By Jeffrey Freeman, Lauren Sauer, Kaitlin Rainwater-Lovett, Cassidy Rist, Matthew D’Angelo, Melissa Givens
In public health and medicine, there is no business model for preparedness. This is because our nation’s health system operates like a restaurant after the dinner rush. For those who haven’t had the pleasure of working in the food service industry, what you need to know is that the lion’s share of the money is made during traditional dinner hours when most folks arrive to eat, but restaurants are typically open a few hours after the rush, operating mostly on a skeleton crew. Keeping a bunch of waiters, hosts, and cooks working after business has slowed down each night isn’t feasible, as it reduces the restaurant’s financial margins.
Unfortunately, the occasional school bus with a high school band or sports team may pull up to the restaurant after the dinner rush. With only a skeleton crew working, the restaurant can’t manage customer demand, essentially breaking the kitchen. The food comes out late and often wrong. If you’ve worked in a restaurant, you know this scenario all too well, and if you’ve visited a restaurant when its happened, you’ve likely left frustrated. Hospitals face a similar predicament. The difference is, while you might leave a busy restaurant hungry or disappointed, a patient in a busy hospital might by harmed or they may not leave the hospital at all.
Due to the high cost of delivering medical care and the need to maintain increasingly razor-thin financial margins, hospitals must operate as efficiently as possible. It’s not feasible to maintain a large number of physicians, nurses, and technicians standing around with nothing to do until the proverbial disaster bus pulls up. When crises do occur, hospitals are often overwhelmed and struggle to meet demand. The situation worsens if a crisis persists, as with a pandemic. There are no easy answers to this problem. Hiring and retaining more clinical staff or keeping additional unused medical supplies on hand is costly, eating away at financial margins and likely raising the cost of care to unsustainable levels. It’s true, there simply is no business model for preparedness.
Without a sustainable model in place, our public health and medical communities are often left to build capacity in real-time when disasters strike, operating on an ad hoc basis. In essence, they are tasked with 'building the plane while flying it’. The consequences of this approach are a slower, more chaotic, and often less effective and potentially dangerous response, especially in the early stages of a crisis. The toll of developing capacity on the fly is often levied on the healthcare team, increasing burnout and moral injury.
Building on the fly was common throughout the COVID-19 pandemic, and the negative impact of deploying such an approach was also clear. From the attainment of critical information to the development and acquisition of life-saving treatments, our nation’s public health and medical communities were forced to build capacity urgently, while also watching public confidence in their efforts erode as they took the necessary time to build what they lacked.
One of the earliest and most trusted sources of information during the pandemic was the Johns Hopkins COVID-19 dashboard, but its development was not without challenges. It took months to fully buildout the IT infrastructure required to capture the world’s COVID-19 data at a speed that delivered information to the public in a way that could be trusted. This was not a capability that existed prior to the pandemic. It was built entirely on the fly, and therefore, lacked the necessary trust to be integrated within the federal response, especially early on when decision makers opted for more established but less timely and complete data sources.
Another example of building on the fly was the development of monoclonal antibody (mAb) infusion therapy for high-risk COVID-19 patients. Although mAb therapy existed pre-pandemic, its use as a treatment for COVID-19 had to be developed, trialed, approved, and ultimately adopted by the nation’s hospital systems. Development and approval came far quicker than anyone imagined, but adoption was slower. An Emergency Use Authorization (EUA) was granted by the Food and Drug Administration (FDA) in late 2020, but questions remained as to the real-world effectiveness of mAb therapy and hospitals desperately needed to know the burden they should expect when adopting a new therapeutic.
To answer these questions, the federal government deployed a field team to conduct studies on both the real-world effectiveness and the protocol for adoption. The former was meant to convince hospitals it was worth adopting the new treatment: infusing COVID-19-positive patients with mAb reduced severe disease, hospitalization, and therefore hospital system capacity strain. The latter aimed to inform an approach for hospitals to maximize patient throughput while minimizing the resources required from already strained health systems. While mAb therapy would become less effective in treating new variants much later, these studies found that mAb therapy was highly effective early the pandemic, reducing the risk of hospitalization in high-risk patients by 82%. They also found that the protocols available for adoption were far more burdensome than necessary, which may have been as significant a barrier to adoption as were the questions of effectiveness. This inefficiency was not a consequence of poor planning or lack of effort; it resulted from the resource-intensive way in which risk is managed when implementing new processes under a crisis. The same situation that creates the need for building on the fly, also urges caution in its novelty.
Perhaps the most high-profile example of building on the fly during the pandemic was the development of novel mRNA vaccines from Moderna and Pfizer. While the science behind these therapeutics was well-founded and evidence-based, the approach to the logistics of rapid scale up for the pandemic was not. Like mAb therapy, mRNA vaccine development and approval came quickly. Appropriate, given the name of the government initiative that led their development, Operation Warp Speed (OWS). But vaccine deployment and delivery to the nation, and ultimately adoption by the public, was plagued by inefficiencies and logistical constraints. As the vaccine rollout continued, communications in support of immunization by the public health community was overcome by misinformation, which further eroded trust in the response.
To be clear, mAb therapy and vaccines helped save tens of millions of lives and should be celebrated, but building on the fly requires time and can be messy, unnecessarily wasteful, and lead to distrust, especially early on. Nonetheless, building on the fly is not a luxury but a fundamental requirement of responding to large-scale emergencies. In some ways, this may seem counterintuitive to conventional wisdom, which suggests that for something to be used in a disaster, it must have a so-called ‘day job’. The presumption is simple: if something is not used on a day-to-day basis, then it is unlikely to be used or used effectively during a crisis. In practice, however, this assumption is often violated. New capabilities and processes are commonly developed entirely on the fly during a crisis, and some of those prove to be the most used and effective tools in a response. In contrast, other well-established tools with more routine applications are often insufficient to meet the mission requirements of a large-scale disaster.
In COVID-19, for example, new data sources and surveillance systems, like the CDC’s Aggregate Cases and Death Counts (ACDC) and the Unified Hospital Dataset, were used in lieu of long-established surveillance systems like the National Syndromic Surveillance Program (NSSP) and the National Healthcare Safety Network (NHSN). In fact, ACDC and the Unified Hospital Dataset were among the most used data sources across the response and informed decision-making at every level of government and for everything from ventilator distribution to testing campaigns to vaccine rollouts. These critical sources of data, and many of the systems that put them to work, were built entirely on the fly. COVID-19 is not the exception to the rule.
As the U.S. shifts its attention to the Great Power Competition and the threat of large-scale combat between superpowers looms, the nation must prepare for the possibility of thousands of casualties per day returning home from war in need of care. The U.S. experienced significant casualties during the Second World War. Between December 1944 and March 1945, nearly 170,000 casualties disembarked from transport within the continental U.S. At its peak in March 1945, more than 1,500 patients arrived daily. Although the complexity of injuries for those who returned from World War II will likely be far different from those anticipated in future conflicts, combat casualty care today far exceeds that of the mid-20th Century. Casualty flow to the “Zone of the Interior” in World War II was successful because military leadership harnessed and integrated military and civilian resources. Casualties disembarked from five primary locations across the country. Typically, within 72 hours of arrival, the service member would depart by ambulance to local destinations or by hospital train to points of care within the U.S.
While entirely different challenges, the COVID-19 pandemic and World War II share several important characteristics. Unlike most disasters that more commonly present as acute shocks constrained to a geographic region, these events required sustained responses over prolonged periods of time and across much wider geographic areas. The scale of resources needed to execute both missions also far exceeded other emergencies and overwhelmed local and regional capacity, which required substantial capability development throughout the events, well above and beyond what could be maintained in a pre- or post-event environment. While each developed substantial capability on the fly, those efforts took time to develop and often struggled, especially in the early stages. As with a pandemic, the cost of time and struggle in a war can be measured in disease and death, but lives are saved as improvements are made.
Today’s threat landscape is vast, and the health challenges facing our nation and the world are growing. Individually, disasters may seem infrequent and unpredictable, yet we know disasters are near-continuous. The likelihood of large-scale disasters occurring in the future is near certain. From observed increases in the frequency and severity of extreme weather events to the array of threats posed by advances in technology to the heightened risk of war between superpowers, the U.S. must contend with the genuine possibility of a wide-spread catastrophe.
Our nation as well as our partners and allies must be ready to respond to truly disastrous events, including those of a scale we have rarely seen and can hardly imagine. An overseas large-scale combat operation (LSCO) between the U.S. and a peer adversary, for example, would bring challenges to the nation’s health and medical communities that have not been experienced since the end of the Second World War. We could expect a steady stream of thousands of casualties returning home daily to a health system with little margin to accommodate their needs. Our nation is not ready.
The specter of war with a peer adversary is not an unfamiliar problem. Going back to the 1980s, and the height of the Cold War, the National Disaster Medical System (NDMS) was established by Congress to provide care for U.S. military casualties and other citizens following a potential conflict with the Soviets or other adversaries. In fact, the original mission of the NDMS was “to provide medical evacuation and definitive care in the U.S. for military casualties returning from an overseas war.”
Today, the NDMS is comprised of Department of Defense (DOD) medical treatment facilities, Veterans Affairs (VA) medical centers, and a network of over 1700 private-sector hospitals coordinated by the Administration for Strategic Preparedness and Response (ASPR) under the Department of Health and Human Services (HHS). Since its inception, the NDMS has been used effectively to respond to a wide variety of disaster-level events, however, the medical evacuation and definitive care aspects of the system have never been fully activated. A recent assessment of the NDMS suggests it has not been resourced or equipped well enough to meet the demands of a large-scale combat operation, or other wide-spread disaster.
In 2020, recognizing the limitations of the NDMS, Congress directed the DOD to conduct a five-year NDMS Pilot Program to assess and improve the capacity and interoperability of the NDMS. Led by the National Center for Disaster Medicine and Public Health (NCDMPH), a component of the Uniformed Services University (USU), the NDMS Pilot Program has been working with partners across the federal interagency, academia, and industry to assess gaps in the NDMS, develop and validate solutions with the potential to scale, and make recommendations to Congress on policy changes, as well as additional investments, that may be needed to meet the mission requirements of a truly catastrophic event.
Under the pilot program, efforts have been undertaken to fortify today’s military and civilian health systems, and recommendations will be made for improving the system of tomorrow, but the absence of a business model for preparedness will remain a challenge to this and all other preparedness efforts. The substantial resources required to respond effectively to a large-scale combat operation or the next global pandemic cannot be sustained financially or logistically under steady state. Substantial capacity will need to be built in the moment. To ready our nation for an uncertain future, we must become better prepared to build capacity on the fly, but we must do so more effectively than we ever have before. In a sense, we must be prepared to build on the fly by design.
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Part 2 of this article will introduce Building on the Fly by Design, a new initiative launched by the National Center for Disaster Medicine and Public Health, in collaboration with the University of Nebraska Medical Center.
The views and opinions expressed in The Disaster Blog are those of the authors and not those of the Uniformed Services University, the Department of Defense, or the United States Government.