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Young Inventors Work On Secret Proteins To Thwart Antibiotic-Resistant Bacteria

Christian Choe, Zach Rosenthal, and Maria Filsinger Interrante, who call themselves Team Lyseia, strategize about experiments to test their new antibiotics.

Christian Choe, Zach Rosenthal, and Maria Filsinger Interrante, who call themselves Team Lyseia, strategize about experiments to test their new antibiotics. Linda A. Cicero/Stanford News /Courtesy of Stanford University hide caption

toggle caption Linda A. Cicero/Stanford News /Courtesy of Stanford University

Three college-age scientists think they know how to solve a huge problem facing medicine. They think they’ve found a way to overcome antibiotic resistance.

Many of the most powerful antibiotics have lost their efficacy against dangerous bacteria, so finding new antibiotics is a priority.

It’s too soon to say for sure if the young researchers are right, but if gumption and enthusiasm count for anything, they stand a fighting chance.

I met Zach Rosenthal, Christian Choe and Maria Filsinger Interrante in the lower level of the Shriram Center for Bioengineering & Chemical Engineering on the campus of Stanford University.

Filsinger Interrante just graduated from Stanford and is now in an M.D./Ph.D. program. Rosenthal and Choe are rising seniors.

Last October, Stanford launched a competition for students interested in developing solutions for big problems in health care. Not just theoretical solutions, but practical, patentable solutions that could lead to real products.

The three young scientists thought they had figured out a way to make a set of proteins that would kill antibiotic resistant bacteria.

They convinced a jury of Stanford faculty, biotech types and investors that they were onto something, and got $10,000 to develop their idea.

“And we want to see if our proteins are more effective at killing these resistant bacteria than what’s currently available,” says Filsinger Interrante.

Choe says there’s a reason industry hasn’t solved the antibiotic crisis.

Christian Choe seals a plate with E. coli bacteria that contain a ring of genetic material to produce the antibiotic protein.

Christian Choe seals a plate with E. coli bacteria that contain a ring of genetic material to produce the antibiotic protein. Linda A. Cicero/Stanford News /Courtesy of Stanford University hide caption

toggle caption Linda A. Cicero/Stanford News /Courtesy of Stanford University

“Big pharmaceutical companies aren’t that interested in pursuing antibiotics,” he says, “largely because the market size is small, and because bacteria develop resistance relatively quickly.”

But these young entrepreneurs think they’ve licked the resistance problem.

“The way that our proteins operate, that if the bacteria evolve resistance to them, actually the bacteria can no longer live anymore,” says Rosenthal. “We target something that’s essential to bacterial survival.”

Bacteria have managed to evolve a way around even the most sophisticated attempts to kill them, so I was curious to know more about how the proteins these young inventors say they’ve found worked.

“We’re not able to disclose, unfortunately,” says Filsinger Interrante. It’s their intellectual property, she explains, that they hope will attract investors. “We think that our protein has the potential to target very dangerous, multidrug-resistant bacteria.”

“I’ve been working in the field of antibiotics for the past 25 years and this is as good as any an idea as I’ve heard,” says Chaitan Khosla, a professor of chemical engineering and chemistry at Stanford. He’s also the director of a new program called ChEM-H, for Chemistry, Engineering & Medicine for Human Health, that’s supporting the students’ hunt for a new antibiotic.

But Khosla warns that many good ideas fall by the wayside, and even if the team’s proteins clear the initial hurdles, it would be years or decades before there’s a product ready to bring to market.

The trio are aware of the long odds. But for now, Rosenthal says they’re going to give it all they’ve got, even it means working late into the night, after classes and other commitments are finished.

“I lose some sleep, but I love what I’m doing, so it’s worth it,” he says.

The team reports preliminary results for their new antibiotic proteins are looking good, so all that work may be paying off.

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In Boston's 'Safe Space,' Surprising Insights Into Drug Highs

Tommy, a repeat patient at the Supportive Place for Observation and Treatment in Boston, says the room has saved lives.

Tommy, a repeat patient at the Supportive Place for Observation and Treatment in Boston, says the room has saved lives. Jesse Costa/WBUR hide caption

toggle caption Jesse Costa/WBUR

Some arrive on their own, worried about what was really in that bag of heroin. Some are carried in, slumped between two friends. Others are lifted off the sidewalk or asphalt of a nearby alley and rolled in a wheelchair to what’s known as SPOT, or the Supportive Place for Observation and Treatment, at the Boston Health Care for the Homeless Program.

Nine reclining chairs have been full most days, especially during peak midday hours. It may be the only room in the country when patients can ride out a heroin or other high under medical supervision.

“It’s a safe place to be,” says Tommy, 39, who’s been using heroin for at least 21 years. “It’s a lot safer than being out on the street, possibly walking into traffic. I might OD if I was alone out there.”

Tommy is looking for a job and housing, and we’ve agreed not to use his full name. He’s one of 180 people who’ve come to this former conference room to ride out an opioid or other drug high since SPOT opened in late April. Nurses have logged almost 900 visits. At least half of the patients have come more than once.

If the person can speak, a nurse will ask what they took before settling them in a chair, wrapping a blood pressure cuff around one arm and placing an oxygen monitor over a finger.

“The monitors are really convenient,” Dr. Jessie Gaeta, chief medical officer for BHCHP, says as she pulls the Velcro edges of a blood pressure cuff apart. “It takes a lot of the guessing out of understanding how far someone is into an overdose syndrome.”

Gaeta coined the term “overdose syndrome” to describe what’s happening to patients in this room. In many cases, she is surprised by what she’s seeing.

“A classic opiate overdose is characterized by a person who stops breathing,” Gaeta says. “They have central nervous system depression. So it’s mostly respiratory depression and respiratory arrest.”

But Gaeta says about 75 percent of her SPOT room patients show something different. “What we’re seeing in this room is more depression of heart rates and blood pressures as actually the primary — sometimes the only — abnormalities,” Gaeta says. So the patient may be unconscious with low blood pressure, but have nearly normal breathing.

Dr. Jessie Gaeta, chief medical officer of the Boston Health Care for the Homeless Program, stands at a setup where heroin users would be monitored while riding out a high.

Dr. Jessie Gaeta, chief medical officer of the Boston Health Care for the Homeless Program, stands at a setup where heroin users would be monitored while riding out a high. Jesse Costa/WBUR hide caption

toggle caption Jesse Costa/WBUR

Patients tell Gaeta they may start the day with heroin or another opioid and then, a few hours later, take pills that will enhance the high.

“People are talking about that a lot here,” Gaeta says, “about the layering of this cocktail of medications and that’s really reflected in the vital signs that we’re seeing, which is not indicative of pure opiate overdoses. I’m not sure that we’d have seen that without doing this kind of monitoring.”

Gaeta describes a typical combination or cocktail of four drugs: heroin or another opioid, clonidine (which lowers blood pressure), Klonopin (to control for anxiety) and gabapentin (used to treat seizures or nausea).

The observations are just a snapshot based on a small number of addiction patients in one area of Boston. But what Gaeta is seeing in is reflected in overdose death reports and is changing the way she and her staff respond to these patients who look like they are falling into a deep sleep. To boost sinking blood pressures, for example, they’ve brought IV fluid equipment into the room. They are going through many more tanks of oxygen than expected.

Dr. Barbara Herbert, president of the Massachusetts chapter of the American Society of Addiction Medicine, says she’s never heard anyone use the term overdose syndrome. “But I think it’s a great phrase, and I suspect it will move into more conversations. Because we created a safe space, can now think about what’s in front of us with more science than we could before we had this,” she says. “So while all of us knew this cocktail could produce overdose, few of us have ever had the opportunity of seeing people after they use and monitoring their blood pressure or their heart rate. So, this is an unexpected positive for us, coming to understand the disease better from that safe space.”

SPOT nurse April Donahue says some patients in the room appear so sedated that they don’t respond when she speaks loudly in their ear or raps on their sternum. But, she says, some of those people, “have rock solid vital signs, better than mine.” So, she says, “What you see subjectively looking at someone and what their vital signs are, don’t always match up.”

If Donahue weren’t monitoring the vital signs, she says she’d be racing to inject naloxone, the drug that reverses the effects of opioids. But Donahue found she can sometimes avoid using naloxone, which is very harsh on the body, by giving patients oxygen or fluids to keep patients alive.

The facility is going through many more tanks of oxygen than expected because of what medical staff are learning about what's going on in the body while people are high.

The facility is going through many more tanks of oxygen than expected because of what medical staff are learning about what’s going on in the body while people are high. Jesse Costa/WBUR hide caption

toggle caption Jesse Costa/WBUR

The nurses speak to each patient about addiction treatment. Getting patients into treatment is their top priority after keeping people safe while high.

“I think what’s struck me the most is the gratitude — just to get out of that environment, even for a little while, to get off the street and be cared for,” Donahue says. “I mean, so many of our participants don’t have anyone who’s caring for them.”

It’s one reason Tommy is becoming a repeat client. “This is just a great start,” Tommy says. “I think it will slow down a lot of overdoses and could save a lot of lives. It will save a lot of lives in the long run.”

And Tommy knows. He went into respiratory failure a few weeks ago while at SPOT and was brought back with naloxone.

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

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Trans And Adopted: Exploring Teen Identity

Nathan Tasker is transgender and adopted. He was surprised and delighted to meet other adopted transgender children at his camp in Maine.

Nathan Tasker is transgender and adopted. He was surprised and delighted to meet other adopted transgender children at his camp in Maine. Jesse Costa/WBUR hide caption

toggle caption Jesse Costa/WBUR

Two summers ago, when Nathan Tasker was 13, his mom drove him from Melrose, Mass., to Maine, where he would attend his first session at a transgender camp. Nathan remembers feeling happy for the first time in years.

“I finally, finally finally was not alone,” says Nathan, a young man with dark, sparkling eyes and a wise smile.

But even at this camp, Nathan expected to be different. He’s transgender — and adopted.

“I thought I was just a packaged deal, like, this only happens to one kid in every place in the world,” he says. But then, as fellow campers told their stories, Nathan realized he was not all that different. “I was like, ‘You know what? There are a lot of adopted kids who are trans.’ And that’s pretty amazing.”

Doctors at Boston Children’s Hospital’s Gender Management Service clinic, where Nathan is a patient, began making the same connection a few years ago. They combed through patient records and found that 8.2 percent of the 184 young people seen in the clinic between 2007 and 2015 were raised in adoptive families. Overall, only 2.3 percent of children living in Massachusetts were adopted.

“Before I started seeing transgender kids, it would not have occurred to me that we might see more adopted kids,” says Dr. Daniel Shumer, a pediatric endocrinologist who treated transgender kids at the GEMS clinic for three years before moving to Ann Arbor, Michigan, to work in a similar clinic. Shumer and three co-authors recently presented their adoption data at a conference and have submitted it for publication.

Nathan and his doctors aren’t the only members of the transgender community who’ve noticed this phenomenon.

“People have been talking about this for a long time,” says Dr. Johanna Olson-Kennedy, medical director of the Center for Transyouth Health and Development at Children’s Hospital in Los Angeles, the largest such clinic in the country. Olson-Kennedy says she often hears colleagues around the country say, “we have a lot of kids who are adopted in the gender clinics.”

And Diane Ehrensaft, a psychologist and author of the book, Gender Born, Gender Made: Raising Healthy Gender-Nonconforming Children, says in an email, “I am seeing the same thing in my work as a gender specialist in the San Francisco Bay Area.”

Looking For Explanations

No one seems to know why. But there is some agreement about possible explanations.

First, it may be that there’s a higher percentage of trans adopted children who get health care, rather than a higher rate of trans kids who are adopted.

“Adopted people of all ages, especially children, are disproportionately represented in clinical settings,” says Adam Pertman, president of the National Center on Adoption and Permanency, and author of the book Adoption Nation. “The majority of adoptions today are from foster care. Then add to those the children adopted from institutions abroad and you have a population who suffered early trauma — so of course they are disproportionately represented in clinical settings.”

Shumer suggests another factor when it comes to families with adopted trans children: “Perhaps parents who adopt kids are more open to differences in gender identity — may have less shame in the fact that their child may be transgender,” he says, “[and] may be more likely to present to clinics for help.”

That idea resonates with Olson-Kennedy,

“When parents have biological children [who] are transgender,” she says, “what happens is a blame game, like, ‘Whose fault is it?’ I’ve heard many families say, ‘Well, you know, my husband has two gay cousins’ or, ‘My wife has a trans aunt.’ “

Olson-Kennedy says adoptive parents seem to “let go of the ‘this is my fault’ piece.”

But maybe there’s something else about growing up adopted — about coming to terms with that experience — that explains why transgender clinics are seeing more such children.

“Adopted children who are aware of their adopted status also have an easier time being ‘other’ than their parents, and therefore find greater ease in being forthcoming in expressing their true gender selves,” says Ehrensaft.

Shumer says he wonders whether children who grow up knowing they are adopted might develop their identities in ways that make them more open to rethinking gender.

“As adoptive kids are becoming teenagers,” Shumer says, “they may more actively consider their gender identity in the context of their overall identity [than kids who aren’t adopted]. This might help them identify that they have a gender difference more frequently than kids that aren’t adopted, that aren’t going through as rigorous an identity-formation thought process.”

Pertman says that’s a new, but reasonable idea.

“Identity in adoption is a complex issue,” Pertman says. “I mean it’s complex for everybody, but there’s a whole other layer for adopted people that sort of triggers, in many of them, a deeper look within themselves about identity. And maybe this is part of what they find.”

More Theories — And The Need For More Study

Roz Keith with her son Hunter, who was adopted at birth. Hunter, now 17, began his transition from female to male at age 14.

Roz Keith with her son Hunter, who was adopted at birth. Hunter, now 17, began his transition from female to male at age 14. Courtesy of the Keiths hide caption

toggle caption Courtesy of the Keiths

Maybe, but that reasoning doesn’t ring true to Hunter Keith, a 17-year-old trans male who was adopted at birth – at least not in terms of his own experience. Hunter says the gender transition he started in the eighth grade did not coincide with questions about his adoption.

“I’ve been part of my family my whole life,” Hunter says. “I’ve never had that feeling of not belonging. It’s not something I ever questioned.”

Hunter’s mother Roz, who lives with Hunter and her husband and daughter in the metropolitan Detroit area, would like to see more research about the neurological roots of gender identity. She believes there may be all kinds of connections that no one understands yet.

Here’s one possibility Roz Keith has discussed with friends, based on studies that show greater rates of autism and learning disorders among transgender kids than among the general population: Could the kids be inheriting those conditions from their birth parents, and could those conditions be one reason the mothers place their children for adoption?

“There’s this incidence, then, of children who are adopted who have a genetic history coming from families where there are learning issues — ADD, ADHD,” Roz Keith suggests. “It does seem that those things overlap and correspond in greater numbers [in the transgender population].”

Some members of the transgender community say all these theories deserve more attention, but for now, they don’t see any connection between being trans and being adopted.

“I think it’s a stretch, frankly,” says Jamison Green, the immediate past president of the World Professional Association for Transgender Health. “People, in trying to understand what ‘transness’ is and how it manifests, and why some of us are this way, will elicit all kinds of conjectures.”

Nonetheless, Green, who is adopted, says he would like to see more research in this area.

The speculation “speaks to how little we actually know,” Green says. “There’s much more to be learned about transness, about gender, about gender identity development in all people.”

With so little research, it’s not clear if or how these findings should affect care for children at transgender clinics. Shumer says it may help parents contemplating adoption to learn more about gender identity as a spectrum. Doctors, nurses and counselors may want to set up support groups for adopted children, to help kids who might find such groups useful explore any and all sorts of issues as they arise.

Judy Tasker, Nathan’s mom, says she’s sure that being transgender and adopted makes life more complicated for her son.

“It’s the transgender piece that throws everyone off,” she says, “but, really, it’s his issues from being in a poor foster home for the first 15 months of his life that really make him struggle at school, struggle with anger. The trans piece is this little piece, but it over-complicates what therapists see, what schools see, and they is fixate on it.”

Nathan says he’s always assumed that being adopted and being trans were two separate experiences. But, “maybe somehow they’re connected,” he says. “Maybe adopted kids feel some dimensions that non-adopted kids can’t feel, because they haven’t been in that situation.”

There are a lot of maybes in the expanding world of gender identity.

This story is part of NPR’s reporting partnership with NPR, WBUR and Kaiser Health News.

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Zika Cases Surge In Puerto Rico As Mosquitoes Flourish

A health department pickup truck sprays insecticide against mosquitoes in a San Juan, Puerto Rico, neighborhood in January.

A health department pickup truck sprays insecticide against mosquitoes in a San Juan, Puerto Rico, neighborhood in January. Alvin Baez/Reuters hide caption

toggle caption Alvin Baez/Reuters

The Zika outbreak in Puerto Rico is expanding rapidly.

Recently, the island has been reporting more than a thousand new cases of Zika each week.

The situation is expected to get worse before it gets better.

“We are right now probably in the month or 6 weeks of peak transmission,” says Tyler Sharp the lead epidemiologist for the Centers for Disease Control and Prevention’s Zika operation in Puerto Rico.

Previous outbreaks of dengue fever and chikungunya, which are transmitted by the same mosquito as Zika, Aedes aegypti, suggest the hot, wet summer months in Puerto Rico now are just right for Zika to flourish, Sharp says.

“The more rains you get, the more mosquitoes you get. The more mosquitoes, the higher the rate of transmission,” he says. “And also the mosquitoes like warmer temperatures and are able to replicate the virus more efficiently at at least slightly higher temperatures.”

He calls August in Puerto Rico the “Goldilocks zone” for Zika virus replication.

The island has already had more than 8,000 confirmed cases of Zika. The CDC predicts that by the end of the year, 20 percent to 25 percent of the roughly 3.5 million people on the island could be infected with the virus.

Many of those people would have mild symptoms or even none at all. But such a widespread outbreak means that thousands of pregnant women could be exposed and their babies might be at risk of having severe Zika-related birth defects.

And the tools to fight Zika are limited.

Public health officials weren’t able to stop previous outbreaks of dengue and chikungunya while they were in progress, Sharp notes. Zika is even more complicated because it’s transmitted by both mosquitoes and sexually activity.

“So we have things that we think can be effective,” he says. “We know that individuals can take approaches to reduce their risk of infection. But in terms of breaking the epidemic, or stopping transmission, there’s nothing that we know about that’s been scientifically evidenced to show that this will work, that this is the solution.”

There’s no silver bullet.

Even the insecticides that are being used to spray homes or fog some high-risk neighborhoods have been losing their punch. Mosquitoes have been developing resistance to them.

“What we’ve seen in Puerto Rico, as we see in many regions, is that there is a wide variety of resistance not to all insecticides but to many of them,” Sharp notes. “And that [resistance] can change over time depending on what’s being used in the communities, in the population.”

A plan for aerial spraying of an insecticide called Naled caused an uproar here. San Juan’s mayor called the plan “environmental terror” and late last month the governor blocked the proposal. Naled is the same chemical that’s being sprayed from planes over parts of Miami to combat Aedes aegypti mosquitoes there.

Sharp says the efforts against Zika in Puerto Rico rely primarily on people. People protecting themselves from mosquito bites and people attacking mosquito breeding grounds. The only good news is that if previous outbreaks of dengue and chikungunya are any guide, the high levels of Zika transmission here should start to fall in September or October.

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Medical Studies Involving Children Often Go Unpublished

Even when results from studies involving children are available, they frequently aren't published in medical journals.

Even when results from studies involving children are available, they frequently aren’t published in medical journals. Cultura RM Exclusive/Getty Images hide caption

toggle caption Cultura RM Exclusive/Getty Images

Many medical studies involving children never end up being put to use because scientists frequently don’t publish the results of their work, according to an analysis published online Thursday.

The findings raise both scientific and ethical issues regarding research on this vulnerable population.

Previous studies have documented that about a third of all clinical trials conducted in the United States end up as largely wasted effort, because the scientists doing that work don’t take the effort to publish and share their results with the scientific community.

Pediatricians Florence Bourgeois and Natalie Pica at Harvard Medical School and Boston Children’s Hospital wondered whether researchers focusing on children took this obligation to publish more seriously. As they report in the journal Pediatrics, the experience with childhood research is just about as bad.

The report, reviewing clinical trials started in 2008-10, finds that 19 percent of the studies that recruited children didn’t run to completion. That was often because researchers weren’t able to recruit as many volunteers as they needed to run the experiments. And of the 455 trials that were completed, the results from 30 percent weren’t published.

“That means all the participants who are enrolled in these studies aren’t able to contribute in a meaningful way to our clinical information and knowledge,” Bourgeois said. One reason may be that scientists didn’t get the results they were hoping for. It’s less rewarding to publish results that report a failed trial, but Bourgeois says it’s just as important for science to do so.

“The harm is we end up with scientific literature that only shows all the things that do work,” she said. “It may falsely appear that certain interventions do work. So our literature may become biased and may not be representative of the true efficacy or safety of an intervention.”

One result of that is that other scientists may try to run the same failed experiment, and end up down the same blind alley as scientists who had tried it before. “That leads to a lot of inefficiency and waste,” she said.

Parents volunteer their children for these studies with an understanding that their efforts are contributing to the advancement of medical science.

Vincent del Gaizo, the parent of a child with a hard-to-treat form of juvenile arthritis, is passionate about that commitment. He’s taken a very active role in managing his son’s disease. When his son was about 9, he suffered from a flare-up so acute that he couldn’t bend his right elbow at all. Del Gaizo learned of a clinical trial of an experimental drug near his home, in Hackensack, N.J., and decided to take the risk that the drug would help.

Del Gaizo paid close attention to how the drug affected his son. But he also cared about how the work benefited the community more broadly. “It is hugely important to me as a patient-family,” for scientists to publish their results and explain them clearly, he said. It’s important “not only for the patient-families but also for the clinicians,” del Gaizo said. Doctors need to know what works — and what doesn’t work — to guide their treatment of children who aren’t participating in studies.

The results of the clinical trial his son participated in were eventually published: The drug worked better than an injection of plain salt water but hasn’t ended up on the market to treat this condition. But del Gaizo says he talks to many other families, as a patient advocate, and finds they frequently don’t learn the results of the experiments involving their children. “Just having information available to you … would make it so patient-families like us can sleep at night with the decisions we have to make on a daily basis.”

The shortcomings of pediatric research come as no surprise to Dr. Joseph Ross at the Yale School of Public Health. He arrived at similar results when he analyzed clinical trials that include adults. Scientists have many explanations for why they don’t publish their results. “Maybe the results don’t show what the investigator wants and they move on,” Ross said. “But more often people are busy and people don’t focus enough time and attention on getting those results out.”

Ross considers this an ethical lapse. “When you do a clinical study and you’re asking patients to participate and subject themselves to a risk, in order to inform science and generate knowledge, you have an ethical obligation to disseminate those results to the wider scientific community,” he said.

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Medicaid Safety Net Stretched To Pay For Seniors' Long-Term Care

Mel Nickerson moved his wife, Donna, to the Turlock Rehabilitation and Nursing Center in April. She has Alzheimer's disease, and he realized he could no longer care for her safely at home.

Mel Nickerson moved his wife, Donna, to the Turlock Rehabilitation and Nursing Center in April. She has Alzheimer’s disease, and he realized he could no longer care for her safely at home. Courtesy of the Nickerson family/Kaiser Health News hide caption

toggle caption Courtesy of the Nickerson family/Kaiser Health News

Donna Nickerson spent her last working years as the activity and social services director at a Turlock, Calif., nursing home.

But when she developed Alzheimer’s disease and needed that kind of care herself, she and her husband couldn’t afford it: A bed at a nearby home cost several thousand dollars a month.

“I’m not a wealthy man,” said Nickerson’s husband Mel, a retired California State University-Stanislaus professor. “There’s no way I could pay for that.”

About half of all people turning 65 today will need daily help as they age, either at home or in nursing homes. Such long-term care will cost an average of $91,100 for men and double that for women, because they live longer.

In California and across the U.S., many residents can’t afford that, so they turn to Medicaid, the nation’s public health insurance program for low-income people. As a result, Medicaid has become the safety net for millions of people who find themselves unable to pay for nursing home beds or in-home caregivers. This includes middle-class Americans, who often must spend down or transfer their assets to qualify for Medicaid coverage.

Medicaid, known as Medi-Cal in California, was never intended to cover long-term care for everyone. Now it pays for nearly 40 percent of the nation’s long-term care expenses, and the share is growing. As baby boomers age, federal Medicaid spending on long-term care is expected to rise significantly — by nearly 50 percent by 2026.

The pressure will only intensify as people age, so both state and federal officials are scrambling to control spending.

State Medicaid directors are closely watching as long-term care spending takes up larger shares of their budgets and squeezes out other programs, said Matt Salo, executive director of the National Association of Medicaid Directors.

“There isn’t a day that goes by they are not thinking about long-term care,” Salo said. “It makes up a huge portion of the entire budget and it’s growing … It is absolutely not sustainable.”

In the meantime, people who need long-term care are depleting their savings or transferring their assets to others so they can qualify for Medicaid. Long-term care insurance rates are rising, and many seniors find they can no longer afford policies they purchased long ago.

In California, seniors typically can qualify for Medi-Cal if their yearly incomes are under $16,395. To get long-term care through Medi-Cal, they also must show a need for assistance with certain “activities of daily living,” such as dressing or bathing. Incomes can be higher if seniors can demonstrate medical need and have spent much of their savings, with some exemptions for homes and other assets.

About 21 percent of the state’s over-65 population is enrolled in Medi-Cal, according to the state Department of Health Care Services. Medi-Cal paid for long-term care for an estimated 716,000 people who are aged, blind or disabled in 2013, the most recent data available. In 2014, nearly a quarter of Medi-Cal’s dollars went to pay for long-term care — about $14.7 billion, according to the California Health Care Foundation.

Herb Schwartz, a former computer program analyst, and his wife rely on Medi-Cal to pay for their care at the Los Angeles Jewish Home in Reseda, Calif. They moved there after he suffered a fall.

Herb Schwartz, a former computer program analyst, and his wife rely on Medi-Cal to pay for their care at the Los Angeles Jewish Home in Reseda, Calif. They moved there after he suffered a fall. Heidi de Marco/Kaiser Health News hide caption

toggle caption Heidi de Marco/Kaiser Health News

When Nickerson, 85, realized a nursing home bed was too expensive, he sought guidance from an attorney, who helped him take his wife’s name off their home and take their assets out of her name. Then Nickerson applied for her to receive Medi-Cal, and he helped her move into a Turlock nursing home near the one where she once worked.

Now, Nickerson said he pays about $1,700 a month from her Social Security, and Medi-Cal picks up the rest of the tab, he said. Nickerson said his wife, now 84, is getting the care she needs, and he can’t imagine having her anywhere else.

“It is absolutely the best place for her,” he said. “She needs help 24 hours a day.”

If more middle-class Californians like the Nickersons seek help from Medi-Cal, however, the program could be overwhelmed and unable to help the people who need it most, said Joanne Handy, CEO of LeadingAge California, an advocacy group that represents nonprofit nursing homes.

“The pressure on the state Medicaid budget, not only here in California but across the country, is just going up, up, up,” she said. “If you put on top of that more and more what we call middle-income Californians spending down and then going onto Medi-Cal, it is just a crazy policy.”

Salo, of the National Association of Medicaid Directors, said people shouldn’t have to impoverish themselves to get financial help paying for long-term care, but states cannot afford to cover the care for everyone who needs it and are trying to come up with ways to control spending.

More than a dozen states, including California, are contracting with managed care companies to provide both medical care and long-term care services to their Medicaid beneficiaries. These services can range from nursing home care to at-home assistance with bathing, chores and transportation to medical appointments.

States are hoping that contracting with managed care plans will help save money, improve care and better coordinate services for seniors. But some health advocates say that managed care organizations — traditionally geared towards providing only medical care — aren’t necessarily prepared to offer other forms of care such as bathing or cooking and could end up restricting services or providers to save money.

California recoups some of what it spends on nursing homes and other services by collecting what it is owed from people’s estates.

“We can’t do both — serve as a payer of last resort and let people keep their assets,” said Jennifer Kent, head of the state’s Department of Health Care Services.

The state has been holding informational hearings in Sacramento this year to brainstorm about other ways to grapple with long-term care costs in California. “It all falls to Medicaid, and that is problematic,” said state Sen. Carol Liu (D-La Cañada Flintridge).

Several organizations, including the SCAN Foundation, the Urban Institute and the Bipartisan Policy Center, also have been working together to come up with possible solutions. These could include new insurance options that would take some burden off Medicaid.

About 1.4 million people are in nursing homes nationwide, and about 62 percent of those beds are paid for by Medicaid.

The percentage is even higher at the Los Angeles Jewish Home in the San Fernando Valley, where about 85 percent of the beds are paid for with Medi-Cal dollars. Some of the residents “exhaust every penny they have” to be able to afford the care, said CEO Molly Forrest.

Sitting in a courtyard at the nursing home, Josephine Rudolph, 99, said she gets help with dressing and bathing. Rudolph, who still loves to read, said Medi-Cal has paid for her to live at the home since 2005. Otherwise, she said, she couldn’t afford it.

Josephine Rudolph, 99, says she couldn't afford to live at the Joyce Eisenberg Keefer Medical Center Skilled Nursing Facility in Reseda, Calif., without Medi-Cal assistance.

Josephine Rudolph, 99, says she couldn’t afford to live at the Joyce Eisenberg Keefer Medical Center Skilled Nursing Facility in Reseda, Calif., without Medi-Cal assistance. Heidi de Marco/Kaiser Health News hide caption

toggle caption Heidi de Marco/Kaiser Health News

Herb and Judie Schwartz, both in their 80s, also rely on Medi-Cal to live at the Jewish Home. Family photographs cover their walls. An oxygen tank and a walker sits in a corner. Just above the bed is an emergency tab that notifies the nurse’s station if the couple needs help.

They moved to the Jewish Home about four years ago after Herb Schwartz, a former computer program analyst, had a fall and it was no longer safe for the couple to live at home.

“I don’t know where we would have been without Medi-Cal,” said Judie Schwartz, a retired teacher. “We would have probably ended up with one of our kids. I love them but I can’t imagine having to live with them.”

This story was produced by Kaiser Health News, which publishes California Healthline, a service of the California Health Care Foundation.

Blue Shield of California Foundation helps fund KHN coverage in California, and The SCAN Foundation supports KHN’s coverage of aging and long-term care issues.

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FDA-Approved Knock-Offs Of Biotech Drugs Could Safely Save Big Bucks

In 2015, the Sandoz unit of drugmaker Novartis won Food and Drug Administration approval of a drug called Zarxio, which is similar to Amgen's Neupogen, a medicine that boosts the production of white blood cells.

In 2015, the Sandoz unit of drugmaker Novartis won Food and Drug Administration approval of a drug called Zarxio, which is similar to Amgen’s Neupogen, a medicine that boosts the production of white blood cells. Sebastien Bozon/AFP/Getty Images hide caption

toggle caption Sebastien Bozon/AFP/Getty Images

Copycat versions of biotech drugs work just as well as the originals and cost a lot less, according to an analysis of studies of the medicines.

The analysis by researchers at Johns Hopkins Bloomberg School of Public Health finds that so-called biosimilars — medications that are meant to mimic, and compete with, complex and expensive biotech drugs — perform as well as the brand-name versions.

The researchers looked at data from 19 studies of biosimilar drugs that treat rheumatoid arthritis, inflammatory bowel disease and psoriasis, and found that they were comparable to the originals and would cost less. The findings will appear in the Aug. 2 issue of Annals of Internal Medicine.

“Hopefully, this will encourage the brisk adoption of these products,” said Caleb Alexander, the study’s lead researcher, in a release. “There is no question that greater competition in this market will benefit patients, prescribers and society in the long run.”

Biologics include proteins and antibodies that are typically made by living organisms. They’re more difficult to produce than medications made from mixtures of chemicals. It’s also next to impossible to make an exact copy of a biological product, which is why the drugs are often referred to as biosimilars.

There was a provision in the Affordable Care Act meant to encourage development and approval of biosimilars, but progress has been slow. The Food and Drug Administration has approved only two such drugs since the law passed in 2010.

Zarxio, the first biosimilar drug approved in the U.S., is expected to save about $6 billion a year because it costs less than Amgen’s Neupogen, the brand-name product. The medications help boost the immune systems of chemotherapy patients by increasing production of white blood cells.

In April, the FDA approved a second drug that is similar to Johnson & Johnson’s Remicade to treat colitis and Crohn’s disease. That drug, called Inflectra, is one member of the class of biosimilars that the researchers at Johns Hopkins examined. There are several other biosimilar drugs in this class available in Canada, Asia and Europe.

The Johns Hopkins study is important because drugmakers have raised questions about biosimilars since they aren’t identical to the drug they’re supposed to mimic. Many are fighting approval of the drugs, and some argue that they should not be substituted for a brand-name drug without a patient’s consent.

But IMS Health Informatics says there are 50 biosimilars under development. All told, they could save U.S. and European health systems as much at $110 billion over the next five years, the company estimates.

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The Costs Of The Pulse Nightclub Shooting

A makeshift memorial continues to grow outside the Pulse nightclub, the day before the one month anniversary of a mass shooting, Monday, July 11, 2016, in Orlando, Fla.

A makeshift memorial continues to grow outside the Pulse nightclub, the day before the one month anniversary of a mass shooting, Monday, July 11, 2016, in Orlando, Fla. John Raoux/AP hide caption

toggle caption John Raoux/AP

Mario Perez lives in Miami, but he was in Orlando for a housewarming party Saturday, June 11. After the party, the 34-year-old went to Pulse for Latin night.

At 2 a.m., he heard gunshots. Loud. He knew it was real.

“And the minute he started shooting, I got hit from the side, I got grazed by a bullet,” Perez says. “My first instinct was to fall to the floor, that’s what you’re taught to do.”

He heard gunshot after gunshot after gunshot. It was too many to count. But then there was a brief break in the firing, and Perez ran out the back of the club. He hid inside the kitchen of a nearby 7-Eleven until police and paramedics showed up. He was taken to Orlando Regional Medical Center, and was at the emergency room from 3 a.m. until 8 a.m.

The gunshot wound on his side is purple and swollen, and he has nerve damage from the bullet fragment. He cut his elbow from glass on the floor of the nightclub and received six stitches. Perez doesn’t know how much bills coming from specialists, X-rays or other tests may cost him. But his bill from Orlando Regional Medical Center’s emergency department: $20,000.

“$20,000,” Perez said. “That’s the quote, that’s what they told me.”

Perez has no health insurance. He’s working for a temp agency right now and doesn’t have the money to be seen by a doctor for follow-up care in Miami.

So just how much will the Pulse nightclub shooting cost all of the victims? It’s a difficult, if not impossible question to answer right now. At last check, there were 56 people brought to the hospital, including three patients who spent two weeks in the intensive care unit, and one patient is still in the hospital in critical condition.

Embry Howell is a senior fellow at the Urban Institute, a think tank in Washington, D.C. She studied the average cost of a gunshot victim in 2010. Using that benchmark, she estimates the hospital costs from the Pulse shooting will be about $1 million.

“And I would imagine that would be an underestimate,” Howell said.

Howell said many of the victims may be in the same boat as Mario Perez – uninsured.

“They’re young, primarily Latino and living in Florida,” she says, a state that has not expanded Medicaid to its population.

“My guess would be you have a high rate of uninsured,” she concludes.

Ted Miller is a researcher with the Pacific Institute for Research and Evaluation. He has been studying the cost of firearm injuries for more than two decades. He used the 2011 shooting of former Congresswoman Gabby Giffords and 18 others in Arizona to make what he calls a conservative estimate.

That estimate: $4 to $7 million dollars in medical costs and mental health costs for victims and survivors of people who died. That’s the lifetime medical costs for the survivors, the costs of surgery, the cost of rehab. But it doesn’t count the long-term costs for those who are severely injured.

“They said some time ago that there were six people in ICU who would have long time, serious consequences,” Miller said. “And my guess is most of those folks will have traumatic brain injuries that will have continuing lifetime care.”

Miller also makes a broader estimate beyond just the medical costs. That includes the cost of the police response, the cost to employers – and the dollar value of those 49 lost lives.

“I estimate that the total cost of the Orlando shooting is around $385 to $390 million,” Miller says. “To put that in context, on that same day, the cost of other gunshot wounds in the U.S. was probably about $600 million. So about one and a half times the cost of the Orlando incident. That tells you that there are a lot of people killed and injured by firearms every day in this country,” he says. And, he explains, “Suicide deaths account for the largest share of gun violence costs.”

What’s not included in Miller’s $385 million estimate is the cost of mental health counseling for people who were in the club but not physically shot – and friends and family of those there. And then there’s the cost of fear: People being afraid to go out to a dance club, or maybe skipping a visit to the theme parks.

Orlando Regional received 44 of the shooting victims. A hospital spokeswoman says some patients have insurance coverage, some don’t. The hospital is going to look for payment sources from the community or the state, such as victim funds that are raising money across the country. But she says the hospital expects unreimbursed costs of more than $5 million.

Pulse shooting victim Mario Perez is calculating his personal costs. He’s worried he’s going to lose his job. He’s anxious knowing millions of dollars have been raised to help victims, but his bills are arriving now. He started his own GoFundMe campaign but it’s only raised about $600.

“As long as it gets covered, I’m going to be fine,” Perez said. “If they don’t cover it, I’m stuck in a hole. I don’t know what I’m going to be able to do if they don’t assist me.”

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

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Campaign For Universal Health Care In Colorado Seeks Bernie Sanders' Help

"I believe that health care is a right, not a privilege," Sen. Bernie Sanders told Denver supporters in February. ColoradoCare supporters hope to leverage his charisma for a win on their state amendment.

“I believe that health care is a right, not a privilege,” Sen. Bernie Sanders told Denver supporters in February. ColoradoCare supporters hope to leverage his charisma for a win on their state amendment. Marc Piscotty/Getty Images hide caption

toggle caption Marc Piscotty/Getty Images

Backers of ColoradoCare — the state ballot initiative that would establish universal health care in Colorado — think they have the perfect job for former presidential candidate Sen. Bernie Sanders.

With the Democratic National Convention in Philadelphia behind him, Sanders “comes to Colorado and campaigns for single-payer — and we win,” says T.R. Reid, one of the architects of ColoradoCare. The initiative aims to provide every resident of Colorado with affordable health insurance. Sanders made universal coverage one of the cornerstones of his presidential bid.

The proposal comes with a $38 billion annual price tag — to be paid by a tax on workers and businesses. The program would eliminate the need for insurance premiums and deductibles, and proponents claim it would save the state and individuals a lot of money.

Reid says the backers of ColoradoCare have pitched Sanders’ team, hoping he will campaign on behalf of the measure that will come before voters in November.

Sanders has already championed the issue in the state — he pushed for a single-payer system during his Democratic primary campaign in Colorado. It was one of his key health care positions, and it got thousands of his supporters cheering at an event in Denver in February.

“I believe that health care is a right, not privilege,” Sanders told cheering crowds.

He also beat that drum during a TV appearance with MSNBC’s Rachel Maddow in May. Sanders pointed out that Canada started what would eventually become its nationwide system of universal health care by persuading lawmakers in each province — one province at a time.

“So if you’re asking me, do I think if a major state — whether it’s Colorado or California or whatever — goes forward and it works well, [will] other states say ‘Hey, you know, I got a brother over there in Colorado and he’s getting health care, great health care and it’s less expensive than the current system,’ ” Sanders said. “Yeah, I think that is one possibility.”

The whole concept of ColoradoCare — or Amendment 69, as it will appear on the ballot — appeals to Andrew Kleiman, a 35-year-old Sanders supporter from Grand Junction.

“I think we’re just at such a tipping point,” Kleiman says. “The momentum of Bernie’s campaign carried over into something like this would be a perfect fit and pretty necessary.”

Kleiman says if Sanders actively backed the proposal in Colorado it would help motivate millennials like him to vote.

Reid agrees. “The last poll showed 60 percent of millennials support ColoradoCare,” he says. “Those are Bernie people and if he can turn them out to vote, we win.”

But a coalition of opponents, including conservatives, insurance firms and business groups, has come out against the initiative, which is expected to draw big money from both sides.

“I don’t think the economics of it work out,” says Nina Anderson, a small business owner in Grand Junction. She says the proposed program would be too expensive for small businesses and employees.

Colorado has been on the cutting edge of some other big policy changes, like legalizing recreational pot. Anderson says she’s not ready for the state to take the lead on a huge government-run health care system, and does not think Sanders should jump in.

“That is the scary part, I think, about being in Colorado and being on the forefront of anything that is attempting to move to socialized care,” Anderson says. “You do get everybody with outside interests coming in and playing in your sandbox.”

Cody Belzley, who served as senior health policy analyst to former Democratic Gov. Bill Ritter, opposes the proposal and says she’s not sure what difference Sanders would make — if he did come.

“It’s such a strange political year,” Belzley says. “I think it’s really hard to know what’s going to impact Colorado voters or the outcome of Amendment 69. I think this is a decision to be made by Colorado voters, based on what’s going to be best for them and their families.”

Colorado voters haven’t passed a general tax increase in years. Obamacare cut the state’s uninsured rate in half, but many residents still struggle with high premiums and deductibles.

Belzley, who works for a group opposing the amendment, Coloradans for Coloradans, urges voters to look at the details. “I think when folks look at that,” she says, “they come to understand this is just too risky a proposal.”

Sanders’ presence in Colorado could motivate voters on both sides, says Seth Masket, a political science professor at the University of Denver.

“That’s kind of the mixed message of initiatives,” Masket says. “They can really draw out both sides, depending on how passionate people are on the subject. The key for supporters of this initiative would be to translate passion for Sanders into passion for this initiative. Sanders is probably the best equipped to actually make that case.”

A representative from the Sanders campaign, Michael Briggs, says the topic is something that “interests Bernie very much. We don’t have a trip scheduled yet, but he has been keeping a close eye on this.”

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

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Doctors Need A New Skill Set For This Opioid Abuse Treatment

Dr. Michael Frost demonstrates use of Probuphine, an implant that dispenses medication to treat opioid addiction.

Dr. Michael Frost demonstrates use of Probuphine, an implant that dispenses medication to treat opioid addiction. Karen Shakerdge/WXXI hide caption

toggle caption Karen Shakerdge/WXXI

In a big hotel conference room near New York’s Times Square, six doctors huddle around a greasy piece of raw pork. They watch as addiction medicine specialist Michael Frost delicately marks the meat, incises it and implants four match-sized rods.

“If you can do it well on the pork, you can easily do it on the person,” Frost tells his audience.

Frost consults for Braeburn Pharmaceuticals, the company behind the newly FDA-approved treatment Probuphine, and is teaching doctors how to use it. They are learning to implant it in pork so they can later implant it in patients’ arms.

Although addiction specialists welcome Probuphine, which delivers a constant dose of the drug buprenorphine over six months, at this early stage it’s complicated for physicians to add it to their repertoire. Because physicians who treat addiction don’t necessarily have experience with surgery or access to sterile spaces, some are having to learn a new skill and develop new systems.

Probuphine is unlike any other addiction treatment on the market. It promises to be life-changing for people already stable in recovery using medication-assisted treatment, who would otherwise need a daily dose of a similar drug to stay free of cravings and withdrawal pains.

Patients using Probuphine were 14 percent more likely to stay opioid-free compared to those using a daily sublingual version of buprenophine, according to a study published this month in JAMA, the Journal of the American Medical Association. Patients in this study had been stable on buprenorphine for an average of three and a half years beforehand. The authors do caution against generalizing these findings. Most participants, they note, were white, employed, had at least a high school education and were previously addicted to prescription opioids rather than heroin.

“They don’t have to be dependent on taking something every day. It takes the choice out of that,” says Ella Leers, a doctor who treats substance abuse at the Carnegie Hill Institute in Manhattan.

The FDA approved Probuphine under the condition that physicians are trained and tested before implanting or even prescribing the treatment. There are three kinds of certification: implanter, prescriber or both. If doctors can’t perform the implanting themselves, they need to coordinate with another doctor who can.

To date, over 1,800 healthcare practitioners have been certified — 27 have implanted dozens of patients, according to a representative for Braeburn Pharmaceuticals, Probuphine’s maker.

Gloria Baciewicz, chief of addiction psychiatry at the University of Rochester Medical Center, says using the new treatment will take some adjustments. But, she adds, there need to be as many effective treatments as possible for opioid use disorder.

“Now with Probuphine, we have to take it up to a whole different level because we have to have either agreements with implanters or a room where we can implant. We have to get the equipment. There will be a lot more to do,” she says. Her team was already planning on moving to another space, which will have the facilities they need to conduct minor surgery.

Prescribing Probuphine may also call for a new approach to the counseling and behavioral therapy that is typically recommended for those on medication-assisted treatment.

“If you’re implanting something that can be there for six months, you want to make sure that the patients are still coming in to get the other types of support that they can use because of their addiction issues,” says Leers.

There are also questions about insurance coverage. Billing codes are still being established. For now, doctors need to buy the Probuphine kits that run almost $5,000 themselves, and then bill patients or insurance companies.

Braeburn has offered to help physicians verify if an insurance plan would reimburse any of the cost. According to the company, Blue Cross Blue Shield and United Healthcare approved reimbursement for a few patients who have implants. Medicare, Medicaid and the VA have Probuphine in their formulary and are required to cover it if deemed medically necessary.

Despite having to get certified and the other hurdles, many doctors welcome the treatment option. Opioid drug overdoses have reached epidemic levels — roughly 78 Americans die every day from opioid overdose, according to the Center for Disease Control and Prevention.

So it’s good to have a another way to deliver medication-assisted treatment, says Richard Rosenthal, medical director of addiction psychiatry for the Mount Sinai Health System. Rosenthal was one of two principal investigators on a Probuphine clinical trial.

“Everybody is waking up to the fact that we’re in the midst of an opioid epidemic,” says Rosenthal. “There are actually very few medications for addiction of any kind. Given the addiction treatment system in the United States, most of the treatment that’s given is psychosocial. There’s very little use of FDA-approved medications.”

Probuphine made a difference, says Scott Jernigan of Jacksonville, Fla. He was in recovery for almost a year, taking another medication, when he signed up for a Probuphine clinical trial. He said Probuphine freed him from weekly doctor visits and pharmacy runs, and from fears of how sick he’d feel if he missed a dose or forgot to take his medication.

“[It] meant that I could become more of what my normal is going to be,” Jernigan says.

Some specialists recommend patients stay on medication-assisted treatment for years, or even indefinitely. For now, Probuphine can only be prescribed for two runs of six-month use and is meant for people already stable on 8 mg or less of a medication like buprenorphine.

Authors of the JAMA study suggest further investigation of Probuphine to gauge issues often associated with buprenorphine, such as diversion or pediatric exposure.

This story is part of a reporting partnership with NPR, Side Effects Public Media and Kaiser Health News.

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