Bayes, Bugs, and Bioterrorists

Lessons Learned from the

Anthrax Attacks

Kimberly M. Thompson, Robert E. Armstrong, and Donald F. Thompson 

Center for Technology and National Security Policy 

National Defense University

April 2005 
The views expressed in this article are those of the authors and do not reflect the official 

policy or position of the National Defense University, the Department of Defense or the 

U.S. Government. All information and sources for this paper were drawn from

unclassified materials. 

Kimberly M. Thompson is Associate Professor of Risk Analysis and Decision Science 

at the Harvard School of Public Health (http://www.hsph.harvard.edu/faculty/ 

KimberlyThompson.html). Dr. Thompson can be contacted via e-mail at 

kimt@hsph.harvard.edu or by phone at (617) 432-4285.

Robert E. Armstrong is a senior research fellow in the Center for Technology and 

National Security Policy at the National Defense University. Dr. Armstrong may be 

contacted via e-mail at armstrongre@ndu.edu or by phone at (202) 685-2532. 

Donald F. Thompson is a senior research fellow in the Center for Technology and 

National Security Policy at the National Defense University. Dr. Thompson may be 

contacted via e-mail at thompsond1@ndu.edu or by phone at (202) 685-2406. 

Defense & Technology Papers are published by the National Defense University Center for Technology and 

National Security Policy, Fort Lesley J. McNair, Washington, DC. CTNSP publications are available online at 

http://www.ndu.edu/ctnsp/publications.html.

ii
Contents 

Executive Summary...........................................................................................v 

Introduction........................................................................................................1 

Thinking Big: A “Straw Man” Framework .......................................................5 

Acting Wisely ....................................................................................................9 

Understanding Anthrax....................................................................................19 

Managing Anthrax in the Future......................................................................29 

Appendix A: NDU Anthrax Conference..........................................................51 

Appendix B: Johnson-Winegar Review...........................................................53 

iii 
iv 
Executive Summary 

The U.S. government continues to improve its plans for protecting civilians and soldiers 

from attacks with biological weapons. Part of this effort focuses on developing strategies that 

recognize the difficult choices to be made in using and deploying resources. This paper presents 

a risk- and decision-based framework—derived from the field of Bayesian statistics—for 

developing strategies that facilitate managing the risks of biological agents. The framework 

recognizes the significantly different attributes of potential biological weapons and offers a 

strategy for improving communication to effectively coordinate national biopreparedness efforts. 

The framework identifies generic decisions related to routine immunization, response planning, 

stockpiling vaccines and therapeutic agents, surveillance choices, containment, emergency 

response training, research, media and communications preparations, information management, 

and policy development. This paper provides a straw man to be used in wargames, exercises, 

practices, etc., at all levels of government. 

 Given the attention on anthrax following the 2001 attacks, this paper applies the 

framework to managing the risks of anthrax to provide an illustrative example. The example 

demonstrates that by organizing information at this level, decisionmakers can quickly understand 

the critical connections between different options (e.g., vaccinating with a new vaccine requires 

an investment in research; research might increase the opportunities for breaches of 

containment). With respect to managing the risks of an attack with anthrax, this analysis suggests 

the need for creation of a comprehensive national management plan that includes quantitative 

evaluation of resource investments. 

The authors conclude that the government should adopt a process—based on decision 

science and using the power of decision trees as an analytical tool—to develop a strategy for 

managing the risks of bioterrorism. Using this type of approach, the government can better 

characterize the costs, risks and benefits of different policy options and ensure the integration of 

policy development. Additionally, confirmed use and refinement of decision trees during 

exercises will provide analysis of the long-term consequences of decisions made during an event 

and give policymakers insights to improve initial decisions. 

v 
vi 
Introduction 

Following the anthrax attacks in the fall of 2001, the U.S. government 

significantly increased its commitment of resources and its efforts for biopreparedness. 

Some observers of the anthrax attacks may downplay the event, given the relatively small 

burden of illness and death that resulted (22 cases, 5 deaths)1

 compared to the potential 

impact from alternative methods of dispersal of weaponized anthrax. However, the U.S. 

government incurred significant costs associated with the attacks, which effectively 

created terror. Congress provided over $1 billion dollars to the U.S. Postal Service 

(USPS) alone for its initial interventions (including gloves and masks for workers, 

irradiation of mail, decontamination of facilities, and introduction of technology to 

protect workers against dust from letters passing through handling equipment). Cleanup 

of the Hart Senate Office Building exceeded $24 million, and direct cost to the USPS 

may exceed $3 billion.2

A study conducted in late 2001 suggested that as many as 2 million Americans 

might have taken Cipro unnecessarily,3

 which explains observed shortages in supply.4

(See the “Too Much of a Good Thing” text box on page 22.) At a cost of approximately 

$600 for a 60-day supply of Cipro (approximately $60 for doxycycline), this implies 

additional expenditures in excess of $1 billion. Other non-traditional costs also arose in 

the context of the potential challenge to the patent for Cipro.5

 Collectively, this represents 

a fraction of the over $500 billion annual budget for the Department of Health and 

 

1 Daniel B. Jernigan et. al., “Investigation of bioterrorism-related anthrax, United States, 2001: 

Epidemiologic Findings.” Emerging Infectious Diseases 8, no. 10 (October 2002): 1019. 2

 David Heyman, Lessons from the Anthrax Attacks: Implications for U.S. Bioterrorism Preparedness, A 

Report on a National Forum on Biodefense (Washington, DC: Center for Strategic and International 

Studies, April 2002): vii. Available at <http://www.fas.org/irp/threat/cbw/dtra02.pdf>. 3

 Robert J. Blendon et al., Harvard School of Public Health/Robert Wood Johnson Foundation Survey 

Project on Americans’ Response to Biological Terrorism Tabulation Report (Media, PA: International 

Communications Research, Oct. 24-28, 2001): 5. 

4

 British Broadcasting Company, “Cipro demand outstrips supply,” October 21, 2002. Available at 

<http://news.bbc.co.uk/1/hi/world/americas/1618783.stm>. “In New York, demand for Cipro has increased 

203% from the week ending 14 September through the week ending 12 October, according to NDCHealth, 

a drug research company. Nationally during the same period of time, the number of Cipro pills dispensed 

has increased 41%, according to the company. Mr Weinstein said: ‘Cipro seems to be the one that's got the 

most press, and people seem to think that it is the only one they think will work against anthrax.’" 

5

 British Broadcasting Company, “America’s anthrax patent dilemma,” October 23, 2001. Available at 

<http://news.bbc.co.uk/1/hi/business/1613410.stm>. 
Human Services,6

 but it also displaced other investments and contributed to deficit 

spending. The existence of weaponized anthrax with demonstrated lethality and failure to 

apprehend the perpetrator(s) of the anthrax letters create a demand for the U.S. 

government to develop a strategic plan to manage risks from anthrax and to manage 

resource investments at this level. 

Figure 1 – Results from a 2001 survey suggest that as many as 2 million Americans may have

taken the drug Cipro (ciprofloxacin hydrochloride) unnecessarily during Fall 2001—at a cost 

that probably exceeded $1 billion. Image Source: David McNew/Getty Images, 

http://pubs.acs.org/cen/topstory/7945/7945notw3.html. 

The U.S. government continues to organize its efforts for biopreparedness and 

biodefense to promote homeland security. Among the government departments and 

agencies that play critical roles in the management of risks of biological agents are the 

Department of Homeland Security (DHS), charged with providing security, the 

Department of Defense (DOD), charged with protecting soldiers from biological weapon 

attacks and defending U.S. interests from attacks, the Centers for Disease Control and 

Prevention (CDC), the part of the Department of Health and Human Services (HHS) 

charged with protecting the public health, and state and local law enforcement authorities 

and health departments. While information sharing and planning efforts continue to 

evolve and improve, the nation remarkably still lacks a national plan for managing the 

 

6

 United States Department of Health and Human Services, FY2004 Budget in Brief, 2003. Available at 

<http://www.os.HHS.gov/budget/04budget/fy2004bib.pdf>. 

2
risks for even a single biological agent, and remains far from a national health 

surveillance and biodefense system.

7

Coordination is a major challenge. As the response to the anthrax attacks in the 

fall of 2001 showed, communication and coordination make a big difference in ensuring 

alignment of objectives across agencies.8

 For example, the CDC and the DOD did not 

share the same information about the dispersal ability of the weaponized anthrax used in 

the attacks, and this may have contributed to confusion about the threat posed by the 

anthrax letters and the need for active response.9

Part of the challenge arises from the fact that managing the risks requires making 

several critical decisions related to vaccination (whom to vaccinate, which vaccine to 

administer), surveillance, response, post-exposure treatment (adequacy of stockpile), lab 

containment, and research. Developing strategies for action requires recognition that 

difficult choices must be made to best utilize and deploy resources and that costeffectiveness information should guide resource decisions.10 

The authors recognize that more work is needed to provide insight into the issues 

of intra- and interagency coordination and to translate theory into practice. It presents a 

risk- and decision-based framework for developing strategies to manage the risks of an 

attack with a biological agent and provides an example applied to anthrax. The paper 

aims to begin the work toward integration of existing efforts and improved 

decisionmaking and coordination. Create an ongoing process for management and to 

implementing strategies to better focus resources will require more coordinated effort 

than currently exists and a focus on better characterization of the costs, risks, and benefits 

of different policy options. 

This paper outlines a generalized analytical approach that uses decision trees to 

present options and demonstrate the connections between them. (The approach is derived 

from the work of 18th century mathematician and theologian Thomas Bayes. See “Risk 

Analysis and Decision Trees,” p. 9.) With this approach, analysts can quickly 

 

7

 Darryl Greenwood, “Health Surveillance and Biodefense System (HSBS) Study: HSBS Feasibility and

Implementation Study.” MIT Lincoln Laboratory Special Report Volume 1 (July 2002): 90-1028. 8

 Ibid., 1026. 9

 Richard Preston, The Demon in the Freezer (New York, NY: Random House, 2002): 1-26. 10 Richard Danzig, Catastrophic Bioterrorism – What is to be Done? (Washington, DC: Center for 

Technology and National Security Policy, National Defense University, August 2003): 13. 

3
communicate with decisionmakers about the implications of combinations of options.11

This approach is currently being used to provide analytical support for decisionmakers 

facing the complex decisions related to managing polio, once it is eradicated. In the polio 

context, for example, decisionmakers currently face choices that include whether to 

continue vaccination (with oral polio vaccine and/or inactivated polio vaccine), whether 

to create a vaccine stockpile, and whether to continue the existing surveillance.12 We

emphasize that this approach of focusing on decisions provides a means to cross 

interdisciplinary and other boundaries (e.g., military and non-military decisionmakers, 

various levels of government) and consequently it provides a useful organization and 

communication tool to promote effective management. 

 

11 Nanilee K. Sangrujee, Radboud Duintjer Tebbens Victor M. Cáceres and Kimberly M. Thompson, 

“Policy Decision Options During the first Five Years Following Certification of Polio Eradication.” 

Medscape General Medicine 5, no. 4 (December 18, 2003): 35. Available at

<http://www.medscape.com/viewarticle/464841> (subscription). 12 Those thinking about polio only as a common infectious disease should recognize that these choices also 

play a role in the risks of the potential future use of polioviruses as a biological weapon. 

4
Thinking Big: A “Straw Man” Framework 

The challenge of developing a universal framework for managing the risks of 

bioweapons stems in part from the reality that the potential weapons differ in important 

ways. For example, bioagents differ with respect to their ability to grow, spread through 

human contact and other vectors, disperse, change, survive in the environment, and 

ability to bring on lethality (in some cases the organisms pose the threat to humans while 

in other cases the toxins they produce pose the threat). The delayed effects of biological 

weapons create a window of opportunity for taking action to reduce the impact of health 

effects, but also allow for attacks and attackers to go undetected. The other complication 

associated with biological weapons comes from the reality that they often produce 

symptoms similar to those from natural diseases. Consequently, patients and health care 

providers may find it difficult to distinguish an attack from background illness. 

While health care and increased vaccination continue to evolve to reduce 

background burdens of disease, technological advances also fundamentally change the 

opportunities for attackers, since they can now cultivate bioengineered microorganisms to 

optimize their delivery, infectivity, detectability, and treatability. The current genetic 

engineering techniques that automate laboratory processes give attackers more tools than 

ever to produce bioweapons. Of much concern to the U.S. government, some major statefunded offensive biological weapons efforts developed expertise related to bioweapons.13 

Despite the important differences between potential biological agents, a 

framework can be developed that identifies the key decisions that risk managers must 

make for any biological agents. The authors recognize the enormous existing campaigns 

within different levels of the government. For example, efforts to prioritize led the 

Centers for Disease Control and Prevention (CDC) and the National Institute of Allergy 

and Infectious Diseases (NIAID) to develop and maintain a priority list of agents.14 

 

13 Ken Alibek, Biohazard (New York, NY: Random House, 1999); Judith Miller, Stephen Engelberg and

William Broad, Germs: Biological Weapons and America’s Secret War (New York, NY: Simon and

Schuster, 2002). 14 U.S. Centers for Disease Control and Prevention (CDC), 2004. Available at 

<http://www.bt.cdc.gov/agent/agentlist-category.asp>. 

5
CDC PRIORITY CATEGORIES1

• Category A: “The U.S. public health system and primary healthcare providers must be

prepared to address various biological agents, including pathogens that are rarely seen

in the United States. High-priority agents include organisms that pose a risk to national 

security because they can be easily disseminated or transmitted from person to person;

result in high mortality rates and have the potential for major public health impact; might

cause public panic and social disruption; and require special action for public health 

preparedness.” Examples of agents currently in Category A: Anthrax (Bacillus 

anthracis), Botulism (Clostridium botulinum toxin), Plague (Yersinia pestis), Smallpox

(variola major), Tularemia (Francisella tularensis), Viral hemorrhagic fevers, (filoviruses 

[e.g., Ebola, Marburg] and arenaviruses [e.g., Lassa, Machupo]). 

• Category B: “Second highest priority agents include those that are moderately easy to 

disseminate; result in moderate morbidity rates and low mortality rates; and require 

specific enhancements of CDC's diagnostic capacity and enhanced disease 

surveillance.” Examples of agents currently in Category B: Brucellosis (Brucella 

species), Epsilon toxin of Clostridium perfringens, Food safety threats (e.g., Salmonella 

species, Escherichia coli O157:H7, Shigella), Glanders (Burkholderia mallei), Melioidosis 

(Burkholderia pseudomallei), Psittacosis (Chlamydia psittaci), Q fever (Coxiella burnetii), 

Ricin toxin from Ricinus communis (castor beans), Staphylococcal enterotoxin B, 

Typhus fever (Rickettsia prowazekii), Alphaviruses (e.g., Venezuelan equine 

encephalitis, eastern equine encephalitis, western equine encephalitis), Water safety 

threats (e.g., Vibrio cholerae, Cryptosporidium parvum). 

• Category C: “Third highest priority agents include emerging pathogens that could be

engineered for mass dissemination in the future because of availability; ease of 

production and dissemination; and potential for high morbidity and mortality rates and 

major health impact.” Examples of agents currently in Category C: Emerging infectious

diseases such as Nipah virus and hantavirus. 

1

CDC, 2002. For more discussion of the process to develop this list see “Report Summary: Public Health 

Assessment of Potential Biological Terrorism Agents,” Emerging Infectious Diseases 8, no. 2 (2002): 225-230. 

The categorization process also recognized that changes in microbiology, 

weaponization strategies, vaccination, technology, and other variables will lead to 

iteration, but the current priority list includes anthrax in Category A, and a recent report 

provides details about the NIAID’s progress on its biodefense research agenda related to 

Category A agents.15 With all of this focus on bioterrorism and recognition that any 

biological attack could create impacts on multiple scales (from local to international), the 

 

15 National Institute of Allergy and Infectious Diseases, NIAID Biodefense Research Agenda for CDC

Category A Agents – Progress Report, August 2003. Available at 

<http://www2.niaid.nih.gov/NR/rdonlyres/424B5936-3146-419D-BCF6-

E5AA80045B4C/0/category_A_Progress_Report.pdf>. 

6
Federal Government must recognizes its role in facilitating national biopreparedness. 

Providing consistency across all branches and levels of government, between the military 

and non-military government agents, and between all of the key stakeholders (including

health care providers, nongovernmental organizations, industry, and the media) is an 

essential component of biopreparedness efforts. The challenge clearly emerges as one of 

successfully organizing enormous numbers of individuals and groups to ensure 

communication and cost-effective uses of resources—simply stated, finding a framework 

that facilitates all efforts to make good choices. 

In the context of the wide array of potential agents, focusing on a single agent 

considerably narrows the set of issues. At the most basic level, several agent 

characteristics that affect the public health serve as criteria for sorting agents (e.g., into 

the CDC priority categories): 

• Treatability: Currently we benefit from two major options for treating the 

health effects of biological organisms: pharmaceuticals (antibiotics, antivirals, etc.) 

and vaccines. We benefit from a large and diverse supply of antibiotics that 

effectively control many bacterial infections, but antibiotic resistance threatens the 

efficacy of these powerful tools.16 Consequently, decisionmakers must consider the 

existing options for treating any disease, which may include vaccination and/or 

prophylaxis. This raises important questions related to developing a stockpile of 

vaccines and/or pharmaceutical products and the need for development of plans to 

use the stockpile when needed. If a vaccine exists, then decisionmakers face policy 

questions related to distributing the vaccine for different groups in the population 

(military, non-military, first responders, etc.). 

• Virulence: Part of the assessment of priorities recognizes the differences 

between agents in their ability to produce human diseases. The combination of a 

susceptible population exposed to a virulent agent yields a big impact. The anthrax 

strain used in the October 2001 attacks differed significantly from the veterinary 

vaccine strain used unsuccessfully by Aum Shinrikyo, a Japanese cult that 

reportedly made several attempts to release B. anthracis without success in 

 

16 Kimberly M. Thompson with Debra Fulgram Bruce, Overkill: How Our Nation's Abuse of Antibiotics 

and Other Germ Killers Is Hurting Your Health and What You Can Do About It (Emmaus, PA: Rodale, 

2002). 

7
producing illness.17 The virulence of an agent plays a critical role in decisions 

related to the choice and use of medications and communications to the public and 

authorities. 

• Environmental load and persistence: The natural environment destroys many 

biological agents, but some agents show significant long-term viability (e.g., 

anthrax forms extremely hardy spores). The environmental load and persistence (a 

measure of the ongoing threat) determine the best strategy for managing an 

impacted area. Some of this depends on the organism used, but choices about 

management (cleanup, evacuation, etc.) depend on the concentration that people 

might be exposed to compared to the levels that cause illness. The exposure 

depends on the type of weaponization, the method of dispersion, spread, and 

processing techniques that impact the ability of the organism to effectively infect 

people. These issues lead to critical decisions about whether, how, and how much to 

cleanup, risk trade-offs between the agent and the often toxic chemicals used to 

clean, and risks to cleanup personnel. 

• Amplification potential: Decisionmakers must consider several factors that 

might amplify the impact of an attack. First, a contagious disease (one that easily 

spreads through person-to-person contact) raises issues of protecting those initially 

not infected and questions about quarantine. (The treatability of the disease plays an 

important role and significantly impacts the choices.) Second, the public perception 

of the threat can significantly impact management; public health authorities must 

manage the chaos associated with panic18 and deal with allocating limited treatment 

resources for those with and without illness. 

 

17 Amy E. Smithson and Leslie-Anne Levy, Ataxia: The Chemical and Biological Terrorism Threat and the 

US Response (Washington, DC: The Henry L. Stimson Center, October 2000), Report No. 35: xi. Available 

at <http://www.stimson.org/cbw/pubs.cfm?ID=12>. 18 Thomas A. Glass and Monica Schoch-Spana, “Bioterrorism and the People: How to Vaccinate a City 

against Panic.” Clinical Infectious Diseases 34 (January 15, 2002): 217-223. 

8
Acting Wisely 

While complexity makes management a challenge at all levels, the simplest 

concept of a framework is assessing the sets of decisions that must be made and fine 

tuned as information becomes available, and ensuring the creation of a process to answer 

these questions. The set of questions can be represented using decision trees, which 

policymakers can use to identify the key options and interactions between them and to 

understand the risks, costs, and benefits of choices. The following two pages represent a 

first attempt to identify a generic decision tree that includes major categories of decisions. 

The next section provides a first-cut example in the context of anthrax to demonstrate 

how the generic decision tree translates into an agent-specific tree. 

RISK ANALYSIS AND DECISION TREES

At first glance, the use of decision trees seems a straightforward, even simplistic, approach to a

very complicated problem. However, considerable analytical depth supports this approach. A 

brief overview of the field of risk analysis may help demonstrate its value. 

Risk analysis includes risk perception, risk assessment, risk communication, and risk 

management, each of which may include multiple components. The process focuses on asking

critical questions about the risks and understanding the uncertainties involved. With large 

uncertainties, risk analysis in this context of bioterrorism focuses on questions like: How 

probable is an attack? How lethal is a likely attack? What will be societal response? What can be 

done prior to an attack to limit its effect? After an attack? 

Using decision trees provides a means of structuring the information related to choices clearly 

and efficiently. The Reverend Mr. Thomas Bayes, an 18th century mathematician and theologian

who published his famous Bayes Theorem in 1763, receives credit for some of the earliest 

conceptual development. Remarkably, Bayesian analysis recently emerged as a powerful 

analytical tool with profound influence in the way we analyze decisionmaking.

By using a decision tree diagram, we can quickly see all of the options and combinations of

paths, and the relationships may emerge as important considerations. This saves time and

money when making decisions. By using such schemes now—especially during “wargames,” 

drills, practices, etc.—much work can be done before an attack by identifying key pathways and 

preparing. 

Bayesian networks also are useful because they basically “tell a story.” A frequently used

illustration includes five random variables: burglary, earthquake, alarm, neighbor call, and radio 

announcement to demonstrate the independence and conditional dependence of these 

variables.1

 The power of such an approach derives from the ability to take a collection of random, 

independent variables and easily calculate their joint probability. 

1 Daryle Niedermayer, “An Introduction to Bayesian Networks and their Contemporary Applications,” December 1, 

1998. Available at <http://www.niedermayer.ca/papers/bayesian/bayes.html>. 

9
Generic Decision Tree 

Routine 

Immunization:

Event 

response:

Maintain 

stockpile:

Surveillance: Containment:

* “Level of intervention” refers to the financial costs incurred by the Federal 

Government for taking the initial path in any given decision tree. Hindsight, however, 

might reveal that low initial costs might mean higher long-term expenditures. (For 

example, no vaccination may seem an appropriate initial response in a hypothetical 

situation. Ultimately, however, the loss of life and subsequent compensation might 

prove it to have been a very costly choice.) The value of using such a standardized

approach in wargames, drills, practices, etc., arises from the opportunity to consider 

many possible scenarios and examine their consequences at varying periods of time 

from the initial decision. Ultimately, this may lead to initial decisions that appear 

unnecessarily costly in the short run, but that may prove preferable as a result of the 

analysis of long-term consequences. 

New Vaccine

Mass 

vaccinate

with current 

vaccine 

No 

vaccination 

Vaccinate 

military

only

Vaccinate 

high-risk 

groups 

only

Develop, exercise 

and improve 

multi-agency

response plan 

Develop multi-agency

response plan 

No response

plan 

Develop agency

response plan 

National stockpile 

with time critical

items stored in 

highest risk cities 

No stockpile 

National

stockpile for 

both vaccine 

and treatment 

stored 

regionally

Regional stockpile

with “just in time”

delivery and 

distribution;

integrated into

city surge 

capacity plans 

Integrate 

automated event 

characterization 

system based on 

epidemiological, 

bio, chem models

and artificial 

intelligence

Develop integrated 

surveillance 

system-of-systems

that relies on 

multiple sources 

None 

Passive 

surveillance; rely

on healthcare and 

lab reporting only

Deploy

environmental 

sensors into 

high risk areas 

Proactively

engage with 

international 

economic and 

diplomatic 

strategy

HIGH 

Identify

international 

vulnerabilities 

and renegotiate

to enhance 

*Level Enforce 

biological and 

toxic weapons 

convention 

provisions 

of 

Intervention

Do not enforce, 

ignore 

National 

stockpile with

antibiotic 

treatment only

Do not enforce, 

renegotiate 

LOW 

Figure 2 – The generic decision tree above can be used to develop a more explicit, 

purposefully tailored agent-specific tree for different pathogens or infectious diseases.

10
Generic Decision Tree

Media 

preparations:

Emergency 

response 

training:

Research 

portfolio:

Information 

management:

Policy 

development:

Engage reporters and 

public in exercise

and training to 

enhance messages

Educate 

reporters and 

public in 

advance 

None 

Develop public 

messages 

Educate 

public in 

advance 

Create multi-agency, 

multi-jurisdictional 

exercise and training

process 

Integrate multiple

responders (i.e.,

public health, 

medical, 

environmental)

into first 

responder plan 

No 

responders 

Local first 

responders—

EMS, fire, law

enforcement

Local, regional

and national 

first 

responders 

Fund basic and 

applied research 

into nonspecific

mechanisms of

action for 

multiple human 

pathogens 

Redirect existing 

medical products 

and 

pharmaceuticals 

to biodefense 

None 

Focus on basic 

science to keep 

abreast with 

scientific

advances 

Identify

promising 

scientific

technology

that may have

bioterrorism 

application 

Develop protocols 

to integrate assets

with needs 

Develop 

inventory of 

assets, 

capabilities 

None 

Develop 

inventory

of assets

Develop 

inventory

of 

capabilities 

Proactively

address legal, 

ethical issues 

Wait for event,

then address 

issues that arise

Level

of 

Intervention

HIGH 

LOW 

Figure 2 (cont.) – This represents a “first-cut” set of trees, as each initial decision then leads to 

a more refined tree for each topic.

11
The decision tree identifies 10 major categories of decisions that apply broadly for 

any potential biological weapon and that involve stakeholders at various levels and with 

divergent roles and responsibilities. Figure 2 also provides placeholders to demonstrate 

potential options intended to make the decision tree capture more of the complexity, but 

which should not be taken as the only or necessarily the appropriate options for any 

specific biological agent. We also recognize that other categories of decisions might 

emerge for some biological agents, and we expect iteration and improvement of the 

framework to result from the process of applying this approach to specific agents (like the 

example of anthrax in the next section). We elaborate on each of these generic decision 

areas to provide an overview of the decisions that we believe fall within each of these 

categories. 

• Routine immunization: Fortunately, for many biological agents opportunities 

exist to prevent disease through immunization. Vaccines for endemic diseases 

generally represent highly cost-effective tools for managing those diseases and in 

some cases for significantly reducing the burden of the disease. However, in the 

context of potential bioweapons, decisionmakers generally face limited options 

related to vaccines. Consequently they must generally decide whether to seek 

development of a new vaccine for a specific biological agent. If a vaccine exists, 

then they must decide which groups of the population to vaccinate, if any, and 

evaluate the risks (mainly the adverse events of those vaccinated compared to the 

impact of having no one protected if an event occurs), costs (mainly comprehensive 

vaccine purchase and delivery costs), and benefits (mainly costs saved from better 

preparedness if an event occurs). This major decision category raises many 

potential sub-decisions about vaccination schedule, production constraints that 

generally involve the private sector vaccine producers, and vaccination policies (see 

the last category in the tree). 

• Event response: This category represents a broad range of choices. At the 

most basic level it focuses on the questions related to developing and iterating on a 

comprehensive response plan for the specific biological agent. We recognize that no 

such plans currently cover all stakeholders and levels of government for any single 

biological agent, although some policymakers at some levels developed plans 

12
covering their domains. Decisions under this category should include evaluation of 

the therapeutic options for treating people if an event occurs, which means 

assessing the cost-effectiveness of different antibiotics, antivirals, and other drugs 

that emergency responders might need if an event occurs. Clearly this leads to 

decisions related to rapidly acquiring the tools required to respond, including drugs 

and means to administer them (see the stockpile decisions that follow) and choices 

about restricting access and clean-up of impacted areas. It relates to decisions about 

surveillance, containment, media and risk communication preparations, and 

emergency response training (see these specific categories below). At this level, we 

assume that national policymakers must prioritize resources available for

coordination efforts and make a choice about investing in a process to create an 

event response plan for a specific biological agent, creating and testing that plan, or 

not, although other options may also exist as indicated. Decisions here also raise a 

number of policy decisions (see last category of the tree).

• Stockpile: The CDC currently maintains a Strategic National Stockpile 

(SNS).19 Thus, for any given agent, the key decisions should begin with 

assessments of the adequacy of existing resources, and include consideration of 

stockpiling vaccine (if one exists) and/or specific therapeutic agents as part of the 

SNS or separately (i.e., in an independent stockpile). Some decisionmakers may 

differ in the constraints on their choices. For example, military and non-military 

decisionmakers may evaluate the need for stockpiles differently given very different 

anticipated risks. 

• Surveillance: Currently surveillance represents a “hot topic” given the 

proliferation of technologies developed to detect biological agents in people and the 

environment.20 Decisionmakers often face a significant number of specific 

technological options for surveillance. At the baseline, no surveillance simply 

implies the current passive surveillance provided by the nation’s health care 

 

19 Stephen D. Prior, Who you gonna call? Responding to a medical emergency with the Strategic National

Stockpile, (Washington, DC: Center for Technology and National Security Policy, National Defense 

University, June 2004): 5. 20 Robert E. Armstrong, Patricia K. Coomber and Stephen D. Prior, Looking for Trouble: A Policymaker’s 

Guide to Biosensing, (Washington, DC: Center for Technology and National Security Policy, National 

Defense University, June 2004): 44-51. 

13
providers, who detect and report disease following the presentation of patients with 

symptoms (as observed in the anthrax 2001 events). Other options exist to develop 

increased surveillance within the health care system, but still relying primarily on 

health care providers to collect information. Environmental surveillance represents 

another option, which could potentially detect organisms in the environment prior 

to patients presenting with symptoms. The critical questions that decisionmakers 

face in the context of investing in surveillance come down to understanding the 

value of the information obtained from surveillance: Do the benefits of the 

information obtained from any surveillance option under consideration exceed the 

system’s costs (including the costs of false positives and false negatives)?

• Containment: The existing international agreements about biological agents, 

specifically the Biological and Toxic Weapons Convention Provisions (BTWCP), 

represented voluntary agreements to restrict development. If followed, they would 

preclude the need to address issues of containment. However, as demonstrated by 

the 2001 anthrax event and the still unknown perpetrator(s), those willing to use 

weaponized anthrax may have retained it, and this suggests the need for decisions 

about containment. For some biological agents, this decision may simply focus on 

whether and how to enforce existing policies, like the BTWCP, but for other agents 

it may involve negotiating new policy. To the extent that the government invests in 

research efforts related to the biological agent and this makes the agent more 

available (given its presence in research laboratories), this category also includes 

questions about policies for containment of the agent (and possibly related agents) 

in research labs.

• Media and risk communication preparations: Several studies demonstrate 

the lack of public knowledge about the risks of bioterrorism broadly and with 

respect to specific threat agents.21 Given basic misunderstandings and the potential 

for miscommunication that could lead to costly and risky outcomes in the case of an 

event (e.g., traffic jams that prevent orderly evacuation, injuries and deaths from

 

21 Baruch Fischhoff, Roxana M. Gonzalez, Deborah A. Small and Jennifer S. Lerner, “Evaluating the 

Success of Terror Risk Communications,” Biosecurity and Bioterrorism: Biodefense Strategy, Practice, 

and Science 1 (2003): 255-258. Available at <http://wwwmarketing.wharton.upenn.edu/ideas/pdf/Small/Evaluating%20Biodef.pdf >. See also Blendon et al. 

14
accidents resulting from panic), decisionmakers face important choices related to 

educating members of the media in advance so that they can more effectively 

communicate to the public and/or developing messages that they can roll out 

effectively in the case of an event. Given the general lack of risk education in the 

population, this area may also require an investment in research to understand 

mental models (perceptions, attitudes, and beliefs) and characterize anticipated 

behaviors.

• Emergency response training: All stakeholders recognize that emergency 

response may involve numerous groups ranging from local (since any event occurs 

at some locality) to international (e.g., exotic disease experts from around the world 

and global policymakers) and from health care to law enforcement. For any specific 

biological agent, decisionmakers face choices about which emergency responders to 

train, how to best train them, and how to facilitate the necessary coordination to 

ensure an optimal response to an event. Decisions may also include making choices 

about obtaining necessary personal protective equipment and communication tools 

for responders and training them to use these. Numerous table top exercises 

demonstrate the value of simulations for training purposes, but clearly lessons 

learned need to extend beyond the group involved in the actual exercise when 

possible. In the absence of a specific event response plan, emergency response 

training may still occur and still represents a set of decisions. If an emergency 

response plan exists, then it may call for or assume emergency response training, 

and decisionmakers may primarily face decisions related to allocating the resources 

necessary to achieve training objectives and evaluation of the training. 

• Research portfolio: The choice to engage in research related to biological 

agents represents a spectrum of options including both basic science and social 

science. For any specific agent, identifying the key uncertainties that impact 

decisions is an important starting point. In the context of a vaccine-preventable 

disease, research efforts will be required to develop and test a vaccine. In some

cases, basic science research that provides a better understanding of the organism

itself might be important investments for the development of vaccines and 

therapeutic agents. Applied research, including risk analysis modeling (e.g., to 

15
characterize the potential impacts of events), and social science research (e.g., to 

characterize people’s behaviors and understanding of risks) represent critical 

research areas as well. This category represents the need for policymakers looking 

at the big picture to ensure a good match between research priorities that come from

understanding the uncertainties that drive decisions and actual investments in 

research.

• Information management: For any specific agent, policymakers face choices 

about whether and how to manage the information. This includes basic types of 

information like inventories of places and people that possess certain capabilities 

and assets (including agents themselves). The existence of such information 

management systems also raises questions of security.

• Policy development: As discussed with many of the prior categories, 

policymakers must recognize that several legal and ethical issues arise in the 

context of managing the risks from biological agents. Issues like whether and how 

to quarantine, choices about providing and/or rationing vaccines and therapeutic 

agents in the case of an event, and sharing health information with potential 

violation of privacy protections in the interest of national security all represent 

obvious areas for developing policy positions and engaging in debate prior to an 

event. The decisions about developing policy should also serve to help 

decisionmakers understand existing policies and recognize constraints.

While we recognize that this framework initially provides just a starting point 

within each category, we also see critical insights that come from looking at managing 

the risks of a specific disease at this level. For example, while many of these observations 

may appear obvious, in some cases decisionmakers responsible for one part of the tree 

make assumptions that are inconsistent with the assumptions made by those responsible 

for other parts. Clearly, we cannot vaccinate if we haven’t invested in the necessary 

research to develop the vaccine, which implies the need for alignment between research 

and immunization options. In the case of an outbreak, responders cannot treat effectively 

if they don’t have enough of required therapeutics (if what they need is not widely 

available or is in an accessible stockpile). We cannot possibly detect an attack before it 

16
leads to adverse health effects if we aren’t looking. Those responsible for management 

will not be effective in reassuring the public if they don’t understand what the public 

knows and believes, or if the public doesn’t trust them. It’s also very important to 

recognize that we cannot assume that people will take the right action in response to an 

event if they don’t know what that is. 

Recommendations

• Decisionmakers cannot effectively operate just in a limited scope when the 

choices of others significantly impact their options. We must engage in a process 

to develop a comprehensive national plan. 

• HHS must develop a blueprint for a national biodefense strategy and a multiyear 

implementation strategy that includes relevant Federal, state, and local 

governmental organizations, private and public healthcare delivery systems, and 

industry. 

17
18
Understanding Anthrax 

The October 2001 anthrax attacks, which killed 5 American citizens and cost 

billions of dollars to contain, decontaminate, and investigate, remarkably have not yet led 

to the development of a coherent national plan to manage the risks from the use of 

anthrax as a bioweapon. The absence of a coherent plan probably stems at least in part 

from the complexity of the various dimensions on which the risks must be considered, 

including the large number of stakeholders (e.g., local, state, national, and international 

levels of government and agencies, medical and public health communities, the media, 

law enforcement, military), the complexity of the science and assessment of the risks, and 

the potentially large resource requirements associated with managing these risks. As the 

mystery about the origin of the anthrax attacks continues to raise public skepticism about 

the ability of the government to deal with anthrax as a bioweapon, this is a critical time 

for the government to develop a national plan for managing the risks of anthrax. 

Context 

Historically, anthrax represents an important pathogen. Pioneers of microbiology 

worked on anthrax, including Pasteur and Koch, because during their lifetimes anthrax 

presented a significant, deadly disease in animals.22 Based largely on their work and 

sustained efforts by veterinarians, anthrax was essentially eradicated from domestic 

animals in the last century. Consequently, anthrax disease in the U.S. occurs naturally

only very rarely in humans, with most cases historically associated with animal contact. 

However, the anthrax letter attacks in 2001 made the threat of weaponized anthrax very 

real and suggest that containment of any existing anthrax remains an ongoing issue, and 

the fact that the criminals remain at large suggest an ongoing and real domestic threat. 

The attacks also demonstrated that weaponized forms of anthrax exist with demonstrated 

 

22 George Sternbach, “The history of anthrax,” Journal of Emergency Medicine 24, no. 4 (May 2003): 464.

19
lethality,23 even though they may present technical challenges that limit the ability of 

some potential attackers to produce them.

24 

More significantly, numerous opportunities exist to disperse anthrax, for example 

as an aerosol, in water25 or food, or in solid media that travel (i.e., mail, packages, etc.). 

In addition, while antibiotics exist to treat people with anthrax when detected early, the 

technologies exist for attackers to create genetically modified, antibiotic resistant forms 

of anthrax (although this remains undemonstrated to date and the probability now seems 

low). Anthrax disease depends on contact with the agent in the environment, and not on 

person-to-person contact, a basic fact that one study found nearly half (47%) of the 

population surveyed did not know.26

 

23 H. Clifford Lane and Anthony S. Fauci, “Bioterrorism on the Home Front,” Journal of the American 

Medical Association 286 (November 28, 2001): 2595-2596. Available at 

<http://www.niaid.nih.gov/director/pdf/jama_and_lane.pdf>. 24 Thomas V. Ingelsby. “Anthrax: A possible case history,” Emerging Infectious Diseases 5, no. 4 (JulyAugust 1999): 556-560. Available at <http://www.cdc.gov/ncidod/EID/vol5no4/pdf/inglesby.pdf>; 

Thomas V. Inglesby, Donald A. Henderson, John G. Bartlett et al., “Anthrax as a Biological Weapon,”

Journal of the American Medical Association 281, no. 18 (May 12, 1999): 1736. Available at 

<http://jama.ama-assn.org/cgi/reprint/281/18/1735.pdf>. 25 W. Dickinson Burrows and Sara E. Renner, “Biological Warfare Agents as Threats to Potable Water,” 

Environmental Health Perspectives 107, no. 12 (December 1999): 975-984; W. Seth Carus, Working 

Paper, Bioterrorism and Biocrimes: The Illicit Use of Biological Agents Since 1900 (Washington, DC: 

Center for Counterproliferation Research, National Defense University, 1998); Percy Frankland and Harry

Marshall Ward, “Second Report to the Royal Society Water Research Committee: The Vitality and

Virulence of Bacillus Anthracis and its Spores in Potable Waters,” Proceedings of the Royal Society of 

London 53 (1893): 164-317. 26 Fischhoff et al., 2. 

20
21

WHAT IS ANTHRAX?

Anthrax is a bacterium with a long history of affiliation with the human race. Primarily, a disease 

of animals that eat vegetation—cattle, sheep, goats, camels, antelopes, etc., human exposure 

primarily comes from contact with infected animals or their tissue. 

Humans can get infected through three routes: 

1) Cutaneous (skin) exposure happens when the bacterium enters a wound on the skin, such as a 

worker handling contaminated animal wool or hides. About twenty percent of cutaneous

infections will result in death, if untreated. Effective antibiotic treatments are readily available, 

and death of treated patients is rare. 

2) Intestinal exposure results from eating contaminated meat. When untreated, death rates can

be as high as sixty percent. However, effective antibiotic treatments make death unlikely. 

3) Inhalational anthrax is usually fatal if untreated. Although it is curable with antibiotics, the time

between exposure and onset of treatment needs to be very short—possibly as few as 36 hours.

Figure 3 – Microscope picture of spores and vegetative cells of anthrax of the bacterium 

Bacillus anthracis (left) and colonies of the baterium Bacillus anthracis on blood agar (right).

Source: WHO/Eric Miller, 2004, http://www.who.int/multimedia/anthrax/photo.html.

In general, anthrax is a problem mainly in developing countries that lack adequate veterinary

public health programs. The fact that anthrax remains a powerful pathogen that exists in some

places around the world makes it a sustained concern in the United States. 

Several characteristics of anthrax may explain its use as the weapon of choice for the 2001 

attacks. Anthrax survives as a very hardy organism that can form spores under severe

environmental conditions. The exact environmental conditions that can trigger the bacterium to

form spores remain uncertain, along with the conditions that cause the spores to revert to the

bacterial form. 

The warm, moist environment of the human lung, however, clearly offers an ideal environment 

for bacterial growth. Moreover, by entering the lung as spores, anthrax may effectively bypass

the immune system’s triggers and escape the first few lines of the body’s defenses. By the time 

the immune system recognizes the presence of a foreign “invader,” the attack is well underway. 

Another aspect of the bacterium that makes it particularly well-suited to use as a bioweapon is its

ability to produce a lethal toxin. (Most bacteria lack this capacity.) The toxin actually consists of 

three separate proteins, each harmless on its own. Working in conjunction with each other, 

however, the proteins gain entry into the body’s cells and lead to death. Scientists continue to

study the three collaborating proteins: protective antigen (PA), edema factor (EF) and lethal 

factor (LF) and to use knowledge about them to develop pharmaceutical products. Although 

antibiotics help to control the growth of the bacteria, they but do nothing to stem the effects of

the toxin. Current research focuses on the development of drugs that would neutralize one or

more of PA, EF, or LF. Such drugs could be used in concert with antibiotics to treat infected

individuals.

1

1

 John A. T. Young and R. John Collier, “Attacking Anthrax,” Scientific American (March 2002): 48-59.
TOO MUCH OF A GOOD THING?

Antibiotics kill bacteria. That’s a good thing. In the case of antibiotics, however, one 

can get too much of a good thing. In fact, the overuse of antibiotics and rise in 

antibiotic resistant bacteria have begun to threaten our ability to control common 

infections. 

Antibiotics kill bacteria by disrupting activities within the bacteria.1

 For example, Cipro

effectively destroys anthrax—and various other bacteria causing a variety of diseases 

from bronchitis to gonorrhea—by disrupting an enzyme that helps in the production of 

DNA. The anthrax cannot survive without the ability to reproduce, and it needs DNA to 

do so. The affected enzyme—topoisomerase II—does not exist in humans, so Cipro 

produces no effect on human cells.2 

Over time, however, antibiotics become less effective because the bacteria adapt and 

change in one of three ways. Bacteria may change from a spontaneous mutation, or 

they may change through new genetic combinations that arise as a result of 

“transformation”—the equivalent of sexual reproduction between bacteria. Finally, 

small circles of DNA called plasmids can pass between bacteria and carry genes for 

drug resistance.3 

As we introduce more antibiotics into the environment, this places greater selective 

pressure on the bacteria to evolve alternate enzymes or biochemical pathways that

differ from those being acted on by the antibiotics. (Even if a person appropriately 

takes antibiotics, some still get introduced into the greater environment through 

elimination.) The development of antibiotic resistant forms of anthrax by the former 

Soviet Union provides a good illustration of how bacteria can change. Because of their 

rapid growth rate—meaning many generations produced in a short time-span—a Ciproresistant strain eventually would arise from just normal, spontaneous mutation.4

 The 

development of such strains would not require any advanced genetic engineering 

techniques. 

The problem of antibiotic resistant bacteria has reached the point where some consider

it the number one public health problem.5

 Indeed, deaths from hospital acquired 

infections in the U.S. rose from 13,300 per year in 1992, to about 90,000 in 2004 because

of the rise of antibiotic resistant bacteria.6

 Thus, needlessly taking Cipro—or any other 

antibiotic—as a prophylaxis against possible anthrax exposure contributes to an 

already serious problem. 

1 Bacteria are living organisms and are susceptible to the actions of antibiotics. Viruses are very different from 

bacteria and technically are not living organisms. Antibiotics are ineffective against viruses. 2

 Marshall Brain, “How Cipro Works.” Available at <http://health.howstuffworks.com/cipro3.html>. 3

 Ricki Lewis, “The Rise of Antibiotic-Resistant Infections,” FDA Consumer Magazine (September 1995): 12. 

Accessed at <http://www.fda.gov/fdac/features/795_antibio.html>: “In 1968, 12,500 people in Guatemala died in an 

epidemic of Shigella diarrhea. The microbe harbored a plasmid carrying resistance to four antibiotics!” 4

 Ibid., 11. 

5

 Helen Branswell, “Anthrax Scares May Fuel Growth of Antibiotic Resistance,” Canadian Press, October 15, 2001. 

Available at <http://www.canoe.ca/Health0110/15_anthrax-cp.html>. 6

 National Institute of Allergy and Infectious Diseases, “The Problem of Antibiotic Resistance” (April 2004). Available 

at <http://www.niaid.nih.gov/factsheets/antimicro.htm>. 

22
Anthrax disease has three forms: inhalational, gastrointestinal, and cutaneous, 

which differ in their characteristics. Inhalation of B. anthracis spores represents the major 

threat, because this leads to respiratory anthrax, the most lethal form of the disease, with 

mortality rates approaching 100% when untreated. Following the 2001 attacks, estimates 

of the dose that kills 50% of the population (i.e., the Lethal Dose 50, commonly written 

as LD50) decreased greatly as scientists learned more about the clinical character of 

inhalational anthrax. Today we remain uncertain about the minimum dose that can cause 

disease. Patients with inhalational anthrax present with nonspecific flu-like symptoms for 

a few days, and then suddenly show fever, dyspnea27 (sometimes severe), diaphoresis,28

hypoxia,29 and shock, all of these rapidly progressing over a few hours. (Note that for any 

form, progression of the disease may depend on exposure and the nature of the agent 

used). Despite the lowered LD50, physicians learned that early recognition and 

aggressive treatment of symptoms greatly reduced death rates. 

Gastrointestinal anthrax follows ingestion of B. anthracis spores from

contaminated meat, which produces symptoms of nausea and vomiting, and leads to 

bloody diarrhea, sepsis,30 and death.31 The rarity of disease, combined with the inability 

to diagnosis it early, explains the observed high mortality rates in naturally occurring 

cases. Cutaneous anthrax produces characteristic lesions that clinicians can often detect 

early enough to effectively treat with antibiotics. 

 

27 Dyspnea is defined as difficulty in breathing, often associated with lung or heart disease and resulting in

shortness of breath. This condition can also be referred to as “air hunger.” 28 Diaphoresis is another word for perspiration, especially when copious and medically induced. 

29 Hypoxia is classified as a deficiency in the amount of oxygen reaching body tissues. 30 Sepsis is characterized by the presence of pathogenic organisms or their toxins in the blood or tissues. 31 Thira Sirisanthana and Arthur E. Brown, “Anthrax of the Gastrointestinal Tract,” Emerging Infectious

Diseases 8, no. 7 (July 2002): 649-651. Available at <http://www.cdc.gov/ncidod/EID/vol8no7/pdf/02-

0062.pdf>. 

23
Figure 4 – Cutaneous anthrax lesions. Source: CDC, 2004, 

http://www.bt.cdc.gov/agent/anthrax/anthrax/anthrax-images/cutaneous.asp.

Bioweapons experts recognized the potential threat of anthrax long ago and 

conducted research related to its weaponization. The long-term survival of spores, which 

the UK demonstrated can remain dangerous for decades in its tests at Gruinard Island,

32

makes anthrax a particularly costly agent, because it requires extensive cleanup. 

Investigations of the 1979 Sverdlovsk anthrax release in Russia demonstrate the lethality 

of aerosolized anthrax in humans,33 and other studies provide insights into the potentially 

significant impacts of anthrax attacks in the U.S. and the potential benefits of early 

detection and response.34 

Anthrax Attacks in October 2001 

The anthrax attacks that occurred in 2001 provide important context for 

discussions about the U.S. management of anthrax risks. The attack involved envelopes 

containing weaponized anthrax sent on September 18 and on October 9, 2001 to 

 

32 British Broadcasting Company, “Britain’s Anthrax Island,” July 25, 2001. Available at 

<http://news.bbc.co.uk/1/hi/scotland/1457035.stm>. 33 Jeanne Guillemin, Anthrax: The Investigation of a Deadly Outbreak (Berkeley, CA: University of 

California Press, December 1999); Matthew Meselson, Jeanne Guillemin, Martin Hugh-Jones et al., “The

Sverdlovsk Anthrax Outbreak of 1979.” Science 266 (December 9, 1994):1202-1208. Available at

<http://www.anthrax.osd.mil/documents/library/Sverdlovsk.pdf>. 34 Arnold F. Kaufmann, Martin I. Meltzer and George P. Schmid, “The Economic Impact of a Bioterrorist

Attack: Are Prevention and Intervention Programs Justifiable?” Emerging Infectious Diseases 3, no. 2 

(April-June 1997): 83-94. Available at < http://www.cdc.gov/ncidod/eid/vol3no2/kaufman.htm>. Also see

Meselson et al., 1206-1207. 

24
prominent government leaders and members of the media. The attacks ultimately led to 

22 cases and 5 deaths. 

Figure 5 – At the time of this publication’s printing, the FBI’s investigation into the Fall 2001 

anthrax attacks, entitled “Amerithrax,” was still ongoing. For more information, see 

http://www.fbi.gov/anthrax/amerithraxlinks.htm.

Figure 6 – Letter containing anthrax addressed to Senator Tom Daschle (D – SD). Source: 

Federal Bureau of Investigation, http://www.thesahara.net/anthrax_rules.htm.

Many uncertainties still exist related to these attacks, including the identity of the 

attacker and how several of the individuals exposed came in contact with anthrax. Several 

key lessons learned provide important insights related to planning for potential events:35

• Under-investment in the nation’s public health infrastructure (which relies on 

mostly passive survey reports from doctors, uses the minimum possible 

workforce, and lacks coordination between public health agencies, emergency 

medical services, and law enforcement) meant that the system quickly became 

 

35 Heyman, 8-26. 

25
strained by the attacks (with the least supported rural areas in some cases 

representing weak links36),37

• Insufficient laboratory capacity for processing samples, unsophisticated sample 

processing techniques, and lack of coordination within the laboratory network led 

to long delays in sample processing,38

Figure 7 – A diagram of the Laboratory Response Network (LRN). The LRN includes 3 major 

types of labs: national, reference, or sentinel. The CDC and the U.S. Army Medical Research 

Institute for Infectious Diseases (USAMRIID) are the only two national laboratories, and they 

maintain responsibility for performing definitive characterization. Reference labs provide

confirmation of samples from sentinel labs. Sentinel labs include the thousands of hospital 

labs in facilities that provide care to patients. These labs must recognize the suspicious 

samples and refer them to an appropriate reference lab. The labs all follow standard protocols 

for analyzing samples. The anthrax attacks of 2001 led to approximately 125,000 samples and

more than 1 million separate tests by LRN labs. Source: CDC, 2004, 

http://www.bt.cdc.gov/lrn/factsheet.asp and 

http://www.bt.cdc.gov/agent/LevelAProtocol/anthraxlabprotocol.pdf.

• Inadequate knowledge of the pathology of disease caused by anthrax, 

characteristics of the bacteria, uncertain potency and effectiveness of treatment, 

and the lack of a national research agenda made it difficult to identify experts and 

rapidly obtain critical information,39

 

36 Elin A. Gursky, Hometown Hospitals: The Weakest Link? (Washington, DC: Center for Technology and

National Security Policy, National Defense University, June 2004): 1-4. 37 Heyman, 8-9. 38 Ibid., 10-11. 

39 Ibid., 11-12. 

26
• Detection and surveillance relied on medical practitioners, some of whom lacked 

adequate training to respond appropriately (e.g., astute physicians who identified 

the probable threat and acted quickly to contain and warn other clinicians 

prevented a second death in Florida, but a Washington postal worker who later 

died of inhalational anthrax was sent home from a Maryland hospital with flu-like 

symptoms after a co-worker was admitted to another hospital with inhalational 

anthrax),

40

• While responders took steps that helped to save lives, they did so without any 

plan, checklist, or clear list of best practices, and they lacked good information to 

make critical decisions about cleanup (e.g., how clean is clean enough and what 

methods clean the most cost-effectively?),41

• The lack of a clear chain of command slowed the process of management and 

cleanup, and the lack of prior training meant people involved in management did 

not already know each other or have a clear sense of responsibilities,42

• CDC’s deployment of the antibiotics in the Strategic National Stockpile 

demonstrated the utility of this resource, but some challenges arose in the context 

of mass-medication and delivery. The experience also revealed the lack of

strategies for dealing with the need for counseling large numbers of people, 

triaging and prioritizing patients for care and treatment, and potential issues of 

quarantine,43 and

• Poor communication presented one of the largest problems. Media outlets sought 

statements from any potential expert, including uninformed spokespersons. 

Meanwhile, leading officials shared information poorly and generated conflicting 

messages.

44 The lack of a coordinated media strategy, combined with a scared 

public that was poorly educated about anthrax, led to many Americans seeking 

and using prophylaxis inappropriately, which further strained resources.

 

40 Heyman, 14-15. 41 Ibid., 24-25. 42 Ibid., 16-19. 43 Ibid., 19-20. 44 Ibid., 20-23. 

27
Figure 8 – Cases of anthrax associated with mailed paths of implicated envelopes and 

intended target sites. NY, New York; NBC, National Broadcasting Company; AMI, American 

Media Inc.; USPS, United States Postal Service; CBS, Columbia Broadcasting System. 

*Envelope addressed to Senator Leahy, found unopened on November 16, 2001, in a barrel of 

unopened mail sent to Capitol Hill; **dotted line indicates intended path of envelope 

addressed to Senator Leahy. Source: Jernigan et al., (note that this is Figure 2 from the 

original article), supra note 1. 

Figure 9 – Images of FBI and EPA personnel sorting through sequestered Congressional mail 

and opening a letter addressed to Senator Leahy containing anthrax. Source: 

http://www.fbi.gov/anthrax/vanharp/introleahy.htm and 

http://www.fbi.gov/anthrax/searchantpicts.htm. 

28
Managing Anthrax for the Future 

This section develops a specific plan for managing any future anthrax incident 

and serves as a model for demonstrating the use of decision trees to help policymakers 

reach timely and science-based conclusions when faced with a public health crisis—

whether caused by terrorists or Mother Nature. 

The elements of a national plan for anthrax should address the wide range of 

issues identified in the generic decision trees. With respect to anthrax, while the risks 

remain uncertain, the 2001 attacks demonstrated the risks are real. The existence of a still 

unidentified attacker, potentially with access to weaponized anthrax, suggests that 

decisionmakers should actively consider the options that exist for managing them, the 

perspectives and roles of all stakeholders,45 and the implications of their decisions in a 

broad context. 

 

45 The Business Roundtable, Terrorism: Real threats. Real costs. Joint solutions (Washington, DC: The 

Business Roundtable, June 2003): 13-18. Available at <http://www.businessroundtable.org/pdf/984.pdf>.

29
Actual Response to 2001 Anthrax Attacks as Mapped by Decision Trees

Routine 

Immunization:

Event 

response:

Maintain 

stockpile:

Surveillance: Containment:

New Vaccine

Mass 

vaccinate

with current 

vaccine 

*No 

vaccination 

Vaccinate 

military

only

Vaccinate 

high-ris

group

only

k

s

Develop, exercise 

and improve 

multi-agency

response plan 

Develop multi-agency

response plan 

**No response

plan

Develop agency

response plan 

National stockpile 

with time critical

items stored in 

highest risk cities 

No stockpile 

National 

stockpile for 

both vaccine 

and treatment 

stored 

regionally

Regional s

with “just in tim

delivery and 

distribution;

integrated into

city surge 

capacity pla

tockpile

e”

ns

Develop integrated 

surveillance 

system-of-systems 

that relies on 

multiple sources 

None 

Passive 

surveillance; rely

on healthcare and 

lab reporting only

Deploy

environmental 

sensors into 

high risk areas 

Integrate 

automated event 

characterization 

system based on 

epidemiological,

bio, chem models

and artificial 

intelligence

Proactively

engage with 

international 

economic and 

diplomatic 

strategy

Identify

international 

vulnerabilities 

and renegotiate

to enhance 

Do not enforce, 

ignore 

Do not enforce, 

renegotiate 

Enforce 

biological and 

toxic weapons 

convention 

provisions 

Level

of 

Intervention

HIGH 

LOW 

National 

stockpile with

antibiotic 

treatment only

*Only persons who 

were felt to be 

exposed were 

offered vaccine 

**1993 National Response Plan (NRP) 

with 1999 Terrorism Incident Annex 

used. The FRP limits Federal

agencies to responding to state 

requests 

Figure 10 – This decision tree map of the 2001 anthrax attacks was developed after the fact, 

using the analysis of the incident conducted by Gursky, et al. (Gursky, E, Inglesby, T., and 

O’Toole, T. 2003. “Anthrax 2001: Observations on the Medical and Public Health Response.” 

Biosecurity and Bioterrorism: Biodefense Strategy, Practice, and Science, 1:97-110). 

These decision trees map the actual response taken by the Federal Government 

in 2001. Note that, in general, the relatively conservative initial responses ranked as 

“low” with respect to level of intervention. However, some of the low-level responses

ultimately resulted in costly consequences. See pages 32-33 for a proposed set of 

responses in the event of future anthrax attacks.

30
Actual Response to 2001 Anthrax Attacks as Mapped by Decision Trees

Media 

preparations:

Emergency 

response 

training:

Research 

portfolio:

Information 

management:

Policy 

development:

Engage reporters an

public in exercise

and training to 

enhance mess

d 

ages

Educate 

reporters and 

public in 

advance 

None

Develop p

message

ublic

s

Educate 

public in 

advance 

Create multi-agency, 

multi-jurisdictional 

exercise and training

process 

Integrate multiple

responders (i.e.,

public health, 

medical, 

environmental)

into first 

responder plan 

No 

responders 

Local first 

responders—

EMS, fire, law

enforcement

Local, regional

and national 

first 

responders 

Fund basic and 

applied research 

into nonspecific

mechanisms of

action for 

multiple human 

pathogens 

Redirect existing 

medical products 

and 

pharmaceuticals 

to biodefense 

None

Focus on basic 

science to keep 

abreast with 

scientific 

advances 

Identify

promising 

scientific

technology

that may have

bioterrorism 

application 

Develop protocols 

to integrate a

with needs 

ssets

Develop 

inventory of 

assets, 

capabilities 

None

Develop 

inventory

of assets

Develop 

inventory

of 

capabilities 

Proactively

address legal, 

ethical issues 

Wait for event,

then address 

issues that arise

Level

of 

Intervention

HIGH 

LOW 

Figure 10 (cont.)

31
Idealized Decision Tree for Response to Anthrax Attacks 

This figure shows the recommended first-cut trees for anthrax. The remainder 

of this section discusses each of the ten trees in the context of existing policies that 

provide important context for future management. While quantifying the risks remains

a challenge, and the science and technology continue to evolve, we believe that 

organizing the information in this way provides a very useful tool for integration and 

communication. We also review existing policies to provide context for current 

delegations of authority/responsibility to exercise the different options.

Figure 11 – The first-cut decision tree, tailored to more effectively manage anthrax.

Routine 

Immunization:

Event 

response:

Maintain 

stockpile:

Surveillance: Containment:

New Vaccine

Mass 

vaccinate

with current 

vaccine 

*No 

vaccination 

Vaccinate 

military

only

Vaccinate 

high-risk 

groups only

Develop, exercise 

and improve 

multi-agency

response plan 

Develop multi-agency

response plan 

No response

plan 

Develop agency

response plan 

National stockpile 

with time critical

items stored in 

highest risk cities 

No stockpile 

National 

stockpile for 

both vaccine 

and treatment 

stored 

regionally

Regional stockpile

with “just in time”

delivery and 

distribution;

integrated into

city surge 

capacity plans 

Integrate 

automated event 

characterization 

system based on 

epidemiological, 

bio, chem models

and artificial 

intelligence

Develop integrated 

surveillance 

system-of-systems 

that relies on 

multiple sources 

None 

Passive 

surveillance; rely

on healthcare and 

lab reporting only

Deploy

environmental 

sensors into 

high risk areas 

Proactively

engage with 

international 

economic and 

diplomatic 

strategy

Identify

international 

vulnerabilities 

and renegotiate

to enhance 

Do not enforce, 

ignore 

Do not enforce, 

renegotiate 

Enforce 

biological and 

toxic weapons 

convention 

provisions 

Level

of 

Intervention

HIGH 

National 

stockpile with

antibiotic 

treatment only

LOW 

32
These recommendations are meant not to criticize the actual handling of the 

2001 anthrax attacks, but to illustrate the benefit of careful consideration of the longterm outcomes of decisions. These recommendations clearly should remain the 

subject of debate and benefit from three years worth of analysis and review of the 

actual events. The value of using decision trees during wargames, practices, drills, etc., 

comes from their ability to provide a de facto analysis of the long-term consequences 

of decisions made during the early stages of an event. 

Level

of 

Intervention

HIGH 

LOW 

Idealized Decision Tree for Response to Anthrax Attacks

Media 

preparations:

Emergency 

response 

training:

Research 

portfolio:

Information 

management:

Policy 

development:

Develop protocols 

to integrate assets

with needs 

Proactively

address legal, 

ethical issues 

Develop 

inventory

of assets

Develop 

inventory

of 

capabilities 

Develop 

inventory of 

assets, 

capabilities 

Focus on basic 

science to keep 

abreast with 

scientific

advances 

Identify

promising 

scientific

technology

that may have

bioterrorism 

application 

Redirect existing

medical products 

and 

pharmaceuticals 

to biodefense 

Fund basic and 

applied research 

into nonspecific

mechanisms of

action for 

multiple human 

pathogens 

Local, regional

and national 

first 

responders 

Local first 

responders—

EMS, fire, law

enforcement

Integrate multiple

responders (i.e.,

public health, 

medical, 

environmental) 

into first 

responder plan 

Create multi-agency, 

multi-jurisdictional 

exercise and training

process 

Develop p

message

ublic

s

Educate 

public in 

advance 

Engage reporters an

public in exercise

and training to 

enhance messages

d 

Educate 

reporters 

and public 

in advance 

No 

responders 

Wait for event,

then address 

issues that arise

None None None

Figure 11 (cont.) – The first-cut decision tree, tailored to more effectively manage anthrax.

33
Routine immunization

The U.S. first licensed a human vaccine for anthrax in 1970 using a nonencapsulated, toxigenic strain that reduces the virulence of the bacterium. The FDA 

approved Anthrax Vaccine Adsorbed (AVA) for veterinarians, workers handling 

potentially infected animals or their products, and laboratory workers conducting 

research on anthrax. When exposed to vaccine, the body produces an antibody response 

to protective antigen, one of three proteins produced by anthrax as part of its toxin. (See 

the “What Is Anthrax?” text box on page 21.) The existing dosage schedule for effective 

protection pre-exposure involves 6 doses given subcutaneously over 18 months followed 

by an annual booster. The vaccine poses risks of systemic reactions and serious side 

effects similar to flu and hepatitis, and local reactions in the arms of 30-60% of 

recipients, with women showing higher rates of local reactions than men. It is not 

indicated for pregnant women and must be given with caution to immunosuppressed 

persons. Studies of the vaccine conducted in 1962 demonstrated its effectiveness for 

workers in wool mills, primarily against cutaneous exposure to anthrax.46 Although the 

military maintained high interest in using AVA to protect troops, limited and unreliable 

supply of AVA and issues related to the limited license that did not include aerosol 

exposure presented challenges. More recent tests in rhesus monkeys show effectiveness 

of AVA against inhalational anthrax,

47 but the military faced significant challenges to its 

policy of mandatory vaccination for anthrax, and controversy continues to date, even 

though surveillance shows few, if any, clinically significant side effects.48 (See the 

“Anthrax Vaccine” text box on page 37.) 

 

46 Philip S. Brachman, Herman Gold, Stanley A. Plotkin et al., “Field evaluation of a human anthrax 

vaccine,” American J Public Health 52, no. 4 (April 1962): 632-645. Available at 

<http://www.anthrax.osd.mil/media/pdf/field_eval.pdf>. 47 Arthur M. Friedlander, Phillip R. Pittman and Gerald W. Parker, “Anthrax Vaccine: Evidence for Safety 

and Efficacy Against Inhalational Anthrax.” JAMA 282 (1999): 2104-2106. Available at <http://jama.amaassn.org/cgi/reprint/282/22/2104.pdf>. 48 Jeffrey L. Lange, Sandra E. Lesikar, Mark V. Rubertone and John F. Brundage, “Comprehensive 

Systematic Surveillance for Adverse Effects of Anthrax Vaccine Adsorbed, US Armed Forces, 1998-

2000,” Vaccine 21, no. 15 (April 2, 2003): 1620. Available at 

<http://www.anthrax.osd.mil/documents/library/science.pdf>. 

34
Figure 12 – Anthrax vaccine adsorbed (AVA) dosage schedule. Source: 

http://www.anthrax.osd.mil/vaccine.

Currently, no routine, non-military, non-occupational, human immunization for 

anthrax occurs.49 A practical universal vaccination option does not exist, given the 

severely limited supply of vaccine and unclear public receptivity to mass vaccination for 

anthrax. 

Research efforts continue to improve the scientific knowledge about anthrax and 

show promise toward the development of a new vaccine.50 The NIAID commissioned 

VaxGen to begin human clinical trials on a new, and hopefully safer anthrax vaccine, 

rPA102 (see the “Anthrax Vaccine” text box on page 37) that the U.S. Army Medical 

Research Institute of Infectious Diseases (USAMRIID) previously developed and tested 

in animals.51 This vaccine remains several years from licensure and large-scale 

production potential, but research efforts to support expanded routine immunization 

options are underway, and these may lead to future discussions about potential mass 

immunization. 

 

49 Advisory Committee on Immunization Practices (ACIP), “Use of Anthrax Vaccine in the United States,” 

MMWR Recommendations and Reports 49, no. 15 (December 15, 2000): 1-4. Available at

<http://www.cdc.gov/mmwr/preview/mmwrhtml/rr4915a1.htm>. Supplement available at 

<http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5145a4.htm>. 50 Gi-Eun Rhie, Michael H. Roehrl, Michael Mourez et al., “A dually active anthrax vaccine that confers 

protection against both bacilli and toxins,” PNAS 100, no. 19 (September 16, 2003):10925-10930. 

Available at <http://www.pnas.org/cgi/reprint/100/19/10925>. 51 VaxGen, Inc. website, available at <http://www.vaxgen.com/products/index.html>. 

35
Based on current policy, we expect the U.S. to continue its use of routine 

vaccination only for high-risk groups, which means that most of the population remains 

vulnerable to a large-scale attack. 

Recommendations

• Given the possibility of a new vaccine in the future, efforts should be initiated 

now to determine the public acceptability of a new vaccine as a function of 

anticipated risks and benefits, and cost-effectiveness studies should evaluate 

how investment of public health resources in routine vaccination compare to 

other competing options. 

• More broadly, with public health resources already scarce, the government 

should evaluate the ability to increase overall public health expenditures to 

support the inclusion of additional vaccines. 

• HHS should consider alternate, risk-based vaccine and prophylaxis strategies 

where first responders (emergency medical services, fire fighters, and law 

enforcement) as well as emergency room doctors and staff are provided 

treatment. (In the case of smallpox, the treatment of first responders is especially 

important to consider.)

36
ANTHRAX VACCINE

The anthrax vaccine generated significant controversy involving Federal judges, Congressional 

hearings, government regulatory agencies, National Research Council study committees, and 

“disobedient” service members. 

The anthrax vaccine—known as Anthrax Vaccine Adsorbed (AVA)—received its license in 1970. 

The AVA manufacturers initially targeted veterinarians and workers who processed animal 

products, such as hair or hides that might harbor anthrax spores. Use of the vaccine expanded to 

the Department of Defense (DOD) in the 1990s. Some 150,000 of the military personnel deployed 

to the Gulf War received AVA, and in 1998 the Anthrax Vaccine Immunization Program (AVIP) 

called for the vaccination of all military personnel. 

The AVIP effort slowed by 2000 as a result of limited vaccine supply and delays in Federal 

approval for the release of newly manufactured vaccine lots. Concerns expressed about AVA’s

efficacy and safety, as well as its production, contributed to the remarkable result that some 500

service members refused vaccination under AVIP and became subject to disciplinary action,

including discharges, fines, and jail sentences.1

) 

As a result of the concerns, Congress directed the conduct of an independent analysis, and in 

October 2000, the Institute of Medicine convened the Committee to Assess the Safety and

Efficacy of the Anthrax Vaccine. The committee concluded that AVA was an effective vaccine. 

Moreover, because part of the vaccine’s action was directed against the bacterium’s toxin, the 

committee noted that the vaccine should be effective against all known strains of the bacterium, 

as well as any potential bioengineered strains.2

AVA was also deemed to be reasonably safe. The committee noted accounts of reactions, but

concluded they were within the guidelines associated with any vaccine. 

The production procedures at BioPort, the country’s only manufacturer of AVA, were also

reviewed by the committee. With newly validated manufacturing processes being approved at

BioPort’s renovated facility, the Food and Drug Administration (FDA) anticipated a greater 

assurance of vaccine consistency. 

At the end of October 2004, however, a Federal judge ordered the DOD to stop requiring 

vaccination of all military personnel. In response to the order, the Secretary of Defense ordered a 

“pause” in the program. (The judge’s ruling was based on his finding that the FDA did not follow 

its own rules requiring public comment on the vaccine’s safety and effectiveness.) The military 

uses a layered approach to protection, so “pausing” the vaccination program will not leave 

troops completely unprotected.

3

A new version of the vaccine is set to be manufactured by VaxGen, Inc., a California-based

company. The vaccine is manufactured differently from the one made by BioPort and is based on

the bacterium’s own Protective Antigen (PA), one of the proteins involved in the production of

the anthrax toxin. (The new vaccine is made with recombinant DNA technology and is called 

rPA102.) Vaccination with rPA102 will require only three shots, vs. the current six. Because it is 

based on a single protein, it potentially should have fewer side-effects.4

The new vaccine is being purchased by the Federal Government under the Project Bioshield Act 

of 2004. Under that legislation, the Department of Health and Human Services is seeking to

secure a stockpile of 75 million doses of anthrax vaccine for use by the civilian population. 

1

 “Judge Halts Forcing of Anthrax Shots,” New York Times, October 28, 2004. Available at 

<http://www.nytimes.com/2004/10/28/politics/28anthrax.html>. 2

 Lois M. Joellenbeck, Lee L. Zwanziger, et al. (eds.), The Anthrax Vaccine: Is It Safe? Does It Work? (Washington, 

DC: Committee to Assess the Safety and Efficacy of the Anthrax Vaccine, Institute of Medicine, National Academies 

of Science, 2002): 71. 

3

 Ibid., 33. 

4 VaxGen, Inc. corporate press release, October 15, 2004, available at 

<http://www.vaxgen.com/pressroom/index.html>.

37
DISTRIBUTING THE DRUGS: WHERE TO START?

Pharmaceutical intervention—whether vaccines, antibiotics, or antivirals—will likely present a 

difficult problem for policymakers, regardless of the agent used in a bioattack. This table 

presents a proposed scheme for prioritizing the use of available drugs, given the high probability 

that supplies will be limited or, at best, not immediately available in the affected area. (Note the 

middle box at the bottom of the table for specific references to anthrax.) 

Category 1 - (Highest priority) (public health recommendation)

- Persons known to be exposed or at the geographic location of exposure

- Persons with clinical symptoms consistent with disease 

Category 2 - (public health recommendation) 

- Household or work contacts of known or probable cases 

- Healthcare and first responder personnel with known or probable contact with cases 

Category 3 - (public health recommendation) 

- All healthcare, law enforcement, first responder, and public health personnel in geographic

location of release or cases

- Potentially exposed persons based on contact tracing

----------------------------------------------------------------------------------------------------------------------------------- 

Categories 4, 5 and 6 apply when resources are inadequate for mass prophylaxis/vaccination 

----------------------------------------------------------------------------------------------------------------------------------- 

Category 4 

- Essential service personnel, e.g., Continuity of Government (COG)(government officials), public 

works personnel, private security 

Category 5 

- Utilities, transportation, communications workers 

Category 6 

- Home healthcare workers, consider community volunteers, high priority commercial workers 

(food, financial), news media

Potential initial prophylaxis strategies

Communicable agents – smallpox, plague

Attack parameters Exposure Categories for Prophylaxis 

Unknown source 1, 2, 3 

Small, confined, localized area 1, 2 

Large area, many exposed persons 1, 2, 3 

Multiple sites or subsequent releases 1, 2, 3, consider 4 in severe circumstances 

Secondary transmission beyond release 

point 

Add 1-2 categories 

Anthrax (non-communicable; contacts should not be treated. Potential exposure groups may need to be

broadened, as symptoms may not start until 4-6 days after exposure) 

Attack parameters Exposure Categories for Prophylaxis 

Unknown source 1, 3, consider 4 

Small, confined, localized area 1, 3 

Multiple sites or subsequent releases 1, 3, consider 4 and 5 

Tularemia, Ricin, Botulinum toxin (non-communicable; contacts should not be treated) 

Attack parameters Exposure Categories for Prophylaxis 

Unknown source 1, 3 

Small, confined, localized area 1, 3 

Multiple sites or subsequent releases 1, 3, consider 4 

38
Event response 

Based on the 2001 attacks, the CDC developed many components of a 

comprehensive event response plan. For example, the CDC provides a dedicated page on 

its Internet site for anthrax

52 that provides links to its antibiotic treatment guidelines for 

clinicians,

53 protocols for laboratory testing and confirmation,54 epidemiological tool 

kit,55 sampling and cleanup guidelines,56 and other resources. 

With respect to treatment, the CDC guidelines suggest treatment with antibiotics 

that are readily available because of their use to treat other infectious diseases and are 

part of the Strategic National Stockpile (e.g., Cipro and doxycycline). The CDC also 

tested post-exposure vaccination during the 2001 anthrax attacks under an Investigational 

New Drug (IND) application that used informed consent.57 The post-exposure dosage 

schedule involved 3 doses given subcutaneously over 4 weeks along with 60 days of 

antibiotic. The scientific literature currently lacks studies of estimates of the costeffectiveness of AVA, other potential vaccines, or antibiotics for treatment of anthrax, or 

papers that evaluate the cost-effectiveness of prevention and preparedness efforts. 

Cleanup remains an important area of event response that warrants additional 

attention, particularly given the magnitude of the resources required. While the National 

Contingency Plan provided a means for the EPA to use part of the Superfund for cleanup 

in the Hart Senate Office Building, the U.S. Postal Service (USPS) cleanup and the 

American Media Inc. (AMI) building proved much more difficult. The USPS faced 

widespread contamination of a very large area, and contractors faced significant 

technological challenges in designing and implementing a cleanup strategy. In 2003, 

Congress bought the AMI building, which remained closed after the death of one of the 

 

52 CDC, 2004, available at <http://www.bt.cdc.gov/agent/anthrax/index.asp>. 53 CDC, 2004. available at <http://www.bt.cdc.gov/agent/anthrax/anthrax-hcp-factsheet.asp>. 54 CDC, 2004. available at <http://www.bt.cdc.gov/agent/anthrax/lab-testing/index.asp>. 55 Dori B. Reissman, Ellen B. Steinberg, Julie M. Magri and Daniel B. Jernigan, “The Anthrax 

Epidemiologic Tool Kit: An Instrument for Public Health Preparedness,” Biosecurity and Bioterrorism: 

Biodefense Strategy, Practice, and Science 1, no. 2 (2003):111-116. Available at 

<http://bioterrorism.dhmh.state.md.us/AnthraxEpiToolkit.pdf>. 56 CDC, 2004, available at <http://www.bt.cdc.gov/agent/anthrax/environment/index.asp>. 57 CDC, 2001. available at <http://www.bt.cdc.gov/DocumentsApp/Anthrax/12182001/hhs12182001.asp>. 

39
workers.58 Issues of quarantine for contagious agents in event response, and restricting 

access and cleaning up private property remain significant ones that still need attention. 

Such efforts will require engaging the business community effectively.59

Recommendations

• Efforts to evaluate the benefits of the substantial national governmental 

investments in bioterrorism preparedness deserve attention, particularly if the 

investments provide dual-use benefits or impose costs by diverting resources 

from other public health priorities. The nation needs a strategy to ensure that all 

levels of responders are ready in the event of another attack with anthrax, and 

this requires a sustained commitment and discussions with even broader groups 

of stakeholders. 

• HHS should perform a comprehensive assessment of biodefense grants to 

identify and prioritize those that both meet urgent preparedness needs and 

provide collateral benefit to the public health infrastructure. 

Maintaining a stockpile

Currently, the SNS contains the antibiotics that authorities would need to respond 

to an attack with anthrax, and efforts to procure vaccine are underway. CDC deployment 

of the SNS represents one part of the system working in the 2001 anthrax attacks,60 and 

the future decisions focus on maintaining this resource. 

 

Recommendations

• Analysts should construct mathematical models to estimate the potential size of 

attacks and compare these to the stockpile resources. Various designs for the 

stockpile could be developed. In addition, analysts should consider whether the 

inclusion of some pharmaceutical products in the SNS might create incentives for 

attackers related to bioengineering agents resistant to SNS available treatments, 

and whether (and how) the actual formulary of the SNS should periodically 

change. 

• HHS/CDC should reevaluate SNS contents and distribution processes and

develop enhanced mechanisms to deliver those few, time-sensitive items to the 

US population at the greatest risk. In addition, policies should be developed—

based on mathematical modeling—for deploying SNS resources if supplies are 

limited. 

58 Kathy Bushouse, “Congress agrees to buy, clean up anthrax-tainted AMI building,” South Florida SunSentinel, February 14, 2003. Available at <http://www.ph.ucla.edu/epi/bioter/cleanupamianthax.html>. 59 The Business Roundtable, 2003, i. 60 Heyman, 3. 

40
Surveillance 

Many options exist to deploy sensors that might assist in providing warning of an 

attack, but these systems are currently under development and they raise many issues.61

While it appears that efforts to develop new technologies abound, the government has not 

focused sufficient attention on important questions about the value of the information that 

might be obtained from these systems. At the broad level, system designers must 

determine whether anthrax is something for which they should be looking, presumably 

because an early warning might prove valuable in saving lives or response costs, or 

because it allows capture of the attacker and possibly retribution. However, surveillance 

can yield both false negatives, meaning that it can miss real cases, and false positives or 

false alarms, meaning that it incorrectly indicates an attack. 

As promising technologies emerge, they should be evaluated with respect to the 

quality and cost of the information that they provide. If the information does little to

speed up response or could lead to costly false alarms, which may include some injuryrelated deaths if people panic or receive some inappropriate treatment, then careful 

consideration of the trade-offs should drive decisions about deployment. For any 

proposed technology, decisionmakers must play a critical role in discussions about how 

they would use information, particularly imperfect information. Efforts to characterize 

the full costs of these systems, including the costs of training the people who might 

receive information from them, warrant particular attention in informing the national 

debate about biodefense. 

 

61 Armstrong, 6-16. 

41
Recommendations

• In the case of anthrax, authorities should evaluate the value of the information 

from a sensor network and compare this to the cost of such a network. While no 

technology currently exists for wide-scale deployment, efforts to develop the 

analytical methods needed to model the sensor system and the uncertainty in the 

information it might provide are a priority. These methods should consider the 

general guidance on cost-effectiveness analysis1

 and focus on the incremental 

benefits of any new technologies over the existing system of passive surveillance 

by the health care system. They should consider the training of health care 

providers as part of this analysis. 

• HHS should commission a study that integrates governmental, civilian, and 

military needs and capabilities to develop a prioritized national action plan for 

surveillance and response. 

1

Marthe R. Gold et al., Cost-effectiveness in Health and Medicine, (New York, NY: Oxford University Press, 1996). 

Containment 

The existing Biological and Toxic Weapons Convention Provisions provide 

agreements about biological agents, but compliance with these agreements and their 

enforcement remain on-going challenges. The fact that the 2001 anthrax attacks appeared 

to use anthrax developed in the U.S. raises important questions about containment of any 

existing anthrax here and abroad. The CDC is undertaking an effort to develop an 

inventory for anthrax entitled the Select Agent Program,

62 a first step toward national 

containment. However, important decisions remain about our international agreements, 

and given the existence of bioweapons as justification for its decision to go to war in Iraq, 

the government faces complicated policies and politics. 

In addition, the expanded research on biological agents motivated by the anthrax 

attacks and significant infusion of resources has expanded the market for these agents. In 

the context of vaccine development and other scientific studies, researchers sometimes 

require access to agents. These materials must be produced and transported, which 

creates opportunities for breaches of containment. Recently, the Children’s Hospital and 

Research Center at Oakland reported a serious breach of B. anthracis containment that 

 

62 Learn more about the CDC’s Select Agent Program at <http://www.cdc.gov/od/sap/>. 

42
led to exposure of 7 lab workers to live B. anthracis instead of inactivated bacteria. (All 

of the researchers took a 60-day course of Cipro and the material was recontained.63) 

Recommendations

• The fact that these decisions are complicated suggests the need for particular 

attention to resources and policy tools that promote destruction and containment 

of potential bioweapons. The U.S. government successfully removed from the 

open patent literature some information that could prove useful, but the rapid 

evolution of biotechnology means that containment efforts must address 

molecular synthesis capabilities and the existence of highly-trained and wellequipped scientists who continue to advance our knowledge. Containment efforts 

should ensure that all involved with hazardous biological agents receive 

adequate training and face incentives that encourage compliance. 

Media preparations 

In the 2001 anthrax attacks, communication was one of the weakest links, and 

little has been done to improve the situation. The reality of bioterrorism risks means that 

authorities should place higher priority on risk communication and risk education to 

avoid panic and achieve the optimal response. 

Studies of public opinion and perception of biological weapons suggest that many 

Americans lack basic knowledge about pathogens and how they cause disease. The fact 

that a study found that 47 percent of the population surveyed did not know that anthrax 

does not spread person-to-person suggests that, despite all of the media attention on 

anthrax from the 2001 attacks, people still need education about basic anthrax 

information.64 Additional studies may also reveal other misperceptions about anthrax. 

 

63 John Dudley Miller, “US lab is sent live anthrax,” The Scientist, June 11, 2004. Available at 

<http://www.biomedcentral.com/news/20040611/03>. 64 Fischhoff et al., 255. 

43
Recommendations

• Clearly we need to engage in active risk communication efforts to better prepare 

the country to manage risks and to ensure that all stakeholders recognize their 

important roles. Efforts to train members of the media to communicate 

uncertainty and to provide context will help, but identifying spokespeople and 

developing messages before they’re needed are important priority areas in which 

work should begin now. 

• HHS and CDC—in conjunction with private sector healthcare clinicians—should 

engage media and risk communication experts to proactively develop effective 

communication strategies that consider message, messenger, and recipient. 

Emergency response training 

A bioterrorism event involves people at all levels of government. The need for a 

response plan is clear, yet national investments in training must focus on developing costeffective strategies for insuring preparedness while respecting the limits of time and other 

resources. The CDC invested $1.1 billion in 200265 and $1.4 billion in 200366 to assist 

state and local governments in the development of bioterrorism response plans, but 

remarkably little coordination of these efforts has occurred between states. More 

significantly, the effort does not include assessment of common needs or development of 

generic models that might assist in characterizing the spread of disease or impact of 

response options. More than two years after the program began, national progress has 

been inadequate. 

With respect to the defense of major cities, while each city is unique, all urban 

areas with a large population (e.g., over 500,000 people) share features. For example, 

each large city: 

• Supports the lives of hundreds of thousands of people (water, sewer, power, 

transportation, energy), 

• Operates a major airport, 

• Has major highways and railways that either run through the city or next to it, 

 

65 Health and Human Services Press Office, “News Release: Guidelines for Bioterrorism Funding 

Announced,” May 9, 2003. Available at <http://www.hhs.gov/news/press/2003pres/20030509.html>. 66 Health and Human Services Press Office, “News Release: HHS Announces $1.1 billion in Funding to

States for Bioterrorism Preparedness,” January 31, 2002. Available at 

<http://www.hhs.gov/news/press/2002pres/20020131b.html>. 

44
• Runs schools, 

• Houses government buildings, a jail or prison, at least one large academic 

institution, and a stadium and/or other sports arena, 

• Depends on centers of commerce and maintains open access to them, 

• Supports local media (e.g., radio stations and at least one local TV station), 

• Offers services in major hospitals and emergency treatment centers, and

• Hosts major events (e.g., state fairs, concerts, holiday parades, New Year or 4th of 

July celebrations, races, etc.), some regularly or annually and some on a one-time

basis. 

In addition, some cities themselves share common features (e.g., all coastal cities have

ports and boat access, and all cities that cross a major river have at least one major 

bridge). 

Given these similarities, it is remarkable that states and cities currently develop 

their emergency plans almost completely independently. This generally means that they 

do not learn from the efforts and experiences of others, which ultimately may translate 

into wasted resources. In addition, development of processes and training materials do 

not benefit from sharing, and much the same is true of smaller cities and rural areas. 

Further, because of the focus on major metropolitan areas, rural areas are a continued 

weak link.67 Regional response planning is minimal at best. 

Recommendations

• Current efforts to train responders should explicitly consider the level of training 

needed at each level of government as well as integration of new procedures. The 

efforts should also explore the opportunities to share some of the analytical work 

(i.e., modeling) where generic models would provide useful tools. Better 

coordination between military and civilian responders and evaluation and peer 

review could lead to significant improvement of plans and cross-fertilization of 

good ideas. Focus on anthrax as a single agent for discussion is likely to lead to 

the identification of key issues that existing generic plans might miss. 

• HHS should pioneer an effort to develop national preparedness standards—

including local, state, and regional coordination requirements—and should tie 

Federal grants to meeting these requirements. 

 

67 Gursky, 1-4. 

45
Research portfolio 

The NIH, CDC and DOD all maintain active research efforts related to anthrax, 

but they lack overall coordination and largely focus on basic science and on promoting 

local public health or military preparedness. These research efforts continue to make 

progress that furthers our understanding of anthrax and our abilities to deal with it. 

However, the research to date includes relatively little focus on quantitative evaluation of 

the risks, costs and benefits of different actions. Consequently, national decisionmakers 

continue to lack the policy tools they need to allocate scarce resources properly. 

Recommendations

• The government needs to develop the analytical methods required to evaluate its 

investments in basic science and technology development. These methods 

should include mechanisms for improving local, state and Federal coordination in 

planning and response, as well as ways to measure the benefit that may be 

achieved from such efforts. While significant levels of support exist, continued 

support may depend on demonstration of real benefit and reasonable trade-offs 

between costs and benefits. Demand for these analyses may also significantly 

advance efforts to explore dual-use opportunities and to encourage better 

information sharing and coordination between military and non-military 

researchers and policymakers. 

• The National Academy of Sciences should be asked to evaluate the efforts made 

thus far—in government, industry and academia—to address issues of 

bioterrorism in general and anthrax in particular. The Academy should be asked 

to propose a quantitative evaluation process to help prioritize expenditures 

directed to bioterrorism and public health preparedness. 

EXAMPLE OF AN ANTHRAX RESEARCH INVESTMENT THAT RECENTLY PAID OFF1

FDA approved a new test, produced by Immunetics, Inc., and funded by the CDC, to rapidly and 

easily determine whether patients have been infected with anthrax. Called the Anthrax Quick 

ELISA test, the test takes less than one hour. It detects an immune response to a protein

produced by the infecting anthrax bacteria. Availability of this test means that state and private 

laboratories can test to rule out anthrax instead of needing to send every sample to either the 

CDC or the U.S. Army (USAMRIID). 

1

CDC Media Relations, “CDC Collaboration Yields New Test for Anthrax,” June 7, 2004. Available at 

<http://www.cdc.gov/od/oc/media/pressrel/r040607.htm>. 

46
Information Management 

With the staggering amount of information being generated, organization emerges 

as a critical issue. Inventories of resources and capabilities are important tools in 

coordination. The inventory of anthrax laboratories represents an important improvement 

in information management; other tools should include flowcharts with decision points 

and identified information needs that can aid in coordination of responding to an event.68

Recommendations

• For anthrax, much of the needed information management within the CDC and 

other government agencies exists. Coordination with other stakeholders now is a 

major priority. As information increasingly becomes available on the Internet, 

stakeholders will need tools to sort through and find the high-quality information 

that they need. 

• Professional medical societies should develop clinical protocols for early 

detection, response, treatment, and reporting of biological warfare cases in 

coordination with CDC requirements. 

Policy development 

A number of policy issues arise in the context of managing the risks from

biological weapons. The ability to foresee many of these risks leads to opportunities to 

address (some of) them and engage in debates without the pressure of a crisis. The legal 

issues span a huge range. They include clearly identifying roles and responsibilities so 

that all stakeholders know who has which authorities and responsibilities to make 

decisions and act, and the limits on these. Key issues of concern include quarantine 

policies and restrictions on freedom, including limiting access to private property and

compensation for use of private property. 

With all of the demands for coordination and information sharing, issues 

inevitably arise regarding individual privacy and the need to protect the public. Federal 

laws, such as the Health Insurance Portability and Accountability Act of 1996 (HIPAA), 

create an important context for some individuals. Protecting emergency responders and 

 

68 CDC, “A National Public Health Strategy for Terrorism Preparedness and Response, 2003-2008” (March 

2004): 4. Available at <http://www.mipt.org/pdf/National-Public-Health-Strategy-Terrorism-PreparednessResponse-2003-2008.pdf>. 

47
cleanup contractors from liability may also be critical to creating the right incentives for 

them to help. For example, if doctors are asked to help in the response, but lack adequate 

liability protection, patient care may be degraded. With respect to vaccines, ethical issues 

arise if vaccination is not voluntary. Ethical issues may also arise if authorities must 

ration scarce resources and deny treatment to some. Finally, with respect to our own 

national behavior, we must consider the issues that arise from any actions taken that 

appear not in good faith with respect to international agreements, even if we know other 

parties are in violation. 

Recommendations

• For anthrax, policymakers should decide which legal, ethical, and other policy 

issues would benefit from proactive efforts to develop policies before a crisis, 

and which issues to leave until the time of a crisis. 

• The appropriate authority should charter a commission to identify the ethical, 

legal, privacy and civil liberties issues associated with a national response—not

just a Federal response—to a health crisis. This evaluation should identify policy 

gaps and make specific recommendations for any legislative and/or regulatory 

solutions. 

Integration 

In surveying the decisions related to risk management for anthrax, we see a 

complicated, but manageable picture. If we think of all of the decisions and bits of 

information as the pieces of a puzzle, then one perspective is that the decision tree 

provides the helpful box-top image of how they all fit together. 

The major theme that emerges is one of using decision analysis to make better 

choices, and doing a better job characterizing the risks to promote cost-effective efforts 

that address the correct priorities. Decisionmakers need to focus on concrete outcomes 

that can be measured or modeled, including mortality and morbidity prevented and 

dollars and time spent or saved. Recognizing that uncertainty exists due to our lack of 

knowledge, we must move toward better characterization of critical uncertainties and use 

the concepts of value-of-information analysis to evaluate our investments of resources in 

48
opportunities to reduce these uncertainties.69 In the context of pubic health today, the risk 

of widespread anthrax remains small, while every year common infectious diseases like 

flu take a significant toll. Efforts to improve preparedness for a bioterrorism event must 

recognize that some stakeholders may have greater priorities, and this should lead to 

discussions about the set of expectations and objectives that drive choices. 

Summary 

Many efforts are underway in the Federal Government to prepare for a 

bioterrorism attack. Some argue that, three years after the anthrax attack, we are less 

prepared than ever.70 This study does not include a comprehensive review of the 

government’s preparedness efforts and does not comment on the current degree of 

biodefense readiness—or lack thereof. However, anecdotal reporting from colleagues and 

personal experiences suggest that readiness could be significantly improved by the 

adoption of standardized approaches. 

The risk management approach recommended in this paper offers a proven, 

effective way of “organizing for combat” in the public health arena. Introducing this 

approach piecemeal into every organization concerned with biodefense is unrealistic. 

Moreover, there is no single government official who speaks with final authority on the 

topic of biodefense and who could direct the adoption of such a framework. Introducing 

it into the interagency process through “wargames,” drills, practices, exercises, etc., 

seems the most efficient way to disseminate the methodology. 

Specifically, on the topic of anthrax, this study makes no bold or sweeping 

recommendations. Rather, it argues that anthrax must be viewed in the larger framework 

of possible and probable infectious diseases to which the human race is exposed—both

naturally and as a result of deliberate terrorist activity. However, given our recent 

experience with anthrax, the specific decision trees for anthrax (see pp. 32-33) are offered 

 

69 Fumie Yokota and Kimberly M. Thompson, “Value of Information (VOI) analysis in Environmental 

Health Risk Management (EHRM),” Risk Analysis 24, no. 3 (2004): 287-298. 70 John Mintz and Joby Warrick, “U.S. Unprepared Despite Progress, Experts Say,” Washington Post, 

November 8, 2004. Available at <http://www.washingtonpost.com/wp-dyn/articles/A32738-

2004Nov7.html>. 

49
as an analytical tool to aid future policy decisions. Indeed, the lessons learned from the 

2001 attack should facilitate the use of these trees. 

Of all the topics covered in this decision tree approach, media preparation appears 

to be the one with the potential for greatest and most immediate return on investment. 

There is a clearly identified need for public education messages, using nationally 

recognized and respected spokespersons, to address topics related to bioterrorism. Some

of the messages would be generic and applicable to any disease outbreak—natural or 

man-made—while others would be specific to a given organism/disease. The strongest 

recommendation of this study is that decisionmakers at HHS, in conjunction with its 

subordinate organization the CDC, begin the preparation of such messages—but only 

with close cooperation of clinicians involved in healthcare delivery in the private sector 

(see p. 44).71 The effort to curb the overuse of antibiotics is an excellent example of how 

public health education campaigns can be very effective in changing behavior.72

 

71 Elin A. Gursky, Thomas V. Inglesby and Tara O’Toole, “Anthrax 2001: Observations on the Medical

and Public Health Response,” Biosecurity and Bioterrorism: Biodefense Strategy, Practice, and Science 1, 

no. 2 (November 2, 2003): 100. Available at

<http://www.homelandsecurity.org/bulletin/Anthrax202001.pdf>. 72 Background on antibiotic resistance available at <http://www.cdc.gov/drugresistance/community/>. 

50
Appendix A – NDU Anthrax Conference 

In May 2004, Dr. Anna Johnson-Winegar, former Deputy to the Assistant 

Secretary of Defense for Chemical and Biological Defense, hosted a senior level seminar 

at the National Defense University on the topic of anthrax. The seminar, sponsored by the 

Center for Technology and National Security Policy and entitled “From A to X: An Endto-End Review of Anthrax,” reviewed various topics related to anthrax. (This study grew 

out of one of the presentations at the seminar.) 

Dr. Johnson-Winegar’s summary follows as Appendix B. A list of the presenters 

is provided below. All of their presentations are included on the CD inserted in the inside 

back cover of this report. The CD also contains a full list of participants and their 

organizations to aid continued discussion and coordination among professionals in this 

field. 

51
CTNSP/NDU Senior Level Seminar Series 

Anthrax Workshop 

National Defense University

George C. Marshall Hall, Room 155 

Wednesday, 12 May, 2004 

0815 Registration Available for Workshop Attendees (Continental Breakfast Served)

0900 Welcome / Workshop Introduction Dr. Anna Johnson-Winegar 

0915 Setting the Stage

“Biological Warfare: Where We’ve Been; 

Where We Need to Be” 

Col Donald Thompson, MD, MPH&TM (U.S. Northern 

Command) 

1000 Break 

1015 Panel Discussion – DOD and CDC 

Perspectives

DOD Medical Policy 

AVIP Program

Legal Issues and 

Procedures 

Civilian Welfare 

Q&A for Panel

COL Terry Rauch, Health 

Affairs

COL Steve Jones, MVA 

Director 

John Casciotti, Office of 

General Counsel

Dr. Nina Marano, Center 

for Disease Control & 

Prevention 

1215 Catered Lunch Courtesy of CTNSP 

1245 Luncheon Speaker Ms. Judith Miller, New York Times

1330 Risk Management and Integrated

Decisionmaking

Q&A 

Dr. Kim Thompson, 

Harvard School of Public 

Health

1415 Break 

1430 Panel Discussion – Policy Concerns for the 

Future

Department of Homeland

Security

Impact on the Mail 

First Responders 

Anthrax & Public Policy

Q&A for Panel

Dr. Carol Linden, 

Science Based Threat 

Assessment and 

Response 

John Bridges, 

U.S. Postal Service 

James Rohan, U.S. 

Capitol Police 

Dr. Stephen Prior, 

NSHPC, Potomac 

Institute for Policy

Studies 

1630 Wrap-up 

52
Appendix B – Johnson-Winegar Review 

From A to X: An End-to-End Review of Anthrax 

Anna Johnson-Winegar, Ph.D. 

Introduction

Anthrax has been studied for centuries—yet we still have much to learn. In the early days 

of microbiology, Robert Koch, Louis Pasteur and others made observations on the 

physical characteristics of Bacillus anthracis, the causative organism. Anthrax was 

known primarily as a disease of cattle, sheep, and other types of livestock, but it also 

infects others species, including monkeys and humans. In 1876, Koch published his 

pivotal work on “Koch’s Postulates,” which provided the basic methodology used by 

scientists and clinicians to link a specific bacterium with a resultant specific disease. Not 

only was anthrax the case study for Koch, but it was also the first bacterium for which a 

vaccine was developed. In 1881, Louis Pasteur created the first vaccine for anthrax. Thus, 

mankind has been worried about the effects of anthrax for well over a century. 

Anthrax infection in humans manifests itself in three ways: cutaneous, gastrointestinal, 

and inhalational (respiratory). These forms of the disease generally indicate the route of 

infection for the exposed individual. The cutaneous form of the disease is the most 

common, accounting for about 95 percent of all cases, and is also the most easily treated. 

The gastrointestinal form is more severe, and results from ingestion of contaminated meat 

(this was the original explanation given by the Soviets for the deaths following the 

Sverdlosk accident in 1979). The inhalational form of anthrax is by far the most deadly, 

approaching 100 percent fatality if untreated. 

One unique aspect of the anthrax bacteria is the hardiness of the spore stage, and there 

have been reports of spores being viable after many decades in the soil. This is but one of 

the attributes that make anthrax the probable favorite of all the potential biological 

warfare agents. Other characteristics of an organism that make it a good choice for a BW

agent are the following: ease of preparation; resistance to ultra-violet light; stability in 

various types of weapons systems; a relatively short incubation period; ability to be 

dispersed as a liquid or dry powder; and a small amount required for a mass casualty 

effect. Numerous estimates have been developed that indicate a few kilograms of anthrax, 

if delivered efficiently, could cause casualties in excess of one million individuals 

(assuming ideal weather conditions). Therefore, it is easy to see why anthrax has been the 

number one choice of a BW agent for both terrorists and organized nations or state 

sponsored groups. If, indeed, anthrax has been on the top of everyone’s list for decades, 

why don’t we have the problem solved? The answers are complex—they encompass both 

the scientific and political worlds. 

53
The DOD Response to the Threat of Anthrax

Although anthrax had been at or near the top of the validated threat list since its 

inception, the DOD had not been aggressive in developing a posture to protect the 

military forces. Indeed, the Persian Gulf War of 1990-1991 was a strong wake-up call for 

the DOD. Never before had the senior leadership addressed the possibility of biological 

warfare so seriously. Numerous briefings were held on a regular basis for the Joint Chiefs 

of Staff (JCS), and when intelligence assessments indicated a strong possibility that 

Saddam Hussein possessed biological weapons (including anthrax), the DOD developed 

a comprehensive plan to afford maximum protection. Elements of the plan included 

deployment of rather rudimentary sensor devices to provide early warning and detection; 

individual protection (masks and protective overgarments); collective protection and 

shelters; and the initiation of immunizations in theater. 

The decision to immunize military forces against anthrax was not an easy one. Again, 

numerous briefings were held with intelligence analysts, policy staff, military operators, 

and acquisition officials. Although military forces are routinely vaccinated for many 

endemic diseases, large-scale use of a vaccine against a biological warfare agent had 

never been conducted. The anthrax vaccine was developed under contract to the U.S. 

Army, and was subsequently produced and licensed in 1970 by the Michigan Department 

of Public Health (MDPH). Prior to 1990, the MDPH had sold a few hundred doses of 

vaccine per year, primarily to at-risk laboratory workers, veterinarians, and some workers 

in the wool sorter and animal hides industry who might come in contact with 

contaminated materials. One of the logistical issues surrounding this vaccine was the

need for six shots given over a period of eighteen months to provide full immunity as

described in the license. The MDPH facility increased production to the best of its ability; 

however, the production process is time consuming and constrained by biological issues 

(e.g. a 30 day potency test in guinea pigs). Since the amount of vaccine that had been

stockpiled was minimal, the DOD began its immunization program with less than a full 

supply of vaccine for total forces protection. Due to the short duration of the conflict, 

most military members actually received only one or two doses of vaccine in theater. The 

commitment on the part of the DOD to complete the immunization series for those 

individuals became a difficult issue to resolve with the Food and Drug Administration. 

The Food and Drug Administration (FDA) is the regulatory agency with purview over 

vaccines. It maintains responsibility for approving the release of each lot of manufactured 

product and for following and adverse reactions to the immunization. The DOD worked 

closely with the FDA to describe the specifics of the situation and clarify the intent to 

provide the full immunization series to individuals who had started the series. Adequate 

supply of vaccine was the primary factor in the inability to complete the program that had 

been initiated. Inadequate supply also precluded the DOD from providing anthrax 

vaccine to Allies and coalition partners. Following the Gulf War, the DOD continued to 

evaluate the pros and cons of large scale immunization. Following recommendations 

from senior staff, including the Assistant to the Secretary of Defense (Health Affairs), 

and others, Secretary of Defense Cohen announced a decision for immunization of the 

total force in 1998. Some of the rationale for such a decision was the rotation of troops; 

54
the long period required to achieve full immunity; the desire to conduct immunizations 

prior to any deployment; and the necessity to maintain optimal readiness. This decision

included a mandate for an external review of the program by subject matter experts. 

During the implementation of the anthrax vaccination policy, numerous legal issues 

arose. Some challenged the lawful order and the right of the individual to consent. Others 

addressed the issue of whether the vaccine should be considered investigational since the 

license did not specifically state that the vaccine protected against an aerosol challenge 

with anthrax spores. Several individuals developed medical complications following their 

vaccination and attributed their disability to a direct cause of the vaccine. These claims 

were not upheld in court and the Presidential Advisory Commission on Gulf War Illness 

(GWI) indicated they found no direct linkage of anthrax vaccination to the cause of GWI. 

Further study by the Institute of Medicine found the anthrax vaccine to be safe and 

effective. Later in 2000 and 2002, the policy was amended to indicate vaccination only of 

those forces deployed early to high threat areas. 

The DOD has become more aware of the need to address total force protection and has 

instituted more proactive measures to evaluate individual health issues prior to 

deployment, and immediately upon return from deployments. Although not a perfect 

solution, these steps toward understanding the consequences to one’s health (both 

immediate and delayed) will go a long way in allaying concerns. 

Anthrax Vaccination for the Civilian Sector

Although the DOD’s anthrax immunization policy has been underway for several years, 

the possibility of a similar policy for civilians has not been seriously considered. 

Following the anthrax letters in the fall of 2001, the Department of Health and Human 

Services (HHS) (led by the Centers for Disease Control and Prevention) advised use of 

antibiotics following potential exposure. Since there were limited data available about the 

effectiveness of vaccine post exposure, there was not wide spread use of vaccine, even in 

those workers on Capitol Hill who had most likely been exposed to anthrax spores. 

Today, the HHS has decided to procure ample quantities of anthrax vaccine 

(approximately 25 million doses) for the Strategic National Stockpile with the intent to

administer vaccine plus antibiotics post exposure. Some of the initial material in the 

stockpile is the currently licensed vaccine, produced by BioPort (successor to MDPH); 

however, the long-term strategy is to use a new recombinant vaccine, based on the 

protective antigen (PA) factor of the anthrax toxin. First, however, FDA must license any 

new vaccine (recombinant or other). In the absence of the ability to conduct clinical 

efficacy trials, it will be necessary to establish clear criteria for surrogate markers in 

animal studies. Second, since post-exposure use of vaccine to treat anthrax is not 

currently licensed by the FDA, these types of regimens would have to comply with the 

provisions of the Investigational New Drug (IND) regulations. While this may be feasible 

in a small controlled scenario, it is most likely not possible in a large scale outbreak, and 

the DOD has found immense difficulty in complying with these provisions in a combat 

setting. Full approval and licensing of anthrax vaccine for post exposure use will require 

55
specific clinical studies for safety and immunogenicity. These studies must compare use 

of extended use of antibiotics alone and in combination with vaccine. National security 

issues regarding the strategic national stockpile of medical countermeasures (to include 

anthrax vaccine and antibiotics) are being transferred from the HHS to the Department of 

Homeland Security. 

Understanding the Threat

One of the primary tasks facing the National Biosecurity Analysis and Countermeasures 

Center (NBACC) is the thorough evaluation of the threat from anthrax and other 

biological warfare agents. Scientists will work in conjunction with intelligence analysts to 

perform appropriate modeling and simulation studies, in conjunction with laboratory tests 

to learn more about important criteria. One of the major unanswered questions posed to 

date includes a reaffirmation of the lethal dose of spores for humans. The currently 

espoused range of 8000-10000 has come into question following the delivery of the 

anthrax letters through the postal system. It appears likely that some of the victims may 

have received a much smaller dose than that previously thought to be fatal. While it is 

difficult to ascertain the dose delivered to a specific individual, it becomes critical in 

understating the pathogenesis of the disease, the need for more sensitive detection and 

identification systems and appropriate medical countermeasures. These types of studies 

will help characterize the vulnerability of the population. 

Another primary thrust for the NBACC is the forensic analysis required following any 

type of use of a biological warfare agent. Various types of analyses and signatures 

attributed to select strains of Bacillus anthracis and other pathogens need to be analyzed 

and developed into data bases appropriate for data mining. Knowledge management is a 

key component of pulling together the necessary bits and pieces of information that need 

to be connected for a comprehensive study. 

Another aspect of analyzing the threat is the current program in biosurveillance and 

monitoring. The DHS has established BioWatch in selected urban areas and will continue 

to collect valuable data related to background levels of organisms. In conjunction, there is 

a comprehensive effort underway to monitor increases in disease outbreaks through local 

health clinics, private physicians’ offices, school absences; and over-the-counter sales of 

specific medications (including those for treating upper respiratory infections, diarrhea, 

and headaches). While it is too early to critically evaluate the potential usefulness of 

these surveillance systems, efforts such as these to bolster the public health infrastructure 

and methods to improve faster communication of data represent essential elements of an 

overall strategy. 

56
From Hypothesis to Reality

While the specter of biological warfare had been looming for many years, the actual 

delivery of anthrax spores through the postal service made the nation into believers. From

the initial case in Florida, through the additional cases in the Brentwood postal facility in 

Washington, D.C. on to the letters delivered to Capitol Hill, the attention of the American 

public was captured. 

Two aspects dominated the attention of the postal service and the capitol police in dealing 

with the anthrax letters. The first dealt with obtaining confirmatory evidence of the 

identification of the material. Initial assays were performed using the hand-held “tickets,” 

a system based on immunologic reagents. Confirmatory tests were provided by laboratory 

analysis, using immunoassays, polymerase chain reaction, growth of samples on cultures 

plates and visual examinations. The need for analysis of literally tens of thousands of 

samples clearly highlighted the sparse capacity of the laboratory infrastructure available. 

Presumptive testing proved to be sufficient for most of the decisionmaking. The large 

number of both environmental samples (i.e. swipes from furniture, etc), and clinical 

samples for diagnosis (e.g. nasal swabs) inundated the available labs in the area. The 

need for more laboratory testing capacity through the public health system (including 

state health laboratories) is being addressed through additional funding provided to HHS 

and administered through state and community grants. Under the auspices of the CDC, a 

tiered structure has been put in place allowing local labs to do initial screening, with 

reference laboratories scattered throughout the country that are able to do more 

sophisticated tests and to handle BL-4 pathogens. 

Decontamination of infected areas at the postal facility and the Senate office building

proved to be a large challenge. As already noted, anthrax spores are extremely hardy and 

resistant to many types of decontaminating materials that are appropriate for most 

biological agents. Eventually the use of chlorine dioxide, under controlled temperature 

and humidity, proved effective for the Hart Senate office building. More extensive testing 

was required to assure decontamination of the larger Brentwood postal facility. These 

efforts were extraordinarily expensive and consumed vast resources. Simultaneously, 

testing was done by DOD laboratories to validate the process of decontaminating the mail 

by irradiation. Again, the basic data available and knowledge of the technical complexity 

was insufficient. Although the DOD had been investing in decontamination of chemical 

and biological agents for decades, their focus had been on military vehicles and large 

open areas. No one had really considered appropriate methods of decontamination that 

would be effective against anthrax spores, yet safe for use on office furnishings (carpet, 

drapes, computers, etc). Today the Environmental Protection Agency is the lead Federal 

agency charged with the responsibility for decontamination, and research continues for a 

better decontaminant. Requirements vary, but desirable attributes include developing a 

decontaminant that is environmentally friendly; safe to use on humans; safe for use on 

sensitive electronic equipment; effective against a broad range of chemical, biological, 

and radiological agents; requires little or no water; is easy to disperse; works in a short 

period of time; and is relatively inexpensive. 

57
The Way Ahead

Unfortunately, today, we still have many unanswered questions about these incidents 

involving the use of anthrax spores. We do not know who was responsible. We do not 

know the source of the anthrax spores (i.e. were they produced, stolen, or purchased?). 

We do not know the motive for the attacks. And, therefore, we are unable to make 

intelligent assessments about the likelihood of similar attacks in the future. Clearly there 

is a need for additional intelligence assessment and further technical understanding of the 

use of biological organisms as biological warfare agents—either by terrorists or by 

military adversaries. 

Knowledge and communication have emerged as two primary focal areas for 

improvement. It is incredibly important for the public to be kept informed in order to 

lessen the possibility of panic. It is critical for the responsible government officials to 

provide accurate information in a timely fashion. We can diffuse terror and panic by 

increasing situational awareness. In the absence of solid information, confusion reigns. 

One approach toward sharing knowledge and improving communication is through 

exercises- both table-top and actual field training. The first responders to an incident in 

the civilian population will be the local fire, police, emergency medical technicians, and 

others. This community, as a whole, is in need of substantially higher funding for 

education, training, and equipment. The Federal, state, and local entities must work 

together to share knowledge and improve responsiveness. 

Learning how to manage the risk associated with the use of anthrax (or any other 

biological agent used by a terrorist) is among the highest priorities. Many decisions must 

be made in a short period of time by numerous individuals or organizations that may have 

been previously unconnected. Development of a matrix that covers broad topics is a 

logical first step. Some examples that would be considered in this matrix include the 

following: 

58
7/17/2004

None

AVA only

high-risk

groups

New

vaccine?

Passive only

Passive + 

environmental

None

Routine

immunization:

Event 

response:

Maintain

stockpile:

Surveillance:

AVA more

broadly

National 

vaccine

stockpile

(include

some AVA)

National 

treatment

stockpile 

(antibiotics 

included)

National 

stockpile 

for both 

vaccine

and 

treatment

No 

stockpile

Enforce Biological 

and Toxic Weapons 

Convention

Provisions

Do not enforce, 

ignore

Containment:

Treat first with IV 

Cipro, switch if

tests reveal not 

resistant (use

oral if too many)

Treat with any

antibiotic in 

tetracycline

family

Treat with any

antibiotic in 

FQ family

Treat with either 

IV or oral Doxycy

Treat with either

IV or oral Cipro

Treat with IV 

Doxycycline

Treat with IV

Cipro or 

Doxycycline

Treat with either 

IV or oral Cipro or

Doxycycline

Many decisions....

Environmental 

only

No policy

Do not enforce, 

renegotiate

59
7/17/2004

None

Educate

reporters/ 

public in 

advance

Educate

reporters/ 

public and 

develop 

messages

Inventory of 

capabilities

Inventory of 

assets

None 

(issues 

related to

security)

Media

preparations:

Emergency 

response

training:

Research 

portfolio:

Information

management:

Develop 

messages

Basic 

science to

support

new

vaccine/

treatment

Applied 

research

(e.g., 

modeling 

efforts to

support

planning), 

tech. 

development

Both

Neither

Proactively address

legal/ethical issues

Wait for event then 

address issues that

arise

Policy

development

All responders 

(local, regional, 

national)

Other 

combinations...

No 

responders

Medical only

Law enforcement

only

National 

responders

Regional

responders

Public health only

Many decisions....

Inventory of 

capabilities

and assets

Local

responders

In order to develop a cohesive national policy and strategy, it is incumbent for the various 

Departments of the Administration to work together for each has been assigned various 

responsibilities in the National Response Plan and outlined in other Presidential Decision 

Directives. In addition, the state and local agencies and departments must be incorporated 

into a plan. 

Anthrax has long been recognized as a biological threat (in fact many experts agree it 

remains the number one threat from both terrorists and military adversaries). While we 

have learned a great deal over the past few years (as evidenced by the increased number 

of publications in the scientific literature and the greater understanding of the lay public), 

there is more to be done. Some of the detailed research needed to understand more about 

60
this pathogen will take years to complete; other actions can be completed in the short 

term. 

The concept of eradication of disease has been presented to the public in terms of 

naturally occurring smallpox. In addition, there is currently an effort underway to 

eradicate polio from the earth. These campaigns can be successful since there are no 

other natural reservoirs for these viruses; however, anthrax remains a zoonotic disease 

and it would be extremely difficult to remove all natural sources of this bacterium from 

the earth, without even giving consideration to stockpiles of spores that may be held by 

potential enemies or terrorists. Therefore, if one acknowledges that some form of anthrax 

will always be present, one must concentrate on managing the situation rather than 

attempting to totally avoid it. 

Improved education of the public and senior government officials is critical. A better 

understanding of the possible consequences will eliminate panic, and will facilitate 

emergency planning. Training exercises are essential for all members of the first 

responder communities that may be faced with an anthrax situation. Increased research 

efforts must be continued to improve the sensitivity and specificity of detectors. A valid 

concept of operations must be implemented following a positive detection alarm. Better 

medical countermeasures are needed to provide protection in advance (improved vaccine) 

and for post exposure therapy (possibly anti-toxins or generic drugs that interfere with 

toxin binding) as well as definitive clinical studies on the value of antibiotics and vaccine 

post exposure. Finally, decontamination remains a key issue when considering anthrax 

because of the durability of the spores. Comprehensive programs must be developed;

programs must be prioritized; support and funding must be sustained; and intelligence 

must be constantly evaluated. Anthrax has been with us for centuries. It is not an easy 

task to “take it off the table” as a choice of biological weapons for either terrorists or 

military adversaries. It will require commitment and sustained interest from all involved. 

61