States Fear Price Of New Zika Vaccine Will Be More Than They Can Pay

French pharmaceutical group Sanofi is expected to receive an exclusive license to market a new Zika vaccine.

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Editor’s note: This story has been updated to include information on how Sanofi Pasteur was chosen as the company to license the Zika vaccine.

The U.S. Army is planning to grant an exclusive license to the French pharmaceutical company Sanofi Pasteur, Inc. to manufacture and sell a Zika vaccine the Army developed last year.

And that has Rebekah Gee, Louisiana’s secretary of health, worried about paying for it.

“God forbid we have a Zika outbreak. We’re in the middle of a fiscal crisis, we’re already cutting services to people and we’re already potentially cutting our funding to fight the Zika virus,” Gee says.

If the Army goes through with its plan, she says, Sanofi could set a price for the vaccine at a level that Louisianans just won’t be able to afford.

Gee is among a growing number of public officials and activists who are demanding that Sanofi agree to show restraint when it sets the price for the vaccine, which was developed by the Army.

She wants the company to promise in writing that it won’t charge U.S. buyers any more than it charges in other wealthy countries – like its home, France.

“If the American public funds the life-saving intervention, we need price protections for states that have to foot the bill,” Gee says.

Last week, several groups including Doctors without Borders and Knowledge Ecology International appealed to the Army to delay granting Sanofi the exclusive license until the company agrees to reasonable price terms.

Zika is a virus that is transmitted by the Aedes aegypti mosquito. It can cause severe defects to babies born to infected mothers.

Because of its hot, wet climate, Louisiana is a prime target for the Zika virus in this country, Gee says. If there were a local outbreak, the state would want to ensure that every person of childbearing age got vaccinated. And today, there are about 540,000 people of reproductive age on Louisiana’s Medicaid rolls, which means the state and federal governments would cover the costs to vaccinate them.

There’s no vaccine against Zika available yet. So there is no way to determine where Sanofi, or any other company may set the price. But if it were too high?

“We’d then be in a situation where we’d have to decide between funding for K-12 education and the Zika vaccine,” Gee says. “And that just shouldn’t happen when the U.S. government and the taxpayers of this nation paid to develop this drug.”

It’s actually not unusual for the government to give private companies an exclusive license to government research and inventions to develop medications. In most cases, however, the government has paid for only part of the development.

In the case of the Zika vaccine, the government’s contribution is much larger.

“The inventors of the vaccine are all federal employees — they’re all employees of the army,” says Jamie Love, director of Knowledge Ecology International, a non-profit public interest group.

Knowledge Ecology and other groups filed a formal appeal earlier this month. They want the Army to require Sanofi to give U.S. buyers a fair price — charging the same price here as it charges in other wealthy countries — like its home country France. Louisiana Gov. John Bel Edwards also asked the Army for such a guarantee.

The groups have been pressing the Army for months over the proposed license. The Army wrote in an April 21 letter that it has to give the company exclusivity because of the “high risk and high costs involved in advanced vaccine development.”

Those costs aren’t clear however, at least when it comes to Sanofi.

“It’s not obvious what they’ve done,” Love says of Sanofi. “They didn’t invent the vaccine, they didn’t do the Phase 1 [clinical trial]. They’re not paying for the Phase II or III trials.”

The Army right now is conducting the Phase I trial, intended to determine whether the vaccine is safe.

If that goes well, the Department of Health and Human Services will give Sanofi $43 million for a Phase II trial, which determines whether the vaccine actually works and whether it has side effects.

And HHS is offering up another $130 million for the Phase III trial if the second stage is successful.

Sanofi says it has devoted 60 scientists to the project full time and is using “proprietary technical manufacturing expertise,” as well as the clinical trial network it has developed over the years in testing other vaccines to help with the studies.

“So while it’s true that those costs are being paid for by the U.S. government, we do have substantial investments in this vaccine,” says Dr. Jon Heinrichs, an associated vice president at Sanofi Pasteur in Pennsylvania, where he leads vaccine development.

“And really what it costs us are the opportunity costs where those individuals could be working on projects that have a more certain commercial return,” he says. “And while they’re working on Zika, they can’t be working on those projects.”

It’s still not certain the vaccine developed by the Army will work, or that there will be a market for it in the end, he says. There are many other efforts to develop Zika vaccines, some of which have government funding, and it’s not clear which will be most effective. Plus viruses can mutate, so a vaccine that is effective this year may not be in the future.

And Elias Zerhouni, a former director of the National Institutes of Health and president of global research and development at Sanofi said in a letter to the New York Times that the company will pay royalties to the Army for the license, so the government can recoup its investment.

Sen. Bernie Sanders, I-Vermont, isn’t impressed with Sanofi’s arguments. He has been urging the Army to withhold the license from Sanofi until the company agrees to charge U.S. customers a fair price.

“It seems to me that if we are providing substantial amounts of money to a company to distribute and develop this drug that the American people should be guaranteed that they’re going to be able to afford the price of the vaccine,” Sanders tells Shots. “And currently that is not the case.”

Sanders says the Army has asked Sanofi for a guarantee that it will charge U.S. customers, including state and federal public health and Medicaid programs, no more than it charges other wealthy countries for the vaccine. And the company, Sanders says, refused.

“Well, you know, we have not refused,” Heinrichs says. “And we intend to make this vaccine available at a reasonable price. And I think our record stands, and that we have made many of our vaccines available to those who need them at affordable prices.”

The Army did not respond to multiple calls to its Medical Research and Material Command at Ft. Detrick, Md., where the Zika work is happening.

But in a letter to Knowledge Ecology, Barry Datlof, chief of the Army’s Office of Research and Technology Applications, said the Army had talked with several companies and Sanofi “was the only one to move forward” with executing the collaborative research agreement and submitting a license application.

He said Sanofi, as a private company, has to make such decisions on the potential profit it can earn.

“Considering the high risk and the high cost involved in advanced vaccine development, granting an exclusive license for federally developed technology is often the only incentive significant enough to attract a competent and willing commercial partner,” Datlof wrote.

Love argues that the government could hold off on granting the license to the vaccine until after the next round of clinical trials. At that point, its value would be more clear and the Army will be in a better bargaining position.

Sanders and Knowledge Ecology point out that Sanofi has charged more in the U.S. for many medications, including the multiple sclerosis drug Aubagio, which costs Medicare more than $5,000, but in France it’s priced at about $745.

“Sanofi wants to do business the old-fashioned way, and that is take taxpayers money and then charge any price that they want,” Sanders says. “Our job now is to make it clear that what Sanofi wants it not acceptable.”

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Adult ADHD Can't Be Diagnosed With A Simple Screening Test, Doctors Warn

Adult ADHD can be difficult to diagnose.

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Diagnosing attention deficit hyperactivity disorder can be difficult. The symptoms of the disorder, as defined by the Diagnostic and Statistical Manual, or DSM, have changed multiple times.

And, even if you know what to look for, many of the symptoms are pretty general, including things like trouble focusing and a tendency to interrupt people. Discerning the difference between people who have a problem and those who are just distracted requires real expertise.

Which is why many people were excited when earlier this year a World Health Organization advisory group endorsed a six-question screening test that a study published in the Journal of the American Medical Association reported could reliably identify adults with ADHD.

A lot of people were intrigued by the seeming simplicity of the screening. We reported on it, including one implication of the study’s findings: that there could be a significant population of U.S. adults with undiagnosed ADHD.

But that may not be the case and, even if it is, some ADHD researchers say the six-question screening test is not necessarily the simple diagnostic solution its proponents hope it will be.

“Despite the questions put out by WHO and mentioned in JAMA, in America if your talents and temperament don’t match your goals and aspirations, that incongruity generates a series of feelings or behaviors that match quite nicely the diagnostic criteria in the DSM-V,” explains Dr. Lawrence Diller, a behavioral pediatrician and ADHD specialist who has been following trends in ADHD diagnosis and medication since the mid-1990s.

For example, he says some adult patients meet multiple criteria for ADHD, such as inattention, hyperactivity or impulsivity, but may not have the disorder.

“So you meet the criteria, but the question is ‘Are your goals realistic for who you are? Or are you trying to do too much?’ he cautions. “I think this culture absolutely encourages people to do too much.”

Doctors, drug companies and patients

Dr. David Goodman, an ADHD specialist at Johns Hopkins University and the Adult Attention Deficit Disorder Center of Maryland, agrees that not everyone who experiences the symptoms of ADHD necessarily suffers from the disorder, and that a simple screening test cannot diagnose it.

Diagnosing ADHD in adults takes time, he explains. “The diagnosis gets made in a clinical interview with the patient over the course of an hour or so, tracking the symptoms from childhood into adulthood,” Goodman says. ADHD in adults typically occurs with other psychiatric disorders, he says, such as anxiety or mood disorders, “so we need to sort out which disorder accounts for the symptoms.”

But, Goodman says, he believes there is evidence of a significant population of adults whose lives are being disrupted by ADHD, and who remain undiagnosed.

“Children with ADHD grow up into adults with ADHD,” he says, citing longitudinal studies by a team in Canada that suggested more than half of children with ADHD continued to experience symptoms as adults.

“If you’re disorganized, your confused, you’re tardy, you’re not following through, you’re making a lot of errors, your spouse or partner is going to grow increasingly frustrated,” Goodman says.

And Goodman says simple screening tests can be helpful to identify who those undiagnosed people might be, and encourage them to see a specialist.

Alan Schwarz is the author of the book ADHD Nation and a former investigative reporter for The New York Times, where he investigated ties between pharmaceutical companies and doctors.

“The six-question screening instrument that was endorsed by the World Health Organization was devised by doctors with a very long history in ADHD research,” he says. “These are, generally, men who have been enriched by the pharmaceutical industry in order to churn out research and churn out things like this that merely expand the ADHD market.

“What we’ve seen over the past 10 [to] 20 years is a constant enthusiasm on the part of the ADHD lobby to get more and more adults to consider the possibility that they, too, have ADHD,” Schwarz says.

Questions about drug company influence on prescribing has dogged the industry for years. A 2015 ProPublica analysis of multiple medical specialties found deep financial ties between the pharmaceutical industry and some doctors. And a recent study found that, in general, doctors who have less contact with drug company representatives are less likely to prescribe the company’s brand-name drugs, knowingly or otherwise.

Goodman, for one, has disclosed that he has received money from the pharmaceutical company, Shire, which makes Adderall, and says that in the last two years he has worked as a scientific consultant for multiple companies that make or are testing drugs to treat ADHD. He says that work helps him “provide the latest insight and clinical care for my patients, who seek me out and appreciate the state-of-the-art care they receive.”

Advice for patients

One thing ADHD experts agree on is that people who think they might have ADHD should see a doctor, and preferably an ADHD specialist.

There are multiple treatment options for ADHD, not all of which involve medication. Cognitive behavioral therapy can address symptoms of the disorder, and antidepressants have been shown to help with impulsivity and hyperactivity.

For those who do choose to take amphetamines, Diller says adults should be prescribed long-acting versions, which are harder to abuse than immediate-release versions.

“You can’t, at a minute’s notice, pop one of these into your mouth and hope you’ll get the work done,” he explains. “Use of immediate-release Adderall actually permits and facilitates an ADHD lifestyle of impulsivity.”

And many physicians stress the importance of being monitored by a professional, to make sure that whatever treatment is prescribed is actually helping with the symptoms, and making life easier.

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Handshake-Free Zones Target Spread Of Germs In The Hospital

One hospital in California has created designated no-handshake zones in an effort to curtail the spread of germs.

Katherine Streeter for NPR

Dr. Mark Sklansky, a self-described germaphobe, can’t stop thinking about how quickly microbes can spread.

“If I am at a computer terminal or using a phone or opening a door, I know my hands are now contaminated, and I need to be careful and I need to wash my hands,” says Sklansky, a professor of pediatrics at the David Geffen School of Medicine at UCLA.

Not all health workers are so careful, despite strict handwashing policies in virtually all medical facilities. A 2010 study published in the journal Infection Control & Hospital Epidemiology shows that only about 40 percent of doctors and other health care providers comply with hand hygiene rules in hospitals.

Hospital-acquired infections are a serious and potentially life-threatening problem. On any given day, 1 in 25 hospital patients suffers from at least one infection acquired while they are in the hospital, according to the Centers for Disease Control and Prevention. And studies show the hands of health care workers are often to blame.

Mark Sklansky, a pediatric cardiologist and self-described germaphobe, tested a new method for limiting the spread of germs: a handshake-free zone. He tested it in two UCLA neonatal intensive care units.

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So Sklansky decided to test a new method for limiting the spread of germs and reducing the transmission of disease in the hospital: a handshake-free zone.

“We are trying to do everything to minimize hospital-acquired infection except for the most obvious and easiest thing to do, in my opinion, which is to stop shaking hands,” he says.

Sklansky doesn’t believe this is a substitute for handwashing, but he does think reducing handshakes could help cut down on the spread of infection. He first proposed the idea in a 2014 editorial published in the Journal of the American Medical Association. His proposal launched a lively debate about the possible risks of the time-honored greeting.

Then in 2015, Sklansky decided to try out the idea with a six-month experiment. He picked a place where patients are especially vulnerable — the neonatal intensive care unit at two of UCLA’s hospitals, one in Westwood and one in Santa Monica. Infections among infants can cause them pain, prolong their stay in the NICU, require more medications and even put their lives at risk.

Staff and families in the units were told the reasons for dropping the handshake. And signs were posted designating the new handshake-free zones.

The signs feature two hands gripping each other inside a circle with a blue line through it and the words: “To help reduce the spread of germs, our NICU is now a handshake-free zone. Please ?nd other ways to greet each other.”

Instead of a handshake, non-contact greetings like a bow, a wave, or a smile are encouraged.

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Courtesy of UCLA Health/Kaiser Health News

Other greetings include options like a fist bump, a bow or a wave. Handshakes weren’t banned outright, but it was recommended that a smile or another non-contact form of salutation like a Namaste gesture might be better.

“We aren’t like a military operation,” says Sklansky. “We are just trying to limit the use of handshakes.”

In a survey of staff and family members about the experience, Sklansky and his colleagues found that establishing handshake-free zones does reduce the frequency of handshakes. And most health care workers support the idea.

The findings were published in the American Journal of Infection Control. The survey didn’t determine whether avoiding handshakes actually reduced the rate of infections, but Sklansky hopes to answer that question in a future study.

The formal experiment is now over, but the signs in the NICUs remain. And doctors and nurses still discourage handshakes.

It’s is an effective way to decrease the spread of germs, says Maureen Shawn Kennedy, editor-in-chief of the American Journal of Nursing.

“There are just so many reasons to avoid handshakes, even when people are washing their hands,” Kennedy says. “Just because someone is walking around in a white coat […] doesn’t mean they don’t have bacteria on their hands.”

Health care providers do wash their hands frequently, she says, but often they don’t do it for long enough or use the right technique. And bacteria live on computers, phones, medical charts and uniforms throughout hospitals, she notes.

Although there is no data to prove that reducing handshakes limits hospital infections, one study showed that bumping fists was more hygienic than shaking hands.

However, some infectious disease specialists believe health care workers don’t need to stop shaking hands. They just need to scrub better.

“The problem isn’t the handshake: It’s the hand-shaker,” says Herbert L. Fred, a Houston physician and associate editor of the Texas Heart Institute Journal.

In a 2015 editorial he urged doctors to ensure their hands are clean before touching patients. After all, he wrote, “If we ban the handshake, we might as well ban the physical examination. Both practices can spread germs,” — if you don’t wash your hands properly.

Handshake-free zones are not the solution for hospital-acquired infections, according to Didier Pittet, director of infection control at the University Hospital of Geneva. They simply “reflect the lack of capacity in infection prevention and control,” he wrote in an e-mail.

Sklansky agrees that hospitals need to improve compliance with hand hygiene. He says handshake-free zones aren’t designed to replace hand washing but to complement it.

“I actually think handshake-free zones will bring attention to the hands as vectors for disease and help improve compliance with hand hygiene,” he says.

Neonatologist Joanna Parga, who was part of UCLA’s handshake-free survey, says she liked the idea when she first heard about it, but wasn’t convinced it would work. Shaking hands is “so ingrained in our culture,” she says. And it is how many doctors connect with patients.

New mom Brittney Scott said she’d never heard of a handshake-free zone and wasn’t sure about the idea. “But once you really understand the meaning behind it, it’s great,” she said.

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After trying several alternatives to shaking hands, including bowing, making eye contact and touching people on the shoulder, Parga now believes some of these other options are more intimate than a handshake. And they open up a conversation about safety, she says.

On a recent afternoon, as Parga walks through the Westwood NICU, she introduces herself to a mother holding her infant son.

“Hi. I’m Dr. Parga,” she says. “Are you Mom? I’m not gonna shake your hand.” Parga explains she’s just trying to help prevent infection in the NICU.

Not shaking hands can feel uncomfortable, says Meena Garg, a neonatologist and medical director of the Westwood NICU. Patients often extend their hands in greeting, so sometimes “you feel like you are being rude,” she says.

But Garg supports the handshake-free zone, because it is an easy and inexpensive way to reduce infections.

“I am the medical director, so I have to look at costs,” she says. “This doesn’t cost anything, but it may be just as important as anything else we do.”

As part of the UCLA survey, Sklansky and his colleagues asked staff and parents what they thought of the new handshake-free zones.

The majority of health care workers support the idea, especially medical school students and nurses. Male doctors are the most resistant, partly because they aren’t convinced stopping handshaking is necessary to prevent infections.

Families, however, are universally supportive of the handshake-free zones, Sklansky found.

On one recent day, Brittney Scott stands beside the crib of her 2-week-old son, Samuel, as he sleeps. He’s in the NICU because of intestinal problems.

Scott had never heard of a handshake-free zone, and instinctively offered her hand to a doctor when she first arrived. She was “a little taken aback at first” when the doctor declined to take her hand. “But once you really understand the meaning behind it, it’s great,” Scott says.

Scott knows Samuel is at risk of infection, so avoiding germs is critical. She now prefers a smile to a handshake.

“A smile goes a long way in here,” she says. “There’s a lot of ups and downs […] being a parent to a NICU baby.”

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In The Age Of Digital Medicine, The Humble Reflex Hammer Hangs On

The good old reflex hammer (like this Taylor model) might seem like an outdated medical device, but its role in diagnosing disease is still as important as ever.

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Receiving a diagnosis in 2017 — at least one made at a medical center outfitted with the latest clinical gadgetry — might include a scan that divides your body into a bread loaf of high-resolution digital slices. Your DNA might be fed through a gene sequencer that spits out your mortal code in a matter of hours. Even your smartphone might soon be used to uncover health problems.

Yet nearly 130 years since its inception — after decades of science has mapped out our neuronal pathways — a simple knob of rubber with a metal handle remains one of medicine’s most essential tools. I’m referring to the cheap, portable, easy-to-use reflex hammer.

This unassuming device can be invaluable in diagnosing nervous and muscular disorders, and in determining whether a patient’s pathology lies in the brain or elsewhere in the body. It can also help curtail healthcare spending by preventing unnecessary, often expensive testing. Yet like so many major medical and scientific discoveries, the reflex hammer has humble origins, in this case: the basement of a Viennese hotel.

The inn was run by the father of Leopold Auenbrugger, an 18th century doctor who is considered to be among the founders of modern medicine. To gauge how much wine was left for customers, hotel employees would thump casks with their hands and listen for a dull thud or hollow tympany. Auenbrugger realized that the same technique — now called “percussing” — could be applied to the human torso to, say, determine how much fluid had built up around a diseased heart. He wrote as much in his 1761 paper New invention to detect diseases hidden deep within the chest.

Leopold Auenbrugger (here with his wife, Marianne) is regarded as one of the founders of modern medicine, having applied the idea of detecting disease by sound.

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Wellcome Library, London

Relflex hammer warfare

Thought to be more accurate than the human hand, it wasn’t long before percussion hammers were being designed to more precisely diagnose disease. Competition ensued.

Scottish physician Sir David Barry’s model, released in the 1820s, was the first. German doctor Max A. Wintrich’s came shortly after and was more popular, but was not without its critics: “[Wintrich’s hammer] is inconvenient to hold, it is rigid … it required education to use it, and even then it does not fulfill its purposes,” a rival inventor commented.

As neurologist Dr. Douglas J. Lanksa wrote in a 1989 paper on the many types of reflex hammers, “Some were T-shaped or L-shaped, others resembled battle axes, tomahawks, or even magic wands.” He adds that no material was off limits: wood, ebony, whale bone, brass, lead, even “velvet-covered worsted” (a type of yarn).

As percussion hammer warfare waged on, doctors and scientists were also beginning to understand the concept of reflexes, or involuntary, near-immediate responses to stimuli that occur before any sensory information reaches the brain. Muscular jerks. Blinking. Sneezing. Gagging. All of these are automatic feedback loops between sensory and motor neurons that help us navigate our environment and protect us from danger.

In 1875, German neurologists Drs. Heinrich Erb and Carl Friedrich Otto Westphal were among the first to realize that eliciting a reflex by briskly tapping the tendons of major muscles might be useful. They felt the knee jerk — or “patellar-tendon” reflex — in particular could help assess nerve function.

Anton Wintrich introduced this percussion hammer model in 1841.

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Wellcome Library, London

Hammers specifically suited to test reflexes were soon developed, the first of which had the now classic shape we’re accustomed to — a thin metal handle with a triangular rubber head. Designed by American physician John Madison Taylor in Philadelphia in 1888 — and modified ever since by many — the simple device was heavy enough to elicit reflexes, and had round edges to ease impact. An entry level model runs just $2.25 on Amazon.

The Krauss hammer, developed by German-American physician William Christopher Krauss, was designed around the same time. It had two rounded heads: a large one for knees and a smaller one for biceps. Dr. Ernst L.O. Trömner’s did too, but it also tapered to a thin end to assess skin reflexes. There were also the Queen Square hammer, the Babinski hammer, the Buck hammer and the Berliner hammer. The Stookey hammer flaunted a camel hair brush to get a better sense of touch sensation. The list goes on.

Past to present

Daniella C. Sisniega is a third year medical student at the Boston University School of Medicine. Last month at the American Academy of Neurology’s annual meeting, she presented a poster explicating the reflex hammer’s past.

“I’m fascinated by how the reflex hammer started out as a percussion hammer, but was [then] adapted to elicit reflexes and has been in every neurologist’s tool box ever since,” she told NPR. “I also did not know that the little rubber triangle was the first reflex hammer. I feel like I owe it an apology!”

Sisniega jokes about the lackluster quality of the inexpensive Taylors.

“The little tomahawk is included in the kit everyone receives when they enter medical school,” she recalls. “The rubber is cheap and very light, while the other hammers are heavier on the head so that you can use the ‘swing’ of the hammer as opposed to the strength of the strike to test the reflex.”

While attending the AAN conference myself, I asked multiple sclerosis expert Dr. Stephen Krieger about the role of the reflex hammer in modern medical diagnosis.

“We could argue about the nuances of the hammer — the Queens Square, the Tomahawk, plastic handle, metal handle, weighted, flexible or rigid — but the hammer itself is always in the hand. Reflexes tell the story of neurologic diseases of all sorts,” he says.

Krieger explains how disorders of the brain, like a stroke or brain tumor, result in hyperactive reflexes, while conditions affecting muscles and peripheral nerves usually result in reduced or non-existent reflexes. Reduced reflexes are, for example, a common symptom of back pain due to degenerative disk disease.

Dr. Andrew Wilner, an assistant professor of neurology at the Mayo Clinic, recounted the story of one of his patients, who had back pain, weakness and numbness of the legs. Wilner was leaning toward a diagnosis of either Guillain-Barre Syndrome (GBS) — an autoimmune disorder of peripheral nerves — or a myelopathy, an injury of some kind to the spinal cord. Both conditions can lead to medical emergencies, but each requires drastically different treatment.

“The reflex hammer was arguably our most important tool in narrowing down the differential diagnosis,” he says. “Had we found diminished or absent deep tendon reflexes, GBS would have been more likely. As it turned out, the patient had brisk pathological knee jerks, pointing to a lesion in the brain or spinal cord.”

Based on these findings, Wilner ordered an imaging study of the patient’s spinal cord, where a lesion was found — as opposed to pursuing the costly tests involved in a GBS diagnosis.

Wilner feels that the simple art of interviewing and examining a patient can get overshadowed by the myriad new diagnostic technologies. When it comes to clinical tools, he feels, sometimes basic is better.

“Technology is glorious,” admits Krieger, “and [it] will teach us things about patients that we could never have known or imagined. But the simple, elegant, inexpensive almost plebeian swing of the reflex hammer has a cost/benefit ratio that I think no advanced technology will likely ever match.”

Bret Stetka is a writer based in New York and an editorial director at Medscape. His work has appeared in Wired and Scientific American, and on The Atlantic.com. He graduated from the University of Virginia School of Medicine in 2005. He’s also on Twitter: @BretStetka

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Two Sisters Try To Tackle Drug Use At A Montana Indian Reservation

Charmayne Healy (l) and Miranda Kirk (r), co-founders of the Aaniiih Nakoda Anti-Drug Movement, have helped Melinda Healy, center, with their peer-support programs.

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There’s a narrative about the methamphetamine epidemic in Montana that says the state tackled it in the 2000s, yet now it’s back with a vengeance because of super labs and drug cartels in Mexico. But here on the Fort Belknap Indian Reservation, it never really went away.

“Getting high in your car in front of the store; that ain’t a big deal,” says Miranda Kirk.

Kirk works on the reservation, which is about 40 miles south of the Canadian border. She says no one even bothers to hide their drug use.

“Leaving your paraphernalia out in the open for someone to walk in, that’s alright. Having and seeing needles everywhere, that’s ok. Even talking about selling your needles — that’s normal too,” Kirk says.

Kirk is a 27-year-old mother of four. Born and raised in Fort Belknap, home to the Aaniiih and Nakoda tribes, she grew up around drugs, alcohol and addiction. She struggled with opioids after a miscarriage landed her in the ER and she was discharged with a handful of prescriptions. But, she says, with the help of her church, she broke that addiction. Now, she wants to help others.

According to the Tribal Epidemiology Centers of the Indian Health Service, dependence on methamphetamine and other psychostimulants more than tripled for tribal members in Montana and Wyoming between 2011 and 2015.

“People are saying they’re seeing it as young as third grade, because, ‘Oh that’s ok, I see that at home — my aunt does this, my mom does this, my dad does this, my grandpa does this.’ So, they can’t see the error in it. Or they don’t see it as a risk,” says Kirk.

Miranda Kirk and her sister, Charmayne Healy, felt like everyone had given up trying to do anything about the rampant drug use. And, they worried about their kids falling into the same trap. So they went to tribal leaders last year and said someone needs to do something — now.

George Horse Capture, Jr., vice president of the Fort Belknap Tribal Council, helped the sisters persuade the council to declare a state of emergency against methamphetamine last January. Tribal leaders then gave Kirk and Healy $150,000 to fund a substance-abuse prevention and treatment program.

The sisters were caught off guard, but right away, Kirk started hunting for a model that might work with the strengths of Fort Belknap. She heard about something called peer recovery, a movement centered on the idea that people who have succeeded in conquering from their own addictions are uniquely equipped to coach others.

The Fort Belknap Indian Reservation in north central Montana is home to two tribes, and substance abuse is a major problem.

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“The light bulb came on,” Kirk says. “That works, because what got me clean, in a sense, were peer mentors. They’ve been there. That made it easier for me to be able to express myself and not feel judged, or condemned. Like I’m a horrible person for what I was going through.”

She’s determined to break the stigma attached to reaching out for help.

In early 2016, Kirk and her sister officially launched the Aaniiih Nakoda Anti-Drug Movement, a native-led peer recovery project.

Jessica Healy, 30, came knocking before they were even up and running. Her only son was taken away last year.

“They helped me. And it took a big step … it took all that I had,” Jessica Healy says.

She had been using drugs on and off since the age of 18.

Once a week, one of Kirk’s peer recovery groups, the Life Givers Circle, meets at the Lodge Pole Elementary school.

“We talk about stuff and we make ribbon skirts, [do] activities, and we just help each other out,” Jessica Healy says.

It’s one of about four peer support groups that Kirk and Charmayne Healy have helped start, both on and off the reservation.

“It was a good feeling to be clean and to be close to people that had been going through the same thing. To know that there are others out there,” Jessica Healy says.

In addition to peer meetings, Aaniiih Nakoda members go to schools and talk to kids about prevention. They help organize events like zombie walks, in which people pretend to be the drug-addled walking dead.

There’s only one outpatient drug treatment facility in Fort Belknap, and no emergency housing or sober-living facilities. The only longer-term support available is Kirk’s group.

Dr. Aaron Wernham, of the Montana Healthcare Foundation, says that what Montana needs is a more integrated, team-based approach to treating addiction. That means primary care doctors working next to behavioral health professionals, and coordinating care all along the way.

“Peer recovery fits in very well with it, but if you decided you were just going to build a whole treatment system around peer recovery, you probably wouldn’t end up getting the results you want,” he says.

A new state law enacted in March goes a long way toward recognizing peer support specialists as legitimate members of a treatment team.

The law sets clear professional standards, and paves the way for billing insurance companies and, potentially, Medicaid.

The challenge is how to bring that comprehensive care to Fort Belknap.

Until that happens, the sisters’ grassroots peer program is one of the only options available for people. And she’s intent on doing that work, no matter what.

“You have to keep your phone on during the night because addiction don’t sleep and normally we don’t either,” she says.

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

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As Nursing Homes Evict Patients, States Question Motives

Vincent Galvan first went to a nursing home in 2012 after his right leg was amputated. He was evicted after complaining about his care.

Mariah Woelfel/WVIK

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People complain about nursing homes a lot: the food’s no good or there’s not enough staff, and so on. It’s a long list. But the top complaint, according to the federal government, is eviction from a nursing home.

Technically, it’s known as involuntary discharge, and in 2015 it brought in more than 9,000 complaints. Now, a couple of states are looking for ways to hold nursing homes accountable for unnecessary evictions.

One of those states is Maryland. Brian Frosh, the state’s attorney general, says that, in Maryland, more than half of all involuntary discharges have come from just one small chain of nursing homes run by Neiswanger Management Services, or NMS Healthcare.

“Your odds of getting evicted from an NMS nursing home are about a hundred times what they are of any other nursing home in the state,” says Frosh.

Maryland is now suing NMS for Medicaid fraud. The suit alleges that the company charged the state for services it didn’t deliver, specifically for discharge planning. Nursing homes are supposed to make sure a resident has a safe place to go. But Frosh says that NMS sent residents with complex medical needs to homeless shelters or to unlicensed board-and-carefacilities.

For example, according to the complaint, a woman with severe dementia was dropped off in front her son’s home. Someone from NMS “just opened the car door and let her out and drove away,” says Frosh. “Her son found her wandering around several hours later when he came home from work.”

The company’s motivation was purely financial, says Frosh. To understand his argument you need to know two things. First, Medicare pays nursing homes a lot more than Medicaid does. And, second, Medicare payments for long-term care only last for 100 days. Frosh says that NMS evicted hundreds of residents just as they were transitioning from Medicare to the lower-paying Medicaid.

“We cite emails in the complaint that offer a bounty for getting patients out quickly,” says Frosh. “A hundred bucks is offered for somebody who can make a bed vacant within two hours.” That made more room for new patients who were on Medicare.

Attorneys for NMS did not make anyone available to NPR for comment. But, in court documents, the company calls the state’s charges false, reckless and inflammatory.

In Illinois, concern over nursing home evictions goes way beyond a single nursing home chain. That’s because nursing home evictions in the state have more than doubled in the last five years for which data is available. State Sen. Daniel Biss has sponsored legislation to crack down on nursing homes that improperly discharge residents. It would also beef up enforcement of staffing standards.

“We’re seeing nursing homes that have made a financial decision that they would like a certain type of resident,” says Biss.

He means residents who are compliant and don’t require too much staff time, and when a nursing home has a resident who doesn’t fit the mold “they’re able to essentially drop them at the hospital and walk away,” Biss says.

That’s what happened to a 57-year-old Chicago man named Vincent Galvan, who first went to a nursing home in 2012 after his right leg was amputated. His left side was already damaged from an earlier accident. He thinks he was evicted because he complained too much, especially about staffing levels and about not getting the physical therapy he needed to use a new prosthetic leg.

First, he complained to the staff at the nursing home, “but they didn’t pay no attention,” says Galvan. “So, I heard they had a hotline for the corporation they belong to. I called them also. And nothing really happens.” He also called the Illinois Department of Public Health. As he tells it, one day without warning, the paramedics showed up and took him to a hospital psychiatric unit.

Top Five Complaints About Nursing Homes, FY2015

  1. Discharge/eviction-planning, notice, procedure and implementation, including abandonment
  2. Failure to respond to requests for assistance
  3. Staff attitudes (dignity and respect)
  4. Medications (administration and organization)
  5. Resident conflict, including roommates

Source: U.S. Aministration for Community Living

“They were actually accusing me of being aggressive and that I was a schizophrenic, that I have manic depression. And none of that was true,” he says.

Galvan’s hospital progress notes confirm that he did not have a serious mental illness. But the nursing home still wouldn’t take him back. It took the hospital 102 days to find another nursing home for Galvan. All that time he remained in the psychiatric ward.

“It was crazy,” he says. “It was really crazy. It was one of the worst experiences of my life.”

There are perfectly legal reasons to evict someone from a nursing home. For example, a resident might improve and no longer need nursing care. Residents can also be evicted if they are a danger to other people. And residents have a right to protest if they think that the law wasn’t followed, but, in Illinois, even if the nursing home is found to be in the wrong, the Department of Public Health can’t force the nursing home to take the resident back.

That’s what Biss’s legislation would change.

“It gives the department the power to order a resident readmitted,” he explains, and failure to do that would result in a fine of $250 per day, which could add up quickly.

“This bill … goes above and beyond what should happen,” says Matt Hartman, Vice President for Public Policy at the Illinois Health Care Association which represents nursing homes. He disagrees about the magnitude of the evictions problem. Anyone can complain, he says. That’s not the same thing as verified wrong-doing, and he says that raising fines on nursing homes won’t help residents.

“Anything that takes that much money away from resident care and away from staffing and medical equipment is just not the correct approach,” he says.

Hartman has been making that argument in negotiations with Illinois lawmakers, who could vote on the bill before the end of the year.

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Can Comfort Care At The ER Help Older People Live Longer And Suffer Less?

As baby boomers age, more older Americans are visiting the emergency room, which can be an overcrowded, disorienting and even traumatic place.

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A man sobbed in a New York emergency room. His elderly wife, who suffered from advanced dementia, had just had a breathing tube stuck down her throat. He knew she never would have wanted that. Now he had to decide whether to reverse the life-sustaining treatment that medics had begun.

When Dr. Kei Ouchi faced this family as a young resident at Long Island Jewish Medical Center, he had no idea what to say. The husband, who had cared for his wife for the past 10 years, knew her condition had declined so much that she wouldn’t want to be rescued. But when Ouchi offered to take out the tube, the man cried more: “She’s breathing. How can we stop that?”

Ouchi had pursued emergency medicine to rescue victims of gunshot wounds and car crashes. He was unprepared, he says, for what he encountered: a stream of older patients with serious illnesses like dementia, cancer and heart disease — patients for whom the life-saving techniques he was trained to perform often only prolonged the suffering.

As baby boomers age, more of them are visiting the emergency room, which can be an overcrowded, disorienting and even traumatic place. Adults 65 and older made 20.8 million emergency room visits in 2013, up from 16.2 million in 2000, according to the most recent hospital survey by the Centers for Disease Control and Prevention. The survey found 1 in 6 visits to the ER were made by an older patient, a proportion that’s expected to rise.

Half of adults in this age group visit the ER in their last month of life, according to a study in the journal Health Affairs. Of those, half die in the hospital, even though most people say they’d prefer to die at home.

Some states on board

The influx is prompting more clinicians to rethink what happens in the fast-paced emergency room, where the default is to do everything possible to extend life. Hospitals across the country — including in Ohio, Texas, Virginia and New Jersey — are bringing palliative care, which focuses on improving quality of life for patients with advanced illness, into the emergency department.

Interest is growing among doctors: 149 emergency physicians have become certified in palliative care since that option became available just over a decade ago, and others are working closely with palliative care teams. But efforts to transform the ER face significant challenges, including a lack of time, staffing and expertise, not to mention a culture clash.

Researchers who interviewed emergency room staff at two Boston hospitals, for instance, found resistance to palliative care. ER doctors questioned how they could handle delicate end-of-life conversations for patients they barely knew. Others argued that the ER, with its “cold, simple rooms” and drunken patients screaming, is not an appropriate place to provide palliative care, which tends to physical, psychological and spiritual needs.

Ouchi saw some of these challenges during his residency in New York, when he visited the homes of older patients who frequently visited the emergency room. He saw how obstacles like transportation, frailty and poor vision made it difficult for them to leave the house to see a doctor.

“So what do they do?” Ouchi asks. “They call 911.”

When these patients arrive at the emergency room, doctors treat their acute symptoms, but not their underlying needs, Ouchi says. In more severe cases, when the patient can’t talk and doesn’t have an advanced directive or a medical decision-maker available, doctors pursue the most aggressive care possible to keep them alive: CPR, intravenous fluids, breathing tubes.

“Our default in the ER is pedal to the metal,” says Dr. Corita Grudzen, an emergency physician at NYU Langone Medical Center who studies palliative care in the ER. But when doctors learn after the fact that the patient would not have wanted that, the emergency rescue forces families to choose whether to remove life support.

When older adults are very ill — if they need an IV drip to maintain blood pressure, a ventilator to breathe, or medication to restart the heart — they are most likely to end up in an intensive care unit, where the risk of developing hospital-acquired infections and delirium is increased, Grudzen says. Meanwhile, it’s not clear whether these aggressive interventions really extend their lives, she adds.

Some have sought to address these problems by creating separate, quieter emergency rooms for older patients. Others say bringing palliative care consultations into regular emergency rooms could reduce hospitalization, drive down costs and even extend life.

There’s no hard evidence that this approach will live up to its promise. The only major randomized controlled trial, which Grudzen led at Mount Sinai Hospital in New York City, found that palliative care consultations in the emergency room improved quality of life for cancer patients. It did not find statistically significant evidence that the consultations improved rates of survival, depression, ICU admission or discharge to hospice.

Trying to avert suffering

But frontline doctors say they’re seeing how palliative care in the ER can avert suffering. For instance, Ouchi recalls one patient — a man, in his late 60s — who showed up at the emergency room for the fifth time in six months with fever and back pain. Previous visits hadn’t addressed the underlying problem: The man was dying of cancer.

This time, a nurse and social worker called in a palliative care team, who talked to the patient about his goals.

“All he wanted was to be comfortable at home,” Ouchi says. The man enrolled in hospice, a form of palliative care for terminally ill patients. He died about six months later, at home.

Now Ouchi and others are trying to come up with systematic ways to identify which patients could benefit from palliative care.

One such screening tool, dubbed P-CaRES, developed at Brown University in Providence, R.I., gives ER doctors a list of questions. Does the patient have life-limiting conditions such as advanced dementia or sepsis? How often does the patient visit the ER? Would the doctor be surprised if the patient died within 12 months?

Doctors are using the tool to refer patients at the University of California-San Francisco Medical Center at Parnassus to palliative care doctors, says Dr. Kalie Dove-Maguire, a clinical instructor there. The questions pop up automatically on the electronic medical record for every ER patient who is about to be admitted to the hospital.

Dove-Maguire says UCSF hasn’t published results, but the tool has helped individual patients, including a middle-aged man with widespread cancer who showed up at the ER with low blood pressure. The man “would have been admitted to the ICU with lines and tubes and invasive procedures,” she says, but staff talked to his family, learned his wishes and sent him to home hospice.

“Having that conversation in the ER, which is the entry point to the hospital, is vital,” Dove-Maguire says.

Measured in minutes

But time is scarce in ERs. Doctors’ performance is measured in minutes, Grudzen notes, and the longer they stop to make calls to refer one patient to hospice, the more patients line up waiting for a bed.

Finding someone to have conversations about a patient’s goals of care can be difficult, too. Ouchi enlisted ER doctors to use the screening tool for 207 older ER patients at Brigham and Women’s Hospital in Boston, where he now works as an emergency physician. They found a third of the patients would have benefited from a palliative care consultation. But there aren’t nearly enough palliative care doctors to provide that level of care, Ouchi says.

“The workforce for specialty palliative care is tiny, and the need is growing,” says Grudzen.

Palliative care is a relatively new specialty, and there’s a national shortfall of as many as 18,000 palliative care doctors, according to one estimate.

“We’ve got to teach cardiologists, intensivists, emergency physicians, how to do palliative care,” she said. “We really have to teach ourselves the skills.”

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

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Do You Know What Red Nose Day Is?

Mindy Kaling is one of many celebrities who have put on a red nose for Red Nose Day, raising the question: Huh, what?

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May 25 is Red Nose Day in the United States.

And millions of people are probably going, “huh, what?”

The short explanation: It’s a campaign to raise money to fight child poverty.

But how does buying a red foam nose at a drugstore for a buck help the cause? And does this charity with the silly name really do good work?

We did some reporting, and here’s what we learned.

The British charity Comic Relief started Red Nose Day in England in 1985 as a way to raise money to fight child poverty. Why Red Nose Day and not, say, Fight Child Poverty Day? It’s hard to get a definitive answer. But it appears the organizers wanted a symbol that would make people laugh. Everyone from the Spice Girls to Hugh Grant have put on red noses to promote the fundraising effort.

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Red Nose Day is held every two years in the U.K. and has raised $1.4 billion, which is distributed to charities that fight child poverty.

Three years ago, the event crossed over to the U.S., where it’s become an annual event. Although it hasn’t yet become a household word. Last year, Comic Relief USA surveyed 1,000 Americans and found that “60 percent didn’t quite understand what we did,” says Janet Scardino, CEO of the group.

In the weeks leading up to Red Nose Day and on the day itself, money is raised in all sorts of ways. Of the dollar people pay to buy a red nose at Walgreens and Duane Reade drugstores, 50 cents goes to charity (the other half covers the cost of producing the nose). The public can also make direct donations on the Red Nose Day telethon airing Thursday night on NBC.

According to the organization’s 2015 tax filings, 85 percent of the proceeds go to a handful of charity partners that support children in need around the world. In the U.S., that includes multiyear grants to groups like Feeding America, the Boys & Girls Clubs of America, Save the Children and Gavi, the Vaccine Alliance.

The Bill & Melinda Gates Foundation, a supporter of NPR, is also backing Red Nose Day in the U.S. by matching donations to the cause made on Facebook up to total of $1 million.

Charity Navigator, which rates nonprofits using a four-star evaluation system, has found that most of Red Nose Day’s charity partners have a three or four-star rating.

But Comic Relief has been criticized in the past for its controversial investments. In the U.K, some funds raised by Red Nose Day are invested in various ways, with the returns going toward the cost of the campaign. In 2013, the BBC program “Panorama” reported that around $816,000 was invested in the arms company BAE Systems while $3.5 million was invested in tobacco companies.

A spokesperson from Comic Relief U.K. told NPR that the group stopped investing in those companies in 2014.

And then there’s the question of the goofiness of it all. Part of the appeal of Red Nose Day is that it makes people feel good, says David Bishai, a professor who specializes in economics and public health at Johns Hopkins University. “The red nose doesn’t drag you into the dark side of the poor, showing you children with swollen bellies. That’s not fun,” he says. “The [campaigners] say: We understand there’s terrible suffering in the world and we’re doing something about it.”

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But it’s a tricky line to toe. This year’s BBC telethon for Red Nose Day in the U.K., on March 24, garnered 150 complaints for profanity and lewd comments from the celebrity entertainers. There was a skit showing a bounty of biscuits followed by footage of a starving infant in Liberia. One viewer tweeted: “Comic Relief … painful.” Asked to comment on the controversy, a spokesperson for Comic Relief U.K. did not address the issue specifically but told NPR: “The broadcast was a live studio event enjoyed by a peak audience of 7.6 million. The amazing British public yet again dug deep to raise over 73 million pounds [about $94 million] so far.”

U.S. campaigns haven’t brought in quite as much: more than $60 million in the first two years. Still,“that’s nothing to sneeze at,” says Sandra Miniutti of Charity Navigator.

But the name might be an obstacle, suggests Miniutti. “Stand Up For Cancer, I know I’m giving to cancer,” she says. “Red Nose Day doesn’t have that attribute.”

So on Red Nose Day the group devotes a lot of effort to explaining what kinds of projects it supports. Tonight, for example, Julia Roberts guest stars on a Red Nose Day episode of the TV series Running Wild with Bear Grylls. Grylls and Roberts head out to delivervaccines from Wamba Hospital in Kenya to children in the a remote community. The challenge? They must keep the vaccines cold the whole time — while avoiding crocodiles and hippos.

Tonight’s Red Nose Day TV marathon also features a reunion of the cast of the 2003 movie Love Actually.

It sounds gimmicky, but academics who study charitable giving don’t seem to mind. “I could have been holy about it — but they’re helping Americans think about those less well-off in other countries,” says Bishai. “Give them a break.”

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