Tag Archives: Medicine

The Last Person You’d Expect to Die in Childbirth

The U.S. has the worst rate of maternal deaths in the developed world, and 60 percent are preventable. The death of Lauren Bloomstein, a neonatal nurse, in the hospital where she worked illustrates a profound disparity: the health care system focuses on babies but often ignores their mothers.

A view of photographs of Laura and Larry in the Bloomstein’s home on Burgundy Dr., in Holmdel, N.J., on Saturday, April 29, 2017. CREDIT: Bryan Anselm for ProPublica

by Nina Martin, ProPublica, and Renee Montagne, NPR
May 12, 2017

As a neonatal intensive care nurse, Lauren Bloomstein had been taking care of other people’s babies for years. Finally, at 33, she was expecting one of her own. The prospect of becoming a mother made her giddy, her husband Larry recalled recently, “the happiest and most alive I’d ever seen her.” When Lauren was 13, her own mother had died of a massive heart attack. Lauren had lived with her older brother for a while, then with a neighbor in Hazlet, New Jersey, who was like a surrogate mom, but in important ways she’d grown up mostly alone. The chance to create her own family, to be the mother she didn’t have, touched a place deep inside her. “All she wanted to do was be loved,” said Frankie Hedges, who took Lauren in as a teenager and thought of her as her daughter. “I think everybody loved her, but nobody loved her the way she wanted to be loved.”

Other than some nausea in her first trimester, the pregnancy went smoothly. Lauren was “tired in the beginning, achy in the end,” said Jackie Ennis, her best friend since high school, who talked to her at least once a day. “She gained what she’s supposed to. She looked great, she felt good, she worked as much as she could” — at least three 12-hour shifts a week until late into her ninth month. Larry, a doctor, helped monitor her blood pressure at home, and all was normal.

On her days off she got organized, picking out strollers and car seats, stocking up on diapers and onesies. After one last pre-baby vacation to the Caribbean, she and Larry went hunting for their forever home, settling on a brick colonial with black shutters and a big yard in Moorestown, not far from his new job as an orthopedic trauma surgeon in Camden. Lauren wanted the baby’s gender to be a surprise, so when she set up the nursery she left the walls unpainted — she figured she’d have plenty of time to choose colors later. Despite all she knew about what could go wrong, she seemed untroubled by the normal expectant-mom anxieties. Her only real worry was going into labor prematurely. “You have to stay in there at least until 32 weeks,” she would tell her belly. “I see how the babies do before 32. Just don’t come out too soon.”

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When she reached 39 weeks and six days — on Friday, Sept. 30, 2011 —  Larry and Lauren drove to Monmouth Medical Center in Long Branch, the hospital where the two of them had met in 2004 and where she’d spent virtually her entire career. If anyone would watch out for her and her baby, Lauren figured, it would be the doctors and nurses she worked with on a daily basis. She was especially fond of her obstetrician-gynecologist, who had trained as a resident at Monmouth at the same time as Larry. Lauren wasn’t having contractions, but she and the OB-GYN agreed to schedule an induction of labor — he was on call that weekend and would be sure to handle the delivery himself.

Inductions often go slowly, and Lauren’s labor stretched well into the next day. Ennis talked to her on the phone several times: “She said she was feeling okay, she was just really uncomfortable.” At one point, Lauren was overcome by a sudden, sharp pain in her back near her kidneys or liver, but the nurses bumped up her epidural and the stabbing stopped.

Inductions have been associated with higher cesarean-section rates, but Lauren progressed well enough to deliver vaginally. On Saturday, Oct. 1, at 6:49 p.m., 23 hours after she checked into the hospital, Hailey Anne Bloomstein was born, weighing 5 pounds, 12 ounces. Larry and Lauren’s family had been camped out in the waiting room; now they swarmed into the delivery area to ooh and aah, marveling at how Lauren seemed to glow.

Larry floated around on his own cloud of euphoria, phone camera in hand. In one 35-second video, Lauren holds their daughter on her chest, stroking her cheek with a practiced touch. Hailey is bundled in hospital-issued pastels and flannel, unusually alert for a newborn; she studies her mother’s face as if trying to make sense of a mystery that will never be solved. The delivery room staff bustles in the background in the low-key way of people who believe everything has gone exactly as it’s supposed to.

Then Lauren looks directly at the camera, her eyes brimming.

Twenty hours later, she was dead.

The ability to protect the health of mothers and babies in childbirth is a basic measure of a society’s development. Yet every year in the U.S., 700 to 900 women die from pregnancy or childbirth-related causes, and some 65,000 nearly die — by many measures, the worst record in the developed world.

American women are more than three times as likely as Canadian women to die in the maternal period (defined by the Centers for Disease Control as the start of pregnancy to one year after delivery or termination), six times as likely to die as Scandinavians. In every other wealthy country, and many less affluent ones, maternal mortality rates have been falling; in Great Britain, the journal Lancet recently noted, the rate has declined so dramatically that “a man is more likely to die while his partner is pregnant than she is.” But in the U.S., maternal deaths increased from 2000 to 2014. In a recent analysis by the CDC Foundation, nearly 60 percent of such deaths were preventable.

While maternal mortality is significantly more common among African Americans, low-income women and in rural areas, pregnancy and childbirth complications kill women of every race and ethnicity, education and income level, in every part of the U.S. ProPublica and NPR spent the last several months scouring social media and other sources, ultimately identifying more than 450 expectant and new mothers who have died since 2011. The list includes teachers, insurance brokers, homeless women, journalists, a spokeswoman for Yellowstone National Park, a co-founder of the YouTube channel WhatsUpMoms, and more than a dozen doctors and nurses like Lauren Bloomstein. They died from cardiomyopathy and other heart problems, massive hemorrhage, blood clots, infections and pregnancy-induced hypertension (preeclampsia) as well as rarer causes. Many died days or weeks after leaving the hospital. Maternal mortality is commonplace enough that three new mothers who died, including Lauren, were cared for by the same OB-GYN.

The reasons for higher maternal mortality in the U.S. are manifold. New mothers are older than they used to be, with more complex medical histories. Half of pregnancies in the U.S. are unplanned, so many women don’t address chronic health issues beforehand. Greater prevalence of C-sections leads to more life-threatening complications. The fragmented health system makes it harder for new mothers, especially those without good insurance, to get the care they need. Confusion about how to recognize worrisome symptoms and treat obstetric emergencies makes caregivers more prone to error.

Yet the worsening U.S. maternal mortality numbers contrast sharply with the impressive progress in saving babies’ lives. Infant mortality has fallen to its lowest point in history, the CDC reports, reflecting 50 years of efforts by the public health community to prevent birth defects, reduce preterm birth and improve outcomes for very premature infants. The number of babies who die annually in the U.S. — about 23,000 in 2014 — still greatly exceeds the number of expectant and new mothers who die, but the ratio is narrowing.

The divergent trends for mothers and babies highlight a theme that has emerged repeatedly in ProPublica’s and NPR’s reporting. In recent decades, under the assumption that it had conquered maternal mortality, the American medical system has focused more on fetal and infant safety and survival than on the mother’s health and well-being.

“We worry a lot about vulnerable little babies,” said Barbara Levy, vice president for health policy/advocacy at the American Congress of Obstetricians and Gynecologists (ACOG) and a member of the Council on Patient Safety in Women’s Health Care. Meanwhile, “we don’t pay enough attention to those things that can be catastrophic for women.”

At the federally funded Maternal-Fetal Medicine Units Network, the preeminent obstetric research collaborative in the U.S., only four of the 34 initiatives listed in its online database primarily target mothers, versus 24 aimed at improving outcomes for infants (the remainder address both). Under the Title V federal-state program supporting maternal and child health, states devoted about 6 percent of block grants in 2016 to programs for mothers, compared to 78 percent for infants and special-needs children. The notion that babies deserve more care than mothers is similarly enshrined in the Medicaid program, which pays for about 45 percent of births. In many states, the program covers moms for 60 days postpartum, their infants for a full year. The bill to replace the Affordable Care Act, adopted by the U.S. House of Representatives earlier this month, could gut Medicaid for mothers and babies alike.

At the provider level, advances in technology have widened the gap between maternal and fetal and infant care. “People became really enchanted with the ability to do ultrasound, and then high-resolution ultrasound, to do invasive procedures, to stick needles in the amniotic cavity,” said William Callaghan, chief of the CDC’s Maternal and Infant Health Branch.

The growing specialty of maternal-fetal medicine drifted so far toward care of the fetus that as recently as 2012, young doctors who wanted to work in the field didn’t have to spend time learning to care for birthing mothers. “The training was quite variable across the U.S.,” said Mary D’Alton, chair of OB-GYN at Columbia University Medical Center and author of papers on disparities in care for mothers and infants. “There were some fellows that could finish their maternal-fetal medicine training without ever being in a labor and delivery unit.”

In the last decade or so, at least 20 hospitals have established multidisciplinary fetal care centers for babies at high risk for a variety of problems. So far, only one hospital in the U.S. —  New York-Presbyterian — has a similar program for high-risk moms-to-be.

In regular maternity wards, too, babies are monitored more closely than mothers during and after birth, maternal health advocates told ProPublica and NPR. Newborns in the slightest danger are whisked off to neonatal intensive care units like the one Lauren Bloomstein worked at, staffed by highly trained specialists ready for the worst, while their mothers are tended by nurses and doctors who expect things to be fine and are often unprepared when they aren’t.

When women are discharged, they routinely receive information about how to breastfeed and what to do if their newborn is sick but not necessarily how to tell if they need medical attention themselves. “It was only when I had my own child that I realized, “˜Oh my goodness. That was completely insufficient information,'” said Elizabeth Howell, professor of obstetrics and gynecology at the Icahn School of Medicine at Mount Sinai Hospital in New York City. “The way that we’ve been trained, we do not give women enough information for them to manage their health postpartum. The focus had always been on babies and not on mothers.”

In 2009, the Joint Commission, which accredits 21,000 health care facilities in the U.S., adopted a series of perinatal “core measures” — national standards that have been shown to reduce complications and improve patient outcomes. Four of the measures are aimed at making sure the baby is healthy. One — bringing down the C-section rate — addresses maternal health.

Meanwhile, life-saving practices that have become widely accepted in other affluent countries — and in a few states, notably California — have yet to take hold in many American hospitals. Take the example of preeclampsia, a type of high blood pressure that only occurs in pregnancy or the postpartum period, and can lead to seizures and strokes. Around the world, it kills an estimated five women an hour. But in developed countries, it is highly treatable. The key is to act quickly.

By standardizing its approach, Britain has reduced preeclampsia deaths to one in a million — a total of two deaths from 2012 to 2014. In the U.S., on the other hand, preeclampsia still accounts for about 8 percent of maternal deaths — 50 to 70 women a year. Including Lauren Bloomstein.

When Lauren McCarthy Bloomstein was a teenager in the 1990s, a neighbor who worked for a New York publishing firm approached her about modeling for a series of books based on Louisa May Alcott’s classic “Little Women.” Since her mother’s death, Lauren had become solitary and shy; she loved to read, but she decided she wasn’t interested. “Are you kidding? Go do it!” Frankie Hedges insisted. “That would be fabulous!” Lauren relented, and the publisher cast her as the eldest March sister, Meg. She appeared on the covers of four books, looking very much the proper 19th-century young lady with her long brown hair parted neatly down the middle and a string of pearls around her neck. The determined expression on her face, though, was pure Lauren. “She didn’t want sympathy, she didn’t want pity,” Jackie Ennis said. “She wasn’t one to talk much about her feelings [about] her mom. She looked at it as this is what she was dealt and she’s gonna do everything in her power to become a productive person.”

In high school, Lauren decided her path lay in nursing, and she chose a two-year program at Brookdale Community College. She worked at a doctor’s office to earn money for tuition and lived in the garage apartment that Hedges and her husband had converted especially for her, often helping out with their young twin sons. Lauren “wasn’t a real mushy person,” Hedges said. “She wasn’t the type to say things like “˜I love you. ‘” But she clearly relished being part of a family again. “You can’t believe how happy she is,” Ennis once told Hedges. “We’ll be out and she’ll say, “˜Oh, I have to go home for dinner!'”

After graduating in 2002, Lauren landed at Monmouth Medical Center, a sprawling red-brick complex a few minutes from the ocean that is part of the RWJBarnabas Health system and a teaching affiliate of Philadelphia’s Drexel University College of Medicine. Her first job was in the medical surgical unit, where her clinical skills and work ethic soon won accolades. “I cannot remember too many healthcare employees that I respect as much as Lauren,” Diane Stanaway, then Monmouth’s clinical director of nursing, wrote in a 2005 commendation. “What a dynamite young lady and nurse!” When a top hospital executive needed surgery, Larry recalled, he paid Lauren the ultimate compliment, picking her as one of two private-duty nurses to help oversee his care.

Larry Bloomstein, who joined the unit as an orthopedic surgical resident in 2004, was dazzled, too. He liked her independent streak — “She didn’t feel the need to rely on anyone else for anything” — and her levelheadedness. Even performing CPR on a dying patient, Lauren “had a calmness about her,” Larry said. He thought her tough upbringing “gave her a sense of confidence. She didn’t seem to worry about small things.” Lauren, meanwhile, told Ennis, “I met this guy. He’s a doctor, and he’s very kind.” Their first date was a Bruce Springsteen concert; five years later they married on Long Beach Island, on the Jersey shore.

One of Lauren’s favorite books was “The Catcher in the Rye” — “she related to the Holden Caulfield character rescuing kids,” Larry said. When a spot opened at Monmouth’s elite neonatal intensive care unit in 2006, she jumped at it.

The hospital has the fifth-busiest maternity department in the state, delivering 5,449 babies in 2016. Monmouth earned an “A” grade from Leapfrog, a nonprofit that promotes safety in health care, and met full safety standards in critical areas of maternity care, such as rates of C-sections, and early elective deliveries, a hospital spokeswoman said. Its NICU, a Level III facility for high-risk newborns, is the oldest in New Jersey.

“With NICU nursing, it’s one of those things either you get it or you don’t,” said Katy DiBernardo, a 20-year veteran of the unit. “The babies are little, and a lot of people aren’t used to seeing a teeny tiny baby.” The NICU staff included nurses, neonatologists, a respiratory therapist and residents. Lauren, DiBernardo said, “just clicked.”

One of the things Lauren liked best about her work was the bonds she formed with babies’ families. Nurses followed the same newborns throughout their stay, sometimes for weeks or months. She was a touchstone for parents — very good at “calming people down who have a lot of anxiety,” Larry said –and often stayed in contact long after the babies went home, meeting the moms for coffee and even babysitting on occasion.

She also cherished the deep friendships that a place like the NICU forged. The neonatal floor was like a world unto itself, Lauren Byron, another longtime nurse there, explained: “There’s a lot of stress and pressure, and you are in life-and-death situations. You develop a very close relationship with some people.” The environment tended to attract very strong personalities. Lauren’s nickname in the Bloomstein family football pool was “The Feisty One,” so she fit right in. But she could stand her ground without alienating anyone. “She was one of those people that everyone liked,” Byron said.

Another person everyone liked was OB-GYN John Vaclavik. He had come to Monmouth as a resident in 2004, around the same time as Larry, after earning his bachelor’s from Loyola College in Baltimore and his medical degree at St. George’s University on the island of Grenada. Medicine was the family profession: Two uncles and two brothers also became doctors and his wife was a perinatal social worker at the hospital. Lauren and her colleagues thought he was “very personable” and “a great guy,” Larry said.

“She was good friends with my wife and she felt comfortable with me,” Vaclavik would recall in a 2015 court deposition.

After his residency, Vaclavik joined Ocean Obstetric & Gynecologic Associates, a thriving practice that counted numerous medical professionals among its clients. Vaclavik was a “laborist”Â — part of a movement that aimed to reduce the number of C-sections, which tend to have more difficult recoveries and more complications than vaginal births. In a state with a C-section rate of 37 percent, Monmouth’s rate in 2016 was just 21 percent.

The neonatal nurses had plenty of opportunity to observe Vaclavik and other OB-GYNs in action — someone from NICU was called to attend every delivery that showed signs of being complicated or unusual as well as every C-section. “We always laughed, “˜They’ll call us for a hangnail,'” DiBernardo said. Lauren was so impressed by Vaclavik that she not only chose him as her own doctor, she recommended him to her best friend. “She kept saying, “˜You have to go to this guy. He’s a good doctor. Good doctor,'” Ennis said.

In other ways, though, the NICU staff and the labor and delivery staff were very separate. The neonatal nurses were focused on their own fragile patients — the satisfaction that came from helping them grow strong enough to go home, the grief when that didn’t happen. Once Ennis asked Lauren, “How do you deal with babies that don’t make it? That’s got to be so bad.” Lauren replied, “Yeah, but we save more than we lose.”

Loss was less common in labor and delivery, and when a new mother suffered life-threatening complications, the news did not always reach the NICU floor. Thus, when a 29-year-old special education teacher named Tara Hansen contracted a grisly infection a few days after giving birth to her first child in March 2011, the tragedy didn’t register with Lauren, who was then three months pregnant herself.

Hansen lived in nearby Freehold, New Jersey, with her husband, Ryan, her high school sweetheart. Her pregnancy, like Lauren’s, had been textbook perfect, and she delivered a healthy 9-pound son. But Hansen suffered tearing near her vagina during childbirth. She developed signs of infection but was discharged anyway, a lawsuit by her husband later alleged.

Hansen was soon readmitted to Monmouth with what the lawsuit called “excruciating, severe pain beyond the capacity of a human being to endure.” The diagnosis was necrotizing fasciitis, commonly known as flesh-eating bacteria; two days later Hansen was dead. One of Vaclavik’s colleagues delivered Hansen’s baby; Vaclavik himself authorized her discharge. According to court documents, he said nurses failed to inform him about Hansen’s symptoms and that if he’d known her vital signs weren’t stable, he wouldn’t have released her. The hospital and nurses eventually settled for $1.5 million. The suit against Vaclavik and his colleagues is pending.

Vaclavik did not respond to several interview requests from ProPublica and NPR, including an emailed list of questions. “Due to the fact this matter is in litigation,” his attorney responded, “Dr. Vaclavik respectfully declines to comment.”

Citing patient privacy, Monmouth spokeswoman Elizabeth Brennan also declined to discuss specific cases. “We are saddened by the grief these families have experienced from their loss,” she said in a statement.

Larry Bloomstein’s first inkling that something was seriously wrong with Lauren came about 90 minutes after she gave birth. He had accompanied Hailey up to the nursery to be weighed and measured and given the usual barrage of tests for newborns. Lauren hadn’t eaten since breakfast, but he returned to find her dinner tray untouched. “I don’t feel good,” she told him. She pointed to a spot above her abdomen and just below her sternum, close to where she’d felt the stabbing sensation during labor. “I’ve got pain that’s coming back.”

Larry had been at Lauren’s side much of the previous 24 hours. Conscious that his role was husband rather than doctor, he had tried not to overstep. Now, though, he pressed Vaclavik: What was the matter with his wife? “He was like, “˜I see this a lot. We do a lot of belly surgery. This is definitely reflux,'” Larry recalled. According to Lauren’s records, the OB-GYN ordered an antacid called Bicitra and an opioid painkiller called Dilaudid. Lauren vomited them up.

Lauren’s pain was soon 10 on a scale of 10, she told Larry and the nurses; so excruciating, the nurses noted, “Patient [is] unable to stay still.” Just as ominously, her blood pressure was spiking. An hour after Hailey’s birth, the reading was 160/95; an hour after that, 169/108. At her final prenatal appointment, her reading had been just 118/69. Obstetrics wasn’t Larry’s specialty, but he knew enough to ask the nurse: Could this be preeclampsia?

Preeclampsia, or pregnancy-related hypertension, is a little-understood condition that affects 3 percent to 5 percent of expectant or new mothers in the U.S., up to 200,000 women a year. It can strike anyone out of the blue, though the risk is higher for African Americans, women with pre-existing conditions such as obesity, diabetes or kidney disease, and mothers over the age of 40. It is most common during the second half of pregnancy, but can develop in the days or weeks after childbirth, and can become very dangerous very quickly. Because a traditional treatment for preeclampsia is to deliver as soon as possible, the babies are often premature and end up in NICUs like the one where Lauren worked.

As Larry suspected, Lauren’s blood pressure readings were well past the danger point. What he didn’t know was that they’d been abnormally high since she entered the hospital– 147/99, according to her admissions paperwork. During labor, she had 21 systolic readings at or above 140 and 13 diastolic readings at or above 90, her records indicated; for a stretch of almost eight hours, her blood pressure wasn’t monitored at all, the New Jersey Department of Health later found. Over that same period, their baby’s vital signs were being constantly watched, Larry said.

In his deposition, Vaclavik described the 147/99 reading as “elevated” compared to her usual readings, but not abnormal. He “would use 180 over 110 as a cutoff” to suspect preeclampsia, he said. Still, he acknowledged, Lauren’s blood pressure “might have been recommended to be monitored more closely, in retrospect.”

Leading medical organizations in the U.S. and the U.K. take a different view. They advise that increases to 140/90 for pregnant women with no previous history of high blood pressure signify preeclampsia. When systolic readings hit 160, treatment with anti-hypertensive drugs and magnesium sulfate to prevent seizures “should be initiated ASAP,” according to guidelines from the Alliance for Innovation on Maternal Health. When other symptoms, such as upper abdominal (epigastric) pain, are present, the situation is considered even more urgent.

This basic approach isn’t new: “Core Curriculum for Maternal-Newborn Nursing,” a widely-used textbook, outlined it in 1997. Yet failure to diagnose preeclampsia, or to differentiate it from chronic high blood pressure, is all too common.

California researchers who studied preeclampsia deaths over several years found one striking theme: “Despite triggers that clearly indicated a serious deterioration in the patient’s condition, health care providers failed to recognize and respond to these signs in a timely manner, leading to delays in diagnosis and treatment.” Preeclampsia symptoms — swelling and rapid weight gain, gastric discomfort and vomiting, headache and anxiety — are often mistaken for the normal irritations that crop up during pregnancy or after giving birth. “We don’t have a yes-no test for it,” said Eleni Tsigas, executive director of the Preeclampsia Foundation. “A lot of physicians don’t necessarily see a lot of it.” Outdated notions — for example, that delivering the baby cures the condition — unfamiliarity with best practices and lack of crisis preparation can further hinder the response.

The fact that Lauren gave birth over the weekend may also have worked against her. Hospitals may be staffed differently on weekends, adding to the challenges of managing a crisis. A new Baylor College of Medicine analysis of 45 million pregnancies in the U.S. from 2004 to 2014 found mothers who deliver on Saturday or Sunday have nearly 50 percent higher mortality rates as well as more blood transfusions and more perineal tearing. The “weekend effect” has also been associated with higher fatality rates from heart attacks, strokes and head trauma.

According to Lauren’s records, Vaclavik did order a preeclampsia lab test around 8:40 p.m., but a nurse noted a half-hour later: “No abnormal labs present.” (According to Larry, the results were borderline.) Larry began pushing to call in a specialist. Vaclavik attributed Lauren’s pain to esophagitis, or inflammation of the esophagus, which had afflicted her before, he said in his deposition. Around 10 p.m., according to Lauren’s medical records, he phoned the on-call gastroenterologist, who ordered an X-ray and additional tests, more Dilaudid and different antacids — Maalox and Protonix. Nothing helped.

Meanwhile, Larry decided to reach out to his own colleagues in the trauma unit at Cooper University Hospital in Camden. In his training, perhaps the most important lesson he’d learned was to ask for help: “If there’s a problem, I will immediately get another physician involved.” By chance, the doctor on call happened to be a fairly new mother. As Larry described Lauren’s symptoms, she interrupted him. “You can stop talking. I know what this is.” She said Lauren had HELLP syndrome, an acronym for the most severe variation of preeclampsia, characterized by hemolysis, or the breakdown of red blood cells; elevated liver enzymes; and low platelet count, a clotting deficiency that can lead to excessive bleeding and hemorrhagic stroke.

Larry’s colleague urged him to stop wasting time, he recalled. Lauren’s very high blood pressure, the vomiting, and the terrible pain radiating from her kidneys and liver were symptoms of rapid deterioration. “Your wife’s in a lot of danger,” the trauma doctor said. (She didn’t respond to ProPublica’s and NPR’s requests for comment.)

Earlier this year, an analysis by the CDC Foundation of maternal mortality data from four states identified more than 20 “critical factors” that contributed to pregnancy-related deaths. Among the ones involving providers: lack of standardized policies, inadequate clinical skills, failure to consult specialists and poor coordination of care. The average maternal death had 3.7 critical factors.

“It’s never just one thing,” said Roberta Gold, a member of the Council on Patient Safety in Women’s Health Care, whose daughter and unborn grandson died from a pregnancy-related blood clot in 2010. “It’s always a cascading combination of things. It’s a slow-motion train wreck.”

The last 16 hours of Lauren’s life were consistent with that grim pattern. Distressed by what the trauma doctor had told him, Larry immediately went to Lauren’s caregivers. But they insisted the tests didn’t show preeclampsia, he said. Not long after, Larry’s colleague called back to check on Lauren’s condition. “I don’t believe those labs,” he recalls her telling him. “They can’t be right. I’m positive of my diagnosis. Do them again.'”

Hailey Bloomstein, 5, plays on a swing in the backyard of their home on Burgundy Dr., in Holmdel, N.J., on Saturday, April 29, 2017. CREDIT: Bryan Anselm for ProPublica

Meanwhile, Lauren’s agony had become almost unendurable. The blood pressure cuff on her arm was adding to her discomfort, so around 10:30 p.m. her nurse decided to remove it — on the theory, Larry said, “We know her blood pressure is high. There’s no point to retaking it.” According to Lauren’s records, her blood pressure went unmonitored for another hour and 44 minutes.

Larry had given up on getting a specialist to come to the hospital so late on a Saturday night, but he persuaded Vaclavik to call in a general surgical resident. Around 11:55 p.m., according to the nurses’ notes, Lauren begged, “Do anything to stop this pain.” Vaclavik prescribed morphine, to little effect.

Just after midnight, her blood pressure about to peak at 197/117, Lauren began complaining of a headache. As Larry studied his wife’s face, he realized something had changed. “She suddenly looks really calm and comfortable, like she’s trying to go to sleep.” She gave Larry a little smile, but only the right side of her mouth moved.

In an instant, Larry’s alarm turned to panic. He ordered Lauren, “Lift your hands for me.” Only her right arm fluttered. He peeled off her blankets and scraped the soles of her feet with his fingernail, testing her so-called Babinski reflex; in an adult whose brain is working normally, the big toe automatically jerks downward. Lauren’s right toe curled as it was supposed to. But her left toe stuck straight out, unmoving. As Larry was examining her, Lauren suddenly seemed to realize what was happening to her. “She looked at me and said, “˜I’m afraid,’ and, “˜I love you.’ And I’m pretty sure in that moment she put the pieces together. That she had a conscious awareness of “¦ that she was not going to make it.”

A CT scan soon confirmed the worst: The escalating blood pressure had triggered bleeding in her brain. So-called hemorrhagic strokes tend to be deadlier than those caused by blood clots. Surgery can sometimes save the patient’s life, but only if it is performed quickly.

Larry was a realist; he knew that even the best-case scenario was devastating. Chances were that Lauren would be paralyzed or partially paralyzed. She’d never be the mother she had dreamed of being. She’d never be a nurse again. But at least there was a chance she would live. When the neurologist arrived, Larry asked, “Is there hope here?” As he recalls it, the neurologist responded, “That’s why I’m here. There’s hope.”

Larry began gathering Lauren’s loved ones — his parents, her brother, Frankie Hedges and her husband Billy, Jackie Ennis. On the phone, he tried to play down the gravity of the situation, but everyone understood. When Larry’s mother arrived, the hospital entrance was locked, and Larry and Vaclavik came to meet her. “The obstetrician just said, “˜She’s going to be all right,'” Linda Bloomstein said. “And Larry was standing behind him, and I saw the tears coming down, and he was shaking his head, “˜No.'”

Around 2 a.m., the neurosurgeon finally confirmed what the trauma doctor had said four hours before: Lauren had HELLP syndrome. Then he delivered more bad news: Her blood platelets — essential to stopping the hemorrhage — were dangerously low. But, according to Larry, the hospital didn’t have sufficient platelets on site, so her surgery would have to be delayed. Larry was dumbfounded. How could a regional medical center that delivered babies and performed all types of surgery not have platelets on hand for an emergency? Vaclavik called the Red Cross and other facilities, pleading with them to send any they had. “In my understanding, there was a complete shortage of platelets in the state of New Jersey,” he said in the deposition. Hours passed before the needed platelets arrived.

The neuro team did another CT scan around 6 a.m. Larry couldn’t bring himself to look at it, “but from what they’ve told me, it was horrifically worse.” While Lauren was in surgery, friends began dropping by, hoping to see her and the baby, not realizing what had happened since her cheerful texts the night before. Around 12:30 p.m., the neurosurgeon emerged and confirmed that brain activity had stopped. Lauren was on life support, with no chance of recovery.

All this time, Hailey had been in the newborn nursery, being tended by Lauren’s stunned colleagues. They brought her down to Lauren’s room and Larry placed her gently into her mother’s arms. After a few minutes, the nurses whisked the baby back up to the third floor to protect her from germs. A respiratory therapist carefully removed the breathing tube from Lauren’s mouth. At 3:08 p.m., surrounded by her loved ones, she died.

In the U.S., unlike some other developed countries, maternal deaths are treated as a private tragedy rather than as a public health catastrophe. A death in childbirth may be mourned on Facebook or memorialized on GoFundMe, but it is rarely reported in the news. Most obituaries, Lauren’s included, don’t mention how a mother died.

Lauren’s passing was more public than most, eliciting an outpouring of grief. Hundreds of people attended her wake and funeral — doctors and nurses from the hospital, friends from around the country, families Lauren had taken care of. Vaclavik was there, utterly devastated, Larry’s family said. The head of Monmouth’s OB-GYN department paid his respects and, according to Larry, promised in a private conversation at the wake to conduct a full investigation.

In the days after Lauren’s death, Larry couldn’t dwell on the implications of what had happened. He had to find a burial plot, choose a casket, write a eulogy. He was too shattered to return to the Mooresville house, so he took Hailey to his parents’ place, a one-bedroom apartment they were renting while they renovated their home, and slept with the baby in the living room for the first month.

After the funeral, he turned all his attention to his daughter. He knew nothing about newborns, always imagining Lauren would teach him — “What could be better than having your own NICU nurse to take care of your baby?” he had thought. He relied on his mother and sister and Lauren’s friends to guide him. He took time off from his job at Cooper, figuring three months would be enough. But as his return date approached, he knew he wasn’t ready. “I don’t think I can see a patient that’s on a ventilator right now,” he realized. “Or even just a hospital bed.” He didn’t want to leave Hailey. So he quit.

He sold the house, though he couldn’t bring himself to attend the closing — “I couldn’t stand handing those keys over to someone else.” He took Hailey a couple of times to stay with his sister and her family in Texas, where he didn’t have to answer the constant questions. But traveling with his baby daughter was painful in its own way. People didn’t know what to make of him. “It’s strange for people to see a father alone.” Wherever he went, he felt disconnected from almost everything around him. “You’re walking around this world and all these people are around you, and they’re going on with their lives and I just felt very, very isolated and very alone with that.”

Back in New Jersey, Larry found a job closer to his parents’ place, performed one operation and tried to quit. His new employers, though, persuaded him to stay. To avoid reliving the funeral, he returned to Texas for the first anniversary of Hailey’s birth and Lauren’s death in late September 2012. In one of his suitcases, he packed a giant cupcake mold Lauren had bought when they first married — she thought it would make a perfect first-birthday cake for the kids she yearned for. He baked the cake himself — chocolate, Lauren’s favorite, covered with sprinkles.

Other people in Lauren’s and Larry’s circle had been asking questions about her care since the night she died. “That was the first thing I literally said when I walked [into the hospital] — I said, “˜How did this happen?'” Jackie Ennis recalled. In the next week or two, she probed Larry again: ” ‘Did they do everything they could for her?’ He said, “˜No, there were warning signs for hours before.'” Ennis was too upset to dig any deeper.

As Larry’s numbness wore off, his orthopedist friends began pushing him as well. Larry was hesitant; despite the missteps he had witnessed, part of him wanted to believe that Lauren’s death had been unavoidable. “And my friends were like, “˜We can’t accept that. “¦ With our technology, every single time a woman dies [in childbirth], it’s a medical error.'”

Lauren’s death, Larry finally admitted to himself, could not be dismissed as either inevitable or a fluke. He had seen how Lauren’s OB-GYN and nurses had failed to recognize a textbook case of one of the most common complications of pregnancy — not once, but repeatedly over two days. To Larry, the fact that someone with Lauren’s advantages could die so needlessly was symptomatic of a bigger problem. By some measures, New Jersey had one of the highest maternal mortality rates in the U.S. He wanted authorities to get to the root of it — to push the people and institutions that were at fault to change.

That’s the approach in the United Kingdom, where maternal deaths are regarded as systems failures. A national committee of experts scrutinizes every death of a woman from pregnancy or childbirth complications, collecting medical records and assessments from caregivers, conducting rigorous analyses of the data and publishing reports that help set policy for hospitals throughout the country. Coroners also sometimes hold public inquests, forcing hospitals and their staffs to answer for their mistakes. The U.K. process is largely responsible for the stunning reduction in preeclampsia deaths in Britain, the committee noted its 2016 report — “a clear success story” that it hoped to repeat “across other medical and mental health causes of maternal death.”

The U.S. has no comparable federal effort. Instead, maternal mortality reviews are left up to states. As of this spring, 26 states (and one city, Philadelphia) had a well-established process in place; another five states had committees that were less than a year old. In almost every case, resources are tight, the reviews take years and the findings get little attention. A bipartisan bill in Congress, the Preventing Maternal Deaths Act of 2017, would authorize funding for states to establish review panels or improve their processes.

New Jersey’s review team, the second-oldest in the U.S., includes OB-GYNs, nurses, mental health specialists, medical examiners, even a nutritionist. Using vital records and other reports, they identify every woman in New Jersey who died within a year of pregnancy or childbirth, from any cause, then review medical and other records to determine whether the death was “pregnancy-related” or not. Every few years, the committee publishes a report, focusing on things like the race and age of the mothers who died, the causes of death, and other demographic and health data. In the past, the findings have been used to promote policies to reduce postpartum depression.

But the New Jersey committee doesn’t interview the relatives of the deceased, nor does it assess whether a death was preventable. Moreover, like every other state that conducts such reviews, New Jersey “de-identifies” the records — strips them of any information that might point to an individual hospital or a particular woman. Otherwise, the medical community and lawmakers would refuse to go along. The goal is to “improve care for patients in general,” said Joseph Apuzzio, a professor of obstetrics and gynecology at Rutgers-New Jersey Medical School who heads the committee. This requires a process that is “nonjudgmental” and “not punitive,” he said. “That’s the best way to get a free discussion of all of the health care providers who are in the room.”

Yet the result of de-identification, as Larry soon realized, is that the review is of little use in assigning responsibility for individual deaths, or evaluating whether some hospitals, doctors or nurses are more prone to error than others. To Larry, this seemed like a critical oversight — or perhaps, willful denial. In a preventable death or other medical error, he said, sometimes the who and the where are as important as the why. “Unless someone points the finger specifically,” he said, “I think the actual cause [of the problem] is lost.”

Someone eventually steered Larry toward the New Jersey Department of Health’s licensing and inspection division, which oversees hospital and nursing home safety. He filed a complaint against Monmouth Medical Center in 2012.

The DOH examined Lauren’s records, interviewed her caregivers and scrutinized Monmouth’s policies and practices. In December 2012 it issued a report that backed up everything Larry had seen firsthand. “There is no record in the medical record that the Registered Nurse notified [the ob/gyn] of the elevated blood pressures of patient prior to delivery,” investigators found. And: “There is no evidence in the medical record of further evaluation and surveillance of patient from [the ob/gyn] prior to delivery.” And: “There was no evidence in the medical record that the elevated blood pressures were addressed by [the ob/gyn] until after the Code Stroke was called.”

The report faulted the hospital. “The facility is not in compliance” with New Jersey hospital licensing standards, it concluded. “The facility failed to ensure that recommended obstetrics guidelines are adhered to by staff.”

To address these criticisms, Monmouth Medical Center had implemented a plan of correction, also contained in the report. The plan called for a mandatory educational program for all labor and delivery nurses about preeclampsia and HELLP syndrome; staff training in Advance Life Support Obstetrics and Critical Care Obstetrics; and more training on the use of evidence-based methods to assess patients and improve communications between caregivers.

Some of the changes were strikingly basic: “Staff nurses were educated regarding the necessity of reviewing, when available, or obtaining the patients [sic] prenatal records. Education identified that they must make a comparison of the prenatal blood pressure against the initial admission blood pressure.” And: “Repeat vital signs will be obtained every 4 hours at a minimum.”

An important part of the plan of correction involved Vaclavik, though neither he nor the nurses were identified by name. The head of Monmouth’s OB-GYN department provided “professional remediation for the identified physician,” the Department of Health report said. In addition, there was “monitoring of 100% of records for physician of record per month x 3 months.” The monitoring focused on “compliance of timely physician intervention for elevated blood pressures/pain assessment and management.”

The department chairman, Robert Graebe, found Vaclavik’s charts to be 100 percent compliant, Vaclavik said in the deposition. Graebe was asked in a March 2017 deposition if Vaclavik was in good standing at the hospital at the time of Lauren’s treatment. “Was and is,” Graebe replied.

In a separate note, the Department of Health told Larry that it forwarded his complaint to the Board of Medical Examiners and the New Jersey Board of Nursing. Neither agency has taken disciplinary action, according to their websites.

Larry’s copy of the DOH report arrived in the mail. He was gratified by the findings but dismayed that they weren’t publicly posted. That meant hardly anyone would see them.

A few months after the DOH weighed in, he sued Monmouth, Vaclavik and five nurses in Monmouth County Superior Court in Freehold, New Jersey. For a medical malpractice lawsuit to go forward in New Jersey, an expert must certify that it has merit. Larry’s passed muster with an OB-GYN. But beyond the taking of depositions, there’s been little action in the case.

As the maternal death rate has mounted around the U.S., a small cadre of reformers has mobilized. Some of the earliest and most important work has come in California, where more babies are born than in any other state — 500,000 a year, one-eighth of the U.S. total.

Modeled on the U.K. process, the California Maternal Quality Care Collaborative is informed by the experiences of founder Elliott Main, a professor of obstetrics and gynecology at Stanford and the University of California-San Francisco, who for many years ran the OB-GYN department at a San Francisco hospital. “One of my saddest moments as an obstetrician was a woman with severe preeclampsia that we thought we had done everything correct, who still had a major stroke and we could not save her,” he said recently. That loss has weighed on him for 20 years. “When you’ve had a maternal death, you remember it for the rest of your life. All the details.”

Launched a decade ago, CMQCC aims to reduce not only mortality, but also life-threatening complications and racial disparities in obstetric care. It began by analyzing maternal deaths in the state over several years; in almost every case, it discovered, there was “at least some chance to alter the outcome.” The most preventable deaths were from hemorrhage (70 percent) and preeclampsia (60 percent).

Main and his colleagues then began creating a series of “toolkits” to help doctors and nurses improve their handling of emergencies. The first one, targeting obstetric bleeding, recommended things like “hemorrhage carts” for storing medications and supplies, crisis protocols for massive transfusions, and regular training and drills. Instead of the common practice of “eye-balling” blood loss, which often leads to underestimating the seriousness of a hemorrhage and delaying treatment, nurses learned to collect and weigh postpartum blood to get precise measurements. Hospitals that adopted the toolkit saw a 21 percent decrease in near deaths from maternal bleeding in the first year; hospitals that didn’t use the protocol had a 1.2 percent reduction. By 2013, according to Main, maternal deaths in California fell to around 7 per 100,000 births, similar to the numbers in Canada, France and the Netherlands — a dramatic counter to the trends in other parts of the U.S.

“Prevention isn’t a magic pill,” Main said. “It’s actually teamwork [and having] a structured, organized, standardized approach” to care.

CMQCC’s preeclampsia toolkit, launched in 2014, emphasized the kind of practices that might have saved Lauren Bloomstein: careful monitoring of blood pressure and early and aggressive treatment with magnesium sulfate and anti-hypertensive medications. Data on its effectiveness hasn’t been published.

The collaborative’s work has inspired ACOG and advocates in a few states to create their own initiatives. Much of the funding has come from a 10-year, $500 million maternal health initiative by Merck, the pharmaceutical giant. Originally intended to focus on less developed countries, Merck for Mothers decided it couldn’t ignore the growing problem in the U.S. The U.S. maternal mortality rate is “unacceptable,” said Executive Director Mary-Ann Etiebet. Making pregnancy and childbirth safer “will not only save women’s lives but will improve and strengthen our health systems “¦ for all.”

But the really hard work is only beginning. According to the Institute of Medicine, it takes an average of 17 years for a new medical protocol to be widely adopted. Even in California, half of the 250 hospitals that deliver babies still aren’t using the toolkits, said Main, who largely blames inertia.

In New York state, some hospitals have questioned the need for what they call “cookbook medicine,” said Columbia’s Mary D’Alton. Her response: “Variability is the enemy of safety. Rather than have 10 different approaches to obstetric hemorrhage or treatment of hypertension, choose one or two and make it consistent. “¦ When we do things in a standardized way, we have better outcomes.”

One big hurdle: training. Another: money. Smaller providers, in particular, may not see the point. “It’s very hard to get a hospital to provide resources to change something that they don’t see as a problem,” ACOG’s Barbara Levy said. “If they haven’t had a maternal death because they only deliver 500 babies a year, how many years is it going to be before they see a severe problem? It may be 10 years.”

In New Jersey, providers don’t need as much convincing, thanks to a recent project to reduce postpartum blood loss led by the Association of Women’s Health, Obstetric and Neonatal Nurses. A number of hospitals saw improvements; at one, the average length of a hemorrhage-related ICU stay plunged from 8 days to 1.5 days. But only 31 of the state’s 52 birthing hospitals participated in the effort, in part — perhaps — because nurses led it, said Robyn D’Oria, executive director of the Central Jersey Family Health Consortium and a member of the state’s maternal mortality committee. “I remember having a conversation with [someone from] a hospital that I would describe as progressive and she said to me, “˜I cannot get past some of the physicians not wanting to buy into this.'”

So New Jersey hospitals are about to try again, this time adopting mini-toolkits created by the ACOG-led Alliance for Innovation on Maternal Health for hemorrhage and preeclampsia. “We’re at the very beginning” of a rollout that is likely to take at least two years, D’Oria said. Among those helping to create momentum has been Ryan Hansen, the husband of the teacher who died at Monmouth Medical Center a few months before Lauren Bloomstein.

Still, as hospitals begin to revamp, mothers in the state continue to perish. One was Ashley Heaney Butler. A Rutgers University graduate, she lived in Bayville, where she decorated the walls of her house with anchors, reflecting her passion for the ocean. She worked for the state Division of Vocational Rehabilitation Services as a counselor, and served as president of the New Jersey Rehabilitation Association. Her husband Joseph was a firefighter. She gave birth at Monmouth last September to a healthy boy and died a couple of weeks later at the age of 31, never leaving the hospital. It turned out that she had developed an infection late in her pregnancy, possibly related to a prior gastric bypass surgery. She was under the care of several doctors, including Vaclavik.

The death of a new mother is not like any other sudden death. It blasts a hole in the universe. “When you take that one death and what that does, not only to the husband, but to the family and to the community, the impact that it has in the hospital, on the staff, on everybody that’s cared for her, on all the people who knew them, it has ripple effects for generations to come,” Robyn D’Oria said.

Jackie Ennis felt Lauren’s loss as an absence of phone calls. She and Lauren had been closer than many sisters, talking several times a day. Sometimes Lauren called just to say she was really tired and would talk later; she’d even called Ennis from Hawaii on her honeymoon. The night Lauren died, Ennis knew something was wrong because she hadn’t heard from her best friend. “It took me a really long time not to get the phone calls,” she said. “I still have trouble with that.”

During Lauren’s pregnancy, Frankie Hedges had thought of herself as Hailey’s other grandmother. She and Lauren had made a lot of plans. Lauren’s death meant the loss of their shared dreams for an entire extended family. “I just feel she didn’t get what she deserved,” Hedges said.

Vaclavik’s obstetric practice is “larger” than in 2011, and he continues to have admitting privileges at Monmouth and two other hospitals, he said in his deposition. “I will never forget” Lauren’s death, he said. “”¦ I probably suffer some post-traumatic stress from this.”

Hailey is five years old, with Lauren’s brown hair and clear green eyes. She feels her mother’s presence everywhere, thanks to Larry and his new wife Carolyn, whom he married in 2014. They met when she was a surgical tech at one of the hospitals he worked at after Lauren died. Photos and drawings of Lauren occupy the mantle of their home in Holmdel, the bookcase in the dining room and the walls of the upstairs hallway. Larry and Carolyn and their other family members talk about Lauren freely, and even Larry’s younger daughter, 2-year-old Aria, calls her “Mommy Lauren.” On birthdays and holidays, Larry takes the girls to the cemetery. He designed the gravestone — his handprint and Lauren’s reaching away from each other, newborn Hailey’s linking them forever. Larry has done his best to keep Lauren’s extended family together — Ennis and Hedges and their families are included in every important celebration.

Larry still has the video of Lauren and Hailey on his phone. “By far the hardest thing for me to accept is [what happened] from Lauren’s perspective,” he said one recent evening, hitting the play button and seeing her alive once more. “I can’t, I literally can’t accept it. The amount of pain she must have experienced in that exact moment when she finally had this little girl. “¦ I can accept the amount of pain I have been dealt,” he went on, watching Lauren stroke Hailey’s cheek. “But [her pain] is the one thing I just can’t accept. I can’t understand, I can’t fathom it.”

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Do you know someone who died or nearly died in childbirth? Please tell us your story. If you want to reach out to us directly, email us at Maternal@propublica.org.

Research editor Derek Kravitz and engagement reporter Adriana Gallardo at ProPublica and researcher Bo Erickson at NPR contributed to this story.

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When Evidence Says No, But Doctors Say Yes

Years after research contradicts common practices, patients continue to demand them and doctors in the U.S. continue to deliver. The result is an epidemic of unnecessary and unhelpful treatment.

FIRST, LISTEN TO THE STORY with the happy ending: At 61, the executive was in excellent health. His blood pressure was a bit high, but everything else looked good, and he exercised regularly. Then he had a scare. He went for a brisk post-lunch walk on a cool winter day, and his chest began to hurt. Back inside his office, he sat down, and the pain disappeared as quickly as it had come.

That night, he thought more about it: middle-aged man, high blood pressure, stressful job, chest discomfort. The next day, he went to a local emergency department. Doctors determined that the man had not suffered a heart attack and that the electrical activity of his heart was completely normal. All signs suggested that the executive had stable angina — chest pain that occurs when the heart muscle is getting less blood-borne oxygen than it needs, often because an artery is partially blocked.

Illustration byBruceBlaus, Creative Commons/Wikipedia Blausen.com staff. "Blausen gallery 2014". Wikiversity Journal of Medicine. DOI:10.15347/wjm/2014.010. ISSN 20018762.

Illustration by BruceBlaus, Creative Commons/Wikipedia

A cardiologist recommended that the man immediately have a coronary angiogram, in which a catheter is threaded into an artery to the heart and injects a dye that then shows up on special x-rays that look for blockages. If the test found a blockage, the cardiologist advised, the executive should get a stent, a metal tube that slips into the artery and forces it open.

While he was waiting in the emergency department, the executive took out his phone and searched “treatment of coronary artery disease.” He immediately found information from medical journals that said medications, like aspirin and blood-pressure-lowering drugs, should be the first line of treatment. The man was an unusually self-possessed patient, so he asked the cardiologist about what he had found. The cardiologist was dismissive and told the man to “do more research.” Unsatisfied, the man declined to have the angiogram and consulted his primary-care doctor.

The primary-care physician suggested a different kind of angiogram, one that did not require a catheter but instead used multiple x-rays to image arteries. That test revealed an artery that was partially blocked by plaque, and though the man’s heart was pumping blood normally, the test was incapable of determining whether the blockage was dangerous. Still, his primary-care doctor, like the cardiologist at the emergency room, suggested that the executive have an angiogram with a catheter, likely followed by a procedure to implant a stent. The man set up an appointment with the cardiologist he was referred to for the catheterization, but when he tried to contact that doctor directly ahead of time, he was told the doctor wouldn’t be available prior to the procedure. And so the executive sought yet another opinion. That’s when he found Dr. David L. Brown, a professor in the cardiovascular division of the Washington University School of Medicine in St. Louis. The executive told Brown that he’d felt pressured by the previous doctors and wanted more information. He was willing to try all manner of noninvasive treatments — from a strict diet to retiring from his stressful job — before having a stent implanted.

The executive had been very smart to seek more information, and now, by coming to Brown, he was very lucky, too. Brown is part of the RightCare Alliance, a collaboration between health-care professionals and community groups that seeks to counter a trend: increasing medical costs without increasing patient benefits. As Brown put it, RightCare is “bringing medicine back into balance, where everybody gets the treatment they need, and nobody gets the treatment they don’t need.” And the stent procedure was a classic example of the latter. In 2012, Brown had coauthored a paper that examined every randomized clinical trial that compared stent implantation with more conservative forms of treatment, and he found that stents for stable patients prevent zero heart attacks and extend the lives of patients a grand total of not at all. In general, Brown says, “nobody that’s not having a heart attack needs a stent.” (Brown added that stents may improve chest pain in some patients, albeit fleetingly.) Nonetheless, hundreds of thousands of stable patients receive stents annually, and one in 50 will suffer a serious complication or die as a result of the implantation procedure.

“Nobody that’s not having a heart attack needs a stent,” says David Brown, cardiologist and professor at the Washington University School of Medicine.  (Whitney Curtis for ProPublica)
Brown explained to the executive that his blockage was one part of a broader, more diffuse condition that would be unaffected by opening a single pipe. The cardiovascular system, it turns out, is more complicated than a kitchen sink. The executive started medication and improved his diet. Three months later, his cholesterol had improved markedly, he had lost 15 pounds, and the chest pain never returned.

Now, listen to the story with the sad ending: Not long after helping the executive, Brown and his colleagues were asked to consult on the case of a 51-year-old man from a tiny Missouri town. This man had successfully recovered from Hodgkin’s lymphoma, but radiation and six cycles of chemotherapy had left him with progressive scarring creeping over his lungs. He was suffocating inside his own body. The man was transferred to Barnes Jewish Hospital, where Brown works, for a life-saving lung transplant. But when the man arrived in St. Louis, the lung-transplant team could not operate on him.

Four months earlier, the man had been admitted to another hospital because he was having trouble breathing. There, despite the man’s history of lymphoma treatment, which can cause scarring, a cardiologist wondered whether the shortness of breath might be due to a blocked artery. As with the executive, the cardiologist recommended a catheter. Unlike the executive, however, this man, like most patients, agreed to the procedure. It revealed a partial blockage of one coronary artery. So, doctors implanted a stent, even though there was no clear evidence that the blockage was responsible for the man’s shortness of breath — which was, in fact, caused by the lung scarring. Finally, the man was put on standard post-implantation medications to make sure he would not develop a blood clot at the site of the stent. But those medications made surgery potentially lethal, putting the man at an extremely high risk of bleeding to death during the transplant. The operation had to be delayed.

Meanwhile, the man’s lung tissue continued to harden and scar, like molten lava that cools and hardens into gray stone. Until one day, he couldn’t suck in another breath. The man had survived advanced-stage lymphoma only to die in the hospital, waiting until he could go off needed medication for an unneeded stent.

~~~

WHAT THE PATIENTS IN BOTH STORIES had in common was that neither needed a stent. By dint of an inquiring mind and a smartphone, one escaped with his life intact. The greater concern is: How can a procedure so contraindicated by research be so common?

When you visit a doctor, you probably assume the treatment you receive is backed by evidence from medical research. Surely, the drug you’re prescribed or the surgery you’ll undergo wouldn’t be so common if it didn’t work, right?

For all the truly wondrous developments of modern medicine — imaging technologies that enable precision surgery, routine organ transplants, care that transforms premature infants into perfectly healthy kids, and remarkable chemotherapy treatments, to name a few — it is distressingly ordinary for patients to get treatments that research has shown are ineffective or even dangerous. Sometimes doctors simply haven’t kept up with the science. Other times doctors know the state of play perfectly well but continue to deliver these treatments because it’s profitable — or even because they’re popular and patients demand them. Some procedures are implemented based on studies that did not prove whether they really worked in the first place. Others were initially supported by evidence but then were contradicted by better evidence, and yet these procedures have remained the standards of care for years, or decades.

Even if a drug you take was studied in thousands of people and shown truly to save lives, chances are it won’t do that for you. The good news is, it probably won’t harm you, either. Some of the most widely prescribed medications do little of anything meaningful, good or bad, for most people who take them.

In a 2013 study, a dozen doctors from around the country examined all 363 articles published in The New England Journal of Medicine over a decade — 2001 through 2010 — that tested a current clinical practice, from the use of antibiotics to treat people with persistent Lyme disease symptoms (didn’t help) to the use of specialized sponges for preventing infections in patients having colorectal surgery (caused more infections). Their results, published in the Mayo Clinic Proceedings, found 146 studies that proved or strongly suggested that a current standard practice either had no benefit at all or was inferior to the practice it replaced; 138 articles supported the efficacy of an existing practice, and the remaining 79 were deemed inconclusive. (There was, naturally, plenty of disagreement with the authors’ conclusions.) Some of the contradicted practices possibly affect millions of people daily: Intensive medication to keep blood pressure very low in diabetic patients caused more side effects and was no better at preventing heart attacks or death than more mild treatments that allowed for a somewhat higher blood pressure. Other practices challenged by the study are less common — like the use of a genetic test to determine if a popular blood thinner is right for a particular patient — but gaining in popularity despite mounting contrary evidence. Some examples defy intuition: CPR is no more effective with rescue breathing than if chest compressions are used alone; and breast-cancer survivors who are told not to lift weights with swollen limbs actually should lift weights, because it improves their symptoms.

A separate but similarly themed study in 2012 funded by the Australian Department of Health and Ageing, which sought to reduce spending on needless procedures, looked across the same decade and identified 156 active medical practices that are probably unsafe or ineffective. The list goes on: A brand new review of 48 separate studies — comprising more than 13,000 clinicians — looked at how doctors perceive disease-screening tests and found that they tend to underestimate the potential harms of screening and overestimate the potential benefits; an editorial in American Family Physician, co-written by one of the journal’s editors, noted that a “striking feature” of recent research is how much of it contradicts traditional medical opinion.

That isn’t likely to change any time soon. The 21st Century Cures Act — a rare bipartisan bill, pushed by more than 1,400 lobbyists and signed into law in December — lowers evidentiary standards for new uses of drugs and for marketing and approval of some medical devices. Furthermore, last month President Donald Trump scolded the FDA for what he characterized as withholding drugs from dying patients. He promised to slash regulations “big league. … It could even be up to 80 percent” of current FDA regulations, he said. To that end, one of the president’s top candidates to head the FDA, tech investor Jim O’Neill, has openly advocated for drugs to be approved before they’re shown to work. “Let people start using them at their own risk,” O’Neill has argued.
Stents for stable patients prevent zero heart attacks and extend the lives of patients a grand total of not at all.
So, while Americans can expect to see more drugs and devices sped to those who need them, they should also expect the problem of therapies based on flimsy evidence to accelerate. In a recent Stat op-ed, two Johns Hopkins University physician-researchers wrote that the new 21st Century Cures Act will turn the label “FDA approved” into “a shadow of its former self.” In 1962, Congress famously raised the evidentiary bar for drug approvals after thousands of babies were born with malformed limbs to mothers who had taken the sleep aid thalidomide. Steven Galson, a retired rear admiral and former acting surgeon general under both President George W. Bush and President Barack Obama, has called the strengthened approval process created in 1962 the FDA’s “biggest contribution to health.” Before that, he said, “many marketed drugs were ineffective for their labeled uses.”

Striking the right balance between innovation and regulation is incredibly difficult, but once remedies are in use — even in the face of contrary evidence — they tend to persist. A 2007 Journal of the American Medical Association paper coauthored by John Ioannidis — a Stanford University medical researcher and statistician who rose to prominence exposing poor-quality medical science — found that it took 10 years for large swaths of the medical community to stop referencing popular practices after their efficacy was unequivocally vanquished by science.

According to Vinay Prasad, an oncologist and one of the authors of the Mayo Clinic Proceedings paper, medicine is quick to adopt practices based on shaky evidence but slow to drop them once they’ve been blown up by solid proof. As a young doctor, Prasad had an experience that left him determined to banish ineffective procedures. He was the medical resident on a team caring for a middle-aged woman with stable chest pain. She underwent a stent procedure and suffered a stroke, resulting in brain damage. Prasad, now at the Oregon Health and Sciences University, still winces slightly when he talks about it. University of Chicago professor and physician Adam Cifu had a similar experience. Cifu had spent several years convincing newly postmenopausal patients to go on hormone therapy for heart health — a treatment that at the millennium accounted for 90 million annual prescriptions — only to then see a well-designed trial show no heart benefit and perhaps even a risk of harm. “I had to basically run back all those decisions with women,” he says. “And, boy, that really sticks with you, when you have patients saying, ‘But I thought you said this was the right thing.’” So he and Prasad coauthored a 2015 book, “Ending Medical Reversal,” a call to raise the evidence bar for adopting new medical standards. “We have a culture where we reward discovery; we don’t reward replication,” Prasad says, referring to the process of retesting initial scientific findings to make sure they’re valid.

Steven Nissen, chairman of cardiovascular medicine at the Cleveland Clinic, says the situation with stents, at least, is improving. As a previous president of the American College of Cardiology, he helped create guidelines for determining when a stable patient might be a reasonable candidate for a stent. (Both Nissen and David Holmes, a Mayo Clinic cardiologist and also a former ACC president, said that in cases in which patients have had bad responses to medication and persistent, life-altering chest pain, even a short-term reduction of symptoms may justify a stent.) Thanks to such guidelines, the frequency of clearly inappropriate stent placement declined significantly between 2010 and 2014. Still, the latest assessment in more than 1,600 hospitals across the country concluded that about half of all stent placements in stable patients were either definitely or possibly inappropriate. “Things have gotten better,” Nissen says, “but they’re not where they need to be.” Nissen thinks removing financial incentives can also help change behavior. “I have a dozen or so cardiologists, and they get the exact same salary whether they put in a stent or don’t,” Nissen says, “and I think that’s made a difference and kept our rates of unnecessary procedures low.”

Adam Cifu, a physician and University of Chicago professor, has studied the leaps medical researchers often make — without sufficient evidence — from observations to assuming a clear cause-and-effect to implementing a clinical practice that later turns out not to work. (Taylor Glascock for ProPublica)
Two years ago, a trio of Bloomberg journalists reported that Mount Sinai Hospital in New York City was scheduling “emergencies-by-appointment” for patients to get stents, because, the report said, insurance is more likely to cover the procedure in an emergency situation. (For a patient who is having a heart attack, a stent can be life-saving.) Mount Sinai’s catheter lab features annual reports that boast of how many stents are implanted, alongside patient testimonials, like one from 77-year-old Nelly Rodriguez, who notes that her doctor “reassures me that as long as I follow his instructions, eat healthy, and remain smoke-free, the stents he has put into my arteries over the years should last and I will feel well.” In most cases, every word of that sentence between “smoke-free” and “I will feel well” could be deleted and it would be just as true.

It is, of course, hard to get people in any profession to do the right thing when they’re paid to do the wrong thing. But there’s more to this than market perversion. On a recent snowy St. Louis morning, Brown gave a grand-rounds lecture to about 80 doctors at Barnes Jewish Hospital. Early in the talk, he showed results from medical tests on the executive he treated, the one who avoided a stent. He then presented data from thousands of patients in randomized controlled trials of stents versus noninvasive treatments, and it showed that stents yielded no benefit for stable patients. He asked the doctors in the room to raise their hands if they would still send a patient with the same diagnostic findings as the executive for a catheterization, which would almost surely lead to a stent. At least half of the hands in the room went up, some of them sheepishly. Brown expressed surprise at the honesty in the room. “Well,” one of the attendees told him, “we know what we do.” But why?

In 2007, after a seminal study, the COURAGE trial, showed that stents did not prevent heart attacks or death in stable patients, a trio of doctors at the University of California, San Francisco, conducted 90-minute focus groups with cardiologists to answer that question. They presented the cardiologists with fictional scenarios of patients who had at least one narrowed artery but no symptoms and asked them if they would recommend a stent. Almost to a person, the cardiologists, including those whose incomes were not tied to tests and procedures, gave the same answers: They said that they were aware of the data but would still send the patient for a stent. The rationalizations in each focus group followed four themes: (1) Cardiologists recalled stories of people dying suddenly — including the highly publicized case of jogging guru Jim Fixx — and feared they would regret it if a patient did not get a stent and then dropped dead. The study authors concluded that cardiologists were being influenced by the “availability heuristic,” a term coined by Nobel laureate psychologists Amos Tversky and Daniel Kahneman for the human instinct to base an important decision on an easily recalled, dramatic example, even if that example is irrelevant or incredibly rare. (2) Cardiologists believed that a stent would relieve patient anxiety. (3) Cardiologists felt they could better defend themselves in a lawsuit if a patient did get a stent and then died, rather than if they didn’t get a stent and died. “In California,” one said, “if this person had an event within two years, the doctor who didn’t intervene would be successfully sued.” And there was one more powerful and ubiquitous reason: (4) Despite the data, cardiologists couldn’t believe that stents did not help: Stenting just made so much sense. A patient has chest pain, a doctor sees a blockage, how can opening the blockage not make a difference?

In the late 1980s, with evidence already mounting that forcing open blood vessels was less effective and more dangerous than noninvasive treatments, cardiologist Eric Topol coined the term, “oculostenotic reflex.” Oculo, from the Latin for “eye,” and stenotic, from the Greek for “narrow,” as in a narrowed artery. The meaning: If you see a blockage, you’ll reflexively fix a blockage. Topol described “what appears to be an irresistible temptation among some invasive cardiologists” to place a stent any time they see a narrowed artery, evidence from thousands of patients in randomized trials be damned. Stenting is what scientists call “bio-plausible” — intuition suggests it should work. It’s just that the human body is a little more Book of Job and a little less household plumbing: Humans didn’t invent it, it’s really complicated, and people often have remarkably little insight into cause and effect.

CHANCES ARE, you or someone in your family has taken medication or undergone a procedure that is bio-plausible but does not work.

According to the Centers for Disease Control and Prevention, about one in three American adults have high blood pressure. Blood pressure is a measure of how hard your blood is pushing on the sides of vessels as it moves through your body; the harder the pushing, the more strain on your heart. People with high blood pressure are at enormously increased risk for heart disease (the nation’s No. 1 killer) and stroke (No. 3).

Blood Hipressure_measurement_(2009)

Measuring blood pressure Photo: Creative Commons/Wikipedia

So it’s not hard to understand why Sir James Black won a Nobel Prize largely for his 1960s discovery of beta-blockers, which slow the heart rate and reduce blood pressure. The Nobel committee lauded the discovery as the “greatest breakthrough when it comes to pharmaceuticals against heart illness since the discovery of digitalis 200 years ago.” In 1981, the FDA approved one of the first beta-blockers, atenolol, after it was shown to dramatically lower blood pressure. Atenolol became such a standard treatment that it was used as a reference drug for comparison with other blood-pressure drugs.
In 1997, a Swedish hospital began a trial of more than 9,000 patients with high blood pressure who were randomly assigned to take either atenolol or a competitor drug that was designed to lower blood pressure for at least four years. The competitor-drug group had fewer deaths (204) than the atenolol group (234) and fewer strokes (232 compared with 309). But the study also found that both drugs lowered blood pressure by the exact same amount, so why wasn’t the vaunted atenolol saving more people? That odd result prompted a subsequent study, which compared atenolol with sugar pills. It found that atenolol didn’t prevent heart attacks or extend life at all; it just lowered blood pressure. A 2004 analysis of clinical trials — including eight randomized controlled trials comprising more than 24,000 patients — concluded that atenolol did not reduce heart attacks or deaths compared with using no treatment whatsoever; patients on atenolol just had better blood-pressure numbers when they died.

“Yes, we can move a number, but that doesn’t necessarily translate to better outcomes,” says John Mandrola, a cardiac electrophysiologist in Louisville who advocates for healthy lifestyle changes. It’s tough, he says, “when patients take a pill, see their numbers improve, and think their health is improved.”

The overall picture of beta-blockers is complex. For example, some beta-blockers have been shown clearly to reduce the chance of a stroke or heart attack in patients with heart failure. But the latest review of beta-blockers from the Cochrane Collaboration — an independent, international group of researchers that attempts to synthesize the best available research — reported that they “are not recommended as first line treatment for hypertension as compared to placebo due to their modest effect on stroke and no significant reduction in mortality or coronary heart disease.”

Researchers writing in Lancet questioned the use of atenolol as a comparison standard for other drugs and added that “stroke was also more frequent with atenolol treatment” compared with other therapies. Still, according to a 2012 study in the Journal of the American Medical Association, more than 33.8 million prescriptions of atenolol were written at a retail cost of more than $260 million. There is some evidence that atenolol might reduce the risk of stroke in young patients, but there is also evidence that it increases the risk of stroke in older patients — and it is older patients who are getting it en masse. According to ProPublica’s Medicare prescription database, in 2014, atenolol was prescribed to more than 2.6 million Medicare beneficiaries, ranking it the 31st most prescribed drug out of 3,362 drugs. One doctor, Chinh Huynh, a family practitioner in Westminster, California, wrote more than 1,100 atenolol prescriptions in 2014 for patients over 65, making him one of the most prolific prescribers in the country. Reached at his office, Huynh said atenolol is “very common for hypertension; it’s not just me.” When asked why he continues to prescribe atenolol so frequently in light of the randomized, controlled trials that showed its ineffectiveness, Huynh said, “I read a lot of medical magazines, but I didn’t see that.” Huynh added that his “patients are doing fine with it” and asked that any relevant journal articles be faxed to him.

Brown, the Washington University cardiologist, says that once doctors get out of training, “it’s a job, and they’re trying to earn money, and they don’t necessarily keep up. So really major changes have to be generational.”

Data compiled by QuintilesIMS, which provides information and technology services to the health-care industry, show that atenolol prescriptions consistently fell by 3 million per year over a recent five-year period. If that rate holds, atenolol will stop being prescribed in just under two decades since high-quality trials showed that it simply does not work.
Atenolol did not reduce any more heart attacks or deaths than using no treatment whatsoever; patients on atenolol just had better blood-pressure numbers when they died.

JUST AS THE CARDIOVASCULAR SYSTEM is not a kitchen sink, the musculoskeletal system is not an erector set. Cause and effect is frequently elusive.

Consider the knee, that most bedeviling of joints. A procedure known as arthroscopic partial meniscectomy, or APM, accounts for roughly a half-million procedures per year at a cost of around $4 billion. A meniscus is a crescent-shaped piece of fibrous cartilage that helps stabilize and provide cushioning for the knee joint. As people age, they often suffer tears in the meniscus that are not from any acute injury. APM is meant to relieve knee pain by cleaning out damaged pieces of a meniscus and shaving the cartilage back to crescent form. This is not a fringe surgery; in recent years, it has been one of the most popular surgical procedures in the hemisphere. And a burgeoning body of evidence says that it does not work for the most common varieties of knee pain.

Something like the knee version of the oculostenotic reflex takes hold: A patient comes in with knee pain, and an MRI shows a torn meniscus; naturally, the patient wants it fixed, and the surgeon wants to fix it and send the patient for physical therapy. And patients do get better, just not necessarily from the surgery.

A 2013 study of patients over 45 conducted in seven hospitals in the United States found that APM followed by physical therapy produced the same results as physical therapy alone for most patients. Another study at two public hospitals and two physical-therapy clinics found the same result two years after treatment.

A unique study at five orthopedic clinics in Finland compared APM with “sham surgery.” That is, surgeons took patients with knee pain to operating rooms, made incisions, faked surgeries, and then sewed them back up. Neither the patients nor the doctors evaluating them knew who had received real surgeries and who was sporting a souvenir scar. A year later, there was nothing to tell them apart. The sham surgery performed just as well as real surgery. Except that, in the long run, the real surgery may increase the risk of knee osteoarthritis. Also, it’s expensive, and, while APM is exceedingly safe, surgery plus physical therapy has a greater risk of side effects than just physical therapy.

At least one-third of adults over 50 will show meniscal tears if they get an MRI. But two-thirds of those will have no symptoms whatsoever. (For those who do have pain, it may be from osteoarthritis, not the meniscus tear.) They would never know they had a tear if not for medical imaging, but once they have the imaging, they may well end up having surgery that doesn’t work for a problem they don’t have.

For obvious reasons, placebo-controlled trials of surgeries are difficult to execute. The most important question then is: Why, when the highest level of evidence available contradicts a common practice, does little change?

For one, the results of these studies do not prove that the surgery is useless, but rather that it is performed on a huge number of people who are unlikely to get any benefit. Meniscal tears are as diverse as the human beings they belong to, and even large studies will never capture all the variation that surgeons see; there are compelling real-world results that show the surgery helps certain patients. “I think it’s an extremely helpful intervention in cases where a patient does not suffer from the constant ache of arthritis, but has sharp, intermittent pain and a blockage of motion,” says John Christoforetti, a prominent orthopedic surgeon in Pittsburgh. “But when you’re talking about the average inactive American, who suffers gradual onset knee pain and has full motion, many of them have a meniscal tear on MRI and they should not have surgery as initial treatment.”

Still, the surgery — like some others meant for narrower uses — is common even for patients who don’t need it. And patients themselves are part of the problem. According to interviews with surgeons, many patients they see want, or even demand, to be operated upon and will simply shop around until they find a willing doctor. Christoforetti recalls one patient who traveled a long way to see him but was “absolutely not a candidate for an operation.” Despite the financial incentive to operate, he explained to the patient and her husband that the surgery would not help. “She left with a smile on her face,” Christoforetti says, “but literally as they’re checking out, we got a ding that someone had rated us [on a website], and it’s her husband. He’s been typing on his phone during the visit, and it’s a one-star rating that I’m this insensitive guy he wouldn’t let operate on his dog. They’d been online, and they firmly believed she needed this one operation and I was the guy to do it.”

So, what do surgeons do? “Most of my colleagues,” Christoforetti says, “will say: ‘Look, save yourself the headache, just do the surgery. None of us are going to be upset with you for doing the surgery. Your bank account’s not going to be upset with you for doing the surgery. Just do the surgery.’”

~~~

RANDOMIZED, PLACEBO-CONTROLLED TRIALS are the gold standard of medical evidence. But not all RCTs, as they are known, are created equal. Even within the gold standard, well-intentioned practices can muddle a study. That is particularly true with “crossover” trials, which have become popular for cancer-drug investigations.

In cancer research, a crossover trial often means that patients in the control group, who start on a placebo, are actually given the experimental drug during the study if their disease progresses. Thus, they are no longer a true control group. The benefit of a crossover trial is that it allows more people with severe disease to try an experimental drug; the disadvantage is the possibility that the study is altered in a manner that obscures the efficacy of the drug being tested.

In 2010, on the strength of a crossover trial, Provenge became the first cancer vaccineapproved by the FDA. A cancer vaccine is a form of immunotherapy, in which a patient’s own immune system is spurred by a drug to attack cancer cells. Given the extraordinary difficulty of treating metastatic cancer, and high expectations following the abject failureof other cancer vaccines, the approval of Provenge was greeted with ecstatic enthusiasm. One scientific paper heralded it as “the gateway to an exciting new paradigm.” Except, Provenge did not hinder tumor growth at all, and it’s hard to know if it really works.

Provenge was approved based on the “IMPACT study,” a randomized, placebo-controlled trial initially meant to see whether Provenge could stop prostate cancer from progressing. It didn’t. Three-and-a-half months into the study, the cancers of patients who had received Provenge and those who had received a placebo had advanced similarly. Nonetheless, patients who received Provenge ultimately had a median survival time of about four months longer than those who received the placebo. Due to the way in which the IMPACT trial unfolded, however, it’s hard to tell if Provenge was truly responsible for the life extension.

Because Provenge did not halt tumor growth, many of the patients who began the study on it also started to receive docetaxel, a chemotherapy drug that is well established to treat advanced prostate cancer. The cancers of the patients on a placebo were also progressing, so they were “crossed over” and given Provenge after a delay. Their cancer continued progressing, and after another delay, many of them also got docetaxel. In the end, fewer patients in the group that started on a placebo received docetaxel, and, when they did, they got it later in the study. So Provenge may have worked, but it’s impossible to tell for sure: Was the slightly longer survival of one group because they got Provenge earlier or because the other group got docetaxel later?

Vinay Prasad, a hematologist and oncologist, was influenced by a case early in his career in which a woman suffered permanent damage during an unnecessary procedure. He has become a strident critic of weak methodologies in medical research. (Thomas Patterson for ProPublica)
The year after Provenge was approved, the federal government’s Agency for Healthcare Research and Quality issued a “technology assessment” report examining all of the evidence regarding Provenge efficacy. The report says there is “moderate” evidence that Provenge effectively treats cancer, but it also highlighted the fact that more patients who got Provenge at the beginning of the seminal trial also received more and earlier chemotherapy. The report concludes that the effect of Provenge is apparent “only in the context of a substantial amount of eventual chemotherapeutic treatment.” In other words, it is unclear which effects in the trial were due to Provenge and which were due to chemotherapy.

“The people who went on docetaxel went on it because their disease was progressing, so you’ve already broken the randomization,” says Elise Berliner, director of AHRQ’s Technology Assessment Program. Prasad, the oncologist who advocates for higher standards of preapproval evidence, is less diplomatic: “If the treatment were Pixy Stix, you’d have a similar effect. One group gets Pixy Stix, and when their cancer progresses, they get a real treatment.”

The larger issue has nothing to do with Provenge specifically but about the way it gained FDA approval. Therapies are frequently approved for use based on clinical trials that can’t actually prove whether they work. “Clinical trials almost all have issues like this one,” Berliner says, “and it’s very hard to do randomized controlled trials after drugs are approved.” According to a new paper in the Journal of the American Medical Association Oncology, even when cancer drugs clearly do work in trials, they often don’t work or work substantially less well in the real world, perhaps because subjects in trials are not representative of typical patients. Berliner is hoping to expand and improve registries that track large numbers of real-world patients as an additional source of information. “I’ve been here for 15 years producing these reports,” she says, “and I’m getting frustrated.”
“Just do the surgery. None of us are going to be upset with you for doing the surgery. Your bank account’s not going to be upset with you for doing the surgery. Just do the surgery.”

~~~

IDEALLY, FINDINGS THAT SUGGEST a therapy works and those that suggest it does not would receive attention commensurate with their scientific rigor, even in the earliest stages of exploration. But academic journals, scientists, and the media all tend to prefer research that concludes that some exciting new treatment does indeed work.

In 2012, a team of scientists from UCLA published an article in the prominent New England Journal of Medicine, the most cited medical journal in the world, showing that deep brain stimulation — delivered via electrodes implanted in the brains of Parkinson’s patients — improved spatial memory, a lot. The study was understandably small — just seven subjects — as there are only so many people with electrodes already implanted in their brains. It was covered in outlets like The New York Times (“Study Explores Electrical Stimulation as An Aid to Memory”), The Wall Street Journal (“Memory Gets Jolt in Brain Research”), and LiveScience (“Where Did I Park? Brain Treatment May Enhance Spatial Memory”). The NEJM itself published an editorial in the same issue noting that the study was “preliminary, is based on small samples, and requires replication” but was worth following up with “well-designed studies.”

Given the potential impact, an international team led by Joshua Jacobs, a biomedical-engineering professor at Columbia University, set out to replicate the initial finding with a larger sample. “If it did indeed work, it would be a very important approach that could help people,” Jacobs says. The team took several years and tested 49 subjects, so that their study would give more statistically reliable results. The scientists were rather stunned to find that deep brain stimulation actually impaired spatial memory in their study. It was a disappointing result, but they were encouraged to show that brain stimulation could affect memory at all — a step toward figuring out how to wield such technology — and they felt an obligation to submit it to the NEJM. That is how science is supposed to work, after all, because failing to publish negative results is recognized to be a massive source of scientific misinformation.

~~~

REPLICATION OF RESULTS in science was a cause-célèbre last year, due to the growing realization that researchers have been unable to duplicate a lot of high-profile results. A decade ago, Stanford’s Ioannidis published a paper warning the scientific community that “Most Published Research Findings Are False.” (In 2012, he coauthored a paper showing that pretty much everything in your fridge has been found to both cause and prevent cancer — except bacon, which apparently only causes cancer.) Ioannidis’s prescience led his paper to be cited in other scientific articles more than 800 times in 2016 alone. Point being, sensitivity in the scientific community to replication problems is at an all-time high. So Jacobs and his coauthors were bemused when the NEJM rejected their paper.

One of the reviewers (peer reviewers are anonymous) who rejected the paper gave this feedback: “Much more interesting would have been to find a set of stimulation parameters that would enhance memory.” In other words: The paper would be better if, like the original study, it had found a positive rather than a negative result. (Last spring, ProPublica wrote about heavy criticism of the NEJM’s reluctance to publish research that questioned earlier findings.) Another reviewer noted that electrodes were placed on most of the subjects differently in the replication study compared with those in the original study. So Jacobs and his coauthors analyzed results only from patients with the exact same electrode placement as the original study, and the findings were the same. Three of the authors wrote back to the NEJM, pointing out errors in the reviewer comments; they received a short note back saying that the paper rejection “was not based on the specific comments of the reviewers you discuss in your response letter” and that the journal gets many more papers than it can print. That is, of course, very true, particularly for important journals. Neuron, one of the most prominent neuroscience-specific journals, quickly accepted the paper and published it last month. (It did not receive the media fanfare of the original paper — or almost any at all — although The Wall Street Journal did cover it.)

The same week the paper appeared in Neuron, Columbia University held a daylong symposium to discuss the replication problem in science. The president of the National Academy of Sciences and the director of the U.S. Office of Research Integrity spoke — so too did Jeffrey Drazen, editor-in-chief of the NEJM. Jacobs was in the audience.

In the final Q&A, Jacobs stepped up to one of the audience microphones and asked Drazen if journals had an obligation to publish high-quality replication attempts of prominent studies, and he disclosed that his team’s had been rejected by the NEJM. Drazen declined to discuss Jacobs’s paper, but he said that “as editors, we’re powerless,” and the onus should be on the replication researchers, or “the complainant,” as he put it, “and the original paper author to work together toward the truth. We’re not trying to say who’s right and who’s wrong; we’re trying to find out what we need to know. Veritas, to advance human health, it’s that simple.”

Jacobs did not find the answer that simple. He found it strange. On a panel about transparency and replication, Drazen seemed to be saying that journals, the main method of information dissemination and the primary forum for replication in science, could do little and that “complainants” need to sort it out with de facto defendants. Many doctors, scientists, patient advocates, and science writers keep track of new developments through premier publications like the NEJM. The less publicly a shaky scientific finding is challenged, the more likely it becomes entrenched common knowledge.

~~~

OF COURSE, MYRIAD MEDICAL INNOVATIONS improve and save lives, but even as scientists push the cutting edge (and expense) of medicine, the National Center for Health Statistics reported last month that American life expectancy dropped, slightly. There is, though, something that does powerfully and assuredly bolster life expectancy: sustained public-health initiatives.

Medicine can be like wine: Expense is sometimes a false signal of quality. On an epochal scale, even the greatest triumphs of modern medicine, like the polio vaccine, had a small impact on human health compared with the impact of better techniques for sanitation and food preservation. Due to smoking and poor lifestyle habits, lung cancer — which killed almost no Americans in the early 20th century — is today by far the biggest killeramong cancers. Thankfully, public pressure to curb smoking has put lung-cancer deaths in rapid decline since a peak in the 1990s. Deaths from lung cancer should continue to diminish, as they are tightly correlated to smoking rates — but with a 20-year lag; that is, lung cancer deaths will decline 20 years after smoking rates decline.

The health problems that most commonly afflict the American public are largely driven by lifestyle habits—smoking, poor nutrition, and lack of physical activity, among others. In November, a team led by researchers at Massachusetts General Hospital pooled data from tens of thousands of people in four separate health studies from 1987 to 2008. They found that simple, moderate lifestyle changes dramatically reduced the risk of heart disease, the most prolific killer in the country, responsible for one in every four deaths. People deemed at high familial risk of heart disease cut their risk in half if they satisfied three of the following four criteria: didn’t smoke (even if they smoked in the past); weren’t obese (although they could be overweight); exercised once a week; ate more real food and less processed food. Fitting even two of those categories still substantially decreased risk. In August, a report issued by the International Agency for Research on Cancer concluded that obesity is now linked to an extraordinary variety of cancers, from thyroids and ovaries to livers and colons.
“Relative risk is just another way of lying.”

~~~

AT THE SAME TIME, patients and even doctors themselves are sometimes unsure of just how effective common treatments are, or how to appropriately measure and express such things. Graham Walker, an emergency physician in San Francisco, co-runs a website staffed by doctor volunteers called the NNT that helps doctors and patients understand how impactful drugs are — and often are not. “NNT” is an abbreviation for “number needed to treat,” as in: How many patients need to be treated with a drug or procedure for one patient to get the hoped-for benefit? In almost all popular media, the effects of a drug are reported by relative risk reduction. To use a fictional illness, for example, say you hear on the radio that a drug reduces your risk of dying from Hogwart’s disease by 20 percent, which sounds pretty good. Except, that means if 10 in 1,000 people who get Hogwart’s disease normally die from it, and every single patient goes on the drug, eight in 1,000 will die from Hogwart’s disease. So, for every 500 patients who get the drug, one will be spared death by Hogwart’s disease. Hence, the NNT is 500. That might sound fine, but if the drug’s “NNH” — “number needed to harm” — is, say, 20 and the unwanted side effect is severe, then 25 patients suffer serious harm for each one who is saved. Suddenly, the trade-off looks grim.

Now, consider a real and familiar drug: aspirin. For elderly women who take it daily for a year to prevent a first heart attack, aspirin has an estimated NNT of 872 and an NNH of 436. That means if 1,000 elderly women take aspirin daily for a decade, 11 of them will avoid a heart attack; meanwhile, twice that many will suffer a major gastrointestinal bleeding event that would not have occurred if they hadn’t been taking aspirin. As with most drugs, though, aspirin will not cause anything particularly good or bad for the vast majority of people who take it. That is the theme of the medicine in your cabinet: It likely isn’t significantly harming or helping you. “Most people struggle with the idea that medicine is all about probability,” says Aron Sousa, an internist and senior associate dean at Michigan State University’s medical school. As to the more common metric, relative risk, “it’s horrible,” Sousa says. “It’s not just drug companies that use it; physicians use it, too. They want their work to look more useful, and they genuinely think patients need to take this [drug], and relative risk is more compelling than NNT. Relative risk is just another way of lying.”
A Different Way to Think About Medicine

For every 100 older adults who take a sleep aid, 7 will experience improved sleep, while 17 will suffer side effects that range widely in severity, from simple morning “hangover” to memory loss and serious accidents. As with many medications, most who take a sleep aid will experience neither benefit nor harm.
=Effective=No Benefit or Harm=Harmful
Source: Adapted from a Waitemata District Health Board handout, based on data from Glass et. al. BMJ (2005) “Sedative hypnotics in older people with insomnia: meta-analysis of risks and benefits”

Even remedies that work extraordinarily well can be less impressive when viewed via NNT. Antibiotics for a sinus infection will resolve symptoms faster in one of 15 people who get them, while one in eight will experience side effects. A meta-analysis of sleep-aid drugs in older adults found that for every 13 people who took a sedative, like Ambien, one had improved sleep — about 25 minutes per night on average — while one in six experienced a negative side effect, with the most serious being increased risk for car accidents.

“There’s this cognitive dissonance, or almost professional depression,” Walker says. “You think, ‘Oh my gosh, I’m a doctor, I’m going to give all these drugs because they help people.’ But I’ve almost become more fatalistic, especially in emergency medicine.” If we really wanted to make a big impact on a large number of people, Walker says, “we’d be doing a lot more diet and exercise and lifestyle stuff. That was by far the hardest thing for me to conceptually appreciate before I really started looking at studies critically.”

Historians of public health know that most of the life-expectancy improvements in the last two centuries stem from innovations in sanitation, food storage, quarantines, and so on. The so-called “First Public Health Revolution” — from 1880 to 1920 — saw the biggest lifespan increase, predating antibiotics or modern surgery.

In the 1990s, the American Cancer Society’s board of directors put out a national challenge to cut cancer rates from a peak in 1990. Encouragingly, deaths in the United States from all types of cancer since then have been falling. Still, American men have a ways to go to return to 1930s levels. Medical innovation has certainly helped; it’s just that public health has more often been the society-wide game changer. Most people just don’t believe it.

In 2014, two researchers at Brigham Young University surveyed Americans and found that typical adults attributed about 80 percent of the increase in life expectancy since the mid-1800s to modern medicine. “The public grossly overestimates how much of our increased life expectancy should be attributed to medical care,” they wrote, “and is largely unaware of the critical role played by public health and improved social conditions determinants.” This perception, they continued, might hinder funding for public health, and it “may also contribute to overfunding the medical sector of the economy and impede efforts to contain health care costs.”

It is a loaded claim. But consider the $6.3 billion 21st Century Cures Act, which recently passed Congress to widespread acclaim. Who can argue with a law created in part to bolster cancer research? Among others, the heads of the American Academy of Family Physicians and the American Public Health Association. They argue against the new law because it will take $3.5 billion away from public-health efforts in order to fund research on new medical technology and drugs, including former Vice President Joe Biden’s “cancer moonshot.” The new law takes money from programs — like vaccination and smoking-cessation efforts — that are known to prevent disease and moves it to work that might, eventually, treat disease. The bill will also allow the FDA to approve new uses for drugs based on observational studies or even “summary-level reviews” of data submitted by pharmaceutical companies. Prasad has been a particularly trenchant and public critic, tweeting that “the only people who don’t like the bill are people who study drug approval, safety, and who aren’t paid by Pharma.”

Perhaps that’s social-media hyperbole. Medical research is, by nature, an incremental quest for knowledge; initially exploring avenues that quickly become dead ends are a feature, not a bug, in the process. Hopefully the new law will in fact help speed into existence cures that are effective and long-lived. But one lesson of modern medicine should by now be clear: Ineffective cures can be long-lived, too.

Creative Commons

This story was co-published by ProPublica with The Atlantic. Read the original story here. 

David Epstein has covered science and medicine issues as well as sports science. Prior to joining ProPublica, he was a senior writer at Sports Illustrated.

Listen to the story here:

 ~~~

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Chronic pain fuels opioid epidemic

Pain. Artist: Harrygouvas, via Greek Wikipedia. Creative Commons

Pain. Artist: Harrygouvas, via Greek Wikipedia. Creative Commons

PENNEY KOME: OVER EASY
January, 2017

Of all the stories I’ve seen about the prescription opioid epidemic, only a few touch briefly and lightly on the major factor driving all the prescriptions — chronic pain — before they skip on to recommend better patient and physician education.

“For 20 years, doctors have prescribed opioids — drugs such as oxycodone, hydromorphone, fentanyl and others — liberally for chronic pain, one of the most common problems we see.” wrote David Juurlink, head of the University of Toronto’ pharmacology department, in a Globe and Mail op-ed piece.

“Chronic pain not caused by cancer is among the most prevalent and debilitating medical conditions,” said a New England Journal of Medicine (NEJM) article, “but also among the most controversial and complex to manage.”

“Chronic pain is a major public health problem,” said an article from the U.S. National Institutes of Health, “which is associated with devastating consequences to patients and families, a high rate of health-care utilization, and huge society costs related to lost work productivity. The existing treatments for chronic pain are unable to address the problem and better therapies are urgently needed. The need for these therapies is the backdrop for the expanding use of opioid drugs.”

Chronic pain is not a given, it’s a catastrophe

Let’s define chronic pain as constant, incessant, stabbing, aching, throbbing, agonizing sensations that people live with day in and day out, with no hope they’ll ever get better. Between three and four out of every 10 Americans meet each day painfully. “More than 30 per cent of Americans have some form of acute or chronic pain,” says the NEJM. “Among older adults, the prevalence of chronic pain is more than 40 per cent.”

Here, for me, is where most reports start to lose perspective. The NIHI article continues, “Given the prevalence of chronic pain and its often disabling effects, it is not surprising that opioid analgesics are now the most commonly prescribed class of medications in the United States.” I take issue with practically every clause in this sentence.

First of all, having 40 per cent of the population in chronic pain is not a given, it’s a catastrophe. In Canada, the rate is half that — one in five adults, or 20 per cent, according to the Canadian Pain Society. European data is similar.

Second, prescribing opioids was not a natural or even logical result of these pain levels. A lot of medical people now regret that health care adopted a “fifth vital sign” policy during the 1990s, apparently as a result of military hospital concerns about veterans’ pain being undertreated. Administrators required any nurse who checked a patient’s four vital signs (pulse, temperature, heart rate and breathing rate), also to take “the fifth vital sign” and ask the patient to assess their pain. This well-intended practice almost inevitably led to more pain medication prescriptions. But that’s not how opioid prescriptions became standard medical practice in the U.S. Third, the American Journal of Public Health reports that one aggressive and deceitful company led the way in promoting opioids as safe for long-term use. Purdue Pharma introduced OxyContin during “a
period of liberalization” in prescribing narcotics, with highly profitable but socially disastrous results. Purdue also pioneered marketing directly to doctors, with paid trips and personal pitches.

“When Purdue Pharma introduced OxyContin in 1996, it was aggressively marketed and highly promoted. Sales grew from $48 million in 1996 to almost $1.1 billion in 2000. The high availability of OxyContin correlated with increased abuse, diversion, and addiction, and by 2004 OxyContin had become a leading drug of abuse in the United States.”

In a 2007 court settlement, Purdue agreed to pay the U.S. government a $160 million fine for fraudulently claiming that OxyContin was “abuse resistant,” because it was a time-released medication.

Finally, let’s get back to the chronic pain. In Canada, the main causes of chronic pain are shingles, surgery and fibromyaglia. In the U.S., causes include chronic respiratory issues, mental and substance abuse disorders and neurological disorders. Two of the main five causes are back pain and “musculoskeletal injuries” a term that usually includes conditions such as frozen shoulder, tendinitis, and yes, carpal tunnel syndrome.

The American Journal of Public Health article says chronic pain patients’ numbers started to increase during the 1980s. Doctors started prescribing opioids in the 1990s.

“Productivity” boosts come at a cost

Lest we forget, the 1980s introduced the computer revolution. As a freelance writer, I bought my first computer in 1982, a KayPro64, in a buying co-op with a group of other writers. About the same time, newsrooms all around the world introduced computers according to the best technical advice. By 1992, hundreds and thousands of journalists were reporting intense arm or shoulder pain, or losing the use of their hands.

“Work-related injuries, long the plague of those who do heavy manual labor, have become a scourge among white-collar workers, too,” Jane E. Brody reported in the New York Times in 1982. “Experts say hundreds of thousands of office workers are being disabled each year in an epidemic of motion-related damage to the hands and arms that is costing the nation many billions of dollars annually.”

The 80s also brought in deregulation, union-busting and constant pressure to increase “productivity.” “Productivity” in the business sense means increasing the value added by each employee’s work. In theory, employers can do this by providing mechanical aids, such as offering carts instead of expecting workers to carry loads on their backs.

In the digital age, though, increasing “productivity” usually means speeding up, adding more work or reducing wages and employment expenses. Thus we have supermarket scanners and cashiers wearing wrist braces.

A cashier with a scanner is more “productive” because one job replaces two other jobs, the bagger and the inventory clerk. However, the job’s design is inherently injurious, starting with the constant wrist-flip to push products over the scanner. One study calculated that a cashier who also bagged products, lifted an average of 11,000 pounds a day over the counter to customers. If the cashier walks around the counter to hand you a bag, she’s not being lazy — she’s probably nursing an aching elbow. These days supermarkets are hiring baggers again and installing self-serve cash desks.

Although white-collar workers suffered computer injuries, by far the majority of those affected by RSIs were (and still are) blue-collar factory workers and pink-collar service workers. Affected workers suffer excruciating back pain, red hot elbow pain, frozen shoulders that howl at the slightest attempt to reach out, wrists that throb and hands that tingle and often simply stop working. One radio reporter filed a story about how, suddenly, on a major expressway, her right hand couldn’t grip her steering wheel or steer her car.

Workers’ compensation costs skyrocketed in major urban states. In the U.S., statistics from the Occupational Safety and Health Administration (OSHA) and the Bureau of Labour Statistics (BLS) showed injury rates climbing and health costs soaring. Three per cent of lost time claims — due to repetitive motion injuries — cost 30 per cent of the compensation paid.

RSIs have proved difficult to treat, partly because they develop slowly, and mainly because — after treatment for injuries — most injured workers go back to the same jobs. Fixing the patient usually involves fixing the workplace, and that’s a very difficult project to sell in most workplaces if only one person is injured. Doctors have searched since the 1990s for cures, or at least pain relief. They were ready for a miracle cure.

As more and more workers were injured by repetitive motion, and filed complaints, unions like the (US) AFL-CIO negotiated for ergonomic improvements to their workplaces. Some employers recognized that inefficient workplaces caused the workers’ injuries.

Employers as different as Red Wing Shoes, Lilydaly poultry packers and General Motors brought in ergonomics experts, asked their workers to identify awkward spots and suggest solutions, and redesigned their workplaces to fit their workers, not the other way around. They quickly proved that working together with workers and installing ergonomic equipment more than repaid their investment, especially compared to the cost of one lifetime disability claim.

Most employers, however, balked. They balked at the investment, they balked at inviting in ergonomic consultants, and most of all they balked at sitting around a table taking advice from shop floor workers. Unless a limb swelled up like a balloon, they accused injured workers of malingering. They were already practicing Milton Friedman’s economics, which puts workers on the “liability” side of the spreadsheet, rather than seeing workers’ skills as assets.

As OSHA prepared ergonomics regulations that would have provided guidelines for confused US employers, a new cottage industry sprang up in opposition. Eugene Scalia, son of Supreme Court Justice Antonin Scalia, became known as “Mr Anti-Ergonomics.” He addressed employers’ conventions with scary stories about ergonomics costs and workers in charge of their companies. He crusaded against ergonomics rules not only at OSHA, but in Washington and other states that already included ergonomics in workers’ health and safety regulations. Since then, the Wall Street Journal reports, he has moved on to defending big banks against government regulation aimed at protecting consumers.

OSHA never was able to announce an ergonomics standard for industry, let alone offices. For office ergonomics, U.S. experts rely on the Canadian Standards Association (CSA) guidelines.

Worse, the George W. Bush administration solved the problem by banning any mention of RSIs. He ordered OSHA and BLS to stop tracking repetitive strain injuries (which they called MSDs, MusculoSkeletal Disorders), as they had been doing since 1970, when Richard Nixon signed OSHA into being. The rancour endures. In 2011, U.S. Chamber of Commerce opposition prevented reinstatement of an MSD column on the event-based OSHA incident report.

The Bureau of Labor Statistics, though, somehow continued to gather and report statistics, which are pretty consistent with 1990s figures.

For 2014, the BLS reported that MSDs accounted for nearly a third (32%) of all injury and illness cases. Women accounted for nearly four in 10 (39%) cases of days-away-from-work; they suffered more falls, intentional violence, and repetitive motion.

Gender is another factor — in both the 1990s MSD epidemic and the 2016 opioid epidemic, especially the drug poisoning deaths. Middle-aged women are over-represented in both groups, especially fatalities, which affect more white women. As I wrote last April, the US has to be the only place in the industrialized world to see an increase in mortality rates for mid-life white women.

In the 1990s, many medical articles dismissed any claim that linked workplace duties to invisible symptoms like pain — calling patients “hysterical” because complaints came mainly from women employees. Never mind that the women were doing intensely repetitive jobs while working at desks designed to fit men. Doctors diagnosed their pain as psychogenic, more related to unhappiness at home than to too-tall workstations.

Some of the current medical community discussion about opioid patients closely echoes that rhetoric. For example, the Cleveland Medical Clinic article about patients who use opioids states, “Risk factors are biologic, sociologic, psychological, and
environmental. It [opioid use] is more common in those with depression, anxiety, and substance-use disorders. Pain-associated disability is also more common in those from lower socioeconomic strata and in those who dislike their work or feel underpaid and unsupported at work.”

Let me play devil’s advocate here and suggest that most people with disabilities are already struggling to pay their bills, and to find honest jobs with decent wages. Moreover, people get injured at low-paid jobs because the jobs tend to involve heavy-duty,
labour-intensive work, whether the workers be hauling logs or laundry. Low-wage jobs also tend to be unprotected jobs, precarious work, outside labour legislation because they’re “independent contractors” or part-time workers at two or three jobs.

Most of all, low-wage jobs tend to be repetitive: hoeing vegetables, carrying trays, completing forms, cleaning bathrooms…workers do the same exact thing, over and over. Anybody stuck doing the same action over and over is liable to develop aches and pains. Just clicking a mouse with your forefinger all day can be enough to cause forearm tendinitis. Yet the endless push for productivity encourages employers to break jobs down into the simplest tasks, and have each worker do only one task, so the employer doesn’t have to pay for a skilled worker who can perform the entire task.

Prescribing opioids for soft tissue injuries, even for back pain, may seem like overkill. But that’s what happened. Sam Quinone’s book about the opiate crisis, Dreamland, begins with the story of Carol Wagner, whose “handsome, college-educated” son Chad developed carpal tunnel syndrome (an extreme aching wrist). His doctor prescribed OxyContin. Chad became addicted. The drug became his life. “He lost home and family,” writes Quinone, “and five years later he lay dead of an overdose in a Cincinnati half-way house.”

In 2011, the American Chronic Pain Association produced a 30-second TV public service announcement warning that pain prescriptions were killing people — their legitimate users and others. The ACPA newsletter explained that, while opiates “can make the difference between disability and the ability to function at a more normal level,” most patients received little or no information about how dangerous they were. Hence, the TV spot, with advice about how to keep the medicine safe.

Last on the list of concerns (such as safe storage, not sharing, and keeping close track of doses), the ACPA reported that half of those using opioids legitimately were worried about addiction — 19 per cent very worried, and 34 per cent somewhat worried. The ACPA’s executive director offered reassurances that the risks of addiction when opiates are used legitimately under a professional’s care are “modest.”

A 2016 paper in the Journal of Chronic Pain seems to indicate that specifically RSI patients received opioid prescriptions early and often. The authors searched five medical databases for a year’s worth of studies about opioids and MSDs (Musculoskeletal Disorders, another name for RSIs) and found five historical cohort studies — five groups of comparable people — who filed Workers’ Compensation claims and who received opioid prescriptions within the first 12 weeks. Instead of ordering physiotherapy, the doctors gave RSI patients something that stopped the pain, and sent them back to work. This is like short-circuiting your car’s low-oil light instead of topping up your oil. It’s a recipe for burn-out. In four out of five cohorts, early opioid prescriptions were associated with much longer disability.

The good news is that the entire medical establishment seems to be working on finding other ways to deal with chronic pain. In addition to a wider range of nerve prescriptions (eg, Lyrica), doctors are working with other disciplines such as physiotherapists, chiropractors, massage therapists, and acupuncturists. They’re prescribing pain-relieving ointments like diclofenac and sending patients to radiologists for steroid injections to their painful spot. Some doctors still look to surgery for remedies in severe cases.

The bad news is that the U.S. and (apart from Ontario and BC) most provinces in Canada still don’t have workplace regulations to protect workers from RSIs. Although the fentanyl crisis has spread far beyond the patients who received the early opioid prescriptions, we’d be fools to let it overshadow the workplace factor.

MSDs (RSIs) accounted for one-third of U.S. workplace injuries in 2015, according to the U.S. Bureau of Labour Statistics, and probably about half of lost-time days. Jobs at highest risk were laborers and freight, stock, and material movers; nursing assistants; and heavy and tractor-trailer truck drivers (14,900). Nursing assistants often have lift patients. Workers who sustained strains, sprains or tears (the MSD descriptor) required longer to heal than other kinds of injuries.

Behind the opioid menace is another, less visible threat. RSIs exact a heavy financial and human toll in the workplace. Yet the chronic pain of RSIs is more easily prevented than cured. While employers may save a few short-term dollars by ignoring RSI-caused worker turnover, while Workers’ Comp may have saved a few dollars by encouraging doctors to dope injured workers so they could function a little longer, the rising toll of opioid deaths shows who bears the real costs: society.

Varying the work throughout the work day, fitting the job to the worker, taking frequent breaks — ergonomics techniques involve common-sense measures to protect workers’ health. While artists and athletes suffer RSIs, they consciously take risks for the sake of their passion. Assembly line workers and office workers usually just want to earn a living. They have every right to expect that their employer provides a safe workplace and job description that won’t injure them while they do their duties — that won’t leave them facing years of constant chronic pain.

Until the U.S. enacts ergonomics regulations to make workplaces safer, the American chronic pain problem is only going to increase. Awful as they are, opioid fatalities also signal a deeper problem.

Copyright Penney Kome 2017

Contact:  komeca AT yahoo.com

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Penney KomePenney Kome is co-editor of Peace: A Dream Unfolding (Sierra Club Books 1986), with a foreward by the Nobel-winning presidents of International Physicians for Prevention of Nuclear War.

Read her bio on Facts and Opinions.

Contact:  komeca AT yahoo.com

 

 

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Australia’s other ‘flying doctors’

How can modern medicine include traditional bush healers whose spirits fly around at night diagnosing people’s problems?

GEORGINA KENYON
April, 2016

The stifling outback heat of the early evening feels just ripe for trouble.

It’s Friday night and still over 35°C in the town of Alice Springs in Australia’s Northern Territory. It is market night, and the pubs and streets are full of people.

I hear glass shattering and a man and woman yelling at each other in the front yard of a nearby house. A group of young white men walk past me: “It’s going down!” they laugh.

More yelling comes from inside the house as the police pull up.

Pikaringkupai,” an elderly indigenous man says quietly. It means ‘fight’. “Drugs, marijuana,” he adds, shaking his head. He walks past me, heading down to the Todd river, typically empty of water, where indigenous people are camping among the old red gum trees. Many have come for cultural reasons, such as attending funerals and ceremonies that go on for weeks, sometimes longer. Others have come to visit relatives in hospital and have nowhere else to stay.

Heading away from town, I hear a woman screaming. Dingoes and wild dogs start howling from the nearby MacDonnell Ranges; police cars, sirens deafening, speed past and stop at a row of houses ahead, all hidden from view by tall corrugated iron barriers.

The following morning I pay a visit to the Ngaanyatjarra Pitjantjatjara Yankunytjatjara Women’s Council Aboriginal Corporation (NPYWC). Their one-storey rectangular white building, built around a shady courtyard, is a tiny oasis of tranquillity in Alice Springs. I have come to hear about the work of the ngangkari – Aboriginal healers of the deserts of central Australia – and how they might be able to help ‘close the gap’ in the health and wellbeing of indigenous people.

One of the ngangkari I meet is Josephine Watjari Mick: “I can help with pain, I help people with pain in their heads,” she tells me through a translator. “So many young people here are in pain, mental pain.”

Mick was born in Pipalyatjara in the outback, more than 500 km south-west of Alice Springs. Like most ngangkari, she is a senior member of her community, over 60 years old, although she can’t be sure of her age exactly because people born in the outback often don’t have records of their births.

“We grew up in families where we watched each other, kept an eye on our family and kids,” she says. “But now, drugs and TV have started the breakdown of family. Also, the cost of these drugs, like marijuana, adds to the stress when someone gets hooked – it puts families under more stress when there is no money left.”

Domestic violence, drug abuse and mental health problems are challenges in many outback communities, as well as in Alice Springs. Arguments and threats often spiral out of control very quickly, she explains.

Ngangkari treat mental health and physical problems using plants, minerals, animal products and spiritual healing, drawing on knowledge passed down verbally from generation to generation for an estimated 60,000 years. The NPYWC ngangkari tell me they do not directly treat drug addiction or other diseases such as diabetes that they say were unknown in indigenous communities before European settlement brought new social problems and diets high in processed sugar and flour. But they will treat people suffering from mental distress or physical conditions such as injuries and trauma, muscular diseases, and issues surrounding pregnancy.

Their approach to mental health in particular has been praised in Australia and beyond. But although their role in helping indigenous communities is acknowledged by parts of the medical establishment, some ngangkari advocates believe more formal integration is needed to address entrenched health inequalities between indigenous and white Australians.

Statistics from the Australian Institute of Health and Welfare show that the life expectancy of indigenous people is about 10 years less than that of nonindigenous people (69.1 years compared with 79.7 for men; 73.7 compared with 83.1 for women), and indigenous people generally have worse health throughout their lives.

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There are many reasons for this gap: some cultural, some genetic (such as a greater propensity for developing diabetes) and many social. In these very remote areas, people rely on small health clinics; often staffed by nurses, not all of these clinics have a permanent doctor, but the Royal Flying Doctor Service is available to fly people to hospitals in Alice Springs or Adelaide if required. Even so, indigenous people often delay turning to Western medicine, sometimes due to cultural tensions (although there are efforts to introduce more indigenous health workers and community-led healthcare services across Australia), other times due to a simple lack of transport. As a result, poor remote communities tend to have lots of problems with skin and eye infections, while diabetes, kidney disease and pneumonia are also particularly common.

Successful treatment is more difficult to achieve if there is a delay before seeing a doctor, but there can be other challenges to indigenous people’s health, such as a lack of money, lack of work, or the feeling that they have to live in a foreign culture. If someone continues to be ill despite getting medical attention, indigenous people will often say that person has ‘lost their way’, lost their connection to their homeland, and that maybe a ngangkari will be able to help them instead.

By Ben Tillman - Own work, CC BY-SA 3.0, https://commons.wikimedia.org/w/index.php?curid=10485001

“To the ngangkari, the outback’s semi-arid landscape is a rich kitchen and pharmacy – a medicine chest to heal body and soul.” Alice Springs. Photo Ben Tillman via Wikipedia, CC BY-SA 3.0

To the ngangkari, the outback’s semi-arid landscape is a rich kitchen and pharmacy – a medicine chest to heal body and soul. Different plants are used to treat everything from headaches to respiratory problems like colds. Even caterpillar nests are used as a kind of burns dressing.

Pantjiti Unkari McKenzie, another ngangkari, tells me about some of the treatments she uses with her patients. Heating the leaves of the desert fuchsia, a scrubby plant also known as emu bush that grows to over a metre and a half high, produces steam that people can inhale to treat chest infections, or it can be used to make a rub to help sore muscles and joints.

“We call it irmangka-irmangka,” she says. In the office at the NPYWC, they are making up a batch. The plant has been cooked with oil (butter or beeswax can also be used) and the result is sitting in a bucket on a large table. I dip my finger in the lurid yellow-green gel-like substance: it smells fresh and sweet. It will be spooned into small glass jars and sold in shops and tourist hotels around Australia for people to massage into their skin to treat sore muscles and headaches.

Rubbing, massage and touch – pampuni – are all important in ngangkari practice, along with singing and dancing – inma – and a blowing technique that is a bit like soothing a child by blowing on a graze. But plants are a vital component. The desert fuchsia is also known as ‘medicine number one’ and, like many of the plants used by ngangkari, it contains active compounds with medicinal potential.

Plants from all over the world have provided treatments for mainstream medicine, not least Australia’s native eucalyptus tree, which has decongestant properties. In recent years, scientists have identified antibacterial compounds in the desert fuchsia, and the World Health Organization has reported on the antiviral potential of the Casuarina tree, native to Australia and other countries. An Aboriginal ‘pharmacopoeia’ documenting indigenous medicines, their active compounds and their traditional uses was published in 1988, and the Commonwealth Scientific and Industrial Research Organisation (CSIRO) is currently working with indigenous people on a new atlas of medicinal plants to preserve more of this knowledge in print.

Medicinal activity and 60,000 years of practice are not enough for ngangkari treatments to be recognised and regulated as part of mainstream healthcare, however, and some campaigners feel this is a big problem for the health of indigenous people.

According to the Australian Therapeutic Goods Administration, compounds require rigorous clinical testing or a proven record of over 75 years of safe use before they can be marketed and used as medicines. Traditional use by Aboriginal people is not in itself proof of safety, and it is impossible to show effectiveness without extensive documentation – not practical in a culture with an oral tradition and no written records. An alternative approach would be to register ngangkari healing as a complementary therapy, which requires only proof of safety. Although this route led to the acceptance of acupuncture in the Australian healthcare system, it is an expensive, laborious process, and it would be difficult to account for different practices among the ngangkari.

 

But perhaps the biggest disconnect between the ngangkari and the mainstream Australian health system is the ngangkari’s concept of reality, which can be described as magical realism or a spirit world. “If you ever see a ngangkari shouting and beating a tree with a stick, it could mean that the tree has bad spirits hiding there. We know it is there because the hair on the backs of our necks stands up,” McKenzie tells me. “Many people are sad and distressed because of harmful spirits.”

A lot of indigenous people still feel part of this reality, although they integrate it into modern life, freely switching back and forth between thinking they are in the spirit world and functioning in the present. Like many people, regardless of spiritual or religious beliefs, they can hold seemingly contradictory ideas at the same time: “It’s like when my Christian husband died,” says McKenzie. “He went to heaven.”

Their tolerance is not fully reciprocated. Ngangkari have received awards for their work, notably the 2009 Mark Sheldon Award for contributions to indigenous mental health in Australia or New Zealand and the 2011 Sigmund Freud Award from the City of Vienna. But while the Australian government recognises and respects many traditional practices, the regulatory systems that have developed around Western medicine have no room for the spiritual dimensions of traditional healing, and the medical profession has profound concerns about such approaches.

Eva O’Driscoll, Director of Communications for the Australian Medical Association (AMA) in South Australia, says the AMA would be “wary” of recommending ‘alternative’ therapies, including ngangkari, unless the treatments had been fully regulated. “There have been instances of some tragic outcomes when people have not followed the guidance of doctors when they have been diagnosed, for example with cancer,” she explains.

So while acupuncture, part of traditional Chinese medicine, has been integrated as a regulated complementary therapy in Australia, the homegrown ngangkari continue in an ad hoc way. A general practitioner is free to recommend that a patient see a ngangkari if they are depressed or feel disconnected from their culture, but the cost is not covered in the same way as medical treatments, and fees paid to healers can vary widely. If they are contacted privately, or working in the bush, the fee is often set by the ngangkari according to what the patient can afford, which sometimes means the ngangkari works for free.

Even in states like South Australia, where the state health department often does cover ngangkari treatments, there is no coordinated payment system. Some ngangkari do not have bank accounts to pay cheques into, and many live in poverty, even though they are working, because payment is so irregular.

Ngangkari feel they are highly trained, having learned so much about medicinal plants and health. Inconsistent pay and a lack of acceptance of their work are all part of the ongoing unfairness, they say, between indigenous and nonindigenous people in Australia. Although some ngangkari, like the NPYWC group in Alice Springs, are happy enough with the current system, other campaigners say change is urgently needed if their knowledge, skills and culture are to be effective in helping to improve the physical and mental health of indigenous people.

Born in Rome, Francesca Panzironi came to Sydney to study law. After 10 years in academia, she is now an independent researcher and the Chief Executive Officer of the Anangu Ngangkari Tjutaku Aboriginal Corporation (ANTAC) in South Australia. ANTAC advocates for the rights of ngangkari, pushing for their methods and practices to be absorbed into mainstream healthcare, or at least for them to receive consistent government funding to practise.

Panzironi lives for part of the year in Adelaide and for part in Fregon in the remote north-west of South Australia in the APY lands (where the indigenous languages Anangu, Pitjantjatjara and Yankunytjatjara are spoken). Permits are needed to travel through the area if you do not live there. After many emails and phone calls, I finally set up a meeting with her and some of the ngangkari she works with so that I can arrange a visit to the APY lands myself.

Ngangkari healer Maringka Burton © David Maurice Smith/Oculi

Ngangkari healer Maringka Burton © David Maurice Smith/Oculi

Unfortunately, it is not to be.

“Bad time to travel to the APY lands,” Panzironi informs me when I arrive at her home in Adelaide. “Men’s business time, cultural time, the roads can be closed.”

And the ngangkari I’d been expecting to meet, stopping over on their way to an indigenous conference in Peru, are out shopping. I say nothing; perhaps I had misunderstood on the phone.

Two small pale blue desert finches chirp in a small white cage by the window in Panzironi’s modern home–office apartment. I ask her why she thinks she has been accepted by the ngangkari as an advocate even though she is European and not of their culture.

“I ask for nothing and I want nothing from them, I fit in,” she replies. She talks about the APY lands being a place of mercenaries, misfits and missionaries, a wild frontier. What the local people dislike, it seems, is when white people go and get paid a lot of money in Sydney using their ngangkari knowledge to write a PhD and become an expert. “Whereas I’ve gone the other way: from academia to the APY lands.”

Panzironi is convinced the ngangkari are needed to bring down the high rates of morbidity and mortality among indigenous people. The fact that ngangkari often already live in remote communities means they are more accessible and could help people get earlier treatment. Ngangkari, she says, have a ‘team-based approach’ to healthcare, meaning they accept that both Western and traditional methods can be beneficial when a person is ill. After treating a person spiritually and psychologically, the ngangkari might treat the person’s physical problems as well, but will just as often recommend they see a Western doctor, too.

“Ngangkari are kind of like a mixture between a general practitioner and a psychiatrist all in one,” she explains. “Their medicine is holistic in nature, concerned with a person spiritually and physically, and this is important to many indigenous people.”

In particular, Panzironi says mainstream doctors can misdiagnose mental disorders among indigenous people because of a lack of understanding of their culture. Spiritual disorders, grieving and palliative care are all culturally sensitive, but can be misinterpreted by Western doctors – she has heard of people being diagnosed with psychosis when they believed “a bad spirit had been put on them”, a belief that would be understood very differently in indigenous culture.

Her vision, therefore, is a ‘two-way’ healthcare model that provides spiritual healers “hand in hand with Western medicine”, and she has called on the government to take on board her ideas. She believes the gap will close when both the traditions and healthcare of indigenous people are taken seriously by the government.

Her proposals would require funding for the systematic provision of Aboriginal traditional healers in the South Australian health system, and a consistent fee-for-service payment schedule, negotiated in partnership with the ngangkari, Aboriginal community-controlled health services and mainstream health services. Another important recommendation is a database of ngangkari consultations, akin to a patient’s records held by their general practitioner, to document treatments and results.

But, Panzironi says, the government has yet to respond to her recommendations and has not made any comment about her 2013 publication ‘Hand-in-hand: report on Aboriginal traditional medicine’.

South Australia Health (SA Health), the state government health department in Adelaide, says it already provides strong medical and cultural services. “We are committed to ensuring the South Australian health system is responsive to the needs of Aboriginal people through supporting Aboriginal people’s access to culturally respectful, appropriate and relevant services,” says April Lawrie-Smith, Director of its Aboriginal Health Branch.

SA Health also says that some of the recommendations in Panzironi’s report were addressed in 2011, when it established its Traditional Healer Brokerage Program. This enables referrals for indigenous clients to access the services of traditional healers. SA Health recognises a number of organisations providing ngangkari services, including ANTAC, and these organisations can bill SA Health to cover the cost of a healer.

This is not true in all of Australia’s states, however, and formal regulation and inclusion in Medicare, Australia’s universal healthcare scheme, would be an issue for the federal government. When I ask the national health department in Canberra, it confirms that the federal government is not currently considering including the ngangkari in Medicare.

Treating social and mental health issues is a cultural activity as much as a medical one. For tens of thousands of years, the ngangkari have played a significant role in their communities, and they still do today. Back in Alice Springs, where the ngangkari are content with their current role and status, I ask Angela Lynch, Programme Manager at the NPYWC, if she has heard of Panzironi’s campaign.

“Yes,” she says, “but our views and outlook are very different.”

While Panzironi’s group seem wary of outsiders visiting their lands but are calling for much greater inclusion in the health system, the NPYWC would like more people to visit their cooperative in Alice Springs but are proud to be separate from mainstream healthcare.

Indeed, Lynch says she cannot see how ngangkari could ever integrate with mainstream medicine, as they are completely different in the ways that they approach illness. “The ngangkari here are part of an old belief system. They don’t want regulation, but prefer to operate as a parallel health service,” she says. “Many are happy not to be part of the health system.”

To help me understand, Lynch asks some of the NPYWC ngangkari to tell me how they became healers.

“I knew I was going to be a ngangkari. In a dream I saw fire, a tongue of fire and a bright light,” explains Mick.

Maringka Burton, from Indulkana in the APY lands, says her father was a ngangkari: “When he gave me the ngangkari power I could see everything differently and I was able to travel into the skies with other ngangkari, soaring around the sky, travelling great distances, and coming back home in time for breakfast.”

Lynch asks them to explain more about what happens at night. “Just our spirits travel, our bodies remain sleeping on the ground and our spirits join together as we fly,” replies Burton.

I realise now why my questions about whether the ngangkari will become regulated are somewhat baffling.

“They believe they fly at night, checking on all the people in their community, seeing who is sick and who is not,” says Lynch. “In the morning they come back to ground. How can anyone regulate flying spirits around the sky?”

The ngangkari laugh. They know that to a Westerner like me, flying around at night is unbelievable. But to them, it is real and a vital aspect of what modern therapies lack for many of Australia’s first people: a deep understanding of their cultural and spiritual lives.

The stifling outback heat of the early evening feels just ripe for trouble.

It’s Friday night and still over 35°C in the town of Alice Springs in Australia’s Northern Territory. It is market night, and the pubs and streets are full of people.

I hear glass shattering and a man and woman yelling at each other in the front yard of a nearby house. A group of young white men walk past me: “It’s going down!” they laugh.

More yelling comes from inside the house as the police pull up.

Pikaringkupai,” an elderly indigenous man says quietly. It means ‘fight’. “Drugs, marijuana,” he adds, shaking his head. He walks past me, heading down to the Todd river, typically empty of water, where indigenous people are camping among the old red gum trees. Many have come for cultural reasons, such as attending funerals and ceremonies that go on for weeks, sometimes longer. Others have come to visit relatives in hospital and have nowhere else to stay.

Heading away from town, I hear a woman screaming. Dingoes and wild dogs start howling from the nearby MacDonnell Ranges; police cars, sirens deafening, speed past and stop at a row of houses ahead, all hidden from view by tall corrugated iron barriers.

The following morning I pay a visit to the Ngaanyatjarra Pitjantjatjara Yankunytjatjara Women’s Council Aboriginal Corporation (NPYWC). Their one-storey rectangular white building, built around a shady courtyard, is a tiny oasis of tranquillity in Alice Springs. I have come to hear about the work of the ngangkari – Aboriginal healers of the deserts of central Australia – and how they might be able to help ‘close the gap’ in the health and wellbeing of indigenous people.

One of the ngangkari I meet is Josephine Watjari Mick: “I can help with pain, I help people with pain in their heads,” she tells me through a translator. “So many young people here are in pain, mental pain.”

Mick was born in Pipalyatjara in the outback, more than 500 km south-west of Alice Springs. Like most ngangkari, she is a senior member of her community, over 60 years old, although she can’t be sure of her age exactly because people born in the outback often don’t have records of their births.

“We grew up in families where we watched each other, kept an eye on our family and kids,” she says. “But now, drugs and TV have started the breakdown of family. Also, the cost of these drugs, like marijuana, adds to the stress when someone gets hooked – it puts families under more stress when there is no money left.”

Domestic violence, drug abuse and mental health problems are challenges in many outback communities, as well as in Alice Springs. Arguments and threats often spiral out of control very quickly, she explains.

Ngangkari treat mental health and physical problems using plants, minerals, animal products and spiritual healing, drawing on knowledge passed down verbally from generation to generation for an estimated 60,000 years. The NPYWC ngangkari tell me they do not directly treat drug addiction or other diseases such as diabetes that they say were unknown in indigenous communities before European settlement brought new social problems and diets high in processed sugar and flour. But they will treat people suffering from mental distress or physical conditions such as injuries and trauma, muscular diseases, and issues surrounding pregnancy.

Their approach to mental health in particular has been praised in Australia and beyond. But although their role in helping indigenous communities is acknowledged by parts of the medical establishment, some ngangkari advocates believe more formal integration is needed to address entrenched health inequalities between indigenous and white Australians.

Statistics from the Australian Institute of Health and Welfare show that the life expectancy of indigenous people is about 10 years less than that of nonindigenous people (69.1 years compared with 79.7 for men; 73.7 compared with 83.1 for women), and indigenous people generally have worse health throughout their lives.

There are many reasons for this gap: some cultural, some genetic (such as a greater propensity for developing diabetes) and many social. In these very remote areas, people rely on small health clinics; often staffed by nurses, not all of these clinics have a permanent doctor, but the Royal Flying Doctor Service is available to fly people to hospitals in Alice Springs or Adelaide if required. Even so, indigenous people often delay turning to Western medicine, sometimes due to cultural tensions (although there are efforts to introduce more indigenous health workers and community-led healthcare services across Australia), other times due to a simple lack of transport. As a result, poor remote communities tend to have lots of problems with skin and eye infections, while diabetes, kidney disease and pneumonia are also particularly common.

Successful treatment is more difficult to achieve if there is a delay before seeing a doctor, but there can be other challenges to indigenous people’s health, such as a lack of money, lack of work, or the feeling that they have to live in a foreign culture. If someone continues to be ill despite getting medical attention, indigenous people will often say that person has ‘lost their way’, lost their connection to their homeland, and that maybe a ngangkari will be able to help them instead.

To the ngangkari, the outback’s semi-arid landscape is a rich kitchen and pharmacy – a medicine chest to heal body and soul. Different plants are used to treat everything from headaches to respiratory problems like colds. Even caterpillar nests are used as a kind of burns dressing.

Pantjiti Unkari McKenzie, another ngangkari, tells me about some of the treatments she uses with her patients. Heating the leaves of the desert fuchsia, a scrubby plant also known as emu bush that grows to over a metre and a half high, produces steam that people can inhale to treat chest infections, or it can be used to make a rub to help sore muscles and joints.

“We call it irmangka-irmangka,” she says. In the office at the NPYWC, they are making up a batch. The plant has been cooked with oil (butter or beeswax can also be used) and the result is sitting in a bucket on a large table. I dip my finger in the lurid yellow-green gel-like substance: it smells fresh and sweet. It will be spooned into small glass jars and sold in shops and tourist hotels around Australia for people to massage into their skin to treat sore muscles and headaches.

Rubbing, massage and touch – pampuni – are all important in ngangkari practice, along with singing and dancing – inma – and a blowing technique that is a bit like soothing a child by blowing on a graze. But plants are a vital component. The desert fuchsia is also known as ‘medicine number one’ and, like many of the plants used by ngangkari, it contains active compounds with medicinal potential.

Plants from all over the world have provided treatments for mainstream medicine, not least Australia’s native eucalyptus tree, which has decongestant properties. In recent years, scientists have identified antibacterial compounds in the desert fuchsia, and the World Health Organization has reported on the antiviral potential of the Casuarina tree, native to Australia and other countries. An Aboriginal ‘pharmacopoeia’ documenting indigenous medicines, their active compounds and their traditional uses was published in 1988, and the Commonwealth Scientific and Industrial Research Organisation (CSIRO) is currently working with indigenous people on a new atlas of medicinal plants to preserve more of this knowledge in print.

Medicinal activity and 60,000 years of practice are not enough for ngangkari treatments to be recognised and regulated as part of mainstream healthcare, however, and some campaigners feel this is a big problem for the health of indigenous people.

According to the Australian Therapeutic Goods Administration, compounds require rigorous clinical testing or a proven record of over 75 years of safe use before they can be marketed and used as medicines. Traditional use by Aboriginal people is not in itself proof of safety, and it is impossible to show effectiveness without extensive documentation – not practical in a culture with an oral tradition and no written records. An alternative approach would be to register ngangkari healing as a complementary therapy, which requires only proof of safety. Although this route led to the acceptance of acupuncture in the Australian healthcare system, it is an expensive, laborious process, and it would be difficult to account for different practices among the ngangkari.

But perhaps the biggest disconnect between the ngangkari and the mainstream Australian health system is the ngangkari’s concept of reality, which can be described as magical realism or a spirit world. “If you ever see a ngangkari shouting and beating a tree with a stick, it could mean that the tree has bad spirits hiding there. We know it is there because the hair on the backs of our necks stands up,” McKenzie tells me. “Many people are sad and distressed because of harmful spirits.”

A lot of indigenous people still feel part of this reality, although they integrate it into modern life, freely switching back and forth between thinking they are in the spirit world and functioning in the present. Like many people, regardless of spiritual or religious beliefs, they can hold seemingly contradictory ideas at the same time: “It’s like when my Christian husband died,” says McKenzie. “He went to heaven.”

Their tolerance is not fully reciprocated. Ngangkari have received awards for their work, notably the 2009 Mark Sheldon Award for contributions to indigenous mental health in Australia or New Zealand and the 2011 Sigmund Freud Award from the City of Vienna. But while the Australian government recognises and respects many traditional practices, the regulatory systems that have developed around Western medicine have no room for the spiritual dimensions of traditional healing, and the medical profession has profound concerns about such approaches.

Eva O’Driscoll, Director of Communications for the Australian Medical Association (AMA) in South Australia, says the AMA would be “wary” of recommending ‘alternative’ therapies, including ngangkari, unless the treatments had been fully regulated. “There have been instances of some tragic outcomes when people have not followed the guidance of doctors when they have been diagnosed, for example with cancer,” she explains.

So while acupuncture, part of traditional Chinese medicine, has been integrated as a regulated complementary therapy in Australia, the homegrown ngangkari continue in an ad hoc way. A general practitioner is free to recommend that a patient see a ngangkari if they are depressed or feel disconnected from their culture, but the cost is not covered in the same way as medical treatments, and fees paid to healers can vary widely. If they are contacted privately, or working in the bush, the fee is often set by the ngangkari according to what the patient can afford, which sometimes means the ngangkari works for free.

Even in states like South Australia, where the state health department often does cover ngangkari treatments, there is no coordinated payment system. Some ngangkari do not have bank accounts to pay cheques into, and many live in poverty, even though they are working, because payment is so irregular.

Ngangkari feel they are highly trained, having learned so much about medicinal plants and health. Inconsistent pay and a lack of acceptance of their work are all part of the ongoing unfairness, they say, between indigenous and nonindigenous people in Australia. Although some ngangkari, like the NPYWC group in Alice Springs, are happy enough with the current system, other campaigners say change is urgently needed if their knowledge, skills and culture are to be effective in helping to improve the physical and mental health of indigenous people.

Born in Rome, Francesca Panzironi came to Sydney to study law. After 10 years in academia, she is now an independent researcher and the Chief Executive Officer of the Anangu Ngangkari Tjutaku Aboriginal Corporation (ANTAC) in South Australia. ANTAC advocates for the rights of ngangkari, pushing for their methods and practices to be absorbed into mainstream healthcare, or at least for them to receive consistent government funding to practise.

Panzironi lives for part of the year in Adelaide and for part in Fregon in the remote north-west of South Australia in the APY lands (where the indigenous languages Anangu, Pitjantjatjara and Yankunytjatjara are spoken). Permits are needed to travel through the area if you do not live there. After many emails and phone calls, I finally set up a meeting with her and some of the ngangkari she works with so that I can arrange a visit to the APY lands myself.

Unfortunately, it is not to be.

“Bad time to travel to the APY lands,” Panzironi informs me when I arrive at her home in Adelaide. “Men’s business time, cultural time, the roads can be closed.”

And the ngangkari I’d been expecting to meet, stopping over on their way to an indigenous conference in Peru, are out shopping. I say nothing; perhaps I had misunderstood on the phone.

Two small pale blue desert finches chirp in a small white cage by the window in Panzironi’s modern home–office apartment. I ask her why she thinks she has been accepted by the ngangkari as an advocate even though she is European and not of their culture.

“I ask for nothing and I want nothing from them, I fit in,” she replies. She talks about the APY lands being a place of mercenaries, misfits and missionaries, a wild frontier. What the local people dislike, it seems, is when white people go and get paid a lot of money in Sydney using their ngangkari knowledge to write a PhD and become an expert. “Whereas I’ve gone the other way: from academia to the APY lands.”

Panzironi is convinced the ngangkari are needed to bring down the high rates of morbidity and mortality among indigenous people. The fact that ngangkari often already live in remote communities means they are more accessible and could help people get earlier treatment. Ngangkari, she says, have a ‘team-based approach’ to healthcare, meaning they accept that both Western and traditional methods can be beneficial when a person is ill. After treating a person spiritually and psychologically, the ngangkari might treat the person’s physical problems as well, but will just as often recommend they see a Western doctor, too.

“Ngangkari are kind of like a mixture between a general practitioner and a psychiatrist all in one,” she explains. “Their medicine is holistic in nature, concerned with a person spiritually and physically, and this is important to many indigenous people.”

In particular, Panzironi says mainstream doctors can misdiagnose mental disorders among indigenous people because of a lack of understanding of their culture. Spiritual disorders, grieving and palliative care are all culturally sensitive, but can be misinterpreted by Western doctors – she has heard of people being diagnosed with psychosis when they believed “a bad spirit had been put on them”, a belief that would be understood very differently in indigenous culture.

Her vision, therefore, is a ‘two-way’ healthcare model that provides spiritual healers “hand in hand with Western medicine”, and she has called on the government to take on board her ideas. She believes the gap will close when both the traditions and healthcare of indigenous people are taken seriously by the government.

Her proposals would require funding for the systematic provision of Aboriginal traditional healers in the South Australian health system, and a consistent fee-for-service payment schedule, negotiated in partnership with the ngangkari, Aboriginal community-controlled health services and mainstream health services. Another important recommendation is a database of ngangkari consultations, akin to a patient’s records held by their general practitioner, to document treatments and results.

But, Panzironi says, the government has yet to respond to her recommendations and has not made any comment about her 2013 publication ‘Hand-in-hand: report on Aboriginal traditional medicine’.

South Australia Health (SA Health), the state government health department in Adelaide, says it already provides strong medical and cultural services. “We are committed to ensuring the South Australian health system is responsive to the needs of Aboriginal people through supporting Aboriginal people’s access to culturally respectful, appropriate and relevant services,” says April Lawrie-Smith, Director of its Aboriginal Health Branch.

SA Health also says that some of the recommendations in Panzironi’s report were addressed in 2011, when it established its Traditional Healer Brokerage Program. This enables referrals for indigenous clients to access the services of traditional healers. SA Health recognises a number of organisations providing ngangkari services, including ANTAC, and these organisations can bill SA Health to cover the cost of a healer.

This is not true in all of Australia’s states, however, and formal regulation and inclusion in Medicare, Australia’s universal healthcare scheme, would be an issue for the federal government. When I ask the national health department in Canberra, it confirms that the federal government is not currently considering including the ngangkari in Medicare.

Treating social and mental health issues is a cultural activity as much as a medical one. For tens of thousands of years, the ngangkari have played a significant role in their communities, and they still do today. Back in Alice Springs, where the ngangkari are content with their current role and status, I ask Angela Lynch, Programme Manager at the NPYWC, if she has heard of Panzironi’s campaign.

“Yes,” she says, “but our views and outlook are very different.”

While Panzironi’s group seem wary of outsiders visiting their lands but are calling for much greater inclusion in the health system, the NPYWC would like more people to visit their cooperative in Alice Springs but are proud to be separate from mainstream healthcare.

Indeed, Lynch says she cannot see how ngangkari could ever integrate with mainstream medicine, as they are completely different in the ways that they approach illness. “The ngangkari here are part of an old belief system. They don’t want regulation, but prefer to operate as a parallel health service,” she says. “Many are happy not to be part of the health system.”

To help me understand, Lynch asks some of the NPYWC ngangkari to tell me how they became healers.

“I knew I was going to be a ngangkari. In a dream I saw fire, a tongue of fire and a bright light,” explains Mick.

Maringka Burton, from Indulkana in the APY lands, says her father was a ngangkari: “When he gave me the ngangkari power I could see everything differently and I was able to travel into the skies with other ngangkari, soaring around the sky, travelling great distances, and coming back home in time for breakfast.”

Lynch asks them to explain more about what happens at night. “Just our spirits travel, our bodies remain sleeping on the ground and our spirits join together as we fly,” replies Burton.

I realise now why my questions about whether the ngangkari will become regulated are somewhat baffling.

“They believe they fly at night, checking on all the people in their community, seeing who is sick and who is not,” says Lynch. “In the morning they come back to ground. How can anyone regulate flying spirits around the sky?”

The ngangkari laugh. They know that to a Westerner like me, flying around at night is unbelievable. But to them, it is real and a vital aspect of what modern therapies lack for many of Australia’s first people: a deep understanding of their cultural and spiritual lives.

Creative Commons

This article first appeared on Mosaic and is republished here under a Creative Commons licence. Visit photographer David Maurice Smith’s site here. (Images used here with permission.)

References and further information:

You can find out more about the work of the NPYWC’s Ngangkari Program on their website.

Panzironi’s ‘Hand-in-hand’ report is available from ANTAC.

 ~~~

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Ebola: the Black Death Revisited

There is no rational reason to fear Ebola in the developed world, writes Ewa Bacon, because we know the source of contagion and have methods to deal with it.  However, panic has set in.  Image: Plague is defeated -- a detail of the "Column of the Plague" (Pestsäule), in Graben, Vienna, Austria. Photo by Jebulon via Wikimedia, Creative Commons

There is no rational reason to fear Ebola in the developed world, writes Ewa Bacon, because we know the source of contagion and have methods to deal with it. However, panic has set in. Above, a detail of the “Column of the Plague” (Pestsäule) in Vienna, Austria, photographed by Jebulon via Wikimedia, Creative Commons

EWA BACON, Lewis University
Published with permission by F&O October 24, 2014

We fear an extinction event. We search the environment and note the loss of plants and animals. We worry as we examine “Martha,” the last ever passenger pigeon. We examine the geological record and note that not even the mighty dinosaur survived the cataclysm of Cretaceous period.

Could that happen to us as well? We search history and note some sobering examples of global catastrophes. Few are as renowned as the “Black Death.” Early in the 1300’s Europeans received news of unprecedented diseases raging in the wealthy, remote and mysterious realm of China.

Had the plague in Asia erupted in the 10th or 11th century, it would have stayed in Asia. However, by the 14th century long dormant contacts with Asia had revived. This was an age of globalization. Ideas and products were traded with the Far East. And so, it turns, was disease.

In 1346 the plague arrived in the great Italian trading ports of Genoa and Venice. Galleys arrived in Genoa laden with precious cargoes of spices but also horribly infected and dying men. The citizens of the town drove them off with violence, but it was too late. The contagion had spread to the city. The Black Death had arrived in Europe. 

The manifestation of the disease was horrific: disfiguring skin eruptions, an unbearable stench, vile urine. The course of the contagion was rapid and deadly. If it attacked the lymphatic system, the victim was likely to die within ten days. Perhaps a quarter of the sick survived this attack. If, however, the plague attacked the lungs, death was certain within a week. The rarest form of the plague was septicemic, attacking the blood itself. Death occurred within a day. 

The most frightening aspects of the contagion were the speed with which it killed and the speed with which it spread. When the first wave hit the wealthy and densely populated city of Florence, frightened witnesses saw hundreds of corpses stacked in the street with not enough burial grounds to accommodate them. Whole families died within a week. There were no remedies. Those who could, fled the city to find safety in isolated villas and homes in the countryside.

In Venice and Florence, hundreds of thousand citizens were dead within months. Medieval doctors were among the first to die. Health regulations were useless and finally concentrated on disposal of the dead. Today we estimate that as the epidemic spread across Europe, 40% of all Europeans perished. 

This was not an epidemic. This was a pandemic. The change in modifier is significant. “Pan” refers to the Greek god of chaos and disruption. It is also the source of the word “panic.” As we watched the Ebola epidemic in Africa, safely far away, we commiserated. But now that we think that this is a world-wide contagion, we panic.

There is no rational reason to fear Ebola in the developed world. Unlike our fore-fathers of the 14th century, we know the source of contagion and have methods to deal with it. However, panic has set in. The New York Times on October 16, 2014, featured this headline: “Experts offer steps for avoiding public hysteria, a different contagious threat.” 

This pandemic is a disease but it is also a psychological contagion of irrational fear, public hysteria. This morning as I was reading a daily science post, I noted an advertisement for the “Ebola Emergency Food Kit.” It is not Ebola that is stalking the land, but anxiety and fear. An ABC newscaster yesterday asked a passenger coming off a plane whether she feared contagion. Well, yes: there was someone coughing on the plane and perhaps they were a carrier. Note: coughing is not a symptom of Ebola.

Newspaper articles and bloggers are trying to be reassuring. After all, tens of thousands of people die annually from influenza or from hepatitis or from MRSA. This is a hopeless attempt to reassure us because millions of people have encountered these familiar scourges and are not afraid of them. Ebola is different because it is astoundingly lethal and while not air-borne, it is frighteningly contagious. This is a new pestilence.

But it is also more than just another pestilence. It is a reminder that not only are our lives finite; our species is finite. The globe is warming, the missile silos are still out there, medieval jihadists are stalking us, economies are cyclical: these are familiar fears.

But a mystery disease, highly lethal, visible in the media daily? Do we share what is, for lack of a better term, a historical traumatic memory of the Black Death? Now that we understand how fragile we are on a small planet that has had tremendous disruption, is this THE disruption?

 Copyright Ewa Bacon 2014

Re-Published with permission. Ewa Bacon is a professor of history at Lewis University in Romeoville, IL, U.S. This column is republished from Lewis’s history site.

References and further reading:

Experts offer steps for avoiding public hysteria, a different contagious threat, by Benedict Carey, New York Times 
 Ebola’s first casualty: clear thinking. By Jonathan Manthorpe, F&O International Affairs columnist (paywall*) 
Biodefence Drives Ebola Drug Development. By  Christopher Degeling, on F&O.

 

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Gut bacteria linked to depression and brain health

Photo by Ryan Melaugh via Flickr, Creative Commons

The lives of the bacteria in our gut are intimately entwined with our immune, endocrine and nervous systems — and we are starting to understand how they affect the brain, writes Clio Korn. Photo by Ryan Melaugh via Flickr, Creative Commons Photo by Ryan Melaugh via Flickr, Creative Commons

By Clio Korn, University of Oxford
October 22, 2014

One of medicine’s greatest innovations in the 20th century was the development of antibiotics. It transformed our ability to combat disease. But medicine in the 21st century is rethinking its relationship with bacteria and concluding that, far from being uniformly bad for us, many of these organisms are actually essential for our health.

Nowhere is this more apparent than in the human gut, where the microbiome – the collection of bacteria living in the gastrointestinal tract – plays a complex and critical role in the health of its host. The microbiome interacts with and influences organ systems throughout the body, including, as research is revealing, the brain. This discovery has led to a surge of interest in potential gut-based treatments for neuropsychiatric disorders and a new class of studies investigating how the gut and its microbiome affect both healthy and diseased brains.

Research linking gut bacteria and brain health has sparked interest in new  treatments for neuropsychiatric disorders. Colour lithograph of a woman suffering melancholia, 1892, J. Williamson,via Wikimedia. Public domain.

Research linking gut bacteria and brain health has sparked interest in new treatments for neuropsychiatric disorders. Colour lithograph of a woman suffering melancholia, 1892, J. Williamson,via Wikimedia. Public domain.

The microbiome consists of a startlingly massive number of organisms. Nobody knows exactly how many or what type of microbes there might be in and on our bodies, but estimates suggest there may be anywhere from three to 100 times more bacteria in the gut than cells in the human body. The Human Microbiome Project, co-ordinated by the US National Institutes of Health (NIH), seeks to create a comprehensive database of the bacteria residing throughout the gastrointestinal tract and to catalogue their properties.

The lives of the bacteria in our gut are intimately entwined with our immune, endocrine and nervous systems. The relationship goes both ways: the microbiome influences the function of these systems, which in turn alter the activity and composition of the bacterial community. We are starting to unravel this complexity and gain insight into how gut bacteria interface with the rest of the body and, in particular, how they affect the brain.

The microbiome-immune system link is established early on. Over the first year of life, bacteria populate the gut, which is largely sterile at birth, and the developing immune system learns which bacteria to consider normal residents of the body and which to attack as invaders. This early learning sets the stage for later immune responses to fluctuations in the microbiome’s composition.

When a normally scarce strain becomes too abundant or a pathogenic species joins the community of gut bacteria, the resulting response by the immune system can have wide-reaching effects. Depression has been linked with elevated levels of such molecules in some individuals, suggesting that treatments that alter the composition of the microbiome could alleviate symptoms of this disorder.

Such an intervention could potentially be achieved using either prebiotics – substances that promote the growth of beneficial bacteria – or probiotics – live cultures of these bacteria. It is even possible that the microbiome could be manipulated by dietary changes.

In one experiment, researchers transplanted the human microbiome into germ-free mice (animals that have no gut bacteria) in order to study it in a controlled setting. They found that, simply by changing the carbohydrate and fat content of the mice’s food, they could alter basic cellular functions and gene expression in the microbiome.

Depression is not the only psychiatric disorder in which the microbiome may play a role. Research in rodents, as well as a few preliminary studies in humans, indicate that the state of our resident microbes is tied to our anxiety levels.

Germ-free mice, for example, appear to be less anxious than normal mice on behavioural tests of anxiety, whereas mice infected with pathogenic bacteria behave more anxiously. Interestingly, there seems to be a window during development when the presence of a microbiome leads to normal levels of anxiety in adulthood: germ-free mice that were exposed to microbiome bacteria at three weeks of age subsequently behaved like normal mice, whereas those exposed at ten weeks of age continued to be less anxious than normal animals. Like the data on microbiome-immune interactions, these findings highlight the critical role gut bacteria play early in life.

This research also reveals the complexity of the relationship between the microbiome and psychological state. Although the general trend is that fewer bacteria mean lower anxiety levels, it is not just the number but the identity of the bacterial species that determine how gut dynamics interact with mental state.

For example, adding beneficial bacteria through probiotic treatment may reduce elevated anxiety levels caused by inflammation and infection. A key factor in this relationship is stress and the way the body responds to it.

Researchers have shown that the presence or absence of microbes in young mice affects the sensitivity of the hypothalamic-pituitary-adrenal (HPA) axis – a key pathway in the body’s stress response system. The activity of the microbiome during development thus sways how we respond to future stressors and how much anxiety they cause us.

How do the bacteria in our gut wield such influence over our brains and bodies? The mechanisms of microbiome-host interactions appear to be as numerous and varied as the interactions themselves.

Gut microbes help break down food into its component parts, so the molecular building blocks available in the body depend in part on which bacteria are present to extract them. This can influence brain function by, for example, affecting the availability of molecules needed to make neurotransmitters.

Some gut bacteria can even alter neurotransmitter levels directly by converting glutamate – an excitatory transmitter – into GABA – an inhibitory brain chemical. And gut microbes, along with neighbouring intestinal cells, communicate with a branch of the nervous system called the enteric nervous system (ENS) whose neurons surround the entire gastrointestinal tract. This part of the nervous system is so sophisticated that many refer to it as the body’s second brain.

The study of microbiome-gut-brain interactions is still young, yet it is already spurring the development of new branches of medical research. At this rate, it is poised to become one of the most fascinating stories in neuroscience.

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Clio Korn blogs at http://neurobabble.co.uk.

This article was originally published on The Conversation. Read the original article.

 

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