Cheap and simple medical devices could improve performance and lower health-care costs, but first they have to overcome deeply rooted biases.
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HN Discussion: https://news.ycombinator.com/item?id=19135505
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(karma: 1946)Post stats: Points: 173 - Comments: 121 - 2019-02-11T16:13:47Z
At less than the price of a cup of coffee, it might be one of the world’s most economical lifesaving devices. The “uterine balloon tamponade” does not look like much: a syringe, some blue tubing, a lubricated condom. All this is contained in a plastic bag, along with a checklist and a laminated set of instructions. But, when the condom is attached to the end of a catheter and inflated with water, it can stop uterine bleeding in women who have just given birth—one of the leading causes of maternal mortality in developing countries. “I get pictures every day from women—in India, in Kenya, in Tanzania—from women who have survived,” Thomas Burke tells me, holding up his phone, as we sit in the living room of his house in the Boston suburbs. “We’ve heard it called the miracle device.” In his basement are boxes containing thousands of the kits.
Nearly a decade ago, Burke, an emergency physician who heads the Division of Global Health Innovation at Massachusetts General Hospital, was in South Sudan, where he and a team of doctors had been tasked with setting up programs to improve maternal and newborn health. Complications from pregnancy were at the top of the list. “There are places on earth where between one in six and one in eight women lose their life because of pregnancy,” Burke says. Ninety-nine per cent of new mothers globally who die do so in “resource-poor settings.”
More than half of maternal deaths in developing countries—and one in three of all maternal deaths—are caused by postpartum hemorrhage (PPH), in which the uterus, often fatigued after hours of labor, bleeds uncontrollably. Few of the standard medical responses to PPH—uterotonic drugs, interventional radiology, even hysterectomies—were readily available in the fledgling, conflict-ravaged Republic of South Sudan, so Burke and his colleagues shifted their attention to uterine balloons, a simple mechanism that compresses against the source of the bleeding and helps activate the body’s own clotting response.
But the typical uterine balloon can cost upward of three hundred dollars. Burke had learned about a lower-cost, unregulated UBT—sometimes dubbed Sayeba’s method, after Sayeba Akhter, the Bangladeshi doctor often credited with coming up with the idea, in 2000—constructed from a standard catheter and a condom. Burke and his colleagues wondered if there was a middle ground between the medical-grade balloons and the ad-hoc condom-catheter device. Back in Boston, he began “walking through the aisles of Home Depot, just wandering around our hospital,” looking for inspiration.
Burke is under no illusion of having reinvented the wheel. “This is just about taking some low-cost things that are right in front of us and assembling them in a—people often say, a ‘MacGyver’ fashion,” he told me, with a gently derisive snort. He made some design refinements—like adding a one-way valve to make sure the condom stayed inflated—but the real innovation was presenting the device as a package, a self-contained kit with easily replaced parts and, important in regions where health-care workers often can’t read, graphically rendered instructions.
Today, the E.S.M.-UBT—E.S.M. stands for “Every Second Matters”—has been deployed many thousands of times, in countries from Peru to Zambia. The survival rate of women who received it—many of whom are in advanced or even end-stage shock—is ninety-seven per cent over all, according to numbers compiled by Massachusetts General.
At a rural medical college in Sevagram, India, founded by Gandhi’s personal physician, the UBT has helped save hundreds of lives. It has also lowered costs by reducing the number of hysterectomies and blood transfusions, and the hospital is now working on producing its own UBT kits. This imitation is, Burke says, the whole point: “In India, the government keeps saying, ‘Dr. Burke has been so kind to give us his patent.’ I keep saying, ‘There is no patent, this is yours, go for it!’ ”
The UBT is just one in a series of low-cost medical technologies that Burke and his colleagues hope to disseminate.These devices may not rise to the absolute gold standard of care but they are just good enough—particularly when lives hang in the balance. Their use is most obvious and immediate for doctors in developing countries working with immense constraints and high stakes; but is there a lesson here for wealthier countries, too?
As a practicing emergency physician, Burke long ago learned the art and science of making do. He carries a medical kit with him at all times and has inserted breathing tubes for the victims of car crashes where he happened to be on the scene; once, at a rural hospital in Uganda, he consulted an old British military surgery guide—he isn’t a surgeon—to treat abdominal bleeding. And he has a curious propensity for witnessing historic events, from the standoffs at Ruby Ridge and Waco to the attacks in Benghazi. When I first met him, during his stint as the onboard physician for a round-the-world expedition, he had recently dealt with a midtrip heart attack.
People in emergency medicine often joke “that you can figure out a solution with a couple of popsicle sticks. It may not be the ideal tool, but you can muddle through,” Burke says. Through low-cost, research-backed innovations, Burke wants to take that popsicle-stick thinking and do more than muddle through, to help transition from “crisis to long-term strategy.”
His is a bottom-up approach in a world accustomed to top-down solutions. When it comes to health care, Burke says, “you can go to almost any hospital in the world in a poor setting, and you can see piles of technologies that have been presented from do-gooders.” But, without the right supply chains or technical support, such “upstream” solutions quickly surrender to a sort of reverse obsolescence, outmoded less by the future than by the weight of history. An emphasis on bringing in the latest technology is often misguided. There are some cases where ultrasound machines, for example, are essential, but, Burke says, “we’ve not been able to show that ultrasound during pregnancy changes population-level outcomes of newborns.”
Rather than wait for expensive technologies to become more affordable, or to be helicoptered in by well-meaning relief agencies, Burke shapes his approach by observing what is actually being used on the ground and trying to create a set of best practices. Millions of babies worldwide, for example, Burke says, need oxygen support in the first year of life. But CPAP machines, the standard device in a country like the U.S., are expensive and require uninterrupted electricity. In many countries, Burke says, doctors resort to using a makeshift solution: a Coke bottle filled with water and attached to some tubing. The D.I.Y. approach can save an infant’s life but risks causing blindness. Burke took this simple yet flawed idea and improved it, designing the E.S.M.-CPAP, which is comparable to its high-tech equivalent but costs around thirty dollars. Like the UBT, it comes with a simple how-to.
Or take ketamine—known to many people in the West, if at all, as a recreational narcotic. Burke had long been aware of the semi-underground use of ketamine as an emergency anesthetic—he himself administered it at Ruby Ridge. Ketamine works, he says, because it “scrambles you”: “It’s a dissociative drug—it literally dissociates you from the stimulus that is happening, even the world that you and I live in.” It’s not a perfect anesthetic—for one, it’s not a muscle relaxant—but it doesn’t require expensive machinery, or a trained professional to insure a patient keeps breathing. One recent study found that Ethiopia, a country of eighty million people, had only nineteen anesthesiologists. Ketamine costs a few cents a dose and has now become an ad-hoc, unregulated alternative throughout the world. In Kenya, some eighteen hundred documented surgeries under ketamine have been performed, with no attributable deaths.
As word of Burke’s practice spread, via a journal article, something curious happened. A doctor from a Canadian hospital that sometimes suffered from a shortage of trained anesthesiologists got in touch with Burke, wanting to know more about the technique. A few months later, a team of Canadian doctors and nurses travelled to Kenya to observe surgical procedures performed under ketamine. The typically rigid flow of knowledge and resources so often seen in global medicine seemed finally ready to reverse.
In 1968, researchers in Dhaka, Bangladesh, began administering a solution of glucose and salts to patients suffering from severe cholera-related dehydration. Oral rehydration therapy (ORT) was a revelation in pediatric health, helping to stem an epidemic in children’s deaths from diarrhea—from an estimated five million deaths per year in 1968 to between four hundred thousand and six hundred and sixty thousand in 2016. The Lancet, in 1978, called ORT “potentially the most important medical advance this century.”
In developed countries, the standard treatment for diarrhea was to administer an intravenous fluid, a costly procedure requiring hospitalization. ORT—which basically amounts to drinking Pedialyte—costs just several cents a dose and can be administered anywhere by anyone, yet the magic bullet was resisted by many doctors. As Joshua Nalibow Ruxin, a public-health researcher and entrepreneur, noted in the journal Medical History, it had to overcome deep institutional bias: “Intravenous therapy appeared more scientific, there was an apparatus, and the physician could have precise control over the intake of a patient.” It took until 1992 for the Centers for Disease Control and Prevention to declare it the favored treatment for children with diarrhea in the U.S., and its use in high-income countries remains low. One possible reason? Hospitals get bigger reimbursements when they use I.V.s.
ORT is a classic case of what has been called “reverse innovation”: taking a technology or solution born of the resource constraints in developing countries and adopting it in wealthier ones. For many, it’s one of the most promising avenues for improving performance and lowering health-care costs. For the U.S., these are pressing goals: a 2012 study looking at health care in the most industrialized nations placed the U.S. near the bottom in almost every ranking. One of the few categories where it’s ranked first is cost: for these sub-stellar outcomes, U.S. citizens had the privilege of paying, on average, twice as much for health care as citizens of other countries in the report.
But reverse innovation can be a hard sell in the U.S. First, there’s entrenched cultural bias: How can we learn something from a place we are sending our expertise to? The very term “reverse innovation,” some suggest, merely reinforces this schema of knowledge transfer. And then there’s the lack of incentives. As Ashish Jha, the director of the Harvard Global Health Institute, argues, the U.S. health-care system lacks a strong central price-setting mechanism and exists in a highly uncompetitive market. If someone shows up with a “nice and cheap way of doing something, most hospitals are going to be skeptical: Why would they want something cheap if it’s going to lower their reimbursement?” And, even if the maker of a low-cost medical innovation were to get through the costly process of F.D.A. approval, it would then have to compete with manufacturers of more expensive products and try to sell to busy doctors with little interest in cheap solutions.
The high hurdles do not mean people are not trying. Arbutus Medical, a Canadian startup, was founded after a medical team working in Uganda observed local surgeons using cheap hardware-store drills—rather than traditional, clinical drills, which can cost upward of thirty thousand dollars—wrapped in unsterile towels. The team fashioned a better, sterile version of the drill cover that, attached to a DeWalt drill, is more than ninety per cent cheaper. The device was originally intended for low-resource settings but has attracted interest from the Canadian and U.S. military, and hospitals in the U.S., Canada, and the U.K. are considering trials.
In Clayton Christensen’s famous model of “disruptive innovation,” a lower-cost, initially lower-quality product goes on to conquer an established market dominated by higher-cost, higher-quality products. Digital cameras kill off Kodak, and Netflix runs Blockbuster into the ground. But health care in wealthier countries has been largely immune to this kind of disruption. Some of this makes sense—pricey drugs persist, at least in part, because of high research-and-development costs—but for the actual machinery of medical care, it’s harder to explain. Take MRIs. As Harvard’s Jha notes, MRIs are nineteen-eighties technology: “Sure, they’ve gotten marginally better over time, but the price keeps going up.” Medicine, it seems, is a unique beast. People may be pleased to see the price of flat-screen TVs drop, but they aren’t necessarily comforted to see the cost of medicine decline. As Jha puts it, “Do I really want a cheap version of X, because, hey, it’s my mom you’re talking about—plus insurance is paying for it.”
Even comparing the costs of health-care solutions gets into dicey political ground—echoes of “rationing” and “death panels”—as well as larger ethical issues. Virginia Rowthorn, an expert in global health law at the University of Maryland, gives the example of detecting cervical cancer with vinegar—a technique used in many developing countries. “If that technology were taken to an underserved area in the U.S., you can imagine the debate that would raise. Not only are we bringing in tech from a low-income country, now we’re using it with vulnerable populations in our society—it could be seen as another form of systematic discrimination against these groups.”
Many in the U.S. would object to the idea of people getting something they perceive to be less than the standard of care, even if the alternative is no access at all. (Because medical devices are rarely tested against each other, we don’t always know if cheaper technologies are more or less effective than expensive ones.) But this moral stance may simply be a fig leaf for another moral quandary. “In the U.S., we’ve tended to say cost is no object, but at the same time we’re comfortable with millions of people being uninsured,” Nancy Kass, a professor at Johns Hopkins University’s Berman Institute of Bioethics said. “We make our own tradeoffs here; we just don’t describe them the same way.”
Michael Saag, a professor at the University of Alabama at Birmingham who worked on a novel AIDS-prevention program in Zambia, some elements of which were ultimately adopted in his state, believes that the flow of ideas and technologies between higher- and lower-income countries should be “bidirectional,” for a simple reason: “A lot of the problems that we see in sub-Saharan Africa we see in rural Alabama, especially in regards to access to care for pregnant women. There are entire counties lacking in maternal-health resources.”
Burke’s uterine-balloon device has captured the attention of midwives and other health-care providers working in the U.S. and Canada. Susana Ku, a midwife and teacher at Ryerson University, told me that there are places in Canada where the more expensive uterine balloons are prohibitive for many midwives and providers, many of whom cover far-flung rural territories and work with underserved indigenous populations. Burke’s UBT is currently under review by the F.D.A.; even if it’s approved, it won’t necessarily be used in the U.S. anytime soon. Regardless of its efficacy, it’s hard to imagine a company stepping in to do the necessary marketing and sales for a low-cost product whose use is infrequent. Burke says that his work was always focussed on resource-limited countries, but perhaps that definition is more elusive than one might think. “We’re the only country on earth, other than Syria, where the maternal-mortality rate has gone up in the last decade,” he says, of the United States. “Syria’s at war!”
Kass, the bioethicist, is trying to puzzle out the ethics of what might be seen as lower-quality solutions. Consider, she says, a doctor on a plane. “They’re called to do something, and they don’t have everything with them, but you’re glad that they can do a little bit of what they can until the plane lands.” Burke has been that doctor. He, like many others, is doing what he can until women’s medicine improves, until standard anesthesia becomes widespread, until people across the globe have the access to the care they all deserve. He did not have his patients in Boston in mind when he began looking for low-cost, unorthodox solutions to stubbornly persistent global health problems. But, in a country like the U.S., faced with spiralling health-care costs and access-to-care issues, where innovation typically leads to more expensive and sometimes unnecessary technologies, it may be time for medicine, still often dominated by a closed, guild-like mentality, to think more inventively. Home Depot might not be a bad place to start.
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Cheap and simple medical devices could improve performance and lower health-care costs, but first they have to overcome deeply rooted biases.www.newyorker.com