Such updates are like weather reports in the middle of a storm. “Such is the fragility of JIT: a surprise event can paralyze entire networks and even industries,” the management scholars Toshihiro Nishiguchi and Alexandre Beaudet observed the following year, in a case study of the episode. Add in diagnostic errors, and it could be a lethal one. Author Siddhartha Mukherjee outlines his family’s genetic history with mental illness. Efficiency at the cost of resilience is like a silent aneurysm waiting to rupture. In each arena, the pandemic has revealed some strengths—including frank heroism and ingenuity—but it has also exposed hidden fractures, silent aneurysms, points of fragility. The story of Mike Bowen, a manufacturer in North Richland Hills, Texas, offers some clues. When I e-mailed the Strategic National Stockpile, a spokesperson emphasized that the role of the S.N.S. Born in New Delhi, Mukherjee is a noted biologist, oncologist and the author of several acclaimed books, including the Pulitzer Prize-winning 'The Emperor of All Maladies: A Biography of Cancer'. eventually responded was by developing an “accelerated approval” process. Between February 28th and March 1st, Greninger’s team worked around the clock to prepare the virology lab for testing hundreds of patient samples. Coronavirus Chronicles. Perhaps our hospital system’s emergency department should be alerted. professor who studies supply-chain economics and how enterprises respond to disasters. Sarah, a 2003 MacArthur Fellow, is an internationally admired artist … Not every provisional finding will pan out. (A puff of aerosolized saccharin might be sprayed near your face; if you can detect the sweetness, the mask isn’t fitting properly.) ), “It’s the way the system is,” she said. Medicine is a system for delivering care and support; it’s also a system of information, quality control, and lab science. was “to supplement”—her emphasis—“state and local supplies during public-health emergencies,” not to fulfill everyone’s needs. Boom-and-bust cycles in research have consequences: lab technicians are skilled workers who are laid off or retrained as priorities shift. To what extent did the market-driven, efficiency-obsessed culture of hospital administration contribute to the crisis? “Look, we live in uncertain times,” Michael Lauer, a senior administrator at the N.I.H., said. “But resilience is much harder.” So we reward managers for efficiencies—and overlook any attendant fragilities. Public Relations does that for both small and large brands by relating with their stakeholders. South Korea has so many test kits that it’s now exporting them for use in the United States. form, from March 7th, was just seven pages. failed to work properly, labs across the country scrambled to fill the void. systems have failed medicine, and yet an executive order from New York State, issued at the end of March by Governor Andrew Cuomo, amounted to a grim epitaph: “Health care providers are relieved of recordkeeping requirements to the extent necessary for health care providers to perform tasks as may be necessary to respond to the COVID-19 outbreak. (The F.D.A. We need to think not about resumption but about revision. May 4, 2020 Issue. Neeta Thakur, a pulmonologist and researcher at the University of California in San Francisco, told me about the byzantine process (involving “ten to fifteen disconnected steps”) that was required in order for a patient to receive oxygen at home—a patient who is then at the mercy of the intermittent delivery schedules of understocked venders. The problem builds into a failure cascade: if patients cannot be discharged from the hospital because they cannot have oxygen at home, the resultant logjam delays the treatment of other patients who need those beds for acute care. Time and again, technicians in New York found, one of the probes—probe N3—registered false positives: even distilled water triggered a positive result. Her work has helped that of other Penn scientists, including the virologist Sara Cherry, who are searching for drugs that might block coronaviruses from entering cells and replicating. by Siddhartha Mukherjee, on May 19, 2016. The company shouldn’t have been so vulnerable to such an event. View Video. By Lavina Melwani. The first coronavirus conference was organized in 1980, in Würzburg, Germany. Download books for free. A Rhodes scholar, he graduated from Stanford University, University of Oxford, and Harvard Medical School. For a while, exports declined to a trickle. What Went Wrong with Coronavirus Testing in the U.S. A New Doctor Faces the Coronavirus in Queens. A putative advantage of digital hospital records is to enable on-the-fly searches—not the kind of data project that the N.I.H. Afterward, some companies expanded their supply lines to other parts of Asia. I spoke to Alex Greninger, the assistant director of the virology lab at the University of Washington. But that’s only a fraction of the demand; he has had to turn away orders for hundreds of millions a day. For COVID-19, in turn, the F.D.A. Ad Choices. In the absence of effective drugs, care is mainly supportive. I think of it as reading and writing in some ways. The original one, from January 19th, was thirty pages and filled with dense boilerplate. Research does not benefit from a feast-or-famine ecology. application. For Greninger’s team, devising a lab test for the new coronavirus, SARS-CoV-2, wasn’t particularly difficult: its genomic sequence was already available, which made it possible to design the right probe for detecting the viral material. The government identified more than twenty reputable venders, certified their products through a sound evaluation process, and set their factories loose to meet the demand. He spoke deliberately, with the slightest Texan drawl. Siddhartha Mukherjee. … September 2016) (Learn how and when to remove this template message) The Gene: An Intimate History is a book written by Siddhartha Mukherjee, an Indian-born American physician and oncologist. must think hard about how to balance speed and oversight, adjusting the ratio to meet the moment but abandoning neither. On February 28th, Greninger and colleagues sent a letter to Congress, noting, “No test manufacturer or clinical laboratory has successfully navigated the E.U.A. Still no dice: he had e-mailed the material, and the F.D.A. The E.M.R., as a colleague of mine put it, is “electronic in the same sense that your grandfather’s radio is electronic.” The energized, improvisatory role of medical Twitter inevitably draws attention to what our balky, billion-dollar systems should have been providing—to the cost, in dollars and lives, of the rapid clinical learning that we’ve forgone. “The investigators came and then they left,” Stanley Perlman, a microbiologist at the University of Iowa, told me. I could have been Siddhartha Mukherjee before Siddhartha Mukherjee, but poor decision-making and twists of fate denied me. It modified its just-in-time system to allow for at least a month’s worth of specialized components, building strategic slack into its operation. In this state of emergency, delivering care has required both personal protective equipment (masks, gowns, gloves) for medical personnel and devices (including supplemental oxygen and ventilators) for patients. that can launch pandemic surveillance within days, not months; research priorities that don’t erase recent history; an F.D.A. The N.I.H. It should be a simple task to encrypt or remove a patient’s identifying details while enlisting his or her medical information for the common good. Start with health care as a delivery system. He told me about floods in Thailand that shut down factories responsible for critical computer and automotive parts. When COVID-19 hit, China shut down many of its factories, and retained most of its diminished production of masks for its own use. Meanwhile, the infection spread on flights and in movie theatres and during visits to grandparents, seeding itself in other cities and states: New York, New Jersey, Louisiana, Connecticut. He has published articles in Nature, The New England Journal of Medicine, The New York Times, and Cell. 894646. Medicine needs to do more than recover; it needs to get better. The N95, meant for a single use, is designed to filter particulates as small as 0.3 microns in diameter. A resident in Boston who worked in an E.R. On Sunday, April 4th, Tatiana Prowell, a doctor at Johns Hopkins, messaged me on Twitter. I searched a database called Grantome to confirm Weiss’s observations. Instead, the medical infrastructure of one of the world’s wealthiest nations fell apart, like a slapdash house built by one of the three little pigs. Greninger, a square-jawed athletic figure who favors hoodies over suits, didn’t blame anyone at the C.D.C. ; in fact, he told me that he found the officials “extremely responsive and easy to work with.” As he described the situation, it was the process that failed. No set of reforms will deal with every problem, such as a President who, bickering with scientists, equivocated and delayed what could have been a lifesaving, economy-protecting, coördinated response. Yet resilience isn’t simply a matter of having supplies at hand. But, most of all, we need an identified capacity—a network that can be activated on demand, repurposing manufacturing lines, recalibrating agency protocols. He is best known for his 2010 book, The Emperor of All … should have done, long before the pandemic arrived on these shores. To revisit this article, visit My Profile, then View saved stories. He’s another veteran coronavirus researcher who has watched labs drift away from his field of concern. Registered office: 1 London Bridge Street, SE1 9GF. Because clotting is a frequent issue among patients with cancers, I called my colleague Azra Raza, the director of Columbia’s Myelodysplastic Syndrome Center, to ask if we could search through the database of her patients for any who had reported being infected, and, if so, had experienced blood clots. So we had to lay off all of those people.” Bowen almost went bankrupt. Securing samples of that material to validate the test wasn’t easy, but Greninger found a way. Year; Laminar forced convection in power-law and Bingham plastic fluids in ducts of semi-circular and other cross-sections. But what the pandemic has exposed—call the experience a stress test, a biopsy, or a full-body CT scan—is painfully clear. A storm-forecasting system that warns us after the storm has passed is useless. Still, anecdotal patterns can lay the groundwork for a case series, and then a case-control study, and, ultimately, a randomized, controlled trial of a clinical approach. When I worked in a viral immunology lab as a grad student at Oxford, our research infrastructure was supported by dozens of technicians, each trained one-on-one by yet another layer of skilled technicians. Yet, for some researchers, it would prove to be a roadblock in itself. Title. “And, of course, suddenly everyone was interested,” Weiss recalled. The first was the history of mental illness in my family - particularly schizophrenia and bipolar disease. In the later stages of a pandemic, the ability to test on a wide scale allows agencies to concentrate on hot spots and contain them with limited, local lockdowns. In a discussion moderated by Deputy Editor Seema Chishti and Senior Editor Paromita Chakrabarti, Mukherjee … could run the equivalent of fire drills, identifying the capacity, almost on the model of Toyota’s Rescue database, to create and mass-manufacture such kits during a time of crisis. says that the original design it approved had performed well; the trouble arose when additional lots of the kit were manufactured.) It isn’t what anyone is taught in medical school; it doesn’t fit in with the professional’s image as a purveyor of rigorously tested interventions. Before the pandemic, each cost between fifty cents and a dollar or so. If a fifth of that workforce were involved in some contact with virus-infected patients, and if no more than two N95 masks were used per worker each day, the entire S.N.S. (This requirement was later withdrawn. Will be used in accordance with our Privacy Policy. Patient records that once were scribbled on clipboards now sit in electronic medical-record (E.M.R.) Please help improve this article by adding citations to reliable sources. By Kristen MasciaJune 05, 2019 “Drugs Into Bodies” too easily devolves into bad drugs delivered into vulnerable bodies. My mother, in New Delhi, was in … In short, the F.D.A. TIM FOLGER is a contributing editor at Discover and writes about science for several magazines. bags and pill bottles generally had their origins in petri dishes and microarrays. Jitender Gupta Doing ground-breaking cancer research and writing a Pulitzer Prize-winning book are probably amongst the toughest things in the world but Dr Siddhartha Mukherjee has done both. An F.D.A. Having seen the fragility of a tight chain, those companies had now established a network with some spring in it. Mukherjee is an assistant professor of medicine at Columbia University and a cancer physician and researcher. 543, £ Darwin came tantalisingly close to understanding them, 20th-century eugenicists obsessed over them, and with modern science, we … Siddhartha Mukherjee is a cancer physician and researcher, a stem cell biologist and a cancer geneticist. This may require regular “Requests for Applications,” determined by an advisory panel, that will encourage researchers both to advance our microbiological understanding of such agents and to develop interventions and therapeutic platforms. The Aisin factory normally produced almost thirty-three thousand valves a day, and was, at the time, the exclusive supplier of the part for the Toyota Motor Corporation. It’s one of the largest virology labs in the country, and researchers there began developing a test just days after the first case of covid-19 was detected on American soil—a thirty-five-year-old man who appeared at a clinic in Snohomish County, Washington, on January 19th, coughing and feverish. relaxed its position, allowing “high complexity” clinical labs to test for virus infection in advance of agency review and approval. “Could we cut it short today? Rather, he told me, “I think of slack as capacity and capabilities.” What you really want to measure, model, and establish is the capacity to build something when a crisis arises. N95 respirators, those heavy-duty face masks with two straps and a metal nose bridge, are a case in point. The plot of federal grants awarded for coronavirus research in the past few decades looks like a bell-shaped curve. “When the tide goes out,” Warren Buffett once said, “you discover who has been swimming naked.” The pandemic has been merciless in what it has exposed. Think of it as a kind of intranet: flexible, programmable, easy to use. One way that the F.D.A. Inventory diminished; delivery times increased. The whole of the N.I.H. by Siddhartha Mukherjee Scribner, New York, 2016 Arthur L. Caplan1 Division of Medical Ethics, New York University Langone Medical Center, New York, New York, USA When you have written a best-selling, Pulitzer Prize-winning book, your next book is going to garner a great deal of attention. had authorized only the C.D.C. The Gene by Siddhartha Mukherjee review – intriguing and entertaining Despite flaws, this lively and accessible history of the gene and its implications for the future is bursting with complex ideas You’d have to hire someone specifically to look through it.”, A cardiologist at Massachusetts General Hospital, in Boston, echoed this frustration on Twitter: “Why are nearly all notes in Epic . to permit its use. The Author. supply would last eleven days. The N.I.H. A recent fiasco in the U.K. illustrates the point: the government spent twenty million dollars on COVID-19 tests, peddled by two Chinese companies, that proved unreliable. Instead, they negotiate contracts as members of a Group Purchasing Organization—representing hundreds or thousands of hospitals—and, as Bowen explained, the G.P.O. What was its approach? The F.D.A. The company maintains constant communication with its suppliers under “ordinary operating conditions.” But it also trains employees to operate during disasters, and evaluates the risk to the entire company if nodes in the network should falter. On March 4th, six weeks after the first case of COVID-19 had been reported in America, the S.N.S. The first is the “time to survive”; that is, how long can an enterprise endure when there’s a sudden shortage of some critical good? production: parts, such as P-valves, were produced according to immediate needs—to precisely match the number of vehicles ready for assembly—rather than sitting around in stockpiles. system that’s versatile enough to serve as a tool for everyday use but also as a research application during a crisis, identifying techniques that improve medical outcomes, and disseminating that information to physicians across the country in real time. A front-line physician at Elmhurst Hospital sees how closely socioeconomic status is tied to the disease, and tries to help patients who are dying without their families. We have noticed that there is an issue with your subscription billing details. “Slack”—underutilized resources, inventory waiting to be put to use—was shunned. duly worked with the C.D.C. “My phone is full of msgs from physicians from every specialty asking if others are also seeing unexpected thromboembolic events in young, healthy patients with COVID-19. And then, when it ended, the whole thing fell apart. In the pre-pandemic world, when I encountered a patient suspected of having influenza or TB, say, I would put one on, and discard it in the biohazard trash after each use. It would permit the use of “surrogate” metrics to judge the success of a medicine; that is, rather than waiting to measure patient survival rate over some period of time, researchers could establish effectiveness simply by documenting a decrease in viral loads, or the recovery of the immune system. Siddhartha Mukherjee, oncologist and Pulitzer Prize-winning author, with The Indian Express Deputy Editor Seema Chishti (right) and Senior Editor Paromita Chakrabarti. Take the debacle of the C.D.C. We hired an extra hundred and fifty people. It was a product of time and the accretion of expertise. T he call came at three in the morning. Format: Tips on citation download: Download … Working as a cancer physician, researcher and assistant professor at Columbia University doesn’t seem to be enough action for Dr. Siddhartha Mukherjee. Chinese doctors had apparently seen such blood clots, and started giving patients blood thinners to prevent them. “Hospitals promised to retain us as suppliers after the flu.” But promises are not contracts. Simply select your manager software from the list below and click on download. Overtaut strings inevitably break. “Recovery” is the word of the moment; it connotes a return to a previous state of well-being. The people that we helped went back to the foreign-made masks. Ebooks library. could have had a streamlined E.U.A. evaluates its entire portfolio every five years. announcement, the state of Massachusetts requested seven hundred and fifty thousand N95 masks (and a similar number of surgical gowns and gloves) to protect its doctors and nurses. Interview Transcript. has sought to fast-forward trials by means of its Coronavirus Treatment Acceleration Program, working with developers of treatments and vaccines. The day after the S.N.S. It is a set of protocols for quality control—from clinical-practice guidelines to drug and device approvals. Some were tiny, nearly undetectable, and some were huge. Medicine isn’t a doctor with a black bag, after all; it’s a complex web of systems and processes. Because companies that moved manufacturing abroad—including Bowen’s old employer, Kimberly-Clark—would undercut him on price, he often had a hard time landing orders. The valve was small and cheap—about the size of a fist, and roughly ten dollars apiece—but indispensable. His view can be summarized simply: we’ve been overtaught to be overtaut. But, as a physician and researcher, I fear that the resumption of normality would signal a failure to learn. . Instantly recognizable in the long passageways of the lab by her nimbus of curly brown hair, she has spent her career working on coronaviruses. The next step was getting the F.D.A. “And in any case, because of all the concerns around privacy, if you wanted to report the findings you would have to file with the institutional review board.”, “But that would take a month, at least,” I protested. While other labs at the university are under lockdown, hers is now in hyperdrive: she is studying coronavirus proteins and their interaction with the human immune system—a topic she has pursued for forty years. Siddhartha Mukherjee. All Work. The Gene; The Emperor of All Maladies; The Laws Of Medicine; Scientific Papers; Video & Interview; In the news; contact; Ken Burns; Ted Talk ; Scientific Papers. “We were just naïve,” he said. Here’s where attention to “mature quality systems” matters. might fund (its grants take weeks to process even on an accelerated schedule) but the kind that might be completed in an hour. But mid-crisis, when the need for these masks in hospitals and clinics was most acute, doctors and nurses ran short. The answer was thirteen million. form already in hand—preferably without a requirement that it be sent by pigeon post—rather than having labs waste critical time placating its bureaucracy. “If you want to report the number of times a patient has cut her nails in the last week, you would need approval. process for SARS-CoV-2 to date.”. If you have the appropriate software installed, you can download article citation data to the citation manager of your choice. Right now, its potential as a resource is blocked, not least by the owners of the proprietary software, who maintain it as a closed system, and by complex rules and regulations designed to protect patient privacy. What will happen when the epidemic is over?” Once the incidence of COVID-19 subsides, so will the sense of urgency when it comes to building infrastructure, or stockpiling equipment—masks, ventilators, reagents—that might sit unused in warehouses for a decade or more. The Bodley Head, pp. When labs at American hospitals and elsewhere devised detection assays of their own, the agency prohibited their use until an “Emergency Use Authorization” had been applied for and granted. Now he's the scientific adviser of an immuno-oncology start-up that's tackling a rare form of leukemia. The F.D.A. But the company’s executives realized that it was also a story of failure. I spoke to David Simchi-Levi, an M.I.T. I e-mailed a doctor in London; in autopsies, he told me, “we are finding micro-emboli, small clots, in the lungs.” During the next few days, my in-box and my Twitter feed brimmed with notes from doctors and researchers remarking on these findings, and wondering about trials for virus-infected patients and blood thinners. In fact, the “slow collective” awakening was already well under way—elsewhere. Brother Industries, a Japanese company best known for its sewing machines and typewriters, adapted a computerized milling device that made typewriter parts to start making P-valves. . Why wasn’t our research investment remotely commensurate with our threat assessments? SIDDHARTHA MUKHERJEE, cancer physician and researcher, is the author of The Emperor of Maladies: A Biography of Cancer, the 2011 Pulitzer Prize winner for general nonfiction. Last summer, long before the pandemic, pulmonologists were raising concerns about a lack of oxygen supplies—the result of cost-cutting measures by suppliers of durable medical equipment. has essentially recused itself from evaluating these tests before they come on the market. Patients suffered. Days after the Aisin fire, a typewriter factory was putting out brake-system components. It was a “war room,” one official recalled. Trials became leaner and swifter, expediting the development and approval of the antiviral “cocktail” therapies that are now used to treat patients with H.I.V. “Squeeze more efficiency, squeeze cost, squeeze more products out at the same cost, squeeze out storage costs, squeeze out inventory. As Greninger was quick to point out, without some F.D.A. COVID-19 has similarities to familiar conditions, but it is a new condition and, like all new conditions, it has its peculiarities.