Prioritizing the Defense Department's Response to Biological Warfare Threat Agents

DoD's Challenges and Realities

Government officials responsible for defending against biological warfare are faced with an array of potential threat agents. Formulating an agent-specific prioritized list enabled a focused approach on countermeasure development, production, and acquisition. When directive 6205.3 was promulgated in 1993, the military focused its medical defenses primarily on vaccines, because preventing disease was thought to be a better approach than trying to treat deployed troops who became ill after a biological attack. A vaccine-oriented approach requires development of a separate product for each threat agent.

Over time, however, DoD found the one vaccine–one threat agent approach untenable based on the time needed and the cost of product development. Subsequent to that realization, it has given increased attention to broad-based postexposure therapeutics. This shift in focus emerged as DoD better understood the risks posed by emerging infectious diseases that could be adopted for use as biological warfare agents, increased its understanding of pathophysiological pathways common to many infectious agents, and, perhaps more significantly, raised concerns that an adversary might develop novel biological agents by engineering traditional agents to evade vaccine protections. ⁴

Given the estimated average 15-year timeline required to develop a new vaccine, balanced against the possibility of the unexpected appearance of a new threat agent,^5-7 the postexposure treatment approach may be the most prudent option. This explains why 1 of the 4 goals of the Chemical and Biological Defense Program is “preventing surprise by anticipating threats and developing new capabilities for the Warfighter to counter emerging threats.” ^{8 (p9)}

The Failure of the “Chairman's List”

In practice, the directive 6205.3 process never worked as intended. The unified commands responsible for providing their assessments of the threat lacked the expertise to make informed judgments, either to evaluate the available intelligence or to analyze the operational implications of biological warfare threats. Nor did the joint staff possess such skills. Ultimately, the Chairman's List was generated by biological warfare experts at DIA and essentially became an intelligence product.

The bigger problem with the Chairman's List, however, was that it hurt medical research and development. In contrast to the current Department of Homeland Security (DHS) biodefense prioritization process, the directive 6205.3 process did not incorporate a risk assessment. No consideration was given to the medical impact of the agent. Therefore, ricin was considered as serious a threat to warfighters as anthrax, Marburg, or smallpox. As a result, vaccine developers discovered that ricin, which should have been a much lower priority threat, was assigned higher priority than an agent such as smallpox, which, unlike ricin, was communicable and associated with high morbidity and mortality.

The complaints sparked several efforts to look at how DoD prioritized biological warfare threats. Most important, the Armed Forces Epidemiological Board requested that the US Army's Surgeon General's office undertake a medical risk assessment. Predictably, the resulting study demonstrated that the unique epidemiologic and pathologic characteristics of different biological warfare agents significantly affected their medical significance and that taking account of this consideration affected agent prioritization. Although that study was not a comprehensive risk assessment, its authors recognized the need to take into account additional issues related to agent production and weaponization. However, a subsequent integrated risk assessment taking into account all risk-related considerations was not produced.

DoD officials also identified other problems with the Chairman's List. The most important was dependence on intelligence inputs, despite concerns that the intelligence community could not reliably identify the threat agents that US military forces needed to protect against.^9,10 The 2005 Commission on the Intelligence Capabilities of the United States Regarding Weapons of Mass Destruction, by a senior intelligence official, noted: “We don't know more about the biological weapons threat than we did five years ago, and five years from now we will know even less.” ^{11 (p506)} This posed a serious problem. The Chairman's List was supposed to guide a vaccine research and development process, yet DoD could only begin development of a vaccine once a threat was on the list. Since a vaccine can take from 8 to 35 years to develop—from basic research through Food and Drug Administration licensure—this Chairman's List effectively meant that DoD could remain vulnerable to emergent threats for years or even decades.

The Chairman's List also was used for purposes beyond its original intent. Created to support vaccine development, it was being used inappropriately to prioritize a range of other medical and nonmedical defense programs. Surprisingly, the GAO made the same mistake. Even though directive 6205.3 relates to DoD's vaccine policy, the GAO assumed that it was intended to guide all medical countermeasure development.

Finally, the Chairman's List focused on presumed overseas battlefield use and did not take into account potential threats to military personnel and civilians located behind the battlefield or to the US homeland. By the late 1990s, DoD officials responsible for chemical and biological defense increasingly were concerned that attacks might target facilities in rear areas or even in the United States, especially if an adversary wanted to disrupt US power projection capabilities.

Ultimately, the Chairman's List had only one real value, different from its intended purpose. It provided an authoritative list that guided combatant command personnel as they planned for military operations. In other words, the Chairman's List was most useful as a guide for near-term military action.

Abandoning the Chairman's List left DoD with a new problem. It no longer had any mechanism for prioritizing its resource expenditures. As a result, it often seemed that investments were made based on the best judgment of senior officials. As changing administrations brought new officials to critical offices, they often brought different priorities and instituted radical changes in course. These changes might then be reversed later as the next new officials assumed programmatic responsibility. In any case, skepticism about the usefulness of the Chairman's List in the office of the Secretary of Defense was sufficient to ensure that it was never updated, although alternative lists appeared occasionally during subsequent years.

A New Prioritization Process

The DoD response to the GAO report by Andrew Weber, Assistant Secretary of Defense for Nuclear, Chemical, and Biological Defense Programs, is particularly apt: “The Department will review the directives addressing BW threats to ensure they align with current capabilities-based planning processes to reflect a holistic threat-informed, risk-based assessment.” ^{1 (p46)} This suggests that DoD will abandon the existing process and adopt a totally new one. We believe that that would be the right step.

Developing such a broader-based prioritization process would allow DoD to address its entire biodefense portfolio: vaccines and other preexposure therapies, postexposure therapeutics, medical diagnostics, environmental detectors, decontaminants, and bioforensics capabilities. Intelligence information should be factored into the process as but one of many possible inputs, rather than the primary driver. The resulting list, no longer the Chairman's List, should be designed to incorporate new information as it becomes available, rather than on an annual schedule. Nor should it duplicate the existing DHS biodefense risk assessment. Rather, DoD can use the DHS civilian sector–focused assessment to inform its own prioritization process that also would take account of threats from state biological warfare programs.

The priorities will need to be continually reviewed and revised to reflect expanding scientific knowledge of commonly shared disease pathways. Future countermeasures may be designed to be more “universal,” such as by targeting an early step in an inflammatory or infectious response cascade in the body rather than being aimed at the pathogen alone. Such universal countermeasures may prove useful in treating common pathologic processes that may be associated with some chemical, radiological, or nuclear exposures as well.

In summary, the GAO recommendation is misguided. For a new prioritization process to begin, DoD needs to rescind directives 6205.3 and 5160.3 and formulate a new directive focused on 21st century needs.