The National Blueprint for Biodefense Is a Flawed Policy Vehicle
The initial direction of the Bipartisan Biodefense Commission remains questionable
I am probably going to spend too much time talking about the Bipartisan Commission on Biodefense, formerly known as the Blue Ribbon Panel on Biodefense between 2014-2019. This is a little personal to me for two reasons - first of all, I’m tired of the many many videos and reports that the commission has released to the high praises of some out there who think that this group is somehow moving the needle on national biopreparedness. They are not. More to the point, I have a fundamental disagreement with their philosophy and how they want to shape public policy on national biopreparedness. I am going to use that term “biopreparedness” a lot because it’s the proper term for what this group pretends to be concerned about. Last week, I talked about the panel’s initial membership and its role in shaping the definitions of biodefense and biothreats in the 2018/2022 National Biodefense Strategies and the 2023 DoD Biodefense Posture Review. So if you’re curious as to who the players are and why it’s important to discuss national biodefense, please start there.
I don’t know the origin story for the Blue Ribbon Panel on Biodefense. If you read their literature, it was all about their unselfish desire to highlight perceived gaps and inadequacies in the nation’s ability to address biological threats, whether caused by deliberate attacks, natural-occurring outbreaks, or accidental exposure. I always wondered about the timing, considering that the Obama administration had released a national strategy on countering biological threats in 2009 and certainly there were numerous executive agency and legislative actions addressing biological threats between 2004 and 2014. There had been a H1N1 pandemic in 2009 and people were sensitive about disease outbreaks. Being a cynic myself, I noticed the long list of financial backers to the Blue Ribbon Panel and surmised that Big Pharma had gotten irritated by the lack of new investments into medical countermeasures research and development and decided to “help” illustrate what they say is a significant issue.
Someone knows the origin story but that’s not important. The Bipartisan Commission on Biodefense and its predecessor have hosted a number of panel discussions and released numerous reports calling on the U.S. government to increase its spending on federal biodefense measures. It should be of public interest to understand what they’re recommending and whether it makes sense. I’m going to take on its first report, released in October 2015 concurrent with the two co-chairs’ testimony to the House Committee on Homeland Security and Governmental Affairs. What immediately strikes me is that there are terms of reference or glossary to define biodefense or biothreats, although they use the terms a lot. I think the definitions came later as people started to take this group more seriously.
It may be illustrative to take a look at the panel’s second meeting in January 2015 and in particular one of the early speaker’s words. David Franz, former commander of USAMRIID and chief inspector on three UNSCOM missions to Iraq (among many other things he did in his long and illustrious career), had an interesting observation as to how complicated this area of biodefense policy was.
“Eventually right after 9/11 and 10/4,1 started talking about and promoting health engagement for national security. It wasn’t something I really thought that much about before. I sort of set up a hypothesis in those days and said working together on hard technical id - public infectious disease - and public health problems, common problems, can give us the following - one, it can impact the naturally occurring disease in the area, and that’s a testable hypothesis. I said it can provide some transparency regarding capabilities and maybe even intent in the area in which you’re working. I said maybe it can undermine popular support for terrorism in that region and finally, if those things occur, it can reduce the likelihood of an intentional event.
My friends were skeptical. Some are still skeptical. My security friend said it won’t stop terrorism, my public health friend said ‘I don’t want to do security.’ Some legislators and staffers, I believe, said it’s not national security, it’s public health. And my international colleagues on more than one occasion said ‘I trust you, Dave, I don’t trust your government.’ I had some really smart colleagues here in the U.S. that I talked to - with whom I talked - about these issues and on more than one occasion, they would sort of pat me on the head and say ‘Dave, you’re doing the Lord’s work, it’s fine, it’s okay,’ but not a lot of buy-in. I don’t really see this. I don’t blame them for this feeling, because I think engagement for biosecurity isn’t a perfect solution, but it can make a difference and at a relatively low cost. I think it must be at least part of the solution. I believe that science engagement can serve to dissuade at a personal or even national level. It can stabilize a region, making it less comfortable for … health security can certainly stabilize a region.
One can see the broad outlines of the conflict that public health specialists had then and still consider an issue. Following 9/11, there was a lot of buzz and funds thrown at the potential security threats of terrorists using biological organisms, with statements about how a biological attack might be equal to a nuclear explosion.2 The public health community expressed their frustration that similar funds were not increased to address natural disease outbreaks that represented a much higher threat to the U.S. population, especially given the uneven status of public health programs across the country. Many advocated increasing funds for public health as a way to reduce the impact of bioterrorism incidents. My observation is that medical professionals can be very threat-agnostic as to their views on disease prevention. They don’t care if an infectious disease was caused intentionally, by nature, or accidentally released as much as how they can prepare for an infectious disease outbreak and respond quickly to the event. While this is an admirable trait, developing and funding policy initiatives in the Beltway requires focusing on a specific outcome. Health care and public health are huge, complex beasts, and responding to bioterrorism is a much more focused issue. The Blue Ribbon Panel, however, did not make that distinction.
The panel hosted four panels in 2014-2015 under the topics of threat awareness, prevention and protection, surveillance and detection, and response and recovery. This is the general framework laid out in HSPD-10/NSPD-33, “Biodefense for the 21st Century” Take a look at the agenda of that second workshop in January 2015 (noted in the appendix of the report). The general topic of the day was on prevention and protection. We see a lot of very smart and degreed professionals coming to talk about:
Biological arms control, cooperative threat reduction, global health security, and quarantine
Biosecurity, select agent program, and synthetic biology (yes, as early as 2015, it was a thing)
Resilience, biodeterrence,3 first responder vaccination, and agricultural defense
Insights on Ebola and pandemic influenza response
And this was just for one day’s meeting! Any one of these bullets would be a good basis for a multi-day conference. The topic of national biopreparedness has multiple policy challenges that all have very technical and complex issues, and yet the Blue Ribbon Panel/Bipartisan Commission wants to take on all of the issues. The result is a broad selection of diverse topics that have no single agency to execute the recommendations and no sense of scope as to the funds required to address them.
I really dislike using the term “biodefense” as a catch-all for all actions take to address deliberate biological threats, natural disease outbreaks, or laboratory accidents. It obscures the U.S. military’s mission to develop biodefense capabilities required to counter adversaries that have biological weapons intended for battlefield use. Military biodefense is a significant challenge that requires focus. Using the term “national biopreparedness” allows for the same widespread concern as “biodefense” without confusing policy agendas on biosecurity, biodefense, and bioterrorism response. Health security is a useful term, which refers to the protection of people’s health from epidemics, natural disasters, and other external health threats. But health security isn’t solely focused on biological threats, and national security professionals don’t appreciate the sensitivities of working global health issues.4
I’d like to quicky examine the report’s recommendations. And there are a lot of them.
Recommendation 1 - Institutionalize biodefense in the Office of the Vice President. When Leiberman and Ridge testified before Congress, they hit hard on the issue of “centralized management” of a biodefense enterprise. Because the topic crosses several agencies, they saw the need for a heavy hand on coordination and collaboration activities between executive agencies. This is a role more suited for the National Security Council, but then again, the NSC can be more focused on crisis management than long-term strategy and implementation. Giving the VP budget authority over biodefense projects was an absolutely idiotic idea, considering that someone would have to first identify all of the individual program lines that supported the very broad definition of biodefense, then convince the executive agencies not to undermine the effort to avoid scrutiny and budget moves, and then get Congress to accept a “biodefense budget” that cut across committees. This was just a really bad idea.5 There was a “WMD Czar” position at one time in the NSC staff, and although this was a good idea in spirit, this position was only used for than arms control.
Recommendation 2 - Establish a Biodefense Coordination Council at the White House. Everyone thinks that bringing agencies together on a common topic will make things more efficient and accountable. It never works in real life, because no one inside the Beltway is willing to give up power and money to someone else. There is no altruistic side to "solving government problems.” The commission also wanted state, local, tribal, and private sector participation. Part of the Trump biodefense strategy was to put HHS in charge of an interagency Biodefense Steering Committee, it never worked, and the Biden administration moved it to the White House for implementation. I haven’t seen anything productive result. Yes, people talk to each other about their organizational efforts. Talk is good, but it doesn’t move anything forward. It doesn’t change the agenda because nothing changed in the budget.
Recommendation 3 - Develop, implement, and update a comprehensive national biodefense strategy. This recommendation actually was accepted! But the panel’s recommendations to collate all biodefense policy, identify all federal requirements, assess spending histories, develop a gap analysis, and institute a quadrennial review under this strategy were not accepted. You end up with a strategy that just restates what every federal agency already does for biodefense, writ large. Again, no changes.
Recommendation 4 - Unify biodefense budgeting, to include developing an annual biodefense call for data across the executive agencies and conduct a cross-cutting budget analysis. Never happened, see recommendation 1. Congress would never allow this to happen, again because the commission’s definition of biodefense was too broad and cut across multiple committees’ jurisdictions.
Recommendation 5 - Determine and establish a clear congressional agenda to ensure national biodefense. The report acknowledges that there were at least two dozen committees with oversight on biodefense-related issues. The panel members thought that there wasn’t effective oversight in this effort and that jointly executed oversight would be better. Homeland security issues are spread out among several committees as well, people know it’s inefficient, and nothing is going to change that. I never could understand how former congresspeople and former executive agency leaders could think this recommendation was possible, given how Congress works.
Recommendation 6 - Improve management of the biological intelligence enterprise. The panel wanted biological weapons programs and related activities to be a discrete intelligence topic. Given that the National Counterproliferation Center was founded in 2005 under the Office of the Director for National Intelligence to do just this mission, I have no idea why the panel thought that more effort was needed here.
Recommendation 7 - Integrate animal health and One Health approaches into biodefense strategies. Sure, right after we have a national health system that allows for the development of health care approaches that span across state and local jurisdictions. The CDC talks about One Health approaches but no one can enforce it.
Recommendation 8 - Prioritize and align investments in medical countermeasures among all federal stakeholders. They wanted to tell NIH and NIAID how to build program agendas and to get adequate funds for MCM development, because that wasn’t being done previously? Come on.
Recommendation 9 - Better support and inform decisions based on biological attribution. The National Bioforensic Analysis Center and National Biological Threat Characterization Center had been at Fort Detrick since 2004, but the panel didn’t like DHS being in charge of running it for some reason and thought the FBI should run it.
Recommendation 10 - Establish a national environmental decontamination and remediation capacity. Again, already done. FEMA and the EPA already have clearly defined roles here. Maybe they need more money but this isn’t necessarily a gap.
Recommendations 11-14 are about national biosurveillance capabilities. The panel acknowledges that there are “myriad surveillance and detection systems” but they’re not fast enough, don’t share data easily, don’t cover companion animal and wildlife zoonoses. Again this is all about money, the desire to push more funds into biosurveillance that supports rapid response. And sure, good point, but because biosurveillance covers all hazards and not just biological threats, it’s a very big data capture effort and Congress isn’t going to increase funding here.6
Recommendations 15-17 is about funding state/local/territorial/tribal public health emergency preparedness, because the state governors who have the responsibility to adequately plan and fund these efforts are disinterested and don’t want to raise taxes. So this set of recommendations dies from lack of interest.
Recommendations 18-21 are about funding hospitals to prepare for biological events, but this will never happen because health care is a business operation and not an altruistic non-profit organization. Recommendations 22-23 are about working the medical countermeasures response efforts in the CDC and HHS/ASPR in reference to the Strategic National Stockpile. The panel thought these agencies were not being sufficiently energetic in doing their jobs.
Recommendations 24 is about protecting pathogen and biotech information from cyber threats. This is beyond my knowledge, but sure, this sounds like a good thing. How to do it is another challenge, considering there is no transparency as to the number of U.S. biological research laboratories and what they do. I don’t think anyone is focusing on this particular aspect of cyber-attacks.
Recommendation 25 is to renew U.S. leadership of the Biological and Toxin Weapons Convention. Which would be a great thing, but the U.S. government’s well-known position on the BWC is to stop any effort to develop a verification and compliance regime under this treaty. Biotech industry doesn’t want inspection teams looking at their intellectual property, so the focus is on confidence-building measures. The U.S. government does a fairly good job engaging on international arms control and nonproliferation activities, but there’s nothing that the government would see as needing urgent address.
Recommendation 26 calls for the implementation of military-civilian collaboration for biodefense. This one really sets me off, as if the military medical community doesn’t already talk to or wasn’t aware of the civilian medical researchers working on similar efforts under HHS. The panel called for a review of collaborative efforts to identify “best practices” and be formalized, to mandate mil-civ collaboration on biodefense research, that it was unclear how military assets would respond to domestic biological attacks, and that the military’s biodefense doctrine was somehow not “technically feasible and politically acceptable.” What does that even mean? What really pisses me off is that this one recommendation is the only one that addresses the scenario of a nation-state using biological weapons.
There is narrative there to somewhat explain this set of recommendations, but it’s stupefying to read and digest. The panel suggests that DoD needs to tell DHS/FEMA and HHS how to best plan for and operate in a contaminated biological environment to prepare for a major biological attack against the United States. At the same time, the panel says that “U.S. warfighter preparedness for and protection against biological attacks is inadequate.” So what is it, is DoD supposed to help DHS with specialized military assets and logistics to respond to biological attacks or is DoD just not up to the task of preparing for biological attacks? And believe me, I’m not defending the U.S. military’s preparedness for military operations against an adversary with biological weapons. But the panel fundamentally does not understand the problem and offers the wrong recommendations.
Recommendations 27-30 are about funding medical countermeasure development and making BARDA more accessible to contracting activities. Ah, now we get to the meat of the panel’s interests, or at least the organizations funding the panel’s report. I have no doubt that the process by which Big Pharma brings new medical countermeasures to fruition could be improved, especially after seeing how the COVID-19 response rolled out. I’m not the right person to comment on this. I have to laugh, though, that on page 53, the report notes:
The DOD had a transformational medical technologies initiative that was paving the way to develop capabilities that would enable rapid pathogen characterization, antigen identification, and platform technology approaches. Despite early success, the initiative was reduced in scope largely due to criticism that it was too risky and funding could be better used on traditional CBRN equipment and technologies. The DOD should consider initiating a similar medical technologies initiative today, challenging the risk-averse culture and leading the way for other agencies to follow.
The DoD TMTI (circa 2007-2012) was a horrible model for medical countermeasures research and development. The DoD Chemical-Biological Defense Program spent over $2 billion before it collapsed without producing any successful products. At best, one can argue that the government’s scientists learned a lot about what didn’t work.
Recommendation 31 calls for developing a "21st century-worthy environmental detection system.” There were a few Project BioWatch haters talking to the panel, calling for the program to be pulled down and replaced with a detection system that used rapid agent characterization and confirmation. And no question that there were better and more expensive detector systems out there. DHS tried to develop a Gen-3 detector and failed. Congress decided not to fund the modernization effort and BioWatch is still operating with its older air sampler/lab analysis concept of operations. Ironically, we (in the community) all understand the current system’s capability gaps but there is no interest in Congress to fix it because it will cost more.
Recommendation 32 is to review and overhaul the Select Agent Program. The panel believes that the current process does not fully address biosafety and biosecurity issues and that it does not take into account advances in synthetic biology. I guess this is a good idea, but I find it difficult to think that HHS and USDA do not already have a process to review and update the Federal Select Agent Program as needed. I know the list has grown, I am just not in a position to evaluate its effectiveness. My one point is, will continue to be, that there are a lot of other dangerous biological organisms that aren’t on the list, and federal agencies can’t do anything about that biological research from taking place. Now we talk about a potential pandemic pathogens (PPP) list, but I don’t think there are regulations about them.
Recommendation 33 is to “lead the way” toward establishing a functional and agile global public health response apparatus. There is a Global Health Security Agenda, HHS is the lead government agency to execute it, and there is a State Department aspect to the agenda. The question now is whether the United States should develop global response capacity, push regional and cross-border surveillance, and build regional medical countermeasure stockpiles. This goes back to Dave Franz’s comments in which his international friends say “I trust you, Dave, but not your government.” The entire aspect of how the United States works with other nations on global health security is a huge undertaking that, at best, the U.S. government can ask for cooperation but leading a response capability? That may be unachievable. We can all agree that the Ebola outbreak in West Africa was terrible, but the U.S. government had a pretty good response capability in which other nations participated. And here’s the kicker, there are still more deaths in Africa caused by malaria, AIDS, tuberculosis, diarrheal diseases, and lower respiratory infections than by Ebola. It’s just that U.S. political leaders were more afraid of an Ebola outbreak making it to the United States.
I’m done evaluating the panel’s 2015 National Blueprint for Biodefense. You can see that the overwhelming majority of its recommendations are about public health, but they want to address deliberate biological attacks so they use “biodefense” as a catch-all. The medical community wants to use the term “biodefense” to include any actions taken against infectious disease outbreaks irrespective of their source. That’s their job, but it’s a horrible approach to developing public policy that addresses specific aspects of national biopreparedness. I tried to explain my position on why this is a bad policy approach in this early post. We cannot hope to advance any public policy issues in this area when the pundits insist on grouping all biological issues under one umbrella. It does not work. I do believe that the panel/commission members are intelligent beings, but they aren’t being effective here, and I think they know that.
Of interest, the commission released this report card in 2021 as to what governmental actions had been taken that address their recommendations. Of the 87 action items under 33 recommendations, three actions have been completed, partial efforts have been taken on 56 action items, no movement on 22 action items, and six action items were temporarily taken in response to the COVID-19 pandemic. Let’s be honest, the commission can’t take credit even for “partial efforts” when the majority of its recommendations were addressing efforts that were already ongoing. It’s not a great record. But that gives them the excuse to continue to beat the drum - the U.S. government has not met their goal, more meetings are necessary.
So why is the Bipartisan Commission on Biodefense so popular? I think there are a few reasons. The panel asks for the expert testimony from professional groups that work on biological research and development programs (public health experts, military biodefense, bioterrorism response, laboratory biosecurity, agricultural biosecurity). Of course they’re glad to come to a posh DC conference room and talk to these distinguished panel members. Technically-focused professionals LOVE to talk about their work and how important it is. I love talking at symposiums, it’s part of the academic culture. The panel sucks it all up and puts it into the sausage grinder, and as long as the reports scream “THE BIOTERROR THREAT IS REAL,” Big Pharma and its subsidiaries are pleased. It’s always about the money.
Next week, I am going to look at the commission’s 2021 report “The Apollo Program for Biodefense” and Max Brooks’ graphic novel on germ warfare. BLUF, two stars, would not recommend.
“10/4” refers to the first identified case of inhalation anthrax in a journalist in Florida as a result of the 2001 Amerithrax incident.
In the process of selling HSPD-10/NSPD-33, the White House had an illustrative PowerPoint slide that said a large-scale aerial attack using anthrax on Washington DC would result in more casualties than a low-yield nuclear detonation. It was a ridiculous strawman argument, considering that the more feasible terrorist attack would be the use of a small amount of biological organisms in a ground release and that most nuclear attacks on a city would have a much larger explosive capability.
Interesting talk from Bruce Miller, former assistant for homeland security to VP Cheney, starts at 3:03 on the YouTube video. He preferred deterrence by denial, which I don’t believe would work because no one would invest in the level of defenses required to discourage a terrorist or nation-state from using biological agents against an unprotected population.
Topic which requires a longer discussion. Good article on the national security debate on global health here.
Back in the late 1990s-early 2000s, there was an effort to document and assess DoD counterproliferation programs under the Counterproliferation Review Committee. None of the services supported this because it could potentially take authorities away from their Title 10 responsibilities to train, organize, and equip. Talks about a “unified budget” on counterproliferation or even portfolio management died a quick death.
This deserves more explanation but not here. A lot of policy makers think that biosurveillance is only about bio threats, but the medical community uses it to address all health hazards to humans, animals, and plants. It’s a big bucket.