[Photomicrograph of Bacillus anthracis, the anthrax bacteria, in human tissue. From the CDC, 1976.]

For all the attention drawn by biological weapons, they are, for now, rare. Countries with bioweapon programs started during World War 2 or the Cold War have apparently dismantled them, or at least claim to, after the 1972 international Biological Weapons Convention. The largest modern bioweapon attack on US soil was in 1984, when an Oregon cult sprayed salmonella in a salad bar in the hopes of getting people too sick to vote in a local election. 750 people were sickened, and nobody died. In 2001, anthrax spores were mailed to news media offices and two US senators, killing 5 and injuring 17.

A few countries are suspected to have violated the Biological Weapons Convention, and may have secret active programs. A couple terrorist groups were found to have planned attacks, but not carried them out. Biotechnology is expanding rapidly, the price and know-how required to print genomes and do genetic editing and access information is dropping. An increasingly globalized world makes it easier to swap everything from information to defensive strategies to pathogens themselves.

This should paint the picture of an uneasy world. It certainly does to me. If you buy arguments about why risk from bioweapons is important to consider, given that they kill far fewer people than many other threats, then this also suggests that we’re in an unusually fortunate place right now – one where the threat is deep and getting deeper, but nobody is actively under attack. It seems like an extraordinarily good time to prepare.

The Blue Ribbon Study Panel on Biodefense is a group of experts working on US biodefense policy. I heard about them via the grant they won from Open Philanthropy Project/Good Ventures in 2015. Open Philanthropy Project suggests them as a potentially high-impact organization for improving pandemic preparedness.

Philanthropy isn’t an obvious fit for biodefense – large-scale biodefense is mostly handled in governments. The Blue Ribbon Study Panel was funded because of its apparent influence to policy (and because OPP suspected it wouldn’t get funded without their grant, which allowed the panel to issue its major policy recommendation.)

I wrote this because the panel’s descriptions of current biodefense measures in the US seemed comprehensive and accurate. What follows is my attempt to summarize the panel’s view. I haven’t necessarily looked into each claim, but they’re accurate as far as I can tell. The actual paper is also interspersed with some very good-sounding policy recommendations, which I won’t cover in depth.

What the Blue Ribbon Study Panel found

China, Iran, North Korea, Russia, and Syria (as assessed by the Department of Defense) seem to be failing to comply with the Biological Weapons Convention. Partially-destroyed or buried weapons are accessible by new state programs. Weapons are taking less time and resources to create, by terrorists, small states, domestic militias, or lone wolves. Synthetic biology is expanding. Natural pandemics and emerging diseases are spreading more frequently. Escapes from laboratories are also a risk.

This presents an enormous challenge which the US has not currently measured up to. Previous commissions on the matter have continually expressed concern, and these concerns have never been fully addressed.

Currently, responsibility for one aspect or another of biodefense is spread between literally dozens of government agencies, acting without centralized coordination. In the recent past, this has led to agencies tripping over each other trying to mount appropriate responses to threats, and it’s very unclear what the response would be or who would take charge of it in a more massive or threatening pandemic, or in the case of bioterrorism.

(One example comes from the 2013-15 Ebola outbreak, when the CDC took it upon itself to issue guidelines to hospitals for personal protective equipment (PPE) requirements for preparing for Ebola. But the CDC isn’t usually responsible for PPE requirements, OSHA is – and the CDC didn’t consult with them when issuing their recommendations. They ended up issuing guidelines that were hard to follow, poorly distributed, and not appropriate for many hospitals.)

Also, funding and support for pandemic preparedness programs is on the decline, even though most experts will agree that the threat is growing.

The paper recommends producing a unified strategy, a central authority, and a unified budget on biodefense.

Areas in need of more focus and coordination

A recurring theme in the Blue Ribbon Study Panel’s analysis:

• The government is currently paying at least some attention to a particular topic, but not very much, and it’s not well-funded, and efforts are scattered in several different agencies that aren’t coordinating with each other.
• This despite all biodefense experts saying “this topic is hugely important to successful biodefense and we need to put way more effort into it.”

Some of these topics:

• “One Health” focuses
  • One Health is the concept that animal, human, and environmental health are all inseparably linked.
  • 60% of emerging diseases are zoonotic (they occur in humans and animals), as are all extant diseases classified as threats by the DHS (e.g., all but smallpox).
  • Despite this, environmental and animal health are significantly more underfunded and poorly tracked than public health.
• Decontamination and remediation after biological incidents
  • This is kind of the purview of OSHA, the EPA, and FEMA. OSHA is good and already has experience in some limited environments. The EPA has lots of pre-existing data and experience, but is not equipped to work quickly. FEMA is good at working quickly, but usually isn’t at the table in remediation policy discussions. The EPA currently does some of this coordination, but isn’t required to.
• A comprehensive and modern threat warning system
  • Existing systems are slow, sometimes outdated (e.g. the DHS BioWatch program, which searches for some airborne pathogens in some major cities, which is slow and hasn’t been technologically upgraded since 2003.)
  • A better system could become aware of threats in hours, rather than days.
  • This is especially true for crop and animal data, especially livestock.
• Cybersecurity with regard to pathogen and biotechnology information
  • Much pathogen data and biotechnology data is swapped around government, industry, or academic circles on the cloud or on unsecured servers.
• Department of Defense and civilian collaboration
• Attribution of a specific biological threat
  • A hard problem theoretically studied by the National Biodefense Analysis Center, but which other agencies in practice don’t necessarily cooperate with.

Medical Countermeasure development

A few major players into research in responding to biological threats are: BARDA, PHEMCE, NIAID. Project Bioshield is a congressional act that funds medical countermeasures (MCM, e.g., vaccine stockpiles or prophylactic drugs), mostly through BARDA.

These agencies’ funding for the development of MCM goes mostly to early R&D – discovering new possible treatments, countermeasures, etc. Advanced R&D in bringing those newfound options to a usable state, however, is by far the more lengthy and expensive part of the process, and receives much less funding. Compare industry’s 50% of money on advanced development, to the government’s 10-30%. PHEMCE is trying to correct this. Rapid point-of-care diagnostics are especially underexplored.

The government typically hasn’t used innovative or high-risk/high-reward strategies the way the private sector has, but biodefense requires some amount of urgency and risk-taking. Even if the problem were well-understood (it’s not), the response under the current regime wouldn’t be clear.

The government has managed to produce viable MCMs quickly at times, as in Operation Desert Storm or the 2014 Ebola outbreak (when three vaccines and one therapeutic were pushed from very early stages to clinical development in less than three months.)

Certainly, the government isn’t the same as private industry – the “surge model” of MCM development wouldn’t be effective for a business, but from the government has been a successful strategy in the past. MCM development is commercially risky, and the federal government is the only actor that can incentivize it.

That said, BARDA has efficiently partnered with the industry in the past, pushing twelve new MCM into available use with six billion dollars. Normally, bringing a drug to the commercial market takes over two billion each. Twelve MCM is far from enough, but proves that this kind of partnership is feasible. Project Bioshield is also facing low amounts of funding, which is confusing, given its relative success, bipartisan support, and a sustained threat.

Other notes from the panel

Research suggests that in the event of a catastrophic pandemic, emergency service providers are especially at risk, and only likely to help respond if they believe that they and their families are sufficiently protected – e.g. with vaccines, personal protective equipment, or other responses. EMS providers only have these now for, say, the flu and HIV, and not rarer diseases (with different protective equipment needs) that could be used in an attack. Since much bioterrorism knowledge is classified, it would also be difficult to get it into the hands of EMS providers. This is also true for hospital preparedness.

The Strategic National Stockpile is the nation’s stockpile of medical countermeasures (MCM) to biological threats. Existing MCM response architecture doesn’t have centralized leadership, goals, funding, coordination, or imagination for non-standard possible scenarios, which is, well, an issue. There aren’t clinical guidelines for MCM use from the CDC, and there isn’t a solid way to deliver them to anyone who might need them. On the plus side, a few places like New York City have demonstrated that their EMS providers can effectively distribute MCMs.

The Select Agent Program (SAP) is the primary federal tool to prevent misuse of pathogens and toxins. It only names agents, and doesn’t fully address risks, approaches, ensuring that standards are met, or its own transparency. Synthetic biology has also expanded since its creation, and the SAP hasn’t been updated in response. Its actual ability to improve security are also in doubt.

The Biological Weapons Convention and biorisk across the globe

International law meets federal policy in the 1972 Biological Weapons Convention, where 178 signatory nations agreed never to acquire or retain microbial or other biological agents or toxins as weapons. A major shortcoming of the convention is that it lacks a verification system or clear judgments or protocols to compare peaceful and non-peaceful possession of biological agents. The 5 signatory nations mentioned at the top of this section are in fact suspected of violating the convention.

Emerging diseases, especially zoonoses, often come from developing countries and especially urban areas in developing countries. Developing countries lack human and animal health structures. The US has the potential to assist the WHO and OIE with public health resources for resource-strapped areas.

About the report

For the solutions proposed by the Blue Ribbon Study Panel, you can read the entire report, or you could ask me for my 25-page summary (which is, admittedly, not much of a summary.) The short version is that they propose a unified strategy and budget addressing all of the above specific issues, put in a well-organized structure under the ultimate control of the office of the Vice President. They made 46 specific policy recommendations.

Since the report was published in October 2015  (mostly according to a follow-up published by the panel):

• The Zika pandemic happened. The response continued to lack coordination in ways the Blue Ribbon described for past events.
• Al-Qaeda and ISIL have both been found with plans and materials to create and use bioweapons.
• The 2015 Federal Select Agent Program annual report described 233 occupational exposures or releases of select agents or toxins from laboratories, demonstrating that biocontainment needs improvement.
• The US attended the 8th Biological Weapons Convention (BWC) Review Conference in November 2016. The ambassador attending, Robert Wood, wrote a report criticizing the Convention nations for failing to come to strong consensus or create solid strategies.
• As of a December 2016 follow-up report, 2 of the 46 specific recommendations were completed (both of them involving giving full funding to pre-existing projects), and partial progress was made on only 17 of the 46.
• That said, as a direct result of the report, a bill to create a national biodefense strategy was introduced to the senate where it sits now (and has for several months, with the last alteration in October 2016.)

The senate bill is both interesting, and suggests a possible anti-biorisk action if you live in the US – trying to get it passed. The biodefense strategy bill appears to be a step in the right direction of filling a major need in the US’ biodefense plan, and I can’t see major negative externalities from this plan. I imagine that the straightforward next action is contacting your senators and asking them to support the bill.