National Biodefense: You’re Doing It Wrong

November 9, 2015

Recently, former Sen. Joe Lieberman and former Gov. Tom Ridge met with the Senate Homeland Security and Government Affairs Committee to deliver a message on the state of the nation’s biological defense capabilities. They were there to warn the committee that the capabilities were inadequate. The United States is unprepared for the “very real biological threats we face” from terrorists and naturally emerging diseases. Despite concerns about the outbreak of biological diseases over the past 15 years, they believe that “no one has yet taken the lead to address this threat in a strategic and coordinated fashion.”

The two gentlemen were the co-chairs of a Blue Ribbon Study Panel on Biodefense, which included four other prominent members and a host of nationally recognized medical experts. Congress did not direct the formation of this commission. Rather, it was sponsored by two think tanks and financially supported by a number of firms, to include several biotech and pharmaceutical companies. The report contains 33 recommendations with about 100 action items to fix existing governmental biodefense efforts.

In particular, this group believes that the vice president of the United States should personally lead a “Biodefense Coordination Council,” and that one of the first things this council should do is to create a national strategy for biodefense. They call for significant increases in funding across the board for new initiatives (although a specific number is lacking in the report), and significant changes in how biodefense is executed within the federal, state, and local communities. While this group had some very talented and smart individuals working on this report, their approach and recommendations are flawed. Proposing a centralized, top-down approach and a unified budget to address all biological threats that are military and public health concerns will not work.

Their report starts with the usual dramatic statements about how “the threat is real” followed by a fictitious scenario of how terrorists released Nipah virus — an exotic virus that affects pigs and pig farmers in Southeast Asia — through aerosol generators (although the virus isn’t communicated through the air) placed in Washington, DC. Nipah virus isn’t on anyone’s threat list (outside of these pig farmers), and this sort of literary license is hardly warranted.

The panel takes the approach of combining military biological warfare agents, general bioterrorism threats, and naturally occurring infectious diseases under a single category: biological threats. While there is some overlap in the fact that they are all agents of biological origin and the medical community responds in a uniform manner against these threats, the actual approach to dealing with these three categories of threats are significantly different. The military has a short list of biological warfare agents that have been optimized as weapons of war, and the military requires particular concepts and equipment to defend against their use while conducting their main mission of defeating the enemy. This is biodefense. The medical community has a mission of protecting the public’s health from any threat, no matter the source. This is biosafety. Finally, there is biosecurity, in which arms control and antiterrorism experts try to reduce the possibility of intentional use of biological organisms from external actors.

Mauroni-CBT-graphic

 

Each area has unique priorities, funding, and authorities. To group them all together would be to lose distinct desired objectives in each area. For instance, the military’s priorities for its troops include protecting against anthrax, pneumonic plague, smallpox, tularemia, and botulinum toxin. These are not the priorities for public health, which is focused much more on protecting the general public from bacterial diarrhea, malaria, dengue fever, influenza, and hepatitis. Measures to fight bioterrorism emphasize preventing sub-state groups from accessing the know-how and equipment needed to acquire the means to use biology as a weapon. If the policy approach does not differentiate between these missions and priorities, then we’re not solving specific policy objectives. The Defense Department moved away from threat-based assessments to capability-based assessments for just this purpose.

The report is right that the solution to these myriad threats all require sound leadership, but not a single leader. In 1999, the Deutch-Specter Commission Report recommended that the vice president should lead counterproliferation discussions and work with a national director to focus government efforts against the challenge of adversarial nations developing nuclear, biological, and chemical weapons. The biodefense panel wants to take the same approach. It wasn’t adopted then and it won’t be adopted now. It’s not practical, given the way our governmental bureaucracy works. But we do need oversight on the current leaders who are responsible for biodefense, biosafety, and biosecurity.

As an example, in 2010, the Office of the Secretary of Defense pushed to change military chemical-biological defense from what it termed a “Cold War” emphasis to more of a public health role of medical surveillance and biological threat reduction. Ironically, at the same time the Department of Homeland Security was failing to convince Congress to fund the development of a new detector for Project BioWatch, and the armed services were rejecting an automated biological detector that the Defense Department had spent 15 years developing. The Office of the Secretary of Defense redirected funds intended to protect military troops to build a billion-dollar vaccine production plant, duplicating a Health and Human Services effort to build two similar facilities. The U.S. military is losing biodefense capabilities because of a fixation on biosecurity.

The National Security Council (NSC) should be able to oversee this area if it considers biological threats to be a great enough concern. If the Department of Homeland Security’s National Biosurveillance Integration Center is not getting cooperation from other government agencies, that is an issue for the NSC to correct. The Defense Department and Department of Health and Human Services already work closely on an integrated medical biodefense portfolio, but the pace of the Food and Drug Administration’s regulatory process to ensure medical countermeasures are safe and effective is the limiting factor. Finding U.S. leadership to offer sound verification protocols for the Biological Weapons Convention is not something that requires a lot of energy — we already know that this needs to be addressed.

After pouring nearly $80 billion into various governmental biodefense efforts over a 15-year effort, to call for significantly increased funding for medical countermeasures and vaccine stockpiles sounds odd. Doubling the funding for developing medical countermeasures for biological disease outbreaks will not convince the pharmaceutical industry to invest in this area, due to low profit margins and continued concerns about lawsuits relating to how the drugs will be used. Will Congress suddenly change its perspective on biological threats because “the threat is real” and create larger government programs in this constrained budget environment? Will Congress allow for a consolidated biodefense budget that cuts across interest areas of military defense, counter-terrorism, and public health? It is, to say the least, incredibly unlikely.

The two co-chairs mentioned the U.S. government’s response to the Ebola outbreak in Africa as an example for why Congress ought to be concerned about biological threats. The U.S. government response was not smooth, and the world’s response was not well coordinated. But to be clear, this is a thinly veiled attempt to scare people using a biological disease that has terrifying symptoms, but that is not the greatest threat to civilians in Africa, or for that matter, the world in general. It was a bad outbreak from a historical perspective, but the reason why the United States has not developed a vaccine or post-treatment for Ebola was simply because it was not a political priority for resources and it probably still should not be. There are other diseases with more significant impacts on human lives — pneumonia, malaria, and HIV/AIDs kill tens of thousands every year. It is not that the U.S. government could not have developed an Ebola vaccine and post-treatment given adequate resources and a streamlined approval process. And to be clear, once the response was underway, the Department of Defense was working smoothly with their civilian counterparts.

The panel calls for a national strategy. We have, in fact, three of them. There’s the “Biodefense for the 21st Century” in 2004, the “National Strategy for Countering Biological Threats” in 2009, and the “National Strategy for Biosurveillance” in 2012. The challenge isn’t in creating a “national strategy” — it’s been the lack of oversight of a “whole of government” effort for a poorly defined threat that has no specific objectives other than “spend more money on what you’re currently charged to do.” Creating another national strategy isn’t going to change the dialogue. On the other hand, the panel does identify a number of specific areas that can be fixed without a new strategy.

Fix intelligence collection on biothreats. Fix national bioforensics and biosurveillance. Fix how we share information between federal and state emergency management functions. Fix the verification protocols for the Biological Weapons Convention. Fix infection control guidelines. Fix the Strategic National Stockpile. Tighten up information security around biotechnology efforts. Fix the Select Agent Program. The responsible executive agencies should assess and improve these capabilities, but there are other priorities that compete for government funding, and that has to be considered.

One area that doesn’t need fixing is the military’s engagement with the civilian community on biodefense issues. The military’s medical community is well linked with their civilian equivalents and they collaborate on many levels. The report’s recommendation to update the military’s biological defense concept is misplaced. We have a valid counter-WMD operational concept that addresses biological warfare threats, and a force health protection program that counters naturally occurring diseases. They are separate but coordinated efforts, because they address different military objectives using common tools such as medical diagnostics.

The report’s insisting that the military do more in its defense support to civil authorities (DSCA) role for bioterrorism is frankly mystifying. The military’s response teams are well suited for terrorist chemical and radiological incidents, given the immediate effects caused by these hazards and lack of capability at the local emergency responder’s level. But biological terrorism incidents — if they ever happen — have a very different profile. Other than checking out the occasional “white powder” hoax, there’s nothing much they can do in a public health outbreak (unless it’s a zombie apocalypse). The Department of Health and Human Services has the lead in this area, and the military’s medical agencies are already aligned to support those response efforts.

The panel did not like the “WMD Czar” concept, even though that position is in theory supposed to address biodefense concerns. They’re right — government czars have limited authorities and don’t get to move money across government agencies. The WMD Czar position has been empty for over a year, which gives one an indication of how “important” the U.S. government views this position. But the NSC’s senior director for WMD terrorism and threat reduction and the assistant secretary of defense for nuclear, chemical, and biological defense should not be the government leads on a Global Health Security Agenda. It’s not their area of expertise. This is and should remain a Health and Human Services effort.

Because the general topic of biodefense and health surveillance is so broad — addressing military combat scenarios, natural disease outbreaks (animal, human, and plant), and terrorism response — it would be a mistake to use a single threat-specific policy to develop the government’s many required capabilities in response. If the U.S. government consolidates these areas into one portfolio and resourcing is not increased, then funding for public health threats that affect tens of thousands of people every year will be prioritized over military countermeasures for biological warfare agents. The WMD Czar position should assess biological threat response that is within arms control, the military’s defense acquisition efforts, and national incident response. This effort needs to be shared across the Defense Department, State, Health and Human Services, and Homeland Security. Resourcing has to be addressed in concert with other existing programs, and we shouldn’t expect significant increases in biological countermeasure funding. The good news is, there is a lot being done and a lot of money going toward this problem. We don’t have the option to make it less complicated or more synchronized, so let’s figure out how to make the current processes work as they are intended.

 

Al Mauroni is the Director of the U.S. Air Force Center for Unconventional Weapons Studies. The opinions, conclusions, and recommendations expressed or implied within are those of the author and do not necessarily reflect the views of the Air University, U.S. Air Force, or Department of Defense.

 

Photo credit: David Mulder

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One thought on “National Biodefense: You’re Doing It Wrong

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