Biodefense Business Masquerading as Policy Analysis
The unobvious grift that keeps on giving
I’ve been thinking about the Bipartisan Commission on Biodefense for some time, looking for an opportunity to critique the group in their efforts over the past ten years to recommend actions that the U.S. government should take to address biological threats. This private commission (not directed by Congress, but rather funded by think tanks, advocacy groups, and pharmaceutical firms) was formed in 2014 to “assess gaps and provide recommendations to improve U.S. biodefense.” And by biodefense, they meant all government actions taken to address deliberate biological attacks, emerging and re-emerging infectious diseases, and accidental laboratory releases. I was immediately critical of this group’s initial report, in particular as to their use of the terms “biodefense” and “biological threats.” I did not think then and do not believe today that these terms allow for the focused application of resources against discrete policy objectives.
The Bipartisan Commission on Biodefense was originally known as the “Blue Ribbon Panel on Biodefense” when they started panel hearings in December 2014. The initial list of commissioners was impressive:
Former Democratic Senator Joe Lieberman, chair
Former DHS Secretary and Pennsylvania governor Tom Ridge, chair
Former DHHS Secretary Donna Shalala
Former Democratic Senator Tom Daschle
Former Republican congressman Jim Greenwood
Former Homeland Security Advisor to President G.W. Bush, Ken Wainstein
I don’t know what attributes the last two individuals brought to the team but certainly the others are known players in Washington DC and are familiar with biological threats. Tom Daschle’s office received an anthrax letter in October 2001, so I understand his concern. Today, the roster is a little different. Former Republican congressperson Susan Brooks and Peggy Hamburg, former FDA director under President Barack Obama, joined the board in 2021. Wainstein left in 2022 and was replaced by former Republican congressperson Fred Upton in 2023. Lieberman passed away in March 2024. It’s largely a collection of political, not medical, experts.
There are two people I will probably talk about later. Asha George, a former professional staffer for the House Committee on Homeland Security, moved up from senior staff to become the Commission’s executive director in 2019. She served four years in the Army’s military intelligence before moving into public health issues. Lacking any specific government experience in this area, she does get a lot of talking roles. Bob Kadlec is listed in the 2015 report as the “founding staff director.” You may remember him as the former HHS Assistant Secretary for Preparedness and Response under President Donald Trump. He served in the Air Force as a medical services officer and was later a staffer for the Senate Select Committee on Intelligence.1
They also had a very strong stable of Big Pharma backers, including Bavarian Nordic, Biotechnology Industry Organization, Elusys Therapeutics, Emergent BioSolutions, PharmAthene, REGENXBIO, SIGA Technologies, and others. They received an initial grant of $300K from the Open Philanthropy Project to support the release of the report, which grew to $1.3M in 2016, $2.5M for 2018-2019, nearly $3M in 2020, $1.35M in 2021, and $5.2M for 2023-2024. For a bunch of smart DC politicos, they really wrote a mind-boggling bad report (which I will examine later). But because they had Very Important People on the panel, they got the ear of Congress and the White House.
Before I dive into examining this group and its reports on “biodefense,” I want to note this recent report from the Library of Congress on the terminology related to biosecurity and biosafety. The staff took a look at how 19 of the G20 nations (Russia wasn’t included) used the terms “biosecurity” and “biosafety” in terms of legislation, regulation, and guidelines. The overview of the findings was very interesting:
Among the G20 nations’ laws discussed in this report, the methods for defining the terms “biosafety” and “biosecurity” generally fall into one of four categories. In the first category, “biosafety” and “biosecurity” are clearly defined in legislation or regulations, with specific distinctions. In the second set of jurisdictions, the term “biosecurity” is applied generally to topics such as laboratory safety, protecting the environment, and guarding against criminal activity involving biological agents that may harm people, plants, animals, and the environment. In other nations, laws may include one identified term, but government strategy statements or publications by government-related scientific organizations supplement the available legal definitions with more detailed descriptions of “biosafety” and “biosecurity.” The remaining nations addressed in this report have enacted laws addressing biosecurity matters, but these laws contain no legal definitions for “biosafety,” “biosecurity,” or similar terminology.
As discussed in greater detail below, the United States falls into the third category described above. While US laws and regulations contain some definitions for biosafety-related terms, as well as lists of select agents and toxins, researchers should consult guidelines, laboratory manuals, other publications outside laws to understand how “biosafety” and “biosecurity” interrelate and are understood in practice in the US.
We can all (hopefully) agree that the biological sciences and biotechnology have been instrumental in preparing for and responding to natural disease outbreaks. At the same time, the accidental misuse or deliberate abuse of the life sciences can lead to catastrophic impacts across the globe. You’d think that developing international biosecurity and biosafety definitions would be a good thing. But this report shows that the G20 nations are not of one mind. France, for instance, defines biosafety the way that Brazil, Australia, and Turkey define biosecurity, and defines biosecurity the way that those three nations define biosafety. You’d hope that the United States would be in the first category of clearly defining biosafety and biosecurity as distinct elements for the purposes of oversight and legislation, but you would be wrong.
As described in Section II(A), below, few definitions associated with biosecurity and biosafety topics are found in the United States (US) Code. Instead, federal statutes primarily cross-reference parts of the Code of Federal Regulations (C.F.R.) for definitions. Additionally, federal statutes task federal agency heads, such as the secretary of the US Department of Health and Human Services (HHS) and the secretary of the US Department of Agriculture (USDA), with maintaining lists of qualifying agents or toxins that meet certain criteria, including “the potential to pose a severe threat to animal or plant health, or to animal or plant products.” Several federal guidelines listed in Section II(C), below, provide clearer and more detailed procedures and policies related to biosafety protocols, including the National Institutes of Health guidelines and the National Animal Health Emergency Management System (NAHEMS) guidelines, among other examples.
Federal guidelines are good, but they’re just guidelines for specific purposes. Industry practitioners can choose to ignore guidelines if they are not receiving federal funds from a particular executive agency or if they are not working with select agents or toxins. It becomes very difficult to seek internationally-accepted definitions of biosecurity and biosafety when no one can agree on the terminology.
The value of having standard definitions in US Code is that the executive and legislative branches of government could expand on these to establish enforceable standards that improve public safety and work across international boundaries to prevent bioincidents. I do have two definitions in mind that are pretty mainstream.
Biosafety is the application of knowledge, techniques, and equipment to prevent the accidental exposure of biological organisms to personnel, the laboratory, or environment. It can also apply to efforts to address concerns over the nature of dual-use research or newly created strains of biological organisms
Biosecurity is the prevention of theft, diversion, or deliberate malicious use of the biological sciences, to include threat assessments, physical security, emergency response planning, and inspections and reporting. This is usually understood as an aspect of good laboratory practices or agricultural industry controls.
Biosafety procedures establish measures to protect laboratory personnel from accidental exposure and to prevent accidental biological releases, which happened a lot during the mid-twentieth century. This requires a particular mindset and equipment for safety concerns. Biosecurity measures are intended to prevent unauthorized persons from obtaining biological organisms from laboratories or to protect biological organisms from unintentional exposure that might affect them. This requires a different mindset and equipment for security purposes. Neither one is a synonym for biodefense, which is what military service members use to protect themselves against adversarial forces that use biological weapons. Or we might see “biodefense” as those measures used by emergency responders to protect civilians from sub-state groups or individuals using biological hazards as a weapon. It ought to be easy to define and exercise these lanes of expertise, but people deliberately misuse these terms to advance their own personal agendas.
The Library of Congress report notes that 6 US Code section 105(b) tasks the director of Homeland Security to define biodefense for the federal government. There’s nothing on DHS’s website to show how they defined biodefense, so the Library of Congress refers to the 2022 White House’s National Biodefense Strategy, which defines it as “actions to counter biological threats, reduce biological risks, and prepare for, respond to, and recover from bioincidents, whether naturally occurring, accidental, or deliberate in origin and whether impacting human, animal, plant, or environmental health.” This is an incremental change to the 2018 National Biodefense Strategy that says biodefense is “actions to counter biological threats, reduce risks, and prepare for, respond to, and recover from bioincidents.” Bioincidents are “any act of biological warfare or terrorism; a crime involving a biohazard … any natural or accidental occurrence in which a biohazard harms humans, animals, plants or the environment …” The 2023 DoD Biodefense Posture Review used pretty much the exact same words.2 These definitions are too broad for proper policy development.
The Trump administration’s National Biodefense Strategy was produced after Congress directed the Secretaries of the Defense Department, Health and Human Services, Homeland Security, and Agriculture to “jointly develop a national biodefense strategy and implementation plan.” This was directed within the National Defense Authorization Act for FY 2017, enacted in December 2016. Joe Lieberman and Tom Ridge briefed the Senate Committee on Homeland Security and Governmental Affairs about their report’s recommendations on October 28, 2015, stressing the need for a centralized leader (the Vice President, a national strategy, and a unified budget on biodefense. They got the national strategy due to Congress but not the centralized leadership or unified budget.
Connect the dots. The reason why the U.S. government and the Department of Defense have bad definitions associated with policy initiatives to address biological threats is because the Blue Ribbon Panel on Biodefense gave them the starting material.3 If you want good policy, you have to start with a strong and clear definition of what the problem is and to propose an agenda for action. We didn’t get that. The failure to properly define biodefense has diluted U.S. federal guidance and confused policy direction. The U.S. government still does not have a biodefense portfolio. Rather, it allows each executive agency to determine what biodefense means for its own purposes and agendas, with the limited resources available to each single agency.
It’s not just that the 2015 Blue Ribbon Panel’s report was so bad and ineffective, it’s that they just keep banging this drum for a decade now and people keep going to their hearings and sagely nod their heads to this ridiculous tripe. It’s maddeningly frustrating to see this advocacy group wield such power over the process of defining and developing efforts to prevent, prepare for, respond to, and recover from deliberate biological incidents, natural disease outbreaks, and biological accidents. It’s not helping us to get ready for the next pandemic outbreak, and it’s not helping DoD to get ready for an adversarial nation from using biological weapons.
If you need some evidence of how the national biodefense strategies don’t change anything, see this GAO report titled “BIODEFENSE: Actions Needed to Address Long-Standing Challenges.”
In 2018, the White House issued the National Biodefense Strategy, which outlined five high-level goals and functions. It was designed to strengthen federal biodefense capabilities to address naturally occurring, accidental, and deliberate biological threats. An accompanying Presidential memorandum set up a governance structure to guide its implementation, coordinate federal biodefense activities, and assess the effectiveness of goals and objectives. However, in 2020, GAO found a lack of clear procedures and planning to analyze data in a way that leveraged resources and advanced national biodefense capabilities, among other findings.
No agency has changed the way they’ve approached biological threats within their respective areas of responsibility from the way it’s been done for the past 15 years (if not longer). This is not to say that health security and biodefense is broken. Rather, there’s a process by which the executive agencies (e.g., HHS, DoD, DHS) prepare their budgets and request Congressional funding. They offer a particular agenda, and if Congress sees fit, they might receive incremental increases in funding for particular issues. Congress doesn’t like big changes when it comes to putting money into existing program areas such as military biodefense, bioterrorism response, natural disease prevention and response, laboratory biosecurity, and agricultural biosecurity.
Advocacy group recommendations are in general too idealistic and don’t consider funding challenges (I’ll talk to the Commission’s 2015 report next week), which leads to a relatively poor level of acceptance by federal government agencies. The Bipartisan Biodefense Commission released a new report in May 2024. I’ll get to that report in a future post, but just to show you how crazy this all is — they aren’t satisfied with just addressing domestic and global health security. They want to go interstellar. No, I’m serious. They want NASA to authorize its “Office of Planetary Protection” to address extraterrestrial biological contamination, and to establish a planetary biodefense board to inform the National Space Council on biodefense issues. Maybe the incoming president’s space advisor, Elon Musk, will get on that.
I don’t know if my pointing out the inane recommendations from this Commission will do anything. They get a lot of press, again probably because of the status of their commissioners and probably because people who are asked to talk to the Commission enjoy the opportunity to talk about their perspectives on this issue. I don’t blame them. Maybe the public health community secretly dislikes this group and uses them to advance their own agendas. I’m just tired of seeing the Commission trumpet their recommendations as if they discovered the formula for curing cancer, while at the same time these recommendations are ignored by the Beltway agencies. More to come.
Full disclosure, I’ve known Bob Kadlec since he was an AF colonel working in the OSD counterproliferation office after 9/11. I haven’t seen him for a while, certainly not during the Trump administration. He always struck me as a smart and talented guy. We didn’t always agree on issues, but he had solid analytical chops. What he did as HHS ASPR during the COVID-19 outbreak is a story for someone else to tell.
The 2018 definition of biodefense is word for word the same as the 2023 definition of biodefense in the DoD Biodefense Posture Review. The bioincident definitions in the two documents are very similar in form and word. The OSD officials in charge decided that the DoD approach had to mirror the USG approach to countering biological threats in every detail, despite the significant differences in how these agendas were executed. I’m embarrassed for the military officers who acceded to OSD staffers’ demands as they participated in the Biodefense Posture Review.
I’m going to clarify here that the 2009 National Strategy to Counter Biological Threats did not define biological threats or biodefense as terms of use. But it refers to biological threats on page 2 as something from “a catastrophic attack or accidental release.” The 2009 document was officially designated as PPD-2, replacing the Bush 43 administration’s 2004 “Biodefense for the 21st Century” or HSPD-10/NSPD-33. The 2004 document also does not define biological threats or biodefense but very clearly is directed at bioterrorism.