept at desks as they reviewed the cases.

By May of last year, senior staff in the office had urged Quinn, in an internal memo, to challenge the separations. “CRCL should express great concern over our exclusion from these critical decisions,” which CRCL has the authority to review, the memo said. “Deliberately harming children to deter parental behavior would require an exceedingly strong justification to pass muster as a reasonable seizure under the Fourth Amendment, among other concerns.”

Lawyer and former CRCL senior adviser Scott Shuchart, who resigned from the office last year, said his and other advisers’ concerns were “blown off” by CBP and other DHS leadership in meetings.

One complaint to CRCL in January 2018 reported that CBP separated a 4-month-old infant from a Mexican father who had prior immigration violations but feared being sent back to Mexico.

Another reported that an 8-year-old said CBP officers “kicked him and/or hit him with a shoe” to wake him. Dozens of other complaints described children upset about their parents’ uncertain whereabouts and abrupt disappearance — including a 14-year-old in CBP custody who said he was separated after a meal break and was then “told by officers that his father would be deported.”

About 95% of all complaints logged came from the federal Office of Refugee Resettlement, a unit within the U.S. Department of Health and Human Services that’s responsible for migrant-children shelters.

Former senior staff in this federal resettlement office say the volume of complaints is unprecedented. Robert Carey, ORR director during the final two years of Barack Obama’s presidency, said he thinks ORR employees were trying to stop separations by filing complaints.

“You probably have a deeply traumatized, possibly hysterical child that you’re trying to care for,” Carey said. “I’m guessing some of those cases would require … the intervention of a therapist, particularly if you’re talking about, in some instances, young children.”

HHS officials declined to make leaders in its Office of Refugee Resettlement available for an interview.

Most other complaints came from nonprofit legal aid groups — including 18 filed by the Phoenix-based Florence Immigrant and Refugee Rights Project, where Maite Garcia works.

The complaint about Pulido’s blind daughter and toddler son appears on page 276 of CRCL’s 366-page document.

Another Florence complaint filed on June 14 of last year appears on page 321. It raises objections to CBP’s separation of a Guatemalan mother from her 17-year-old son — who is unable to hear or speak — without regard for his disability. The boy could have qualified to be “paroled” into the U.S., a conditional form of humanitarian release. But that never happened — and the case shows how a formal complaint can wither in the Department of Homeland Security’s Office for Civil Rights and Civil Liberties.

Deaf boy’s mom taken away

The story of the mother and her deaf son “exhibits the cruelty, the chaos” of how migrants are treated, the mother’s attorney said. The teen had long been bullied in Guatemala, and thieves had robbed him at gunpoint. When mother and son got to Arizona and requested asylum, U.S. Customs and Border Protection separated them into cages segregated by gender and age.

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The story of the mother and her deaf son “exhibits the cruelty, the chaos” of how migrants are treated, said Elizabeth Jordan, an attorney with Denver’s Civil Rights Education and Enforcement Center. She represented the mother while the woman was in ICE lockup in Colorado.

On April 25 of last year, the mother and her 17-year-old deaf son approached CBP officers after crossing the Arizona border and asked to apply for asylum.

The boy and his mother now live in Florida, where they are in the process of applying for asylum. In an interview, the mother, who asked that her name not be disclosed, said she’d worked previously in the state, sending money to Guatemala to rent a room for her son and pay his tuition at a school for the deaf there. She eventually returned to Guatemala to care for her son and her own frail mother.

Three months after she got there, her mother died, and her deaf son lost his primary caregiver. He’d long been bullied in Guatemala, and thieves had robbed him at gunpoint. Mother and son both set out for the United States some months later.

“I don’t do this for me. I do it for him,” she said, “because I’m not going to be alive for all of his life.”

After Customs and Border Protection took her and her son into custody near San Luis, Ariz., the mother said, officers ignored her pleas to keep them together rather than place them in cages segregated by age and gender. Her son, she told the officers, needed her to interpret. When she protested further that her son was mute, she said an officer answered, “He won’t need to do much talking where he’s going.”

At some point, while her son was asleep, guards took her out of her cage, the mother said, and transported her to an ICE detention center pending prosecution. She said she was told “you have to pay for what you did” because she’d been turned away at the border the year before. She was sentenced to 30 days in an Arizona jail for reentry and then transferred to an ICE detention center in Colorado, pending deportation.

Meanwhile, U.S. Customs and Border Protection had sent her son on a long bus ride to an Office of Refugee Resettlement shelter in Arizona, where his only means of communication was drawing pictures.

For more than a month, the mother pleaded in vain with detention guards, first in Arizona and then in Colorado, to arrange a video call so she could at least see and sign with her son. Medical records from the boy’s time in the shelter indicate he was distraught: He struck his head against walls and cut himself with a paper clip. In an interview in Florida, interpreted by his mother, he said that to prevent him from getting out of bed one night, he was physically restrained.

“She was profoundly distressed and so worried about him,” lawyer Jordan said of the mother. “This is a person who has devoted her life to keeping him safe and getting the best she can for him. And then, for her to be totally unable to check in on him for weeks …”

A round of emails between the boy’s attorneys and DHS’ civil rights office ultimately went nowhere.

Initially, a CRCL adviser seemed to be working on the Florence project’s June 2018 complaint, arguing that the deaf boy merited humanitarian parole and that for two months the shelter hadn’t “provided him with the appropriate accommodations” for his disability. The adviser wrote that the civil rights office was “reviewing your concerns”; he asked for proof the boy was deaf.

In July 2018, one of the boy’s lawyers emailed CRCL to write that when CBP held the boy in custody, he “was able to understand that the agents were mocking him” because they didn’t believe he was deaf.

The lawyer further argued that CBP, ICE and the Office of Refugee Resettlement, the federal agency in charge of shelters, were all in violation of disability rights because they had failed to arrange a video call between the boy and his mother.

The official from the civil rights office then replied that he was “unable to look into [the boy’s] ongoing concerns” because the teenager had been transferred by CPB, which is within DHS’ jurisdiction, to ORR, which is not.

Instead, he suggested, the civil rights office could investigate the mother’s concerns because she was in ICE custody, which, like CBP and CRCL, falls under DHS. The boy’s attorneys gave the civil rights official contact information for Jordan, the mother’s Colorado lawyer.

By that time, Jordan had already been emailing local ICE officials repeated pleas to set up a video call. The call finally happened — nearly three months after U.S. Customs and Border Protection officers had separated the mother and her son. But it wasn’t because of action by DHS’ civil rights office, Jordan said. It was because DHS was by then under court order to put separated migrant family members in touch with one another by phone and then reunite them.

“In my interactions with individual CRCL officers,” Jordan said, “I don’t get the sense that they’re out to lunch or bad people. I think that they just ultimately can’t get much done. I think it comes from being really hamstrung by the fact that they have to work with ICE and get ICE to concur in their recommendations and actually make changes.”

In the children’s interest

Although Trump ended his zero-tolerance policy in June 2018 after a public outcry, U.S. border agents have continued to separate families due to parents’ criminal records, even for minor offenses, or because of prior deportations.

Immigrant rights groups have long pressed DHS to consider the children’s interests, and they’ve noted that family separation “causes great harm, disrupting emotional and psychological well-being.”

For failed asylum-seeker Nadia Pulido, the groups’ pressure came too late.

Pulido was born in Mexico but is a fluent English-speaker who arrived in California as an undocumented child and was raised by relatives. She could have qualified for a special visa for abandoned children, but no one sought such a visa on her behalf. When she was “literally just young, stupid and hanging around the wrong crowd,” she said, she was convicted of robbery and deported.

Because of that history, U.S. Customs and Border Protection and ICE chose to send her children to a shelter and keep her in detention last year while her asylum case went forward.

ICE could have released her on humanitarian parole. Instead, she was held in detention for eight months, until she lost her asylum bid. She could have appealed, but that would have meant more detention — and more time apart from her young children. In the end, Pulido agreed to be deported to Mexico.

After four months in a shelter, Pulido’s blind daughter and toddler son were finally released to her husband, a U.S. citizen. Attorneys for the children and Pulido believe a federal lawsuit that led to a court order unifying migrant families was likely a factor. And they doubt their complaint to DHS’ civil rights office did anything to hasten the children’s release.

In Mexico, where the kids have now joined her, Pulido said she’s still scared. To support her need for refuge, she presented Mexican police reports about incidents involving her ex-partner; and in her asylum application, she wrote that he assaulted her while she was pregnant and held a gun to her head.

“We were leaving Mexico to seek help in the United States,” she said, “to stay free of danger.”

Susan Ferriss is a reporter with the Center for Public Integrity, a nonprofit investigative newsroom in Washington, D.C. Alison Kodjak reported this story for NPR, and independent journalist Joshua Phillips did so for the Center for Public Integrity. Journalists Madeline Buiano and Pratheek Rebala also contributed to this story.

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$2,733 To Treat Iron-Poor Blood? Iron Infusions For Anemia Under Scrutiny

Plump red blood cells — tumbling amid infection-fighting white blood cells and purple platelets in this colorized, microscopic view — need adequate levels of iron to be able to carry and deliver oxygen around the body. Iron-deficiency anemia is sometimes remedied with IV iron infusions — and the bill can vary by thousands of dollars.



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Shannon Wood Rothenberg walked into her annual physical feeling fine. But more than a year later, she’s still paying the price.

Routine bloodwork from that spring 2018 medical visit suggested iron-deficiency anemia. The condition runs in Rothenberg’s family and is often treated with over-the-counter iron pills, which typically cost under $10 for a month’s supply. Her doctor advised exactly that.

But after two months with no change, the doctor told Rothenberg to see a hematologist who could delve into the source of her problem and infuse an iron solution directly into her veins.

So, the 48-year-old public school teacher went twice in July 2018 to a cancer center, operated by Saint Joseph Hospital in Denver, to get infusions of Injectafer, an iron solution.

When the bill arrived in March, after prolonged negotiations between the hospital and her insurer, Rothenberg and her husband were floored.

The hospital initially had billed more than $14,000 per vial of Injectafer. Since her treatment was in network, Rothenberg’s insurance plan negotiated a much cheaper rate: about $1,600 per vial. She received two vials. Insurance paid a portion, but Rothenberg still owed the hospital $2,733, based on what was still unpaid in her family’s $9,000 deductible.

“I have twins who are going to college next year. I’m already a bit freaked out about upcoming expenses,” she says. “I don’t have $2,700 sitting around.”

Anemia, the principal outgrowth of low iron levels, can cause headache, fatigue and an irregular heartbeat. People with certain medical conditions, including a history of heavy menstrual periods, inflammatory bowel disease and kidney failure, among others, are prone to low iron levels and anemia, which can be severe.

Crunching the national data

Although Rothenberg had private health insurance, a close look at Medicare data suggests her experience with pricey iron infusions is pretty common. Since 2013, the first year for which data are available, about 9 million Americans in the federal government’s health plan for people 65 and above have gotten iron infusions each year. That’s almost one infusion for every five Medicare recipients.

In other countries, doctors usually would not be so quick to resort to iron infusions for anemia — especially in healthy patients like Rothenberg, who have no underlying disease and no obvious symptoms.

In Great Britain, for example, “it would be extremely unlikely that IV iron would be administered,” says Richard Pollock, a health economist at London-based Covalence Research, who studies the use of iron products.

But one key difference between the United States and other countries is that American physicians and hospitals can profit handsomely from infusions. Under Medicare, a doctor’s payment is partly based on the average sales price of the prescribed drug. Critics say that gives health practitioners an incentive to pick the newer, more expensive option.

For patients who have private insurance, hospitals and doctors can mark up prices even more. Intravenous infusions, generally administered in a hospital or clinic, also generate a “facility fee.”

That creates a financial incentive to favor the most expensive infused treatments, rather than pills or simple skin injections that patients can use readily at home.

Indeed, a Kaiser Health News analysis of Medicare claims found that Injectafer and Feraheme — the two newest (and priciest) infusions on the American market — made up more than half of IV iron infusions in 2017, up from less than a third in 2014. Cheaper, older formulations — which can go for as little as a tenth the cost — have seen their share of Medicare claims fall dramatically.

Situations like these, which drive up Medicare spending, are why the Trump administration has suggested changing how Medicare pays for intravenous drugs. The administration would tie Medicare reimbursements for some IV drugs to the price paid in countries that set drug prices at a national level — prices that are partly based on an estimate of each drug’s comparative value. This plan has generated sharp backlash from conservative lawmakers and the medical and pharmaceutical industries.

Physicians argue that they simply prescribe the most effective medication for patients, regardless of what the payment system would suggest.

But the government’s own Medicare claims data, research and stories like Rothenberg’s paint a different picture.

“When there’s a financial incentive … that might move the physician away from the choice the patient would optimally make, we might be concerned,” says Aditi Sen, a health economist at Johns Hopkins Bloomberg School of Public Health, who is researching how doctors prescribe and are paid for intravenous iron treatments.

The example of iron infusions, she adds, suggests “a clear financial incentive to prescribe more expensive drugs.”

Iron-poor “tired blood” and the marketing of iron supplements

Treatments for iron deficiency are nearly 100 years old. Geritol, a decades-old dietary iron supplement for iron-poor “tired blood,” was among the first medicines widely advertised on TV in the 1950s and ’60s.

The first federally approved iron infusion didn’t hit the U.S. market until 2000, but the treatments have since surged in popularity. For one thing, infusions carry fewer side effects than do pills, which can cause constipation or nausea. And scientific advances have mitigated the risks of intravenous iron, although getting infusions still comes with inconvenience, some discomfort, the risk of infection at the IV site and, rarely, serious allergic reactions.

Five branded products now dominate the American market for IV iron, and three have generic counterparts. They have different chemical formulations but, by and large, are considered mostly medically interchangeable.

“There’s not a huge amount of difference in the efficacy of iron formulations,” Pollock says. So, for value, “the question really does come down to cost.”

Doctors are supposed to recommend infusions only if patients don’t respond to iron pills or dietary changes, Pollock says. Instead of steering patients toward “unnecessarily costly” infusions, physicians should determine the underlying cause of low iron and treat that directly.

Injectafer, which Rothenberg received, is one of the most expensive infusions, retailing for more than $1,000 a vial. And, as Rothenberg learned the hard way, hospitals can charge privately insured patients whatever they choose. Insurers then negotiate that hospital “list price” down.

An analysis of private insurance claims conducted by the Health Care Cost Institute, an independent research group funded by insurers, found that in 2017, private health plans paid $4,316 per visit, on average, if a patient received Injectafer infusions. Feraheme, the next most expensive infusion drug, cost private plans $3,087 per visit, while the other three on the market were considerably cheaper. Infed was $1,502, Venofer $825 and Ferrlecit $412, the institute found, in an analysis for Kaiser Health News.

The share of newer, pricier infusions has crept up in the private market too. In 2017, 23% of privately billed iron infusion visits involved Injectafer or Feraheme, compared with 13% in 2015, according to the institute’s data.

Nobody told Rothenberg that cheaper options might exist or warned her about her treatment’s price, she says. The hematologist who treated her did not respond directly to our repeated requests for comment.

But Alan Miller, the chief medical director of oncology for SCL Health (Saint Joseph’s umbrella organization), says the hospital stopped using Injectafer in August 2018 — a month after Rothenberg’s visit — because of the relatively high cost to patients. The hospital now turns to Venofer and Feraheme instead.

There are some other, nonmedical reasons doctors might choose the more expensive drug. Newer, more expensive drugs are more likely to be heavily marketed directly to doctors, says Stacie Dusetzina, an associate professor of health policy at Vanderbilt University.

Walid Gellad, an associate health policy professor at the University of Pittsburgh, says some formulations may be more convenient in terms of how many doses they require or how long patients have to sit for an infusion. Or a certain patient might have a distinctive profile that makes one drug an obviously better fit.

None of those explanations sit particularly well with Rothenberg, whose iron levels are now fine — but who is still paying off her $2,700 bill in installments over two years.

“If they had said, ‘This is going to cost you $3,000,’ I would have said, ‘Oh, never mind,’ ” Rothenberg now says. “It’s a big mental shift for me to say, ‘I’m supposed to weigh the costs against the health benefits. I’m not supposed to necessarily do what the doctor says.’ “

Kaiser Health News is a nonprofit, editorially independent program of the Kaiser Family Foundation and is not affiliated with Kaiser Permanente.

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