U.S. Biopreparedness Needs Direction, But Does This Study Provide It?

The medical community continues its stubborn insistence to use the wrong definitions

For years now, there has been a constant drumbeat about the need to better protect against and respond to “biological threats,” defined broadly as natural disease outbreaks, deliberate biological incidents, and laboratory accidents. At the same time, there’s been little to no desire by Congress to actually change anything in this area. The Trump administration has made significant cuts across nearly all areas of health policy in the past year, but it still falls to some to suggest “well what if we gave them some suggestions anyway?” Thusly, the CSIS Bipartisan Alliance for Global Health Security has released this a study titled “Protecting America from Biological Threats.”

This report is intriguing for a number of reasons, not the least of it is that it has four authors and 40 signatories who worked on the report. I know a number of them to be serious health policy and biodefense experts; a few of them are not serious people but let’s not let that detract from the content of the study. I hesitate to critique this report given this list of heavy hitters, but I have questions. I certainly do not pretend to have the deep experience and professional insights as many in this group, but the methodology and terms of reference trouble me. I continue to believe that people who are sincerely interested in addressing this broad term “biological threats” do not advance their cause by building on the failed National Biodefense Strategies of the Trump and Biden administrations. The definitions used in those strategies - and I use that term loosely - are not conducive to developing policy platforms to address these distinctly different biological threats.

This study has several good points, but it will fail to get traction under this White House, not just for the obvious reason - that the Trump administration has absolutely no interest in “making America healthy again” and instead has increased the threat of natural disease outbreaks and slashed research funds for noncommunicable diseases. Congress also remains a challenge, not the least of which is because it does not oversee and resource “biological threats” as a distinct public concern. This is a basic challenge of implementing any policy recommendations, that different biological threats require distinct focus. I’ve voiced in previous articles that there are five distinct areas that are addressed by different executive agencies and legislative committees:

• Disease prevention, managed by public health to protect the public from natural diseases

• Bioterrorism response, managed by law enforcement and emergency responders to protect the public from deliberate biological incidents

• Biodefense, managed by the US military to protect its servicemembers from biological weapons

• Biosurety, managed by laboratory directors to protect its workers and the environment from accidental releases

• Agricultural biosecurity/food biosafety, managed by farms and ranchers to protect food and livestock from biologics

These terms are particularly important if you want Congress to put specific funds against what is perceived to be a discrete public challenge that requires federal address. You mix up the terms, then resources are wasted.¹

I suggest that the term “national biopreparedness” is a much better term than “national biodefense” when it comes to defining and implementing U.S. policy that address prevention, protection, response, and recovery activities in these different sectors. Biodefense is something the military does, period. My belief is that, for years, the public health community has tried to appropriate this term - deliberately blurring the lines between disease prevention and military biodefense - to get more funding. It doesn’t work. Congress is not going to consolidate these functions or allow for an integrated budget for “biodefense” because they like having separate buckets of money for distinct constituent groups. Biopreparedness appropriately uses terms congruent with the National Preparedness Framework to address more than one biological threat and more than just response and recovery.

I also disagree with the study’s definitions of biosafety and biosecurity. The study says:

Biosafety—protecting the United States and the world against the accidental release of biological agents—and biosecurity—protecting against the deliberate deployment of biological weapons—are essential capabilities to prevent bioincidents. The risk of deliberate biological threats has grown, fueled by the convergence of AI, biotechnology, and computational power. Russia and North Korea have bioweapons, and other state and non-state actors are seeking to develop them. The risk of accidental biological threats has grown due to the rapid proliferation of high-containment laboratories with limited training and oversight. Uncertain federal leadership and weakened U.S. capabilities raise the imperative for legislative action to improve domestic and global biosafety and biosecurity.

There’s a lot there, but I was thrown off by this failure to properly define these two terms. The Government Accountability Office has a recent report that says:

Biosafety helps protect lab workers, the community, and the environment from accidental exposure to or release of biological agents. Biosecurity helps protect against the loss, theft, deliberate release, or misuse of biological agents.

These two definitions are not the same. In general, biosafety and biosecurity have nothing to do with preventing, protecting against, or responding to nation-states or substate groups who intend to use biological weapons.² Biosafety isn’t about protecting the world or the United States; it’s about ensuring that a lab worker doesn’t accidently infect himself or herself with infectious disease organisms or forget to turn the hood ventilation on when working with agent. It’s about protecting the citizens who live and work near the laboratory. There’s no need to get fancy here.

Biosecurity is about not allowing the wrong people to get access to dangerous organisms. It’s about locks and access and accountability, not preventing biological weapons use. It’s pretty simple, and yet there is no standard definition across U.S. pharmaceutical companies, biological research labs, and agricultural industries. Nor is there, perhaps surprisingly, any consensus across the globe as to what these two terms cover. This study even admits as much (“No One in Charge”) and has some recommendations to address this issue - which is good. But I would have rather they had the right definitions at the beginning of this section.

The study’s authors say that they decided to use the 2018 National Biodefense Strategy, developed in the first Trump administration, as a framework for this study. I guess that it’s okay to ignore the 2022 National Biodefense Strategy by the Biden administration, since they both use the same framework and basically say the same thing.³ Sure, the current administration would be insulted if this study said it used the more recent Biden strategy, but it seems a little too much like pandering when the authors say ‘[t]he first Trump administration leveraged its 2018 National Biodefense Strategy to create Operation Warp Speed, a public-private partnership that built on decades of federally funded research into coronaviruses and the mRNA delivery platform to deliver safe and effective tests, treatments, and vaccines, saving millions of lives and trillions of dollars.” Come on.

Anyway. This study is a quick read, easy for policymakers to digest, and worth the time to read its points. In all seriousness, I do like many of the recommendations, but I don’t believe it has a chance in hell of being adopted. Let’s look at the first area, modernizing biosurveillance. The authors want:

• A new White House Office of Biopreparedness to oversee interagency biosurveillance activities and their budgets. There is an Office of Pandemic Preparedness and Response Policy, but I guess the authors don’t believe the office should be limited to natural disease outbreaks. It’s a mistake. Natural disease outbreaks should be the sole focus because it affects the entire American public.⁴

• The return of the National Counterproliferation and Biosecurity Center under the ODNI to do threat assessments of AI and biotech convergence. Not gonna happen under Tulsi Gabbard’s reign, and unnecessary. Give the task to the National Biodefense Analysis and Countermeasures Center or NIST instead.

• Axing Project BioWatch with the CDC getting the responsibility for national biosurveillance. Standardize federal biosurveillance data so that it can be used more quickly and efficiently. Sure, absolutely. BioWatch was a slapdash idea that sounded good in 2004, but it’s a beast with little value. But Congress won’t kill it because they don’t understand technology and they’re afraid that if they do get rid of it and a bioterror incident happens, they’ll have to explain why they killed it.

• Get the State Dept to get serious on global health security. to include working with the World Health Organization. Sure, absolutely, but again, not these guys.

In the second area, we have “ensure biosafety and biosecurity to prevent bioincidents.” I have already criticized their particular definitions, and I don’t understand why they have to stress “bioincidents.” Aren’t bio-accidents also a thing? There is a difference. Anyway, here we go.

• Reestablish the ODNI NCBC to monitor for foreign development of bioweapons and fund the DoD to protect the United States from them. I could write an entire separate post on why this is such a bad idea. We could ask the Defense Intelligence Agency and Bureau of Intelligence and Research to, I don’t know, DO THEIR JOBS instead of tasking the ODNI. DoD never had nor wants the role of “protecting the homeland” from bioweapons.⁵ That’s why DHS got the job and had a Countering WMD office (for a while at least).

• Get the Commerce Dept to work biotech innovation, to include monitoring compliance with biosafety and biosecurity regulations. Great idea, as soon as Congress gets serious about writing stringent biosafety and biosecurity regulations. And right after they figure out where all the BL-2, 3, and 4 research labs are located in the United States, which they absolutely do not know.

• Require the Office of Science and Technology Policy to guide the development of safety and security practices to address the convergence of AI and biotech. I am completely not concerned about this but sure, send the OSTP out there. They’re good people. But they’re not going to get industry to be responsive.

• Be technical leaders in the global community to reduce vulnerabilities from natural, deliberate, and accidental biological threats. Accelerate biosafety and biosecurity cooperation with China. Great idea, completely not on this administration’s agenda. Not gonna happen.

The third area is “reverse the decline of the biodefense enterprise.” First of all, there is no U.S. biodefense enterprise, there never was. There are pharmaceutical firms, there are state and local public health offices, there are agricultural food industries, and there is a (relatively) tiny military biodefense enterprise. They all have different interests. Only the first two are key to researching, developing, manufacturing, distributing, and dispensing medical countermeasures to the American public. But okay. What do you have for us?

• Get that White House Office of Biopreparedness to integrate budget requests and spending plans. Update the National Biodefense Strategy (that does nothing but document executive agency roles and responsibilities). Implement a “whole of government” approach to strengthen medical supply chain resilience. Never going to happen because Congress won’t let a White House office tell them how to fund Big Pharma, HHS research, DoD research and procurement, and USDA and FDA operations (well, in normal times).

• The second recommendation is very long and basically says “we need more money across the board - more money for HHS agencies that have been stripped back; more money for public, veterinary, and plant health preparedness; more money to provide world leadership in vaccine development and indoor air quality; more money for rapid medical countermeasure development; more money for surge production of medical equipment. Counterpoint, one out of every four U.S. federal dollars already goes to health services and programs, about twice that of national defense spending.⁶

• Get DoD, HHS, and USDA to work private-public partnerships “modeled after Operation Warp Speed and recent activities to reduce Chinese control of rare earth metals.” Come on. OWS was never a model of good practice. It was an ad-lib effort and wasteful program at which the U.S. government threw billions of dollars because hundreds of thousands of Americans were dying. Second, how did Chinese rare earth metals get in here? No idea.

• The last one is on “international burden sharing,” and I have to quote this because it’s so damned idealistic. “Require departments and agencies to ensure that U.S. biopreparedness investments leverage commitments to biopreparedness by key allies, partners, and multilateral bodies. Incorporate biopreparedness into exercises with partners to reduce supply chain vulnerabilities and promote U.S. innovations abroad.” This administration? These guys? Nope. Nope. Nope.

The last area is a call to strengthen response and recovery. The medical community puts a lot of time and thought into this, because of all of the national preparedness phases (prevent, protect, mitigate, respond, recover), there actually is a commonality in how the medical community responds to and how a community would recover from natural, deliberate, and accidental biological threats. They want:

• The White House Office of Biopreparedness to coordinate the national response and recovery from any biological emergency. Because it totally makes sense to have a Department of Homeland Security coordinate all the interagency activities for non-bio catastrophic incidents and accidents and this office to focus on bio incidents and accidents. Makes no sense.⁷

• Restore funding for the National Response Framework and in particular investigatory and attribution capabilities, because why have the CDC Global Operations Center and an FBI WMD office anyway.

• Fund the states and local authorities to respond to all biological threats, even though they don’t adequately fund response activities for natural disasters.

• Fund outreach campaigns for the rural areas who don’t trust Washington DC. Fund the private sector to make deals with the federal governments. Fund the international partnerships that work on global biological emergency response. Fund the development of agreements with other countries on agrothreat concerns. Fund it all. Money for everyone, despite U.S. health care spending reaching $5.3 trillion in 2024.

This is a serious report written by serious professionals. And here’s their bumper sticker.

This report from the CSIS Bipartisan Alliance for Global Health Security Working Group on Biodefense lays out a vision to enhance U.S. biodefense built on actionable, affordable, bipartisan steps. The working group drew upon a strong bipartisan foundation of knowledge and expertise, as well as decades of analytical and policy work. Clarifying federal leadership, strengthening private sector partnerships, enhancing core programs and requirements, and sustaining international cooperation are the essential areas that the working group argues must be prioritized in order to bolster U.S. defenses against biological threats.

Ultimately, success rests on the high-level leadership and political will of Congress and the administration.

The hope of this working group is that this report helps to clarify the threats facing the United States and informs decisions that will mitigate risks to the American people, economy, and national security

So we’re pretty much doomed, aren’t we? Well, if not this administration, maybe the next one will read this. And then ignore it as too utopian and go back to reacting to whatever the immediate crisis du jour is. I will stress again that noncommunicable and chronic diseases are far more of a threat to Americans than infectious diseases. The annual CDC mortality charts routinely demonstrate this fact. This group understands that the threat of deliberate biological incidents and laboratory accidents are tiny in comparison to the threat of natural disease outbreaks, but maybe they think that they have to beat the “national security” drum to get attention. It’s not good policy.

Thais may not be entirely fair. I appreciate the thoughtfulness of this group, if not their choice of terms. It’s a good report but it’s not going to change U.S. policy. If I had one request, it would be to stop using this approach of trying to get one’s arms around all biological threats and to consolidate all federal government actions under one omnipresent organization that has their fingers on all of the money. This is not how the U.S. government works. Failure to appreciate this will only lead to more frustration and lack of progress toward a realistic national biopreparedness capability.

1. For instance, allowing the DoD CB Defense Program to spend biodefense dollars on natural disease outbreaks and military wastewater surveillance programs would be a mistake. And yet, we see this happening because nobody cares to make an issue of it.

2. There are particular people who insist on using the term “biosecurity” to describe all capabilities required to prepare for and protect against adversaries who deliberately release biological agents for the purposes of causing a mass casualty event. They add to this confusion, perhaps deliberately, to bolster the concept that public health preparedness could address all biological threats, if adequately funded. I disagree with this and want biosecurity to mean just one thing, focused on research labs and agricultural businesses.

3. That said, I like the Biden strategy a little better because they actually named lead agencies and supporting agencies. I don’t believe either strategy really changed the status quo though. Budget is policy, and the budgets didn’t change for addressing biological threats.

4. There’s a longer conversation necessary here, but I don’t want to digress. Short version, biosurveillance isn’t just about biological threats, it’s all potential hazards in the global biosphere that can adversely impact humans, animals, and plants. It’s a really big data grab and that’s why the health sector is always demanding more money for it. It’s never enough.

5. Even after 9/11, DoD (under Rumsfeld) went to great lengths to insist that they didn’t do homeland security, they did homeland defense by going overseas and killing bad guys. They reluctantly took on the WMD civil support (response) mission because the National Guard basically got Congress to love the idea, but OSD leaders never wanted the job.

6. This WotR author bemoans the 2024 budget of $20 billion into pandemic preparedness as compared to what’s spent on preparing for AI-biotech risks. To me, that’s a clear signal of what Congress wants and it’s appropriate. But more funding? Prob not.

7. This White House Office of Biopreparedness has a lot of tasks lining up here. Again, something the medical community seems to like to do, insist on consolidation of all federal activities related to biosurveillance and developing medical countermeasures under one roof, because only medics can understand this.