At my first biopreparedness conference over a decade ago, I was amazed by the number of possible naturally emerging infections or acts of bioterrorism that could threaten the public. Fortunately, there were also dedicated federal, state, and local government officials, public health practitioners, and other experts planning and preparing to protect United States and global public health under different scenarios. After the terrorist attacks of September 11, 2001 and the subsequent anthrax bioterrorism attacks, U. S. biopreparedness efforts had increased significantly. Funding for biodefense research had increased and pandemic planning had occurred across public and private sectors.
The 2009 H1N1 influenza pandemic tested those preparedness plans and revealed strengths and weaknesses in U.S. biopreparedness. Luckily, H1N1 disease outcomes were relatively mild to moderate. During the 2014 Ebola virus disease epidemic, the approximately 50% mortality rate was much higher than seasonal influenza, but since the virus primarily infects close contacts, there was little community spread in the U.S. and many countries. SARS-CoV-2, the virus causing the current coronavirus disease pandemic (COVID-19), exhibits both a higher infection rate and mortality rate than seasonal influenza—a dangerous combination. The U.S. was not prepared to combat this pandemic early on because of existing challenges in pandemic preparedness that were exacerbated by the Trump administration.
There are persistent challenges in preparedness for a natural or man-made biological event. Preparedness experts worry most about low-prevalence, high-consequence events because policymakers may not see the need to invest and prepare continuously for an event that may not happen during their tenure. But when such an event does happen, as it invariably does periodically, there can be dire consequences. While it is impossible to predict exactly where, when, and how an emerging infection will become a threat, we do know some of the factors that make these events more likely. For example, a virus that crosses from an animal into a human can be dangerous because there may not be existing immunity in human populations. If that virus is capable of human-to-human spread, it can spread quickly through a population. Pandemic preparedness efforts have focused on the most dangerous pathogens such as avian influenza, but were also designed to be flexible and adaptable enough to respond to different threat scenarios. Yet despite the potential consequences of a serious infectious disease outbreak or other biological event, there has traditionally been a lack of investment in infectious disease diagnostics, public health capacity, and other preparedness needs.
It is notoriously challenging to convince policymakers to invest in health initiatives that have less visible outcomes, and I have spent my policy career raising the visibility of unmet clinical and public health needs. There are components of our health care system that are taken for granted until an outbreak or other incident occurs. It is easier to show the direct impact of providing a certain number of pills or vaccines to a population than to measure the indirect impact of disease prevention programs and diagnostic testing. Continuous funding for public health capacity is needed to support surveillance, outbreak response, and preparedness. There has also been chronic underinvestment in infectious disease diagnostics even though diagnostics are generally less expensive to develop than therapeutics and vaccines. In 2013, I co-authored a policy paper outlining why better infectious disease diagnostics are needed, the barriers to research, development, and deployment of these diagnostics, and policy recommendations to overcome the barriers. Many of the barriers still remain today, but there are mechanisms intended to accelerate diagnostic availability during a public health emergency, such as an emergency use authorization from the U.S. Food and Drug Administration (FDA).
While there are long-standing challenges to pandemic preparedness, these challenges were amplified under the Trump administration. The administration has not adequately prioritized scientific expertise, government capacity, international collaboration, and biopreparedness. Lessons learned from past epidemics were ignored, as the White House downsized the global health and biodefense office at the National Security Council (NSC) that had been expanded under the Obama administration to monitor and respond to global health security threats. I previously worked as an international health advisor on the Pandemic and Emerging Threats team in the Office of Global Affairs at the U.S. Department of Health and Human Services (HHS). In that role I worked with the NSC global health and biodefense office on antimicrobial resistance and other global health security threats, helping to coordinate discussion among HHS agencies and providing information and recommendations to NSC staff. Reducing the capacity and prioritization of the NSC global health and biodefense office diminished the NSC’s ability to inform, lead, and coordinate the early U.S. response to the COVID-19 outbreaks.
The Trump administration has repeatedly proposed significant budget cuts to the Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH), which would have even more significantly impacted the U.S. coronavirus response, but fortunately Congress blunted those cuts. At a press conference on February 26, 2020, President Trump acknowledged that expert capacity in the government had been reduced but asserted that this capacity could be quickly recovered when needed. That is not the best way to prepare and respond to health security threats. Continued investment, planning, and training is needed to ensure that institutional knowledge is maintained in government agencies and that personnel are ready to execute preparedness plans. Infectious disease experts often use combat analogies to describe the fight against microbes. The global COVID-19 pandemic is demonstrating that biological threats are true national security threats, and that pandemic preparedness requires a level of investment and training analogous to military readiness.
The Trump administration’s “America First” policy translated into a broad devaluing of international collaboration. This undermined pandemic preparedness because infectious diseases do not respect national borders. The administration reduced funding to international organizations such as the World Health Organization and reduced government capacity in agencies and offices working on international issues. Funding for global health at the CDC and United States Agency for International Development (USAID) was reduced. The international team at the HHS Assistant Secretary for Preparedness and Response was eliminated and the HHS Assistant Secretary for Global Affairs was downgraded to an office with reduced capacity. When the outbreak started in Wuhan, the administration relied mostly on a containment strategy and limited travel from China. As the epidemic widened, the administration continued to focus on preventing the virus from entering the U.S. even though the virus was already circulating domestically. The folly of containment as the principal strategy prevented the administration from executing on other response priorities, including establishing diagnostic test capacity.
The COVID-19 diagnostic testing fiasco resulted from a lack of leadership, planning, and coordination among federal agencies. In preparing for a potential public health emergency due to an emerging infection, CDC usually develops the first diagnostic test and FDA approves it under an emergency use authorization (EUA). The EUA is a regulatory mechanism designed to accelerate the availability of diagnostic tests during a public health emergency. In past epidemics caused by Ebola, Zika, and Middle East Respiratory Syndrome (MERS) viruses, the government test was followed by the development and approval of a commercial diagnostic test, usually about two months later. In the case of the current pandemic, CDC developed a test and FDA approved it on February 4, 2020. The tests were shipped to public health labs in all states, but one of the reagents resulted in inconclusive results, and it took CDC three weeks to investigate and identify the issue with the test kit. Mistakes do happen during a response to a novel pathogen, but the fatal flaw in this process is that a backup plan for testing was not implemented during that time. The administration, led by FDA, could have worked more aggressively with diagnostic companies to develop and approve a commercial test. The administration could have approved and acquired some of the tests being used in other countries. Many academic hospital and state public health laboratories have the capability of developing their own diagnostic tests, and FDA could have used enforcement discretion to allow them to use their own laboratory-developed tests. Multiple solutions were available, but it appears that none were pursued until the end of February because of a lack of leadership, urgency, and coordination within the White House. The White House’s Coronavirus Task Force as announced on January 29, 2020 did not even include the FDA Commissioner as a member. With stronger leadership, such as the NSC office for global health security and biodefense, these problems could have been identified earlier and solutions developed. During the first two weeks of March some of the solutions were finally being implemented, additional diagnostic tests were approved by the FDA, and testing capacity was slowly being ramped up across the country.
The focus has now turned to other pandemic response strategies, including community mitigation strategies such as social distancing and school closures, medical surge capacity, and accelerating the development of therapeutics and vaccines. It is gratifying to see strong leadership by state and local governments and public health authorities, and a significant response by individuals and communities to adopt social distancing measures. But the federal government needs to accelerate its response and marshal available resources to help state and local governments prepare facilities to be temporary treatment centers, distribute supplies from the Strategic National Stockpile and acquire more needed healthcare supplies, and provide uniform guidance on community mitigation strategies. Everyone must do their part for us to get through this global pandemic.