# Randall Larsen and Lynne Kidder on USA bio-response

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Colonel Randall Larsen, USAF (Ret), is the National Security Advisor at the UPMC Center for Health Security, and a Senior Fellow at the Homeland Security Policy Institute, George Washington University. He previously served as the Executive Director of the Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism (2009-2010); the Founding Director and CEO of the Bipartisan WMD Terrorism Research Center (2010-2012), the Founding Director of the ANSER Institute for Homeland Security (2000-2003), and the chairman of the Department of Military Strategy and Operations at the National War College (1998-2000).

Lynne Kidder is the former President of the Bipartisan WMD Terrorism Research Center (the WMD Center) and was the principal investigator for the Center’s Bio-Response Report Card.  She is currently a Boulder, CO-based consultant, a research affiliate with the University of Colorado’s Natural Hazards Center, and also serves as the co-chair of the Institute of Medicine’s Forum on Medical and Public Health Preparedness for Catastrophic Events. Her previous positions include Sr. Vice President at Business Executives for National Security, Senior Advisor to the Center for Excellence in Disaster Management and Humanitarian Assistance (US Pacific Command), and eight years as professional staff in the U.S. Senate.

Luke Muehlhauser: Your Bio-Response Report Card assesses the USA’s bio-response capabilities. Before we explore your findings, could you say a bit about how the report was produced, and what motivated its creation?

Randall Larsen: The 9/11 Commission recommended that a separate commission examine the terrorism threat from weapons of mass destruction (WMD). The bipartisan leadership in the Senate and House asked former US Senators Bob Graham (D-FL) and Jim Talent (R-MO) to head the Congressional Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism (WMD Commission). The WMD Commission completed its work in December 2008 and published a report, World at Risk. In March 2009, the bipartisan leadership of Congress asked Senators Graham and Talent to re-establish the Commission to continue its work and provide a report card on progress. This was the first Congressional Commission to be extended for a second year.

I became the Executive Director for the WMD Commission’s second year, and in January 2010, the Commission released a WMD Report Card assessing 37 aspects of the WMD threat. The grades ranged from A’s to F’s. The failing grade that received the most attention, both on Capitol Hill and in the press, was the F grade for “preparedness to respond to a biological attack.”

At the commissioners’ final meeting in December 2009, they encouraged Senators Graham and Talent to continue their work with a focus on the biological threat. To do so, a not-for-profit organization (501c3) was created in March 2010, The Bipartisan WMD Terrorism Research Center (WMD Center). Senators Graham and Talented agreed to serve on the board of advisors, I became the CEO, and recruited Lynne Kidder to serve as the President.

Launching the project was a bit of a challenge, since many of the traditional national security organizations that support such work were solely focused on the nuclear threat—a reflection of the Congressional perspective. The legislation that created the WMD Commission had not contained the words bioterrorism or biology—ironic since World at Risk clearly identified bioterrorism as the most likely WMD threat.

We began work on the Bio-Response Report Card in January 2011 by recruiting a world-class team of senior advisors. They included a former Deputy Administrator of the Food and Drug Administration, a former Special Assistant to the President for Biodefense, the Director of Disaster Response at the American Medical Association, the VP and Director of RAND Health, the Founding President of the Sabin Vaccine Institute, and experts in the fields of public health, emergency medicine, and environmental remediation.

The Board of Advisors helped inform methodology of the project, helped define the categories of bio-response, and then proposed metrics in the form of questions, by which to assess capabilities in each category.

Luke: In the Methodology section of your report (p. 20), you explain that the project’s “Board of Advisors… informed project methodology, the categories of bio-response, and then proposed metrics by which to assess capabilities in each category,” and that you “enlisted a separate group of diverse subject-matter experts to perform much of the research and analysis required to answer these questions.” It looks like a challenging project, requiring hundreds or thousands of hours of labor from knowledgeable experts. It also looks as though, lacking an easily-imitable template that would satisfy the goals of the project, you had to come up with much of the methodology yourself. Could you give more detail as to the process that generated the report? A chronological account might be the easiest to remember and share.

Lynne Kidder: Yes, this was a very labor-intensive project. The biggest challenge was that no one had ever attempted a national-level, end-to-end assessment of bio-response capabilities ranging from initial detection through environmental cleanup. No federal department or agency has the ability to do such a study without getting considerable pushback for grading the work of many other organizations with related missions. This is why the study needed to be accomplished outside of government—preferably by a not-for-profit.

Additionally, we had to work with our Board of Advisors to develop a “scale of events”—none existed. This fact had caused great confusion within the national security and biosecurity communities. When some people talked of a biological attack, they had in mind an event similar to the anthrax envelopes of October 2001 (22 infected and 5 deaths), while others were referring to a catastrophic event that would threaten the lives of hundreds of thousands. Working with our Board of Advisors, we identified six scenarios (small-scale non-contagious, small-scale contagious, large-scale non-contagious, large-scale contagious, large-scale drug-resistant, and a global crisis). See page 21 of the report card for specific examples and details of each scenario.

We quoted George E. P. Box, “Essentially, all models are wrong, but some are useful.” Our model was not perfect, but we found it shocking that the federal government had not developed such a model for analysis, and we were convinced ours was useful for our study and as a standard for others to use.

The second step for our Board of Advisors was to complete our framework for analysis with a matrix. The vertical axis listed the eight (generally agreed upon) mission areas: Detection & Diagnosis, Attribution, Communication, Medical Countermeasure Availability, Medical Countermeasure Development & Approval Process, Medical Countermeasure Dispensing, Medical Management, and Environmental Cleanup. The horizontal axis listed the six scales of attack. (See page 9.)

We then discovered there were no agreed upon standards of performance for the eight mission areas, so we also had to develop them. We first defined each mission area, and then provided standards of performance–what we called, “Fundamental Expectations”. We concluded that the American public and their elected representatives would have these fundamental expectations based on the tens of billions of dollars that have been spent on biodefense since 2001. For instance, in the mission area of Medical Countermeasure Distribution & Dispensing, we listed these fundamental expectations:

• Appropriate types of medical countermeasure stockpiles, strategically located, subject to rigorous security and environmental controls, with schedules of resupply, rotation, and shelf-life extension
• Distribution and dispensing mechanisms that are timely, efficient and deliver medical countermeasures to the point of need
• Redundant and community-based dispensing strategies developed to address specific population needs (age distribution, at risk populations, logistics, etc.)
• Supporting communications strategies that are multi-lingual, multi-cultural, and multi-channel
• A trained and knowledgeable workforce (professional and/or volunteer) with the skill set, willingness, and necessary preparation to participate in mass dispensing activities

The final step for our Board of Advisors was to develop a set of questions for each mission area—questions that would be provided to the eight teams of subject-matter-experts to evaluate the nation’s capability to meet the Fundamental Expectations. In the mission area of Medical Countermeasure Distribution & Dispensing the Board of Advisors provided six questions to the subject-matter-experts. Here is an example of one of the questions:

Can medical countermeasures in the Strategic National Stockpile be dispensed to affected populations within 48 hours (as specified in HSPD-21)?

Note: This is one of the very few areas where there actually was an agreed upon standard of performance.

Mission area definitions, scale of attacks, fundamental expectations, and questions were provided to eight teams of subject-matter-experts (SMEs). The SMEs provided detailed answers to the staff of the WMD Center. Senators Bob Graham and Jim Talent, Randy and I, plus two consultants (Dave McIntyre, PhD and Sara Rubin, MPH) prepared the report card—using the inputs from the Board of Advisors and SMEs—and assigned grades.

Luke: What process did you use to find and select the SMEs? Roughly how many ended up contributing, in how many different teams?

Randall: I have worked in the biodefense community since 1994, and Lynne Kidder had more than a decade’s experience –plus she was serving (and still is) as the Co-Chair of the Institute of Medicine’s Forum on Medical and Public Health Preparedness for Catastrophic Events. Between us, we knew most of the leading biodefense experts, in both the public and private sectors.

Our Board of Advisors were nationally-recognized senior leaders in the field. Their names were listed in our report, but they were only involved in setting up the study. This added credibility to our study, but since they were not involved in the assessment and grading, it protected these senior leaders from the highly-politicized environment in the nation’s capitol.

On the other hand, the SMEs we chose to answer the questions, and provide suggested grades, remained anonymous—so that any criticism of grades could only be directed at Graham/Talent/Larsen/Kidder.

We had a “team” of SMEs assigned to each of the eight mission areas, but in fact they weren’t real teams. Each individual worked independently—unaware of who else was answering the same questions. This allowed us to identify those areas in which there was general agreement, and more importantly, areas in which there was disagreement. For those mission areas that had widely different assessments (answers to our questions) we would follow up with the SMEs, and in some cases, recruited additional SMEs. For one mission area, we ended up with five SMEs.

Surprisingly (at least to us) there were few areas of major disagreement. When there was, it was often about interpretation of specific policies and guidelines provided by the federal government. For instance, was the “48-hour standard” (for getting antibiotics to affected populations) established in the Bush Administration, still the standard for the Obama Administration?

All of the Board of Advisors were paid honoraria, and the SMEs were paid consulting fees. We also reached out to other SMEs who agreed to participate pro bono–including government employees, industry representatives, and several from the academic/think tank community.

Luke: Are you able to reveal the total cost of preparing the report, or a ballpark figure? How was funding acquired?

Lynne: Our budget for the 10-month project was $500,000. Smith Richardson Foundation contributed$200,000 and the Skoll Global Threats Fund contributed $300,000. Luke: In January 2010, a research associate at the James Martin Center for Nonproliferation Studies (CNS) published a somewhat-critical review of the earlier WMD report card by Bob Graham and Jim Talent, focusing on some of its claims about biosecurity. Were you aware of that article while preparing your followup, the Bio-Response Report Card (published Oct. 2011)? If so, did it influence your work on the Bio-Response Report Card? Do you have any general comments on the article? Randall: We certainly agreed with the final sentence in the article, “Accordingly, their report card should be read and considered with a critical eye.” All reports, including the report written by Mr. Kirk Bansak, a research associate at CNS, should be carefully and thoughtfully read and considered. Unfortunately, Mr. Bansak appears to have misunderstood the WMD Commission’s grading system. As described on page 5 of the WMD Commission’s Report Card, “This report card uses letter grades to assess the U.S. Government’s progress in implementing the Commission’s recommendations.” These were not grades on the overall status of preparedness and nonproliferation efforts, rather grades on specific responses to the recommendations in World at Risk—the tasking given to the Commission by the bipartisan leadership in Congress when the commission was extended for a second year. For instance: Recommendation 1-2 in World at Risk “Develop a national strategy for advancing bioforensic capabilities.” The report card gave this an A, commenting, “An Interagency Bioforensics Strategy has been finalized and approved by the U.S. Office of Science and Technology Policy and exceeds the criteria stated in the Commission’s recommendations.” This was clearly not an A for bioforensics writ large, but specifically a grade for response to a World at Risk recommendation—“develop a national strategy.” An F grade was given for Recommendation 1-5, “Enhance the nation’s capabilities for rapid response to prevent biological attacks from inflicting mass casualties.” Mr. Bansak states, “Graham and Talent, who also include logistical strategy and planning in their list of biothreat preparedness needs, also appear to overlook President Obama’s Executive Order assigning the U.S. Postal Service responsibility for dispensing medical countermeasures in the event of a biological attack…” This was hardly overlooked. At the Commission meeting when grades were debated and assigned, top officials from the White House briefed the commissioners on a wide variety of WMD issues, and provided copies of the soon-to-be-released Executive Order regarding the U.S. Postal Service. The commissioners were not impressed with this two-page document. As the Executive Director of the WMD Commission, I did not have a vote for the assignment of grades. I just counted the votes. In many areas, there was considerable discussion and debate amongst the commissioners—lengthy debates whether a particular area should receive a B- or C+, or a C- or D, and in one case, an A or A+. However, when we got to the issue of preparedness to respond to a biological attack (Recommendation 1 in World at Risk) the discussion was short and the grade unanimous—F. Regarding the “too generous grade” for actions on the Biological Weapons Convention, we can only state, once again, Mr. Bansak appears to have misunderstood the grading criteria. Recommendation 2-4 in World at Risk stated, “Propose an action plan for achieving universal adherence to the Biological Weapons Convention.” The report card grade was a B+, based on the release of the National Strategy for Countering Biological Threats by the National Security Council in December 2009. A comment was also offered on what actions the Administration would need to take to raise the grade to an A. Mr. Bansak comments on the B+ grade with, “This plaudit, while not unwarranted, seems inappropriate for this section because it overlooks the failing of the BWC…” Once again, we can only say, this was not a grade for the BWC. It was a grade for the government’s response to a specific recommendation in World at Risk. It appears that the primary objection from Mr. Bansak and CNS is on the issue of verification—discussed at length in the CNS report. CNS is a strong supporter of improved verification, however, the commissioners clearly agreed with the decisions of both the Bush and Obama Administrations that “bad verification is worse than no verification.” The CNS assessment of the WMD Commission’s Report Card of January 2010 did not influence the WMD Center’s Report Card of October 2011. The primary purpose of the second report card was to move from a single letter grade of F (for the federal government’s response to a recommendation in World at Risk), to a much more detailed strategic analysis of this country’s capabilities to respond to a biological attack. Luke: If a philanthropist granted your WMD Center$10 million to make research progress on the issue of national biodefense, and you were available full-time to lead such research efforts over the next five years, which project(s) might you execute? In other words, what do you see as the most urgent and desirable “next steps” for research into national biodefense?

Lynne: One top priority would be medical countermeasures (MCMs): developing new models where the public and private sectors can work in close cooperation to develop new MCMs for the Strategic National Stockpile (SNS); developing the capability for rapid development of MCMs in response to new bio-threats (both man-made and naturally-occurring); and the greatest MCM challenge, finding the means to rapidly gain FDA approval for use of new MCMs.

Another priority would be to promote best practices in states and local communities for biodefense preparedness. The majority of our work at the WMD Commission and WMD Center has been focused on federal programs. Senator Bob Graham, the former two-term governor of Florida, has encouraged looking at these issues from a local perspective—the frontlines of biodefense. There have been numerous private-public partnerships created at the state and local level to strengthen disaster preparedness and response. Unfortunately, the lessons learned and best practices from these pilot projects have not yet been fully exploited for wide spread use in cities and counties across the nation.

Randall: One specific challenge that will require effective private-public collaboration is the dispensing of medical countermeasures. The federal government has continually received high marks for maintaining the SNS and having the means to rapidly distribute the MCMs to cities and counties in a crisis. However, the problem is getting these MCMs into the hands (and mouths) of the citizens in these communities. If a bio-attack occurred in most American cities today, the feds would get the needed MCMs to the local airport, but there is serious doubt they would get to the residents in time to make a difference. The current situation is like having a fiber-optic cable with 1 gigabyte capability running down your street, but no link to your house.

Another important prospective project is executive education. Today’s leaders in Congress and the Administration do not fully appreciate the 21st century threat of bioterrorism. The biotech revolution has democratized the potential for creating biological weapons. The capability for sophisticated bio-attacks, that could threaten the lives of hundreds of thousands, was once limited to superpowers. Much has changed since the late 1960s. Today, these same (nuclear-equivalent) weapons, can be produced with equipment purchased on the internet and from pathogens readily-available in nature. Until senior leaders in both the public and private sectors fully understand this threat, it is unlikely they will give sufficient priority to developing the required defenses.

Luke: Thank you both!

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