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PROJECT BIOSHIELD: LINKING BIOTERRORISM

THREATS AND COUNTERMEASURE PROCUREMENT

TO ENHANCE TERRORISM PREPAREDNESS

HEARING

BEFORE THE

SUBCOMMITTEE ON EMERGENCY 

PREPAREDNESS, SCIENCE, 

AND TECHNOLOGY

OF THE

COMMITTEE ON HOMELAND SECURITY 

HOUSE OF REPRESENTATIVES

ONE HUNDRED NINTH CONGRESS

FIRST SESSION

JULY 12, 2005

Serial No. 109–29

Printed for the use of the Committee on Homeland Security 

Available via the World Wide Web: http://www.gpoaccess.gov/congress/index.html
COMMITTEE ON HOMELAND SECURITY 

CHRISTOPHER COX, California, Chairman 

DON YOUNG, Alaska 

LAMAR S. SMITH, Texas 

CURT WELDON, Pennsylvania 

CHRISTOPHER SHAYS, Connecticut 

PETER T. KING, New York 

JOHN LINDER, Georgia 

MARK E. SOUDER, Indiana 

TOM DAVIS, Virginia 

DANIEL E. LUNGREN, California 

JIM GIBBONS, Nevada 

ROB SIMMONS, Connecticut 

MIKE ROGERS, Alabama 

STEVAN PEARCE, New Mexico 

KATHERINE HARRIS, Florida 

BOBBY JINDAL, Louisiana 

DAVE G. REICHERT, Washington 

MICHAEL MCCAUL, Texas 

CHARLIE DENT, Pennsylvania 

BENNIE G. THOMPSON, Mississippi 

LORETTA SANCHEZ, California 

EDWARD J. MARKEY, Massachusetts 

NORMAN D. DICKS, Washington 

JANE HARMAN, California 

PETER A. DEFAZIO, Oregon 

NITA M. LOWEY, New York 

ELEANOR HOLMES NORTON, District of 

Columbia 

ZOE LOFGREN, California 

SHEILA JACKSON-LEE, Texas 

BILL PASCRELL, JR., New Jersey 

DONNA M. CHRISTENSEN, U.S. Virgin Islands 

BOB ETHERIDGE, North Carolina 

JAMES R. LANGEVIN, Rhode Island 

KENDRICK B. MEEK, Florida 

SUBCOMMITTE ON EMERGENCY PREPAREDNESS, SCIENCE, AND 

TECHNOLOGY

PETER T. KING, New York Chairman 

LAMAR S. SMITH, Texas 

CURT WELDON, Pennsylvania 

ROB SIMMONS, Connecticut 

MIKE ROGERS, Alabama 

STEVAN PEARCE, New Mexico 

KATHERINE HARRIS, Florida 

DAVE G. REICHERT, Washington 

MICHAEL MCCAUL, Texas 

CHARLIE DENT, Pennsylvania 

CHRISTOPHER COX, California (Ex Officio) 

BILL PASCRELL, JR., New Jersey 

LORETTA SANCHEZ, California 

NORMAN D. DICKS, Washington 

JANE HARMAN, California 

NITA M. LOWEY, New York 

ELEANOR HOLMES NORTON, District of 

Columbia 

DONNA M. CHRISTENSEN, U.S. Virgin Islands 

BOB ETHERIDGE, North Carolina 

BENNIE G. THOMPSON, Mississippi (Ex Officio)

(II) 
(III)

C O N T E N T S

Page 

STATEMENTS

The Honorable Peter T. King, a Representative in Congress From the State 

of New York, and Chairman Subcommittee on Emergency Preparedness, 

Science, and Technology ...................................................................................... 1

The Honorable Bill Pascrell, Jr., a Representative in Congress From the 

State of New Jersey, and Ranking Member, Subcommittee on Emergency 

Preparedness, Science and Technology .............................................................. 3

The Honorable Christopher Cox, a Representative in Congress From the 

State of California, and Chairman, Committee on Homeland Security: 

Prepared Opening Statement .............................................................................. 24 

The Honorable Bennie G. Thompson, a Representative in Congress From 

the State of Mississippi, and Ranking Member, Committee on Homeland 

Security ................................................................................................................. 4 

The Honorable Donna M. Christensen, a Delegate From the U.S. Virgin 

Islands ................................................................................................................... 29

The Honorable Charlie Dent, a Representative in Congress From the State 

of Pennsylvania .................................................................................................... 31

The Honorable Norman D. Dicks, a Representative in Congress From the 

State of Washington ............................................................................................. 42

The Honorable Bob Etheridge, a Representative in Congress From the State 

of North Carolina ................................................................................................. 26

The Honorable Jane Harman, a Representative in Congress From the State 

of California .......................................................................................................... 32 

The Honorable Nita M. Lowey, a Representative in Congress From the State 

of New York .......................................................................................................... 38

The Honorable Michael McCaul, a Representative in Congress From the 

State of Texas ....................................................................................................... 37

The Honorable Stevan Pearce, a Representative in Congress from the State 

of New Mexico ...................................................................................................... 34 

The Honorable Dave G. Reichert, a Representative in Congress From the 

State of Washington ............................................................................................. 41

The Honorable Rob Simmons, a Representative in Congress From the State 

of Connecticut ....................................................................................................... 35

The Honorable Curt Weldon, a Representative in Congress From the State 

of Pennsylvania .................................................................................................... 27 

WITNESSES 

PANEL I 

Ms. Karen T. Morr, Acting Assistant Secretary, Office of Information 

Analysis, Information Analysis and Infrastructure Protection, Directorate, 

Department of Homeland Security: 

Oral Statement ..................................................................................................... 5

Prepared Statement ............................................................................................. 7

The Honorable Stewart Simonson, Assistant Secretary, Office of Public 

Health Emergency Preparedness, Department of Health and Human 

Services: 

Oral Statement ..................................................................................................... 15

Prepared Statement ............................................................................................. 17
Page

IV

Dr. John Vitko, Jr., Director, Biological Countermeasures Portfolio, 

Directorate of Science and Technology, Department of Homeland Security: 

Oral Statement ..................................................................................................... 10

Prepared Statement ............................................................................................. 12

PANEL II 

Dr. Marcus Eugene Carr, Jr., Executive Director, Clinical ResearchHemostasis, Novo Nordisk, Inc.: 

Oral Statement ..................................................................................................... 44

Prepared Statement ............................................................................................. 45

Mr. Michael Greenberger, Director, Center for Health and Homeland 

Security, University of Maryland School of Law: 

Oral Statement ..................................................................................................... 49

Prepared Statement ............................................................................................. 51

Mr. Richard Hollis, Chief Executive Officer, Hollis-Eden Pharmaceuticals, 

Inc.: 

Oral Statement ..................................................................................................... 54

Prepared Statement ............................................................................................. 56

Mr. James A. Joyce, Chairman and Chief Executive Officer, Aethlon Medical, 

Inc.: 

Oral Statement ..................................................................................................... 64

Prepared Statement ............................................................................................. 66

Mr. David P. Wright, President & Chief Executive Officer, PharmAthene, 

Inc.: 

Oral Statement ..................................................................................................... 72

Prepared Statement ............................................................................................. 73

Ms. Nancy Wysenski, President, EMD Pharmaceuticals: 

Oral Statement ..................................................................................................... 67

Prepared Statement ............................................................................................. 69

FOR THE RECORD 

Mr. John Vitko Responses to Questions From the Honorable Mike Rogers ....... 86
(1)

PROJECT BIOSHIELD: 

LINKING BIOTERRORISM THREATS AND 

COUNTERMEASURE PROCUREMENT TO 

ENHANCE TERRORISM PREPAREDNESS 

Tuesday, July 12, 2005

HOUSE OF REPRESENTATIVES, 

COMMITTEE ON HOMELAND SECURITY, 

SUBCOMMITTEE ON EMERGENCY PREPAREDNESS, 

SCIENCE, AND TECHNOLOGY, 

Washington, DC. 

The subcommittee met, pursuant to call, at 9:33 a.m., in Room 

2118, Rayburn House Office Building, Hon. Peter King [chairman 

of the subcommittee] presiding. 

Present: Representatives King, Weldon, Simmons, Pearce, 

Reichert, McCaul, Dent, Cox (ex officio), Pascrell, Dicks, Harman, 

Lowey, Norton, Christensen, Etheridge and Thompson (ex officio). 

Mr. KING. The subcommittee will come to order. 

Good morning. Let me first welcome our distinguished witnesses 

and say how much we appreciate your appearance before us today. 

The purpose of today’s hearing is to evaluate the Department of 

Homeland Security and Health and Human Services’ implementation of the Project BioShield Act of 2004. Initially proposed by the 

President in his State of the Union address in 2003 and enacted 

into law exactly 1 year ago, BioShield was designed to address the 

lack of a commercial market for countermeasures against CBRN 

weapons, creating incentives for biotechnology and pharmaceutical 

companies to invest and do research in the development of such 

products. This hearing is not the first on BioShield’s implementation nor, I am afraid, will it be the last. 

Various House and Senate committees have held numerous committees examining the Department of Health and Human Services 

BioShield responsibilities, effectiveness of BioShield’s market incentives and the need for new legislation to address the need for 

additional private sector concerns such as liability issues, intellectual property rights and the so-called ‘‘valley of death,’’ which is 

the transition from basic research to countermeasure production. 

This hearing, however, is different. It will focus on the critical yet 

relatively unexamined responsibilities of the Department of Homeland Security under BioShield. 

Among other things, the Department of Homeland Security is responsible for assessing and determining which agents present material threats to our Nation’s security. Such assessments and determinations are central to BioShield’s success. They dictate which 
2

specific countermeasures may be eligible for procurement, the specific requirements and whether they are appropriate for inclusion 

in our Nation’s strategic national stockpile, a national repository of 

countermeasures for use in the event of a public health emergency. 

The importance of medical countermeasures cannot be underestimated. The events of September and October, 2001, made it very 

clear that terrorism, indeed bioterrorism, is a serious threat to our 

Nation and the world. The anthrax mailings of 2001 killed five people and required thousands to take post-exposure prophylaxes. If 

there had not been effective countermeasures against that particular strain of anthrax, the death toll may have been higher. 

Effective countermeasures exist for few of the biological threats 

deemed the most dangerous by the Centers for Disease Control and 

Prevention. The paucity of such countermeasurers stems from the 

lack of a significant commercial market. Of course, diseases such 

as Marburg and Ebola occur so infrequently in nature biotechnology and pharmaceutical companies have little incentive to 

invest the millions of dollars required to bring preventive new 

treatments or vaccines to market. 

Experts generally agree that the consequences of a bioterror attack could be devastating. Such an attack could lead to incalculable 

fatalities and casualties and sow significant fear in the population, 

lead to a substantial reduction in interstate and probably international commerce, cause social disruption and severely impact our 

Nation’s economy. 

Quite frankly, we cannot afford to fail in developing effective 

countermeasures against such attacks. Having an appropriate 

stockpile of countermeasures—for example, vaccines, therapeutics 

and devices—is critical to our Nation’s medical preparedness. To 

that end, I look forward to testimony that may clarify many of my 

questions regarding BioShield implementation. 

One of the roles of the Directorate for Information Analysis and 

Infrastructure Protection and Science and Technology within DHS 

is conducting material threat assessments and determinations. 

What is the DHS process for prioritizing which agent besides 

those identified by the CDC as Category A agents warrant such assessments and determinations? 

What is the quality of the threat information used by the Department to fulfill its assessment and determination responsibilities, 

how the Department, given the diversity of potential agents and increasing ability to modify or predict them, will predict and or 

emerging threats, whether the Department’s threat assessment 

and determination process permits adequate consideration, a 

board’s determination or overemphasizes the so-called one-bug/onedrug approach. 

Whether the Department’s assessment and determination process permits adequate consideration of medical devices. 

Whether the Department’s assessment and determination process places an undue premium on vaccines at the expense of antiinfectives, such as post-exposure therapeutics such as antibiotics. 

So I want to thank all our witnesses for being here today. I look 

forward to your testimony. 

With that, I recognize the gentleman from New Jersey, the distinguished ranking member of the subcommittee, Mr. Pascrell. 
3

Mr. PASCRELL. Thank you, Mr. Chairman; and thank you for 

holding what I consider to be a very critical oversight hearing on 

the implementation of Project BioShield. 

This program was designed to encourage the private sector to develop and produce medical countermeasures to combat the effects 

of potential chemical, biological as well as radiological or nuclear 

attacks on American soil. So this is a very vital undertaking and 

one that must be constantly monitored with aggressive vigilance. 

Indeed, we must insure that the Federal money dedicated to this 

program is being spent wisely and that Project BioShield is performing up to its intended capabilities. We must do this because 

the somber reality of our world today is there are a great many 

people who wish to do us harm and the threat of a WMD attack 

in the United States is very real. 

Remember, it has already happened. In October, 2001, anthrax 

attacks were launched from my home State of New Jersey. Two 

weeks ago, a group of 80 arms control and security experts released 

a survey commissioned by Senator Lugar of Indiana stating that 

they believe there is a 70 percent chance of a WMD attack in the 

next 10 years. 

While we all agree that we should focus our efforts on preventing 

any future attack, we must also insure that our citizens and our 

first responders are adequately protected should an attack take 

place. That is the goal behind the program. 

Congress created Project BioShield in 2004 to expedite terrorismrelated procurement hiring and the awarding of research grants. 

Subsequently, Congress appropriated a great deal of money from 

2004 to 2013, with a maximum of $890 million to be allotted in fiscal year 2004. In November of last year, the Department of Health 

and Human Services awarded the first contract of $877.5 million 

for 75 million doses of a new type of anthrax vaccine. Future possible directions for Project BioShield include smallpox vaccines, 

anti-radiation treatments, antitoxins and vaccine in the next generation of plague vaccine. 

While this pork is enormously important, we have some problems, and we must face them now. The private sector maintains 

continued reluctance to participate in the program. One reason for 

this is that vaccines for these diseases are inherently risky. Currently, there are no liability protections for companies who wish to 

participate in the program. This is an issue we need to discuss because, without robust private sector involvement, Project BioShield 

will fail. 

We also have to look at why many companies view the request 

for proposals aspect of the program so difficult to navigate, so unclear in direction. 

Likewise, I am interested in assessing whether the Department 

of Homeland Security and the Department of Health and Human 

Services work effectively together. How many times have we heard 

that question? That many Federal agencies don’t even talk to each 

other as answer is an absolute disgrace, unacceptable to this chairman, unacceptable to this ranking member, unacceptable to everybody on this committee. There is no excuse if that is happening, 

and it is. So we want to know if they are working effectively in for-
4

mulating a response strategy and in developing new countermeasures. 

Since DHS has the lead role in securing the homeland and its 

supporting role in Project BioShield, it is vital that this committee 

continues to conduct oversight into the program. We will do that. 

Homeland Security is a partnership. It is a partnership between 

the Federal Government, the State and local governments. It is a 

partnership between government and industry. If the current program does not provide adequate incentives for industry to participate, then we need to reevaluate the program to make sure we will 

meet all of our needs. 

Thank you, Chairman King, for holding this hearing; and I look 

forward to hearing from our distinguished panelists. Thank you. 

Mr. KING. Thank you, Mr. Pascrell. 

The gentleman from Mississippi, the Ranking Member, Mr. 

Thompson. 

Mr. THOMPSON. Thank you very much, Mr. Chairman. I welcome 

the witnesses who are going to offer testimony at this very important hearing this morning. 

The very real threat of a chemical, radiological or nuclear attack 

is one that government must take seriously and act on quickly and 

effectively. It was in this spirit that Congress passed the BioShield 

Act of 2004. BioShield, though, is only the beginning of a continued 

effort to protect our citizens from this continued threat. The BioShield program has had one partial success. It is helping to meet 

the needs required to counter the threat of anthrax. Even in this 

area, we are not seeing the necessary development and stockpiling 

that BioShield was designed to produce. 

HHS awarded an $877 million contract for 75 million doses of an 

anthrax vaccine, yet it does not expect to receive any doses until 

2006. In the meantime, HHS has paid $125 million for 5 million 

doses of a less effective anthrax countermeasure from another vendor. What does it take to get it right? We will talk a little bit more 

about that in some of the questions that I have for the witnesses. 

One major problem, as I have observed, is that the Department 

of Homeland Security has only completed four material threat assessments in the last year. The Center for Disease Control has 

identified 60 pathogens that they consider dangerous and could be 

used as weapons. Each pathogen requires a material threat assessment to begin the BioShield process. We have no chance of procuring countermeasures for these pathogens if the Department only 

does four assessments in a year. 

Mr. Chairman, I appreciate you calling this hearing today on this 

important topic. I hope the testimony we hear today will insure 

that BioShield fulfills the mission for which Congress intended. I 

yield back. 

Mr. KING. Thank you, Mr. Thompson. 

I will introduce our first panel. We have three witnesses: 

Karen Morr, the Acting Assistant Secretary for Office of Information Analysis in DHS. 

Dr. John Vitko, the Director of Biological Countermeasures Portfolio, Directorate of Science and Technology of the Department of 

Homeland Security. 
5

The Honorable Stewart Simonson, Assistant Secretary, Office of 

Public Health Emergency Preparedness, Department of Health and 

Human Services. 

Mr. KING. Our first witness will be Ms. Morr. You are recognized 

for 5 minutes. 

STATEMENT OF KAREN T. MORR 

Ms. MORR. Good morning. Thank you, Chairman King, Representative Thompson, Representative Pascrell and distinguished 

members of the committee. I thank you for inviting me here today 

to talk with you about the Information Analysis Office and our expertise and our threat assessments and how we support units 

throughout DHS as well as our Federal, State and local partners. 

I have been with IA since its standup in March of 2003, and I 

am proud to serve with the men and women of IA who have 

worked hard to institutionalize an intelligence capability for the 

Department. We are well on our way to developing a Department 

that conducts operations and makes decisions informed by the full 

spectrum of information and intelligence available to DHS. 

I would like to start first by describing the general threat and 

then discuss our processes and products, particularly those dealing 

with bioterrorism. 

The Department takes seriously the threat of bioterrorism. Before we became all familiar with al-Qa’ida and the events of 9/11, 

groups such as Aum Shinrikyo began employing biological agents 

in attacks. After 9/11, al-Qa’ida expressed its intent to pursue biological weapons. Bin Laden himself referenced WMD as a religious 

duty all the way back in 1998. 

Al-Qa’ida documents recovered from a training camp in Afghanistan show interest in a variety of biological agents and mentioned 

plague, anthrax, cholera and tularemia. Although our military operations in the region probably disrupted ongoing biological activity, it is unlikely that such a setback will deter the pursuit of these 

weapons. In fact, it is clear to the intelligence community that the 

intent is there. It is up to the intelligence community, including IA, 

to be constantly on guard for indicators of biological production, enhanced capabilities and operational planning. 

In order to fulfill our responsibility, IA regularly collaborates 

with the National Counterterrorism Center, CIA, FBI, on sharing 

all sorts of intelligence relating to biological and bioterrorist 

threats. As members of the intelligence community, we participate 

regularly in interagency threat assessments. Our analysts coordinate these homeland-focused analyses on the current as well as the 

emerging biological threats, and we note our differences with the 

rest of the community when they occur. 

Our primary mission, however, is to provide as much relevant information as possible to our Federal, State and local partners so 

they understand the nature of this threat and can identify and report suspicious activities that could be considered preoperational 

indicators of a bioterrorist attack. 

IA has established a dedicated chemical, biological, radiological, 

nuclear and explosives analytical team in our Assessments Division; and they are explicitly devoted to the evaluation of all-source 

information on these threats and capabilities. Our analysis is tai-
6

lored to the DHS customers, daily support to the Secretary, Homeland Security Operations Center, the Science and Technology Directorate, the Border and Transportation Security Directorate, 

State and local customers. 

Our team is staffed with analysts experienced in intelligence and 

tradecraft as well as the subject matter of their portfolio. We have 

complemented these analysts with biological, chemical and nuclear 

subject matter experts who are on detail from various Department 

of Energy National Laboratories through an arrangement with the 

Science and Technology Directorate. 

Generally our analysts are engaged in two categories of analytic 

products. This is what I would call our bread and butter. 

The first are typical threat assessments, which are written on 

known actors and are based on specific intelligence. To determine 

threat, we examine an actor’s capability and intent. We assess capability based on factors such as the actor’s level of skill or knowledge, their ability to acquire a biological agent, the materials necessary to grow the agent and their capacity to effectively disseminate a biological agent. For intent, in addition to the actor’s desire 

to simply use biological weapons, we discern which agents they are 

more likely to pursue, their preferred method of deployment and 

which targets they intend to attack. 

We also perform feasibility assessments. Intelligence is never 

complete or all-knowing, and we cannot wait until intelligence is 

received in order to consider plausible scenarios or the impact of 

a particular technique or technology on a bioterrorist’s capability. 

To move beyond this limitation, IA, in partnership with S&T, conducts assessments of biological processes, emerging technologies 

and techniques and determines their feasibility for use in a bioterrorism event. These assessments include indicators that will help 

to identify if a particular venue begins to unfold so we can prevent 

or disrupt the events before they occur. 

In conjunction with these classified feasibility assessments, we 

are producing unclassified excerpts with the indicators which are 

distributed widely to local, Federal, State officials, as well as to the 

private sector to enhance their awareness and to increase suspicious activity reporting and trigger investigations where necessary. 

We recently published Indicators of Terrorist Production of Anthrax in June, 2005, with the knowledge that it will be at the local 

level where these indicators of operational activity are most embedded. 

In terms of our tailored support, under the BioShield legislation 

DHS is charged with assessing current and emerging threats and 

determining which of such agents present a material threat against 

the United States population. 

The Science and Technology Directorate, supported by IA, has 

been conducting material threat assessments and material threat 

determinations in order to guide near-term BioShield requirements 

and acquisitions. These material threat assessments are intelligence informed. However, they are not based on specific intelligence or a known actor. Rather, they are speculative in the sense 

that they represent a best estimate of how—
7

Mr. KING. Ms. Morr, if you could try to wrap it up in the next 

minute or two, because we do have two panels of witnesses today. 

Ms. MORR. Okay, I am sorry. 

Mr. KING. That is all right. 

Ms. MORR. Currently, the MTAs are drafted by S&T, and IA provides assessment before it is provided to HHS. We insure that the 

assessment reflects what IA assesses is the general capability of—

terrorist capabilities—that are pursuing biological weapons. This is 

an important consideration because, if the MTA overestimates the 

capability, the projected casualties and medical countermeasures 

will be artificially inflated. On the other hand, if the adversary is 

underestimated, we could be unprepared. So we perform a contribution into the S&T MTA. 

In summary, I guess I will just conclude by saying that IA has 

a robust and complementary chemical and biological analytic effort. 

We are partnering across DHS units with our State and local partners; and we are providing actionable, accurate expert assessments 

across the board. 

Mr. KING. Thank you. Sorry for the interruption, but we have—

[The statement of Ms. Morr follows:]

PREPARED STATEMENT OF KAREN MORR

Introduction 

Good morning Chairman King, Representative Pascrell, and distinguished members. Thank you for the privilege to discuss the role of the Department of Homeland 

Security’s (DHS) Office of Information Analysis (IA) in the threat assessment process and how these assessments are used to support our DHS operational components as well as our Federal, State, and local partners. 

The Department takes seriously the threat of bioterrorism. On a routine basis IA 

discusses with colleagues at the National Counterterrorism Center, CIA, and FBI, 

all-source intelligence on bioterrorist threats and potential operatives, their plans, 

and activities. Also, as members of the Intelligence Community we participate in 

interagency threat assessments. Our analysts coordinate their homeland-focused 

analysis on the current as well as the emerging biological threats, noting our differences with the rest of the Intelligence Community, when they occur. 

Our primary mission is to provide as much relevant information as possible to our 

Federal, State, and local partners so they understand the nature of this threat and 

can identify and report suspicious activities that could be considered pre-operational 

indicators of a bioterrorist attack. We also provide intelligence-derived threat information to Federal agencies so they can best tailor research, development, and program planning to the current threat streams. 

Today I have been asked to discuss the process by which we develop our threat 

assessments and analytical products, including those for BioShield. Last month one 

of our analysts provided some of the Committee members with a classified briefing 

on the specifics of the current bioterrorist threat to the Homeland. I will not be able 

to revisit this classified threat assessment in this open forum but we would be 

happy to provide this information to additional members in a closed session.

IA’s Approach to Threat Assessment 

IA has established a dedicated chemical, biological, radiological, nuclear, and explosives (CBRNE) analytical team in our Assessments Division explicitly devoted to 

the evaluation of all-source information on these threats and terrorist capabilities. 

Our current analysis and more in depth strategic threat assessments are tailored 

to our DHS customers, including daily support to the Secretary, the Homeland Security Operations Center, and the Science and Technology and Border and Transportation Security Directorates. State and local customers receive threat assessments 

as credible information becomes available. 

Our CBRNE team is staffed with analysts experienced in intelligence analysis and 

tradecraft as well as the subject-matter of their portfolio. We have complemented 

these analysts with biological, chemical, and nuclear subject-matter experts on detail from various Department of Energy National Laboratories through an arrangement with the S&T Directorate. These scientists bring deep technical knowledge 
8

that IA analysts leverage daily in their work so we can provide timely and accurate 

analysis on current WMD-related intelligence and threat information. 

On occasion, we require quick access to information that does not reside within 

IA. In these cases, our analysts are supported to the Biodefense Knowledge Center 

(BKC)—a 24x7 support cell based at Lawrence Livermore National Laboratory and 

sponsored by the S&T Directorate. The BKC possesses vast repositories of biological 

technical information and is able to access SMEs from around the country, such as 

the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), the 

U.S. Army Medical Research Institute for Chemical Defense (USAMRICD), and the 

Armed Forces Medical Intelligence Center (AFMIC), in support of a tasking from IA. 

The BKC compiles the appropriate information and relays it to our analysts who 

integrate the information into their finished intelligence analysis. 

Our analysts regularly collaborate with other intelligence agencies, particularly 

NCTC, DIA, FBI, and CIA. We also work with experts from government, academic, 

and private institutions and partner with scientists who keep us abreast of their potential areas of concern and the trends they see. Interaction with outside public and 

private sector institutions keeps us well-informed of new and emerging technology 

that may be exploited or misused by malicious actors. For example, IA recently 

hosted a workshop on emerging biotechnologies and the future biological threat. 

This provided a forum for non-governmental experts to provide IA with information 

of which they believe we should monitor. 

Our analysts are broadly focused and access a wide array of information in gathering source material for our assessments. They use all-source intelligence, scientific 

and technical information, terrorist profiles, historical trends, and open source information such as media reports and scientific journal articles. We keep current on foreign State biological weapons program developments as these activities may have 

implications for future terrorist events. We look at the intent of the enemy, their 

capabilities, potential scenarios, and attack vectors. Working with counterterrorist 

experts in the Community, we develop link charts on potential associates here in 

the United States of operatives abroad who may have received training in WMD capabilities or have knowledge of WMD programs.

Bioterrorism Analytical Products 

IA has produced several bioterrorism-related products examining the threat posed 

by specific actors, the potential misuse of biotechnology, and to alert operators in 

the field of possible bioterrorism activity. For example, we assessed the implications 

of the H2N2 influenza shipment in which a U.S. contractor sent a highly virulent 

strain of influenza to hundreds of laboratories worldwide. We also recently published an Information Bulletin advising State and local law enforcement officials of 

indicators of covert anthrax production. Generally, our products fall into two categories: threat assessments and feasibility assessments.

Threat Assessments. Threat assessments are written on known actors and are based 

on specific intelligence. To determine threat, we examine an actor’s capability and 

intent. We calculate capability based on factors such as a particular actor’s level of 

skill or knowledge; their ability to acquire a biological agent and the materials necessary to grow the agent; and their capacity to effectively disseminate a biological 

agent. For intent, we consider more than just an actor’s desire to use biological 

weapons. We attempt to discern which agents they are more likely to pursue, their 

preferred method of deployment, and which targets they intend to attack.

Feasibility Assessments. Intelligence is never complete or all-knowing and we cannot 

wait until intelligence is received in order to consider plausible scenarios or the impact of a particular technique or technology on a bioterrorist’s capability. To move 

beyond this limitation, IA, in partnership with S&T, conducts assessments of biological processes, emerging technologies, and techniques and determines their feasibility for use in a bioterrorism event. These assessments include indicators that will 

help to identify if a particular scenario begins to unfold so we can prevent or disrupt 

events before they occur. In conjunction with the feasibility assessment, we are producing unclassified excerpts with the indicators which are distributed widely to 

local, State, Federal officials as well as the private sector to enhance awareness in 

the field and to increase suspicious activity reporting and trigger investigations 

where necessary. 

IA also has produced several bioterrorism-specific ‘‘red team’’ products, which explore issues from a terrorist’s perspective using nongovernmental experts and creative thinkers. These topics have included terrorist use of genetically modified food 

and recombinant DNA technologies to damage the U.S. food supply; possible terrorist exploitation of a U.S. flu vaccine shortage; and the safety and security impacts of a pandemic influenza outbreak.
9

IA Support to BioShield 

Under the BioShield legislation, DHS is charged with assessing current and 

emerging threats of chemical, biological, radiological, and nuclear agents; and determining which of such agents present a material threat against the United States 

population. S&T, supported by IA, has been conducting Material Threat Assessments (MTAs) and Material Threat Determinations (MTDs) in order to guide nearterm BioShield requirements and acquisitions. 

MTAs are intelligence-informed; however, they are not based on a specific intelligence or a known actor. Rather, they are speculative and represent a best estimate 

of how an adversary may create a high-consequence event using the agent/weapon 

in question. Currently, MTAs are drafted by the S&T and IA provides comments 

on the assessment before it is provided to HHS. In our review, we ensure that the 

assessment reflects what IA assesses is the general capability of terrorist groups 

that are pursuing biological weapons. This is an important consideration; if the 

MTAs overestimate an adversary’s capability, the projected casualties and medical 

countermeasure requirements will be artificially inflated. On the other hand, if the 

adversary is underestimated, we could be underprepared and leave a gap in our defenses. 

The MTAs result in an estimate of the number of exposed individuals, the geographical extent of the exposure, and other collateral effects. If these consequences 

are of such a magnitude to be of significant concern to our national security, the 

Secretary of DHS then issues a formal Material Threat Determination to the Secretary of HHS, which initiates the BioShield process. 

To date, one MTA has been completed for anthrax and MTAs for plague, botulinum toxin, tularemia, radiological devices and chemical nerve agents are underway and an MTA for viral hemorrhagic fevers will be initiated next month. MTDs 

have been approved for four agents: smallpox, anthrax, botulinum toxin, and radiological/nuclear devices. Dr. Vitko will provide more information on MTAs and MTDs 

and how they are used by HHS.

IA Bioterrorism Initiatives 

Now I would like to inform you of some of IA’s initiatives to improve our bioterrorism threat knowledge and to pass on that knowledge to operators in the field. 

In March of this year we established a working group of twelve senior biological 

weapons analysts from various Intelligence Community agencies. This group, 

chaired by IA and vice-chaired by NCTC, was formed to provide intelligence support 

to the DHS National Biodefense Analysis and Countermeasures Center (NBACC), 

which is charged with conducting studies and laboratory experiments to fill in information gaps to better understand current and future biological threats. 

The working group is initially supporting the first National Biological Risk Assessment—a quantitative analysis of biological agents based on threat, 

vulnerabilities, and consequences that will enable the U.S. Government to prioritize 

research and development. After the risk assessment is completed later this year, 

the group will serve as the focal point for the Intelligence Community interaction 

with NBACC. The group will provide threat information to NBACC and will review 

their research conducted in support of the Intelligence Community. 

In order to get our information out to our largest user community—local and 

State law enforcement and first responders, IA, in cooperation with NCTC and the 

FBI, is providing WMD outreach briefings around the country. These briefings outline the terrorist WMD threat, including descriptions of the types of weapons used 

and indicators and warnings aimed at increase awareness and reporting. In the 

near future, we hope to expand these briefings to other audiences such as academia 

and the private sector to further increase awareness and reporting. 

IA will be playing a key role in supplying current intelligence to the National Biosurveillance Integration System (NBIS) operations center once it begins operation 

later this summer. NBIS will fuse information on human, plant, and animal health 

with environmental monitoring of air, food, and water systems. This information 

will be integrated with threat and intelligence information to provide real-time situational awareness and identify anomalies or trends of concern to the Homeland Security Operations Center.

Conclusion 

In sum, IA has developed a robust, but complementary, CBRNE analysis capability with other partners in the Intelligence Community. We remain focused on our 

unique Departmental niche which is to push as much information as possible to our 

State and local partners on a timely basis, to focus exclusively on the possibilities 

of, and potential for, a Homeland-focused attack, and to provide actionable, accurate 

expert assessments to DHS leadership and operational components. 
10

We are building a unique culture and rewarding experience for our analysts who 

are comfortable in their intelligence and operational roles and in applying the best 

scientific knowledge available to the U.S. government to combat the enduring 

CBRNE threat to the Homeland.

Mr. KING. Dr. Vitko, again, if you can try to keep it to 5 minutes; 

and the balance of your statement will be made a part of the 

record. 

STATEMENT OF JOHN VITKO, JR., DIRECTOR, BIOLOGICAL 

COUNTERMEASURES PORTFOLIO DIRECTORATE OF 

SCIENCE AND TECHNOLOGY, DEPARTMENT OF HOMELAND 

SECURITY 

Mr. VITKO. I will comply. 

Good morning, Chairman King, Chairman Cox, Congressman 

Pascrell and Ranking Member Thompson and distinguished members of the subcommittee. I am pleased to appear before you today 

to discuss the role that the Department of Homeland Security’s 

threat and risk assessments play in informing and prioritizing BioShield acquisitions and to discuss our close coordination with the 

Department of Health and Human Services throughout the process. 

As you know, the Project BioShield Act of 2004 charges the Secretary of Homeland Security with the responsibility to determine 

which biological, chemical, radiological and nuclear threats constitute a material threat to our Nation’s security. 

To fulfill this responsibility, DHS S&T, in partnership with Information Analysis and Infrastructure Protection Directorate, IAIP, 

has been conducting formal threat risk assessments of the greatest 

concern to establish plausible high-consequence scenarios. 

In this process, IAIP, as you have already heard, in concert with 

other members of the intelligence community, provides information 

on the capabilities, plans and intentions of terrorists and other 

nonstate actors. However, since lack of intelligence on a threat does 

not mean lack of a threat, S&T, in concert with the appropriate 

members of the technical community, assesses the technical feasibility of the terrorists being able to obtain, disseminate and 

produce the agent in question and the resulting vulnerabilities and 

consequences. This information is used to establish a plausible 

high-consequence scenario that provides an indication of the number of exposed individuals, the geographical extent of the exposure 

and other collateral effects. If these consequences are of such a 

magnitude to be of significant concern to our national security or 

public health, the Secretary of DHS issues a formal threat determination to the Secretary of HHS, which initiates the BioShield 

process. 

To date, the Secretary of DHS has issued material threat determinations for four agents: anthrax, smallpox, botulinum antitoxin 

and radiological/nuclear devices. In addition, threat and risk assessments are currently under way and will be completed this year 

for plague, tularemia, radiological devices and chemical nerve 

agents; and a threat assessment for viral hemorrhagic fevers will 

be issued next month in August. 

Once a material threat determination has been issued, HHS assesses the potential public health consequences of the identified 

agent, determines the needs for countermeasures, evaluates the 
11

availability of current countermeasures and the possibility of development of new countermeasures. They are assisted by the interagency Weapons of Mass Destruction Countermeasures Subcommittee. Any recommendations issued for the acquisition of a 

specific countermeasure are evaluated through the interagency 

process that forms the basis of U.S. government requirements. 

After approval of these requirements by the Office of Management 

and Budget, HHS issues a request for proposals and implements 

and manages the subsequent acquisition process through the delivery of countermeasures through the strategic national stockpile. 

Throughout this process DHS works very closely with HHS. HHS 

subject matter experts participate in threat assessments and risk 

assessments. HHS, DHS and Department of Defense co-chair the 

WMD Medical Countermeasures Subcommittee; and HHS keeps 

DHS informed about the subsequent acquisition processes. These 

interactions occur at multiple levels, from formal interagency committees through bilateral management interactions to informal but 

important contact and collaborations amongst the working scientists. 

The threat assessments discussed above focus on those CBRN 

agents widely believed to be of the greatest concerns that guide 

near-term BioShield acquisition policies. In essence, we have jumpstarted the process. 

DHS S&T is also conducting three activities to guide future 

rounds of BioShield acquisition. As part of our responsibilities in 

the President’s request for biodefense in the 21st century, we are 

conducting a formal risk assessment across a wide range of biological threats, including all Category A and B agents from the Centers for Disease Control and Prevention threat list, some Category 

C agents and a number of potential engineered threats. These risk 

assessments will be completed by January of 2006 and factor in the 

technical feasibility of producing and disseminating the threat, the 

vulnerability of different portions of our society to those threats 

and the resulting consequences of any such attacks. 

Looking still further into are the future, we have partnered with 

HHS and others in formulating and implementing the strategy for 

anticipating and responding to engineered threats. Together, we 

have developed and informed them of types of emerging threats 

that might be within the ability of a terrorist organization to develop the near, mid and longer terms and have laid out a strategy 

for addressing them. 

Realizing that there are still large uncertainties, sometimes factors of 10 to 100 and some of the key parameters underlying these 

threat and risk assessments, we have established a National Biodefense and Countermeasure Center to conduct the laboratory experiments needed to reduce these uncertainties. Pending the completion of construction and associated facilities on the four-teacher 

campus in 2008, interim capabilities have been established with 

other government and private laboratories to begin this vital work. 

In summary, the DHS Science and Technology Directorate’s 

threat and risk assessments play a critical role in prioritizing BioShield acquisitions. Throughout the process we work closely with 

our colleagues at HHS to most effectively couple HHS expertise on 
12

threat and risk with HHS expertise on human health to better protect our Nation. 

This concludes my prepared statement. Mr. Chairman, Congressman Cox, Congressman Pascrell, Ranking Member and members of 

the subcommittee, I thank you for the opportunity to appear before 

you; and I would be happy to answer any questions you may have. 

Mr. KING. Thank you, Dr. Vitko. 

[The statement of Mr. Vitko follows:]

PREPARED STATEMENT FOR THE RECORD OF DR. JOHN VITKO, JR. 

INTRODUCTION 

Good afternoon, Chairman King, Congressman Pascrell and distinguished members of the Subcommittee. I am pleased to appear before you today to discuss the 

role that the Department of Homeland Security’s (DHS) threat and risk assessments 

play in informing and prioritizing BioShield acquisitions and to discuss our close coordination with the Department of Health and Human Services throughout that 

process. 

Before focusing on the Department’s specific activities in support of Project Bioshield, I would like to put these activities in the broader context of the overall responsibilities and activities of the DHS Biological Countermeasures Portfolio (Bio 

Portfolio) which I direct. The mission of this Portfolio is to provide the understanding, technologies, and systems needed to anticipate, deter, protect against, detect, mitigate, and recover from possible biological attacks on this nation’s population, agriculture or infrastructure. 

In addressing this mission, DHS has a leadership role in several key areas and 

partners with lead agencies in others. Those areas in which the Science and Technology (S&T) Directorate provides significant leadership are: • Providing an overall end-to-end understanding of an integrated biodefense 

strategy, so as to guide the Secretary and the rest of the Department in its responsibility to coordinate the nation’s efforts to deter, detect, and respond to 

acts of biological terrorism. 

• Providing scientific support to better understand both current and future biological threats and their potential impacts so as to guide the research and development of biodefense countermeasures such as vaccines, drugs, detection systems and decontamination technologies. 

• Developing early warning, detection and characterization systems to permit 

timely response to mitigate the consequence of a biological attack. 

• Conducting technical forensics to analyze and interpret materials recovered 

from an attack to support attribution. 

• Operation of the Plum Island Animal Disease Center to support both research 

and development (R&D) and operational response to foreign animal diseases 

such as foot and mouth disease. 

DHS also supports our partnering departments and agencies with their leads in 

other key areas of an integrated biodefense: the Department of Health and Human 

Services (HHS) on medical countermeasures and mass casualty response; the Department of Defense (DoD) on broad range of homeland security/homeland defense 

issues; the U.S. Department of Agriculture (USDA) on agriculture biosecurity; 

USDA and HHS on food safety; the Environmental Protection Agency (EPA) on decontamination and on water security; the Department of Justice on bio-terrorism investigations; and the Intelligence Community on threat warnings.

THREAT AND RISK ASSESSMENTS 

As noted above, providing threat and risk assessments of both current and future 

threats and the scientific understanding to improve and refine these assessments 

is a major responsibility for DHS. These responsibilities are further defined in the 

BioShield Act of 2004, which charges the Secretary of DHS with the responsibility 

for determining which threats constitute a Material Threat to the national security 

or public health of the Nation and in the President’s Biodefense for the 21st Century,

which charges DHS with the lead in ‘‘conducting routine capabilities assessments 

to guide prioritization of our ongoing investments in biodefense-related research, development, planning and preparedness’’. 

Today, I would like to focus on four major activities that we have undertaken to 

fulfill these responsibilities and that help guide both near and longer-term acquisitions of medical countermeasures: 

1. Material Threat Assessments and Determinations in support of near-term 

Project BioShield procurements; 
13

2. Risk Assessments across a broader range of biological threats; 

3. A Strategy for Addressing Emerging Threats (in partnership with the Department of Health and Human Services (HHS) and others); 

4. Scientific research to better inform these threat and risk assessments.

Material Threat Assessments and Determinations In Support of Near-Term 

Project BioShield Procurements 

Working with the DHS Directorate for Information Analysis and Infrastructure 

Protection (IAIP), DHS S&T has been conducting assessments and determinations 

of biological, chemical, radiological and nuclear agents of greatest concern so as to 

guide near-term BioShield requirements and acquisitions. In this process, IAIP, in 

concert with other members of the intelligence community, provides information on 

the capabilities, plans and intentions of terrorists and other non-state actors. However, since lack of intelligence on a threat does not mean lack of a threat, S&T, in 

concert with appropriate members of the technical community, also assesses the 

technical feasibility of a terrorist being able to obtain, produce and disseminate the 

agent in question. This information is used to establish a plausible high consequence scenario that provides an indication of the number of exposed individuals, 

the geographical extent of the exposure, and other collateral effects. If these consequences are of such a magnitude to be of significant concern to our national security or public health, the Secretary of DHS then issues a formal Material Threat 

Determination to the Secretary of HHS, which initiates the BioShield process. 

To date, the Secretary of DHS has issued Material Threat Determinations for four 

‘‘agents’’: anthrax, smallpox, botulinum toxin, and radiological/nuclear devices. Additional threat assessments are currently underway for plague, tularemia, radiological 

devices and chemical nerve agents and a threat assessment for viral hemorrhagic 

fevers will be initiated next month. 

Once a Material Threat Determination (MTD) has been issued, the HHS then assesses the potential public health consequences of the identified agent, determines 

the need for countermeasures, evaluates the availability of current countermeasures 

and the possibility of development of new countermeasures. They are assisted by the 

interagency Weapons of Mass Destruction Medical Countermeasures (WMD–MC) 

subcommittee. Any recommendations issued for the acquisition of a specific countermeasure are evaluated through interagency processes and form the basis of the U.S. 

Government requirements. After approval of these requirements by the Office of 

Management and Budget, the HHS issues a Request for Proposals and implements 

and manages the subsequent acquisition process through delivery of the countermeasures to the Strategic National Stockpile. 

Throughout this process DHS works very closely with HHS. HHS subject matter 

experts participate in the threat assessments. HHS, DHS, and DoD co-chair the 

WMD–MC committee. And HHS keeps DHS informed about the subsequent acquisition process. These interactions occur at multiple levels from formal interagency 

committees (WMD–MC) through bi-lateral management interactions to informal but 

important contact and collaborations amongst the working scientists.

Risk Assessments Across a Broader Range of Biological Threats 

The preceding discussion dealt with threat assessments of those CBRN agents 

widely agreed to be of greatest concern so as to guide near-term BioShield acquisition processes. As part of its responsibility in the President’s National Biodefense 

Strategy, DHS is conducting a formal risk assessment of a much broader set of biological agents to help prioritize the nation’s ongoing biodefense activities, including 

subsequent rounds of BioShield acquisitions. These risk assessments provide a systematic look at the technical feasibility of a broad range of biological threats, the 

vulnerability of different portions of our society to those threats, and the resulting 

consequences of any such attacks. 

The first such formal risk assessment is due in the winter of 2006, with subsequent assessments due every two years. The scope, process and timescale for this 

first assessment have been presented to and agreed to by the interagency Biodefense Policy Coordinating Committee co-chaired by the Homeland Security Council and the National Security Council. This assessment is addressing:

• All six category A agents from the Centers for Disease Control and Prevention (CDC) threat list; 

• All 12 category B agents; 

• Five representative category C agents; and 

• A number of candidate drug-resistant and emerging agents.

Key outputs will include: 

• A list of bio-threats prioritized by risk; 

• A prioritized list of critical knowledge gaps that if closed should reduce risk 

assessment uncertainty and guide bio-defense research and development; and 
14

• A list of biodefense vulnerabilities that could be reduced by countermeasure 

development and acquisition. 

This risk assessment is being conducted in partnership with the Intelligence Community, the HHS, the Department of Defense, the U.S. Department of Agriculture, 

the Environmental Protection Agency and others. Two advisory boards, one a Government Stakeholders Advisory Board and the other an Independent Risk Assessment Expert Review Board (academia, industry and government) have been established to provide input and advice. 

This and subsequent risk assessments will play a critical role in informing future 

biodefense programs across all agencies, including BioShield acquisitions and the 

longer-term medical R&D leading up to such acquisitions.

A Strategy for Addressing Emerging Threats 

Much of the biodefense efforts to date have focused on protecting against attacks 

with bioterrorism agents that can be (or used to be) found in nature. However, rapid 

advances in biotechnology demand that we also consider the possibility and impact 

of emerging or engineered agents. e.g. modifications to organisms that increase their 

resistance to medical countermeasure or make them more difficult to detect. The 

President’s Biodefense for the 21st Century assigns the HHS the lead in anticipating 

such future threats. We, DHS S&T, are partnering with HHS and others in formulating and implementing a strategy for anticipating and responding to such threats. 

Based on intelligence information, available literature and expert judgment, we 

have developed an informed estimate of the types of emerging threats that might 

be within the ability of a terrorist organization to develop over the near (1–3 years), 

mid (4–10 years), and longer-terms (10 yrs). We have also examined the impact of 

these threats on the four pillars of the National Biodefense Policy: Threat Awareness, Prevention and Protection, Surveillance and Detection, and Response and Recovery. 

In this analysis, four elements stand out as essential to an effective defense 

against emerging threats: 

• Threat, vulnerability and risk assessments to prioritize these threats in terms 

of the difficulty of their development and deployment, as well as their potential 

consequences; 

• Surveillance and detection capabilities to rapidly detect and characterize engineered agents in environmental and clinical samples so as to provide timely 

guidance in the selection of the appropriate medical countermeasure; 

• An expanded range of safe and effective medical countermeasures and an infrastructure to support rapid research, development, test and evaluation 

(RDT&E) of new medical countermeasures; and 

• integrated concepts of operation (CONOPS) for the identification and response 

to emerging threats. In addition to conducting these assessments, DHS will continue to collaborate with HHS as it leads efforts to anticipate agents and to facilitate the availability of medical countermeasures.

Scientific research to better inform these threat and risk assessments 

The threat and risk assessments described above are performed with the best 

available information. However, there are large uncertainties, sometimes factors of 

ten to a hundred, in some of the key parameters and hence in the associated risks. 

One of the major functions of the threat and risk assessments is to identify these 

critical knowledge gaps, which can differ for different threat scenarios—in one case 

it can be the minimum amount of agent needed to infect a person; in another case 

it can be the time that such an agent remains viable (capable of causing an infection) in the air, food or water; and in a third it can be the effect of food processing 

or water treatment on the agent’s viability. Conducting the laboratory experiments 

to close the critical knowledge gaps is a primary function of DHS’s National Biodefense Analysis and Countermeasures Center (NBACC). 

Congress has appropriated a total of $128M for design and construction of 

NBACC with the necessary biocontainment laboratory space and support infrastructure to conduct these and other experiments. NBACC will be built on the National 

Interagency Biodefense Campus (NIBC) at Ft. Detrick MD, where its close physical 

proximity to the DoD’s United States Army Medical Research Institute for Infectious Diseases (USAMRIID), the NIH’s Integrated Research Facility and the USDA’s 

Foreign Disease-Weed Science Research Unit. NBACC is also collaborating with the 

Centers for Disease Control and Prevention to further address the critical knowledge gaps. The Record of Decision for NBACC’s Final Environmental Impact Statement was signed in January 2005. Design of the facility began in March 2005, with 

construction scheduled to begin in FY 2006 and be complete by the fourth quarter 

of FY 2008. 
15

Currently, interim capabilities for both NBACC’s biological threat awareness and 

bioforensic analysis functions have been established with other government and private laboratories to allow vital work in these areas to occur during the NBACC facility’s construction.

CONCLUSION 

In summary, the DHS Science and Technology Directorate’s programs in threat 

and risk assessment play a critical role in prioritizing both near and longer-term 

BioShield acquisitions and hence in furthering the Committee’s goal of ‘‘Linking Bioterrorism Threats and Countermeasure Procurement to Enhance Terrorism Preparedness’’. Throughout this process we work closely with our colleagues at HHS 

through a variety of interagency, bi-lateral, and informal scientist-to-scientist interactions so as to most effectively couple DHS expertise on the threat with HHS expertise on human health to better protect our Nation. 

This concludes my prepared statement. With the Committee’s permission, I request my formal statement be submitted for the record. Mr. Chairman, Congressman Pascrell, and Members of the Subcommittee, I thank you for the opportunity 

to appear before you and I will be happy to answer any questions that you may 

have.

Mr. KING. Now Secretary Simonson. 

STATEMENT OF THE HONORABLE STEWART SIMONSON, 

ASSISTANT SECRETARY, OFFICE OF PUBLIC HEALTH 

EMERGENCY PREPAREDNESS, DEPARTMENT OF HEALTH 

AND HUMAN SERVICE 

Mr. SIMONSON. Thank you. 

Good morning, Mr. Chairman, Chairman Cox, Mr. Pascrell, Mr. 

Thompson and other members of the committee. I am Stewart 

Simonson, Assistant HHS Secretary for Public Health and Emergency Preparedness. I appreciate the opportunity to share with you 

information on the Department’s progress on implementing the 

Project BioShield Act of 2004 and specifically the linkage between 

acquisition programs and threat assessments provided by our colleagues at the Department of Homeland Security. 

The events of September and October of 2001 made it very clear 

that terrorism is a serious threat to our Nation and to the world. 

The Bush Administration and Congress responded forcefully to this 

threat by strengthening our medical and public health capacities to 

protect our citizens from future attacks. To encourage the development of new medical countermeasures against threat agents and to 

speed their delivery, President Bush in his 2003 State of the Union 

Address proposed—and Congress subsequently enacted—Project 

BioShield. The $5.6 billion 10-year Special Reserve Fund was created to assure developers of medical countermeasures that funds 

would be available for the government to purchase critical products. Since enactment, my office has moved aggressively to fill immediate gaps in our countermeasure armamentarium. 

A genuine sense of urgency influences all of our Homeland Security work at HHS, but it is important to note that the successful 

development and manufacture of safe and effective countermeasure 

requires an investment of both money and time. No matter how 

hard we try, some steps in the process cannot be rushed. There is 

a complex spectrum of effort needed along the research and development pipeline to produce a use able medical countermeasure. Defining specifications for a needed countermeasure often reveals few, 

if any, candidates in the pipeline. To date, we have been fortunate 

that some of our highest priority needs for medical counter-
16

measures could be addressed using the available advanced development products already in the pipeline. 

In determining the requirements and evaluating options for medical countermeasure acquisition, the focal point for the U.S. government interagency efforts is the Weapons of Mass Destruction Medical Countermeasure Subcommittee. HHS, along with representatives from the Department of Homeland Security and the Department of Defense, chairs the WMD subcommittee; and stakeholders 

from throughout the U.S. government are represented on its working groups. 

In setting priorities for medical countermeasure acquisitions 

under Project BioShield, the WMD subcommittee considers a number of factors, the credibility and immediacy of specific threats or 

driving factors and are informed by material threat assessments 

conducted by our colleagues at DHS. 

Among biological threat agents, smallpox and anthrax are widely 

recognized as having the greatest potential to cause catastrophic 

harm. Material threat determinations for these agents were among 

the first ones made by the Secretary of Homeland Security, along 

with those for botulinum antitoxin and radiological and nuclear 

agents. We also can consider the current and projected availabilities of appropriate medical countermeasures as well as the target 

population for which the countermeasure would be used. 

In addition, logistical issues are considered, such as the feasibility of deployments in a medical public health emergency, shelf 

life, storage life and maintenance requirements. 

Project BioShield requires a number of findings by the Secretaries of Homeland Security and HHS prior to an acquisition commencing. These findings include three determinations: first, that 

there is a material threat against the U.S. population sufficient to 

affect national security; second, that medical countermeasures are 

necessary to protect the public health from that material threat; 

third, that acquiring a specific quantity of a particular medical 

countermeasure, using the Special Reserve Fund, is appropriate. 

These determinations are followed by a joint recommendation to 

the White House by the two Secretaries. If approved, Congress is 

notified and HHS executes the acquisition program. 

The process that I have outlined has been successfully implemented through contract award three times since the enactment of 

Project BioShield nearly a year ago. HHS has completed contract 

awards for acquisitions for next-generation recombinant protective 

antigen anthrax vaccine, the current-generation licensed anthrax 

vaccine and the pediatric formulation of potassium iodide. Additionally, the acquisition process is in the final execution phases for 

several other needed medical countermeasures, including anthrax 

therapeutics, botulinum antitoxin and a next-generation smallpox 

vaccine. All of these acquisition programs have been threatened by 

material threat determinations by DHS. 

This robust interagency process mines the expertise in the scientific and intelligence communities to define requirements for 

medical countermeasures and enables policymakers to identify and 

evaluate acquisition options to address immediate and future 

needs. 
17

As we move forward with implementation of Project BioShield, 

the decisions about priority setting for how best to use the remaining funding will become more challenging and more dependent on 

guidance from DHS. 

I must emphasize that the number of threat agents from which 

we could guard ourselves is endless. New and emerging threats introduced by man or nature will present continuing challenges. Although we cannot be prepared for every potential threat, we are 

implementing a strategic approach for identifying and combatting 

the highest priority threats as assessed in large part by our colleagues at DHS. 

In closing, let me say that HHS has a clear mandate from President Bush and Congress to lead the charge in medical countermeasure development. We have already made important strides to 

address the public health needs of the Nation, but more needs to 

be done. 

Mr. Chairman, I look forward to working with you, Congressman 

Pascrell and the subcommittee to address the challenges of CBRN 

preparedness and its impact on public health. I would be happy to 

answer any questions. 

Mr. KING. Thank you for your testimony, Mr. Simonson. 

[The statement of Mr. Simonson follows:]

PREPARED STATEMENT OF HON. STEWART SIMONSON

Good morning, Chairman King, Mr. Pascrell, and Subcommittee members. I am 

Stewart Simonson, Assistant Secretary for Public Health Emergency Preparedness, 

Department of Health and Human Services (HHS). I appreciate the opportunity to 

share with you information on the Department’s progress in research, development 

and acquisition programs for medical countermeasures, particularly with regard to 

the implementation of the Project BioShield Act of 2004 (‘‘Project BioShield’’), and 

in particular, the linkage of our acquisition programs to threat assessment provided 

by our colleagues at the Department of Homeland Security (DHS). These programs 

are vital components of our strategy to protect the Nation from threats posed from 

chemical, biological, radiological and nuclear (CBRN) threats. Defending against 

such threats is a top priority for the Bush Administration and having an appropriate armamentarium of medical countermeasures is a critical element of the response and recovery component of the President’s ‘‘21st Century Strategy for Biodefense.’’ The acquisition and ready availability of medical countermeasures, such 

as antibiotics, antivirals, monoclonal and polyclonal antibodies against infectious 

threats, therapies for chemical and radiation-induced illnesses, and vaccines to protect against exposure from biological agents are essential to our Nation’s preparedness and response capabilities.

Protecting Americans 

The events of September and October 2001 made it very clear that terrorism-indeed bioterrorism- is a serious threat to our Nation and the world. The Bush Administration and Congress responded forcefully to this threat by providing funding 

to strengthen our medical and public health capacities to protect our citizens from 

future attacks. Specifically, substantial increases in funding for research, development and acquisition of medical countermeasures against biological threats were directed to the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention’s Strategic National Stockpile (SNS or ‘‘the Stockpile’’). To further encourage the development of new medical countermeasures against chemical, 

biological, radiological and nuclear agents and to speed their delivery and use 

should there be an attack, President Bush, in his 2003 State of the Union address 

proposed and Congress subsequently enacted Project BioShield. The Special Reserve 

Fund, appropriated with $5.6 billion was created to assure developers of medical 

countermeasures that funds would be available to purchase these critical products 

for use to protect our citizens.

The Strategic National Stockpile Today 

The wake-up call that we received in the fall of 2001 highlighted the gaps in our 

medical countermeasure armamentarium and we immediately began working to ad-
18

dress them. Although much remains to be done, we have made significant progress 

in building our Strategic National Stockpile from that time to what we have onhand today. For example, our smallpox vaccine stockpile has grown from 90,000 

ready-to-use doses in 2001 to enough vaccine to protect every man, woman, and 

child in America. Major strides have been made in building our medical countermeasure reserve against anthrax, plague, and tularemia. We are now able to protect 

and treat millions of Americans in the event of an attack with one of these agents. 

We have taken the botulinum antitoxin program started by the Department of Defense in the early 1990s to completion and we are now building our botulinum antitoxin stockpile further. We have also built our stockpile of countermeasures to address the effects of radiation exposure with products such as Prussian Blue and 

diethylenetriaminepentaacetate (DTPA). These countermeasures act to block uptake 

or remove radioactive elements such as cesium, thallium, or americium from the 

body after they are ingested or inhaled. Potassium iodide, a drug that can protect 

the thyroid from the harmful effects of radioactive iodine, is also in the Stockpile.

The Strategic Approach to Addressing Medical Countermeasure Gaps 

The initial focus of our efforts to protect the Nation was aimed largely at those 

threats that could do the greatest harm to the greatest number of our citizens. 

Among biological threat agents, smallpox and anthrax are widely recognized as having the greatest potential to cause catastrophic harm. These Material Threat Determinations were among the initial ones made by the Secretary of Homeland Security. 

A sense of urgency has pervaded our efforts and we have defined new ways of doing 

business. Our new national security environment demands accelerated product development timelines and new paradigms of interactions between industry and government with increased risk-sharing and enhanced intra-governmental collaboration. 

The focal point for USG interagency efforts to prioritize and coordinate medical 

countermeasures acquisition programs is the Weapons of Mass Destruction Medical 

Countermeasures (WMDMC) Subcommittee (‘‘WMDMC Subcommittee’’). HHS, along 

with representatives from the Department of Homeland Security (DHS) and the Department of Defense (DoD), co-chairs the WMDMC Subcommittee and stakeholders 

from throughout the USG are represented on it. Because HHS is the primary federal agency responsible for the development and acquisition of priority medical 

countermeasures, we have a major leadership role in the WMDMC Subcommittee. 

The cornerstone of any sound acquisition program is the determination and 

prioritization of requirements and this is a primary activity of the WMDMC Subcommittee. In setting priorities for medical countermeasure acquisition under 

Project BioShield, the WMDMC Subcommittee considers a number of factors. The 

credibility and immediacy of the specific threats are driving factors and are informed by Material Threat Assessments (MTAs) conducted by the DHS. Acting Assistant Secretary Morr and Dr. John Vitko, here today representing DHS, will provide insight into these efforts. Other factors include an evaluation of the availability 

of appropriate countermeasures, both current and projected, and the target population for which the medical countermeasure would be used. In addition, logistical 

issues are considered such as the feasibility of deployment in a public health emergency, shelf life, and the storage and maintenance requirements. Project BioShield 

also requires a number of findings by the Secretaries of Homeland Security and 

HHS prior to an acquisition commencing. These findings include: 

—Determination of material threat against the US population sufficient to affect national security. This determination is made by the Secretary of Homeland 

Security. 

—Determination that countermeasures are necessary to protect public health. 

This determination is made by the Secretary of HHS. 

—Determination of the appropriateness of funding acquisition of the countermeasure with the Special Reserve Fund (SRF). This determination is made by 

the Secretary of HHS. 

Once these determinations are made, a joint recommendation for the acquisition 

is presented to the White House by the two Secretaries. If approved, Congress is 

notified and HHS executes the acquisition program. 

The process that I have outlined for you has been successfully implemented three 

times since the enactment of Project BioShield less than one year ago. HHS has 

completed contract awards for acquisitions of the next-generation recombinant protective antigen (rPA) anthrax vaccine, the current-generation licensed anthrax vaccine (Anthrax Vaccine Adsorbed, AVA), and the pediatric formulation of potassium 

iodide. Additionally, the acquisition process is in the final execution phases for several other needed medical countermeasures including anthrax therapeutics, botulinum antitoxin, and a next-generation smallpox vaccine. 
19

This robust interagency process mines the expertise of subject matter experts in 

the scientific and intelligence communities to define requirements for medical countermeasures and enable policy makers to identify and evaluate acquisition options 

to address immediate and future needs.

Application of the Strategic Approach: Anthrax. 

The efficiency and effectiveness of the steps used to identify, prioritize, and acquire needed medical countermeasures is best exemplified by our efforts to protect 

the Nation in the event of an anthrax attack. It will also illustrate intra-agency and 

interagency processes. 

Although anthrax is not transmissible from person-to-person, an attack involving 

the aerosol dissemination of anthrax spores, particularly in an urban setting, is considered by public health experts to have the potential to cause catastrophic damage. 

The potential for large-scale population exposure following aerosol release of anthrax spores, the threat demonstrated by the anthrax letters, and our knowledge 

that anthrax had been weaponized by state-actors, highlighted the nature of the 

threat. The Secretary of Homeland Security determined that anthrax presented a 

material threat against the United States population sufficient to affect national security. Because untreated inhalation anthrax is usually fatal, the Secretary of HHS 

identified anthrax as a significant threat to public health. 

The approach to protect citizens against this threat demanded immediate, intermediate and long-term strategies and requirements. First, the existing stockpile of 

antibiotics in the Strategic National Stockpile was increased. Second, there is a need 

for a licensed vaccine to be used not only for pre-exposure protection for laboratory 

and other workers at known risk for anthrax, but for use along with antibiotics after 

an exposure, which could decrease the currently recommended 60-day course of antibiotic therapy. 

Anthrax spores are stable in the environment and would have a profound impact 

if released in an urban population. Therefore, availability of a vaccine may be a critical requirement for repopulation and restoration of the functionality of any exposed 

area. 

Due to limitations inherent in the currently available anthrax vaccine, there is 

consensus in the scientific community about the need to develop and acquire a nextgeneration anthrax vaccine using 21st century technologies An assessment of developing technologies was undertaken by HHS experts in the fall of 2001 and the decision was made that there was a sufficient scientific foundation, including a detailed 

understanding of the pathogenesis of anthrax and how anthrax vaccines provide 

protective immunity, to support the aggressive development of a next generation 

vaccine consisting of recombinant protective antigen (rPA). The research undertaken 

to develop this vaccine, spanning more than a decade, was conducted in large part 

by the United States Army Medical Research Institute of Infectious Diseases 

(USAMRIID) at Fort Detrick, Maryland. 

HHS defined a three-stage development and acquisition strategy with open competition for awards at each stage. The early and advanced development programs 

were supported by the NIH’s National Institute of Allergy and Infectious Diseases 

(NIAID) with contract awards in September 2002 and 2003, respectively. These 

were milestone-driven contracts with well-defined deliverables, including the manufacture of clinical-grade vaccine, the conduct of Phase I and Phase II clinical trials, 

and consistency lot manufacturing of vaccine. Large-scale manufacturing capacity 

would be required to support the civilian requirement for this medical countermeasure, which was defined by the WMD Subcommittee to be the initial protection 

of up to 25 million persons. Senior officials from several Departments of the USG 

evaluated acquisition options to achieve this requirement and, in the fall of 2003, 

approved the decision to pursue this acquisition of rPA anthrax vaccine. 

An evaluation of the NIAID rPA anthrax vaccine development program indicated 

that it was robust enough to suggest that the rPA vaccine could become a licensed 

product within the statutory requirements. In March 2004, the acquisition program 

for this vaccine, under the direction of my office, was launched using the Special 

Reserve Fund created in the FY 2004 DHS appropriations bill. Utilizing a robust 

technical and business evaluation process, we reviewed multiple proposals and negotiated a contract for the acquisition of 75 million doses of the vaccine (anticipating 

a three-dose regimen). Using a milestone and deliverables approach similar to the 

ACAM2000 smallpox vaccine development and acquisition program, and the rPA anthrax vaccine development contracts at NIAID, the rPA vaccine BioShield acquisition contract lays out an ambitious program for the production of this vaccine. In 

accordance with Project BioShield, a critical aspect of this acquisition contract is the 

fact that no payment for product is made until a usable product is delivered to the 

SNS. While awaiting delivery of the rPA anthrax vaccine to the SNS, my office 
20

awarded a contract last month for 5 million doses of the currently licensed AVA vaccine to support immediate requirements. Delivery of this product to the Stockpile 

began soon after contract award and over one million doses of the licensed anthrax 

vaccine are now in the SNS.

Application of the Strategic Approach: Other Medical Countermeasures 

In an effort to fill other medical countermeasure gaps, we have made progress in 

contracting for products that are or will soon be delivered to the SNS. 

Potassium Iodide. 

In March 2005 a contract was awarded under Project BioShield for a pediatric liquid formulation of potassium iodide, a drug that helps limit risk of damage to the 

thyroid, from radioactive iodine. This formulation is aimed at young children who 

have difficulty taking pills and are at the highest risk of harmful effects from exposure to radioactive iodine. This acquisition will provide needed protection for at least 

1.7 million children. Product delivery began in May and should be completed by the 

end of the fiscal year.

Ongoing Project BioShield activities. 

In addition to the acquisition contracts that have been awarded since enactment 

of Project BioShield, there are several other important BioShield procurement-related activities underway. We are engaged in contract negotiations for anthrax 

therapies, and we are continuing to move forward on the acquisition of an antitoxin 

treatment for botulism. Furthermore, HHS has moved forward with the initial 

stages of an acquisition program for a next generation smallpox vaccine to meet a 

requirement for this product that addresses the millions of U.S. citizens who have 

contraindications for existing smallpox vaccines. A synopsis has been announced indicating that the RFP would be released later this month. This follows the consideration of industry comments received in response to a draft RFP that was released 

in May. We have also sought information from industry by releasing an RFI to assess the state of development of therapeutics for acute radiation syndrome. 

Finally, in anticipation of yet to be determined requirements, we actively monitor 

the state of the medical countermeasure pipeline—both within and outside the government—by evaluating USG research and development portfolios and engaging industry through the publication of Requests for Information (RFIs). For example, we 

have recently released three RFIs to assess the timeline to maturity of medical 

countermeasures to treat nerve agent exposure, acute radiation syndrome, and additional products that might be available to treat anthrax. These requests are a key 

tool for HHS to dialogue with industry partners and to inform the development of 

sound USG acquisition strategies.

Priority Setting Beyond Smallpox and Anthrax 

The approach taken to rapidly expand our Nation’s response capacity to meet the 

medical and public health impact of either a smallpox or anthrax attack demonstrate our national resolve to address these threats. However, in many ways, anthrax and smallpox represent the ‘‘low hanging fruit’’ for medical countermeasure 

research, development and acquisition and was largely made possible by a substantial research base developed by USAMRIID and NIH. There was consensus that 

these were our highest priorities and we had countermeasures available or relatively far along in the development pipeline to permit acquisition. Given an almost 

endless list of potential threats with finite resources to address them, prioritization 

is essential to focus our efforts. We rely heavily upon our interagency partner, the 

Department of Homeland Security, to provide us with a prioritized list of threats 

along with material threat assessments that will include reasonable estimates of 

population exposure. This information is critical for future strategic decision making 

regarding how best to focus our National efforts in countermeasure development 

and acquisition, including whether in the short-term, the so-called ‘‘one-bug, onedrug’’ approach should continue while simultaneously investing in more broad-spectrum prevention and treatment approaches for the longer term.

Novel and Emerging Threats 

The initial efforts for medical countermeasure development and acquisition have 

been rightfully focused on those threat agents known to have the potential to inflict 

catastrophic harm on our Nation. In addition, HHS and NIH are investing in efforts 

to address threat agents that we might face in the future, including engineered 

threats. 

As is also the case for the known threat agents, we depend upon our colleagues 

at DHS to lead efforts to identify and prioritize these threats. One of the most recognized potential engineered threats is antibiotic-resistant anthrax, and the HHS, 

NIH and the U.S. Food and Drug Administration (FDA) accomplishments to date 
21

in facilitating the development and acquisition of anthrax vaccines and therapeutic 

antitoxins have made an important impact on reducing our vulnerabilities in this 

area. In addition, NIH has made a robust investment in the development of novel 

antimicrobial agents and in addressing all aspects of antibiotic resistance. For example, investments have been made in the development of antibacterial agents that 

could potentially be useful against a broad spectrum of species and a wide range 

of drug resistance mechanisms. Finally, NIH is working with DoD to leverage medical countermeasure programs and resources of mutual interest.

Challenges to Rapidly Expanding the Strategic National Stockpile 

Although defining priorities and quantifying the size of the threat to the population are the key steps in focusing our efforts, we must be mindful of the realities 

of the spectrum of efforts needed along the research and development pipeline to 

produce a useable medical countermeasure. The process of defining required specifications for a countermeasure often reveals few, if any, candidates in the pipeline. 

Basic research and early development efforts, even when robustly funded, often take 

years before a concept is mature enough for advanced development. The development of medical products—whether for cancer, influenza, or anthrax—is a complex, 

lengthy, and expensive process. Ultimate licensure, approval or clearance from FDA 

requires the rigorous accumulation of sufficient data in humans and animals to establish the safety and efficacy of the product for a specific use and the ability to 

consistently manufacture the product to meet the appropriate standards. It is important to note that a unique aspect of the pathway for medical countermeasures 

is the need to establish efficacy either using surrogate markers (such as the human 

immune response) or, using appropriate animal models, under the ‘‘Animal Rule’’ 

(Federal Register 67:37988–37998, 2002) because demonstration of efficacy against 

the actual diseases in humans is most often not feasible either because the disease 

does not occur naturally or for the obvious ethical reasons that prevent exposing humans to the threat agent. The USG is working to provide support for the developers 

of priority medical countermeasures through the research and development phases, 

and, when a product has reached the advanced development stage, Project BioShield 

provides an important incentive for manufacturers to take the product the rest of 

the way through the pipeline. And, as I have outlined here today, in the less than 

one year since Project BioShield was enacted, the incentive has expedited final development of several products for the Stockpile.

Conclusion 

In closing, I must emphasize that the number of threat agents against which we 

could guard ourselves is endless and new and emerging threats introduced by nature or man will present continuing challenges. Although we cannot be prepared for 

every threat, we are implementing a strategic approach for identifying and combating the highest priority threats as assessed, in large part, by our colleagues from 

DHS. HHS and its agencies including NIH, CDC, and FDA, have a clear mandate 

from President Bush and Congress to lead the charge in responding to threat assessments and implementing sound development acquisition programs for priority 

medical countermeasures. We have already made important strides and will continue to work to address the obstacles identified. Mr. Chairman, I look forward to 

working with you and members of the Subcommittee to address the challenges of 

bioterrorism preparedness and its impact on public health. 

I will be happy to answer any questions you may have.

Mr. KING. Ms. Morr, if IA information analysis has an assessment division with a staff of chemical, biological, radiological and 

nuclear experts, why is the S&T directorate the lead office for conducting BioShield assessments? Do you feel that IA is sufficiently 

involved in that process? 

Ms. MORR. Yes, I would distinguish the two processes as IA putting into the threat process as we know it—that is our bread and 

butter—every day; and the material threat assessments in our view 

are really better characterized as risk assessments because they 

take into account consequences and some vulnerabilities and are 

pushing the high end of the venue. So, yes, we are—we feel that 

we are involved. 

Mr. KING. Let me ask this question for the entire panel. As far 

as organizational issues between DHS and HHS and, you know, 

whether or not there is impediments to getting the job done, 
22

wouldn’t it be better for there to be only one process where DHS 

and HHS experts worked collaboratively to produce the best model 

assessment with respect to a given threat, rather than have it at 

two different junctures? 

Mr. VITKO. I will start. Maybe Stew wants to follow up. 

I think it could be done either way. I think the way it is structured now it falls into the natural domain. They are done collaboratively. HHS participates in the threat and risk assessments. We 

at DHS, in fact, participate in discussions around the medical countermeasure options and selections. It is just that we each have a 

natural expertise in an area and lead that portion. So by the assignment that is given it makes a clear responsibility for somebody 

to carry that action through and follow up on it. 

Mr. SIMONSON. I agree with what Dr. Vitko said. It is done in 

a collaborative manner right now. The statute assigns very specific 

responsibility, as you know, to DHS for preparing the material 

threat determination. But we have tried through the short life of 

this program to do things in a collaborative way. 

Mr. KING. Let me ask a more general question. 

Based on the statement that Congressman Pascrell made at the 

opening of the hearing, that is a concern that we have generally, 

that we have Federal agencies now not talking to other departments, not talking to each other, not cooperating sufficiently. What 

can you tell us today here about the cooperation of HHS and DHS 

on this vital issue? 

Mr. SIMONSON. I think there is an enormous level of cooperation 

among us. I think as the bill was being put together—this is one 

of the objectives in creating a joint institution essentially. The 

money is at DHS, the intel expertise is at DHS, the scientific public 

health expertise is at our place. So I think from the beginning it 

was intended to be a collaborative effort, joint institution. I think 

it has been getting better, and I think it is pretty good right now, 

frankly. 

Mr. KING. Anyone else wish to comment? 

Mr. VITKO. I would be happy to. 

Mr. KING. This is an overriding issue overall, why I appreciate 

your comments on this. 

Mr. VITKO. I think in this case we may be dealing with an exemplary process. Assistant Secretary Simonson said the legislation 

puts the responsibilities for that collaboration, but what is much 

more important is that collaboration exists in practice. 

I cited the mechanisms that we talked about in my list of activities, both in our interagency bilateral and informal capacity. Those 

contacts actually occur several times per week. We know each 

other well. We exchange issues informally. We bring them up in 

formal ways. It doesn’t mean we always agree. In fact, we sometimes bring different perspectives. But we interact regularly and 

work those through to a conclusion. 

Ms. MORR. I guess I would just add to that in this business of 

Homeland Security and performing risk assessments is a spectrum 

in which each of us is representing our expertise and our customers. When we come together to provide those perspectives and 

niches, we come up with a better overall process, provided we keep 

moving with the process and not get hung up with unexpected 
23

delays or inefficiencies. But when we each bring to the table our 

own constituents and our own expertise, we come out with a better 

full process along the whole risk assessment and response process. 

Mr. KING. I yield. 

Congressman PASCRELL. 

Mr. PASCRELL. Thank you, Mr. Chairman. 

I just wanted you to clarify, Mr. Simonson, page 1 of your testimony at the bottom of the page and continuing on page 2, you say 

that we have taken the botulinum antitoxin program started by the 

Department of Defense in the 1990s and we are now building our 

botulinum antitoxin stockpile further. We have also booked our 

stockpile of countermeasures, et cetera. Could you clarify that? 

Mr. SIMONSON. Just, I think, as the first Gulf War was winding 

down 

Mr. PASCRELL. I am sorry? 

Mr. SIMONSON. As the first Gulf War was winding down, the Defense Department undertook a program to build a reserve of botulinum antitoxin. They had 100 horses or more lined up for this. 

They were vaccinated against botulinum, and then the process requires botulinum antitoxin to actually be introduced into them, and 

then they are bled. Plasma is collected. 

They did all of that. But the next phase is to process it and turn 

it into a usable product. Well, they didn’t do that. For a number 

of reasons that I am not familiar with, they decided to just put the 

stuff on ice, which they did. 

When we learned that they had it, after 9/11, we sought to get 

a hold of it, get it transferred over to us, and then to finish it. In 

the meantime, the expertise to do this had largely faded in the 

country, and so we had to go out and get a new contractor to do 

it. That is what that refers to. 

Mr. PASCRELL. So would you define very briefly what the stockpile looks like today? 

Mr. SIMONSON. The numbers of doses? 

Mr. PASCRELL. Give us an idea, relatively speaking, for those of 

us who aren’t experts. 

Mr. SIMONSON. We would prefer not to talk about the exact numbers publicly. I am happy to talk to you about it privately. We 

haven’t divulged those numbers in public forum, as far as I can 

tell. 

Mr. PASCRELL. Then we need to talk. 

In fact, you know, my feeling is—I can only speak for myself—

that the more not only we know but the more the public knows, 

they are put at ease. The less they know, the more difficult they 

have to come to grips with, God forbid, if something happens. 

I would like to ask this question, and anybody who wants to respond. Well, let me ask you, Mr. Simonson, this next question. 

Considering that DHS found that a pandemic influenza, if we 

ever had such an outbreak, can be as lethal or even more lethal 

than an anthrax attack, can you tell us where pandemic influenza 

ranks on your list of concerns in terms of preparations in the strategic national stockpile? 

Mr. SIMONSON. I would say it is at the very top of our list of concerns. There is a program outside of BioShield that is designed to 
24

develop countermeasures against influenza, and those programs 

are under way. 

Mr. PASCRELL. Well, if we cannot combat the flu, how in God’s 

name are we going to combat those other things that we 

associate•th threats, biological threats? How do you do that? Tell 

me how to do that. Explain to the public how to do that. 

Mr. SIMONSON. I am not sure I understand the question. 

Mr. PASCRELL. We agree on my premise that this could be more 

dangerous—

Mr. SIMONSON. Absolutely. 

Mr. PASCRELL. What are we doing about it? 

Mr. SIMONSON. We have a program in—my office let a contract 

a while back to begin developing a new type of influenza vaccine, 

one that is not dependent on chicken eggs. That is how the current 

vaccine is made, in chicken eggs, not in biofermenters. 

We are also in the process of looking for novel forms of administering the vaccine. Right now, it is one-shot 15 micrograms doses. 

The idea is to look and see if there are ways of conserving the antigen and using less material to produce an immunologic response. 

There is an enormous amount going on on this. I would be happy 

to give you a lot of details. 

Mr. PASCRELL. We will be meeting, and you and I are going to 

be talking about anybody else who wants to be involved in the botulinum stockpile. That is a given, correct? 

Mr. SIMONSON. Yes. 

Mr. PASCRELL. My final question is this: We possess no vaccine 

to combat a pandemic influenza. How much has the Federal Government invested in stockpiling anti-virals that could be effective 

against a pandemic influenza? How much are you investing in this? 

We investing? 

Mr. SIMONSON. Last year it was $88 million. I don’t have this 

year’s number, but it is on that order of magnitude. 

Mr. PASCRELL. That is sufficient? 

Mr. SIMONSON. No, but the problem is that the industrial base 

supports only so much production. There is not a lot of this stuff 

out there. 

Mr. PASCRELL. That is critical to what we are here about today— 

Mr. SIMONSON. Yes. 

Mr. PASCRELL. —in terms of the private sector. 

Thank you, Mr. Chairman. 

Mr. KING. Mr. Pascrell. 

The chairman of the full committee, Mr. Cox. 

Chairman COX. Thank you, Mr. Chairman, and thank you to our 

panel. 

The BioShield statute requires that at the beginning of the process the Department of Homeland Security perform the role of determining what are the material threats, and they extend not only 

to biological but also to radiological and nuclear agents. As a result 

of the statutory procedure, the Department of Homeland Security 

has notified Congress of determinations made under the BioShield 

statute. I would ask, Dr. Vitko and Ms. Morr, how many times has 

that taken place? 

Mr. VITKO. It is occurred four times. The material threat determination is done for four agents. It probably occurred in two sepa-
25

rate notifications. The first one was around anthrax, and then 

there was a subsequent one that made threat determinations 

around smallpox botulinum antitoxin and radiological nuclear devices. 

Chairman COX. Once that determination is made, the Department of Health and Human Services takes over, if I am correct? 

Mr. Simonson, what then is the next step that you take, once that 

determination is sent to the Congress? 

Mr. SIMONSON. We evaluate the public health consequences that 

inform the material threat assessment, make a determination if 

countermeasures are needed to combat those consequences. We do 

some modeling of our own as to the public health impact of the 

threat agent; and then, working with our colleagues at DHS, a unified recommendation goes forth to the President. 

Chairman COX. Is all of this prior to the issuance of an RFP? 

Mr. SIMONSON. Yes. 

Chairman COX. What is necessary then for the RFP to be issued, 

finally? 

Mr. SIMONSON. Once we have the approval from OMB to proceed, 

the development of the RFP goes forward, although we sometimes 

lean a little forward and start developing ahead of time. We publish a draft RFP to get comment back from the industry to insure 

that we haven’t missed something or sent something out that is not 

tenable. 

But it is a fairly elaborate process to produce an RFP that keeps 

open options to the proposer so that we don’t get something back 

but then we have to throw out because there was some technical 

inconsistency with the RFP. So it takes some time, once the—

Chairman COX. To use an example, with anthrax, how long did 

it take from front to back from the assessment that was made at 

the Department of Homeland Security to the issuance of the BioShield RFP? 

Mr. SIMONSON. We had the material threat determination—yes, 

we had the material threat determination in January of 2004; and 

the RFP was issued in March. 

Chairman COX. Am I correct that in the anthrax case, which may 

not be an illustrative example for this reason, the threat determination was made first and the assessment was made second? 

Mr. VITKO. Correct. 

Chairman COX. That is not normal? 

Mr. VITKO. That is not normal. That was done to jump-start the 

process. 

Chairman COX. So let us say smallpox, using that as an example. 

I would like to include in this timeline the DHS and HHS pieces, 

if we can get our arms around that total length of time. 

Mr. VITKO. A typical threat assessment takes 3 to 4 months to 

execute in its fullness, okay. That includes several sessions among 

interagency processes and to finalize the documentation. 

We certainly have the information to help guide us in the process 

and be deliberated on the Weapons of Mass Destruction Medical 

Subcommittee before final completion of that document. So finally 

2 to 3 months into that process we are able to start to the next 

steps. 
26

Mr. SIMONSON. An RFP takes about 3 to 4 months from when we 

have the material threat determination to when we can launch the 

final RFP. 

Chairman COX. Well, Mr. Chairman, I see my time has expired. 

We are talking about time here and how much time it takes to 

get us even to the RFP stage, which, after all, is a request for a 

proposal. That is an intermediate step in the process itself. It 

seems to me that Congress needs to reconsider how this process 

works. What we really want to do is get the request out to industries so they know what to respond to. 

What I am inferring from other comments that this committee 

has received is that, in many cases, people who might be interested 

in participating in these RFPs are complaining that the timeline 

for responding is so short that it seems to require that you have 

already got a product in the late stages of development in order to 

participate. What we really should be doing here is, in sending 

things that wouldn’t otherwise be happening—I am not sure that 

the system that we have right now is serving that purpose. 

But my time has expired, and I will come back with the next 

panel. Thank you very much, Mr. Chairman. 

Mr. KING. I thank the chairman; and the gentleman from North 

Carolina, Mr. Etheridge. 

Mr. ETHERIDGE. Thank you, Mr. Chairman. 

Let me, Mr. Simonson, approach this a little different than the 

chairman did. From my understanding—and I would be interested 

in your comment on this—that the Nation’s public health infrastructure, which is a place that we have if we are going to respond, 

is not ready to deliver the countermeasures even if they are successfully procured and stockpiled to HHS. What effort has the Department taken to prepare the public health infrastructure to respond? 

I think it is critical. We haven’t talked about that this morning. 

I would be interested in hearing any comment. 

Mr. SIMONSON. There has been a fairly aggressive program since 

2002 to build infrastructure in the public health sector. But you are 

quite right. We have a concern about localities being able to receive 

the stockpile and get it into the hands of people who need it within 

a very narrow window, and we are not quite there. 

We have an initiative right now, the Cities Readiness Initiative, 

which is intended to really add some capacity there so that, combined with the other entities of the Federal Government, working 

with the local authorities, we can insure that we are able to get 

countermeasures. 

This is especially true in the context of anthrax, countermeasures 

out and into people’s hands within a 48-hour window. But there 

has been an enormous amount spent there. We have not quite seen 

the results we would like on building that distribution capability. 

Some jurisdictions have done a terrific job. But this is not uniform 

across the country, and we are working on that. 

Mr. ETHERIDGE. Let me follow it up. Because the answer I got 

really isn’t, to me, a good answer. You said, ‘‘aggressive, concerned 

initiative.’’ I didn’t hear anything about a plan with the results to 

follow up to make sure we have a measurement to know where we 
27

are with follow-through in terms of having mileposts to know 

where we are. 

Mr. SIMONSON. Well, that is the objective of the Cities Readiness 

Initiative, this program that we have to build capacity. 

Mr. ETHERIDGE. Cities? 

Mr. SIMONSON. Cities Readiness Initiative. 

Mr. ETHERIDGE. For metropolitan areas? 

Mr. SIMONSON. Yes. 

Mr. ETHERIDGE. What about the rural areas? 

Mr. SIMONSON. Well, at this point it is not in the rural areas. It 

is meant to be a threat-based metropolitan— 

Mr. ETHERIDGE. You mean, we are not a United States of America? 

Mr. SIMONSON. No, no, no, that is not what I meant at all. But 

there are varying levels of threats that we are working with, and 

so we are trying to reach out and to make strides there, strides 

which will be replicated across the country. 

Mr. ETHERIDGE. I believe you need to work on your plan some 

more. Because—really and truly. Because we have seen, with what 

is happening in London recently and other places, they are looking 

for soft targets. Seems to me—I understand we have to have a high 

profile first, but we have got to prepare. 

Let me ask each of the three of you this question, if I may. There 

are a number of States—my State of North Carolina included—has 

a large poultry industry. There is a large concern about the possibility of the spread of avian flu. Is DHS considering the use of the 

concern of avian flu as a similar disease? This could be a weapon 

of mass destruction as well. Have you done any work in this area 

at all? 

Mr. VITKO. Yes. We have two activities. One is the risk assessment that I mentioned before in support of the President’s Biodefense for the 21st Century. Avian flu is one of the assessments 

considered in that risk assessment. The second is in the bioportfolio 

that I had. We had a special end-to-end study to look further at 

how avian flu would differ in a terrorist context than if it occurred 

naturally and what the synergisms could be for the public health 

sector in that. 

Ms. MORR. I would say both the National Counterterrorism Center and IA have worked on a red cell product that looks at avian 

flu and tries to get ahead of actually seeing the threat. Dr. Vitko 

mentioned there will be a risk assessment done in January of a 

number of agents. 

Mr. SIMONSON. I have nothing to add to that. 

Mr. ETHERIDGE. Thank you, Mr. Chairman. I assume my time 

has expired. 

Mr. KING. Thank you, Mr. Etheridge. 

The vice chairman of the full committee, Mr. Weldon of Pennsylvania. 

Mr. WELDON. I thank our distinguished witnesses for their testimony today. 

Just to give some history to our colleagues on the committee, in 

October of 1997, as chairman of the Defense R&D Subcommittee, 

we had a hearing where Jessica Stern testified. She was, in her 

testimony, supporting the statement of Senator Richard Lugar that 
28

in the 1993 attack on the World Trade Center the investigators and 

the sentencing judge both agreed that there was, in fact, a large 

cache of sodium cyanide that was actually in the Trade Center that 

was designed to be vaporized. But it wasn’t vaporized. It, in fact, 

was burned. Had it been vaporized we would have had the first 

major attack of a chemical agent on our people that would have affected hundreds of thousands of individuals, from the first attack, 

not the second, the first attack on the Trade Center. 

I am reminded of a hearing that Ken Alibek testified—again before my subcommittee in May of 1998. Dr. Ken Alibek, who is really Alibekov, who will be before this committee tomorrow—was in 

charge of the Soviet biological weapons program called Biopreparat 

before he defected in 1992. Ken Alibek testified back then that 

there were over 2,000 full-time Soviet scientists working on the 

weaponization of biological and chemical agents. 

I won’t go through all of the agents and the diseases, but it is 

significant. I have them all in front of me. I go through this because, as we go through the whole issue of biological warfare, it is 

a multi-pronged approach that we have to take. 

It first of all starts with securing the current agencies stockpiles 

that are still occurring in Russia and the former Soviet states 

today. Our current effort while under President Bush has, I think, 

been improved dramatically, is still not adequate. 

One of the things we are working on is an attempt to work with 

our industry—many in this room attended a session we had last 

evening—to try to work in a collaborative way with the Russian biological and chemical scientists. 

After identifying and securing some 79 sites throughout Russia 

that have been identified, including six that we have never been 

into, the second part is to destroy those agents. That is also a massive project. Because if we don’t secure and destroy them, then it 

is not that difficult for a terrorist organization or a rogue nation 

state to acquire the existing capability that was developed by those 

2,000 Soviet scientists and researchers back in the Cold War. 

The third major effort is to collaborate. That is where reaching 

out to our former enemies is critical. To that extent, we have been 

working for 2 years. Chairman Cox has been involved with this. In 

fact, he had 2-1/2 hour meeting with the counterpart, the chairman 

of the Duma Security Committee, General Vladamir Vassiliev, just 

a couple of months ago on establishing a joint effort that will give 

us access to those six sites in Russia that no foreigner has ever set 

foot on. 

I mention all of this because I understand the importance of BioShield II. In fact, that was the topic of our discussion last evening. 

But it is equally important, if not more important, that we deal 

with the storage and threats and perhaps the continued production 

or research on developing new strains that are still going on within 

the former Soviet states. It is a critical element that this committee 

needs to be questioned on, and tomorrow one of our subcommittees 

will do that when Dr. Alibek comes in. 

We also need to focus on ways to encourage additional development of detection capabilities; and for that our military, our good 

friends at Aberdeen, our good friends at Ft. Detrick, are doing a 
29

fantastic job in cooperation with our Homeland Security administration. 

But, finally, and the subject of this hearing that is most critical, 

how do we encourage those private companies and small entrepreneurs to do research into strains that we have not yet provided 

proper support and protection against? That requires the passage 

of BioShield II, and it requires the input from the private sector. 

What we encouraged last night in a continuing series of BioShield showcase workshops was a—basically an agenda that the 

private sector would bring to us of ideas, changes in our tax laws, 

our investment policies, so that private entrepreneurs and companies have more incentives to do the kind of work on these diseases 

that have been identified largely having been developed in the 

former Soviet States. 

So I don’t have any questions today. I challenge particularly the 

second panel to not just come and testify in this hearing today but 

to come in with a suggestion of ideas, a suggestion of policy options, legislative remedies and ideas that we can pursue in Congress to help have a more dramatic response to what we all know 

to be an obvious threat that has been documented many times over 

the past 10 or so years by a number of top experts, including Dr. 

Alibek. 

I would again encourage our colleagues to attend that subcommittee hearing tomorrow where Dr. Alibek will come back and 

testify. He also wrote a book, Biohazard, which I would encourage 

everyone to read, which was published in 1998. This is a major 

threat to our security and one that deserves the full attention of 

our committee and the subcommittee. 

Mr. KING. I thank the gentleman for his testimony. 

The gentlelady from the Virgin Islands, Mrs. Christensen. 

Mrs. CHRISTENSEN. Thank you, Mr. Chairman. 

I also want to begin with Assistant Secretary Simonson and follow up on the question of my colleague, Mr. Etheridge, because I 

really am not satisfied or clear about the answer. Because even as 

he said, even if we had all the countermeasures we need, which we 

don’t, there is a great concern that the public health fracture is not 

there, and it really goes beyond even just the distribution capability. 

So we are coming on 4 years post 9/11. I would like to know if 

the Department has determined a basic level of public health preparedness or readiness that every community should meet and assess the level of preparedness of public health around the country. 

Have you determined what level of funding is needed to bring it 

up to the state of readiness that it needs to be, and, if so, what 

is your timetable for 

Mr. SIMONSON. Well, let me say that the cooperative agreements 

between CDC and HRSA to make these grants to State and in 

some cases is local units of government, they have outcome-based 

measurements and work is under way right now to evaluate those. 

Mrs. CHRISTENSEN. In terms of those grants, I mean, how close 

do they come to what is really needed to prepare the public health? 

Mr. SIMONSON. We are very comfortable with the cooperative 

agreement and the critical benchmarks that are in there and the 

outcomes that we have sought. There has been a fair amount of 
30

money, you know. Since 2002, $3.6 billion between CDC and HRSA 

have been sent out. We still have—I haven’t checked the last few 

weeks—but we still had—nearly $1 billion of that had not been 

drawn down. Some of that goes all the way back to 2002. So we 

think that the level of funding is adequate. 

Mrs. CHRISTENSEN. Could you—Mr. Chairman, could we ask that 

the Department let us know where those funds have not been 

spent? 

Mr. KING. Mr. Simonson, do you have any problem with that at 

all? 

Mr. SIMONSON. Of course, I would be happy to provide. 

Mrs. CHRISTENSEN. I would like to go on to another question. 

Mr. KING. Provide to the subcommittee as well. I would obviously 

like to see that, as well as Mrs. Christensen. 

Mrs. CHRISTENSEN. Thanks. 

I have been—always been concerned about the dual responsibilities between the Department of Health and Human Services and 

Homeland Security, and we have talked about it insofar as different respects this morning. But in the event of a bioterrorism attack there is still some dual responsibility. How do you see it working? Who is ultimately in charge? Who is in charge? 

Mr. SIMONSON. The Secretary of Homeland Security is the national incident manager in an event, whether it is a CBRN event 

or something else, some hurricane. 

Mrs. CHRISTENSEN. We are talking about a bioterrorism event 

where we have to bring the public health modalities to bear and 

distribute from the stockpile and so forth. How does that work? 

How is that going to work? Who in the Department of Health and 

Human Services is in charge, at what level? Because you are not 

a public health—you don’t have a public health background? 

Mr. SIMONSON. No. The Secretary of Homeland Security is the 

national incident manager. He coordinates all the Federal Government’s response. HHS has the lead for medical and public health 

response in a disaster, act of terrorism. In our Department, the Office of Public Health Emergency Preparedness is the coordinating 

entity among all of our public health service organizations that 

would respond to an emergency like that. 

The CDC has the lead role as an operating division. That is what 

the CDC does. But, in addition to that, there are other elements 

of the Public Health Service, the Commission Corps, the National 

Institutes of Health. Recall back in—

Mrs. CHRISTENSEN. The Office of Emergency Preparedness has 

the top level of responsibility and the Department of Health and 

Human Services? 

Mr. SIMONSON. The Office of Emergency Preparedness is the coordinating agency within the Office of the Secretary, yes. 

Mrs. CHRISTENSEN. Let me ask another question, which any one 

of you could probably answer. But as we went through the BioShield hearings initially, I was one of the members here who was 

probably not very supportive of Project BioShield, or only reluctantly so. Reading the testimony of some of the companies that will 

talk—speak to us on the next panel, one of the issues is that the 

prohibition against utilizing some of these countermeasures in the 

commercial market is a big obstacle to us utilizing some of the 
31

countermeasures that are available and could be used. As we look 

at BioShield II, what can we do about that prohibition against 

using it in the commercial market or some of the other issues? Or 

do you think that we should just scrap BioShield and use DARPA 

and the orphan drug process, which has proven to be effective in 

the past? 

Mr. KING. Mrs. Christensen, your time has expired. I would ask 

the witnesses to answer. In about 15 minutes we are running up 

against some votes. 

Mr. SIMONSON. Let us me answer as to scrapping. BioShield, no. 

DARPA—all the wonderful things DARPA has done it has not produced a lot of medical countermeasures, to my knowledge at least. 

There is no strict prohibition on the commercial market analysis. 

It is a consideration, when the Secretary makes a determination, 

but it is not a condition precedent. So it is not a strict prohibition. 

Mr. KING. The gentleman from Pennsylvania, Mr. Dent. 

Mr. DENT. Thank you, Mr. Chairman. 

My questions are going to be directed to Dr. Vitko and Mr. 

Simonson. Are the Centers for Disease Control prevention list for 

category A, B and C pathogens insufficient or sufficient, number 

one. And, two, how does DHS take into account novel biological 

agents or biologically-engineered agents? How do you take that into 

account? 

Mr. VITKO. I will answer both questions. 

One is we believe the A, B, C lists—the category A, B and C lists 

are a good starting point but need to be expanded. One of the 

things we are looking at now, in fact, in doing the risk assessments 

for the Biodefense of the 21st Century is we are starting with that 

list, doing a fuller examination, doing a full analysis of the risks. 

I expect that we will validate most of the things on that list, but 

there may be some surprises that come up. 

Second, with respect to how do we deal with novel and engineered threats, that actually is an issue that we worked with in 

HHS in developing a strategy. We did that over the course of 3 to 

5 months—I don’t remember exactly how many—in which we made 

our best collective assessment with intelligence inputs about what 

a terrorist might be able to accomplish in the way of engineering 

a drug in the next 3, 5 and 10 years, what indicators one would 

look for that might change our thinking, and then we developed a 

strategy based around that that had four key elements. 

One was to do continuous technology watch and threat assessments to support that. 

The second was to expand our biosurveillance and biodetection 

capabilities to look for unknown agents, not just a set that we are 

normally looking for on the suspect list, if you will. 

The third was, in fact, to pursue additional medical countermeasures, and that might have broader applicability, but also very 

importantly to enhance the infrastructure for the R&D research development, test and evaluation of medical and countermeasures. 

The fourth, very importantly and often overlooked, is to develop 

an integrated concept set of operations that says how would you respond to a new pathogen, whether it was for an emerging disease 

or an engineered threat. What are the steps in there so we could 
32

get those worked out and then look at the places in there where 

we could reduce the timelines. 

Those are the strategies we have been working on. 

Mr. SIMONSON. I agree with Dr. Vitko’s answer. 

Mr. DENT. Thank you. 

Next question, to date, the Department of Homeland Security 

has not completed a material threat assessment determination for 

a chemical agent. Why not, is the main question, and what would 

be your process for prioritizing those chemical agents? 

Mr. VITKO. In fact, we have a draft material assessment written 

and in review on chemical nerve agents. It is still going through 

the vetting process, and this is a useful insight on all of these assessments. 

As you might expect, there is little definitive information and a 

fair agree of uncertainty on a number of these issues. When we 

bring these issues together, we try to vet it extensively in the community. So we vet it from all perspectives and then reach a decision. We are still refining that process, that draft. We are probably 

a month away, is my guess, but I don’t know that, actually, and 

I could give you a specific date when I call back. 

Mr. DENT. Another question. I know the Federal Government 

this year will spend $1.5 billion on BioShield—excuse me, we are 

spending $1.5 billion of BioShield this year for vaccines on anthrax. 

For that cost, how many countermeasures will BioShield actually 

be able to purchase? 

Mr. SIMONSON. It is a difficult question to answer. We haven’t 

got the market research data, I think, to give you a precise answer. 

But we ought to be able—with the existing $5.6 billion we ought 

to make major inroads in chemical, biological, radiological and nuclear threats. 

I can’t give you the exact number of agents that we are likely to 

have direct countermeasures against because, as I said, the process 

is ongoing. I have learned the hard way that you don’t really know 

until after the proposal gets in. You know, you don’t really know 

what it is going to cost. 

Mr. DENT. Finally, last question. We could sit around here all 

day and think of the various frightening scenarios that could be 

launched against us. How will we know when we are done acquiring countermeasures, is my question. Is it based on how much we 

are willing to spend or, you know, what level of risk we are willing 

to accept? Or what countermeasures are not feasible or technically 

possible? 

Ms. MORR. I would hope in this instance the threat would come 

in and play a big role—or at least in the initial guideline on what 

is the list of threats that we continue to see on an initial intelligence-based way to begin to inform whether we have adequate 

countermeasures. 

Mr. SIMONSON. This may be a function of where I work every 

day, but it is hard to imagine a scenario where we will not be buying countermeasures or seeking to develop other countermeasures 

that have less of an adverse action profile, that are more efficacious, that cover a broader band of threats, to avoid the one-bug/

one-drug concept. So I hope we will be developing those for years 
33

to come. Whether or not we will stockpile them in enormous quantities as we do now is another matter. 

Mr. KING. The gentlelady from California, Ms. Harman. 

Ms. HARMAN. Thank you, Mr. Chairman; and I thank our witnesses. I think this is a very good hearing, and your comments and 

responses to questions are strategic. That is something, as I think 

everybody knows is critical if our Homeland Security effort and our 

counter bioterror effort are to succeed. It is not just rearranging 

the deck chairs. It is just creating one deck. As you have gone 

through the different pieces of an effective assessment and response, I think you are all focused on that. I want to commend you. 

My question is about strategy and actions you are contemplating 

beyond U.S. borders. Germs don’t recognize borders. This is obvious. I heard you discussing the avian flu. I am not sure if anyone 

mentioned SARS, but, you know, pick a germ, pick smallpox, pick 

anything. It should be obvious to all of us that if some evidence of 

that is somewhere else, given frequent travel in and out of America, that whatever is out there can come here easily. 

So my question to the panel is, how do you think about intelligence on the existence of these bad germs in other countries, and 

how do you think about those germs coming here, and how do you 

think about the relationships that at least I think we need with 

foreign intelligence services, foreign health services, the World 

Health Organization and so forth with relation to this? 

Maybe Ms. Morr is my candidate for response. I do want to commend her for an excellent report yesterday to the House Intelligence Committee on the London bombings. 

Ms. MORR. Thank you. 

On the intelligence side, the best mechanism that I believe we 

have in place right now is what I would call the red cell or alternative analysis piece of this. The community has done these estimates on SARS. They did it on the avian flu. It is the best way 

to sit down analysts and begin to talk about, you know, the threat 

and how it can evolve. 

I think what the Department is learning how to do is you don’t 

stop there. What is the next operational response that should be 

put in place and then what is the risk for the countermeasures? I 

think at that point, you know, we have got people at the borders, 

we have got other officials that we can, you know, declassify some 

of this information and make them more aware. But I think that 

what I see is, in the intelligence arena, I will call it a whole discipline of alternative analysis and thinking about how it can get to 

the shores is going to be really important as the OD&I sets up that 

whole new capability and gets us more focused on projecting out. 

Ms. HARMAN. I would just add to that how it might leave us and 

go to other places. Let us not just think about America. Let us 

think about a world community, hopefully, which we hope not to 

harm ourselves by exporting some of these bad germs, am I right? 

Ms. MORR. Absolutely. I would again say what is so unique about 

the Department is it doesn’t stop, as you are talking about, with 

terrorism. It pushes the rest of the community to think about 

homeland threats in a much broader, you know, context. I think 

the whole community piece of putting the Department as part of 
34

the OD&I and focusing on the international threats as you are 

talking about is really the wave of the future. 

Ms. HARMAN. Thank you. Other comments? 

Mr. SIMONSON. No, I agree with what Ms. Morr said. We are 

spending an enormous amount of time with respect to flu working 

with the World Health Organization and the impact capability to 

build a surveillance there. So I agree with you this is something 

we need to pay a whole lot of attention to. 

Ms. HARMAN. Let me close with this, because I want to respect 

the time of others. 

It is at our peril we build big walls around America and think 

that threats here are different or our only focus should be or can 

be on threats here. There is one world here, and in an era of terror 

we better get it right across the world. I think ultimately it is the 

only way we will win against the threats of the 21st century. 

Thank you, Mr. Chairman. 

Mr. KING. Timing is everything. 

The gentleman from New Mexico, Mr. Pearce. 

Mr. PEARCE. Thank you, Mr. Chairman. 

My first question I think would be for Ms. Morr. It may have 

been asked, I apologize, if we have enough intelligence to determine the capability and intent, I think that was your testimony, do 

we have enough capability to stop it rather than provide a response? 

Mr. SIMONSON. I am sorry, I didn’t understand. 

Mr. PEARCE. Why don’t we remove the intent and capability, 

rather than trying to inoculate against every response they can do 

to us? 

Ms. MORR. The issue of the capability is that we don’t have all 

of the factors to make a definitive conclusion on capability. What 

we do have is a steady progression of learning and at some point—

for example, we took down some of the training camps. It is not—

the people that have that capability, that kind of expertise are still 

around. They are easily acquired throughout the world. It is never 

something that you can automatically definitively eradicate. A lot 

of this is a skill set that exists in people, in training, and available 

in stockpiles or skill sets around the world. So the capability—

Mr. PEARCE. I use those skill sets to obtain and pass along. Because if we know who the individuals are who would create smallpox, it seems like it would be easier to eliminate them rather than 

spend billions that may not be spent in the proper fashion. 

You don’t have to address that. 

Mr. Vitko, how complex is it to develop and maintain strands of 

smallpox and anthrax, for example? How difficult is it for the terrorists to maintain their ongoing supply stock? 

Mr. VITKO. Let us say that with anthrax it is quite feasible. I 

could give you more specifics in a closed session. 

Mr. PEARCE. It is quite easy for them to develop and maintain, 

in other words—in other words, the vaccine has run out of date. Do 

the diseases that are being created kind of fade if they don’t put 

them into actual act, if they don’t put them into functioning? 

Mr. VITKO. I am missing part of your question. I thought the 

original question was around the technical feasibility of a terrorist 

developing an anthrax—
35

Mr. PEARCE. No, maintaining it if they develop it. Do they have 

to maintain it or, once it is developed, and it is a formulation in 

your mind, or do they then have to develop a sample and culture 

and maintain? 

Mr. VITKO. In the case of anthrax, it is a hardy agent. 

Mr. PEARCE. It is straightforward and stays there. How easy is 

it to develop new strands that are resistant to our countermeasures? 

Mr. VITKO. The other issues, what do you lose when you develop 

those strands? Any kind of genetic engineering comes at a cost in 

an organism and details. Again, because of the sensitivity, I would 

prefer to discuss it in a closed session. 

Mr. PEARCE. Same thing on smallpox. My fear is we are going 

to put—I mean, we have $5.18 billion I think that is targeted, basically 2 on a list of 52 possible threats, and so you begin to genetically add on top of that. I am not sure we are going to add $250 

billion. But even if we do, as we develop the remedy, they develop 

things that are resistant to the remedy—and you are shaking your 

head no. Is that not possible? 

Mr. VITKO. I hope I wasn’t shaking my head no. 

Mr. PEARCE. It was a little quiver. 

Mr. VITKO. No, no. What I would say is that I understand your 

concerns and your extrapolation and just multiplying that. I would 

say that the threats that we have currently addressed—anthrax, 

smallpox and botulinum—are the highest threats on the list. So 

taking that and simply multiplying and saying if I have 20 agents 

I have to do 6.5 times that—

Mr. PEARCE. Fair enough. 

Trying to get my last question in, Mr. Simonson, what is the life 

of the smallpox vaccine that we currently have in stock? You said 

we have enough stock to handle all of our citizens. At what point 

does that become—

Mr. SIMONSON. What is the shelf life? 

Mr. PEARCE. Yes. 

Mr. SIMONSON. The sizable amount of our stockpile has been 

around for a long time and is still very potent. So we are hopeful 

that the new material that we are making will have a very long 

shelf life. 

Mr. PEARCE. Thank you, Mr. Chairman. 

Mr. KING. The gentleman from Connecticut, the chairman of the 

Subcommittee on Intelligence, Information Sharing and Terrorism 

Risk Assessment, Mr. Simmons. 

Mr. SIMMONS. Thank you, Mr. Chairman; and I thank the witnesses for their testimony. 

I wanted to focus on Ms. Morr’s testimony, although others may 

wish to respond. I am recalling one of my favorite movies, Casablanca, with Humphrey Bogart and Peter Lorre where the phrase 

‘‘round up the usual suspects’’ occurs at least once. In looking at 

what we have done to deal with the threat of bioterrorism, by communicating with the National Counterterrorism Center, CIA, FBI, 

the various BKC entities, the labs and so on, I think you have done 

a good job of rounding up the usual suspects. 

My question goes to this, however. Are we also thinking out of 

the box? Are we making substantial initiatives with academia—and 
36

traditionally the intelligence community and academia have had 

somewhat of a difficult relationship. Are we talking full advantage 

of information that is available in the open-source domain, and are 

we trying to solve some of these problems in nontraditional ways 

because we are dealing with a nontraditional threat? That would 

be my first question. 

My second question, are we moving fast enough? I think we have 

one MTA completed, two MTDs, others in the process. Are you satisfied with the speed with which we are moving on some of these 

programs? 

Then the final question is, are we getting the word out to our 

State, local and tribal partners? I know that you are having briefings. I would be interested to know where and how frequently 

those briefings are taking place. Perhaps—ertainly myself, but perhaps members of the committee would like to attend a regional 

briefing, just to see how that goes. So three questions. 

Ms. MORR. Let me start with the last one—

Mr. SIMMONS. Out of the box, fast enough briefings. 

Ms. MORR. Let me start the last one first. The briefings are being 

done, I would say, rather ad hoc on a—as we go out, we know we 

are going to be there, or there is a request. And so we need to beef 

that up, and we plan to do a more thorough outreach program. 

I would also say that I think we have done a much better job of 

getting those information bulletins out to State and locals. We have 

done a couple on like when the financial institution surveillance 

came up, the HVAC systems on the top of those buildings, put out 

a State and local information bulletin on making sure those were 

looked at as protective measures because they could be used as dispersal devices for chemical, biological weapons. 

On the are we pushing the envelope, we frankly rely an awful 

lot on S and T to help us with pushing the envelope. They have 

the types of expertise to bring us together to get in a room and 

push the envelope. Quite frankly, we are just trying to keep up 

with a lot of the basics. 

I will go back again to my remarks to Congressman Harman that 

the DNI now is going to take on a whole lot more responsibility 

when we do these interagency threat assessments. There will be a 

piece on the end of this that sort of pushes the envelope on the 

what if scenario. The sector assessments that we were beginning 

to do out of DHS, the first one will be the chemical sector. These 

are requirements to the private sector. They will also have the 

what if factor to it. So there is a number of mechanisms in place. 

And the middle question was? 

Mr. SIMMONS. Out of the box. 

Ms. MORR. Out of the box. I would go back to our colleagues here 

back in S and T. We depend an awful lot for them to bring us together and do out of the box. We have had a couple briefings from 

people in the community that have come and told us about the 

complex urban environment, how all of this hooks together. So we 

are very much aware of it, just have not had the capability to deal 

with it in a multidisciplinary fashion yet. 

Mr. SIMMONS. I thank you for those remarks. I will simply say 

I think you know I am an advocate for open source intelligence. I 

think it really applies to the Department of Homeland Security, 
37

and I think we can build a robust capability in that area that 

works to answer many of these questions in an open and transparent way, which I think is really important. 

With regard to your regional briefings, if you are coming to the 

New England area, I would be happy to attend. I am sure my colleagues would be happy to attend briefings in New York, New Jersey, and elsewhere. 

Thank you, Mr. Chairman. I yield back. 

Mr. KING. I thank the gentleman for injecting Hollywood into an 

otherwise very somber hearing. 

The gentleman from Texas, speaking of Hollywood, Mr. McCaul. 

Mr. MCCAUL. Thank you, Mr. Chairman. I am reading the book 

1776 by David McCullough. I will go to a literary piece, if that is 

all right. It is interesting, General Washington, as the Revolutionary War is starting, talks about the weapon of choice by the 

British, and he talks about smallpox, how the British were trying 

to infect our troops with the virus. And so this is not a new, a 

brand-new idea. We had our Homeland Security retreat where we 

talked about an epidemic; had a tabletop exercise, an outbreak of 

smallpox globally start in Europe, and the question was, what do 

we do? Do we send some of our stockpiles over to Europe to build 

a ring around there? 

And my question is, I know we have enough stockpiles in this 

country for our own citizens, but in the event of an outbreak in Europe where we want to send the vaccine over to Europe to prevent 

the spread, the issue came up, and this may be a very simple short 

answer—the issue came up with respect to dilution. If we can, if 

it is scientifically possible to dilute the vaccine by a ratio of 2 or 

maybe 4 to 1 and the vaccine still be effective. 

Mr. SIMONSON. There is research over at the National Institutes 

of Health done right after 9/11 that indicates that a 5 to 1 dilution 

still produces a good immunological boost. The license isn’t for 5 to 

1, so it is a little—there is some technical issues that we have to 

deal with, but it can be diluted. Now, we don’t know, I think, about 

the new material; I don’t believe those studies have gone forward 

on the newly produced vaccine. 

I should also say that there is—WHO, World Health Organization, manages a virtual stockpile of about 30 million doses of smallpox. It is 30 million, isn’t it? About 30 million doses of smallpox 

vaccine. And they are building more. Yeah. So just— 

Mr. MCCAUL. So we have an adequate supply; and the answer 

is, yes, we can dilute, if necessary, to stop the spread overseas as 

well, I guess, right? 

Mr. SIMONSON. I am sorry, I was just checking. 

Mr. MCCAUL. That is okay. I guess the answer is we have an 

adequate supply here; but we could also dilute, if necessary, to prevent the spread overseas? 

Mr. SIMONSON. Yes. And, in fact, we participate in and we are 

able to participate in the WHO virtual stockpile because of this 

ability to dilute here originally. Now we have more product one for 

one that we can use. WHO, their objective is to be at around 150 

million doses in this virtual stockpile, but I don’t think they are 

much higher than 30—right now. 
38

Mr. MCCAUL. My second question has to do with security of the 

biological agents in existence, both in the—you know, when the 

former Soviet Republics had this intense biological warfare center 

going, we stopped our program in the Nixon administration, obviously Fort Detrick, we have CDC, we have a lot of level four facilities in this country. I had a tour of the Southwest Research Lab 

in San Antonio, some pretty nasty viruses that they have there. 

And my question is, what are we doing overseas particularly in 

Russia to secure these agents, but also what are we doing at home 

to better secure the biological agents we have in this country? Because when I got the tour, I have to tell you, I was a little surprised at what I noticed to be a lack of security at that facility. 

Mr. SIMONSON. I can answer the domestic part of your question. 

The CDC runs the select agent program, which requires very specific security handling of the most dangerous of these agents, control in the way they are handled in the lab and also in the way 

they are shipped, background checks for people who use them and 

that sort of thing. It is, we think, an effective program. 

But our experience in securing this sort of material is only a few 

years old; and, indeed, when Secretary Thompson directed Public 

Health Service agencies to take much more aggressive steps to secure material, there was a fair amount of resistance because it just 

is counter to the culture in some of these labs. 

I am happy to say that they have all come along very well, and 

we are very happy with the level of security improvements. But the 

select agent rule is our principal mechanism for controlling these 

things domestically. 

Mr. MCCAUL. I am glad to hear that. 

What about—can anybody comment on securing agents in Russia? 

Mr. VITKO. That generally falls under the domain of the Department of Defense and the Cooperative Threat Reduction Program. 

Mr. MCCAUL. Okay. Lastly— 

Mr. KING. The gentleman’s time has expired. 

Mr. MCCAUL. I will pick it up next time. 

Mr. KING. Okay. The gentlelady from New York, my colleague, 

Mrs. Lowey. 

Mrs. LOWEY. Thank you. And I want to thank the Chairman, and 

I apologize having to go to another event in between. 

But I would like to follow up, Mr. Simonson, on your responses 

to Mr. Pascrell’s questions, because one of the things that has concerned me as a New Yorker since 9/11, 3 years later we are still 

not coordinating between the agencies. Now, the center, as you 

probably know, the Infectious Disease Society of America, recommended that the Federal Government stockpile vaccines and 

antivirals in advance of a pandemic influenza outbreak. They recommend a stockpile to cover 50 percent of the population. In the 

United States we have a stockpile of less than 2 percent; England 

has a stockpile of 25 percent; France has a stockpile of 20 percent; 

and Canada for about 17 percent of its population. 

Now, what concerned me when my colleague Congressman 

Pascrell asked you the question, you didn’t have a response. So 

maybe you are not as worried about avian flu and other infectious 

diseases as I am. But when Julie Gerberding appeared before my 
39

committee, Labor, Health and Human Services, Education Appropriations Committee, they clearly didn’t have a plan to get from 1 

percent of Tamiflu antivirals up to even close to what England has, 

what France has, what Canada has. Can you explain this? I don’t 

get it. 

And I would like to know, if a pandemic arrived on the U.S. 

shores tomorrow, has any progress been made to cover the population? Is the CDC working with other agencies in the Federal Government to build up an antiviral stockpile comparable to countries 

like England, France, and Canada? And do you agree with the 50 

percent? 

In other words, what are you doing? Why aren’t we making 

progress? And why can’t you respond to my colleague Congressman 

Pascrell, who is asking a question that I think every American 

wants an answer to? 

And I feel a real sense of responsibility to know why we are not 

moving faster. We have to, it seems to me, have comprehensive 

plans, we have to move fast, and we have to have plans in place 

and then fund them to do this. How much money do you need? 

Why isn’t it moving? Give us a number, and let us get it done. 

Mr. SIMONSON. Well, thank you, Mrs. Lowey. I thought I had responded to the Congressman’s question, so if I hadn’t, I appreciate 

the opportunity to try again. 

We have now a stockpile of antivirals. It is not what the U.K. 

has ordered; however, it surpasses— 

Mrs. LOWEY. What percentage of the population would it cover? 

Mr. SIMONSON. I think you are about right there. 

Mrs. LOWEY. So we are at under 2 percent compared to the U.K., 

compared to France. 

Mr. SIMONSON. Well, actually the U.K. doesn’t have all of theirs 

yet. I mean, we have probably surpassed them right now. It will 

take them some time to build up. We started building this up a 

while back. 

The industrial base to make this stuff does not exist to immediately or even in the intermediate term get up to the numbers 

that you are talking about, 50 million. 

Mrs. LOWEY. And forgive me if I am interrupting you, but I know 

the gavel is going to come down in 5 minutes. We know that it 

would take $100 million and a year to build another factory. We 

had the experience with Chiron; we lost 50 percent—correct?—of 

our vaccine. And this was just for a regular flu. Why can’t we do 

it? Here we are, the richest country of the world, why can’t we do 

it? How much would it cost? How long would it take? 

Mr. SIMONSON. As to Tamiflu, as to that antiviral, the active 

pharmaceutical ingredient comes from Asia, comes from a plant. 

That is the limiting major factor. 

Mrs. LOWEY. Can we make it here? 

Mr. SIMONSON. These are discussions that are occurring. 

Mrs. LOWEY. Three years after 9/11, and we are still having the 

discussions? Why can’t we do it? 

Mr. SIMONSON. We have also invested, as I indicated earlier, in 

technologies to convert over and to be able to surge our vaccine capability. This is the so-called cell culture or tissue culture vaccine, 

entered into a contract some months ago on that. We have taken 
40

steps to secure the egg supply that is used for the current vaccine. 

They are subject to avian disease and so forth. And also, we have 

taken steps to be able to surge production of these eggs so that if 

we needed to vastly expand the amount of vaccine we produce, we 

can do that. 

Unlike the U.K., we have gone in and produced commercial runs 

of H5 and 1 vaccine. And we have H5 and 1. This is the avian 

strain floating around Asia right now. We have clinical tests under 

way right now to determine how that vaccine can be used. 

So there is a fair amount of activity here, and there is no threat 

that we take higher than pandemic influenza. We came forward in 

our 2003 budget request for 100 million to build the Nation’s pandemic influenza preparedness, and that is what helped us do some 

of these things in terms of securing the egg supply and building a 

cell culture base. But it takes some time. There is no way we will 

be able to get up to these levels of coverage, 50 percent, that the 

IDSA is recommending. And even if we did, there is a very serious 

debate in the public health community about the wisdom of that. 

This is a very expensive drug. When you, as Dr. Gerberding has 

said—when you use these things, you lose them, because the virus 

mutates, it develops resistance. And so what we are focusing on is 

much more of a vaccine-driven approach. 

Mrs. LOWEY. Let me just say this in conclusion. I understand, 

based upon information from the CDC and Dr. Gerberding, that 

they are working on a vaccine, and at a minimum it is going to 

take 6 months to get this vaccine produced; isn’t that correct? 

Mr. SIMONSON. We already have some. 

Mrs. LOWEY. It is still mutating. We don’t really know. But if, 

God forbid, that avian flu began aggressively mutating to humans, 

what I don’t understand—and I asked this of Dr. Gerberding, and 

I have great respect for her and Dr. Fauci. What I don’t understand is when the military needs a weapon, we produce it and we 

stockpile it. And if—and I understand if you don’t need it, please, 

God, we won’t need it, you may have to throw it out. So be it. They 

throw out weapons, too. 

I don’t understand why we are at 1 percent, England is at 25 

percent, France is at 20 percent, and Canada is 70 percent. With 

all the people we have working on this, there seems to be a lack 

of determination and a lack of focus. And ask us for the money. I 

mean, ask us for the money. Why are we still depending on one factory? And why are we still depending on an overseas supply? Last 

time it was London; now it is Zurich. 

I think we have real problems here, and I would like to see a 

sense of urgency. And, again, if the vaccine goes bad because we 

don’t have it, so be it. It is like an insurance policy for the American people. And, to me, it is really disappointing that we can’t tell 

the American people that if, God forbid, something happened, we 

are ready. 

Mr. SIMONSON. As much as I admire and respect you, Mrs. 

Lowey, I have to disagree. There is a very serious determination 

at our Department to address influenza. We took very proactive 

steps long before there was interest in the general population and 

indeed some quarters up here on influenza. We were very aggressive. 
41

Mrs. LOWEY. If you are so aggressive, then why do we still have 

one factory. 

Mr. KING. We will let Secretary Simonson answer, then

Mrs. LOWEY. Okay. 

Mr. SIMONSON. They are the developers of this drug. They are 

the ones who own the drug. That is the way it works. 

Mrs. LOWEY. This is a longer discussion, and my time is up. And 

I am rooting for you, and I do hope that we can resolve it because 

the health of the public is at stake. 

Mr. KING. We have just seen a match made in heaven. The gentleman from the State of Washington, Sheriff Reichert. 

Mr. REICHERT. Thank you, Mr. Chairman. 

We are all rooting for you. The whole country is rooting for you. 

You have a tough job, and we know that. Some people might think 

it is a disadvantage to be one of the last people to ask a question; 

those of us who are freshmen Congress Members, House of Representatives Members, are usually left to last. But we kind of get 

the opportunity to sum up just a little bit, too. 

My background is in law enforcement, as the Chairman mentioned the word ‘‘sheriff.’’ I was the sheriff in Seattle for 8 years, 

and 33 years in law enforcement. So what I have heard—and I just 

jot down a few words that all three of you have spoken since I have 

been here this morning. I really am encouraged when you use 

words like technology and research and development and intelligence gathering and assessment, risk assessment, and the sharing of that intelligence, and State and local bulletins. Those are important words for local law enforcement across the country to hear. 

They understand those words. Partnership is huge, outcome-based, 

all of those terminologies. And most of all, I think most important 

is someone used a little bit earlier integrated operation. And this 

is the tough place to get to, and we understand that in the local 

law enforcement world. 

I am also glad to hear that you have a structure set up where 

you have an incident manager, and then you have listed HHS and 

CDC and the Office of Public Health and Commission Corps and 

all of those entities that come under the direction of the incident 

manager. 

I understand incident management very well, having been a 

SWAT commander for years, but there was some concern and always has been about information that comes to or doesn’t come to 

local law enforcement, especially in light of the recent events in 

London and the inability of local law enforcement in the northwest 

part of the country and not hearing about this until hours and 

hours later, and then having to take action in a Metrobus tunnel 

or on a train that might run through the city of Seattle and the 

county that I live in. 

My question is you have mentioned all these other entities, but 

I haven’t heard really any talk about how you might be interacting 

with local law enforcement and what you see their role in the 

whole BioShield Project, because I know that we have a role to play 

in this event. Public health has got the majority of the shouldering 

the burden here, but what do you see as the role of local law enforcement agencies in this effort? 
42

Ms. MORR. As I mentioned before, on the bulletins, one of the 

reasons that we do put out information bulletins, the whole reason 

is to inform people of what to look for, because what we are trying 

to do is encourage the reporting both locally through the JTTFs 

and on through the Department of Homeland Security. And as we 

begin to set up these fusion centers, not we, the Department, but 

as the State and local jurisdictions to begin set up their fusion centers, it is important that we have a reporting mechanism. 

As you may know, we have the Homeland Security information 

networks. Seattle is a robust member of that network. It has interoperability with RISNET and LEO, and so we are continually mining the information that is passed to us, and that is where we post 

the information and the analysis that we do. So we do believe we 

are on the cusp of this more active information exchange, not just 

through paper or faxes or e-mails, but also through the interact 

that the HSIN provides us. 

In terms of local law enforcement, the ones that I have talked to, 

I mean, they have been so proactive of reporting incidents that 

they do see. You may know of our Terrorist Screening Center, for 

example. This isn’t the biothreat, but it is the same mechanism. 

These officers are out there sending in people that they are stopping, and we are getting hits on criminals or in some cases people 

in our terrorist databases. 

So I think it is a revolution in the way that we are reporting information and sharing information. And I see that the same way 

as BioShield. It is going to be the officers on the job who notice that 

there is, you know, funny lab equipment being stockpiled in an 

apartment building that they may go into, or noticing that a student is communicating at an Internet cafe with several others and 

wants to report on that that activity. So I think it is the continued 

spectrum of it is going to happen locally. We need to prepare our 

eyes and ears on the ground. 

Mr. REICHERT. I appreciate that. 

I see my time has expired, Mr. Chairman. Thank you. 

Mr. KING. Thank you, Sheriff Reichert. 

And the gentleman from Washington, Mr. Dicks. 

Mr. DICKS. I know this subject has been discussed, but I would 

like to go back to it. What are we doing with the public health infrastructure? I am told that if we had this, a nuclear attack, for 

example, and you got into advanced radiation syndrome, that, in 

fact, we are going to ship people to other parts of the country by 

rail or train or some other way? Bus? I mean, are we doing enough 

in New York, Washington, and the major cities to have public 

health people who can deal with these victims of an attack? Let us 

say we had a nuclear detonation. Our friend Curt Weldon talks 

about it. We lose a million people. But a lot of them would be the 

people who don’t die but are affected by the radiation. What are 

we doing on that score? 

Mr. SIMONSON. We have made—as I said a bit earlier, we have 

made very substantial investments since 2002 in our public health 

infrastructure, about 5.2 billion between our HRSA grants and 

CDC grants. One of the programs that HRSA funds is a surge capacity program in order to build additional capacity within existing 

hospitals to handle local events. 
43

But an event, Mr. Dicks, like the one you referenced, is not something that is going to be able to be handled in a local part of the 

country or even in a region. We are going to have to move people 

out; we are going to have to bring assets in. A good example of this 

is the burn capacity in the Nation, burn hospitals. We have a fairly 

modest burn capacity in this country, probably no more than 2,000 

licensed burn beds across the whole country. And so one of the 

things that we are doing is working with the Burn Association and 

trying to figure out alternate ways to be able to absorb large numbers of burn patients. 

Mr. DICKS. You mentioned two sources of funding HRSA and 

CDC. Have they been increased, or are these the same budget levels that we had prior to 2001? 

Mr. SIMONSON. They have not been increased. There is a— 

Mr. DICKS. Yeah. I mean, it is the same amount of money that 

we have been using; now we are just using it for these additional 

problems. Isn’t that correct? 

Mr. SIMONSON. Well, and it is not entirely expended. As I said, 

we have monies still from 2002 that have not been drawn down. 

And so it is not clear that more money— 

Mr. DICKS. We are on the Appropriations Committee; we can 

take care of that. Why hasn’t it been spent? 

Mr. SIMONSON. This is a question for the authority receiving it. 

It is within their power to do that. But I can tell you, from fiscal 

year 2002 grants—now, this is an older run. It is good as of June 

14th—we have something like 92 million that has still not been 

drawn down. 

Mr. DICKS. Out of 5 billion? Or how many billion was it? I assume you are talking about the HRSA money. 

Mr. SIMONSON. That would have been—it is about 10 percent of 

the 2002 money that was not drawn down. 

Mr. DICKS. Is this HHS’s fault, or has it been granted? 

Mr. SIMONSON. It is granted. It is out there. It is just a question 

of— 

Mr. DICKS. It just hasn’t been spent. 

Mr. SIMONSON. Right. So as I said, it is not clear to us— 

Mr. DICKS. Can you give us a list of who hasn’t spent the money? 

Mr. SIMONSON. Yeah. Your colleague requested, and I will be 

happy to provide that. 

Mr. DICKS. Thank you, Mr. Chairman. 

Mr. KING. Thank you, Mr. Dicks. 

I want to thank all members of the panel for your testimony 

today, for your patience, and for your perspectives. And, with that, 

the panel is excused. 

Mr. KING. I would ask the second panel to step forward. Thank 

you very much. 

I want to thank the members of the panel for taking the time 

to be with us today and for your patience in sitting through the 

first panel. We will start and try to move this along. We do have 

votes coming up at approximately 12:00. At most it will be a brief 

recess; we will keep the hearing going until everyone has had a 

chance to both testify and answer questions from each member of 

the committee. 
44

I will recognize Dr. Marcus Eugene Carr, the executive director 

for clinical research-hemostatis, at Novo Nordisk, Inc., to testify. 

STATEMENT OF MARCUS EUGENE CARR, JR. 

Dr. CARR. Thank you, Mr. Chairman and members of the subcommittee. I appreciate the invitation to appear on behalf of Novo 

Nordisk today. I am Mark Carr. A little bit of background. I am 

an executive director for clinical research in hemostasis at Novo 

Nordisk. Hemostasis is blood clotting, and I have been involved 

with business development and regulatory approval for a primary 

product known as NovoSeven. I have got extensive experience in 

real-world treatment of acute bleeding and mass casualties, with 

over 3,000 hours as an emergency room physician; I have been a 

professor of medicine in pathology at the Medical College of Virginia in Richmond; and I am currently a colonel in the Medical 

Corps of the Army, having served in Desert Storm, Desert Shield, 

Noble Eagle, Enduring Freedom, and the Kosovo campaign. 

Novo Nordisk is the world leader in diabetes care, and with the 

development of NovoSeven introduction has taken a leading position in the treatment of bleeding disorders; also produces growth 

hormone and hormone replacement therapies. At U.S. bases in 

Princeton, it has greater than 20,000 full-time employees in 78 

countries. And so it is truly a global organization, and produces 

products and markets them in the United States and 180 other 

countries, and is traded on the New York Stock Exchange, London, 

and Copenhagen Exchanges. 

But Novo Nordisk is not a biodefense company, and it does not 

have as its primary focus the Federal market as a marketplace. 

However, we will work diligently to supply medications that the 

Federal Government identifies as critical, and since 9/11 we at 

Novo Nordisk are becoming more and more convinced that 

NovoSeven is such an agent. 

There has already been several discussions about the chemical, 

biological, and nuclear threat. One of the problems with it is the 

similarity of symptoms that some of these agents produce can look 

as simple as a cold, developing into a rash and a fever, and then 

end with massive bleeding disorders. Because of that, in many instances, probably the first indication of a bioterrorist attack may 

be previously healthy people who develop similar symptoms and 

are known to have a common site of exposure. Therefore, it will be 

difficult to get a rapid specific diagnosis, and, therefore, early treatment in lots of cases will be simply symptomatic: Treat what the 

patients appear to be presenting to you. 

Strategies for preparations for such an attack does include preventative, such as vaccines, but also the development of countermeasures for postexposure, and to this point, this has primarily 

been antibiotics. But I would point out there are no approved 

therapies for hemorrhagic fever viruses, and therefore initial treatment will once again be symptomatic. 

There are problems with countermeasures, and these include—

most to this point have been targeted to specific agents, and therefore very few are fully developed, Cipro for anthrax being probably 

the only one. Many are at very early stages of development. There 

is also a very critical window in which they can be applied. If you 
45

give them too early or you give them too late, they simply don’t 

work. There is also a period of latency which makes it even more 

complex, and you can end with a dead man walking syndrome 

where they are not effective. 

Therefore, countermeasures that are broadly applicable to the 

symptoms of the patient will be needed. NovoSeven may be one of 

those measures. It is a mature medical product, having been used 

for treatment of bleeding for more than 10 years. It has a unique 

mechanism of action, stops bleeding that is refractory to all other 

forms of therapy. It works at the site of injury, and therefore side 

effects are reduced. And we think that it might be an agent where 

we can extend the window of opportunity where you could have 

more time to diagnose a patient and treat specifically with the 

agents under development. 

NovoSeven reached the market in 1996, has been given more 

than 700,000 doses. It is 90 percent effective in the worst of bleeders, which is hemophilia, and has reported uses from the literature 

in multiple other indications. It is a recombinant product, it is safe; 

there are no human proteins. It undergoes a dramatic purification 

process, no viral contamination. It is nonantigenic. Its main potential side effect would be thrombosis production, but that has occurred in 104 out of 700,000 doses. 

So why NovoSeven for Project BioShield? First, Novo Nordisk, 

the company producing it, is a qualified health company. Inclusion 

of NovoSeven would send a positive signal to equally qualified companies. NovoSeven is FDA-approved, it is available, it has a broad 

spectrum of activity, and may be of use in things like hemorrhagic 

fever viruses or end stage bleeding from multiple causes. I would 

also point out that it has potential in trauma; and as recent events 

in London have demonstrated, explosive devices remain our enemy’s weapon of choice. 

We do have a couple of proposals for improvements in the BioShield process. The current scheme— 

Mr. KING. Excuse me, Dr. Carr. I would ask you to try, each of 

the witnesses, to keep this to 5 minutes, because we do have a series of votes coming up at 12:00, and to try to get everyone at least 

to make opening statements before we go for the votes, and then 

come back for the questions. So if you could try to wrap up, I would 

appreciate it. 

Mr. CARR. The recommendation I was going to make is that BioShield consider simultaneous stockpiling of vaccines and therapeutics, and also encourage pharmaceutical companies to look at 

their products for potential uses in the BioShield area. This would 

maximize near-term solutions. 

And I thank you for your attention. I will stop there. 

Mr. KING. Thank you, Doctor. I am sorry for the interruption. 

[The statement of Dr. Carr follows:]

PREPARED STATEMENT OF MARCUS EUGENE CARR, JR., M.D., PH.D. 

Mr. Chairman, members of the Subcommittee, thank you for the invitation to appear before you today on behalf of Novo Nordisk. I am Marcus Carr, Executive Director for Clinical Research-Hemostasis of Novo Nordisk. I am here today to give 

you information and perspective about the use of Novo Nordisk’s drug NovoSeven®

as a countermeasure to bioterrorism. I also want to urge the committee to adopt a 

goal to find broadly applicable countermeasures and to look for products that can 
46

save lives today (and not just those that will save lives years from now) as you seek 

to ensure the viability of our Strategic National Stockpile (SNS). 

Since joining Novo Nordisk in March of this year, I have been extensively involved 

with the business development, regulatory approval process, and federal procurement issues related to the potential sale of Novo Nordisk’s innovative therapeutic 

treatment, NovoSeven®, for trauma victims. I have personally used NovoSeven to 

treat bleeding patients since its FDA approval in the late 90s, and have knowledge 

of NovoSeven from a research perspective that dates to the early 1990s. I also have 

extensive experience in treating bleeding patients of all varieties in my roles as an 

emergency department physician, as Director of the Central Virginia Bleeding Disorders Center at the Medical College of Virginia of Virginia Commonwealth University in Richmond Virginia, as Professor of Medicine and Pathology at the same institution and as a Medical Corp officer in the United States Army mobilized for Operations Desert Shield, Desert Storm, Noble Eagle, Enduring Freedom and the Kosovo 

Campaign. 

Novo Nordisk is an established pharmaceutical company and a world leader in diabetes care. The company has the broadest diabetes product portfolio in the industry, including the most advanced products within the area of insulin delivery systems. In addition, Novo Nordisk has a leading position within areas such as hemostasis management, growth hormone therapy and hormone replacement therapy. 

Novo Nordisk manufactures and markets pharmaceutical products and services that 

make a significant difference to patients, the medical profession and society. 

With a U.S. base of operations in Princeton, New Jersey, Novo Nordisk employs 

approximately 20,250 full-time employees in 78 countries, and markets its products 

in the U.S. and nearly 180 other countries. Novo Nordisk’s shares are publicly traded on the New York Stock Exchange (symbol, NVO), as well as the stock exchanges 

in Copenhagen and London.

The Chemical, Biological, Radiological and Nuclear Threat (CBRN) 

As everyone here today knows, the threat of a terrorist attack on the United 

States involving chemical, biological, radiological, or nuclear weapons is very real. 

In October 2001, shortly after the 9/11 terrorist attacks on the World Trade Center 

and Washington, D.C., 5 letters containing anthrax killed five people, sickened nearly two dozen, and required prophylactic antibiotic treatment for 32,000 more. Since 

the 1980s, terrorist organizations have embraced the use of CBRN threats. For instance, in the last 10 years, the Japan-based Aum Shinrikyo cult has attempted an 

aerosolized release of anthrax from Tokyo building tops, unsuccessfully attempted 

to obtain Ebola during an outbreak in Africa and released sarin gas into a subway 

system. Concern continues to mount about the potential use of CBRN agents 

against U.S. troops and interests abroad, as well against U.S. civilian populations. 

Even small scale use of these agents has the potential for enormous social and 

economic disruption and exhaustion of local and national resources needed to combat the threat, treat disease and clean up environmental contamination. As a basic 

first step, therefore, efforts have been made to better understand the scope of each 

threat and the consequences of an attack in order to prioritize pursuit of defenses 

against the highest priority agents.

A Multitude of Threats 

For biological threats, the CDC has identified and classified over 40 agents in Categories A–C. For a vast majority of these agents, there are no effective preventive 

vaccines, diagnostic systems or antidotes following exposure. 

Several national programs exist to monitor and provide early warning in the case 

of a terrorism event, including BioWatch and BioSense, as well global programs 

such as the Emerging Infections Sentinel Networks. In addition to screening the environment for the presence of pathogens, a sudden increase in non-specific syndromes may indicate a bioterrorism event. The recognition of a large number of previously healthy individuals with a common site of exposure presenting with similar 

symptoms including severe respiratory illness with fever, gastrointestinal maladies, 

encephalitis or meningitis, neuromuscular illness, fever with rash or bleeding disorders could indicate a CBRN attack. However, the development of rapid diagnostics 

for both known and unknown threats remains a challenge. 

Even before a definitive diagnosis is made, greater problems will arise in identifying, isolating and treating a potentially large numbers of victims and such a situation could develop into a crisis. In the case of a CBRN attack, there will likely be 

difficulty in diagnosing the causative agent, especially since many of the potential 

threat agents manifest with very similar symptoms. For this reason, it is critical 

to develop countermeasures that are broadly applicable, especially in the absence of 

a diagnosis or in the case of a genetically modified or emerging threat. Further, 
47

countermeasures that are efficacious in treating a variety of ailments are highly desirable since the nature of future terrorist attacks are unknown.

The Need for Broadly Applicable Countermeasures 

There are two main strategies to prepare for a CBRN attack. The first is to develop preventatives for the known threat agents, typically vaccines, such as anthrax 

and smallpox vaccines. This strategy has certain weaknesses. First and foremost, 

it is effective only against a biological attack, not chemicals or radiation. Second, 

it works only with previously known and characterized agents, A third major weakness is the monumental difficulty of vaccinating the entire U.S. population against 

each and every threat agent. Mass vaccinations pose a significant risk/benefit concern with children, the elderly, women of child bearing age and 

immunocompromised individuals. Lastly, to date, anthrax and smallpox are the only 

biological threat agents with FDA approved vaccines, and these vaccines are associated with certain limitations on their use. Therefore, it is clear that preventatives 

alone will never adequately address the CBRN threat. 

The other main anti-CBRN strategy is to have available countermeasures for post 

exposure treatment. There are also certain weaknesses to this strategy. For example, at this point in time, only a few approved therapies exist for exposure to a 

toxin, chemicals or radiation, and treatment is dependent on identifiable symptoms 

in the individual patient. There is no approved treatment for any of the hemorrhagic 

fever viruses. While ribavirin may be used under an Investigational New Drug 

(IND) protocol for the arenaviruses and bunyaviruses, no such treatment exists for 

the filoviruses or flaviviruses. Although countermeasures are being pursued that 

target specific agents, most of these, if successfully developed, will not be available 

for stockpiling for over a decade. Moreover, many of these agents must be administered within a narrow window of time to be efficacious. Often a definitive diagnosis 

is needed to decide upon an appropriate countermeasure to administer. The period 

of latency before symptoms emerge that is associated in particular with biological 

agents adds a significant hurdle in that without adequate diagnostic tests to detect 

disease in early stages, by the time the patient exhibits identifiable symptoms, the 

drugs under development may prove ineffective. 

Therefore, today the reality is that therapy following exposure to most CBRN 

threats will be largely supportive. This leaves us highly unprepared to deal with the 

casualties following a CBRN attack. 

One answer to the difficulties posed above is to have available countermeasures 

that address common symptoms of CBRN agent exposure.

NovoSeven 

This is where our company’s revolutionary new drug, NovoSeven, enters the national medical preparedness picture. But first, let me be clear about one thing to 

the committee today. The primary focus of Novo Nordisk has not been the development of drugs to protect against attack by CBRN weapons. The principal focus of 

our company has been, and remains, pursuit of innovative bio-pharma products for 

the commercial market. We are not a ‘‘biodefense’’ company as that term has come 

to be known in the post-9/11 environment. While we will certainly work diligently 

to supply NovoSeven for whatever purpose the US Federal Government feels appropriate, our business plan, our executives, and our investors do not see the primary 

focus of Novo Nordisk, now or in the future, to be the federal market place. 

Nevertheless, in the years since the horrific 9/11 attacks and the ensuing threats 

which our country faces everyday, we have come to realize that one of our commercial products would be a great asset to responding to terrorist attacks. 

NovoSeven is a mature medical therapy approved by FDA for use in hemophilia 

patients, but it could be also be used to save lives in a CBRN attack by treating 

bleeding disorders caused by a wide array of threat agents. The immense value of 

NovoSeven as a life-saving therapy for CBRN applications lies in its unique mechanism of action to prevent severe blood loss and extend the window of opportunity 

for therapeutic intervention. Availability of NovoSeven would make an immediate 

contribution to enhancing our nation’s medical and public health readiness for mass 

casualty events. To realize these benefits, Novo Nordisk believes that NovoSeven 

should be considered as a key component of the comprehensive national plan for 

readiness against a CBRN attack and as a key asset to the SNS. 

Since it reached the general market in 1996, over 700,000 doses of NovoSeven 

have been administered. NovoSeven is currently only approved by the FDA for use 

in hemophilia A and B patients and is 80–90% effective in treating bleeding episodes. NovoSeven is also approved for use in treating bleeding episodes in acquired 

hemophilia, Factor VII deficiency and Glanzmann’s thrombasthenia in the European 

Union. Other reported uses in normal patients include individuals with trauma or 

surgery-associated hemorrhage, intracerebral and pulmonary hemorrhage, or bleed-
48

ing following bone marrow transplantation. Pivotal phase three trials to support applications for indications in the areas of intracerebral hemorrhage and trauma 

should begin this calendar year in the US, Canada and Europe. An application for 

FDA approval for the use of NovoSeven in inhibitor patients requiring surgery is 

currently pending. Plans are being prepared for a discussion with the FDA on the 

most appropriate pathway for approval of NovoSeven in pulmonary hemorrhage. 

Novo Nordisk currently holds IND protocols for other uses of NovoSeven including 

treatment of bleeding in trauma patients and also thrombocytopenia following chemical or radiological exposure. 

NovoSeven has an excellent safety profile, since it is a recombinant product and 

contains no human products. To produce NovoSeven, the gene for human Factor VII 

was cloned and expressed in baby hamster kidney cells. The recombinant protein 

is secreted into the media of the cells from which it is purified using a 

chromatographic purification process. The purification process has been demonstrated to remove any potential contaminating viruses. Further, no human serum 

or other proteins are used in the manufacturing of this product. 

NovoSeven has been found to be safe and effective in both patients with bleeding 

disorders and those without pre-existing coagulopathy. Even following repeated administration, there is no evidence of antigenicity, or immune responses to the product, in patients receiving NovoSeven. NovoSeven has been shown to be effective 

when other treatments fail, are contraindicated, or blood products are unavailable. 

NovoSeven has a very low frequency of serious adverse events, remaining around 

1% following administration of greater than 700,000 doses. Even when very high 

‘mega’ doses of the drug are administered, it appears to be safe. The most important 

serious adverse event type for NovoSeven is thromboembolic (i.e. serious blood clotting) events; however, only 104 thromboembolic events have been reported following 

administration of more than 700,000 doses of NovoSeven. This represents an event 

rate of two thromboembolic events per 10,000 standard NovoSeven doses—a very 

low frequency considering the clinical severity of diseases in which NovoSeven is 

being used. Of further importance, the mode of action of NovoSeven localizes the 

coagulation effects to the area of injury, thus avoiding systemic activation of clotting 

and the risk of thrombosis.

Use of NovoSeven Against CBRN Agents 

Many companies have the capability to develop new products to protect against 

attack by biological and chemical weapons or other dangerous pathogens. A few 

firms, such as Novo Nordisk, have already done so. In fact, Novo Nordisk is one of 

the largest and most qualified companies to express interest in Project BioShield to 

date. Should the federal government work with Novo Nordisk to negotiate a viable 

business relationship with respect to the federal government’s purchase of 

NovoSeven, it will send an extremely powerful, positive signal to similarly qualified 

companies to enter this marketplace. Of course, the failure of this endeavor could 

have a negative effect on the goal of stimulating greater interest of large biopharma 

companies. 

NovoSeven could be immediately tapped for filling current shortfalls in our medical defense arsenal. NovoSeven has the potential to be broadly used against bleeding disorders caused by a chemical, biological, radiological or nuclear attack. The 

use of NovoSeven might be particularly useful in the immediate time period following a CBRN attack—before confirmed diagnosis of the attack agent or in the 

case of unknown diagnosis. Further, NovoSeven could be a critical component of the 

SNS for treatment of diseases, such as the hemorrhagic fever viruses, that have no 

other treatments. NovoSeven could also be useful in combination with other therapies in difficult patient cases or with genetically modified or emerging threats for 

which treatment is unknown. NovoSeven will also likely be used by health care providers in patients that have not received the proper treatment in time to stop the 

severe end-stage bleeding disorders associated with CBRN attacks. Additionally, 

even where there is a definitive diagnosis, cessation of bleeding would be a valuable 

and necessary component of a combination of treatments to enhance survival in victims with hemorrhagic symptoms.

Proposed BioShield Implementation Improvements 

Recognizing the need to protect its citizens, the U.S. government is committed to 

spurring CBRN medical countermeasure development through policy means. The 

Project BioShield Act of 2004 provides new and necessary tools to improve medical 

countermeasures protecting Americans against a CBRN attack. 

Although Project BioShield is a commendable first step, a number of issues concerning BioShield and the SNS deserve further attention. More specifically, the current implementation scheme for BioShield can be improved upon to maximize the 

authorities granted through the legislation and to more rapidly and effectively bol-
49

ster the SNS. First, the procurement of countermeasures is limited by the current 

implementation scheme because there must be a call for material threat assessments against a specific agent, followed by a call for a countermeasure against that 

threat. Unfortunately, this process is not well-suited to countermeasures such as 

NovoSeven that are effective for treatment of multiple threats. 

Further, the current procurement process precludes products with a significant 

commercial market. This provision of the legislation serves as a disincentive to companies with marketable products with potential broad applications in the CBRN 

arena (e.g., broad spectrum antibiotics) and deters their participation in CBRN medical countermeasure research and development. While many of the specifically targeted countermeasures are in such early stages of development that it will be years 

before they can be stockpiled under IND status and then subsequently licensed, it 

is likely that mature technologies exist that are approved for other uses that could 

also provide near-term solutions to the country’s CBRN defense needs if given the 

opportunity to compete for Project BioShield contracts. Pursuing FDA-approved 

drugs for other CBRN related indications could significantly expedite the regulatory 

and development process since these products have already been used in humans. 

With the two changes identified above, BioShield is more likely to meet its goal 

of establishing a stockpile of vaccines and therapeutics to counter various CBRN 

agents. Our nation should acquire effective countermeasures now, while still promoting an innovative pipeline of countermeasures, thereby stockpiling a broad range 

of products that defend against immediate and future threats. 

In closing, let me say that I hoped I have provided you with valuable information 

about the use of NovoSeven as a broadly applicable countermeasure and also about 

changes to the legislation that represent good, sound public policy that will enhance 

US security. I look forward to hearing the committee’s thoughts and answering any 

questions the members may have. 

Thank you again for this opportunity to testify today.

Mr. KING. Mr. Michael Greenberger. 

STATEMENT OF MICHAEL GREENBERGER

Mr. GREENBERGER. Thank you, Mr. Chairman. My name is Michael Greenberger. I am director of the University of Maryland 

Center for Health and Homeland Security. I am not a scientist or 

involved with any corporation; I am a lawyer by training and a professor of law. But I do work extensively with researchers who have 

been given substantial grants by the National Institute of Allergy 

and Infectious Diseases to develop countermeasures for Class A, B, 

and C agents on the CDC’s lists. 

My focal point of what I would like to say to you in this brief 

time is I think emblematic of the difficulties with Project BioShield 

is that nothing, none of that $5.6 billion, can be released until the 

Department of Homeland Security makes a material threat assessment. You heard time and time again worries about pandemic flu 

and the avian flu, and the answers that we do not have an industrial base. The $5.6 billion was intended to create an industrial 

base. After 1 year after BioShield has been passed, almost 4 years 

after 9/11, 5 years after the Defense Science Board has made findings in this regard, the Department of Homeland Security, its one 

responsibility that it is the leader of under BioShield, has made 

four material threat assessments for anthrax, smallpox, botulism 

toxin, and radiological and nuclear devices. 

Dr. Carr is talking about something that his company has that 

is principally designed to deal with hemorrhagic fevers. You, Mr. 

Chairman, opened the meeting up by talking about Marburg and 

ebola hemorrhage fevers. After 1 year, the hemorrhagic fever is not 

on the material threat assessment list; therefore, the entire country 

who is worried about this is being told do not invest your time, 
50

your research time, your development time, your manufacturing 

time in hemorrhagic fevers. 

Dr. Vitko says—first in prior testimony he said by the end of fiscal year they will—which I take it to mean before October 1st, 

hemorrhagic fevers will be on the list of—material threat assessment list. Today we learned it will be at the end of the fiscal year. 

These—nothing can be done until these items are listed. They have 

talked about a 3—or 4-month assessment to get a draft up with regard to meetings. Dr. Morr says in Afghanistan they found in the 

tents of al-Qa’ida documented information that they intend to use 

tularemia and plague. Tularemia and plague are not yet material 

threat assessments. 

When the BioShield statute was set up, this wasn’t supposed to 

be some complicated hearing endorsed by substantial evidence and 

reviewed by courts of appeals. My reading of the statute is this was 

a very preliminary assessment that was supposed to be made, the 

Defense Science Board, the Center for Disease Control. Congressman Weldon talked about Jessica Stern, who has one of the leading 

scholarships in this area. Her book was published in 1999. She lists 

60 agents that need to be considered. 

Now, Dr. Vitko said the CDC’s work is a good starting point. 

They are going to add to it. Well, the CDC, by however you count, 

is at least 33 agents, and they are going to add to it? How long is 

that going to take? And if there are surprises, he said, some of the 

CDC’s agents aren’t going to be listed. That is going to be a very 

big surprise. 

I can tell you that the scientists I work with are in the elementary stages of developing vaccines for tularemia, plague, smallpox, 

anthrax, avian flu, and many other threats to this country. It 

goes—even if they are successful, it is a long step between the research and going through all the clinical trials and then getting the 

stuff manufactured. And if we can’t do this fundamental work, 

which is the one responsibility the Department of Homeland Security has, in all this time, that is worrisome. And I think this committee should grab the Department of Homeland Security by the 

scruff of its neck and get these assessments made. 

The final point I would make in this regard is that there are—

if we want to create an industrial base, we must move more quickly. I know there is worry about coordination between Department 

of Homeland Security and HHS. To my mind, there is too much coordination. There are a lot of committee meetings, and we have to 

wait until everybody is available for the meeting. 

I am reading a biography now of Winston Churchill. He would 

have not taken 3 to 4 months to figure out material threat assessments when the blitz was happening in London. 

We are essentially—speaking of London, we are in our own kind 

of blitz. We must move more quickly. There are many problems 

with BioShield. I would be happy to answer other questions, but 

I think this is emblematic of the maladministration of a wise program proposed by the President and passed bipartisan by this Congress. 

Mr. KING. Thank you for your understated testimony. Thank you, 

Mr. Greenberger. 

[The statement of Mr. Greenberger follows:]
51

1Symposium, Eliminating Legal, Regulatory, and Economic Barriers to Biodefense Vaccine Development, at the University of Maryland School of Law, June 9, 2004. 2Michael Greenberger, The 800 Pound Gorilla Sleeps: The Federal Government’s Lackadaisical Liability and Compensation Policies in the Context of Pre-event Vaccine Immunization Programs, 8 J. HEALTH CARE L. & POL’Y 7 (2005) (hereinafter Greenberger, 800 Pound Gorilla); 

Michael Greenberger, et al., The Threat of Smallpox: Eradicated but not Erased, J. HOMELAND 

SEC, Feb. 2004, http://www.homelandsecurity.org/journal/Articles/displayarticle.asp?article=103; 

ELIN GURSKY & MICHAEL GREENBERGER, ANSER INSTITUTE FOR HOMELAND SECURITY, INSTI- TUTE COMMENTARY: SUPPOSE THEY GAVE A CIVILIAN SMALLPOX VACCINATION PROGRAM—AND

(ALMOST) NOBODY CAME? (Feb. 20, 2004), http://www.homelandsecurity.org/Hls/commentary/

gurskylsmallpoxlcommentaryl20feb04.html. 3Project BioShield Act, Pub. L. 108–276, 118 Stat 835 (2004). 

4Frank Gotron, Project BioShield, CRS REP. NO. RS21507 (Updated December 27, 2004), at 1. 5 United States Department of Health and Human Services, HHS Fact Sheet—Project BioShield, July 21, 2004, http://www.hhs.gov/news/press/2004pres/20040721b.html 

PREPARED STATEMENT OF MICHAEL GREENBERGER

My name is Michael Greenberger. 

I want to thank the subcommittee for inviting me to testify on the important issue 

that is the subject of today’s hearings. 

From 1999 to 2001, I served as Justice Department’s Principal Deputy Associate 

Attorney General. Included within my portfolio of responsibilities were several 

counterterrorism projects concerning both law enforcement and public health policy, 

including organizing the first nationwide counter terrorism field exercise, ‘‘TOPOFF 

I.’’

I now serve as a Law School Professor at the University of Maryland School of 

Law and, since May 2002, as the Director of the University of Maryland Center for 

Health and Homeland Security. 

At the School of Law, I have designed and teach two courses focused on legal and 

public policy issues concerning counterterrorism: (1) ‘‘Homeland Security and the 

Law of Counterterrorism,’’ which addresses the legal framework surrounding the response to the terrorist threat facing the United States, including the Project Bioshield Act of 2004; (2) ‘‘Homeland Security—The Interdisciplinary Study of Crisis 

and Health Consequence Management Policy in the Era of Counterterrorism’’ which 

is open to students from all of the University of Maryland professional schools and 

explores public health policy implications of counterterrorism strategy, including the 

development of a stable biodefense vaccine industry. 

The University of Maryland Center for Health and Homeland Security (CHHS) 

serves as an advisor on public health emergency planning to various state and local 

agencies. CHHS also works closely with: (1) the Center for Vaccine Development 

(CVD) at the University of Maryland School of Medicine, which is the only university vaccine center in the world engaged in the full range of vaccinology: from basic 

science through vaccine development, clinical evaluation and field studies, including 

groundbreaking work on biodefense vaccines; and (2) the Mid-Atlantic Regional Center of Excellence for Biodefense and Emerging Infectious Diseases (MARCE), one of 

eight Regional Centers of Excellence (RCE) funded by the National Institute of Allergy and Infectious Diseases (NIAID). MARCE is headed by Dr Myron Levine, the 

director of CVD. MARCE is now in the process of researching and developing new 

biodefense vaccine products to be used as prophylaxis against a broad array of biological agents. 

Through CHHS’s work with CVD and MARCE, CHHS has organized symposia 1

and I have written several articles 2 addressing the substantial economic, regulatory, and legal roadblocks to creating biodefense vaccines. 

One of the bright milestones toward the development of a vibrant biodefense vaccine industry was the passage of the Project BioShield Act of 2004. That statute was 

designed ‘‘to provide protections and countermeasures against chemical, radiological, 

or nuclear [CBRN] agents that may be used in a terrorist attack against the United 

States.’’ 3 The most prominent parts of that legislation were its procurement provisions designed to address the key significant impediment to biodefense vaccine production, lack of a significant market.4 These provisions encourage the development 

of effective vaccine countermeasures by establishing a Special Reserve Fund of $5.6 

billion to be spent over the next ten years to purchase for the Nation’s Strategic 

National Stockpile (SNS) the ‘‘next generation of countermeasures against’’ a broad 

array of chemical, biological, radiological, and nuclear agents, all of which were seen 

by Congress as weapons that could be deployed against the United States in the 

War on Terror.5 Due to the substantial expense and risk of bringing a vaccine to 

market, along with the infrequency with which these diseases occur naturally, phar-
52

6 Bioshield: Countering the Bioterrorist Threat: Hearing Before the House Select Committee on 

Homeland Security, 108th Cong. (May 15, 2003) (statement of Alan Pemberton, Pharmaceutical 

Research and Manufacturers of America), available at http://www.globalsecurity.org/security/

library/congress/2003lh/5–15–03lpharmaceutical.pdf; Frank Gotron, Project BioShield, CRS 

REP. NO. RS21507 (Updated December 27, 2004), at 1–2. 7Project BioShield Act of 2004, Pub. L. 108–276, § 3(a)(2), 118 Stat. 835,843–52 (2004); United 

States Department of Health and Human Services, Procurement Items—BioShield Funds, 

March 23, 2005, http://www.hhs.gov/ophep/bioshield/bioshieldfunds.html. 8Project BioShield Act of 2004, Pub. L. 108–276, § 3(a)(2), 118 Stat. 835, 844 (2004). 

9Project BioShield Act of 2004, Pub. L. 108–276, § 3(a)(2), 118 Stat. 835, 843–48 (2004); 

United States Department of Health and Human Services, Procurement Items–BioShield Funds, 

March 23, 2005, http://www.hhs.gov/ophep/bioshield/bioshieldfunds.html. 10 Combating Weapons of Mass Destruction: Hearing Before the Subcommittee on National Security, Emerging Threats, and International Relations of the H. Comm. Of Government Reform,

109th Cong. (June 15, 2005) (testimony of Dr. John Vitko, Jr.. Director, Biological Countermeasures Portfolio, Science and Technology Directorate, Department of Homeland Security), 

available at http://reform.house.gov/UploadedFiles/ST.Govt%20Ref.Vitko.06–14–05.pdf. 11Press Release, United States Department of Health and Human Services, HHS Buys New 

Anthrax Vaccine for Stockpile (Nov. 4, 2004), http://www.hhs.gov/news/press/2004pres/

20041104a.html; Press Release, United States Department of Health and Human Services, HHS 

Awards BioShield Contract for AVA Anthrax Vaccine (May 6, 2005), http://

communitydispatch.com/artman/publish/articlel961.shtml. 12Press Release, United States Department of Health and Human Services, HHS Awards BioShield Contract for Liquid Potassium Iodide (March 18, 2005), http://www.hhs.gov/news/press/

2005pres/20050318.html. 

maceutical manufacturers have little to no incentive to invest without BioShield 

funds.6

In order for the Bioshield Special Reserve Funds to be released for the purchase 

of a countermeasure for SNS, a series of actions must occur.7 However, the first action (and the one on which all later actions are based) is that ‘‘the Homeland Security [DHS] Secretary, in consultation with the [HHS] Secretary and the heads of 

other agencies as appropriate,’’ must make a ‘‘determination’’ of ‘‘current and emerging threats of CBRN agents’’ that ‘‘present a material threat against the United 

States. . .’’ 8 Once that ‘‘material threat assessment’’ is made various government 

agencies, up to and including, the President, through a series of decisions then determine whether promising countermeasures may be purchased with the special reserve funds to address those identified threats.9

The BioShield Act established no procedure for DHS to employ in supervising the 

making of the material threat determinations. Despite what was an obvious Congressional invitation to summarily determine what are the widely recognized CBRN 

threats to the United States, DHS has employed an opaque, highly bureaucratized, 

relatively lengthy process for determining material threats. Over the course of the 

past year, this cumbersome and poorly delineated administrative process has led to 

only four material threat determinations. Findings have been made that Anthrax, 

Smallpox, Botulinum toxin and radiological/nuclear devices pose a material threat 

to the United States. DHS officials have promised that by the close of this fiscal 

year material threat determinations will be made concerning plague, tularemia, and 

viral hemorrhagic fevers.10

Because there have only been material threat determinations pertaining to four 

CBRN agents, BioShield’s Special Reserve funds can only be used for countermeasures directed to those agents. Accordingly, three contracts have been let over 

this last year, two directed to the purchase of anthrax vaccines 11 and one for the 

delivery of pediatric doses of liquid potassium iodide.12 Even if a promising countermeasure were to meet the other requirements for purchase under the statute, it 

would not be eligible for procurement if there were no corresponding finding that 

the agent to which it was directed was a ‘‘material threat.’’ 

DHS’s lassitude in supervising the making of material threat findings is mystifying. The legislative history of the statute is replete with references to a myriad 

of agents, beyond the four agents identified, posing a substantial threat to the 

United States. 

Moreover, the Center for Disease Control (CDC) has a long established and widely 

recognized hierarchy of highly damaging biological agents that are likely to be deployed by terrorists against the United States. CDC’s Category A agents, ranked as 

the most dangerous to the United States, include Anthrax, Botulism, Plague, Smallpox, Tularemia, and Viral hemorrhagic fevers. Only three of those agents have as 

yet been identified under the BioShield bureaucracy as posing a material threat. 

DHS has assured committees of Congress that it will by the end of this fiscal year 

make findings on the remaining three Class A agents identified by CDC. 

When you look at the Category B and C agents identified by CDC, there are total 

of more than 33 agents which ultimately will need to be addressed with medical 
53

13 CDC, Bioterrorism Agents/Diseases (Nov. 19, 2004), http://www.bt.cdc.gov/agent/agentlistcategory.asp. 14 JESSICA STERN, THE ULTIMATE TERRORISTS 24–25 (1999). 15Press Release, United States Department of Health and Human Services, NIH News, NIAID Awards First $27 Million Using New Bioshield Authorities (May 9, 2005), http://

www.nih.gov/news/pr/may2005/niaid-09.htm. 16 Virginia Bioinformatics Institute, Mid-Atlantic Regional Center of Excellence, https://

www.vbi.vt.edu/article/view/426. 17 Center for Vaccine Development, University of Maryland School of Medicine, Nataro Lab, 

http://medschool.umaryland.edu/cvd/natarolab/natarolab.html 18For a complete description of the problems with implementing the BioShield statute, see Crossing the Valley of Death: Bringing Promising Medical Countermeasures to BioShield: Hearing Before the Senate Health, Education, Labor and Pensions Subcommittee on Public Health,

109th Cong. (June 9, 2005) (statement of Dr. Phillip Russell, Major General, Retired, U.S. 

Army), http://help.senate.gov/testimony/t319ltes.html. I agree with almost all of Dr. Russell’s 

assessments. For a proposal to resolve indemnification problems identified by Dr. Russell and 

others, see Greenberger, 800 Pound Gorilla, supra note 2. 19 ARNOLD & PORTER, LLP., CLIENT ADVISORY: ‘‘BIOSHIELD II’’ BILL WOULD EXPAND INCENTIVES TO DEVELOP BIODEFENSE COUNTERMEASURES 1 (May 2005), http://www.arnoldporter.com/

pubs/files/A&PAdvisory-BioshieldII(0505).pdf. 20 Id. at 2.

countermeasures.13 At the rate the ‘‘material threat’’ findings have been made to 

date, it could be years before BioShield procurement funds can be used to purchase 

products designed to counter the as yet undesignated agents. 

Leaving CDC’s findings to the side, scholarship on terrorist threats abound with 

long standing and well recognized findings about a significant number of CBRN 

agents likely to be deployed against the United States. For example, Jessica Stern 

in her 1999 classic, The Ultimate Terrorists, lists two dozen chemical agents that 

have been historically deployed by terrorists going all the back to World War I.14

Not one of these chemical agents has been certified under DHS’ leadership. Nor has 

DHS even committed to making such designations in the future. 

Quite ironically, under other provisions of the BioShield statute concerning HHS 

funding for research (which does not require a ‘‘material threat’’ finding), grants 

have been made for the development of countermeasures relating to tularemia, 

Ebola, and plague.15 Yet, none of these agents has yet been designated as a material 

threat. If HHS has already commenced funding for research in this area, one would 

assume that there is substantial evidence available to DHS demonstrating that 

these agents should be so designated. 

From CHHS own experience, substantial NIH funding outside of the BioShield appropriations is being committed to the development of medical countermeasures not 

yet declared to be ‘‘material threats’’. For example, MARCE is researching countermeasures for tularemia as part of a five-year, grant from NIAID, which is supported 

by funding wholly apart from monies appropriated under the BioShield statute.16

Simultaneously, plague vaccine research is being performed in the laboratories of 

James Nataro, M.D. at the CVD that is funded by funded by a National Institutes 

of Health U19 grant,17 again a project being done wholly apart from the BioShield 

Act. 

The BioShield Act is an impressive starting point for the creation of a vibrant biodefense vaccine industry. It has many problems that must be corrected both administratively and legislatively.18 I would be happy to address each of those issues with 

you today. However, only one of those problems deals directly with DHS, the agency 

over which you have direct oversight responsibilities. DHS bureaucratic quagmire 

in identifying CBRN agents posing a material threat to the United States (thereby 

delaying the use of procurement efforts for well recognized CBRN dangers to this 

country) is a matter that deserves your full attention. 

This problem does not require a legislative fix. What it requires is prodding the 

agency to abandon an administrative morass. It requires directing the agency to follow the well worn path already trodden through scholarship and the work of the 

CDC to quickly list the full panoply of CBRN agents. Such an expedited effort would 

be an encouragement to both researchers and the vaccine industry that a broad 

array of efforts might be funded over the next decade by the BioShield Special Reserve Fund. 

Finally, this subcommittee should be aware that the legislation recently introduced as a corrective to the Bioshield Act (S. 975, or the Project Bioshield II Act 

of 2005) places the major procurement responsibility principally in the hands of 

DHS, reducing substantially the role of HHS.19 This displacement of HHS is supposedly called for because industry supporters of Bioshield II view ‘‘HHS as having 

a contentious relationship with the biopharma industry.’’ 20 However, given the dif-
54

ficulties DHS has had with effectively carrying out its single major mission under 

the existing legislation, Congress should think long and hard before it puts the entire biodefense vaccine apparatus under DHS. 

TESTIMONY SUMMARY

The Department of Homeland Security has employed an opaque, highly 

bureaucratized, and lengthy process under the Project Bioshield statute for determining those chemical, biological, radiological and nuclear (CBRN) agents which 

pose ‘‘material threats’’ to the United States. BioShield’s Special Reserve funds can 

only be used for countermeasures directed to those agents designated by DHS as 

material threats. DHS’s decision-making apparatus has to date only made material 

threat determinations pertaining to four CBRN agents. It is well understood both 

within the Center for Disease Control and in the scientific research community that 

there are as many a 60 agents that now pose a ‘‘material threat.’’ Even if a promising countermeasure were to meet the other requirements for purchase under the 

statute, it would not be eligible for procurement because of a lack of a material 

threat finding. At the rate the ‘‘material threat’’ findings have been made to date, 

it could be years before funds will be eligible to purchase products designed to 

counter those as yet undesignated agents. Moreover, the delay in recognizing agents 

as a material threat amounts to a disincentive to both researchers and the vaccine 

industry to devote resources to CBRN agents that are not as yet designated as material threats.

Mr. KING. The Chair now recognizes Dr. Richard Hollis, the chief 

executive officer of Hollis-Eden Pharmaceuticals. 

STATEMENT OF RICHARD B. HOLLIS 

Mr. HOLLIS. Thank you, Mr. Chairman, members of the committee. My name is Richard Hollis. I am chairman of Hollis-Eden 

Pharmaceuticals, the manufacturer of a product called NEUMUNE. 

It is the first drug that is specifically being developed as a medical 

countermeasure to acute radiation syndrome, commonly referred to 

as radiation sickness, as a result of nuclear terrorism. 

And I also ask that I please have my entire statement entered 

into the record. 

Mr. KING. Without objection. 

Mr. HOLLIS. All of our Nation’s leaders from the President on 

down have concluded that the greatest threat to our Nation is nuclear proliferation and nuclear materials in the hands of a terrorist. 

The head of the Domestic Nuclear Detection Office recently said 

there is a 100 percent chance someone will try to attack the U.S. 

with a nuclear weapon in the next 5 to 10 years. Also, in a recent 

televised interview the Chairman and Vice Chairman of the 9/11 

Commission both stated that not only is a nuclear detonation in 

one or more of our inner major cities possible, but it is also probable. 

Imagine what would happen if a small nuclear bomb went off in 

Washington, New York, or Los Angeles, a bomb similar to the 

mockup that Congressman Weldon uses to demonstrate how small 

these devices actually are. The death toll from the detonation of a 

relatively small nuclear device in one or more of our major cities 

would be devastating. Medical reports indicate the vast majority of 

those who are killed, hundreds of thousands would die from acute 

radiation syndrome, also known as ARS. 

When humans are exposed to radiation injury, the bone marrow 

is incapacitated, and it doesn’t have the ability to produce red blood 

cells that carry oxygen, platelets that help fight blood clots, and 
55

white blood cells that help fight infection, and people will die from 

bleeding and infection. 

The sad thing is the overwhelming majority of these people could 

be saved if the government was better prepared to respond to a nuclear scenario deploying the appropriate medical countermeasures. 

Our inability to manage the aftermath of a nuclear attack is now 

caused by our failure to deploy a drug for acute radiation syndrome. Now, if you can imagine that you could rapidly distribute 

a drug to the people and give it to them much like soldiers with 

autoinfectors following a chemical attack; and imagine if that drug 

could stimulate the body to make white blood cells to fight infection 

and platelets to protect you from bleeding; and, most importantly, 

imagine that up to 90 percent of the people who received the treatment could survive. This is not a fantasy. We have an experimental 

drug with the potential to treat ARS that could be in the strategic 

national stockpiles as early as next year. And primate tests done 

under the Department of Defense oversight using lethal doses of 

radiation, this drug, NEUMUNE, has been shown to increase survival rates up to 90 percent. To date, it has no serious side effects, 

it is inexpensive, and it can be self-administered without hospitalization. 

There is currently no therapy in the stockpile for acute radiation 

syndrome. Prussian Blue and potassium iodide, currently stockpiled, both address long-term health impacts; they do not address 

ARS. What we need is an ARS therapy, and so let me be blunt. 

Every treatment of this drug or something like it given to a victim 

of such an attack stands to save a human life. However, HHS has 

continued to delay the procurement of an effective radiation drug 

for ARS. 

I would submit that the key question for this committee is: Given 

the nuclear threat is the greatest one that we face, and given that 

more than a million lives per detonation may be on the line, and 

given that a promising, effective medical countermeasure to a nuclear attack to treat ARS is close to fruition, and it is now 4 years 

after 9/11, why is this drug not a top priority to be deployed to protect the American public? 

The failure here reflects a series of fundamental disconnects between HHS and DHS’s role under BioShield. Our BioShield priorities are not coordinated with our national security priorities. As 

experts interviewed on Meet the Press just this past Sunday stated, our DHS spending is still not based on prioritized risk assessment. 

Overwhelmingly, experts agree that the greatest threat facing 

this Nation is a nuclear threat. That said, DHS and HHS have 

committed billions of dollars to second- and third-generation products such as anthrax drugs, and we don’t even have a first-generation—or RFP out issued for a first-generation acute radiation syndrome drug. This is in part because DHS has failed to publish a 

prioritized list of BioShield threats. This not only causes confusion, 

but also creates market uncertainties, exactly the opposite of what 

BioShield was intended to do, which is to guarantee markets. As 

a result, since the passage of BioShield, our company has lost over 

$600 million in market capitalization. There needs to be better 

transparency and leadership in implementing BioShield. 
56

At the same time, DHS planned nuclear threat efforts are based 

on assumptions that do not reflect the postnuclear reality. We can’t 

evacuate hundreds of thousands or a million people without an infrastructure. We can’t treat people in medical facilities that will be 

overwhelmed. We can’t treat people without an acute radiation syndrome drug. And we can’t deploy medicines that need to be given 

to victims immediately after an incident. 

Our nuclear response planning should focus on getting effective 

ARS treatments out to the greatest number of victims in the fastest way possible. This is detailed in my full written testimony. 

So, in closing, how will our leaders try to explain why so many 

people died unnecessarily from a nuclear 9/11 when experts are 

predicting this nightmare scenario and we failed to prepare our 

Nation by providing and forward-deploying a drug that could possibly save millions of lives? So I ask your help today in ensuring 

that we look carefully at why this country remains unprepared to 

deal with its greatest threat, that of a nuclear detonation on our 

soil. 

We all know that the terrorists are racing to acquire nuclear 

weapons, and I want to assure the committee and the government 

and the people of America that Hollis-Eden is racing to develop 

NEUMUNE. But our political leaders must also ensure that HHS 

and DHS join that race, because it is the one race we have no 

choice but to enter. Last week in London there were multiple bomb 

blasts—I am wrapping this up—and the world was lucky that those 

bomb blasts were not nuclear. So the question is, can we be so 

lucky next time? 

So, Mr. Chairman and members of the committee, I want to 

thank you for the honor of allowing me to testify today, and I hope 

you agree that Hollis-Eden is a role model for Project BioShield 

and what Congress intended this legislation to achieve, and that is 

to create innovative new pharmaceutical drugs to mitigate the 

medical consequences of weapons of mass destruction. Thank you 

very much. 

Mr. KING. Thank you, Mr. Hollis, especially for giving us the 

benefit of your own dealings with the Federal Government. 

[The statement of Mr. Hollis follows:]

PREPARED STATEMENT OF RICHARD B. HOLLIS

Mr. Chairman, Ranking Member Pascrell, distinguished members of the Committee: 

Thank you for the opportunity to testify before you today. Before I begin, allow 

me to thank you personally for your longstanding leadership, both as a Committee 

and individually, to help safeguard this nation against terrorism, and specifically 

against the threat posed by weapons of mass destruction. 

My name is Richard Hollis. I am Chairman and Chief Executive Officer of HollisEden Pharmaceuticals. Hollis-Eden is a San Diego-based Biotechnology Company 

founded in 1994 and publicly traded on the NASDAQ stock exchange since 1997. 

Hollis-Eden has under development a number of proprietary immune-regulating 

hormones, compounds that are key components of the human immune system. We 

believe that by properly utilizing these hormones we can help the body to mount 

an appropriate immune or metabolic response to a number of different diseases or 

challenges. Specifically, we have developed and tested our compounds for the potential treatment of Acute Radiation Syndrome (ARS, or what is commonly known as 

‘‘radiation sickness’’), among other possible applications.

THE NUCLEAR THREAT 
57

1The NPPS here refers collectively to The Planning Scenarios, Executive Summaries, The 

Homeland Security Council (July 2004), and the accompanying Improvised Nuclear Device, 

Predecisional Draft (undated). 

The President of the United States, the Vice President, the 2004 Democratic candidate for president Senator Kerry, scores of military leaders, leaders from the medical and scientific community, the intelligence agencies, and leaders in homeland security, as well as the chairman and Vice Chairman of the 911 commission have all 

publicly stated that the greatest threat to this nation is nuclear proliferation and 

nuclear material in the hands of a terrorist. In fact, the Director of the Domestic 

Nuclear Detection Office at DHS recently stated that, ‘‘There is a 100 percent 

chance someone will try to attack us with a nuclear weapon in the next five to 10 

years.’’

Imagine that a small nuclear bomb were to go off in Washington or New York 

or Los Angeles. The bomb is similar to the ‘‘mock up’’ Congressman Curt Weldon 

often uses to demonstrate how small these devices can be. 

The results of such an attack on this nation would be devastating. By extrapolation, the Department of Homeland Security’s Nuclear National Planning Scenario 

(NNPS) 1 estimates that the number of lives lost from a terrorist attack on a major 

U.S. city could be as high as one million or more people per detonation. 

Contrary to popular belief, the vast majority of the victims of a terrorist nuclear 

attack would die not from the blast, but from Acute Radiation Syndrome (ARS). 

ARS is the result of radiation-induced bone marrow damage. Specifically, ARS is 

characterized by the loss of infection fighting cells and clotting elements that are 

produced in bone marrow. This loss of the body’s ability to fight infection and prevent bleeding is believed to be the leading cause of sickness and death in the event 

of a nuclear attack. 

In fact, expert estimates of the medical consequences from a nuclear bomb indicate that ARS would likely kill three to five times as many people as the initial 

blast. For example, the British Medical Journal recently estimated that a 12.5 kiloton bomb detonated in New York City would kill at least 50,000 people instantly. 

These 50,000 victims would be beyond help. However, the vast majority of victims—

between 200,000 to 700,000 people—would die days or weeks later from the effects 

of ARS. 

The sad fact is that the overwhelming majority of these people could be saved if 

the federal government was better prepared to respond to a nuclear scenario, including deploying the appropriate medical countermeasures.

OUR INABILITY TO MANAGE THE AFTERMATH OF A NUCLEAR ATTACK 

IS CAUSED BY OUR FAILURE TO DEPLOY A DRUG FOR ARS 

No city has the medical surge capacity to handle the massive numbers of ARS casualties: In the wake of a nuclear attack on a major city, medical facilities will be 

immediately overwhelmed. Adequate hospital and other clinical medical facilities of 

most large cities are already utilized at or near full capacity. A nuclear attack will 

destroy scores of beds and take others off-line because they will be in contaminated 

areas. This would mean little meaningful ability for hospitals to treat the victims 

of a nuclear blast. 

In New York, for example, a study published in the British Medical Journal recently estimated that approximately 1,000 hospital beds would be lost in a nuclear 

blast and an additional 8700 beds would be contaminated from radiation fallout. Additionally, the bulk of any region’s medical personnel—doctors, nurses, technicians, 

EMT’s—are located in the heart of the area most likely to be targeted by such an 

attack. Most of these medical personnel would be victims of the attack and would 

not be mission ready to treat other victims. 

Additionally, in the wake of an attack, we would expect to see hundreds of thousands of ‘‘worried well’’ flood medical facilities. These people will fear that they have 

been exposed to radiation and they will seek treatment from whatever medical facilities remain. There is no inexpensive, fast and accurate method to determine the 

level of radiation exposure and triage radiation victims. This will only complicate 

the difficult task of determining who is among the worried well, who is sick but can 

be saved, and who is beyond help. The burden of tens or hundreds thousands of worried well, on top of hundreds of thousands of ARS victims, will immediately overwhelm area medical facilities. The 2004 influenza vaccine shortage gives only a hint 

of the mass panic and possibly violent demand for medical services that would 

ensue after a nuclear attack. 

Because regional medical facilities will be overwhelmed, one plan is to ship victims 

to distant care, which will only increase death rates: Because medical resources in 

the area of any attack will be severely degraded and dangerously over-stretched, we 
58

have been briefed by DHS and HHS officials that one element of the plan for handling the injured and dying is to ship them off in buses and trains to remaining 

medical facilities that are located at a greater distance from the impacted area. 

This plan is fundamentally flawed in at least three respects. First, as described 

in greater detail below, the transportation infrastructure required to move these 

people will be destroyed or damaged. Second, even if these victims reach medical 

facilities that have capacity, medical personnel will have little to offer beyond prayers and compassion. Third, and most importantly, because ARS kills by opportunistic infection, putting scores of immune system compromised victims into enclosed 

buses and trains will only hasten the spread of infection and death. In other words, 

such evacuation efforts will hurt victims more than they help them. 

Without an ARS treatment first responders will be pulled back—not sent in: The 

typical American believes that if his or her city was hit by a nuclear attack, help, 

in the form of first responders, military units and medical personnel will come 

streaming in to assist victims. This ignores the reality that, at present, we have no 

way to protect first responders from ARS. Because of the lack of protection, we may 

not be able to afford to risk sending these units into contaminated areas to help 

victims and to restore order. 

We will have to evacuate hundreds of thousands of people within 24 hours, because 

of radiation: Because there is no approved and effective treatment for people who 

have been exposed to enough radiation to trigger the onslaught of ARS, the DHS/

NNPS is principally focused on evacuation. The NNPS calls for the immediate or 

near immediate (within 24 hours) evacuation of roughly 450,000 people from the impacted city. The virtual impossibility of such a mass evacuation is self-evident to 

anyone who has negotiated rush hour traffic in a major American city. 

Without an ARS drug, medical personnel will have little to offer victims of radiation: Absent a drug to counter ARS, the only available treatments are bone marrow 

replacement and/or the administration of a drug approved for use in conjunction 

with chemotherapy. Both of these courses of therapy will be of little to no use after 

a nuclear attack. These therapies are highly expensive, making them cost prohibitive for a mass casualty event. Both of these treatments require intensive medical 

care in a fully functioning medical facility. There simply will not be enough hospital 

beds and medical professionals to administer these treatments on a mass casualty 

scale after a nuclear attack. The DHS NNPS states, ‘‘The level of care that can be 

expected may be significantly lower than would normally be expected.’’ 

Victims lucky enough to get themselves to aid facilities will be able to receive help 

in the form of decontamination. This will help halt further radiation damage but 

do nothing for the harm from the radiation already received. Absent the deployment 

of NEUMUNE, even remaining hospitals will have no treatment to offer the mass 

casualties such an attack will produce. For the vast majority of evacuees from the 

impacted area, currently planned rescue and medical efforts provided at the periphery will have little impact on mortality. In short, hundreds of thousands of Americans could die of ARS because we have no effective treatment in the Strategic National Stockpile.

AN EFFECTIVE ARS TREATMENT IS NOW AVAILABLE 

Now imagine that you could rapidly distribute a drug that people could give to 

themselves much like our soldiers do with auto- injectors following a chemical attack. Imagine that that drug stimulated the body to make white cells to fight infection and platelets to protect you from bleeding. More importantly, imagine that up 

to 90 percent of the people who receive this treatment could survive. 

In fact, such a drug isn’t a figment of the imagination. This drug could be procured today under Bioshield and be in the Strategic National Stockpile as early as 

next year. 

Two weeks after the devastating September 11, 2001 attacks on our country, officials from the Armed Forces Radiobiology Research Institute (AFRRI), a research 

division of the Department of Defense, approached Hollis-Eden and told us that they 

wanted to fast track the development of one of our experimental drugs for the treatment of ARS. In some early studies with mice, AFRRI found that this compound 

saved literally 100 percent of the animals that would have otherwise died from 

acute radiation exposure. Since that time, AFRRI has continued testing and publishing results in the medical literature on this compound, known as NEUMUNE, 

for use in mitigating the effects of acute, high-level radiation exposure. 

To date, results in over 200 non-human primates treated with NEUMUNE have 

demonstrated that the investigational drug is safe and effective in the treatment of 

ARS. In one recent trial, 90 percent of the treated primates survived otherwise lethal doses of radiation, but only 55 percent of the untreated group survived. Ex-
59

trapolating those results to a nuclear attack on a major American city, one can see 

how dramatic an effect this drug could have on mitigating human casualties. 

Testing to date has also shown that the drug is stable and can be easily stockpiled. In addition, NEUMUNE can be self-administered in the field by victims of 

such an attack, without the need for supportive medical care. This capability would 

free up medical resources that will be stretched beyond the breaking point. The drug 

has also exhibited no significant negative side effects. And, assuming a contract of 

sufficient size to offer economies of scale, we can provide the drug at a cost akin 

to that of a standard antibiotic. 

Moreover, NEUMUNE can be administered before exposure or for some period of 

time after exposure. The ability to administer the drug before exposure makes 

NEUMUNE ideal for first responders and military units. Protected by NEUMUNE, 

such units could safely be sent into the irradiated area carry out rescue, recovery 

and relief efforts. This ability alone would fundamentally improve our ability to respond to a nuclear attack. More importantly, however, the capability of the drug to 

be self-administered hours after an attack offer us the potential to save hundreds 

of thousands of lives if we respond effectively. 

Perhaps most importantly, NEUMUNE represents a dramatic breakthrough in 

our civilian and military security posture when one considers that here is currently 

no drug in the stockpile for ARS. 

With much fanfare, the federal government has stockpiled two compounds, potassium iodide and Prussian Blue, to address radiation injuries; neither of these compounds will save the lives of the upwards of one million people that will die from 

ARS in the wake of a nuclear attack. Potassium iodide blocks the absorption of certain radioactive isotopes that can lead to thyroid cancer. However, the hundreds of 

thousands of people who will die from ARS within weeks of a nuclear attack will 

perish long before they can contract thyroid cancer. 

The second drug, Prussian Blue, is a dye used for many years by artists which 

can act as a chelating agent that helps the body rid itself of radioactive isotopes 

more quickly, thereby reducing the radiation damage to the gut area. However, 

Prussian Blue has no impact on the two primary causes of death from ARS: opportunistic infection from immune suppression and bleeding caused by platelet loss. In 

other words, this compound will not materially impact the numbers of people that 

will die in the immediate wake of a nuclear attack. 

The limitations and possibly over reliance on these drugs gives rise for concern 

by Congress. In connection with a recent Senate oversight hearing on Project Bioshield implementation, Senator Robert Byrd (D–WV) submitted a question for the 

record to Assistant Secretary Stewart Simonson about the status of the procurement 

and stockpiling of radiation medical countermeasures. Secretary Simonson responded by highlighting the Department’s acquisition and pending acquisition of potassium iodide and Prussian Blue. In addition, he cited the possible emergency offlabel use of an existing drug now given to cancer patients undergoing chemotherapy. 

In addition to the limitations cited of potassium iodide and Prussian Blue, the response failed to indicate that the cancer therapy, in addition to not having been approved specifically for ARS, is prohibitively expensive for mass casualty treatment, 

must be given in a highly controlled clinical (hospital) setting, must be refrigerated 

prior to administration, and would likely need to be given in conjunction with adjunctive therapies, like intravenous platelet administration.

In short: • Drugs now in the stockpile do not address ARS, which will be the primary 

cause of death from a nuclear attack. 

• We need an ARS therapy. 

In contrast—and allow me to say this bluntly—every treatment of NEUMUNE 

given to a victim of such an attack stands to save a life. 

I would submit the key question for the Committee to consider is this: Given that 

the nuclear threat is the greatest threat we face; Given that more than a million 

lives may be on the line; Given that a promising effective medical countermeasure 

to a nuclear attack to treat ARS is close to fruition; And considering the fact that 

nearly four years after the 9/11 terrorist attacks, why hasn’t the procurement of this 

drug apparently been a higher priority for the federal government?

THE FAILURE HERE REFLECTS A SERIES OF FUNDAMENTAL DISCONNECTS BETWEEN HHS’ AND DHS’ ROLE UNDER BIOSHIELD

1. Transparency and leadership are lacking: 

We have worked in Washington for almost 3 1⁄2 years now meeting with numerous 

government agencies about biodefense. We have witnessed a clear lack of consensus 

as to: 

• What the government wants; 
60

• How much they will buy; • What they will spend; • When they will buy it; and, • Who is making the decisions? 

No one seems to be in charge. Who is ultimately responsible? As discussed in 

greater detail in the next section of this testimony, when gaps are identified in our 

defenses, we have seen agencies point the finger of blame at other agencies—rather 

than aggressively fixing the problem. 

2. Our Bioshield priorities are not coordinated with our national security 

priorities: 

There is no apparent linkage between the threats identified for Bioshield purchases and the greatest threats identified by security experts for homeland security: 

The 9–11 Commission, the President, the intelligence community, DHS, others 

agree: greatest threat to our nation is the threat of nuclear terror. However, nearly 

four years after 9–11, and one year after the passage of Project Bioshield there still 

is no binding statement that the federal government is seeking to buy a medical 

counter-measure to a nuclear attack that addresses ARS. In fact, we are still waiting on a promised draft RFP. 

At the same time, we have purchased and are seeking to purchase counter-measures for a range of biological threats that are important but clearly do not rise to 

the level of threat that a nuclear attack does. For example DHS and HHS have committed billions on second and third generation anthrax drugs and we still don’t have 

an RFP issued for a first generation ARS therapy. It may be instructive to note that 

tens of millions of federal dollars have been committed to developing and procuring 

Ebola vaccines, when to the best of our knowledge Ebola is not easily weaponized 

and used as a WMD. This should be compared to the all too real and known threat 

of a nuclear or radiological attack on the United States. 

Additionally, there is no single DHS/HHS common list of major WMD threats and 

intended/desired medical countermeasures to those threats. DHS speaks of one set 

of threats to the nation—and nuclear is typically first on that list. Meanwhile, HHS 

procures drugs from a different list, or, at the very least, a list with vastly different 

priorities. The lack of a list reflects a lack of threat coordination, which hampers 

our security efforts.

In addition, this lack of a coordinated set of threats to be addressed creates market uncertainties—exactly the opposite of what Bioshield intended. As a result: • Industry doesn’t know what the nation needs to protect itself; • This leaves the market undefined; • As a result, industry hasn’t become invigorated by Bioshield; and • Investors are reticent to fund Bioshield ventures. 

This climate does not help us deploy medical countermeasures against WMD. 

In general, the federal government’s Bioshield priorities do not appear to line-up 

with our national security imperatives. 

3. DHS’ planned nuclear response efforts are based on assumptions that 

do not reflect the likely post-nuclear war environment: 

Another disconnect is the how DHS plans to respond to a nuclear attack. These 

plans are fundamental divorced from the reality of the post-nuclear-attack environment. 

Because there is no stockpiled way to treat ARS victims, the NNPS focuses on 

getting people away from radiation contaminated areas as fast as possible. In order 

to do so, the NNPS calls for the immediate or near immediate (within 24 hours) 

evacuation of roughly 430,000 people from the impacted city. Let me emphasize that 

such a Diaspora-scale evacuation is required to reduce the amount of radiation exposure, which is required to prevent ARS, which, in turn, is required because we have 

no scenario-based, field-ready ARS treatment. Here the NNPS states: ‘‘For people 

in Zones 1 through 5 [heavily irradiated areas] this evacuation. . .is absolutely essential and must take place immediately or it will have a significant impact on the 

number of lives that will be lost.’’

These evacuation plans are not grounded in the post-nuclear-attack reality. First, 

the NNPS states that all infrastructure within ° mile will be completely destroyed; 

damage to infrastructure within 3 miles will be severe. Within these areas bridges 

will be down, tunnels will be flooded, and roads will be damaged or destroyed. 

Consider the impact on two of the most likely target cities: Washington, D.C. and 

New York, N.Y. In Washington, the blast will likely destroy or severely damage 

roads and bridges that allow passage out from the city to the South and Southwest. 

Normal prevailing weather conditions will take the fallout plume from Southwest 

to Northeast. This will eliminate the use of the largest evacuation routes out of the 

city. These impacts may leave dry-land evacuation routes (e.g., Wisconsin Avenue) 

that travel to the Northwest as the only passable means of escape. These routes are 
61

heavily congested under normal conditions to say nothing of what conditions would 

be like in the wake of such an attack. 

With respect to the island of Manhattan, it is likely that a terrorist nuclear attack 

would destroy or render unusable most of the bridges that service the city. In addition, train and vehicular tunnels would likely experience flooding as water flows 

into the crater formed by the blast. This would be particularly true if the terrorist 

target was one of the main transit tunnel hubs, such as Grand Central or Penn Stations. These impacts would leave only far northern routes available to those seeking 

to escape fallout from the attack. Here again, under normal rush hour conditions—

with far more means and routes of movement available than an attack would 

leave—these routes can become parking lots for hours as a result of a mere traffic 

accident. 

In addition, in New York, such impacts would likely strand the eight million people who live on Long Island. Depending on the plume path, Long Island residents 

could be left with little other means of escaping a certain death from radiation exposure except by sea in whatever form of craft they could find. 

In both cities even undamaged evacuation routes will be gridlocked by the impacts 

of the attack. For a distance of 13 or 14 miles, people who are looking in the immediate direction of the blast will be blinded, most temporarily. Immediate flash blindness to people operating vehicles will cause scores of accidents along key evacuation 

routes. Additionally, countless people who have been exposed to high levels of radiation will get into their cars and drive to get out of the area. These individuals will 

find themselves stuck in massive tie-ups. Those who are most irradiated will at 

some point begin to get very sick and die; some of them will be behind the wheel 

when this occurs. Their cars—in some cases abandoned and in others wrecked—will 

only further impede the progress of any evacuation. 

The NNPS notes that: ‘‘If [the city attacked] has an efficient, functional transportation infrastructure that is not bottlenecked by bridges, tunnels or other major obstructions and a high percentage of the population has access to the system, it is 

certain that [the high numbers of people exposed to deadly dose levels calculated 

to occur in the NNPS] will be drastically reduced.’’ Query, what major American city 

has such a transportation system on its very best day? (See Graph 1.)

Graph 1: ANNUAL HOURS OF TRAFFIC DELAY PER 

TRAVELER: 2003

Los Angeles ............................................................... 93

San Francisco ............................................................ 72

Washington, DC ......................................................... 69

Atlanta ....................................................................... 67

Houston ...................................................................... 63

Chicago ...................................................................... 58

Miami ......................................................................... 51

New York .................................................................... 49

Phoenix ...................................................................... 49

Philadelphia ............................................................... 38

Source: Texas Transportation Institute 2005.

Further, it is unlikely that the NNPS called for response can be achieved without 

first responders. Here again, ARS will block rescue and recovery efforts and frustrate the NNPS’ efforts to save lives. 

The typical American believes that if his or her city was hit by a nuclear attack, 

help—in the form of first responders, military units and medical personnel—will 

come streaming in to assist victims. This is false. Until such time as NEUMUNE 

is widely deployed, we have no way to protect first responders who enter the irradiated area from falling victim to ARS. Standard issue breathing devices and protective clothing do nothing to protect individuals from deep-body penetrating gamma 

radiation. According to the NNPS, ‘‘First responders may don [protective gear] to 

prevent internalization of fallout, but [this gear] does not reduce the gamma or neutron dose from external sources of radiation.’’ 

As a result, first responder units will actually be pulled back from assisting victims in the impacted area to a safe distance perimeter. Those few first responders 

who ignore these orders, and those already in the irradiated area who remain to 

help victims, will be working in a highly contaminated environment using equipment that is highly contaminated and suffering from ‘‘battlefield stress’’ that also 

works to diminish the body’s immune system; they will soon begin to suffer from 

ARS and their mission readiness will decline precipitously as they go from savior 

to victim. 
62

The NNPS states obtusely, ‘‘In a limited manpower situation, where the total integrated dose that can be absorbed by the finite number of trained and equipped response workers is fixed, as it is likely to be during the first few hours [more likely 

days] after the event, the value of these rescue activities will need to be weighed 

against those of preventing or reducing the future exposure of people in the highdoes fallout regions downwind.’’ Lara Shane, DHS’ Director of Public Education recently put this more directly in an article in the National Journal: in the event of 

a nuclear attack, ‘‘We need people to take care of themselves for 72 hours.’’ Sadly, 

this 72 hour timeframe is the period of time that will determine life and death for 

the vast majority of ARS victims of the attack—and the current plan has the American people on their own during this timeframe. 

Without help during this period, the number of casualties will be staggering. According to the NNPS, ‘‘Victims will continue to absorb radiation doses while waiting 

on rescue and this will result in an increased likelihood of death.’’ Victims lucky 

enough to get themselves to this perimeter will be able to receive help in the form 

of decontamination, which will help halt further radiation damage but do nothing 

for the harm from the radiation already received. In other words, absent a cure for 

ARS, decontamination will do nothing to help those who have already been irradiated to the level that triggers ARS. For the vast majority of evacuees from the impacted area, currently planned rescue and medical efforts provided at the periphery 

will have little impact on mortality. 

Absent first responders to assist in response efforts, the situation within the area 

of the blast—most likely the entire metropolitan area of one of the nation’s largest 

cities—will be horrific. Power will be out for some period of time. The area of outage, according to the NNPS, is likely to span several states. The NNPS further 

states that power will be out for a period of several days to weeks. There will be 

no street lights to direct evacuation traffic flows. There will be no street lamps to 

light evacuation routes. 

Together the loss of power and the effects of the electro-magnetic pulse (EMP) will 

render most modern means of communication—cellphones, television, radio, blackberries, most Internet services, and even most satellite communications devices—inoperable. 

Without direction, victims will be left largely in the dark about the proper courses 

of action. For some, the best course of action will be to shelter in place. However, 

such a response runs counter to normal human instinct. Without the ability to receive information from authorities, most people will leave their homes, offices and 

other places of shelter and seek to evacuate—in doing so they may only increase 

their likelihood of contracting ARS and dying. 

Most food and water will be contaminated; ingesting these staples will cause further radiation injury. Depending on the timing of the attack, parents will be separated from their children, with little or no hope of reuniting during the immediate 

future. ATM machines will be down. Phone-dependent credit card transactions will 

be halted. People will have only cash-on-hand-reserves to pay for survival necessities. 

Without police and military units, which will be kept out of the area do to the 

risk of ARS, some measure of chaos, and likely violence, is inevitable. Curfews will 

exist only for the truly law abiding and scared. 

It may take up to two weeks before radiation in the downtown area falls below 

the Civil Defense ‘‘all clear’’ standard. Those who die from the blast will be left 

where they fell. The injured who cannot fend for themselves and make their own 

way out of the blast area will soon succumb. Bodies will liter the roadsides and rubble. Soon these corpses will begin to decompose and fester causing a wave of disease 

among a population that is already immune-suppressed from ARS. 

Additionally, the timing of medical relief efforts under the current Strategic National Stockpile System does not fit the nuclear attack scenario. Whatever medical 

help we have to offer will arrive too late. 

This system will not work for a nuclear attack. The deadly effects of nuclear radiation will have begun before this system can reach people with drugs. In a nuclear 

attack contamination will cause and require an evacuation Diaspora. Unless we 

reach these victims before they are spread around the nation we will have no way 

of catching them in time. In other words, if we let our preordained, one-size-fitsall system for distributing drugs determine our nuclear response, we will have no 

way to save these people. 

This disconnects between plans and reality is, however, not, at base, DHS’ fault. 

Absent a drug to treat ARS, any realistic plan is doomed to failure. And, DHS has 

not been given an ARS drug to work with by HHS, which is charged with procuring 

such drugs.
63

Our nuclear response planning should focus on getting NEUMUNE out to 

the greatest number of victims in the fastest possible way. 

How do we achieve this? 

Based upon the damage ARS does and the speed at which these health impacts 

occur, the drug will need to be forward deployed in all high-risk areas, such as in 

and around major metropolitan areas, nuclear power plants, nuclear weapons facilities, nuclear waste facilities, and designated national security events. Within these 

areas, NEUMUNE stocks will need to be decentralized to give victims the maximum 

opportunity to obtain the lifesaving drug. For example, we should seriously consider 

pre-positioning the drug at stadiums, large malls, post offices, fire and rescue stations, police stations, hospitals, major employers, and schools and universities. 

Along these lines, the NNPS focuses heavily on using first responders and military 

units to set up decontamination stations. These units will become natural distribution points to get everything from food to blankets into the hands of vast numbers 

of victims and radiation refugees. It would make sense to equip these decontamination centers with NEUMUNE, which could be handed out to people as they enter 

the decontamination process. 

Further, the forward deployment of NEUMUNE has the advantage of knowing, 

generally speaking, where we need to get the drug to be most effective. We not only 

know with some degree of certainty the most likely terrorist nuclear targets, but we 

also know if such an attack were to occur where we would need the drug to be available. We have the benefit of years of data about common prevailing weather conditions for most if not all of these target areas. We know what areas will most likely 

be downwind of an attack.

The NNPS itself notes the importance of downwind focused efforts: 

Early emergency response efforts have historically been focused on lifesaving 

needs close to the emergency site. However, other actions need to be taken 

downwind where the plume will deposit radioactive fallout. Perhaps the greatest impact on saving lives will be activities immediately following the detonation that address the reduction of the future radiation dose that will be received 

by the population in the fallout zone immediately downwind of ground zero. 

We can pre-position the drug in the likely epicenter (e.g., downtown) and in the 

most likely downwind regions. Beyond these commonsense initiatives, our planning 

processes should also consider more creative mechanisms to pre-deploy and push 

NEUMUNE out to the affected population. For example, in the area adjacent to 

ground zero, and directly downwind from the epicenter, the areas that will be hardest hit, we might use other means, perhaps even including carpet-air-drops, to get 

NEUMUNE into victims’ hands. We should also find ways—ranging from the bully 

pulpit to a tax break—to encourage people, families and businesses to have their 

own mini-stockpiles. When DHS called upon people to purchase duct tape and plastic wrap, these goods flew off hardware stores shelves. A similar effort here could 

do far more to actually protect people from the nuclear threat. 

Further, we cannot simply put this drug into our stockpiles and hope that people 

will know what to do in the event of an attack. Any effective plan to use 

NEUMUNE to save vast numbers of people post-nuclear attack must begin with 

public education. Most Americans seem to believe that it is the nuclear blast that 

poses the greatest likelihood of death, when in fact they are more likely to be killed 

by ARS. And most think you cannot possibly survive a nuclear attack, when in fact, 

as I have indicated, ARS can be treated and the chance for survival can be significantly increased. 

These misconceptions and knowledge gaps will undermine the ability of DHS and 

the other response agencies to save lives with NEUMUNE. In fact, given decades 

of doomsday talk, I doubt the average American believes that a mere drug could 

help protect them from a nuclear bomb. We need to begin to educate the American 

people now about how this drug can save their lives and what they should do after 

any such attack to avail themselves of the drug and increase their likelihood of survival. For example, in most instances, if a family has NEUMUNE in the home, and 

if they have prepared by stockpiling food and water, and have a sheltered room in 

the home, that family will be better off not evacuating immediately. Rather, they 

should take the drug and shelter in place for a period of time to allow radiation levels to drop before seeking to evacuate. However, families aren’t going to react in this 

way if they don’t have NEUMUNE or haven’t been educated about how to use it.

CONCLUSION 

Imagine if we fail to act now to deploy an effective medical countermeasure to a 

nuclear attack. Imagine that our worst nightmare comes to pass: Osama bin Laden 

uses a nuclear device on American soil. 
64

Finally, imagine the impact this attack will have on the American public as night 

after night, the entire rest of this nation watches in utter horror as endless news 

coverage captures the dying, the chaos, the ruins of the blast and the streets deserted in the wake of the fallout. The video footage will be heart wrenching. Victims 

left trapped under the wreckage will be seen crying for help and no help will be 

coming. Photographers will capture first responder units sitting on the periphery 

unable to go in to help. Military units, finally unable to stand these images, will 

disobey orders and will go in to help, only to become sick. The Pentagon will struggle with how to handle growing widespread dissension in the ranks. Television 

crews will track the demise of hundreds of thousands of people as ARS slowly kills 

them. We will hear limitless stories of families shattered, promising lives extinguished, and other boundless tragedies and ironies. 

If our attackers are smart they will leave little in the way of a return address. 

Our political and military leadership will look impotent as they struggle with how 

to respond to the greatest tragedy in our nation’s history—in the words of Harvard’s 

Graham Allison, the author of the leading text on the nuclear threat, this tragedy 

‘‘will make 9–11 look like a pin prick.’’

Commentators will appear on the network and cable news stations talking about 

a drug that could have saved hundreds of thousands lives had it only had been 

stockpiled and on hand. Talk radio will be awash with allegations of a vast conspiracy that allowed this to happen. Political leaders will call for hearings and investigations. New commissions will be formed to once again tell us that we suffered 

a ‘‘failure of imagination’’ yet again. 

The failure of imagination here will not be our inability to imagine what the terrorists seek to do to the American people. We know that Osama bin Laden and alQa’ida are working day-in-and-day-out to attack us with a nuclear device. Bin 

Laden has said so himself. 

Here the difficulty is in the inability to imagine how to respond to that threat. 

Imagine how the public will judge their leaders if, after a nuclear attack, they 

learn a drug was available that could have saved hundreds of thousands of lives. 

How will our leaders explain why so many people died unnecessarily from a nuclear attack when there was a drug that could have saved them but their government wasn’t willing to make it available to America’s cities? 

I ask your help today in ensuring that we look carefully at why this country remains unprepared to deal with the greatest threat facing our nation: a nuclear detonation on American soil. 

Thank you for the opportunity to appear before you today

Mr. KING. And now we would recognize Mr. James A. Joyce, 

chairman and chief executive officer of Aethlon Medical, Incorporated. Mr. Joyce. 

STATEMENT OF JAMES A. JOYCE 

Mr. JOYCE. Mr. Chairman, I thank you and the committee members for the opportunity to testify today. My observations and recommendations will be based on both an entrepreneurial and scientific perspective. My name is Jim Joyce. I am the chairman and 

CEO of Aethlon Medical, based in San Diego, California. 

Since 2001, my company has focused on developing a therapeutic 

device that is able to deliver the immune response of clearing 

pathogens and related toxins from circulation. Our technology, 

known as the Hemopurifier, converges the well-established principles of hemodialysis and affinity chromatography with new discoveries of affinity agents that are able to bind a wide range of envelope viruses, including many of those that are currently designated as Class A pathogens. 

Our scientific efforts have been supported and guided by a worldclass team of infectious disease advisers, including the former head 

of the Russian bioweapon program, who Congressman Weldon referenced earlier today, Dr. Alibek, and the former commander of infectious disease research at USAMRIID, which today operates as 
65

our Nation’s top facility in developing countermeasures against biological weapons. 

We believe that our Hemopurifier will serve as an effective adjunctive therapy when treatment options do exist, and most importantly the Hemopurifier is available today as the first line of defense against drug-and vaccine-resistant bioweapons, including 

pathogens that have been genetically engineered for virulence and 

treatment resistance. 

I should reference that the concept of extracorporeal devices to 

filter or clear pathogens is not novel. Hemofiltration was utilized 

in the Soviet Union in 1990 to save a bioweapon researcher from 

late-stage Marburg infection. This is published in scientific journals. Leroy Richmond, a postal worker infected with anthrax in the 

attacks of 2001, attributes the difference between his survival and 

the death of two coworkers as being a series of plasmapheresis procedures he received to combat anthrax toxins. Today, 

hemofiltration has evolved to be a common therapy in treating sepsis and septic shock, which is the primary cause or cause of death 

in most viral conditions, including conditions related to biological 

weapons. 

Now that I have provided the committee with background information, I wish to proceed with two comments related to current 

BioShield legislation. Number one, further clarification in the definition of ‘‘countermeasure.’’ New legislation expands the definition 

of countermeasure to include the general term ‘‘therapeutics,’’ but 

does not reference therapeutic devices specifically. In our pursuit of 

research grants with the NIH, we have found that the general term 

‘‘therapeutic’’ for viral infection is traditionally considered by examiners to mean a drug or vaccine. In this regard, the definition of 

‘‘countermeasures’’ should specify and include therapeutic devices 

that reduce viral load or modulate cytokine production. 

Number two, presence of nonbioweapons markets. Early versions 

of Project BioShield would have eliminated the consideration of a 

stockpile purchase if other significant markets existed for a countermeasure. Such language has since been revised to require the 

presence of another commercial market must be factored into the 

HHS Secretary’s decision to purchase a potential countermeasure. 

I believe that such open-ended language will deter organizations 

from pursuing development of innovative therapies against biowarfare agents. This language is also counterintuitive as the best hope 

for treating such a wide range of threats is through the evolvement 

of postexposure immunotherapeutic countermeasures, especially 

when considering the added challenge of combating pathogens that 

have been genetically modified. 

Therapies that are able to augment the immune function or modulate cytokine production are going to have large market opportunities beyond the treatment of bioweapons. If developed, these 

therapies will globally impact the treatment of other infectious disease, including established pandemics such as HIV and AIDS, and 

new evolving pathogens such as avian flu virus. 

BioShield legislation should be embraced because of these possibilities. If the goal is to attract the development of treatment countermeasures, then references that imply the presence of a broader 

market as being potentially detrimental should be eliminated. 
66

In the case of Aethlon Medical, we are preparing to initiate 

human trials to treat HIV and hepatitis C. We do not have the luxury of betting the life of our company on the hope that BioShield 

legislation will be inclusive of our technology. In that case, we 

would like to think that science itself will drive the value of new 

technologies into the marketplace. Thank you for your time. 

Mr. KING. Thank you, Mr. Joyce. 

[The statement of Mr. Joyce follows:]

PREPARED STATEMENT OF JAMES A. JOYCE

Mr. Chairman, I thank you and the Committee Members for the opportunity to 

testify. The observations and recommendations I provide today are derived from 

both an entrepreneurial and scientific perspective. I am the Chairman, and CEO of 

Aethlon Medical, Inc., based in San Diego, California. Since 2001, my Company has 

focused on developing a therapeutic device able to deliver the immune response of 

clearing pathogens and related toxins from circulation. Our technology, known as 

the Hemopurifier TM converges the established principals of hemodialysis and affinity chromatography, with the recent discovery of affinity agents that are able to 

bind a broad spectrum of envelope viruses, including those that have been classified 

as bioterror threats. 

Our scientific efforts have been supported and guided by a world-class team of infectious disease advisors, including the former head of the Russian Bioweapon Program, and the former Commander of Infectious Disease Research at USAMRIID, 

which today operates as our Nation’s premier bioweapon research institute. We believe that the Hemopurifier will serve as an effective adjunctive therapy when treatment options exist, and most importantly, the Hemopurifier is available today as 

a first line of defense against drug and vaccine resistant bioweapons. This includes 

pathogens that have been genetically engineered for virulence and treatment resistance. 

I should reference that the utilization of extracorporeal devices to filter or clear 

pathogens is not a novel concept. Hemofiltration was utilized in the Soviet Union 

in 1990 to save a bioweapon researcher from late stage Marburg infection. Leroy 

Richmond, a postal worker infected with Anthrax in the attacks of 2001, attributes 

the difference between his survival and the death of two co-workers as being a series of plasmapheresis procedures he received to combat circulating anthrax toxins. 

Today, Hemofiltration has evolved to be a common therapeutic intervention for the 

treatment of sepsis and septic shock, which is often the primary cause of death in 

viral infection. 

Now that I have provided the Committee with background information, I wish to 

proceed with two comments related to current BioShield legislation. 

1. Further Clarification in the Definition of Countermeasure—New BioShield legislation expands the definition of countermeasure to include the general term 

‘‘therapeutics’’ but does not reference therapeutic devices specifically. In our pursuit 

of research grants at the NIH, we have found that the general term ‘‘therapeutic’’ 

for viral infection is traditionally considered by examiners to mean a drug or vaccine. In this regard, the definition of countermeasure should specify and include; 

‘‘therapeutic devices that reduce viral load or modulate cytokine production’’. 

2. Presence of Non-Bioweapon Markets—Early versions of Project BioShield would 

have eliminated the consideration of a stockpile purchase if other significant markets existed for a countermeasure. Such language has since been revised to require 

that the presence of another commercial market must be factored into the HHS Secretary’s decision to purchase a potential countermeasure. I believe that such openended language may deter organizations from pursuing the development of innovative therapies against biowarfare agents. This language is also counter intuitive as 

the best hope for treating such a wide range of threats is through the evolvement 

of post-exposure immunotherapeutic countermeasures. Especially when considering 

the added challenge of combating pathogens that have been genetically modified. 

Therapies that are able to augment the immune function or modulate cytokine production are going to have large market opportunities beyond the treatment of bioweapons. If developed, these therapies would globally impact the treatment of infectious disease, including established pandemics such as HIV/AIDS, and new naturally evolving viral conditions. BioShield legislation should be embraced because of 

these possibilities. If the goal is to attract the development of treatment countermeasures, then references that imply the presence of a broader market as being potentially detrimental should be eliminated. In the case of Aethlon Medical, we are 
67

preparing to initiate human trials to treat HIV and Hepatitis-C. We do not have 

the luxury of betting the life of our Company on the hope that BioShield legislation 

will be inclusive of our treatment technology. As the same time, our pursuit of other 

treatment markets should have no bearing as to whether our technology is stockpiled as a countermeasure against biowarfare agents. The stockpiling of our 

Hemopurifier should be based solely on its ability to save the lives of citizens exposed to biowarfare agents. 

In closing, I thank you again for the opportunity to testify. Bioterrorism is clearly 

one of the most dangerous threats facing our nation, and I commended the committee members for devoting attention to this problem. I would now be pleased to 

address any questions you may have.

Mr. KING. And the Chair now recognizes the president of-Ms. 

Nancy Wysenski, the president of EMD Pharmaceuticals. 

Excuse me, Mr. Wright, I am sorry, we will come back to you, 

sir. 

STATEMENT OF NANCY J. WYSENSKI 

Ms. WYSENSKI. Thank you. Chairman King, Congressman 

Pascrell, members of the committee, thank you for the opportunity 

to appear before you today. My name is Nancy Wysenski. I am the 

president of EMD Pharmaceuticals, located in Durham, North 

Carolina. EMD is a research and development pharmaceutical company specializing in the areas of neurodegenerative diseases, oncology, and cardiometabolic care. Our parent company is also the global provider of Cyanokit, a cyanide antidote kit designed specifically 

to be used as an immediate field antidote against large-scale cyanide poisoning, whether resulting from chemical terrorism, industrial accidents, or due to smoke inhalation. This promising technology has the potential to provide dual-use protection. It has the 

potential benefits not only for responding to terrorist incidents, but 

also to everyday emergencies where our first responders and others 

fall victim to smoke inhalation every day. 

EMD’s Cyanokit is precisely the type of countermeasure the government should be considering for broad deployment to both the 

strategic national stockpile and first responders throughout the 

country. EMD, a subsidiary of Merck, KGaA, is currently working 

with the Food and Drug Administration to register this product in 

the United States. Indeed, the FDA’s Division of Counterterrorism 

has shown significant interest in our development plan to obtain 

U.S. marketing approval. Clinical trials are in progress for the use 

of hydroxocobalamin, the chemical name for the compound comprising Cyanokit, encountering what we believe should be one of 

the most concerning chemical threats facing Homeland Security, 

cyanide poisoning. 

Cyanide is one of the most prevalent industrial chemicals in use 

today in the United States. It is also one of the most deadly chemicals in the environment. Nearly 100,000 tons are produced by various industries in the United States annually, with most of it 

shipped via our inter-model transportation system, rails, highways, 

waterways, et cetera. 

Cyanide is one of the deadliest and most widely available potential agents for use by terrorists as identified by U.S. intelligence 

sources. In public documents released by the Central Intelligence 

Agency on the potential threat of chemical, biological, radiological, 

and nuclear attacks to the U.S., cyanide is listed as the leading potential chemical agent of choice by terrorist groups. Specifically, the 
68

CIA cites that Cyanokit can cause—excuse me. Exposure to cyanide 

can cause nausea, vomiting, palpitations, confusion, 

hyperventilation, anxiety, and vertigo, which eventually progress to 

agitation, stupor, coma, and death. At high doses, cyanide causes 

immediate collapse. 

The reality of the current state of preparedness for meeting the 

threat of cyanide poisoning in the United States is disheartening. 

In 2001, prior to the incidents of 9/11, a medical expert quoted, 

‘‘The United States is under the constant threat of a mass casualty 

cyanide disaster from industrial accidents, hazardous material 

transportation incidents, and deliberated terrorist attacks. The current readiness for cyanide disaster by the emergency medical system in the United States is abysmal. We as a Nation are simply 

not prepared for a significant cyanide-related event.’’ 

During the legislative process that led to the passage of Project 

BioShield, both the House Committees on Government Reform and 

Energy and Commerce directed that provisions should be made to 

address the threat of cyanide poisoning under the supervision of 

the Department of Homeland Security. EMD did nothing to lobby 

for this report language. In fact, it was only brought to our attention by our outside counsel in 2004 when we stepped up our efforts 

for greater outreach to policymakers in Washington, D.C. Thus, it 

appears that the Federal Government, not industry, made Congress aware of the potential benefits of hydroxocobalamin to treat 

cyanide and the need to purchase this important countermeasure 

under Project BioShield. 

Once approved for use in the U.S., or even prior to final FDA approval under IND status or emergency use authorization provisions 

afforded by Project BioShield, hydroxocobalamin can be stockpiled 

and then administered on site at the scene of a chemical terrorism 

disaster, providing immediate aid to victims. The only currently licensed cyanide kit generally requires transport to a local hospital 

and further is cumbersome to administer, consisting of not just one 

component, but three. 

Most importantly, the current antidote cannot be used for victims 

of smoke inhalation; it may worsen their medical condition. However, Cyanokit is available for use in this manner, and according 

to the current implementation of Project BioShield by the Departments of Homeland Security and Health and Human Services, 

DHS must first determine that cyanide is a material threat by conducting a material threat assessment. 

To date, the Secretary of DHS has issued material threat determinations, as we have heard today, for four agents. In our quest 

for an answer, EMD became aware that a material threat assessment had not been conducted for analyzing the cyanide threat, and 

therefore HHS had no grounds for dictating the need for a medical 

countermeasure against cyanide. 

Mr. MCCAUL. [Presiding.] Ms. Wysenski, I would ask that you 

try to wrap up your testimony. Thank you. 

Ms. WYSENSKI. Okay. In conclusion, the need is clear that more 

must be done to address the threat of a terrorist-created cyanide 

poisoning event. The international community is acutely aware of 

just how quickly terrorist organizations are recognizing cyanide 

poisoning as a leading method for inflicting mass casualties. In-
69

1 CIA, ‘‘Terrorist CBRN: Materials and Effects’’. September 2003. 

deed, the Governments of both France and Italy have not only recognized the substantial risks of this threat, but have recently 

stockpiled significant quantities of Cyanokit to better prepare their 

communities for responses to these threats. 

In conclusion, I would suggest that, given the most recent and 

graphic terrorist attacks that have been perpetrated in Europe, it 

is even more important to assess whether we are adequately prepared. This will require much more aggressive focus on material 

threat assessments, a transparent relationship between DHS and 

private industry, and, lastly, a purchase agreement must be clear 

to incent industry to bring products from R&D to our citizens. 

Mr. MCCAUL. Thank you, Ms. Wysenski. 

[The statement of Ms. Wysenski follows:]

PREPARED STATEMENT OF NANCY WYSENSKI

Chairman King, Congressman Pascrell, members of the committee, thank you for 

the opportunity to appear before you on this critically important subject of Project 

BioShield and chemical, biological, radiological, and nuclear medical countermeasures. My name is Nancy Wysenski and I am the President of EMD Pharmaceuticals, located in Durham, North Carolina. EMD is a research and technology 

company specializing in the areas of neurodegenerative diseases, oncology and 

cardio metabolic care. Our parent company is also the global provider of Cyanokit, 

a cyanide antidote kit designed specifically to be used as an immediate field antidote against large scale cyanide poisoning whether resulting from chemical terrorism, industrial accidents, or due to smoke inhalation. This promising technology 

has the potential to provide dual use protection—it has potential benefits not only 

for responding to terrorist incidents, but also, to everyday emergencies where first 

responders and others fall victim to smoke-inhalation every day. EMD’s Cyanokit 

is precisely the type of countermeasure the government should be considering for 

broad deployment to both the Strategic National Stockpile and first responders 

throughout the country. 

EMD, a subsidiary of Merck, KGaA, is currently working with the Food and Drug 

Administration to register this product in the United States. Indeed, the FDA’s Division of Counter-Terrorism has shown significant interest in our development plan 

to obtain US marketing approval. Clinical trials are in progress for the use of 

hydroxocobalamin, the chemical name for the compound comprising Cyanokit, in 

countering what we believe should be one of the most concerning chemical threats 

facing Homeland Security: cyanide poisoning.

The Threat: 

Mr. Chairman, cyanide is one of the most prevalent industrial chemicals in use 

today in the United States. It is also one of the most deadly chemicals in the environment. Nearly 100,000 tons are produced by various industries in the United 

States annually, with most of it shipped via our inter-model transportation system; 

including rail, highway and waterway transportation systems. Cyanide also remains 

one of the deadliest—and most widely available potential agents for use by terrorists as identified by U.S. intelligence sources. 

In public documents released by the Central Intelligence Agency (CIA) on the potential threat of Chemical, Biological, Radiological and Nuclear attacks (CBRN) to 

the U.S., cyanide is listed as the leading potential chemical agent of choice by terrorist groups. The relative ease of access and plentiful supply make cyanide a particularly attractive method for inflicting large scale harm to the general population. 

Specifically, the CIA cites the following rationale as to why much greater concern 

should be given regarding the potential use of cyanide by terrorist groups: 

‘‘several groups of Mujahidin associated with al-Qa’ida have attempted to carry 

out ‘‘poison plot’’ attacks in Europe with easily produced chemicals and toxins 

best suited to assassination and small-scale scenarios. These agents could cause 

hundreds of casualties and widespread panic if used in multiple simultaneous 

attacks. . . Exposure to cyanide may produce nausea, vomiting, palpitations, 

confusion, hyperventilation, anxiety, and vertigo that may progress to agitation, 

stupor, coma, and death. At high doses, cyanides cause immediate collapse. 1
70

2Sauer SW, Kein ME. Hydroxocobalamin: improved public health readiness for cyanide disasters. Annals of Emergency Medicine. June 2001; 37: 635–641

I thank you for your time and I would welcome your questions. 

The most important point to be drawn from the CIA’s analysis is the need to have 

immediate and adequate quantities of antidotes made available in the field prior to 

the emergency or attack to provide the greatest chance of survival. 

However, the reality of the current state of preparedness for meeting the threat 

of cyanide poisoning is disheartening. In 2001, medical experts viewed the ability 

of the United States to respond to a terrorist incident involving cyanide with a high 

degree of angst: 

‘‘The United States is under the constant threat of a mass casualty cyanide disaster from industrial accidents, hazardous material transportation incidents, 

and deliberated terrorists attacks. The current readiness for cyanide disaster by 

the emergency medical system in the United States is abysmal. We, as a nation, 

are simply not prepared for a significant cyanide-related event.’’ 2

This comment came from a publication prior to 9/11, and unfortunately, in the 

last four years, nothing has changed. 

With the passage of Project BioShield, the Department of Homeland Security in 

conjunction with the Department of Health and Human Services now has the mechanism at hand that can greatly increase U.S. emergency medical preparedness for 

a cyanide disaster. They will not meet that goal, however, without increased involvement by industry and a demonstrated willingness for the government to push 

forward with the implementation of Project BioShield in the way Congress intended.

The Challenge: 

During the legislative process that led to the passage of Project BioShield, both 

the House Committees on Government Reform, and Energy and Commerce directed 

that provisions should be made to address the threat of cyanide poisoning under the 

supervision of the Department of Homeland Security: 

‘‘. . .under the authority provided by the bill, the government could procure 

countermeasures against chemical agents (nerve, blister, blood, and pulmonary 

agents) and radiological and nuclear agents. The Administration currently does 

not plan to use the bill’s authority to purchase agents that could mitigate threats 

from these sources, but it could do so if the perceived threat from these agents 

changed or if certain treatments became scientifically feasible. Countermeasures 

that could be acquired under Project BioShield include existing treatments for 

many nerve gases (including VX, Sarin, and Soman gas), Prussian Blue (a treatment for certain types of radiation poisoning), and hydroxocobalamin (a 

treatment for cyanide poisoning that is in an advanced stage of development).’’

EMD did nothing to lobby for this report language. In fact, it was only brought 

to our attention by our outside counsel in 2004 when we stepped up our efforts for 

greater outreach to policymakers in Washington D.C. Thus, it appears that the Federal Government—not industry—made Congress aware of the potential benefits of 

hydroxocobalamin to treat cyanide and the need to purchase this important countermeasure under Project BioShield. 

Hydroxocobalamin is being developed as an antidote for treatment of cyanide poisoning due to smoke inhalation, chemical terrorism, or industrial exposure. As previously stated, the product is already registered by EMD’s French affiliate, Merck 

Sante as a cyanide antidote under the international brand name Cyanokit, and currently is stocked on fire trucks and ambulances for first responder use in France 

where it has been in use for over 8 years. 

Once approved for use in the U.S., or even prior to final FDA approval under IND 

status or Emergency Use Authorization provisions afforded by Project BioShield, 

hydroxocobalamin can be stockpiled and then administered on-site, at the scene of 

a chemical terrorism disaster, providing immediate aide to victims. The only currently licensed cyanide kit generally requires transport to a local hospital and, further, is cumbersome to administer, consisting of not just one component but three. 

More importantly, the current antidote cannot be used for victims for smoke inhalation, because it may actually worsen their medical condition. However, before 

hydroxocobalamin or Cyanokit is available for use in this manner, and according to 

the current implementation of Project BioShield by the Departments of Homeland 

Security and Health and Human Services (DHS and HHS, respectively), DHS must 

determine that cyanide is a material threat by conducting a Material Threat Assessment (MTA). Even though during the first days in Afghanistan in 2001, our military 

seized videotapes from terrorist training camps showing al-Qa’ida experimenting 
71

with cyanide by poisoning dogs, it is our understanding that, as of yet, no MTA is 

underway or planned. 

Within DHS, the Directorates for Information Analysis and Infrastructure Protection (IAIP) and Science & Technology (S&T) work together in conducting assessments and determinations of biological, chemical, radiological and nuclear agents of 

greatest concern so as to guide near-term BioShield requirements and acquisitions. 

Plausible high consequence scenarios that provide an indication of the number of 

exposed individuals, the geographical extent of the exposure, and other collateral effects are drafted. If these consequences are of such a magnitude to be of significant 

concern to our national security or public health, the Secretary of DHS then issues 

a formal Material Threat Determination to the Secretary of HHS, which initiates 

the BioShield process. 

To date, the Secretary of DHS has issued Material Threat Determinations for four 

agents: anthrax, smallpox, botulinum toxin, and radiological/nuclear devices. DHS 

tells us that additional threat assessments are underway for the remaining Category A biological agents as identified by the Centers for Disease Control and Prevention (plague, tularemia, viral hemorrhagic fevers) and for nerve agents. In our 

quest for answers, EMD became aware that an MTA had not been conducted for 

analyzing the cyanide threat and therefore HHS had no grounds for dictating the 

need for a medical countermeasure against cyanide. Disconcertingly, there appeared 

to be confusion among the DHS staff as to who would actually conduct the MTA. 

It is surprising that, to our knowledge, DHS has not addressed the threat of toxic 

industrial chemicals, such as cyanide, considering the high level recognition of the 

threat posed by such chemicals. 

EMD’s status in the BioShield procurement process has been stalled in the very 

first phase of the Material Threat Determination. For over a year EMD has been 

seeking answers to questions that clearly have an impact on critical business decisions. Without the MTA from DHS, HHS understandably is not armed with the information necessary to address our questions. We have no indication if the government will buy Cyanokit, when it will buy it, or how much it will buy. Without the 

MTA, we don?t even know if Cyanokit will fit the operational profile of the countermeasure that is called for to meet cyanide countermeasure needs or if it could be 

adapted to meet those needs. Without such answers, answers that will be informed 

by the results of an MTA on cyanide, EMD cannot adequately plan for production 

and facility expansion, and makes us question whether to proceed with product development at our company’s expense in making Cyanokit available to the USG. 

Without a change in that status, the country is not likely to receive the benefit of 

protection against this looming threat. 

The need is clear that more must be done to address the threat of a terrorist created cyanide poisoning event. The international community is acutely aware of just 

how quickly terrorist organizations are recognizing cyanide poisoning as a leading 

method for inflicting mass casualties. Without adequate countermeasures in place, 

on the ground, stockpiled for use in time of emergency, most if not all victims will 

succumb to the effects of cyanide poisoning. However, without greater cooperation 

between industry and the government and, most importantly, greater transparency 

from the Federal government on how Project BioShield is being implemented, companies with the resources and capabilities of EMD will simply not be able to sustain 

viable interest in this market. The nation, and in fact, the world, cannot afford this 

risk. 

Indeed, the governments of both France and Italy have not only recognized the 

substantial risks of this threat, but have recently stockpiled significant quantities 

of Cyanokit to be better prepared in responding to this threat. 

In conclusion, I would suggest that given the most recent and graphic terrorist 

attacks that have been perpetrated in Europe, it is even more important to assess 

whether we are adequately prepared to deal with the additional threat of a lethal 

release of cyanide in such a circumstance. The events in Tokyo in 1990’s starkly 

bear this fact out. 

If we are to address the threat of cyanide poisoning in the United States, we must 

move forward with the implementation of Project BioShield as Congress and the 

President intended. First and foremost, Material Threat Assessments should be 

completed on all perceived threats. Furthermore, industry needs increased transparency of the BioShield process and feedback from the government to keep us engaged in bio-chem defense efforts and be able to provide the government and public 

with urgently needed medicines. Enhanced communication and teamwork between 

DHS and HHS and industry will greatly aid EMD and other companies to bring 

products from R&D to market for the purpose of defending our Nation against 

chemical, biological, radiological, and nuclear attacks. 

I thank you for your time and I would welcome your questions.
72

Mr. MCCAUL. The Chair now recognizes David Wright, the CEO 

of PharmAthene, Inc., for 5 minutes. 

STATEMENT OF DAVID P. WRIGHT 

Mr. WRIGHT. Mr. Chairman, members of the committee, 

PharmAthene was founded to develop countermeasures for bioterrorism. In 2 short years we have brought two products forward to 

a stage where the national strategic stockpile could soon acquire 

them. PharmAthene has had experience with Project BioShield, 

DHHS, DOD, DHS in developing our products Valortim, an anthrax therapeutic, and Protexia, a chemical bioscavenger against 

nerve agents. 

DHS plays a critical role in determining what constitutes a material threat and what the scope of that threat is. Today I would like 

to discuss how the material threat analysis and requirements, 

products, processes affect biodefense companies like mine. Three 

critical issues I would like to highlight are: Number one, transparency, identifying the government’s countermeasure needs early 

enough for companies to make informed decisions; two, the requirements process, creating a more coordinated streamlined and timely 

process; and, three, BioShield funding, ensuring adequate funds 

are made available to support the Nation’s biological and chemical 

defense needs. 

The Project BioShield procurement process should be more transparent. I believe Department officials should develop ways to integrate industry into countermeasure decisionmaking sooner. DOD, 

which has considerable experience in developing complex weapons 

systems that have no other commercial market, is a good case 

study. DOD identifies future capacity needs early on and fully 

funds these programs. For instance, several times a year DOD officials meet with industry to outline their needs and seek partners. 

Mr. WRIGHT. Once a promising technology is identified, funding 

is available to support complete product development, from proof of 

concept, through the actual acquisition. We contend that Project 

BioShield would attract more interest and investment from industry if it employed similar techniques. 

The second issue, the requirement process, much can be done to 

expedite the process and better communicate the results. The current process is too complicated and disjointed. DHS, HHS and 

many other agencies and departments, including DOD, OMB and 

the Intelligence Community, are involved in decisionmaking. With 

so many chefs in the kitchen, it is unclear who or which department or which agency has the ultimate decisionmaking authority. 

Moreover, the time needed to reach an agreement is substantially 

lengthened. 

Another issue involves a link between the original threat analysis and the actual strategic stockpile requirement. 

Last year PharmAthene responded to an RFP that requested 

bids to provide from 10,000 to 200,000 anthrax treatments. 10,000 

or even 20,000 treatments is not a market any company can afford 

to consider. Furthermore, the cost to the U.S. government would be 

prohibitive on a per dose basis. 

If the MTA indicates only a very limited exposure that leads to 

a small strategic national stockpile requirement, companies need 
73

this information up front to evaluate the program opportunities 

and make informed decisions. We propose that your committee consider mechanisms to both streamline the requirement process and 

communicate early and clearly the government’s procurement intentions. 

Lastly, Congress has taken an important first step to combat biological and chemical terrorism by setting aside 5.6 billion. Unfortunately, it is insufficient to support the breadth of technology’s needed to protect this Nation. Because of this we are troubled by the 

prospect that MTAs may, in some instance, be based on unrealistic 

scenarios to meet a certain fiscal end. 

To be effective, MTA would should into account not only the likely exposure estimate, but also the long-term effects of biological or 

chemical attack. Threat analysis should not be limited to what can 

be accomplished with current funding but should be devised separately from fiscal constraints. 

I am convinced that BioShield II can be a powerful incentive to 

companies in the biodefense sector, and I urge you to include provisions to enhance transparency, streamline the requirement process 

and authorize additional funds as necessary. 

Thank you. 

[The statement of Mr. Wright follows:]

PREPARED STATEMENT OF DAVID P. WRIGHT

Mr. Chairman, Members of the Committee: I commend this committee for its 

focus on the vital legislation which brings us together today. 

I am David Wright, President and CEO of PharmAthene. 

PharmAthene was founded to develop countermeasures for bioterrorism and has 

made significant progress in developing products which prevent and treat anthrax 

and agents of chemical warfare. In two short years, we have brought two products 

forward to a stage where they could soon be acquired for the Strategic National 

Stockpile. 

PharmAthene has had experience with Project BioShield, DHHS, DOD, and indirectly DHS in developing our products. Our lead product, Valortim ΤΜ, which we are 

co-developing with Medarex based in New Jersey, has demonstrated significant efficacy in preventing and treating anthrax and is poised to become an important component of the U.S arsenal to combat this dire threat. Our second product, 

Protexia ΤΜ, an effective countermeasure against chemical and nerve agents, has 

gained critical support from DOD, which has a strong interest in developing and 

procuring effective nerve agent antidotes to protect the war fighter. PharmAthene 

has invested in these technologies because the USG clearly communicated it was 

seeking effective countermeasures in the anthrax and chemical areas. 

As a company devoted to the area of biological and chemical defense we have 

made a great start in a short amount of time. However, it is difficult to determine 

where we should go next, or to substantiate potential acquisitions or investments 

to my board, because the current procurement process is cumbersome from two principal vantage points: (1) it is not transparent and (2) it does not provide sufficient 

information about future countermeasure needs. It costs over $150 million to bring 

a new biodefense drug to the market and a typical drug development program takes 

4-6 years. Companies, particularly small biotechnology companies like 

PharmAthene, cannot afford to make these types of investments unless they believe 

there is a real and sustainable market for their products. 

DHS plays a critical role in determining what constitutes a material threat and 

what the scope of that threat is. It is this role, and how the material threat assessment (MTA) process, which culminates in an actual requirement for SNS procurement, affects biodefense companies like mine, that I would like to discuss this morning. These include:

(1) Transparency—identifying the government’s countermeasure needs early 

enough for companies to make informed decisions 

(2) The Requirements Process—creating a more coordinated, less burdensome, 

and timely requirements process, and 
74

(3) BioShield Funding—ensuring adequate funds are made available to support 

the nation’s biological and chemical defense needs 

In order to be successful, the Project BioShield procurement process must be more 

transparent. I believe Department officials and industry must work together to develop ways to integrate industry into countermeasure decision making sooner. The 

DOD process is a good one to review here, as DOD has a lot of experience developing complex weapons systems and involving industry early. Our Protexia product 

has certainly benefited from the DOD approach. DOD identifies capability needs for 

the near-term, mid-term and long-term and fully funds these programs. These capability needs are shared with industry and several times a year, DOD officials meet 

with industry to outline their needs and seek partners. Further, once a promising 

technology is identified, funding is available to support development across the complete development spectrum through the tech base, Milestone A and Milestone B 

process. Project BioShield would attract more interest and investment from industry 

if it employed similar techniques. 

With regard to the requirements process, much can be done to expedite the process and better communicate the results. The current process is complicated and disjointed. Before DHHS can actually procure a countermeasure for stockpile, a number of activities must occur—DHS must complete an MTA, which can take from several months to several years, DHHS must determine there is a need for new countermeasures, and the many members of the Weapons of Mass Destruction—Medical 

Countermeasures group must agree on a requirement. In addition, to DHS and 

DHHS, many other agencies and Departments are involved in this process including 

DOD, OMB, and the intelligence community. It is unclear who or which department 

or agency has ultimate decision making authority. Plus, with so many chefs in the 

kitchen the time needed to reach agreement is substantially lengthened delaying 

procurement decisions. 

A second issue is, what appears to be, a tenuous link between the original threats 

analysis and the actual SNS requirement. Last year, PharmAthene responded to an 

RFP that requested offerors to bid on providing anywhere from 10,000 treatments 

to 200,000 treatments. Ten thousand treatments or even 20,000 treatments are not 

a market any company can afford to consider. It is not reasonable to expect companies to invest millions of dollars in a technology for such a small order. If the original MTA indicated only a very limited exposure resulting in a limited SNS requirement, companies need this information up front to evaluate program opportunities 

and inform decision making. Furthermore, the cost to the U.S. government would 

be prohibitive on a per dose basis. If, on the other hand, a much larger requirement 

is warranted based on the MTA and DHHS assessments, but the resulting RFP does 

not reflect the real need, there is a disconnect in the requirements process. We 

would hope that given the importance of developing countermeasures to protect the 

nation, that as part of your deliberations on BioShield II, the committee would consider mechanisms to both streamline the requirements process and communicate 

early and clearly the government’s procurement intentions (what, when, how much). 

Finally, I would like to note one other issue that we believe is critical in your consideration of BioShield II—funding. Congress has taken the first step in combating 

biological and chemical terrorism by setting aside $5.6 billion for SNS procurement. 

This is a good first step. Yet it is insufficient to support the breadth of technologies 

needed to protect this nation. To be effective, MTAs should take into account not 

only the likely exposure estimate but also the long-term effects of a biological or 

chemical attack. A realistic anthrax scenario, for example, must address not only 

the morbidity and mortality of the exposed population, but also take into account 

how the geographic area will be impacted. Anthrax can exist in the soil for over 30 

years. The resources necessary to make the area inhabitable again will be enormous. Threat analyses should not be limited to what can be accomplished with current funding, but should be devised separately from fiscal constraints. While industry recognizes that funds in this area are not limitless, a process that begins with 

estimates based on unrealistic scenarios or developed to meet a certain fiscal end, 

will not only discourage companies from entering this market, but also leave our 

country woefully unprotected. 

Thank you for the opportunity to share my views on BioShield II with you today. 

I believe BioShield II can be a powerful incentive to companies in the biodefense 

space, and urge you to include important provisions enhancing transparency, 

streamlining the requirements process and authorizing additional funds as necessary. Doing so, will go a long way toward ensuring that the USG can procure the 

products it needs to protect the American people. 

I would be pleased to address any questions the Committee may have at this 

time. Thank you.
75

Mr. MCCAUL. Thank you, Mr. Wright. The Chair recognizes himself for 5 minutes for questions. 

I mentioned to the previous panel I am reading ‘‘1776’’ by David 

McCullough. He talks about how the British were using their 

weapon of choice beginning at the Revolutionary War. They were 

looking at something called smallpox and infiltrating our troops in 

an attempt to wipe out the enemy. So it is nothing new in our history. It is something that we need to remain vigilant and focused 

on. 

I am very interested in the public and private partnerships in all 

areas of the government. This is clearly one where there is a great 

need for that. What I am concerned about, though, is that the biggest pharmaceutical companies—and I appreciate the ones who are 

here, the smaller companies—but the biggest companies are not interested in participating in BioShield. 

I wanted to see if you could tell me what impact you believe that 

is making on our homeland security and what, if anything, the 

Federal Government could do to bring them to the table so they 

can be full participants in protecting our national security. 

Mr. HOLLIS. I will try to answer that. I don’t really think it 

makes a difference whether it is a big pharma or small biotech. I 

think the bottom line to it is industry needs to understand what 

this biodefense industry really is. The threats need to be identified, 

and the size and scope of the markets, so we can determine whether our technology is worth developing for that particular medical 

countermeasure. 

I think the reason that a lot of small companies are looking at 

this is because they are the ones that are really pushing the envelope on new cutting edge technology. 

Big pharma licenses a lot of its products from small biotech companies. So I don’t know if it is big versus small. I think it is just 

the biodefense sector in general is really not really excitable by the 

capital markets. The capital markets are not responding, because 

they don’t believe that the government is totally committed to this. 

If the capital markets were interested, believe me, so would big 

pharma. 

Mr. MCCAUL. Any other comments? 

Dr. CARR. If I could add a little bit to that. One of the problems 

that was raised earlier in the first panel was about the procurement precluding to a certain degree the products that already had 

significant commercial markets. And although we were told that 

that was not an absolute preclusion, it certainly is a preclusion. I 

think that is one thing that would deter a large company from 

being involved. Also, the fact that several people have addressed, 

in terms of the process, of the material threat assessment followed 

by a specific response to that and a call for grants is very protracted and really precludes responses that might be already inherent in some drugs that have been developed by large pharma companies and have not been looked at for potential in applications in 

these areas. 

I think if the process could be allowed to let them look at some 

of these other indications, you would have drugs that are already 

FDA approved for other indications that might come into application. 
76

Mr. GREENBERGER. I would just use one word, indemnification. 

That is, everywhere you look, phase 1 smallpox program, where the 

President wanted 500,000 first responders vaccinated, 40,000 

ended up being vaccinated. A survey was done, indemnification. Be 

very careful. 

I know that BioShield II is talking about indemnification and 

people want to grab old statutes and say well, here is indemnification. They tried to do that, Congress passed a law in April of 2003 

to indemnify. Not good enough. 

You have to look at this very carefully. If the government needs 

to be a deep pocket in this regard, it is well worth it to get these 

vaccines on the market. 

Mr. JOYCE. Mr. Chairman, I would add one other comment. I was 

privileged to be involved in a gathering of bioindustry thought leaders yesterday afternoon. I think there was one common, and that 

is therapeutic innovation occurs at small companies. The challenges we have today are challenges of efficiency and clarity in the 

system. 

Another conclusion is that small companies do not have experience in navigating through systems that seem to be developed for 

companies of the magnitude of Northrop Grumman and other large 

biodefense or other large defense contractors. So there needs to be 

greater clarity and efficiency of systems. 

The other thing that was a conclusion or a concern is that a lot 

of the decisions being made regarding what pathogens are actual 

threats are being made by individuals that don’t actually have experience in dealing with these pathogens. That is a very large concern, and it goes back to the material threat assessment issues. 

There are people available that do have experience in dealing 

with these pathogens, and there has been a lot of academic pontification regarding what is and what isn’t a threat. I think in many 

cases those thoughts are not the same thoughts of people that have 

experience with dealing with these pathogens. 

Thank you. 

Mr. MCCAUL. Ms. Wysenski. 

Ms. WYSENSKI. If I could add again, the need to expedite the 

process so that we can see a far higher number of material threat 

assessments being done. That is the only way that private industry, small or large, knows that they will have a market to address. 

Most companies are making trade-off decisions between investment 

opportunities. If it isn’t clear what the process is, that a material 

threat assessment will be done, which will likely lead to a market 

demand, companies will be swayed to make their investments in 

other areas. 

Mr. MCCAUL. I thank you. I see my time has expired. The Chair 

now recognizes the ranking member, Mr. Pascrell, for 5 minutes. 

Mr. PASCRELL. Thank you. There seems to be agreement that 

pharmaceutical companies are hesitant to take part in the BioShield program due to the potential for liability, the low or uncertain demand even if products are developed, and the potential that 

companies would lose intellectual property rights if the government 

allowed others to produce the product during an emergency. I think 

that these concerns are reasonable. 

I want you to rank these issues quickly. 
77

Should the Congress address these concerns? How should they 

address those concerns? Why don’t we start with 

Mr. Hollis, as quickly as you can? 

Mr. HOLLIS. Well, sure the liability issues are important because 

pharmaceutical companies have a lot to lose. They are targets for 

lawsuits. I believe that the experience that we had with other products when the anthrax attack first happened, I think it was the 

Secretary who was looking to basically bypass that pharmaceutical 

company’s patents because of a public health emergency. 

So I think patents are extremely important, and there should be 

protection under the legislation that if you are developing a medical countermeasure against WMD that those patents should be 

honored. 

Mr. GREENBERGER. I think liability definitely needs to be dealt 

with in legislation. Congress has tried to do this most recently with 

the SEPA Act in 2003 dealing with smallpox. Both manufacturers, 

medical providers, unions who represent first responders that are 

worried about compensation were uniformly unhappy with that. 

I think the government is going to have to spend a lot of money 

in this area a very small portion of it would be to tell big pharma, 

who is really worried about liability, because they have so much at 

stake. 

And conversely, the first responders, who have to be vaccinated 

pre-event, don’t worry, will step in. This is so important the government will be a deep pocket, and we will take care of things. 

Now, that may sound shocking, but the cost of doing that pales 

against the amounts of money that are being spent on other efforts. 

With regard to patents, you have got to be very careful, what 

happened in anthrax. I mean, we have these very high drug prices. 

And if somebody who holds a patent is going to stand in the way 

of making affordable and easy distribution in an emergency, reassuring the strength of that patent may not be the wisest course in 

an emergency. It is a very tricky issue, but it deserves the attention of Congress, and it can be solved legislatively. 

Mr. MCCAUL. Anybody else? 

Mr. JOYCE. Yes, I would make one comment as a rebuttal and 

it would refer back to what we heard from the Assistant Secretary 

of HHS today. Educated that they had allocated $88 million towards a certain countermeasure issue, the reality is that the average drug, the cost of developing the average drug today is about 

$800 million and takes about 10 years. If you look at the development process of drugs and vaccines, only a very minute percentage 

of those compounds that even go into trials ever are proven to be 

safe and effective. 

So there is a major disconnect between the dollars being spent 

and the dollars required to develop new therapeutics. 

Mr. PASCRELL. Anyone else? 

Dr. CARR. I would just emphasize once again the liability issue. 

I think that goes across the board, because a large company with 

a deep pocket, there is grave concern. But also for a small, could 

be wiped out in these same situations. 

Mr. PASCRELL. You know, Dr. Greenberger, right, I read your testimony quickly. I find it pretty astonishing in terms of what else 

we have heard today and the questions from both sides. 
78

You say on page 3 of your testimony that the BioShield Act established no procedure for DHS to employ and supervise the making of material threat determinations. That is interesting and true. 

Despite what was an obvious Congressional invitation to summarily determine what are the widely-priced CBRN threats to the 

United States, DHS has employed an opaque, highlybureaucratized relatively lengthy process for determining material 

threats. Congressmen—you say poorly-delineated administrative 

strengths. Do you really mean what you said? 

Mr. GREENBERGER. Oh, absolutely. I am absolutely confident that 

when Congress assigned DHS the responsibilities of outlining material threats that they thought that that was going to be a very 

easy and quickly done task. I mean, the testimony here today, 

Chairman King, opened up Marburg and Ebola. Who would argue 

about Marburg and Ebola? Yet that isn’t there. 

I don’t think Congress thought the reason they didn’t establish 

a procedure, maybe they should have and made it clear. But this 

material threat thing has a field that is well trod. You know, Ken 

Ellerbeck from the Soviet Union, Jessica Stern who was referred to 

by Congressman Weldon, the CDC, we know what the material 

threats are. Cyanide is not on it. It is recognized that cyanide is 

a material threat. What is taking so long? 

Mr. PASCRELL. What would you do about the MTAs that are lasting 3 to 4 months? What do you think is the best response to that 

problem? 

Mr. GREENBERGER. Frankly, I think it would be the chairman of 

the committee and the ranking member of the committee and the 

chairman of the subcommittee and the ranking member of the subcommittee getting on the phone with Mr. Chertoff and saying to 

him, this was never intended to be—this is the pivot on which the 

act operates, it is simple, get this done, we want it done by December 31, 2005. 

Mr. PASCRELL. We are going to have the Secretary in front of us, 

the entire committee tomorrow. We should have some interesting 

debate or discussion, whatever. 

Mr. GREENBERGER. You don’t need legislation to fix this. Somebody has to say. I am sure if Mr. Chertoff, who I know and is a 

very intelligent, hard-working guy, this were explained to him—it 

is probably way below his pay grade but if he understood the whole 

statute was coming down because these assessments weren’t being 

made he would have it done in a flash. 

Mr. PASCRELL. Mr. Chairman, so many times we have had problems regardless of what issue we talk about in Homeland Security 

of moving the process along—I almost feel as if people are hesitant 

to make a decision to move the process along and that we are waiting for somebody else or they don’t know who is supposed to make 

the decision. 

Mr. WRIGHT. If I may, I believe that is a very good point. I believe the way the system was put together and using what was 

available was commendable at the time. But there is not a central 

person responsible. There is not a central department. 

It falls in a number of departments, in a number of people’s area 

of responsibility. And trying to coordinate this all has caused these 

problems. It is not just the MTAs and getting them out. It is the 
79

length of time it takes to develop these drugs, and companies are 

going to have to expend hundreds of millions of dollars to meet 

these threats. They have to know that there is something at the 

end of the table. 

If you look at the DOD process—as I mention in my testimony—

the DOD has been buying and creating systems for years that 

there is no other commercial market for. They can’t go out and sell 

an F–15 to anybody else. They have a process for doing that. 

Mr. PASCRELL. You know, Mr. Wright, I am listening to you very 

carefully. I listened to all of you very carefully. There has got to 

be a difference between us developing a particular drug and us developing a particular antidote that is going to save people’s lives. 

We are asking guys and gals to go to Afghanistan and Iraq to 

defend the country. They are sacrificing every day, for whether we 

are for this war or against is immaterial. We support them. I want 

to know what sacrifices are going to be made on homeland to protect us. 

So I know, we don’t want to develop a drug that we are not going 

to get any response to and it is going to be hanging out there. But 

on the other hand, we all have responsibilities on this side as well 

as that side, to develop it. I am very concerned about us simply 

looking at product and how much this product is going to mean to 

the company in terms of the bottom line. The bottom line is, we all 

have a responsibility in this. If we meet it, if we can expedite, if 

we can lay down standards that make sense and move the anecdotal product to the front, then we will have accomplished something. I agree, we have been caught in a bureaucratic trap, which 

is not surprising, is it, 

Mr. Greenberger? 

Mr. MCCAUL. The Chair now recognizes Mr. Reichert for 5 minutes. 

Mr. REICHERT. Thank you, Mr. Chairman. I just want to follow 

up on the latter question that the ranking member has been pursuing. We are getting the message loud and clear that there is a 

problem in DHS in coming up with a material threat assessment. 

Especially, Mr. Greenberger, you were very critical. 

I would just like to ask you, in referring to Mr. Wright’s comments about transparency and requirements and BioShield funding, do you agree with those three assessments as something that 

needs to be addressed? 

The second part of that question is, are there any others that you 

would add to that list of three? 

Mr. GREENBERGER. Well, yes, I agree. I focused on material 

threat assessments, because that is what your committee really has 

direct jurisdiction over. 

Mr. REICHERT. Sure. 

Mr. GREENBERGER. But there are a litany of problems with BioShield. Dr. Phillip Russell, who was the father of BioShield and 

has testified many times in front of committees, has listed problems, and one of those is transparencies. 

It is a question of who is in charge here. Nobody knows where 

to go to and that is a very big problem. I agree, whether it is formally or informally, there needs to be a person who understands 
80

the medicine and can work the bureaucracy to get these things 

ready and out there. 

I do know that Dr. Fauci at NIAD, who is at the research end 

of this, and is giving out money for vaccines to be developed, I 

know this because the University of Maryland School of Medicine 

is the lead institution in that regard and I work closely with the 

center for vaccine development. They are making great strides in 

developing vaccines. 

But all the research in the world—you have to do clinical trials, 

you have to have capitalization, you have to have laboratories. 

That is not being done. I think it is not being done because, unlike 

Dr. Russell, who understood all of this and what was needed, there 

is nobody in charge who understands how the science, the industry 

and the bureaucracies have to come together. 

I am reminded in World War II we had a War Mobilization 

Board, and someone was put in charge of making sure that the 

country produced the products that we needed to defend ourselves. 

We have got lots of committees. 

That is the trouble. Nobody knows which committee is in charge. 

The Weapons of Mass Destruction Committee, this committee, that 

committee, who is running the show? I truly believe no one is running the show. It may very well be because this is not on the top 

of the Secretary of HHS and the Secretary of DHS’s primary focus. 

They have got much more immediate problems to worry about. So 

it should be worked from the top down and bottom up. 

Mr. REICHERT. I wish you would just be honest and tell us what 

you really feel. 

Mr. GREENBERGER. I have no vested interest here. I can tell you 

what I really think. 

Mr. REICHERT. It was very clear, thank you. 

Any other comments in regard to that question? Yes. 

Mr. HOLLIS. Yes, in regards to expediency, when you are coming 

from the private sector like myself, we have invested tens of millions of dollars, over $100 million already year-to-date in developing an acute radiation symptom drug. We were asked to develop 

this product by the Department of Defense. Here we are 4 years 

later and we still don’t even have an RFP out for the nuclear 

threat. 

This is really—I don’t even know how that can be explained, but 

we are still waiting. We are in a real time scenario. 

Mr. DICKS. Will the gentleman yield. Is that from Defense or 

DHS? 

Mr. HOLLIS. That is correct. We have no request for proposal 

from DOD, HHS or DHS. We are in a real-time situation going 

through our FDA approval process. The product is being geared up 

to go through the peripheral efficacy trial for FDA approval. We 

have to commit to manufacturing, we have to commit a lot of 

money to get this drug approved. 

We still don’t know what the size and scope of the market power 

pursuing is. This is really unexcusable. I really believe I am putting a lot of the shareholder dollars at risk not even knowing what 

this market opportunity is. 

Mr. REICHERT. Thank you. 

I yield the balance of my time, Mr. Chairman. 
81

Mr. MCCAUL. The Chair recognizes Mrs. Christensen for 5 minutes. 

Mrs. CHRISTENSEN. Thank you, Mr. Chair. I thank you all for 

your testimony. I think it has been very, very informative, both the 

written and the oral testimony. I wanted to follow up on Mr. 

Greenberger’s last comment. 

Among the things he shared with us is that DFI International’s 

summer, quarterly publication that suggests that we need a standalone biodefense agency to begin to really focus on these issues. 

The fact that it is—for example, biological defense is part of the 

chemical and biological defense program causes biodefense to have 

less priority as the programs are being developed and as budgets 

are being allocated. 

So my question is, do we need a stand-alone biodefense agency 

or office? Would that help? 

Mr. GREENBERGER. I am very hesitant to tell you that, because 

I am worried that every time we have a problem, the solution is 

a new bureaucracy. I think—I presume because of people like D. 

A. Henderson and Jerry Howard, who is sitting here. When they 

were at HHS, Dr. Russell was brought in to shepherd the BioShield 

program through and get it started. He has since left. 

We need somebody of that caliber here to be given the lead opportunity to run this thing, for both Mr. Chertoff and Mr. Leavitt 

to say he is the person who is going to run this. That is a person 

who understands the research side, understands how you get to research to commercialization, knows how to run a bureaucracy and 

can knock heads together, all the legislation in the world. 

I think this is not a partisan concern, it is a bipartisan concern, 

does not help if you don’t tell the secretaries how important this 

is and to get somebody in there. If they do get somebody of that 

caliber in there, this can start to work, and you will get solid advice about what you need going forward in terms of legislative help. 

Mrs. CHRISTENSEN. Anyone else? 

Mr. WRIGHT. I actually believe that a single agency or department or whatever it is that is responsible for biodefense with the 

right resources in it would provide the right focus we need to get 

this thing done. I think with the number of different departments 

involved and the number of different people involved and the true 

lack of responsibility, which has been brought up a number of 

times here this morning, that there is no one you can go to and 

say make this happen and that person has the responsibility and 

resources to make it happen. I think it is a real, a real lack in the 

system. 

Mr. HOLLIS. May I please add something to that? I think someone who is in that position would be beneficial. However, they also 

need to understand capital formation, because if we don’t understand capital formation we are going to be dependent upon taxpayer and grant funding to get these medical products through. 

Someone needs to be the voice to the capital markets that this 

is a very important sector, a biodefense sector and the government 

is committed to it so that investors are willing to take the risk and 

invest in companies that are developing medical countermeasures, 

because without that excitement there will be no investment in this 

area and there will be no medical countermeasures unless the gov-
82

ernment wants to fund the whole thing themselves and all the up 

front risk and research and development money. 

Mrs. CHRISTENSEN. Go ahead. 

Ms. WYSENSKI. I would just like to support both 

Mr. Wright’s and Hollis’ comments in that we really do need to 

have one responsible source to receive direction from in a rather 

transparent way, and beyond that that we do have to deal with the 

very realistic consideration surrounding capital investment. 

We are in the same situation, uncertain about what the demand 

for a cyanide antidote kit may be and at the same time estimating 

2 to 3 years in advance for investments in a production facility. We 

are grappling with that issue as you speak. Until I can show the 

data about the potential size of the market, it is very hard for me 

to make a compelling argument for further investment in capital. 

Mr. JOYCE. I would say one other thing that seems to be quite 

dangerous in these issues. The multitude of different parties involved is starting to turn this into a longer term perspective, that 

the countermeasures that we are talking about are countermeasures that need to be developed, that may not be on the market 

for 5 years, 10 years. It is an open-ended question. 

Because there is not a single entity no one is really asking the 

question, what would we do if we knew there would be an attack 

with an unknown pathogen in the next 6 months? What countermeasures are available now and can be manufactured? There are 

treatments available now. There are things that are applicable to 

other viral conditions that can be developed now. One of the things 

that also needs to be analyzed is there seems to be a lot of focus 

on vaccine development. 

Well, I think you need to closely analyze the history of vaccine 

development. Throwing money at vaccine development does not 

make vaccines appear. I am very familiar with the issues of HIV 

and AIDS. There has been a multitude of dollars, more than anyone is willing to throw at BioShield right now, spent in trying to 

develop a vaccine for the last 20 years. There is not one now and 

there is not one in sight in any time in the future. 

So there has to be a focus on what countermeasures are there 

now, what treatments can be modified to be here in the coming 

months, not in 5 years or in 10 years. Thank you. 

Dr. CARR. I would just like to end by saying I absolutely agree 

with that. There needs to be someone or someplace where they are 

beginning to address the potential near-term solutions, because 

vaccines and the development of them are not near-term solutions. 

Mr. MCCAUL. The Chair recognizes Mr. Dicks for 5 minutes. 

Mr. DICKS. Mr. Hollis, the drug you mentioned in your testimony, is it NEUMUNE? 

Mr. HOLLIS. Yes, sir. 

Mr. DICKS. That has not yet been approved by the FDA. That is 

the big problem here, right? 

Mr. HOLLIS. No, well, we have an open I&D. We are going towards our pivotal trial and we are going towards FDA approval. 

However, BioShield is supposed to give you advance purchase contracts to give you the incentive to invest the dollars to develop the 

drug through the FDA approval process. 
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So if you are developing a drug through the FDA approval process and you have no idea of the size and scope of your market or 

a request for proposal, it is like asking a defense contractor to build 

a tank without knowing what the market is. 

Mr. DICKS. What has been the problem? You said an advance 

purchase agreement? 

Mr. HOLLIS. Yes, sir. 

Mr. DICKS. What has been the problem in getting an advance 

purchase agreement? 

Mr. HOLLIS. Well I think it is unanimous on this panel what the 

problem is—

Mr. DICKS. There is a material threat paper on this issue, right? 

Mr. HOLLIS. You know, I am very glad you asked that. Because 

when we asked DHS about that, they said they had provided a national strategic nuclear threat assessment to HHS. 

When we asked HHS where it was, they said they had not received an official risk assessment. But here we are 4 years into development and we still don’t even have a request for proposal. As 

a consequence, our investors have lost confidence in the BioShield 

procurement process, and that is the reason we have almost a half 

a billion dollars loss in market capitalization because there is no 

transparency. The markets do not know what the government 

wants. When you ask me what the problem is, I really wish I knew, 

sir. 

Mr. GREENBERGER. One point I might add is I do think the BioShield legislation—

Mr. DICKS. But let me on this point—just one second. DHS has 

done an MTA for the nuclear radiological, right? But they haven’t 

given it to HHS. 

Mr. HOLLIS. It is not an official risk assessment document that 

gives HHS the authority to go ahead and put this request for proposal out, is our understanding. 

Mr. DICKS. So it is HHS that does the request for proposal, not 

Homeland Security? 

Mr. HOLLIS. Yes. 

Mr. DICKS. This is screwed up. 

Mr. HOLLIS. Yes. 

Mr. DICKS. So you think Congress should come up with an 

amendment, Mr. Greenberger? 

Mr. GREENBERGER. Well, as I understand—

Mr. DICKS. We put somebody in charge, we can create a deputy 

secretary or an assistant secretary, someone, and say you are in 

charge and pass a bill to change the law and try to fix this? 

Mr. GREENBERGER. Yes. I think that is a good suggestion. I 

would just warn you, as I understand BioShield II, the answer is 

to give this all to DHS. My—because—and I read the big pharma 

counsel’s memo on this, because HHS is hostile to big pharma. 

Now, if DHS, now I am finding out we have been told there are 

material threat assessments for nuclear devices. Now I am told 

there may be but it hasn’t been transferred to HHS. That is astonishing. 

I think that you should be very leery of putting this in the hands 

of HHS certainly. I think HHS is the proper place for it, and I 

think if you want to have a deputy secretary or something for coun-
84

termeasures—and I agree the vaccines are not the only answer—

then that would be very good and make that person in charge of 

making BioShield work. But right now I think what you are hearing here is nobody knows who is in charge, nobody knows what is 

going on. 

Mr. DICKS. Mr. Hollis, again what happened to the Defense Department? I am on defense appropriations. What happened to them 

in this deal? Where did they fall on it or is it just the FDA thing 

that is still holding them up from buying something? 

Mr. HOLLIS. Well, that is a separate department. 

Mr. DICKS. Yes, we realize that. 

Mr. HOLLIS. So I think they are more of an FDA issue because 

they are not operating under Project BioShield. 

Mr. DICKS. The Defense Department? 

Mr. HOLLIS. Yes. 

Mr. DICKS. Are you still working with them? 

Mr. HOLLIS. Yes, as a matter of fact are you familiar with AFRI, 

Armed Forces Research Institute. We are coordinating this product 

with AFRI. AFRI is one of our Nation’s experts in radiobiology. 

Mr. DICKS. How long do you think it will take to take get the 

FDA approval, in your judgment? 

Mr. HOLLIS. I believe we can be on market next year. This is a 

real-time situation. We are actually looking at going into a pivotal 

efficacy trial this year. 

Mr. DICKS. Efficacy trial, I take it that is a human trial? 

Mr. HOLLIS. We are using the FDA’s animal efficacy rule where 

it is unethical to expose human beings to lethal doses of radiation. 

You have to establish it in relevant animal models, in this case 

non-human primates, and then establish the safety in human 

beings. 

Mr. GREENBERGER. One other point I think should be made is 

that the BioShield statute, if you get into this program, which 

starts at the material threat assessment and then moves on, the 

countermeasure can be used even if there isn’t FDA licensing. The 

statute authorizes the Secretary of HHS to do this. But if you don’t 

have a material threat assessment that gets you in the door, then 

you need FDA licensing. 

Mr. DICKS. HHS. Material threat assessment at HHS? 

Mr. GREENBERGER. No. 

Mr. HOLLIS. No, it comes from DHS. 

Mr. GREENBERGER. HHS does the MTAs. 

Mr. DICKS. I know that, but I thought their argument was HHS 

had not seen it and HHS has to do the RFP. 

Mr. GREENBERGER. That is correct. Because HHS must receive 

that, and then they can put in place everything that needs to be 

done to get these contracts out the door. If they don’t get this piece 

of paper—and that is all it is, a piece of paper—they can’t do anything. 

Also, if DHS doesn’t put cyanide or hemorrhagic fever, things 

that everybody recognizes are likely threats, I am for the MTA, 

even if the piece of paper goes to HHS, and it doesn’t have those 

things on it, nothing can be done. Those people then have to worry 

about getting FDA licensing. 
85

The anthrax—the $1 billion spent with VaxGen’s anthrax countermeasure is only in clinical trials. It is way away from FDA licensing. So if you can get in the door here and get BioShield working for you, you can start laying out your capital plan because you 

don’t need all these things. They are looking for promising countermeasures. 

Mr. HOLLIS. However, the process still takes too long because the 

understanding is that when HHS finally started to get the risk assessment here, they put out an RFI, a request for information. 

That was in October. We are here in July. Nine, 10 months later, 

they still have not put out an RFP. 

That is a lot of time to look at a request for information before 

determining what the request for proposal is. So this loss of time 

is really a killer in an industry because you can’t put out your capital plan in developing the product. 

So what I want to ask this committee, not only for acute radiation syndrome but any other medical countermeasure, is they 

need to put these RFPs out to industries so that we know what our 

size and our scope of our market is and we can respond. 

Mr. DICKS. One final thing, Mr. Chairman. 

Mr. MCCAUL. That is fine. 

Mr. DICKS. Just to wrap this up. I want to make sure I understand this now. You said that—who could give FDA, FDA-like approval, the Secretary could? 

Mr. HOLLIS. There is emergency use authorization provision. It 

is called the EUA. If the Secretary determines that—

Mr. DICKS. Which Secretary? 

Mr. HOLLIS. The Secretary of Health. Determines that the benefit of having an identified drug outweighs the risk because of the 

nature of the threat, they can actually procure the drug before it 

is FDA approved. 

Mr. GREENBERGER. Yes. I would just amend that to say they 

could use the drug short of an FDA approval if they make these 

emergency findings, they being the Secretary of HHS. But they can 

purchase the countermeasure before an FDA approval too. That is 

even more important. 

VaxGen’s promising anthrax vaccine is a while away from ap- proval but $1 billion has been spent to purchase it. Now obviously 

when we are talking about forming capital markets, VaxGen’s 

shareholders are pretty pleased with that. They know they are 

going to get $1 billion. All of these other people are sitting up here 

with what they think are great countermeasures and they can’t 

even get in the door because DHS hasn’t started the process by 

making a material threat assessment for cyanide or hemorrhagic 

fevers. If they did, then these people could start, if they knew who 

to go to, start marketing it if they wouldn’t have to worry about 

FDA, because you can get a BioShield contract without FDA approval. 

Mr. DICKS. Well, do you think this is being done simply to stop 

the money from being spent or is it just complete negligence? 

Mr. GREENBERGER. There could be an argument—and I think 

somebody raised that—that they don’t think they have enough 

money to buy all the countermeasures, so they are going into a four 

corners offense to slowly dribble it out. 
86

After all, they have had one major contract for $1 billion. That 

means 15 percent of the money is already gone. If there are, as I 

think there are, at least three dozen candidates to be material 

threats, they may be saying to themselves, whoa, we are going to 

lose this 5.6 before it happens. 

Ms. WYSENSKI. If I could—

Mr. GREENBERGER. If I could respond for a second to that 

thought. Because you have got to believe that a lot of people who 

appear at the door with effective measures for hemorrhagic fever, 

for pandemic flu, Congress may start thinking it may be worth appropriating more than 5.6 if we have got real solutions here. So if 

that is what they are thinking, that doesn’t make a lot of sense. 

Ms. WYSENSKI. It seems to me that one method to really force 

a change in this whole process is to show some quick wins to the 

public and to private industry. In fact, we do have low hanging 

fruit that can easily be turned into a quick win for the government 

and for government industry. 

At EMD, we are in the same situation that Mr. Hollis explained. 

We are nearing completion of our animal studies, because, of 

course, you can’t subject humans to these trials. We have completed the safety work, we are negotiating with the FDA. We are 

preparing to submit the MDA. 

We are going on pure faith to Mr. Pascrell’s earlier comment that 

the government will continue to work with us, because in fact we 

are getting ahead. Until that MTA is done and the purchase order 

can then hopefully be produced in a somewhat timely manner, we 

are really putting these investments down at this point at risk. 

Mr. DICKS. This is your cyanide? 

Ms. WYSENSKI. Yes, sir. 

Mr. DICKS. Thank you for being so generous, Mr. Chairman, I appreciate it. 

Mr. MCCAUL. Thank you. Are there any other members that 

have additional questions at this time. I would like to thank the 

witnesses for their valuable and very insightful testimony and the 

members of the committee may have additional questions for you 

to submit in writing. 

This hearing record will be open for 10 days. Without objection, 

the committee stands adjourned. 

[Whereupon, at 12:50 p.m., the subcommittee was adjourned.]

FOR THE RECORD 

JOHN VITKO RESPONSES TO THE HONORABLE MIKE ROGERS QUESTIONS

Question: 1. Does the Department of Homeland Security consider Avian 

Influenza a potential threat? If yes, did Congress grant authority through 

Project BioShield to the Department of Homeland Security to address the 

threat of Avian influenza? 

Response: The Department of Homeland Security views the natural emergence 

or intentional introduction of a highly pathogenic influenza strain as a potentially 

serious public health risk. If a strain emerges naturally and acquires human-tohuman transmissibility, there is the potential that terrorists might use this strain 

as a bio-terror threat agent. 

The Project BioShield Act of 2004 authorizes the Homeland Security Secretary in 

consultation with the Secretary of the Department of Health and Human Services 

(HHS) and the heads of other agencies to assess current and emerging threats, including biological agents. We interpret the legislative language to be sufficiently 

broad enough that the Secretary of Homeland Security has the authority to issue 
87

a material threat determination for any strain of influenza that poses a threat to 

the United States population sufficient to affect national security.

Question: 2. Has the Department of Homeland Security funded, through 

Project BioShield, research and development of therapeutic drugs to address potential bio-threats? 

Response: Although the Department of Homeland Security is critically involved 

in establishing and prioritizing the medical countermeasure requirements for acquiring medical countermeasures utilizing the BioShield Special Reserve Fund, it is 

HHS, through the Office of Public Health Emergency Preparedness, that is charged 

with actually making such procurements. To date, the Project BioShield Special Reserve Fund has already been used by HHS to contract for a second generation anthrax vaccine (rPA), additional quantities of the current anthrax vaccine (AVA), and 

a pediatric formulation of potassium iodide (for certain radiological/nuclear exposures). HHS is in the midst of procurement actions for additional countermeasures 

including anthrax therapeutics and a next generation smallpox vaccine (MVA). All 

these procurement actions are for vaccines and therapeutics that are relatively far 

along in the developmental pipeline so as to meet the statutory requirement that 

there is ‘‘sufficient and satisfactory clinical experience or research data (including 

data, if available from preclinical and clinical trials) [to] support a reasonable conclusion that the countermeasure will qualify for approval or licensing within eight 

years’’. The Project BioShield Special Reserve Fund is not meant to fund, nor has 

it funded, any early stage R&D. The appropriate funding source for early stage R&D 

is the research funding appropriated to the National Institutes of Health (NIH) 

through the traditional appropriations process. However, the Project BioShield Act 

did provide mechanisms for streamlining and expediting the solicitation, acquisition, 

review, and award process used by NIH to support such projects, and NIH has 

begun using those authorities.

Question: 3. Can Project BioShield fund research for medical countermeasures in order to anticipate potential pandemic threats? 

Response: As noted above, the Special Reserve Fund created under the Project 

BioShield Act is only for the procurement of medical countermeasures that are in 

advanced development and can be reasonably expected to qualify for approval or licensing within eight years. Early, or even mid-stage research is to be funded 

through the NIH research program and not the BioShield Special Reserve Fund. In 

an effort to accelerate this research, the Project BioShield Act did however streamline the peer review process used by NIH in evaluating and selecting such projects.

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