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Tuesday, September 28, 2021

State of Biodefense: How America Has Not Addressed the Threat

Twenty years after 9/11, and six years after we released A National Blueprint for Biodefense, the United States remains at catastrophic biological risk.

Even before September 11, 2001, and the anthrax attacks that began shortly thereafter, the public and private sectors anticipated bioterrorism and grew increasingly concerned about pandemic influenza. They had already started working to strengthen national biodefense. Despite the support of President Bill Clinton, only limited efforts began until the anthrax events of 2001 galvanized the government. Old programs received more support and new programs were established. BioWatch (to detect the terrorist use of biological agents in some large metropolitan areas), the National Biosurveillance Integration System (to analyze data from various federal departments and agencies), and the National Biodefense Analysis and Countermeasures Center were established at the Department of Homeland Security to address biological terrorism and warfare.

Congress also recognized the need for a robust medical countermeasure development pipeline to address current and future biological threats. In 2004, the Project BioShield Act help incentivize and assist industry by providing guaranteed funding to develop and purchase new countermeasures before another biological attack occurred. Two years later, the Pandemic and All Hazards Preparedness Act made the Department of Health and Human Services more capable of responding to large-scale biological events by creating the Office of the Assistant Secretary for Preparedness and Response and the Biomedical Advanced Research and Development Authority.

While some of the initiatives were helpful during the initial response to COVID-19, the pandemic made it clear that critical gaps in our national biodefense remain 20 years later. The global crisis resulted from a foreseeable, easily anticipated combination of mutations, lack of immunity, poor preparedness, limited surveillance, and failure to learn from past pandemics. We failed to ensure that we would be able to respond efficiently, effectively, and quickly. COVID-19 has devastated American lives, the economy, and our national confidence, and yet the next biological event could be even worse and happen at any time.

The United States helped to develop vaccines for COVID-19 faster than anyone predicted and should be proud of that accomplishment. Regardless, nearly every other aspect of our response to the pandemic continues to fall short – not just compared to other countries, but also compared to what we know our Nation can do.

Increasing Biological Threats

When disasters occur, America swings into action. We spend time and resources focused on doing whatever we can, whatever it takes to save lives. Unfortunately, we also often give in to our desires to put the latest disaster behind us, forgetting about the illness and death caused by diseases that spread faster than we can control them. We want so much to believe that pandemics occur only once in a century and that we can make up our losses easily afterwards. But the economic impacts of biological events are staggering – $200 million for Lyme Disease (2002), $10-15 billion for Foot and Mouth Disease (1999-2003), $30-50 billion for Severe Acute Respiratory Syndrome (SARS, also known as SARS-CoV-1, in 2003), $30 billion for H5N1 avian influenza (2004-2009), $1.8 billion for E.coli 0157:H7 (2006), $45-55 billion for H1N1 influenza (2009), $10 billion for Ebola (2014-2016), $7-18 billion for Zika (2015-2017) – and these are just some examples that that made headlines over the past 20 years. For COVID-19, the United States alone has sustained about $16 trillion in economic losses, losses that continue the longer the pandemic continues. Billions and trillions in losses are not easy to make up. Neither are the lives lost.

Despite the human and economic toll, we cannot allow this pandemic to pull our focus entirely away from other biological threats and we cannot ignore the connections between current day events and these threats. One of the reasons the United States worried about biological agents before 2001 was that terrorists had expressed interest in obtaining and using biological weapons. After the anthrax events that same year, we saw how devastating biological attacks could be. Today, we are worried about the failed state of Afghanistan in part because the Taliban and Al Qaeda (both resident in that country) place value on the ability of biological weapons to evoke terror and weaken their enemies. Malevolent actors are actively looking to buy biological agents and weapons on the dark web and in black markets. These actors use the internet to talk about executing biological attacks with anthrax, botulism, and other weaponizable diseases.

Cpl. Albert Gaston, a chemical, biological, radiological and nuclear (CBRN) defense specialist with the CBRN response element (CRE), 31st Marine Expeditionary Unit, relays a report while inspecting a building for mock contamination during CBRN response training at Camp Hansen, Okinawa, Japan, Feb. 1, 2017. (U.S. Marine Corps photo by Cpl. Darien J. Bjorndal)

In addition to bioterrorism, biological warfare is once again a concern. Biological weapons provide terrorist organizations and nation states asymmetric advantages on the battlefield. The U.S. Department of State suspects that China and Iran – and is convinced that North Korea and Russia – possess active biological weapons programs. These and other countries have also made investments into their bioeconomies top budgetary priorities. The biotechnology they are advancing is often dual use, meaning that they could use advanced biotechnology for peaceful, noble purposes, or they could use it produce biological agents and weapons.

Public and private sector laboratory facilities throughout the world and in the United States that work with select agents (biological agents that could severely threaten human and animal public health and safety, animal and plant health, or animal or plant products) also still offer little assurance that they have overcome biosafety and biosecurity concerns. Anthrax escaped the control of the U.S. Army Medical Research Institute of Infectious Diseases in 2002. The Centers for Disease Control and Prevention failed to adequately follow biosafety requirements in 2014, potentially exposing 75 of their staff to anthrax. Dugway Proving Grounds inadequately inactivated anthrax samples and sent them throughout the United States from 2005 to 2015. Tularemia escaped the control of the National Primate Research Center at Tulane University in 2015. Vials containing smallpox were found at an FDA facility in 2014, somehow overlooked for decades. Hundreds of biosafety and biosecurity incidents are reported every year in the United States. Most incidents are unpublicized. The risk of accidental releases of biological agents from laboratory facilities has at best not abated and at worst only increased over time.

Director of National Intelligence Dan Coats told Congress in 2019 about how the Intelligence Community had grown increasingly concerned about biological agents and weapons. He noted that there were more different kinds and that the biological agents and weapons were much easier to produce than ever before. He described the potential impact of biological threats on agriculture, economies, militaries, and public health. This warning came two years before speculation ran rampant regarding the role the Wuhan Institute of Virology might have played in the propagation of COVID-19. We have yet to strengthen our national ability to attribute biological events, making the use of biological attacks more attractive to those actively seeking not to get caught.

Blueprint for Biodefense

The Bipartisan Commission on Biodefense was established in 2014 to recommend and promote changes to U.S. policy and law that strengthen national biodefense and optimize resource investments. In October 2015, the Commission released its foundational report, A National Blueprint for Biodefense: Leadership and Major Reform Needed to Optimize Efforts, containing 33 recommendations (and 87 associated action items) about how the federal government could better defend the Nation against, eliminate vulnerabilities to, and reduce the consequences of, biological threats.

In March 2021, the Commission followed up on that report with Biodefense in Crisis, Immediate Action Needed to Address National Vulnerabilities to describe how far the federal government had come in implementing our recommendations. We determined that from 2015–2020, out of the 87 action items we recommended, the government completed 3, took some action to address 56, took no action on 22, and took emergency or crisis actions on 6 to address the COVID-19 pandemic.

The Ups and Downs of Leadership

Since 2001, we have seen that strong national biodefense depends on strong national leadership. Congress and the White House must hold all federal departments and agencies, as well as other public and private sector entities with responsibilities for biodefense, accountable. They must continuously direct the federal government to make biodefense a priority, especially now that COVID-19 has revealed weaknesses in our defense against biological threats.

Our response to COVID-19 and previous large-scale pandemics (e.g., H1N1) involved many (and in the case of COVID-19, all) federal Departments and agencies, as well as non-federal governments and nongovernmental organizations. Their efforts had to be coordinated. They had to be led. One Department, such as the Department of Health and Human Services, cannot tell other Departments and agencies what to do. One Department also does not possess all of the needed resources or authority to respond to a large-scale biological event by itself. Waiting until COVID-19 overwhelmed the Department of Health and Human Services before requiring other federal agencies to assist did not serve President Trump well.

Making biodefense a high priority only after a crisis begins and letting a leadership vacuum develop after a threat passes is a relatively common occurrence. For example, after the H1N1 influenza pandemic faded away, the Obama Administration eliminated the position of the Special Assistant to the President for Health and Biodefense when it reorganized the White House staff and had the National Security Council staff support both the National Security Council and Homeland Security Council. Subsequently, when Ebola reached the United States in 2014, President Obama brought back Ron Klain to temporarily coordinate the U.S. response to the virus. The Obama Administration subsequently reinstated a directorate, this time in the National Security Council, to deal with global health security and biodefense. President Trump removed this directorate during his term as part of another White House reorganization, choosing instead to place a greater priority on the biological threats created by nation states. As a result, the Trump Administration, like its predecessor, again had to appoint a coordinator for the response to COVID-19. Earlier this year, President Biden restored the global health security and biodefense directorate in the National Security Council.

As far back as the Wilson Administration, various White Houses have emphasized and deemphasized the biological threats to the Nation. Different Presidents assumed or hoped that the latest biological crisis will be the only such crisis to occur in a century, or at least during their terms. But our long history with bioterrorism, biological warfare, naturally occurring diseases that spread quickly, and accidental releases of dangerous pathogens from laboratories and other facilities – coupled with the ease and speed of travel and transportation – clearly demonstrate that the biological threat never really recedes. This Administration and every Administration after it must accept the pervasiveness and ever-present nature of the biological threat and accordingly ensure that high level White House staff continuously address it.

The Commission recommends that the President establish a dedicated Deputy National Security Advisor for Biodefense, overseen by the Vice President of the United States. Two directorates – for Global Public Health Security and Biodefense and for Domestic Public Health Security and Biodefense – should report to this Deputy National Security Advisor. Further, high level staff in the Executive Office of the President should maintain some focus on the biological threat the way National Security Advisor Jake Sullivan and the Director of the Office of Science and Technology Policy Eric Lander do today.

Chaos Over Coordination

Despite the existence of the Trump Administration’s Coronavirus Task Force, the federal government’s early response to the spread of COVID-19 around the world and in the United States was often disorganized and contradictory, making state, local, tribal, and territorial governments responsible for what had historically been considered federal obligations. Chaos ensued as nonfederal governments took wildly different approaches and competed for increasingly scarce personal protective equipment, testing supplies, and other critical materials. Before COVID-19, the Trump Administration emplaced an interagency Biodefense Steering Committee (to oversee implementation of the National Biodefense Strategy) and a Biodefense Coordination Team (established at the Department of Health and Human Services to help the Biodefense Steering Committee execute its duties). The Administration did not empower the Committee or the Team with the authority they needed to coordinate the efforts of all public and private sector entities involved in response to the pandemic. Eventually, President Trump put Vice President Pence in charge of the response, but it took months to coordinate federal efforts effectively.

In 2015, the Commission recommended that the federal government produce a National Biodefense Strategy that took the many different strategies to address parts of biodefense into account. The Trump Administration developed and released the congressionally mandated strategy in 2018. It superseded previously issued strategies (such as that described in Homeland Security Presidential Directive 10) and went far to combine and align the panoply of disparate, uncoordinated federal policies and strategies to address biological threats. Unfortunately, the Trump Administration did not make many strides towards implementing this Strategy. We will never know what impact full implementation of the National Biodefense Strategy might have had on the response to COVID-19 in 2020. The Biden Administration is now in the unenviable position of having to create a more comprehensive implementation plan while responding to an ongoing pandemic and rising biological threats.

Independence Over Collaboration

The National Biosurveillance Integration System (located within the Department of Homeland Security) is supposed to aggregate, analyze, and disseminate biosurveillance information from inside and outside of the federal government. Had it been fully resourced and functioning as intended, it would have proven invaluable during the COVID-19 pandemic. However, few federal departments and agencies provide data to the System, and many question the value of the analysis produced. If other federal departments and agencies do not provide their biosurveillance data to the Department of Homeland Security, the National Biosurveillance Integration System cannot fulfill its congressional mandate.

“We will never know what impact full implementation of the National Biodefense Strategy might have had on the response to COVID-19 in 2020.”

The Nation also needs a stratified hospital system for biodefense. Hospitals throughout the country vary in terms of their capacities and capabilities. All are not equally capable of responding to every disease, no matter what the source. While we expect that all hospitals be able to render some minimal level of care for all ailments, we also know that some hospitals operate at a higher level than others. The Nation has stratified hospitals for trauma response, cardiac care, pediatric emergencies, and other situations requiring specialized care. Many of these stratified systems were put in place well before 2001, but the federal government has not yet established or provided enough incentives or requirements to hospitals to create such a system. As a result, hospitals respond to biological events individually, spontaneously, and in an uncoordinated fashion, as seen during every biological event over the past 20 years, including most recently, the COVID-19 pandemic.

The Department of Health and Human Services began a pilot for the Regional Disaster Health Response System in 2019. The Regional Disaster Health Response System began in three metropolitan jurisdictions and aims to grow. While this effort is promising, it should not take decades to establish a stratified biodefense hospital system throughout the country. It needs the support of the Department’s Hospital Preparedness Program, as well as associated cost reimbursements by the Centers for Medicare and Medicaid Services, well before the next biological event occurs. For their part, Medicare and Medicaid must learn from their slow response to COVID-19 and execute their role in coordinating all health insurers, making preparedness for large-scale biological events a requirement for hospital accreditation.

Quiescence Instead of Innovation

The idea behind the Strategic National Stockpile was deceptively simple: stockpile medical countermeasures, essential supplies, and equipment needed to respond to a biological event, taking into consideration current and likely biological threats. In practice, however, determining what should go into the Stockpile and how to maintain enough inventory to help the entire Nation respond to a large-scale biological event like the COVID-19 pandemic proved to be an enormous challenge. Stockpiling previously developed medicines and old technology that address biological threats identified decades ago is not enough. Diverting funds from the Stockpile to other public health priorities by the Centers for Disease Control and Prevention did not help. When the pandemic hit, federal and non-federal agencies turned to the Strategic National Stockpile to get the supplies they needed, only to find that it could not help much to address a threat that its contents were not specifically designed to address. Supplies in the stockpile that could help with the crisis, including ventilators, were also too few to sufficiently support the demand during the early response to the pandemic.

The contents of the Strategic National Stockpile and the types of drug candidates needed to address today’s threats have not seen enough innovation over the past 20 years. Some federal agencies, such as the Biomedical Advanced Research and Development Authority at the Department of Health and Human Services, helped greatly to foster innovation needed for COVID-19 medical countermeasures. However, these were relatively short-term, quickly funded efforts. Decades have gone by without the long-term funding and investments needed to increase innovation in medical countermeasures at least at the same rate that biological threats are changing and growing. Congress hesitates to provide multi-year funding when that is exactly what is needed to support innovation in this arena. The only other option is to provide much more funding to support short-term hysterical efforts to develop a medical countermeasure once a disease like COVID-19 threatens our country. Congress provided multi-year funding when it established Project BioShield in 2004. Clearly, it needs to do so again. COVID-19 is not the last biological threat we are going to see in our lifetimes. It is not even the last biological threat we are going to see this year.

Medical countermeasures are not the only domain in need of innovation. During the COVID-19 pandemic, distribution of medical countermeasures depended on overburdened supply chains and just-in-time delivery to health care facilities and pharmacies, coupled with the usual difficulties in delivering and distributing contents of the Strategic National Stockpile to states, localities, tribes, and territories. The Department of Health and Human Services could not handle the demands placed on it to deliver countermeasures throughout the Nation, using systems that were originally designed in some cases decades ago for other purposes. The Department of Defense was able to help in this regard because its logistical enterprise continuously innovates. A Medical Countermeasure Response Framework infused with innovative distribution practices can only help.

Soldiers of the 23rd Weapons of Mass Destruction Civil Support Team decontaminate their protective suits after sweeping the area utilizing special biological and chemical detectors in response to a possible biological threat during a training exercise at the David C. Canegata Recreational Center and Sports Complex on Sept. 25, 2019. (U.S. Army National Guard photo by Army Staff Sgt. Gregory Camacho)

A key element of biodefense in need of innovation is biodetection. BioWatch, the Nation’s system of biological detectors was emplaced in 2003 in response a credible bioterrorist threat. Extant technology was used at the time with the intention that it would be replaced with better, more advanced technology as time and science progressed. Today, 18-year-old technology continues to hobble the system, and while some improvements have been made with associated laboratory testing, BioWatch does not perform well and as a result, cannot effectively deter biological attacks. The system screams for innovation, but the Department of Homeland Security has not generated needed innovation since it began trying so many years ago. This is not to say that other federal agencies have experienced the same results. For example, both the Department of Defense and the National Aeronautics and Space Administration have fostered needed biodetection innovation in concert with real-time mission requirements. For their part, industry makes its own investments in the development of innovative technology but struggles to understand how to meet the needs of BioWatch when the Department of Homeland Security depends on a needs assessment conducted 18 years ago and struggles to clearly articulate requirements in the challenging, diverse, multiplicative biological threat environment. New biodetection technology (in conjunction with a reassessment of the BioWatch mission) must provide meaningful information to the political, public health, emergency response communities who will have to act quickly when a biological event occurs.

In January 2021, our Commission released a report, The Apollo Program for Biodefense: Winning the Race Against Biological Threats, that called for significant increases in federal investment in innovation for biodefense. We believe that with smart investments of $10 billion a year for 10 years, the United States of America can effectively take pandemic threats off the table by 2030. We applaud the Biden Administration’s recently released American Pandemic Preparedness Plan for similarly calling for the robust transformation of U.S. biodefense.

Fighting for The Future

COVID-19 is not the end of the biological threat. It is one among many. While we must address this clear and present danger, we cannot do so to the exclusion of all other biological threats. As expected, unimpeded, the biological threat will only increase over time. We should assume that large-scale biological events affecting our national security, public health, and economic well-being could occur now and plan accordingly. The Nation cannot afford to wait until COVID-19 disappears. Other diseases are mutating, too, our enemies are already at work developing and producing biological weapons, and if we are not careful, we will quickly find ourselves unable to compete in the global bioeconomy.

The Bipartisan Commission on Biodefense began its efforts seven years ago in 2014. Over the past 20 years, the biological threat has only increased.  But the country’s efforts to defend against the biological threat have not kept up with the threat. Beginning with the anthrax attacks of 2001, biological events reveal time and again that the numerous gaps remain in the Nation’s ability to prevent, deter, prepare for, detect, respond to, attribute, recover from, and mitigate a biological event. Twenty years after 9/11, and six years after we released A National Blueprint for Biodefense, the United States remains at catastrophic biological risk.

People used to say that dealing with the biological threat was too hard and that because it was too hard, we should not waste our time trying to address it. It was perceived as a problem for some future generation, but hardly a quarter of a generation has passed since September 11, 2001, and the anthrax events that began that same year, during which time the United States has had to deal with eight major pandemics, numerous biological incidents threatening our national security, hundreds of laboratory infractions and lapses, and the reinvigoration of biological weapons programs throughout the world. It no longer matters whether the biological threat is too difficult to deal with. Our hands have been forced and we must deal with it.

America has the opportunity now to face the biological threat squarely. The future is still bright. We can secure the homeland against biological threats by building on the good work that has come before and pushing back against the tyranny of disease.

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Dr. Asha M. George
Dr. Asha M. George is executive director of the Bipartisan Commission on Biodefense. is a public health security professional whose research and programmatic emphasis has been practical, academic, and political. She served in the US House of Representatives as a senior professional staffer and subcommittee staff director at the House Committee on Homeland Security in the 110th and 111th Congress. She has worked for a variety of organizations, including government contractors, foundations, and non-profits. As a contractor, she supported and worked with all Federal Departments, especially the Department of Homeland Security and the Department of Health and Human Services. Dr. George also served on active duty in the U.S. Army as a military intelligence officer and as a paratrooper. She is a decorated Desert Storm Veteran. She holds a Bachelor of Arts in Natural Sciences from Johns Hopkins University, a Master of Science in Public Health from the University of North Carolina at Chapel Hill, and a Doctorate in Public Health from the University of Hawaii at Manoa. She is also a graduate of the Harvard University National Preparedness Leadership Initiative.

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