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                               before the


                                 of the

                        HOUSE OF REPRESENTATIVES

                       ONE HUNDRED NINTH CONGRESS

                             FIRST SESSION


                             JULY 13, 2005


                           Serial No. 109-30


       Printed for the use of the Committee on Homeland Security


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                 Christopher Cox, California, Chairman

Don Young, Alaska                    Bennie G. Thompson, Mississippi, 
Lamar S. Smith, Texas                Ranking Member
Curt Weldon, Pennsylvania            Loretta Sanchez, California
Christopher Shays, Connecticut       Edward J. Markey, Massachusetts
Peter T. King, New York              Norman D. Dicks, Washington
John Linder, Georgia                 Jane Harman, California
Mark E. Souder, Indiana              Peter A. DeFAzio, Oregon
Tom Davis, Virginia                  Nita M. Lowey, New York
Daniel E. Lungren, California        Eleanor Holmes Norton, District of 
Jim Gibbons, Nevada                  Columbia
Rob Simmons, Connecticut             Zoe Lofgren, California
Mike Rogers, Alabama                 Sheila Jackson-Lee, Texas
Stevan Pearce, New Mexico            Bill Pascrell, Jr., New Jersey
Katherine Harris, Florida            Donna M. Christensen, U.S. Virgin 
Bobby Jindal, Louisiana              Islands
Dave G. Reichert, Washington         Bob Etheridge, North Carolina
Michael McCaul, Texas                James R. Langevin, Rhode Island
Charlie Dent, Pennsylvania           Kendrick B. Meek, Florida



                     John Linder, Georgia, Chairman

Don Young, Alaska                    James R. Langevin, Rhode Island, 
Christopher Shays, Connecticut       Ranking Member
Daniel E. Lungren, California        EdwarD J. Markey, Massachusetts
Jim Gibbons, Nevada                  Norman D. Dicks, Washington
Rob Simmons, Connecticut             Jane Harman, California
Bobby Jindal, Louisiana              Eleanor Holmes Norton, District of 
Michael McCaul, Texas                Columbia
Christopher Cox, California (Ex      Donna M. Christensen, U.S. Virgin 
Officio)                             Islands
                                     Bennie G. Thompson, Mississippi 
                                     (Ex Officio)


                            C O N T E N T S



The Honorable John Linder, a Representative in Congress From the 
  State of Georgia, and Chairman, Subcommittee on Prevention of 
  Nuclear and Biological Attack:
  Oral Statement.................................................     1
  Prepared Opening Statement.....................................     2
The Honorable James R. Langevin, a Representative in Congress 
  From the State of Rhode Island, and Ranking Member, 
  Subcommittee on Prevention of Nuclear and Biological Attack....     3
The Honorable Christopher Cox, a Representative in Congress From 
  the State of California, and Chairman, Committee on Homeland 
  Security.......................................................     4
The Honorable Bennie G. Thompson, a Representative in Congress 
  From the State of Mississippi, and Ranking Member, Committee on 
  Homeland Security..............................................    42
The Honorable Donna M. Christensen, a Delegate in Congress From 
  the U.S. Virgin Islands........................................    40
The Honorable Norman D. Dicks, a Representative in Congress From 
  the State of Washington........................................    26
The Honorable Bobby Jindal, a Representative in Congress From the 
  State of Louisiana.............................................    38
The Honorable Edward J. Markey, a Representative in Congress From 
  the State of Massachusetts.....................................    36
The Honorable Eleanor Holmes Norton, a Delegate in Congress From 
  the District of Columbia.......................................    44
The Honorable Christopher Shays, a Representative in Congress 
  From the State of Connecticut..................................    34

                                Panel I

Dr. Kenneth Alibek, Executive Director, Center for Biodefense, 
  George Mason University:
  Oral Statement.................................................     6
  Prepared Statement.............................................     8
Dr. Roger Brent, Director and President, Molecular Sciences 
  Oral Statement.................................................    11
  Prepared Statement.............................................    13
Dr. Michael V. Callahan, Director, Biodefense & Mass Casualty 
  Care, CIMIT/Massachusetts General Hospital:
  Oral Statement.................................................    15
  Prepared Statement.............................................    18




                        Wednesday, July 13, 2005

                          House of Representatives,
                      Subcommittee on Prevention of
                     Nuclear and Biological Attack,
                            Committee on Homeland Security,
                                                    Washington, DC.
    The subcommittee met, pursuant to call, at 10:00 a.m., in 
Room B-318, Rayburn House Office Building, Hon. John Linder 
[chairman of the subcommittee] presiding.
    Present: Representatives Linder, Shays, Jindal, Cox (Ex 
Officio), Langevin, Markey, Dicks, Norton, Christensen, and 
Thompson (Ex Officio).
    Mr. Linder. The Committee on Homeland Security, 
Subcommittee on the Prevention of Nuclear and Biological Attack 
will come to order.
    The subcommittee is meeting today to hear testimony on 
engineering bioterror agents, and the lessons from the 
Offensive United States and Russian Biological Programs.
    I would like to begin this morning by reemphasizing to our 
witnesses and to my colleagues, the primary mission of this 
subcommittee is the prevention of catastrophic terrorist 
attacks. In fact, this subcommittee is the only body of 120 
committees and subcommittees in the U.S. House of 
Representatives that focuses exclusively on preventing two of 
the most catastrophic threats posed by terrorists against our 
Nation, nuclear and biological attack.
    Our hearing this morning is the beginning of a series of 
hearings that will address the biological threat, and will lay 
the groundwork for assessing the role and responsibility of the 
Department of Homeland Security in preventing a bioterrorist 
event from occurring in this country.
    The mission of the Homeland Security Department, first and 
foremost, is to prevent terror attacks from even occurring. The 
secondary mission is to protect the citizenry by hardening our 
Nation's infrastructure against potential terrorist attacks. 
Third, the Department must ensure that we are prepared to 
respond when, inevitably, terrorists devise a means of attack 
against which we have not guarded ourselves.
    Prevention, however, must remain our top priority. This 
country cannot afford to falter to the third mission of 
response whereby we find ourselves picking up the pieces after 
terrorists have succeeded; at that point it is simply too late.
    In April 2004, President Bush issued his biodefense 
directive in the form of HSPD-10. Essential to this first-ever 
mentioned national biodefense strategy are four pillars, of 
which the first is threat awareness. This pillar firmly 
grounded in the notion that through the building of a strong 
intelligent capability to identify and characterize the 
biothreat, as well as understanding of our new scientific 
trends may be exploited by terrorists to develop biological 
weapons is paramount to our success. It is this aspect of the 
biological threat that we hope our experts will be able to 
address today, namely, the capability of nonstate actors to 
engineer organisms that can be used as a bioweapon.
    The key to prevention is the analysis of threats, and this 
analysis is critical in determining where we should invest our 
resources. This government must be able to distinguish between 
any number of terrorist threats where there is a nuclear weapon 
or dirty bomb, and must be able to identify where terrorists 
are attempting to spread smallpox, or worse yet, a 
bioengineered agent that is designed to circumvent any known 
vaccine. And we should know whether they are simply looking to 
blow up an office building.
    Undoubtedly, these are hard choices to make, but they are 
required of this government. And we must use both risk and 
consequence as a means of determining where best to spend our 
money and resources.
    I am hopeful that our experts today will help get us on the 
right path. Since September of 2001, Federal-wide investment in 
biological defense measures has estimated more than $20 
billion. Congress must now work to ensure this substantial 
investment is properly focused, make clear progress toward 
eliminating the most serious biological threats. And the 
witnesses should bring some perspective to the overall threat 
by providing the members of this subcommittee with insight into 
the current abilities of terrorists to develop, acquire and 
deploy a biological weapon.
    I now recognize the ranking member of the subcommittee, Mr. 
Langevin, for an opening statement.

           Prepared Opening Statement of the Hon. John Linder

    I would like to begin this morning by re-emphasizing to our 
witnesses and my colleagues that the primary mission of this 
Subcommittee is the prevention of catastrophic terrorist attacks. In 
fact, this Subcommittee is the only body of the 120 Committees and 
Subcommittees in the U.S. House of Representatives that focuses 
exclusively on preventing two of the most catastrophic threats posed by 
terrorists against our nation--nuclear and biological attacks.
    Our hearing this morning is the beginning of a series of hearings 
that will address the biological threat, and will lay the groundwork 
for assessing the role and responsibility of the Department of Homeland 
Security in preventing a bioterrorist event from occurring in this 
    The mission of the Homeland Security Department, first and 
foremost, is to prevent terror attacks from even occurring. Its 
secondary mission is to protect the citizenry by hardening our nation's 
infrastructure against potential terrorist acts. Third, the Department 
must ensure that we are prepared to respond when, inevitably, 
terrorists devise a means of attack against which we have not guarded 
    Prevention, however, must remain our top priority. This country 
cannot afford to fall to the third mission of response, whereby we find 
ourselves picking up the pieces after terrorists have succeeded. At 
that point, it is simply too late.
    In April 2004, President Bush issued his biodefense directive in 
the form of HSPD 10. Essential to this first-ever national biodefense 
strategy are four ``pillars,'' of which the first is ``Threat 
Awareness.'' This pillar is firmly grounded in the notion that through 
the building of a strong intelligence capability to identify and 
characterize the bio-threat, as well as the understanding of how new 
scientific trends may be exploited by terrorists to develop biological 
weapons, is paramount to our success. It is this aspect of the 
biological threat that we hope our experts will be able to address 
today, namely, the capability of non-state actors to engineer organisms 
that can be used as a bioweapon.
    The key to prevention is the analysis of threats, and this analysis 
is critical in determining where we should invest our resources. This 
government must be able to distinguish between any number of terrorist 
threats, whether it is a nuclear weapon or a dirty bomb. We must be 
able to identify whether terrorists are attempting to spread smallpox, 
or, worse yet, a bio-engineered agent that is designed to circumvent 
any known vaccine. Or, we should know whether they are simply looking 
to blow up an office building. Undoubtedly, these are hard choices to 
make, but they are required of this government, and we must use both 
risk and consequence as a means of determining where best to spend our 
money and resources.
    I am hopeful that our experts here today will help get us on the 
right path. Since September 2001, Federal-wide investment in biological 
defense measures is estimated at more than $20 billion. Congress must 
now work to ensure that this substantial investment is properly 
focused, so that we make clear progress toward eliminating the most 
serious biological threats. Our witnesses should bring some perspective 
to the overall threat by providing the Members of this Subcommittee 
with an insight into the current abilities of terrorists to develop, 
acquire, and deploy a biological weapon.
    I now recognize the ranking member of the Subcommittee, Mr. 
Langevin, for an opening statement.

    Mr. Langevin. Thank you, Mr. Chairman. I would like to take 
the time to welcome our witnesses here today, and I look 
forward to the testimony.
    This hearing mirrors one we had a couple of weeks ago on 
the ability of terrorists to build and detonate a nuclear 
weapon. We talked about the materials needed and the technical 
expertise required to carry out an attack. What we heard in 
this case was that, while building a nuclear weapon is not 
terribly difficult, success hangs on the procurement of fissile 
material. The basic conclusion, no nuclear material, no nuclear 
terrorism, provided my colleagues and I on the committee with a 
clear sense of the urgent need to secure known quantities of 
weapons-grade plutonium and highly-enriched uranium. I am glad 
to see that we are proceeding in a similar spirit to look at 
the threat of biological terrorism.
    From what I have seen and read, there is a lot of competing 
information out there about the seriousness of the threat. I 
look forward to hearing from our panel of distinguished experts 
on this topic in the hopes that when we leave this hearing, we 
will have a concrete idea about the threat we are facing and 
its possible consequences.
    I have read through the testimony, and I get the sense that 
the answer is not going to be a comforting one to the members 
of this subcommittee nor to the American public. The situation 
we are facing seems to be one in which the increased efficacy 
of the technology used in bioengineering has actually lowered 
the bar such that nonexperts now have the ability to build such 
weapons in home laboratories. The situation seems somewhat 
similar to the use of computers 10 years ago; you needed an 
expert to do a lot of tricks, to send or receive audio and 
video files across the Internet. And today, the technology does 
most of the work for you, and anyone can perform these kinds of 
    Unlike the case of nuclear weapons, where we saw that the 
overwhelmingly effective tactic to prevent construction of a 
nuclear weapon is to ensure that all the fissionable material 
is secured, we don't have that luxury in the case of 
    The proliferation of bioagents is vast, and there are 
hundreds of pathogens to choose from. The Centers For Disease 
Control has identified approximately 60 pathogens that they 
consider dangerous, and for which they suggest that the 
government secure its stockpile and countermeasures. And a good 
deal of the equipment needed to develop these weapons is 
readily available. Supplies such as DNA, growth media and other 
solutions can be simply ordered through the mail. The next step 
after creating the pathogen is putting it into a form which can 
be used as a weapon, and delivering the weapon to the target.
    What I would like to accomplish today is to get a very 
clear sense of which points in the process are the sticking 
points, because it is presumably there where we will be best 
able to intervene to prevent such a weapon from being built.
    What would be most helpful to me this morning is to have a 
clear, unvarnished and realistic picture in my mind of the 
threat and the possible consequences that we are dealing with 
in each of the possible bioweapons.
    I look forward to hearing from our witnesses. And I thank 
you, Mr. Chairman, I yield back.
    Mr. Linder. The Chairman now recognizes the gentleman from 
California, the Chairman of the full committee, for any 
comments he might have.
    Mr. Cox. Thank you, Mr. Chairman. This is a very, very 
important hearing because it helps us focus on one of the 
fundamental challenges that policy makers at the Federal, State 
and local level are facing, the need to balance our investment 
against conventional terrorist attacks, such as truck bombs or 
IEDs, with the necessary investment that we must make to 
prevent and protect against potentially catastrophic threats 
such as biological terrorism.
    The terrorist bombings in London last week were tragic, and 
they raised the question, while London was relatively well 
prepared to deal with the aftermath of a conventional series of 
bombings, would the same be true if there had been an anthrax 
attack last week in the London underground. Let's imagine the 
scenario. There are 3 million people who ride the Tube every 
day. When they leave the Tube, they go to work, or if they are 
visitors they tour London or, perhaps, catch an international 
flight. It is only 1 or 2 or 3 days later that people would 
start to get sick. They might then present themselves to an 
emergency room or to their doctor's office with respiratory 
illness symptoms.
    There are no quick diagnostic tests for anthrax, but maybe 
an astute clinician would order a blood culture test for 
anthrax. We might never learn that this attack originated in 
the London underground. Prompt treatment prior to symptoms for 
any victim would be extremely unlikely. The number of deaths 
would easily be in the thousands. And this would be the result 
of a relatively low level biological attack in the same venue 
as the attack that occurred in London last week. A more 
carefully planned attack, with perhaps genetically-engineered 
bioweapons in the future could kill millions.
    The biothreat is particularly worrisome because we know so 
little about terrorist capabilities and intentions. We also 
know that a bioattack could and would result in catastrophic 
loss of life. The Department of Homeland Security, therefore, 
must have experienced analysts to assess the threat on a 
continuing basis, and the Department must play a leading role 
in coordinating the development of antidotes and 
countermeasures to the most virulent agents we face today, and 
will certainly face increasingly in the future.
    But as one of our witnesses has noted, countermeasures are 
fixed defenses. Those defenses can easily be overcome because 
of the rapid pace of technological development. Some experts 
believe that the hurdle for terrorist organizations to 
translate microorganisms into bioweapons is relatively high, 
others believe that this is a thin line of ignorance that could 
easily be crossed. Not only is technology rapidly evaluating 
and being transferred to the private domain, but also experts 
and scientists are spread all over the world. Dr. Alibek, who 
sits before us today, as a product and leader of the Soviet 
Biodefense program, is one of thousands of experts from the 
Soviet program that have the necessary knowledge and training 
to modify and weaponize biological agents. We must take into 
account individuals with this special knowledge as part of our 
antibioterrorism efforts.
    The science and technology revolution in which we are now 
involved offers unprecedented hope if we are smart enough to 
exploit the opportunities before us; that is true both for 
biodefense and for improving our overall quality of life. At 
the same time, there is a dark side to the astounding progress 
of science and technology. The rapid pace of the technological 
development is the greatest single reason that bioterrorists 
must be taken more seriously than ever before.
    I look forward to questioning our experts today, and to 
hearing their views on the unconventional threat posed by 
terrorist engineering of bioagents. I hope this testimony will 
also offer us insight into how best to reduce this threat and 
prevent against acts of catastrophic bioterrorism aimed at the 
United States.
    Mr. Chairman, I want to thank you very much for convening 
this important hearing.
    Mr. Linder. Thank you, Mr. Chairman. Other members of the 
committee are reminded that opening statements may be submitted 
for the record.
    We are pleased to have before us today a distinguished 
panel on this important topic. Let me remind the witnesses that 
their written statements will be made part of the entire 
record, and we would ask you to try to keep your comments to 5 
minutes if you can.
    Our experts are Dr. Kenneth Alibek, distinguished professor 
at George Mason University. Dr. Alibek holds the position of 
president and chief scientist of Advanced Biosystems. Dr. 
Alibek also served as First Deputy Chief in the civilian branch 
of the Soviet Union's Offensive Biological Weapons Program.
    Dr. Roger Brent, President and Research Director of the 
Molecular Science Institute. Since middle 1990s he has advised 
various agencies in the United States and abroad on functional 
genomics, computation of biology and bioengineering.
    Dr. Michael Callahan is the Director of Biodefense and Mass 
Casualty Care, CIMIT/Massachusetts General Hospital, Infectious 
Disease Division. He currently heads the working group on 
biological weapon threat assessment through the Department of 
Homeland Security. Welcome all. We thank you all for being 
    Mr. Linder. Dr. Alibek, you may begin.


    Dr. Alibek. Thank you very much.
    Mr. Chairman, and the members of the committee, thank you 
very much for the opportunity to speak to such a distinguished 
group. I really appreciate this opportunity because I consider 
biological terrorism as one of the main, let me say, threats 
for the world and for the United States.
    I am not going to read my testimony, I would like to put 
just some emphasis on what I consider is the biggest problems 
we are challenging now. First of all, in my view, biological 
terrorism is a kind of unique type of terrorism. What we need 
to keep in mind, biological terrorism is completely different 
from terrorism using explosives; it is a continuous type of 
terrorism. For example, if we remember our experience from 
2001, when we experienced anthrax attack, probably everybody 
noticed that it didn't continue for a day, it continued for 
weeks, it continued for months. And every single day we are 
trying to understand who will be next, what is going to happen 
next, and how much money we need to spend, and what kind of 
economic damage we are going to suffer as a result of this very 
small attack.
    And what we need to remember in this case, the amount of 
anthrax developed by somebody and sent by contaminated or let 
me say tainted mail was very, very little, very small, about 5 
to 7 grams. It is a reasonable amount. And we see the level as 
similar in this case, it was 5 to 7 grams of anthrax, and the 
huge amount of money spent just to mitigate the threat of this 
attack. That is why, in my opinion, biological terrorism is a 
threat we face and will be facing for a long period of time.
    When we talk about the Soviet Union's experience, the 
experience is quite extensive, quite extensive for many 
components. The Soviet Union had a very sophisticated, very 
powerful program. I am not talking about Russia; I don't know, 
and I do believe that Russia is not posing any significant 
threat to the United States, it is absolutely obvious. But when 
we talk about from the standpoint of expertise, knowledge, 
capabilities, the Soviet Union was able to develop one of the 
most--the most sophisticated offense biological program in the 
world. This program includes many different directions, to 
develop different types of biological weapons based on 
bacterial agents, viral agents, toxin agents and some other 
    Significant research was focused on the development of 
industrial processes, what we refer to as biological weapons. 
New prototype biological weapons were under development based 
on new genetically-engineered pathogens. And one of the biggest 
problems was, of course, to develop new pathogens, genetically-
engineered pathogens. And this work started actually sometime 
in the beginning of the 1970s. For a long period of time, the 
Soviet Union was struggling trying to find appropriate ways to 
develop engineered pathogens. It was one time of, I would say, 
unsuccessful work. I don't want to say that people today would 
face the same problems because we are talking about the 1970s, 
1970s is more than 30 years ago. Now science is completely 
different. We have got much higher level of sophistication in 
this field.
    But at the beginning of 1980s, new biological weapons 
engineering pathogens appeared, they existed. And even talking 
about engineered pathogens, we need to keep in mind three major 
directions that scientists exploited in the field of developing 
genetically engineered pathogens, material pathogens. It is a 
simple genetic engineer manipulation which can result in new 
pathogens and new weapons which would be resistant to existing 
antibiotics, or at least some of the existing antibiotics. This 
knowledge exists; this knowledge is, let me say, widely 
published; and there is no significant problem to developing 
genetically-engineered pathogens.
    There is another issue we need to keep in mind, it is the 
issue of how to manufacture these pathogens in large amounts, 
it is a completely difference situation. They can be 
    Another direction, it is called immune subverting, or 
immune system subverting pathogens. There are several 
approaches that have been already developed, and this type of 
pathogens, they exist. There are some publications you would do 
a very thorough analysis. We confirmed there are publications 
already in open literature showing what kind of approaches can 
be used to overcome the natural immune response, or the immune 
response induced by vaccines, or some other immune system 
response. This knowledge is available now.
    One of the most, let me say, unknown areas is the area of 
developing pathogens with newly induced virulent sectors. A 
kind of traditional pathogen could result in--manipulations 
could result in new pathogens having some new virulence 
factors. There are a couple of examples. We have got a 
publication which explains how some genes function in our 
nervous system could be inserted in the form of foreign gene, 
in the form of plasmic, in some material, or viral pathogens. 
And when the disease is developing, it produces completely new 
effect, in addition to existing symptoms. In this case, 
severity of disease is higher.
    Now there are some other examples, and I give these 
examples in my statement. But what I would like to say in this 
case, of course what we need to keep in mind, I don't want to 
say that we are going to see a kind of low level terrorist 
groups they would be able to develop these types of biological 
weapons. But I would like to say is that knowledge is available 
to many countries, and there are some countries we suspect in 
working in the field of developing biological weapons. They do 
have such an ability, and they are able to develop these type 
of pathogens.
    Just take a look at Iran. Of course we don't discuss this 
country in great detail, but if you do this in detail and you 
see what kind of universities and what groups are working in 
the field of microbiology, you would be amazed what kind of 
level of sophistication this country has in the field of 
medical biology engineering. As previously stated, that 
knowledge is already there. We know they are developing this, 
they have been published.
    When we talk about terrorist groups which don't have state-
sponsored programs, or they are not supported by states, they 
wouldn't have such an opportunity for a period of time. But 
when you talk about state-sponsored groups, the knowledge is 
there, and we need to keep that in mind.
    Yes, today probably it is still early to talk about 
genetically-engineered biological weapons; tomorrow it could be 
a reality. Thank you.
    Mr. Linder. Thank you, Dr. Alibek.
    [The statement of Dr. Alibek follows:]

                    Prepared Statement of Ken Alibek

    Mr. Chairman and members of the Committee, thank you for the 
opportunity to discuss with you the threats presented by biological 
weapons and biological terrorism. Addressing the issues of engineered 
biological agents and biological weapons is essential to increasing the 
understanding of how real the threat is and to determining whether or 
not it is likely that the United States will have to protect itself 
from engineered biological weapons in the near future.
    In the former Soviet Union, the work to select new strains of 
virulent pathogens began in the 1970s. As the scientific leader of 
Biopreparat, the civilian branch of the Soviet Union's offensive 
biological weapons program, I was responsible for these projects from 
scientific and financial standpoints. There were a significant number 
of projects focused on developing various types of new BW, including 
the ones that involved genetically engineered pathogens. The projects 
with codenames like ``METOL'', ``FACTOR'', ``BONFIRE'', and 
``PODLESHIK''. These names meant nothing and as I was told they were 
randomly selected and created by a computer. The work being performed 
in these programs, however, lead to a grim new reality in weapons 
development. Among the Soviet Union's areas of interest were new 
genetically engineered pathogens including antibiotic resistant strains 
of anthrax, plague, and tularemia; multi-drug resistant glanders and 
melioidosis; immune-subverting tularemia pathogen, and tularemia and 
plague pathogens with new virulence factors inserted into them. Of 
course I am not able to remember the specific details of each project 
even though I was responsible for all these projects. I had a large 
number of assistants or as we called them, project creators, who helped 
me work with principal investigators and institute directors and deputy 
directors. By 1990, there were approximately 30 project curators 
coordinating more than 300 projects, some of which involved the 
development of novel engineered pathogens and weapons, working for me.
    One must only look at the Soviet Union's BW program to see that it 
is possible to develop genetically engineered pathogens. There is no 
doubt that the probability of developing sophisticated engineered 
pathogens is more feasible nowadays. It is very difficult to predict 
what the primary focus would be of a scientific group working on the 
development of such pathogens. For example, they could focus on the 
development of antibiotic-resistant pathogens, immune-subverting 
pathogens, or on pathogens with ``added'' virulence factors.
    Ironically, even though I knew many of Biopreparat's projects 
during my time as part of the scientific leadership, I learned the 
details of some of these projects after I moved to the United States 
and read articles published by my former colleagues between 1992 and 
2000. Interestingly, after 2000-2001 the number of publications in the 
fields related to biological weapons dropped significantly, then 
virtually disappeared. Before the disappearance of these types of 
articles, one could get a significant amount of information about the 
level genetic engineering research and what could be achieved in the 
field of biological weapons development. For example, two articles I 
read described very sophisticated work that focused on the creation of 
new, genetically engineered pathogens by inserting the human gene, beta 
endorphin, into F. tularensis and a smallpox performed using on non-
virulent microorganisms, but anyone with an understanding of 
microbiology and molecular biology would understand how easily these 
changes could be transferred to pathogenic strains of the same 
    In the first of these publications a group of scientists studied 
how an attenuated strain of F. tularensis would produce beta endorphin 
in experimental animals and examined the changes it could induce in 
them. Immediately after I started reading the article I realized that 
the main purpose of this work was to create a genetically engineered 
pathogen that would produce additional pathogenic effects in humans. I 
found it interesting how they awkwardly tried to explain the necessity 
of the work.
    The article started with a more or less logical explanation of how 
the beta endorphin could be a good replacement for morphine and other 
narcotic painkillers and could be used for the management of pain in 
people with debilitating diseases. It was logical from the point that 
the beta endorphin, which is produced by brain cells, is a more 
powerful painkiller than the existing morphine-like drugs. Another 
benefit of beta endorphin is that it doesn't cause addiction and could 
be used for a long period of time without causing any significant harm 
to the patient. The authors also explained that there were obstacles to 
this approach. For example, beta endorphin is a peptide, meaning it is 
subject to enzymatic cleavage by various proteases produced by our body 
and thus wouldn't have a prolonged effect. For this reason, the authors 
explained, it was necessary to find a way to keep this substance in the 
body for as long as possible to ensure a prolonged pain killing effect.
    Up to this point, the work was logical but as I continued to read, 
the logic became hazy, then disappeared altogether. The authors 
suggested that the best way to keep the beta endorphin in the body for 
a long period of time was to insert a gene of this substance into a 
vaccine strain of F. tularensis, which wouldn't harm the patient, but 
while it multiplies it would produce the beta endorphin long period of 
time. I couldn't understand why they would use even a vaccine strain of 
a pathogen capable of multiplying in our body. Even using a vaccine 
strain would mean establishing an infection in the patient and so it 
made no sense to me why anyone would consider inducing an infection in 
a person to treat them. Additionally, the authors' explanation of using 
a pathogen to increase the length of time the endorphin was produced 
was illogical because the pathogen wouldn't stay in the body for a long 
time. As soon as the immune system developed specific antibodies 
against this microbe it would be eliminated from the body and the 
production of beta-endorphin would stop.
    A third problem with the logic of this approach was that this type 
of treatment could be used just once. As soon as the body developed 
specific antibodies to the microbe future infusions of this 
``therapeutic preparation'' would be ineffective as the microbe 
wouldn't be able to multiply in the body.
    I thought that I might be missing something and continued to read 
the article. At the end of the article was a fascinating and revealing 
account of the results they had obtained. The authors explained that a 
few days after injecting the experimental animals with modified F. 
tularensis the animals developed severe muscle rigidity and became 
catatonic. The real reason for this research was obvious and counter to 
the humane reasons the authors had given at the beginning of the 
    The second article described the effects of beta endorphin when it 
was inserted in the Vaccinia virus, which can be used as a model for 
genetic manipulations of the smallpox virus, Variola major. The results 
were close to the same.
    This work was funded by the former Soviet Union and I do not mean 
to imply that Russia is currently involved in this work. These examples 
are meant only to show what can be achieved in the field of creating 
genetically engineered pathogens.
    In order to clearly understand what is achievable, let me give you 
a number of other examples that demonstrate the prevalence and level of 
sophistication of what is going on in the field of modulating 
pathogenic microorganisms. I am not saying the work described in these 
articles has a dual purpose and is being used to develop BW. What I 
want to say is that there exist many different methods and approaches 
to developing modified pathogens and that biotechnological advancements 
provide a large number of new examples each year. The modulation of 
pathogenic microorganism is not science fiction.
    These are some examples:

    Article One
    Biomed Sci. 1991. All-Union Research Institute of Molecular 
Biology, Novosibirsk region.
    Viral chimeric protein including a determinant of myelin basic 
protein is capable of inducing allergic encephalomyelitis in guinea 
    Shchelkunov SN, Stavitskii SB, Batenko LI, Gashnikov PV, 
Shchelkunova GA, Kostyrev OA, Sandakhchiev LS.
         A hybrid vaccinia virus expressing a chimeric protein 
        consisting of thymidine kinase and the encephalitogenic 
        determinant, S1, from guinea pig myelin basic protein was 
        constructed. Infection of guinea pigs with the virus resulted 
        in the development of allergic encephalomyelitis.

Article Two
    Vopr Virusol. 2000 Nov-Dec;45(6):38-41.
        [Immunogenicity of a recombinant strain of vaccinia virus, 
        expressing a Venezuelan equine encephalomyelitis virus 
        structural protein gene in peroral immunization]
    Sviatchenko VA, Kiselev NN, Ryzhikov AB, Bulychev LE, Mikriukova 
TP, Netesov SV.
         Immunogenicity of recombinant vaccinia virus strain 
        (VR26) expressing Venezuelan equine encephalomyelitis (VEE) 
        virus structural protein genes was studied by oral 
        immunization. Sera of animals immunized with VR26 contained 
        antibodies specific to VEE virus, among which antibodies with 
        virus-neutralizing activity were present. Evaluation of the 
        protective efficiency of oral immunization with VR26 
        demonstrated a high level of animal protection from lethal 
        doses of VEE virus. Rabbits immunized orally were highly 
        resistant (protection index 142.9) to intranasal infection, 
        which is of priority importance for antiVEE vaccine. 
        Comparative analysis of the results of scarification and oral 
        immunization with VR26 indicates that the type of immune 
        response depends on the method of immunization. These results 
        demonstrate good prospects of oral vaccination with recombinant 
        VR26 strain for immunoprophylaxis of VEE.

    Article Three
    Proc Natl Acad Sci U S A. 1983 Sep;80(17):5364-8.
    Construction of live vaccines by using genetically engineered 
poxviruses: biological activity of recombinant vaccinia virus 
expressing influenza virus hemagglutinin.
    Panicali D, Davis SW, Weinberg RL, Paoletti E.
    Recombinant vaccinia viruses containing the cloned hemagglutinin 
(HA) gene from influenza virus were constructed. The biological 
activity of these poxvirus vectors was demonstrated both in vitro and 
in vivo. Expression of HA in cells infected with recombinant vaccinia 
was detected by using specific anti-HA antiserum and 125I-labeled 
protein A, showing that HA synthesized under the regulation of vaccinia 
virus was antigenic. Immunization of rabbits with these recombinant 
poxviruses resulted in the production of antibodies reactive with 
authentic influenza HA as detected by radioimmunoassay, by inhibition 
of HA erythrocyte agglutination, and by neutralization of influenza 
virus infectivity. The production of antibodies directed against 
influenza HA suggested that the HA gene expressed in vaccinia is 
immunogenic. These data indicate the potential of genetically 
engineered poxviruses for use as generic live vaccine vehicles that 
have both human and veterinary applications.

    Article Four
    FEBS Lett. 1993 Mar 15;319(1-2):80-3.
    Genes of variola and vaccinia viruses necessary to overcome the 
host protective mechanisms.
    Shchelkunov SN, Blinov VM, Sandakhchiev LS.
    Institute of Molecular Biology NPO Vector, Koltsovo, Novosibirsk 
region, Russian Federation.
    Analysis of variola virus nucleotide sequence revealed proteins 
belonging to several families which provide the virus with the 
possibility of overcoming the barriers of specific and non-specific 
host defence against viral infection. The complement-binding proteins, 
lymphokine-binding proteins, and serine protease inhibitors can be 
assigned to this type, as can the proteins providing the 
orthopoxviruses with resistance to interferon. The revealed differences 
between the genes (proteins) of variola and vaccinia viruses under 
study are discussed.

    Article Five
    Vopr Virusol. 1997 May-Jun;42(3):115-20.
    [Immunobiological properties of vp24 protein of Ebola virus 
expressed by recombinant vaccinia virus]
    [Article in Russian]
    Chepurnov AA, Ternovoi VA, Dadaeva AA, Dmitriev IP, Sizikova LP, 
Volchkov VE, Kudoiarova NM, Rudzevich TN, Netesov SV.
    Immunological and biochemical parameters were studied in guinea 
pigs immunized with recombinant vaccinia virus containing full-sized 
gene of Ebola virus vp24 protein and then infected with virulent strain 
of Ebola virus. The majority of the studied parameters changed 
similarly in guinea pigs immunized with recombinant vaccinia virus and 
control guinea pigs inoculated with vaccinia virus both before and 
after challenge with Ebola virus. However, in animals immunized with 
recombinant vaccinia virus producing vp24 some biochemical parameters, 
the mean life span after challenge with Ebola virus, the level of 
antibodies to the virus, and the phagocytic activity of neutrophils 
indicated the development of immunological processes other than in 
controls, namely, the development of immune response to vp24. Although 
these processes did not eventually lead to the survival of animals, 
they prolonged the mean life span and resulted in the production of 
anti-Ebola antibodies, though the level thereof was low. These data 
demonstrate that recombinant vaccines against Ebola fever are a 
promising trend of research

    Article Six
    Mol Gen Mikrobiol Virusol. 1997(3):24-7.
     Recombinant vaccinia virus expressing Japanese 
encephalitis virus protein E]
    Cheshenko NV, Petrov VS, Protopopova EV, Netesova NA, Konovalova 
SN, Belavin PA, Loktev VB, Malygin EG.
    Recombinant vaccinia virus expressing protein E of Japanese 
encephalitis virus has been constructed. Polyclonal antibodies to JE 
virus reacted with recombinant protein E in immunoblotting. 
Immunochemical analysis of the recombinant protein E with monoclonal 
antibodies showed that both group specific and receptor domains of the 
protein were intact.

    Article Sevent
    J Virol. 2001 Feb;75(3):1205-10.
    Expression of mouse interleukin-4 by a recombinant ectromelia virus 
suppresses cytolytic lymphocyte responses and overcomes genetic 
resistance to mousepox.
    Jackson RJ, Ramsay AJ, Christensen CD, Beaton S, Hall DF, Ramshaw 
    Pest Animal Control Cooperative Research Centre, CSIRO Sustainable 
Ecosystems, Canberra, Australia. R.Jackson@cse.csiro.au
     Genetic resistance to clinical mousepox (ectromelia virus) 
varies among inbred laboratory mice and is characterized by an 
effective natural killer (NK) response and the early onset of a strong 
CD8(+) cytotoxic T-lymphocyte (CTL) response in resistant mice. We have 
investigated the influence of virus-expressed mouse interleukin-4 (IL-
4) on the cell-mediated response during infection. It was observed that 
expression of IL-4 by a thymidine kinase-positive ectromelia virus 
suppressed cytolytic responses of NK and CTL and the expression of 
gamma interferon by the latter. Genetically resistant mice infected 
with the IL-4-expressing virus developed symptoms of acute mousepox 
accompanied by high mortality, similar to the disease seen when 
genetically sensitive mice are infected with the virulent Moscow 
strain. Strikingly, infection of recently immunized genetically 
resistant mice with the virus expressing IL-4 also resulted in 
significant mortality due to fulminant mousepox. These data therefore 
suggest that virus-encoded IL-4 not only suppresses primary antiviral 
cell-mediated immune responses but also can inhibit the expression of 
immune memory responses.
    Dear members of the committee.
    These examples show the level of sophistication that already has 
been achieved in the areas of creating genetically engineered 
pathogenic microorganisms. Unfortunately, these or similar, techniques 
are already available to countries suspected of being interested in 
developing biological weapons or that are working on dual-use 
technologies. However, we need to be cautious before stating that 
terrorist groups are able to develop sophisticated genetically 
engineered pathogens. Groups that are not state sponsored do not have 
the level of scientific sophistication needed to develop such pathogens 
at this point of time. Of course, that does not mean they will not 
develop this sophistication in the future or that they would not be 
able to obtain such strains. Though the threat of terrorist groups 
developing genetically engineered pathogens may not be immediate, it is 
important to recognize that it could be a threat in the future. We must 
diligently monitor the situation and be on the look out for possible 
changes in the field that could increase the availability of this 
technology to terrorist groups so that we can be best prepared for 
possible bioterrorism attacks involving genetically engineered 

    Mr. Linder. Dr. Brent.

                       SCIENCES INSTITUTE

    Dr. Brent. Well, I am grateful to Chairman Cox, Chairman 
Linder and Ranking Member Langevin for being asked to testify 
    I am from Hattiesburg, Mississippi originally. I graduated 
from the University of Southern Mississippi in math and 
computers. I went to graduate school in Cambridge, Mass to 
learn molecular biology, and stayed at Harvard for the next 25 
    In the 1990s, I helped start Molecular Sciences Institute, 
it is a nonprofit publicly-supported genomic research lab in 
Berkley, California. Now a lot of the work we do involves 
developing technologies, for example, making little machines 
inside cells so the cells can tell you what is going on inside 
them. I am kind of a technology guy in biology. If you want to 
get from point A to point B in a laboratory, I can tell you 
ways to do that, I can probably come up with some new ones. I, 
and a bunch of other people since 1987, wrote one of the main 
manuals or cookbooks on how to do this, four volumes now, 
Current Protocols in Molecular biology; thousands of pages; 20 
years in the public domain; 10,000 and more subscribers 
worldwide. 600 bucks will get you a year subscription continual 
updated to the cookbooks. Those are reasons that I am here 
    By 1996 revelations from Iraq after the first Gulf War, 
combined with stories coming out of the former Soviet Union 
from scary people like Dr. Alibek here, combined with 
information about Al-Qa'ida, have begun to terrify the U.S. 
government about renewed danger from classical biological 
weapons and the increasing dangers from new ones.
    Beginning in 1997, I was tasked to advise the Defense 
Department, along with some other technically-inclined 
biologists--there is only a handful--as to how to strengthen 
the Nation's defenses against biological attack, and I have 
continued to do so. After 2001, September 11, this got much 
less advocational.
    But in this work I regularly received in-depth briefings on 
the U.S. and former USSR programs, trends and offensive and 
defensive capabilities, the public health system and the 
response system, the detection systems. And I have been forced 
to think about the big picture and about the strategic issues. 
I would like to make a few brief points about the threat and 
the defense against it.
    The most important enabler is there is a decentralized 
Moore's Law-type revolution and biological understanding that 
has been going on for more than half a century. Recombinant DNA 
is more than 30 years old. Revolutionary changes, each year 
there is an increase in human capability. Revolution changes 
have revolutionary consequences. And much of the 21st century 
will reflect these changes breaking surface into human affairs. 
And mainly it is for the good, it will help enable personalized 
medicines, longer and healthier lives for Americans, clean 
energy to reduce our dependence on Middle Eastern oil, the list 
goes on. Real cures for the diseases that ravage the developing 
world. But there is a negative consequence. There are now tens 
of thousands of people who could engineer drug resistant 
anthrax, maybe hundreds of thousands. There are tens of 
thousands of people who could remake a virus like SARS, or 
augment existing organisms to make them more deadly, and their 
numbers will only grow. If you imagine a contagious disease 
spread by people who make the disease who just cough on people, 
you could kill millions without the Cold War steps of 
    Because this threat has changed from the days of the Cold 
War germ war program, our defense posture needs to change. 
Although it is a good thing we now have enough smallpox vaccine 
and that we are working on a more modern anthrax vaccine, it is 
important to remember that stockpiles of vaccines and drugs are 
fixed defenses against known threats. In that regard, they are 
a Maginot Line because adversaries, if they know of these 
defenses, can and will outflank them. In the end, fixed 
defensive countermeasures can be no more effective to the 
defense of the United States that the Maginot Lines was to the 
defense of France in 1940.
    So it is a hard problem. But the U.S. leads this revolution 
and it benefits from the consequences. The biology 
establishment in the U.S.--university, industry, non-profit--is 
the best the world has ever seen, and it can help protect 
against the threat if it is constructively engaged.
    Building a defense is a problem of real gravity and 
complexity; it will require R&D and policy efforts sustained 
over decades, which will mean that it will need to enjoy 
sustained consensus bipartisan support, as was true for 
Government support for science and technology during the Cold 
War. So it is a hard problem. But successful effort will pay 
back many fold in better health and increased economic 
activity. And if we can get the right policy, we can help 
ensure that the U.S. can capture the benefit of the investment 
in terms of new industries and economic growth. Thank you.
    Mr. Linder. Thank you, Dr. Brent.
    [The statement of Dr. Brent follows:]

                 Prepared Statement of Dr. Roger Brent

    Chairman Cox, Ranking Member Thompson, Subcommittee Chairman 
Linder, Subcommittee Ranking Member Langevin, distinguished Members, 
it's an honor to appear before you to address issues related to 
engineered biological weapons, lessons from the US and Russian Cold War 
programs, and the consequences that modern developments in biology have 
for development of engineered biological weapons.
    I'm from Hattiesburg, Mississippi, where I graduated from 
University of Southern Mississippi in computers and math. I went to 
graduate school in Cambridge, Mass., to learn molecular biology, and 
stayed at Harvard for 25 years. In 1997 I helped start Molecular 
Sciences Institute, a nonprofit public genomic research lab in Berkeley 
California. My faculty appointment is at UC San Francisco. The science 
we do is fundamental, but has broad applications to biology, medicine, 
and industry, for example to help biotech and pharmaceutical companies 
find drugs.
    A lot of my work involves developing technologies, for example 
making little machines inside cells to tell you what is going on 
inside, and I'm kind of technology guy, You want to get something done 
in the lab, I can tell you good ways to do it and with luck think up 
and get working some new ones as well. Related, since 1987 I help write 
one of the main lab manuals, really kind of like a giant cookbook and 
or recipe book, Current Protocols in Molecular biology, that tells you 
how to work with get from point A to point B working with bacteria and 
viruses and DNA and cells. $600 bucks gets you a year's subscription, 
continually updated, almost 20 years in the public domain, 10,000+ 
subscribers worldwide.
    Which is why I'm here today. By '95-'96 revalations from Iraq after 
the first Gulf war, combined with stories from scary people like Dr. 
Alibek here, and a flow of information about Al-Quade had begun to 
terrify the US government about the danger from classical bioweapons 
and the increasing dangers of new ones. Beginning in 1997, I was tapped 
to to advise the Defense Department as to how to strengthen the 
nation's defenses against biological attack. As such, I continually 
receive in-depth briefings on the U.S. and former Soviet Union 
programs, trends in offensive and defensive capabilities, and the 
public health system and been forced to think about the big picture and 
the strategic issues.
    I'd like to make a few points about the threat and the defense 
against it.
    (1) There is a decentralized, Moore's law type, revolution in 
biological understanding and capability going n worldwide for more than 
half a century. In some cases, biotechnology is advancing faster than 
computer technology. For example, the density of components on computer 
chips continues to double every 18 months--while certain abilities to 
read and write DNA double more like every 12 months. Just as with 
computers, revolutionary changes sustained over time have revolutionary 
consequences, and much of the first part of this century will reflect 
these changes breaking surface to impact human affairs. The US leads 
this revolution and benefits from its consequences, and it is likely 
that the ability to manipulate DNA will be as important to the economy 
of the 21st century as the ability to manipulate electrons and bits was 
to economy of the 20th century. The consequences of this revolution 
will help enable personalized medicines, longer, healthier lives for 
all Americans, clean energy that reduces our dependence on Middle East 
oil, and cures for the diseases that ravage the developing world such 
as AIDS, TB and malaria as well as an improvement its food supply
    (2) Unfortunately, the negative kinds of activities that this 
revolution in knowledge and capability constitute a sea change compared 
to the abilities that powered the US and USSR offensive biological 
warfare programs during the Cold War. Even through the early 1990s, a 
great deal of the activity in programs such as the one Dr. Alibek 
helped direct could be categorized as ``microbiological process 
engineering'', how to ``weaponize'' germs and viruses, coat them with 
agents that protected them from the environment, to make the disease 
causing particles rugged and controllable.
    (3) By contrast, there are tens of thousands of people worldwide 
who can now engineer drug resistant bacteria, and thousands with the 
ability to remake a virus like SARS, or perform other engineering tasks 
too numerous to mention. Their numbers will only grow, so I would not 
be surprised if, by 2010, there were more than 100,000 people worldwide 
who had the knowledge and access to the lab equipment they would need 
to use to make, say, anthrax resistant to Ciproflaxin. Since the 
breadth of dissemination of this technical knowledge base will only 
increase, if you assume that some of these people may be motivated to 
undertake these tasks, then you have to look at the next decades are a 
time of great and increasing risk. If you further assume that some 
individuals or groups may be motivated to use relatively crude 
deployment methods, at the limit including infecting themselves and 
spreading the disease by human transmission, then you have to figure 
that the increase in the risk is higher still. These projects could be 
carried out by individuals or small groups of people; there would be no 
need to recreate the Cold War programs of the nation states.
    (4) And its important to note that the potential mortality is 
enormous. When one uses the words terrorism or bioterrorism, they 
sometimes connotes local events, such as the horror in London. But 
remember that it would be possible to mount a coordinated attack spread 
by aerosol--dust or fog from sprayers--or by infecting members of a 
group with a contagious disease who initiate a multifocal ourbreak of a 
contagious disease transmitted human to human.
    An attack with a contagious disease that circumvented existing 
defenses would not be confined to a single location but would be 
national and international in scope. An attack that killed 1% of the US 
or world human population would be a strategic disaster, a catastrophe 
only rivaled by the 20th century spectre of nuclear war. I believe it 
is the proper province of government to protect against such 
    (5) Although its a good thing we have enough smallpox vaccine, and 
that we are working on a more modern anthrax vaccine, it's important to 
remember that stockpiles of vaccines and drugs are fixed defenses 
against known threats. There is a name for fixed defenses that can 
easily be outflanked. They are called ``Maginot Lines''. Because 
adversaries can and will outflank these defenses, in the end, by 
themselves, stockpiled defenses against specific threats will be no 
more effective to the defense of the US than the Maginot line was to 
the defense of France in 1940.
    (6) It is therefore important to move the US defense posture from 
one mainly based on fixed defenses against known or knowable threats to 
one that is complemented by flexible detection of new threats and agile 
responses to them. Effecting this change is a solvable problem but it 
is a complex one. Doing it right will require changes in strategy, 
policy, and institutions, and generation of a S&T base and an 
industrial structure that can provide the technical means to enable the 
    (7) Numerous elements of the defense effort, both policy, ``soft 
power'' elements, as well as technical elements, are naturally 
international in scope and will require broad international 
participation and support.
    (8) The US biology community, university, nonprofit, industry, is 
the best the world has ever seen. If it can be constructively engaged, 
it is entirely capable of protecting against the current challenges. 
But engaging this community and constructing this defense is a problem 
of such gravity and complexity that it will require R&D and policy 
efforts sustained over decades.
    (9) One consequence of the complexity of the problem that the 
defense effort needs to enjoy sustained, consensus, bipartisan support, 
both from the government, which will need to pay for it, and from the 
scientists, engineers and industrialists who will help execute it. We 
built and maintained such consensuses during the Cold War and they 
enabled us to get the job done.
    (10) Successful effort will pay back manyfold in increased 
security, better health and increased economic activity, and attention 
to right policy will help ensure that the US can capture the benefit of 
its investment in terms of new industries and economic growth.
    I am attaching an article expanding on these topics that has been 
circulating in samizdat form in policy circles for almost two years. A 
version of it will be published in Tara O'Toole's biodefense journal 
later this year.

    Mr. Linder. Dr. Callahan.


    Dr. Callahan. Thank you, Mr. Chairman, committee members.
    Like my predecessors, I can forego much of the testimony 
with regard to the gravity of the threat, and focus with more 
precision on some of the evolutions of the convening of 
technology intent in the nooks and crannies of the planet where 
these features and these factors co-exist.
    I will speak specifically with regard to three 
applications. My first is, as a clinical infectious disease 
doctor who works in the developing countries of the world in 
management of the diseases caused by these agents, specifically 
lassa fever, hemorrhoragic fever, Marlburg, Ebola, epidemics 
from the past, cutaneous anthrax in northern Nigeria and other 
places. These are listed in the testimony.
    My second contribution will shore up a lot of what
    Dr. Alibek has said. I work extensively in the former 
Soviet Union; I spend 30 percent of my time there. I spend that 
exclusively at the bench top with former weapon scientists in 
14 institutes tempering priorities to the Department of State's 
biological bioindustry initiative.
    A key point here that I would like to stress is that this 
program, unlike any of the others, has used the biodefense 
market and the biotechnology market of western nations to 
create a market pull, to bring these former weapon scientists 
to participate in part of the solution. And for this reason we 
have had excellent access to these institutes. These former 
weapons scientists, many of them aging, and many of them with 
their children here in the United States receiving higher 
education, call upon us across international cell lines to tell 
us that there has been a laboratory accident, to tell us they 
have a sick loved one in a Russian or former Soviet Union 
hospital. So as a physician, we attend to them.
    As advocates and collaborators, we try to help them in 
their education. And our statistics are quite good. Out of 177 
currently engaged programs spanning 14 institutes, I will tell 
you that the timeline for radical medical countermeasures to 
the agents of bioterrorism number 11 percent. 11 percent of our 
total portfolio in the Harvard system, and using the best of 
our academic and biotechnology resources here in the United 
States, has new answers coming out of the former Soviet Union 
program. It is that which they prepared, they also mitigated 
against. They had to consider blow back. They will perceive 
that there was an offensive use capability by other nations 
that were targeting them as well.
    So they have been thinking about unknown threat agents 
being lodged at them for some time, and this is a paradigm 
shift in the way they have developed their own science.
    The third and last application, which I will minimize for 
the purposes of this testimony, is that the Department of 
Homeland Security is embarking on a huge effort to bring 
subject matter expertise and intelligence community members 
together to chart a path. We are having great difficulties with 
this because of arbitration and because of some of the 
conflicts, and the fact that, quite frankly, our expertise is 
not read in.
    I would like to contrast, as we go along the remaining 
time, with the sharp distinctions with nuclear weapons. The 
chairman and several others have already talked about these, 
but I would like to crystallize these for you because it is 
quite policy relevant.
    First and foremost, you need to understand that there are 
seven critical ingredients to the manufacture of biological 
weapons. I would like to go through them with just a couple 
comments in each and try to help to develop good questioning 
off of those.
    The first of these ingredients is access to agents. There 
is a lot of attention being spent at the locks or freezers in 
the former Soviet Union, this is important. It is what the 
Defense Threat Reduction Agency's priority goal is, and BII and 
Department of State is doing that as well; it is not necessary, 
though. I work in all of these countries and see these diseases 
as a routine evolution of human ecology, and I have several of 
the supporting materials that are in your folder that will talk 
about that in some detail.
    We have over 200 laboratories in Subsaharan Africa from 
where we have documented anthrax and plague from humans. And 
these are laboratories which have the capability to isolate, to 
purify and to amplify to these agents from all the background 
infectious organisms. I will also note that many of these labs 
are occurring in fundamental Islamic communities or are far 
outside the scrutiny of western nations. They are, quite 
literally, at the end of the path.
    Number two is that, in addition to the agents which are 
easy to get and found in every country of concern to the United 
States, is that there is a critical choke point, an actionable 
choke point with regard to the reagents. There are several 
reagents that are very helpful at amplifying these agents from 
their background. Several reagents. It might be an antibody, it 
might be a plasma that could be used for the construct of a 
genetic organism, or with the advent evolving technologies, it 
might be a small scale fermenter, an ager roller bottle system, 
or an agent which helps to produce a high, dry powder which has 
high loft efficiency. Reagents is a critical actionable place 
to focus on.
    Expertise. Here I return our attention back to the former 
Soviet Union program because it epitomizes this to some degree. 
Expertise migrates much better than the technologies do. And 
the experts from all the programs, and quite frankly, in ill-
intentioned, nefarious-minded, moderately-trained 
microbiologists out of the European program cold return to 
these western nations and reconvene all the necessary 
ingredients of this technology and infrastructure to do covert 
manufacture. I will note also that the reason why this is so 
holoendemic in developing countries in the world is because the 
veterinary communities produce their own pharmaceuticals 
locally. They need anthrax to make an anthrax vaccine that is 
used in northern Nigeria to treat the local economy, which is 
on the hoof. So there is an economic force driving the 
technologies of these developing and small-scale weapons as 
    Technology also contributes in a meaningful way to the 
reconvening--remodeling really--of old-style, traditional 
biological weapons, such as those that were found in the U.S. 
program prior to its dissolution in the early 1970s. You can 
take an old agent, an anthrax spore preparation, and you can 
modernize it, and this increases its magnitude and its ponderal 
impact, its impact upon the human populations. This is depicted 
in my third handout, which talks about, at one magnitude, 
reduction in the number of spores that you need based on the 
incorporation of modern immunologic principles and the use of a 
single new technology which became available in 2002.
    Beyond expertise and technology, I will end quickly with 
some of the small points. One is budget. In our laboratory 
modeling exercises of small-scale biological weapons, we can 
produce 14 million lethal doses of anthrax as a model agent for 
a reagent cost of 36 pounds British Sterling. That is the 
reagent cost, that is not salaries. And this is done. It is not 
a theoretical laboratory modeling exercise, it has been done 
with the surrogates. It was mapped very carefully. It has an 
Excel spreadsheet that goes with it, and a list of reagents and 
    It is also important to note that the people who 
participated in that exercise used all open source information, 
they used the U.S. Patent Office and they used out of print 
microbiology textbooks. It is a scary incredible thing, and it 
is not just theoretical, it has already been capitalized both 
in laboratory modeling and in actual experience. I refer you 
back to the intelligence community's information on the 
American anthrax attack in 2001, which we won't discuss here.
    So after the budget, finishing up, production capability. I 
will just remind you--and this reflects the first point about 
the holoendemic nature of these laboratories is that you need a 
covert production capability. With the modern technologies, 
these laboratories are downsized. The laboratory model that was 
used to produce that anthrax biological weapon was 200 square 
feet, had a capital infrastructure cost of about $220,000, and 
the graduate students were not salaried, so there were some 
cost benefits in there as well.
    What is so often overlooked in our homeland security threat 
analysis programs is that skilled research capital, even 
terrorist capital, needs to be preserved. So another choke 
point is to focus critically on the protection of terrorists 
while they are producing these agents. While biological 
containment, the laboratory equipment that you have that 
protects your workers from being infected can be improvised not 
at the highest level that is needed for aerosolized agents that 
are highly dangerous pathogens.
    So here we look for the hypervaccined individual, and we 
look for things such as consistent antibiotic immuno 
suppression, which has been used in other programs as well.
    My summation is short because it is made easy by colleagues 
here. The traditional weapons exist; they are very possible, 
they are very plausible, they have been modelled extensively by 
our European partners. The agents, the technologies are all 
preexisting. And one of the tragic benefits is that as we 
develop benefits in modern health care and modern technology, 
which serve us well, they have a dark side, they have a down 
side. And it is these same technologies which have dramatically 
increased the efficacy and the efficiency of killing of these 
threat agents.
    I will stop there, and I look forward to your questions.
    [The statement of Dr. Callahan follows:]

             Prepared Statement of Dr. Michael V. Callahan

    Mr. Chairman, distinguished Members, it is an honor to appear 
before you to present information on the threat of traditional and 
next-generation biological weapons. My perspective is derived from 
experiences as a tropical medicine physician who studies and treats the 
diseases caused by these agents, from experiences working with former 
biological weapon scientists in Russia, and threat assessment 
activities on behalf of the Department of Homeland Security's National 
Bioterrorism Analysis and Countermeasures Center (NBACC).
    I am a staff physician in the Division of Infectious Diseases at 
Massachusetts General Hospital in Boston, Massachusetts, and the 
Director of Biological Threat Defense at the Center for Integration of 
Medicine and Innovative Technology (CIMIT). CIMIT is a multi-
institution, non-profit research organization funded by the U.S. 
Government to identify near-term solutions for critical military and 
civilian medical problems. Since January 2002, I have also worked with 
the U.S. Department of State, in particular with the Bio-Industry 
Initiative (BII), a program which uses the U.S. biotechnology market 
and academic collaborations to redirect former Soviet biological 
weapons scientists to peaceful, sustainable medical research. Prior to 
this position I was on faculty at the Center for International Health 
at Boston University where I served as clinical investigator for 
tropical medicine research projects in sub-Saharan Africa. I currently 
maintain tropical disease research activities in five developing 
countries, which is pertinent to the discussion below. Since the 
October 2001 anthrax attack, I have worked with biological terrorism 
working groups from the National Academy of Science, the Department of 
Defense, and the Department of Homeland Security. My focus areas are 
risk analysis of small scale biological weapon production, and 
consequence management following mass-casualty infections and 
    This subcommittee has asked that I provide some perspective on the 
threat of engineered biological weapons. As there is considerable 
debate about several aspects of biological weapons, I have attempted to 
support this testimony with photographs from the field and from 
laboratory modeling activities. I will emphasize here that I am not an 
expert on the former U.S. biological weapons program that was disbanded 
in 1971. I also understand that Dr. Alibek will provide testimony on 
the Soviet biological weapons program under Biopreparat. My reference 
to the FSU (Former Soviet Union) program will therefore, be restricted 
to information gained from ongoing research collaborations with ex-
biological weapons scientists from 10 Russian institutes. It should be 
emphasized that my experiences helping BII to develop drug and vaccine 
commercialization opportunities for former weapons scientists have 
resulted in access to several institutions previously closed to 
westerners (Figure 1). Further transparency is gained, perhaps 
ironically, by relationships forged from my medical care of former 
weapons scientists and their family members, and on occasion, emergency 
medical consultation to infections resulting from laboratory accidents. 
Finally, it is probably relevant that my experiences conducting 
clinical research in remote African and Asian locales have sensitized 
me to some of the challenges a terrorist lab would encounter when 
attempting to make a biological weapon in an austere environment 
(Figure 2).

    What is our current understanding of engineered biological weapons?
    Most experts agree that biological weapons are the original weapons 
of mass destruction. Throughout history, the overwhelming majority of 
biological weapons were used in a crude form. For example the first 
recorded use of biological agents was in 1346 when the Tartars 
catapulted plague-ridden corpses into the city of Kafka. In more recent 
history, a branch of the Japanese army, Unit 731, reportedly dropped 
plague-infected fleas in ceramic bomblets over cities in China in WWII, 
which likely accounts for unusual changes in the epidemiology of this 
disease in several regions. Prior to the genomic revolution of the last 
two decades, laboratories in several countries worked with variable 
success to stabilize infectious microorganisms and toxins so that they 
could be stored and deployed with greater efficiency and 
predictability. The advent of molecular biology, advances in our 
understanding of infectious diseases and immune regulation, and 
advances in micro-particle engineering and micro-encapsulation have all 
resulted in technologies that can be used to either advance the 
properties of biological weapons or as countermeasures to protect 
against them.
    Past military interest in biological weapons was driven by the 
realization that a comparatively small investment is required to make a 
tactical weapon capable of killing a large number of enemies. In rare 
cases, military weapons programs considered biological weapons as part 
of strategic campaigns. The interest in using biological toxins and 
infectious microorganisms as weapons was also driven by characteristics 
of the agents themselves. For example, in contrast with other munitions 
such as nuclear, chemical and conventional high explosives, only 
biological weapons are self-replicating. Moreover, these agents can be 
scaled-up from seed stock to a full stockpile on short notice and with 
considerably less engineering, manufacturing, capital investment and 
production signature than would be produced by nuclear or chemical 
weapons. A related characteristic is that biological weapons can be 
covertly transported as either minute quantities or in a form that 
leaves no signature, thus allowing the agents to cross international 
borders and be produced behind enemy lines. Military strategists also 
noted that only biological weapons could be successfully deployed 
without detection, a desirable characteristic if attribution is to be 
avoided. By the time clinical symptoms would appear, those that 
deployed the weapon would be many hours or days distant. Most 
ominously, and in stark contrast to chemical and nuclear weapons, 
contagious biological weapons such as killer influenza and smallpox, 
have the unique capacity to cause casualties far beyond the immediate 
impact zone.

    Biological Weapons and Terrorism
    Many of the characteristics that make biological weapons attractive 
to past military programs also make them desirable to the terrorist. 
Fortunately, the convening of biological weapon capability and 
terrorist intent has not as yet resulted in a mass-casualty incident. 
Unfortunately, several disquieting observations of the October 2001 
anthrax attack using the U.S. mail system merit emphasis. First, the 
attack illustrated that advanced expertise had readily been exploited 
by a bioterrorist; the preparation in the Daschle letter contained 
extraordinarily high concentrations of purified endospores. Second, the 
spore preparation was coated with an incipient which helped retard 
electrostatic attraction, thus increasing aerosolization of the agent. 
Third, the choice of the near-ubiquitous Ames strain, combined with the 
absence of forensic details in either the agent or the letters, 
indicate that the terrorist is scientifically informed, wary of 
detection and extremely dangerous.
    I use this well-publicized case to demonstrate that from the 
perspective of the terrorist, biological weapons are likely to be the 
optimal choice for inducing terror. As a practical point, the terrorist 
is likely to be attracted to any means which causes maximal disruption, 
terror and loss of confidence while using the minimal amount of skilled 
personnel, specialized resources and financial investment. For example, 
the skills required for bioweapon manufacture may be derived from 
manufacturing practices that use similar technologies such as the 
fermentative and agricultural sciences, vaccine manufacture, potable 
water treatment and environmental microbiology. In this regard, 
bioweapons offer specific advantages for covert manufacture by the 
        1. The agent may be produced using equipment designed for other 
        peaceful purposes (so called `dual use').
        2. Production requires minimal space and time, a characteristic 
        that is increasing with modern technology.
        3. Unlike any other weapon, infectious microorganisms are self-
        perpetuating, and therefore may be propagated among the 
        terrorist groups or cells.
        4. Several agents can cause casualties beyond those originally 
    5. When human assets need to be preserved, these weapons allow the 
perpetrator to escape detection.
    From the perspective of the threat analyst, there are 7 overlapping 
conditions that need to be present for a terrorist group to produce an 
effective biological weapon. Failure to meet any of the following 
conditions can thwart an attempt at weapons production. These 
conditions are consolidated from consensus opinion of different U.S. 
Government working groups, by CIMIT's modeling activities and from 
field experiences working with over one hundred laboratories in 
Southeast Asia and sub-Saharan Africa (reference Figure 1: a clinical 
infectious disease laboratory in rural northern Nigeria. The laboratory 
technician and I are holding up red blood cell agar plates containing 
the non-hemolytic Bacillus anthracis which was isolated from the skin 
lesion on a local goat herdsman. In this region, estimates of 15-40 
cases of cutaneous anthrax are observed annually): the seven conditions 
for biological weapon production are:
        1. Access to agent: this condition requires that the terrorist 
        has the ability to isolate or procure the microorganism or 
        biological toxin. Note that many threat agents are endemic in 
        Neotropical regions of the globe, including all countries of 
        concern to the U.S. Naturally-occurring infections resulting 
        from these microorganisms are routinely encountered in domestic 
        animals, as is the local expertise required to recognize these 
        infections. Procurement can involve coercion, misrepresentation 
        of intent, or illegal purchase from a former weapons program or 
        strain collection.
        2. Reagents: this condition includes availability of factors 
        required for successful biological isolation and amplification. 
        Examples include specialized or improvised culture media, 
        sporulation-inducers, and incipients to stabilize the agent or 
        to improve purity.
        3. Expertise: technical know-how can be derived from other 
        disciplines. In modeling studies stated knowledge gaps to 
        weapons manufacture may be overcome using internet based 
        literature and patent reviews, use of out of print texts, and 
        identification of solutions from parallel scientific or 
        manufacturing disciplines.
        4. Support technology: this category includes laboratory assets 
        such as roller bottles, agar trays, fermentors, lyophilizers, 
        egg incubators, cold storage capability, animal testing 
        capability and biochemical test kits. The recent 
        commercialization of an unnamed technology has dramatically 
        simplified the challenges to manufacture of one bioweapon by 
        allowing a less refined preparation to be used.
        5. Budget: in both resource rich and austere economies, the 
        financial cost of procurement, laboratory consumables, animals 
        and maintenance of laboratory operations is significant. In 
        modeling studies, the anticipated budget required to complete 
        all manufacture tasks posed a greater challenge to a minimally 
        resourced terrorist group than did other tasks.
    6. Covert production: modeling for small scale anthrax suggests 
that a small appropriately-equipped laboratory with a footprint of 250 
ft2 would meet the production needs of a small scale spore weapon. 
Although many agents can be purified and engineered in simple 
microbiology laboratories (which are found worldwide), large scale 
production, coating and stabilization would require a purpose-
designated facility.
    7. Laboratory Safety: skilled technicians require protection, 
however the procurement of specialized safety equipment is closely 
monitored. For this reason safety capability may be improvised, or lab 
workers may be hyper-vaccinated and maintained on antimicrobial 
prophylaxis to permit lower levels of containment to be used.
    What can the Former Soviet Union Weapons Program teach us about 
Engineered biological weapons and bioterrorism?
    Recent terrorist attacks in Russia have prompted government actions 
to protect against terrorism. However, an ethnically diverse 
population, poor border controls, regional corruption, and the 
continued conflict in Chechnya have all produced conditions that could 
still result in a biological weapons attack by terrorists. According to 
one Russian government official, ``In no other place do the microbes, 
the expertise, the infrastructure co-exist in such close proximity with 
terrorist groups and chaotic times'' (name omitted). In the last 2 yrs 
the concern about terrorism has prompted new levels of disclosure and 
cooperation between the Russian Federation and the United States. In 
the last 2 years there have been 4 conferences in Moscow and St 
Petersburg where prevention and response to bioterrorism was a major 
topic. These conferences are important for a second reason in that they 
provide a forum whereby the FSU scientists present previously unknown 
countermeasures or vaccine strategies which were used to protect 
production workers or government personnel from the USSR agents. Some 
recently described technologies, such as non-specific immune enhancers 
(immune modulators) have little precedence in Western biodefense and 
are exciting new additions to the BII's Advanced Vaccine and Drug 
Development program.

    Traditional weapons programs
    Traditional biological weapon manufacture is best illustrated by 
the former U.S., British and Soviet era production methods. In the 
Soviet era program, simple methodologies such as microbial fermentation 
were conducted on a grander scale. In two former production institutes 
(Stepnogorsk and Berdsk) fermentors used to produce weapon strains were 
many thousands of liters in volume, over two stories in height and 
under continuous stringent environmental control.
    In these programs the kill efficiencies of the weapons were 
increased by maximizing the number of viable microorganisms in the 
final munition rather than focusing on engineering of the organisms 
(which came later). SRCAM scientists recount that in the case of 
anthrax, attention was focused on increasing fermentation and spore 
production efficiency, and spore recovery using a number of methods 
such as foam flotation. Other expertise was directed at improved 
methods of milling to produce progressively smaller clusters of spores, 
a condition for successful delivery and sequestration in the terminal 
alveoli of the lung. By report, there were occasional production 
misadventures where fermentation runs were contaminated by other 
bacteria or anti-bacterial phages which destroyed the entire production 
    In the years since the end of the Russian program, our scientific 
understanding of microbial metabolism and the improved efficiency of 
automated small scale fermentors have increased the amount of 
vegetative bacteria that can be produced with minimal resources. 
Parallel sciences, such as biological insecticides which use bacterial 
spores afor peaceful purposes, have provided clues to maximize yield in 
a small laboratory. Perhaps most disturbing is the growing availability 
of small scale, autonomous operating fermentation systems which reduce 
the need for skilled technicians and a complex support infrastructure 
(e.g. Bioflo IV Fermentor, New Brunswick, Inc). These systems are 
becoming more common in agricultural regions of Africa.
    When considered as a whole, traditional weapons technologies with 
alterations rather than genetic engineering are the most likely to be 
employed by a moderately resourced, moderately skilled terrorist group. 
There are many open sources and skilled personnel who can provide 
guidance to help assemble the critical components necessary for weapons 
development. Potentially, a former weapons scientist from Stepnogorsk 
could travel to country in the Middle East and reconvene a weapons 
capability from available veterinary, agricultural and clinical 
microbiology resources. For Middle Eastern countries, the easiest 
solution would be to isolate a virulent epizoonotic pathogen from a 
local infected animal. These scientists need not bring anything with 
them but their expertise.
    To summarize, efforts to prevent traditional biological weapon 
production should include efforts to prevent migration of skilled 
personnel to hostile groups. Additional measures for prevention of 
weapons development include tight scrutiny of international 
collaborations and tracking the importation of small scale bacterial 
growth systems and close human and animal surveillance efforts to 
detect infections resulting from deficits in the safety of a weapons 

    Next-generation Biological Weapons
    Next-generation biological weapons are those that benefit from new 
technologies, those made from previously unknown infectious agents or 
biological toxins, and those where a traditional agent is dramatically 
altered by the addition of a high-tech capability. One concept that is 
central to discussions of enhanced virulence biological weapons is that 
the same open source methodologies that advance our ability to improve 
upon human health may also be commandeered for nefarious purposes. A 
second point is that traditional biological weapons such as those 
produced in military weapons programs can be modernized to achieve new 
levels of lethality. The following case is used to illustrate this 
    In the former U.S. weapons program, estimates were made about the 
number of anthrax spores required for an LD50 (dose required to kill 
50% of a population) and LD90 (dose required to kill 90% of a 
population). Extrapolations from these estimates indicate that between 
8,000-10,000 spores would be required for infection. These estimates 
are likely accurate for the anthrax strains used in the pre-1971 
program. Unfortunately, in recent years there have been dramatic 
advances in the modeling of airflow in the human lung which in turn has 
driven the field of aerosolized drug and vaccine delivery. In the last 
8 years, particle physicists and pulmonary scientists have worked 
together to improve the efficiency with which drugs reach the alveoli 
of the lung, which is also the preferred target for the aerosolized 
anthrax spore. A parallel advancement has occurred in the field of 
immunology where new organic coatings have been invented which 
dramatically increase the uptake of particles by the specialized cells 
in the alveoli. Unfortunately these cells are also responsible for 
providing the anthrax bacillus with a protected beachhead for 
replication. The result is that two unrelated technologies, a method 
for generating small drug and vaccine aerosols, and the development of 
a specialized coating, are responsible for dramatically reducing the 
number of spores required to produce a successful infection. (Figure 3 
depicts the methods used to produce a coated anti-floculated spore as 
well as the calculated reduction in spore concentration required for 
infecting 80,000 people in a large city. Select steps and information 
omitted for this testimony)
    Genetic engineering has also played a role in altering the 
capability of biological weapons. Toward the end of the Soviet 
biological weapons program an effort had been made to make several 
agents resistant to antibiotics. Much of this work was done using 
techniques considered inefficient by today's standards. Biological 
weapon analysts with expertise in molecular biology believe that drug 
resistant biological weapons are a moderate probability event that 
could have disastrous consequences. The reasons for this are based in 
the current health care impact of antibiotic-resistant microorganisms, 
which are arising as a consequence of indiscriminate antibiotic use. 
What is not clear is how likely it is that a biological weapons 
scientist could make a threat agent that is both highly resistant and 
highly virulent. Such balanced capability would require that the 
organism be continuously tested against animals to maintain virulence. 
Thus in this case, the requirements needed to engineer-in genes for 
antibiotic resistance might also require an attendant investment to 
insure that the agent remained highly pathogenic.
    Next generation biological weapons may also be engineered using 
negative selection techniques. In this case antigens to which the 
patient's immune response is directed are removed from the biological 
weapon. In worse case scenarios, the terrorist might eliminate the 
antigen on a bacteria, virus or toxin that was used as the basis for a 
government vaccine. If the patient was exposed to one of these antigen-
negative biological weapons, they would be immunologically naive 
resulting in more severe infection and/or death. These types of agents 
are known as vaccine-evading biological weapons. Unfortunately, the 
concept that such agents could be developed is dramatically illustrated 
by the need for new vaccines to protect against circulating strains of 
influenza A/H3N2.
    Next-generation biological weapons also include the engineering-in 
of properties that influence the ability of the body to mount an immune 
response. In recent years, there have been several publications which 
have demonstrated this concept to biodefense scientists and 
potentially, to any terrorist with internet access. One of the most 
disquieting publication in 2002 described a method for defeating 
vaccine-protected animals by inserting a gene which down-regulated the 
immune system resulting in overwhelming infection and depth (reference 
provided upon request). Another publication which will appear in an 
international journal this September describes a methodology which 
single-handedly solves two separate challenges facing a biological 
terrorist: how to move virulence genes from one agent to another, and 
how to store a biological weapon without depending on freezers and 
liquid nitrogen (reference provided upon request).
    One of the most ominous of engineering feats that could be used by 
biological weapon scientists is to induce host tropism into the agent, 
whereby the agent is altered to favor infection of a specific human 
genotype. This seemingly far-fetched concept is already demonstrated by 
certain tropical parasite infections that cause more significant 
infections and sequelae in certain ethnic groups.
    The efforts of the biological terrorist to produce a new threat 
agent can also be assisted by natural events. This scenario is best 
illustrated by current experience with avian influenza in Southeast 
Asia. Since 1998, the pathogenicity of this bird virus has increased as 
has its ability to infect the upper respiratory systems of pigs and 
humans. The result is that infected patients are exposed to a novel, 
highly pathogenic respiratory virus to which their immune system is 
completely naive. The danger of this event is exacerbated by the fact 
that influenza, unlike anthrax, can be transmitted from person to 
    I will summarize this written testimony by reaffirming the concept 
that the dark science of biological weapon design and manufacture 
parallels that of the health sciences and the cross mixed disciplines 
of modern technology. Potential advances in biological weapon lethality 
will in part be the byproduct of peaceful scientific progress. So, 
until the time when there are no more terrorists, the U.S. Government 
and the American people will depend on the scientific leaders of their 
field to identify any potential dark side aspect to every achievement
    Again, I appreciate the opportunity to present this information 
before the Committee. I shall be happy to answer your questions and to 
provide additional documentation supporting the material presented.




    Mr. Linder. Thank you very much. I want to thank all of you 
for your reassuring testimony.
    This is quite alarming stuff, and I think we are just 
beginning with it. I have said to many people this is a 
subcommittee to prevent nuclear and biological attack, and 
nuclear is really easy compared to biological.
    I will recognize myself for 5 minutes to begin the 
    Dr. Alibek, did they ever weaponize the biology in the 
former Soviet Union? Was the biological weapons, were they 
weaponized or were they just--
    Dr. Alibek. The Soviet Union weaponized a big number of 
biological weapons and had industrial facilities to manufacture 
biological weapons.
    Mr. Dicks. Could you pull your mike up?
    Dr. Alibek. The Soviet Union weaponized a big number of 
biological agents, and had some biological weapons stockpiled, 
and had big production capacity to manufacture many stocks of 
biological weapons, specifically anthrax, plague, tularemia, 
glanders, melioidosis, bacterial biological weapons. Viral 
biological weapons, the smallpox, Venezuelan equine 
encephalomyeltis, new types of biological weapons based on 
Ebola, a GTU hemorrhagic fever.
    In this case, let me put it this way, this new paradigm 
actually appeared when the Soviet Union started manufacturing 
some old antibiotic-resistant biological weapons, antibody-
resistant anthrax, antibody-resistant plague, antibody-
resistant--in the 1980s, there was a big number of attempts to 
develop immune-subverting biological weapons, and so on and so 
    Mr. Linder. That answer is yes.
    Dr. Callahan, are we getting good access to the labs in the 
former Soviet Union?
    Dr. Callahan. Yes. And what is also critical to know is 
that Dr. Alibek is referring to the production capability, 
which is really 4 to 6 institutions, the Croftburg, Stavuguart, 
and several of the others. But the Russians choose those 
programs--and Ken can talk about this in great detail--based on 
the return on the investment, on the capital investment, some 
large fermentation capability involving multi-story, tens of 
thousands of liter fermenters were used. The Russians also had 
a B plan, though. Those were the very expensive high efficiency 
agents that sat on bench tops, and these--the pace to improve 
the efficiency of these agents remained in single scientific 
labs. And this is one of our critical focus areas is going 
after the former Soviet Union B plans. Short answer, yes, there 
is multiple levels of weaponization, there were multiple levels 
of technical development, and all have benefited from the 
evolution of technology and their migration across 
international borders.
    Mr. Linder. Dr. Brent, are we wasting $20 billion?
    Dr. Brent. Good question, sir. I don't think in a 
democratic society, it is possible not to make defenses against 
known threats, smallpox and anthrax; I don't necessarily think 
those are bad things, in fact, I don't think those are bad 
things at all. I do think a defense posture based exclusively 
on stockpiling responses to known threats at a time when what 
is going to come at you is impossible to predict, is not going 
to work in the end.
    So what proportion of our resources we spend on flexible 
detection and agility versus the known threat is a key 
political question.
    Mr. Linder. We are going to face flu every year, and every 
year it is going to be a different version and need a different 
antidote. If a SARS outbreak occurred, something like that, 
could somebody with a modicum talent in this business 
genetically alter that virus and make it more virulent, spread 
faster and make it more difficult to treat?
    Dr. Brent. The short answer is yes, sir. At least--you have 
clear paths to taking a virus like SARS and making it more 
deadly, you don't know that the thing you end up with would be 
as contagious as the thing you began with, but it might. So 
maybe a nation state doesn't take that bet, but maybe a 
terrorist group says what the heck.
    Mr. Linder. But the blow back would concern them just as 
    Dr. Brent. Might.
    Dr. Callahan. I also need to add in here, working the Avian 
Influenza Syndrome and surveillance program throughout Asia, we 
are critically concerned about Avian Flu. I understand Sue 
Simonson has talked to you. We used the tippy top of the 
international flu community to help understand how to mitigate 
against this threat. It is a catastrophe. And one of the 
biggest evidence of this is that the influenza R&D for 
weaponization is occurring in small chicken farms throughout 
southeast Asia; you can't forget that. Second point is that the 
co-infection between a normal circulating strain are current 
H3N2 and an H5N1 is statistically extremely probable. And what 
we see with the evolution of influenza in Southeast Asia, be it 
southern China, Hong Kong, the Himalayan region, and we go and 
see these patients and work with these collaborators, we are 
finding it slightly different from each other. That is bad 
news. That means it is not a single point transition, but it is 
a virus trying to find its way. And this is a very important 
point and is a live fire exercise for biological defense of 
this country.
    Mr. Linder. Thank you. My time is--the Chair will now 
recognize Mr. Langevin for 5 minutes.
    Mr. Langevin. Thank you, Mr. Chairman. And thank you, 
gentlemen, for your testimony again.
    I would like to start, if I could, going back to Dr. 
Callahan, you mentioned choke points during your testimony, and 
I mentioned it in my opening statement, which are actionable. 
One you mentioned was vaccination of the terrorist weapon-
builders. Can you expand on that and other choke points, and 
steps that we could take to identify--how we can identify these 
    Dr. Callahan. The sad misfortune is that vaccination 
technology is as old as dinner, I mean, it is literally two 
centuries old, and for that reason the technologies to 
vaccinate and protect an underresourced biological weapons 
scientist working in a remote lab are preexisting.
    I will note, though, that vaccines have a certain amount of 
efficacy. Our current vaccines are woefully inadequate, with 
the exception of potentially the smallpox dry vac. Without 
exception, our currently deployed stockpiles of vaccines are 
less effective. We use these vaccines as clinical infectious 
disease doctors protecting our people that go into harm's way. 
We are not very interested in their long-term efficacy because, 
quite frankly, there is going to be the need for other care.
    So choke points on vaccines are a difficult issue. One of 
the ones that has shown up, though, in the laboratory modeling 
though has not been control of the agents, has not been 
tracking the vaccines, it has been tracking a critical recently 
emerged technology. In this year alone, in the first 4 months 
of 2005, there are 19 papers that have been produced which 
provide heavy, excellent answers for the challenges facing a 
biological weapon scientist working in the Khandalar cave. They 
usually allow them to forego cold chain refrigeration to store 
their agent. That way they could acquire genome in one place 
and put it into an agent to be used for dissemination.
    So certain technologies are a critical choke point. And Dr. 
Brent can probably comment more on that, as can those that are 
tracking technologies and migration around the planet, so I 
will stop there.
    Mr. Linder. Dr. Brent, did you want to comment?
    Dr. Brent. I would like to, if I could. You wish there were 
more choke points, or that those points felt more narrow than 
they do. Again, there is probably hundreds of thousands of 
people with the expertise in the world and the access to 
laboratory equipment to make anthrax resistant to the main 
drug, Ciproflaxin, it is not hard. So the reagents, you know, 
the equipment and reagents, they are sold to worldwide market. 
The vendors of technologies and synthetic DNAs are all over the 
world, they are in basements in Shanghai selling to the U.S. 
market. They are bombarding you by your e-mail on the Internet 
with special deals and cut price offers.
    I am not convinced that there are very good choke points, 
particularly when you move from this paradigm of a Cold War 
Germ War program with weaponization and so on, to this specter 
of an individual or a dedicated group of individuals who is 
willing to infect themselves and infect other people. Then one 
of the choke points becomes the ability to work with viruses or 
synthetic DNA. There may be tens of thousands of people with 
such expertise in the world, half of them in the U.S., half 
    Mr. Langevin. Dr. Brent--and the other two can comment--you 
seem to indicate in your testimony that fixed response 
capabilities are really inadequate, stockpiling certain 
antidotes may only have a very limited value. Can you expand on 
that? And what are we to do if there really is a minimal 
limited value?
    Dr. Brent. Well, okay. This is a delicate and important 
point. For example, I mean, a Ciproflaxin stockpile, if I am a 
terrorist, I will immediately make sure that my anthrax is 
Ciproflaxin resistant; so that is just a flag, outflank me. So 
that is among the easiest manipulations to perform.
    The amount of the resources you spend on such fixed 
defenses versus the amount you spend trying to devise a more 
flexible detection system and a more flexible response system 
is one of the key questions, but there are almost-- Dr. 
Callahan can correct me--60 pathogens on the so-called select 
agent list. We don't want us to be spending a couple billion 
dollars on each of these agents on the select agent list, 
working down the category, we would bankrupt the country and we 
wouldn't make ourselves more safe.
    Mr. Langevin. Dr. Alibek.
    Mr. Alibek. Just a couple of words to add to his 
    Not all genetically-engineered pathogens would require 
completely new therapeutic measures. For example, if you talk 
about anthrax-resistant Ciproflaxin, we have got some other 
antibiotics which can handle this infection, for example, 
Doxycycline. Doxycycline, they are good antibiotics to treat 
anthrax. For example, we have new technologies now, for 
example, we develop antibodies, specific antibodies for anthrax 
treatment. The antibodies don't care whether this pathogen is 
antibiotic resistant. And we have such a huge number of 
examples. In some cases, let me say some genetic manipulations 
will create a completely new pathogen and our defense wouldn't 
work against this pathogen.
    But in some cases our existing defense, they are still 
capable to deal with these pathogens. So the only issue in this 
case, we need to understand what kind of technologies can bring 
a completely new paradigm against these type of pathogens. We 
need to develop new defense against war pathogens; we shouldn't 
do anything because our existent war is being developed, 
medical measures are capable to protect against these 
    Mr. Linder. The time of the gentleman has expired. We might 
have another round.
    The Chair now recognizes Chairman Cox for 5 minutes.
    Mr. Cox. Thank you.
    We have before us three witnesses, each of whom deserves 
about a half hour time to himself, and I am sorry we have the 
5-minute rule here. I am just going to dive in with a solitary 
question that is unrelated to what I really want to pursue, but 
it is just something, Dr. Brent, that you said in your 
testimony that I hadn't really considered before.
    Are you suggesting the possibility, or are you 
contemplating the possibility of suicide coughers? You know, we 
have got people, as we saw with 9/11, who were content to fly 
airplanes into buildings, I suppose there isn't any reason to 
think that such people wouldn't mind infecting themselves and 
then just spreading themselves about as the agents.
    And what you suggest, therefore, is that the Cold War 
model, or really the model of all prior history in warfare, is 
out the window; we shouldn't be looking necessarily for 
weaponization, the terrorists themselves become the weapons. Is 
that what you are suggesting?
    Dr. Brent. That is correct, sir. That is not to say that if 
a nation state had a lot of money and could employ many 
hundreds of people to make a program, they might not want to 
weaponize their agents and make them more controllable. And 
perhaps, anthrax is easily disseminated but it is not that 
infectious, but a terrorist group might want to use a 
contagious disease, or a disaffected individual. Already the 
technology exists to resynthesize small viral genomes. And an 
important thing to do in the 21st century is to, beyond the 
terrorist, make sure the hacker doesn't appear, the person who 
makes something and just wants to--
    Mr. Cox. And that is really the point I want to get back to 
with you and Dr. Callahan. But first a question for Dr. Alibek. 
When the Soviet Union was at large, the Soviet Union produced 
genetically-altered super plague, and also antibiotic-resistant 
anthrax. By the cease fire of the Gulf War in 1991, when we 
discovered that Iraq had weaponized anthrax, were they using 
the same kind of antibiotic-resistant anthrax that the Soviet 
Union had developed?
    Dr. Alibek. No. The Soviet Union, the major anthrax 
biological weapon developed and manufactured in the Soviet 
Union, it was so-called natural anthrax. It didn't have--
because this technology was quite old, first technology was 
developed sometime in the 1950s for industrial production, 
another technology was developed in the 1980s. It is a new type 
of biological weapon. But it was a biological weapon for 
military deployment, not for terrorist deployment.
    New research on antibiotic-resistant anthrax started 
sometimes in the 1970s, and it resulted in new types of 
antibiotic-resistant anthrax sometime in the second part of the 
1980s. And this new type of anthrax was tested and was ready to 
be accepted by the Minister of Defense for military deployment.
    Mr. Cox. But to your knowledge, this has been contained 
within the Soviet Union, and now Russia.
    Dr. Alibek. Yes. This is what I would like to see in this 
case. The Soviet Union never had desire to share this 
technology with anybody else. Officially there was no, let me 
say, exchange between the Soviet Union and any other country. 
The program was highly secretive, and nobody wanted to share 
any information whatsoever.
    Mr. Cox. Well, that really takes us then to Dr. Brent's 
point about the garage hackers. If is it true that biotech is 
right now on the cusp of an explosion and it is like computers 
in 1965, and it is very primitive right now compared to what it 
is going to become 10 years, 20 years, 30 years from now and 
there is going to be a great democratization in opportunity to 
produce things that up until now have been very sophisticated, 
it poses very serious problems for those of us planning 
    I think, Dr. Callahan, you have been very helpful to the 
committee in providing what I would refer to as the seven 
habits of highly effective bioterrorists. The seven 
characteristics that you describe as sine qua non of terrorist 
groups that might want to produce bioweapons, to what extent 
would this phenomenon of the garage hacker, if you will, if it 
is real, defeat our ability to rely on these seven 
characteristics? I mean, would it really require the kind of 
budget, for example--which is one of your seven factors that 
presently it does--would we be able to drill down on these 
preconditions to prevent terrorism, or do we need to rethink 
    Dr. Callahan. Yes. Those are focus areas for interdiction, 
both for the intelligence community and for those that are 
monitoring migration technologies and agents. Using the garage 
hacker as a term, I need to stress that the technologies are 
now being downsized to the point where the laboratories operate 
autonomously. Before the scientific community and the 
biotechnology community was dependent on critical pieces of 
hardware in other institutions, gene chip machines, PCR 
machines, trial fermenters, and these sort of kept these 
programs very integrated for biodefense, or the normal 
construction of our understanding of clinical infectious 
diseases. The problem now is that there is an incredible 
community which is producing technologies, an entrepreneurial 
community which is producing technologies for civilian peaceful 
use that involved the propagation of infectious agents and 
their byproducts that marry medicine and vaccines, biological 
insecticides, fermentation sciences, endermatic control 
systems, and basically countermeasure flocculents and 
environmental mediation systems all use critical elements that 
are downsized. Literally our 30 liter process fermenter weighs 
130 pounds, it is easy to transport with two people.
    So these systems are throughout Africa. We see them all the 
time, they are a normal part of agricultural pesticide 
generating systems.
    There is a key point that I need to also instill on this, 
it is that the biological technology revolution, if you compare 
it to your analogy of the computer revolution, it is not 1965, 
we are in the late 1980s and the speed is picking up. We are 
consistently spending a lot of our attention looking at the 
open source published literature, and it is outpacing the 
Department of Homeland Security's ability to do threat 
assessment. We can't read fast enough nor cross-train enough 
for the infectious disease or molecular biologists at the pace 
necessary to determine what is the threat.
    So we are just picking up the big stuff, and we are 
probably about a year behind. We have received several red 
alerts this month alone for publications that will show up next 
    And you mentioned, also, this interesting point about the 
suicide biological weaponeer. What is missing in our calculus, 
with the exception of the intelligence community's 
contribution, is terrorist intent and what they are willing to 
do. And think of our situation, when we were responsible for 
controlling the public health security of the homeland during 
2003 SARS epidemic, and we have an international airline en 
route from Hong Kong and we get an alert that there are two 
SARS contacts on board. So what do we do? If we have that 
alert, it is a normal public health problem, it is going to 
inconvenience every passenger on that jet while we do contact 
tracing, but imagine if the intent is different and there is no 
alert. Imagine how that changes the response among civilian 
groups. This has been modeled, not by the Americans, but by the 
Europeans, looking at the American economy and the impact on 
our financial centers. And for the reasons that are obvious in 
an open source forum, we can't go into the specifics, but it is 
    So an e-mail to The New York Times saying, hey, I have 
already been there and done my coughing versus somebody that 
you catch on the plane, these are very different responses to 
basically the same biological threat, the preexisting live fire 
and natural experience, someone with SARS coming to the U.S. 
that we pick up at the borders, versus someone that doesn't 
want you to know.
    Mr. Linder. Dr. Brent.
    Dr. Brent. I couldn't agree more. But to back off a bit, 
maybe there is other ways to approach the issue. So, for 
example, let's not think in terms of the technology. Your 
hacker, if it is a kind of slightly antisocial male teenager, 
may be deterred by a mandatory life imprisonment. If you let 
something out and it hurts people, it won't be funny, you won't 
get a slap on the wrist, you will go to jail for the rest of 
your life, and people would spit at you on the street when you 
are released, should you ever be released. So it is, you know, 
so we can begin to think what deterrents would look like for 
the different kinds of attackers. Deterrence is probably the 
hardest for members of the dedicated terrorist organization.
    Mr. Linder. Thank you. The time has expired.
    The Chair recognizes the gentleman from Washington State 
for 5 minutes.
    Mr. Dicks. Let me ask a question, and any of you can take a 
shot at this. Yesterday we had a hearing in another 
subcommittee on what we are doing in our BioShield program, and 
one of the things that was disturbing was that the Department 
of Homeland Security has only done four material threat 
assessments on--you talked about 60 possibilities here, only 
four of them have been done, and one of them on radiological 
hasn't been transferred over to the Department--or hasn't been 
accepted by Health and Human Services. So it seems as if we are 
not doing a very effective job of looking at vaccines or 
various countermeasures, whether they--how effective they would 
be is a question that has been raised here this morning.
    But have you looked at this, is this an area of grave 
concern, the slowness in which Homeland Security is reacting 
and doing these threat assessments.
    Dr. Alibek. Thank you. It is very important in my opinion, 
a very interesting question. I have been watching what was 
going on in the field of biodefense for the last four or five 
days after we heard the anthrax attack, and I noticed that many 
things have been done correctly, but at the same time, I see 
big holes in our preparedness for biodefense.
    And BioShield program was a very good program, good 
program, let me say, by its intent; but you know, when we came, 
let me say, to the evolution of this problem, we started 
noticing that we still have huge numbers of issues that are 
unresolved. And our problem actually exists on two levels. 
First level is just to understand the reality of one another 
type of threat. First to understand what kind of threat we 
should consider as most and least of threats at this point in 
time, for example, just in terms of types of the pathogens and 
types of biological weapons.
    Second, what would be the most probable way of deploying 
biological agents? We need to know there are very many 
different ways to deploy biological agents.
    Third, what kind of consequences would you expect from each 
type of threat? We should not use something like, say, in the 
case of anthrax attack, we are going to suffer having 1 million 
casualties. Of course, it doesn't work this way. We still, in a 
kind of nonscientific field, are saying just try in some cases 
to reduce the understanding of threat, in some cases to 
increase and make it kind of catastrophic.
    The situation is completely different. We haven't even 
started doing much to understand the differences. Let me give 
you a simple example, because in the field of military 
biotechnology and military biological weapons and biological 
weapons defense, we always analyzed the possible number of 
casualties based on a specific age and range of people--young 
adults, people between the 18 and 50 years old, in this case 
because everything was based on the use of biological weapons 
against troops. But now we have got a completely different 
    We have got a situation where we are going to have a big 
number of children infected with biological agents; we are 
going to have a big number of elderly people. This is the most 
vulnerable population, and the level of threat posed by 
biological weapons to these people is much more grave than when 
we talk about young adult populations.
    Just take a look at a simple example. A lady could die in 
Connecticut. She was 94 years old. It was obvious the 
infectious dose for this lady was much, much lower. She didn't 
require 10,000 to 20,000 spores to get infected. This is one of 
the examples, and we have dozens of areas we haven't started to 
    Mr. Dicks. So you are concerned we are not reacting and 
coming up with various strategies?
    Dr. Alibek. In my opinion, what is going on at this point 
of time, we haven't identified all types of threats, we haven't 
identified all types of specific research we need to conduct; 
and, of course, based on this, we don't have appropriate 
treatment for all possible threats we are going to face.
    Mr. Dicks. Dr. Brent.
    Dr. Brent. Mr. Dicks, if I could, I think whatever good 
there is--and there is probably some good in enumerating 
possible threats and then detailing detailed responses to 
those--what good that has is coming to the end of its shelf 
life, if it hasn't already.
    So we should not call these things strategies, either; we 
should call them tactics. An individual defense against an 
individual thing is a tactic. So I would not think it is a good 
use of time, personally, for the Department of Homeland 
Security to list 100 threats.
    Mr. Dicks. But they can't spend any money out of the 
biological fund, out of the bioweapons fund, until they have 
done a material threat assessment.
    Dr. Brent. Understood, sir.
    Mr. Dicks. So the HHS says, I am sorry, we can't fund you, 
Mr. Pharmaceutical Company or small firm, to develop a 
countermeasure, because the Department of Homeland Security has 
not done its material threat assessment.
    I don't think Congress intended to hold up everything to 
come up with some comprehensive document, and they have only 
touched on four areas out of 60 possibilities that you have 
discussed here today.
    Doctor, do you have anything you want to add?
    Dr. Callahan. I am intimately involved with the material 
threat assessments and can tell you about their benefits and 
their lessons. The key point here though is, if you step back 
and look at it the way our former enemy looks at it, each of 
these strategies is easy to defeat. We have vaccine-evading 
biological weapons. We have detector-evading biological 
munitions. These systems are currentlySec. 
    Mr. Dicks. So do we do nothing?
    Dr. Callahan. Negative. What happens is, there needs to be 
a paradigm shift with our approach to the problem.
    Dr. Alibek actually has worked and has expertise in 
nonspecific immunomodulators, the way you enhance immune 
response in a way that will bolster nonspecific immunity.
    It is absolutely critical to understand that you might not 
get anthrax, you might get something that is anthrax-like. It 
has the guts and the payload of the anthrax bacillus put inside 
another spore. It will defeat our public health surveillance 
capability because it won't grow on the right plates in our 
reference labs. It will defeat the clinical diagnostic criteria 
because it may not show up correctly in the hospital labs, and 
it will present, clinically, differences so that you don't get 
necrotic skin lesions in the injuries.
    So, again, we need to sort of step back and think of an 
integrated approach that involves all elements of our 
scientific discipline, spanning molecular biology, but 
certainly more terrorist intent and understanding the force and 
futures that modulate the strategic thinking to make these 
offensive agents.
    They are agents of terrorism. They want to get away with 
the crime, and they also want to be culpable and say, look what 
we did to you.
    Mr. Dicks. But is anybody doing that actually?
    Dr. Callahan. Think of the subject matter that must have 
been convened by Homeland Security through DHHS in part. What 
happened is that we used an anthrax expert. We used a botulism 
expert. We used a tularemia expert. These people are mono-bug 
people. They have been working all their life with one agent 
and their ability to think like a terrorist in a Kandahar cave 
cannot be replicated by a well-resourced scientist in some 
major academic or biotechnology institution.
    We need to step back and produce a realistic premise for 
the force and features which influence these technologies in 
bringing them together for bad use. So we really need an 
integrated plan. The detectors need to not detect a single 
antigen on an anthrax spore, they need to detect difference in 
change, rapid amplitude escalations we need for the unknown. 
And quite frankly, this has a tremendous return for our public 
health preparedness for avian influenza and the as yet unknown 
infectious diseases that give me job security for next year. 
Nature is working for me.
    Mr. Linder. Your time has expired.
    The gentleman from Connecticut is recognized for 5 minutes.
    Mr. Shays. Thank you.
    One of the points I think you make, Dr. Callahan, is that 
one of the advantages you all have in biological warfare is you 
get everyday practice from Mother Nature; and unlike our 
defense for other types of threats, what we do for Mother 
Nature, we can then transfer in terms of what we ultimately do 
for someone who is manipulating the process.
    It points out, I will just make this observation, the most 
important thing we can do in this country is to have a 
capability to detect so we can prevent an attack. Consequence 
management, it is huge when it comes to biological warfare; it 
not as important, frankly, when it comes to even the horrific 
bombing that happened in London. But it points out the need to 
have the PATRIOT Act, the ability to get into these cells, the 
ability to know what they are thinking before they do it.
    Just an observation I want to put on the table.
    Dr. Alibek, I have been to some of your stomping grounds in 
Russia, and it is pretty frightening still to see biological 
agents that are in refrigerators with string and wax. And it is 
not to prevent someone from opening that refrigerator; it is 
just to know when they did it.
    Speaking about Mother Nature, and I want to know if this is 
true, I was told, as the permafrost melts, that there are 
biological agents that have been basically in a frozen state 
for years that may come to threaten us again.
    Is that hype or is that a possibility, particularly as it 
relates to animals?
    Dr. Alibek. Unfortunately, I participated in the first 
discussion we started in 1989 in terms of the possibility of 
finding the smallpox virus in permafrost. Unfortunately for us, 
what I would like to say is, one of the reasons why one of the 
scientific entities in the Soviet Union started the discussion 
was because of the possible threat that the United States would 
start accusing that facility in working with smallpox when the 
smallpox work was prohibited. The reason to create this story 
about permafrost and the possibility to find a viable virus was 
based on a desire to cover the actual work with the smallpox 
    Then it became--I have no idea at what point it became kind 
of a scientific entity and many scientific groups started 
visiting some locations. But I was a part of a very small 
meeting in 1989 with individuals involving the Deputy Minister 
of Health of Russia, the director of microbiology work and 
myself when I was--
    Mr. Shays. Give me the bottom line here.
    Dr. Alibek. The general idea was, we need to find some 
explanation to cover our work with the smallpox virus.
    Mr. Shays. One of the great organizations in the world, in 
my judgment, is the World Health Organization. They go 
anywhere. They have limited resources. I am just interested in 
knowing, do you feel that we could be using the World Health 
Organization better than we are using it today?
    Let me just start with you, Dr. Brent.
    The question is, can we be using the World Health 
Organization better than we are today?
    Dr. Brent. Certainly, sir. These things like the Centers 
for Disease Control and WHO, which is a little bit more of a 
paper-shuffling place, but not totally, these are like the fire 
department; we need every one of them we can get and we owe 
them our support.
    I would personally like to see a greatly beefed-up World 
Health Organization. The Centers for Disease Control has 
something called the EIS, the Epidemic Investigation Service, 
which is one of the most prestigious postings a young person 
who is interested in public health can have.
    The director of the WHO has called for a world EIS which 
would attract the best young people in the world. I think any 
support we can give them is money that is extremely well spent.
    Mr. Shays. When I went to Geneva a few years ago, and we 
said we wanted to have a meeting with the World Health 
Organization about biological warfare, the director basically 
said, well, they don't really get into that. This was a number 
of years ago. We said, well, we are coming anyway.
    We started to meet with people that he didn't even, 
frankly, know--this is a former director, didn't even know were 
involved in this effort. I thought that was rather curious.
    Let me just go to Dr. Callahan and I will come to you.
    Dr. Callahan. Things have changed at the WHO. They 
recognize their importance as an integrated group to be able to 
do offensive use biological threat mitigation because their 
representative countries include areas that are not often 
traveled by Americans specifically.
    Let me take you, as a practical example, to the benefits of 
the WHO versus agencies of the United States Government. During 
the SARS epidemic the CDC was deployed also to Hong Kong and to 
the Quandong Province in South China. I was on the WHO 
attachment, and I went to all the closed areas, and there were 
no other Americans permitted to go there.
    So this is a critical point, that in order to have--you 
need to be card carrying and integrated into the international 
agencies in order to be not deemed as, you know, a country of 
their concern. So the WHOs can be very critical, unless you 
have some excellent new talent in the WHO from the current 
administration who can continue to further this issue.
    Dr. Alibek. Just a couple of words. I have visited many 
countries, talked to many government officials, talked to many 
experts in the field of biological weapons defense in many 
countries, and what I noticed in many cases they try to acquire 
as much as possible information from the United States 
defensive program. They analyze our publications, they analyze 
what we do, they analyze our CDC efforts and so on and so 
    At this point in time, in my opinion, the international 
community is not involved appropriately in being a part of a 
kind of international biodefense effort. In my opinion, it is 
time to start a bigger international program, and maybe the WHO 
would be a good place to start the program.
    Mr. Shays. If I can respond to the chairman, Mr. Chairman, 
this might be one of the reports that we get out to encourage 
this. I would recommend to this committee we go visit the World 
Health Organization.
    Mr. Linder. We expect to do that. Thank you.
    The Chair recognizes the gentleman from Massachusetts for 5 
    Mr. Markey. Thank you, Mr. Chairman.
    Dr. Alibek, back in the fall of 2001, Mr. Shays and I had 
you in to testify to our nonproliferation task force on these 
issues, and you recommended if there was ever any anthrax 
attack, that the best prevention was to ion the mail, to make 
sure all mail was ioned.
    The next day, this complex was evacuated because of an 
anthrax attack and all of our mail is now irradiated. But you 
gave us a warning with 24 hours' notice that hit us.
    Now, Michal Freedhoff on my staff, she was actually in one 
of the rooms that was hit in the Longworth Building, and she 
wound up on Cipro for 2 months. But we very much appreciate 
your warning.
    My question to you would be, what else should we be worried 
about? Give us a scenario that we might be concerned about, 
attacking the Capitol or attacking some other facility in the 
United States.
    Dr. Alibek. First of all, thank you very much for 
remembering what I suggested.
    But it had a kind of downside, because immediately after I 
said this, CDC started blasting me, saying, never ion the mail, 
because it is going to result in the acceleration of anthrax 
spores. And I was kind of shocked because it was absolutely 
obvious that people who were concerned, they could do this, 
because it was absolutely obvious that spores could be killed 
quite easily.
    In my opinion, the lady who died in Connecticut, if she had 
had a chance to ion this mail, covering it with some piece of 
fabric, the probability was for her to be alive.
    Mr. Markey. Who attacked you at that time?
    Dr. Alibek. CDC.
    Mr. Markey. And what was their misperception?
    Dr. Alibek. It is always, when you put on the scale, two 
things. For example, okay, you ion mail and have got a lower 
probability to get infected, and you don't do this in the high 
probability. You have to choose.
    Mr. Markey. Give us a warning today. Give us something.
    Dr. Alibek. First of all, what I would like to say, of 
course, I don't want to be a kind of alarmist, but I strongly 
believe it is not a matter of if, it is a matter of when, when 
we are going to see the second attack. If you ask me what is 
the probability of using different pathogens in terms of the 
attack, in my opinion, anthrax will be again the weapon of 
    What kind of deployment? There are different scenarios. In 
this case, one of the probable cases--again, maybe anthrax--but 
the number of places to be mailed could be quite large.
    In this case, our preparedness should be based on several 
principles: first, fast identification, fast diagnosis, fast 
treatment of people and providing antibiotics as fast as 
    What is absolutely essential, just organize a visual 
monitoring system. Any person who is appearing with more or 
less obvious symptoms or suspected symptoms of anthrax should 
be treated immediately. It should not be discussion whether or 
not it is anthrax.
    In this case, one more thing: In my opinion, we need to pay 
attention to what DARPA is doing in the field of anthrax 
protection. In my opinion, DARPA is the most sophisticated 
entity at this point of time, and it knows what kind of 
research and what kind of development needs to be done in this 
field to protect against anthrax.
    If we are able to commercialize everything that is being 
paid and funded by DARPA, within in the next 2 or 3 years we 
are going to have three or four very good therapeutic measures, 
new vaccines, highly effective, fast-working vaccines. Second, 
antibiotics, existing and improved antibiotics for anthrax, we 
have very good approaches on specific antibodies to treat which 
could be used compared to antibiotic treatments and several 
other approaches.
    Mr. Markey. Let me go quickly to Dr. Brent, only because 
time is limited.
    Dr. Brent. I would like to echo Dr. Alibek's point that 
DARPA maybe is the most effective government agency right now 
able to prosecute kind of the applied research that is 
sometimes necessary. I would say, however, that if I am an 
adversary and I see there are four or five good anthrax 
countermeasures, I will not attack you with anthrax. So I don't 
know how useful it is to scenariolize.
    Mr. Markey. Dr. Callahan, do you think that we have 
adequate security around biohazard storage facilities in the 
United States?
    Dr. Callahan. Yes, I think they have dramatically improved 
in recent years, but they are easily circumvented by the novel 
engineering of a new agent. And getting a new anthrax strain 
out of Texas, South Dakota or Maine, we can have a few in about 
10 days.
    Mr. Markey. I thank each of you very much for your 
important work in this area. Thank you.
    Mr. Linder. The Chair recognizes the gentleman from 
Louisiana for 5 minutes.
    Mr. Jindal. Thank you, Mr. Chairman.
    In an earlier comment, I heard the panel, and just now, 
talk about these novel bioengineered agents that could be used 
in an attack that might circumvent our detection equipment, our 
treatment, our vaccines.
    My first question is, how easy would it be for a terrorist 
group--an individual agent as opposed to a state-sponsored 
group, how easy would it be for them to manufacture such an 
agent that would easily circumvent our defenses and our 
vaccines? Is that something that a terrorist group acting alone 
can do today, or is the technology diffuse enough that they 
could easily do this today?
    Dr. Brent. I am afraid it is, sir. There are tens of 
thousands of DNA synthesizers worldwide, and the kind of 
capital costs for a lab that you would use to, let's say, 
resynthesize a virus and get live virus out, it is probably a 
couple of million dollars, if that, $1 million worth of capital 
equipment. There are probably more than 1,000 research groups, 
more than 10,000 people with the kind of generalist training to 
do that.
    So is there any intersection between the people who know 
how to do it and the people who might want to do it? I can't 
answer that. Is it likely there will be such an intersection in 
the future? I believe there will be.
    Mr. Jindal. Given that--and I know the ultimate answer is 
obviously we would want to do all these things and we want to 
have an integrated approach, but given that answer, how would 
you allocate scarce resources? As you have to choose between 
hardening targets; as you have to choose between boosting 
generic, as you talked about, nonspecific immunity; as you 
think about developing new vaccines; as you think about new 
detection centers, how do you set priorities?
    Dr. Brent. Sir, if I can, flexible detection. We know we 
have been hit, this is what hit us. Agile response.
    Components of agile response now that could be gotten going 
quickly include things like being able to make prophylactic 
antibodies against a new agent. They may involve new phase 
therapies. There are ways to make vaccines quickly. There are 
ways to speed up drug discovery.
    There is a great amount of creativity within the biological 
community in the U.S. which is kind of up for that. So that 
would be the mantra.
    Mr. Jindal. I am sorry. Yes?
    Dr. Alibek. In my opinion, when we think about a bio 
threat, in addition to vaccine development, it is going to be a 
long shot to develop vaccines. We need to start working very 
hard in the field of developing immunomodulating preparations 
to modulate our immunity response. Because this is the way to 
create, let me say, a kind of broad spectrum of preparations 
capable for self-administration. This is first.
    Second, we need to begin to focus on our--in many cases, 
for viral and bacterial infections, for late-stage and 
therapeutic modalities and preparations, because, for example, 
you would talk about anthrax. The early stages of anthrax we 
can treat. As soon as the disease has come to the late stage, 
we have serious problems and these diseases are becoming 
incurable. We need to be put attention to this.
    In my opinion, what is absolutely essential, there are some 
new signs emerging now, that especially, probably, Dr. Brent 
could support. Recently they started developing a new science; 
the name of the science is bioinformatics. Bioinformatics 
actually allows us to develop, let me say, completely new 
principles for vaccines and, specifically, antibodies. This 
principle we call reverse vaccinology principle, meaning that 
we don't need any pathogen, we don't need to dissect the 
pathogen. What we can do is bioanalysis of genome and 
pathogenics of the pathogen; we can define specific targets. 
And actually, just recent data, emerging data, shows that 
actually it is maybe science fiction now, but it is a way to 
develop multipathogen vaccines and multipathogen antibodies.
    This is what I am saying for the first time in this 
audience, because this is just first ideas, and these ideas are 
feasible; and maybe if we start exploring these directions, in 
3 to 5 years we will be able to bring first vaccines that will 
be effective against three to five different pathogens, for 
example, anthrax and plague.
    Mr. Jindal. One final question. I am sorry to interrupt 
you, but our time is limited.
    Are there other countries, is there any other country out 
there that you see that is further along than we are in terms 
of equipping their public health sector, their emergency rooms? 
Is there anybody out there that is doing this better than we 
are today?
    Dr. Alibek. No. No. The United States is the most 
sophisticated country in this field.
    Mr. Dicks. But is it adequate?
    Dr. Alibek. It is the most sophisticated in the world. But 
when we talk about how much we can achieve, of course, we have 
a significant gap yet.
    Dr. Brent. Mr. Jindal, if I can go back to the flexible 
detection and response, let me say that is what you want to get 
going now, but at the same time you put in things like 
understanding how to gin up the human immune system. That is 
probably a 20-year kind of goal-directed research program to 
get to that.
    So you start doing both now, build your detector network, 
build your agile response, do what you can to conceptualize 
that system, but put the money into something that will pay off 
more properly in decades.
    Mr. Jindal. Thank you, Mr. Chairman.
    Mr. Linder. The Chair recognizes Dr. Christensen for 5 
    Mrs. Christensen. Thank you, Mr. Chairman.
    Just for the record, Mr. Alibek, when you responded to the 
gentleman from Massachusetts on what instructions you might 
give, I note that the instructions were around normal public 
health responses, something that we are stressing. I don't feel 
that we are adequately prepared in this country, and it is a 
point that many of us make over and over again.
    Let me ask a question about a bill that we had introduced 
last year and were planning to reintroduce again called Rapid 
Cures. I have always been concerned as we went through 
BioShield hearings last year that we were talking about 
preparing for agents and we had no clue as to what the 
biological agent might be, what form it might come in, whether 
it would respond to any of the things that we were spending all 
this money to create the countermeasures for. The Rapid Cures 
Act would help us to shorten the time if an agent came that we 
had not previously identified to developing a cure, a vaccine, 
and so forth.
    Would you suggest that in addition to research that would 
boost the general immunity and provide some general protection, 
that we pursue a course of trying to develop the time to 
develop countermeasures? Anyone can answer that.
    Dr. Alibek. You touched a very important topic. In my 
opinion, you are absolutely right when we talk about the 
BioShield program. The program actually is based on old 
traditional approaches, how we deal with these infectious 
diseases. We are talking about diagnostics systems, vaccines 
and therapeutics.
    What we need to do, in my opinion, first, we need to 
develop a new program, we need to analyze new and traditional 
novel approaches for protection development. We haven't started 
doing this work yet.
    Second, in addition to when we talk about specific 
modulation of immunity response, we are hearing very positive 
things. Let me say we allow the immune system to build its own 
defense while the victim is still alive.
    But what is important in this case, and this is one of the 
critical points, when we talk about many diseases, especially 
contagious diseases, we need to keep in mind two things. First, 
we need to save the life of the victim; second, to reduce the 
infectiousness, the contagiousness of this victim; and, third, 
we need to create immunity for the population.
    In this case, let me say, in order to solve all three 
problems, we need to develop some new preparations, and some 
preparations already exist. A person is becoming less 
contagious. We reduce the severity of this infection. This 
issue is important for bioterrorism events and for emerging 
infections, like the common avian flu.
    For example, we try to develop vaccines, but we don't pay 
attention to some other cultures. In many cases, we do two 
things: Either our victim survives or dies. In this case, if he 
or she survives this infection, it is much better than if this 
person dies. It is obvious.
    In this case, when we talk about modulating in a community, 
it is not an issue of saving lives, it is an issue of, first, 
increasing the probability of survival; second, reducing the 
contagiousness of this person; and, third, creating a kind of 
immunity population. In this case, we would be able to prevent 
an epidemic.
    In this case, this is just a short explanation that not all 
directions have we explored yet.
    Dr. Brent. Mrs. Christensen, not only is having anything 
that enables you to move more quickly from a new pathogen to a 
new drug a good thing, but I want to point out one consequence 
in addition to helping the defense.
    Anything that streamlines drug discovery cuts the cost. The 
cost is significant, the drug company might say $800 million, I 
might say $400 million, but it is a lot of money. Cut the time 
drastically, cut the cost drastically, and that enables things 
like the Wellcome Trust, foundations like that; now they can 
spend $40 million for a drug and use it in the developing 
    So national security and some of the other properties in 
the world go hand-in-hand.
    Dr. Callahan. I would comment only that the natural 
experience of facing a threat agent that you don't understand, 
we haven't done very well. If we think back about SARS, that 
was using 2003 technology. It was using some of the most 
resource-rich laboratories around the planet. It took 19 days 
to actually isolate the specific genera of the organism, and 
that came from an electronmicrograph of a patient's lung.
    By the time we returned to Hong Kong, there were 470 people 
on ventilators, and we were flying ventilators all around in 
Southeast Asia to try to shore up their health care capability, 
which, by the way, is a Western standard.
    So, to your first point, to mitigate against these events, 
an unknown threat agent, we are going to do poorly based on 
what our current success record has been with avian influenza 
in the past, orthopox viruses in the past, particularly the 
recent cow pox from several years ago, and SARS being a crystal 
clear example of our capability when put on the line.
    The second point is, DARPA has been mentioned, as has BII. 
These two extremes of resources have not been capitalized on in 
a major way. The reason why I will suggest to you that we need 
a closer attention here to support the Homeland Security effort 
is because BII in Russia is looking at countermeasures that 
haven't even been considered by the Western cognition, by the 
American sort of way of thinking. Classic antibiotics and 
vaccines for one bug, nonspecific immune enhancers and 
bolstering the immunity of a population have some principles in 
natural history and, of course, military history.
    The last and final point is that DARPA is certainly one of 
the convening arms for these technologies and needs to be 
supported with subject matter expertise, it needs to be read in 
and integrated.
    This just raises a critical concern because imagine being 
that biotechnology company that you are trying to entice with 
biodefense dollars, and yet your antigen, the thing in the bug 
that you are trying to block, needs to be classified because it 
is so easy to circumvent it if you are a terrorist. So that is 
not the way that science and certainly not the way basic 
science infectious disease has operated.
    So these are some of the dilemmas which are procedural, 
which are policy relevant and involve all the basic science 
community, which is intending to publish, as well as our 
intelligence and medical intelligence communities.
    Thank you.
    Mr. Linder. The Chair recognizes the gentleman from 
Mississippi for 5 minutes.
    Mr. Thompson. Thank you very much, Mr. Chairman.
    I guess, as I listen to the testimony, I am real concerned 
as to whether or not the approach that we are taking as a 
country and as a committee is the proper approach.
    We heard testimony yesterday on BioShield, and I am 
wondering, first, are we approaching BioShield in a manner that 
the scientific community supports, or are we just putting money 
out there and people are chasing the money? I hope you 
understand what I am saying.
    I will take any answer.
    Dr. Callahan. Clearly, these are large appropriations and 
large allocations, and they entice a lot of competitive grants. 
The trouble is that the best of the experts are oftentimes 
individual scientists in small laboratories and they are 
largely disengaged from the system.
    The second point is, there is a huge resource in the 
biotechnology-for-profit sector. The best of the minds get 
bought away from the academic centers. As opposed to the DHS 
effort, it capitalizes heavily on the national labs, usually 
driven by the need for security clearances and to put big 
fences around things. The trouble is that those shops tend to 
be single shops and they try to keep everybody else out.
    If we are truly mission driven and we are truly trying to 
get the best of the talent at the table, we need to step back a 
little bit to a great review using the best of our review 
capabilities out of NIAID, CDC, DARPA specifically, and 
USAMRID, to find these agents that can really help us with 
    Dr. Brent. Just that BioShield may be necessary, but not 
sufficient, or at least some parts of it might not be. It is 
not a bad thing that there is now enough smallpox vaccine to 
vaccinate everybody in the United States. But it is limited 
after that.
    Then I am going to just cite what Dr. Callahan said. We 
need to engage. There is all the talent here to make the 
defense work, but it needs to be engaged perhaps by 
complementary mechanisms.
    Dr. Alibek. Unfortunately, I don't want to be over-
critical. In 1998 or 1999 when I testified first on the Hill, I 
said if we don't develop in the beginning our concept of 
biodefense and agree to develop a good threat assessment in 
terms of bioterrorism, we are going to suffer and we will never 
have any appropriate defense. This suggestion, of course, my 
testimony could be found in the archives.
    Now, 7 years later, we are still there. I am not saying we 
were not able to develop a better biodefense. Yes, we did. But 
we still suffer because, in many cases, what I notice--and it 
looks like this is what you actually asked--in many cases, when 
some solicitation appears, a huge number of companies start 
applying for these solicitations, in many cases having no 
knowledge in the field.
    What they do in this case, they hire some consultants, they 
put a good list of people who would work for this work. They 
get funding from the government. Then they throw away these 
consultants and start doing this work. In this case, we 
shouldn't expect any kind of good results from this type of 
    In this case, in my opinion, a national register, for 
example, of the most effective biodefense entities, we need to 
establish it, and we need to establish some kind of entity to 
determine what we need first for the country.
    Mr. Thompson. I am going to get back to you, Dr. Brent.
    One of the things, Mr. Chairman, I think at some point we 
are going to have to look at whether or not we are moving along 
in the right direction. We are spending an awful lot of money. 
But if we are spending money on a Model T instead of the latest 
and best science, we are just spending money.
    Mr. Linder. If the gentleman would yield for a moment, it 
gets back to the point that I keep repeating, that there are a 
finite number of terrorists and an infinite number of ways to 
hurt us, and we ought to be looking for people instead of 
    The other point I want to make is, we heard testimony 
yesterday that HHS gave a sole-source contract for a vaccine to 
a company that had never produced the vaccine. I just think 
that that is not a sound business practice. Here we are a year 
from having the vaccine brought to us, and we sole-sourced it. 
We didn't put it on the market. We went out and bought a 
temporary supply of vaccine from another company.
    I am just concerned that with all this money out with 
BioShield and people responding sometimes to RFPs, but 
sometimes just sole-sourcing of the product, that we are still 
not doing what is in the best interests of this country.
    Dr. Brent?
    Dr. Brent. Sir, I would be inclined to cut people a little 
slack on the procurement. There are only six companies or so 
that even have standing in the vaccine business now, and they 
are scrambling. So my inclination would be to cut some slack on 
things like sole-source procurement, but to recognize that the 
procurement model is not alone going to get us through.
    We need technical development programs tantamount to kind 
of radar and ICBMs during the Cold War. You can't just go out 
and shop for that; you have to begin to think how to configure 
the right defense complex.
    Mr. Thompson. So you sole-source it to somebody who hasn't 
done it?
    Dr. Brent. In the first year maybe you cut them a little 
    Mr. Dicks. If the gentleman would yield for a second, are 
you suggesting that we should do R&D, or do like the Defense 
Department does, spend some money on research and development 
before we go out and try to buy the finished product?
    Dr. Callahan. The critical issue, I think, is to test the 
system for its responsiveness. It is research fleet-afoot. We 
can do that again with natural experiments. We are doing it 
with avian influenza at this time by producing an integrated 
surveillance, ironically, in using former Russian biological 
weapons scientists who are capturing avian flu as it migrates 
    The second point is looking at the case studies from SARS 
and West Nile virus. We are doing really badly, and these are 
diseases that, in hindsight, are actually fairly easy to 
subtype. These are practice experiments, they are live-fire 
exercises, they demand capital investment; and everybody is 
working hard, because they know the threat is real. It is not a 
scenario, like TOPOFF or another event. It is a real event; 
people are dying and are on ventilators.
    Dr. Alibek. I talked to both companies, BioPort and VaxGen. 
Both of them, let me say, present the same vaccine, actually, 
based on different technologies. When I talked to 
representatives of these companies, they tried to convince that 
their vaccine is the best one, but when you analyze it, of 
course--let me put it this way.
    I haven't seen anything with the VaxGen vaccine which would 
make this vaccine more appropriate than the existing vaccine. 
In this case, of course, it is not my business; it is the 
business of DHHS. But, for me, it is very difficult to 
comprehend why we are trying to buy a vaccine from a company 
which hasn't proven--which doesn't have a proven record yet, 
instead of, let me say, promoting the existing vaccine.
    I am not supportive of this company, Emerging BioSolutions, 
or BioPort. I know they have got problems. But when we put them 
on the same scale, two different vaccines, I see no big 
    What needs to be done, in my opinion, of course, we try to 
spend about $1 billion to buy this vaccine. Why, for example, 
we don't support at this point of time--when we don't have a 
new vaccine, we support this production, but at the same time 
we develop new regulations, new requirements for new vaccines, 
second generation vaccines, which would be working much better 
than existing vaccines.
    In my opinion, this is the way to go, because when you have 
two different vaccines--which actually are the same, in my 
opinion, of course--it makes no sense to me.
    Mr. Linder. The gentleman's time has expired.
    Ms. Norton is recognized for 5 minutes.
    Ms. Norton. Thank you, Mr. Chairman. I apologize that 
another hearing kept me away from hearing all of the testimony. 
I understand that before I came in there was some mention of 
something that is of special interest to me, that perhaps the 
most likely biometrics attack would be an anthrax attack, an 
attack of the kind we have already had, the one kind of attack 
we know something about.
    The one place that is protected to any degree, of course, 
is the Capitol and the Federal agencies in the event of an 
anthrax attack. Whether anthrax or some other substance, I 
think the public is far more focused on what would happen if 
there were an attack in a closed system like a subway or a bus, 
the kind we have just had in London.
    I just reintroduced a bill for ordinary security protection 
in public transportation systems and rail. That is just the 
ordinary stuff, cameras and so forth. But I think there is far 
more concern about some kind of bioweapons attack, which some 
might regard as easier to do, coordinated London-style.
    I am wondering what you think the consequences of such a 
use, some kind of biological substance, would be in a subway 
system like here in the District of Columbia or in New York.
    Also I am interested in what I understand was some mention 
of broad spectrum antibiotics. Whoever would be best informed 
on those subjects.
    Dr. Callahan. I think that you are hitting a critical 
point, which is that fairly moderate efficiency biological 
weapons gain efficiency when kept contained. They also, if we 
model HVAC systems for indoor air attack and HVAC systems such 
as serving this room, allow for remote delivery of an agent, 
allowing chances for folks to get away.
    The third point, which is very much in evidence in the 
community here, is that buildings tend to house a lot of the 
same type of people, and if those are desirable targets, be it 
military personnel, government officials, school kids, whoever, 
you get a higher return. This is actually modern military 
strategy, it falls into the CARVER-SHOCK analysis.
    So indoor air attack is absolutely critical. The detectors 
are woefully inadequate and the currently deployed ones all 
have device-defeat capability with currently existing 
technology. That is a fact.
    Ms. Norton. Well, if that happened, let us say, in a subway 
car, would you end up shutting down your entire subway system 
for a long time just to decontaminate it? What would be the 
    Dr. Callahan. The area denial consequences are vast. The 
current projections right now, for example, if we have another 
SARS event on an airplane, because that happened in Southeast 
Asia, is, you don't decontaminate the plane, you scrap it.
    With subway systems, the amount of effort that would be 
required to decontaminate those systems to allow for the return 
of public confidence in those systems is so extraordinary, you 
might call upon the cost of the Brentwood postal facility decon 
as an example for that.
    Ms. Norton. Yes.
    Dr. Brent. Ms. Norton, the reference to the anthrax attack 
may be fighting the last war. It may not be. I can't say that. 
But it implies an attack that is confined in space. It is an 
event. It happens at a given time. It infects a given place.
    Not all the threats that are conceivable are of that kind. 
There can be just contagious disease, in which case the 
consequences are catastrophic and the task of defending against 
them is harder even than what you said.
    Ms. Norton. And I take it, we don't have any defense at the 
moment against such an attack in a closed system such as a bus 
or subway.
    Dr. Brent. Well, with SARS, no.
    Dr. Callahan. No, and the key point is the migration. 
Remember, these are not conventional high explosive events, 
neither are they really dirty bombs; but these materials, 
particularly if infectious, but also in the case of anthrax 
spores, they are going to migrate. So your contaminated zone, 
how big a yellow circle you draw around the District of 
Columbia, the city of Boston or New York, gets bigger and 
bigger over time. And if these are infected patients, a 
contagious disease such as killer flu or another agent like 
that, then your problems have a tremendous magnitude.
    Ms. Norton. So I take it the problem of infection is even 
worse than the problem of death.
    Dr. Callahan. Oh, absolutely. It is how big a ring you need 
to treat. And also there are huge consequences to treatment. 
There are several people in this room who have been on Cipro 
for 2 months. That had a burden to them, and for clinical 
infectious disease, we are realizing it now.
    Dr. Alibek. Just again a couple of words. I still believe--
maybe not everybody is going to support this--anthrax at this 
point of time is the biggest challenge and the biggest threat 
for us. Why I am saying this? I know anthrax firsthand. I know 
it is a very stable pathogen. It can be manufactured easily. It 
produces very severe effects. It could cause contamination. All 
parameters, unfortunately, are saying that anthrax is still a 
big threat.
    The issue is this, of course: Even if we discuss that if we 
develop good protection against anthrax, somebody would use 
something else, it is absolutely correct. But what we need to 
do, in my opinion, we need to focus on anthrax for many points.
    Just imagine a situation, an anthrax attack in our subway 
system. In this case, even just--of course, it is very hard to 
say how many casualties we are going to have. It depends on 
many factors, the severity of the attack, the amount dispersed, 
how soon was the attack, how fast we organize treatment and so 
on and so forth.
    But one of the biggest problems is going to be the full 
contamination of the entire Metro system. In this case, can we 
imagine this: Washington, D.C. with a nonfunctional Metro 
system. In this case, people wouldn't go visit the Metro system 
until we say the entire system is absolutely decontaminated.
    In this case, in addition to all these challenges, we are 
going to face the challenge for weeks or for months to just do 
the decontamination work. We can imagine what kind of chaotic 
situation we are going to have in Washington, D.C.
    That is why, in my opinion, when we talk about anthrax--I 
talked to the Department of Transportation, I discussed these 
issues with them. We need to develop--in my opinion, the 
problem we should be focusing on specifically on anthrax as the 
first pathogen we need to take off the table.
    Mr. Linder. The time of the gentlelady has expired.
    Would you be willing to sit through a few more questions? I 
have a couple of questions.
    Dr. Callahan, you talked about the 19 studies that have 
come out this year, talking about the migration and movement of 
these facilities. Would you expand on that?
    Dr. Callahan. Can you restate the question?
    Mr. Linder. You talked earlier about 19 studies you read 
this year about the movement of some of these labs and the 
migration of the expertise.
    Dr. Callahan. Yes, and the tragedy is how difficult it is 
to find a forum outside of Homeland Security and the 
Intelligence Community to share that information. The reports 
come in because they shore up the capability of remotely 
operating terrorists, specifically for small-scale 
    Most of the reports have to do with the new methodology 
which has been proposed by a well-intentioned group which is 
thinking about another problem, the preservation of genomic 
material being a specific example. Then what happens is, they 
go ahead and put it out there, and because of the lack of 
review at the international level and the fact that many of 
these journals are international and Internet-based, that 
allows the information to get out there.
    So there is no single group in the United States at this 
time that is doing formalized reviews, and this is an excellent 
space for the Homeland Security to convene expertise here. The 
closest is the National Bioterrorism Analysis and 
Countermeasures Center, which is a part of Homeland Security, 
based at Fort Detrick.
    But that makes use of highly specific basic scientists. 
Unfortunately, the real space is the convening of all these 
disciplines to help determine the threat waiting, and those 
people are remarkably rare. We have to grow them, in fact.
    Mr. Linder. Did you want to comment on that?
    Dr. Brent. I concur.
    Mr. Linder. You also mentioned several times avian flu. Is 
there a way you think that terrorists could expand on that?
    Dr. Callahan. Yes. We find avian influenza disquieting in 
the extreme, and the reasons are basically that most of the 
work is already being done for the terrorists. The second point 
is that the number of countries that are demonstrating cases of 
avian influenza in humans are increasing by the month, 
effectively, as are the number of cases within each of those 
    Several of those countries have become more difficult to 
work with in recent history because these are economically 
relevant diseases and can stress their economies greatly. I 
call your attention to the reports on 2003 SARS and its impact 
on the Government of China's economy.
    But think also about DPRK. Avian influenza is found on both 
sides of DPRK, and we know it migrates on the wings of birds, 
so you can bet that North Korea has a critical threat to its 
protein stocks. Since one out of three chickens eaten on the 
planet is grown, raised and eaten in China, including in these 
countries, it is a big deal.
    So what do we do about avian influenza? The first thing is, 
we don't know exactly what the final humanized version of avian 
influenza is going to be like. We do have important 
countermeasures from a chemotherapeutic standpoint. These are 
the new inhibitors, drugs that have been on the market for some 
period of time; and it would be technically more difficult--not 
impossible, but more difficult--to clone out or negatively 
select out the resistance of those features.
    So investing in this new class of drug, broadening its 
capability and then, most critically, investing in a fast 
through-put vaccine capability to make this system, to make 
this use of a threat agent less viable, is an appropriate 
investment of resources; and it fits our routine public health 
needs as well as our needs in biodefense.
    Mr. Linder. Thank you.
    Mr. Dicks?
    Mr. Dicks. Thank you.
    Just following up on that, Mr. Chairman, you said prepare a 
quick vaccine preparation capability. Is that what you are 
    Dr. Callahan. Yes.
    Mr. Dicks. Talk about that a little bit. Some of these 
vaccines cost $800 million, or they are very expensive.
    Dr. Callahan. Yes. It is interesting that the production 
cost is actually much smaller. Remember, the majority of these 
vaccines have never been tested with exposure in humans.
    Mr. Linder. If the gentleman will yield, I think Dr. Brent 
said 400 is closer to it.
    Dr. Brent. That is for a small molecule drug, sir.
    Mr. Linder. But when the pharmaceutical firms tell us $800 
million, they are also considering opportunity costs. If they 
spend $400 million for a drug, what could they have made if 
they had invested it elsewhere? Would they have doubled their 
     Mr. Dicks. How much does it cost to have this kind of a 
capability? Do we have it now?
    Dr. Brent. The vaccine--not to bore you with the kind of 
decline of the vaccine industry in the U.S. over the past 40 
years, but the number of companies has contracted. They are 
hunkered down by threats of product liability lawsuits; cost of 
development has gone up, et cetera, at the same time that the 
technical capabilities for making new vaccines have exploded.
    Recombinant DNA taught us how to make flu vaccine that 
would be pretty good within a week or two of sequencing the 
latest flu strain. We don't have that production capability, we 
don't have the kind of precertified and good to go.
    There are other more experimental things, like DNA 
vaccines. I personally believe that a prudent defense strategy 
in the United States would have several kinds of pretty good 
vaccine capabilities stacked up in addition to the ones--
    Mr. Dicks. Should that be done at HHS? Where is it done?
    Dr. Brent. It should be done by creation of a government 
bioindustrial complex, and likely it should be orchestrated by 
the government, but done by the private sector, which is 
somewhat different from the pharmaceutical biotech private 
sector that exists.
    Dr. Callahan. And critically important to national health 
security is that that be American-owned. Our current vaccines 
are purchased overseas, and we know from working with our close 
European partners that vaccines purchased by the U.S. were not 
available for U.S. use when our own vaccines for the past H3N2 
season became compromised with a contaminant.
    In other words, we own vaccines manufactured in offshore 
locations that can be commandeered by the host countries to 
meet their own emergency public health needs. So that is a 
critical point.
    Mr. Dicks. But who should take the lead on this? HHS?
    Dr. Callahan. HHS is absolutely the source for basic 
science expertise. I believe that the biotechnology sector is 
going to advance this, because their incentives are greater and 
they think very much outside of the box.
    Mr. Dicks. The companies themselves?
    Dr. Callahan. The companies.
    Mr. Dicks. They are going to need some incentive from the 
government to do this, right?
    Dr. Callahan. Indeed, the process for which that could be 
executed is not completely clear at this time.
    Mr. Dicks. Since we have not done these material threat 
assessments and we have this money left in project BioShield, 
the $5.6 billion of which only a small part has been committed, 
should we start using that money? Would that be a possible 
    Dr. Callahan. Creating models that mimic the threat for 
which a technology user and a technology response like a 
company can respond to are absolutely valid ways of testing the 
system, absolutely valid.
    The last point I will just mention is computational. Dr. 
Alibek has talked about this. We can predict mutations that can 
arise in an agent. This involves computational science, which 
is a fairly recent intersect with biotechnology and molecular 
    But we can take flu and understand the permutations in its 
genome that will happen over time and anticipate in advance our 
vaccines needs. It will not be in production, which commands 
huge investment in our resources, but it can be there as a 
prototype, as a seedling that is ready to go.
    The last point is that the $800 million--which Dr. Brent 
and others can talk about; we all consult with biotechnology 
companies so we understand their perspective--is that, A, they 
are not getting good guidance; B, they find that the BAAs and 
the allocations and appropriations are not very linear for them 
and easy to decipher; and, C, they don't have the capability to 
test their system and to argue in the marketplace that they 
have the best deal for the government to choose. And the 
discussion of sole-source appropriations, I think, is pertinent 
here as well.
    Mr. Dicks. Dr. Brent?
    Dr. Brent. Mr. Dicks, where the home for this thing is 
within the government almost doesn't matter so much to me from 
the outside. This will be with us for many decades. It is 
important that there be a centralized science and technology 
development apparatus which is able to orchestrate, a la the 
way that DARPA and the other agencies within the Defense 
Department do.
    Mr. Dicks. Should that be at HHS, NIH, CDC? Where would you 
put it?
    Dr. Brent. I would put it either in DHS personally or in 
some new entity. There needs to be DARPA-like technology 
    Mr. Dicks. The reason DHS I think is suspect is because 
they have not handled this material threat assessment thing 
very effectively, and some people feel there is--Chertoff is 
going to come out today and say we need a doctor, somebody with 
medical and the kind of training you have, in the Department of 
Homeland Security, to provide a person who understands all of 
these kinds of issues and how this should work, which we don't 
have at this juncture.
    Dr. Brent. That is a start, sir.
    Mr. Dicks. Well, thank you.
    Dr. Alibek. Unfortunately, I must say this: What we haven't 
done yet, we haven't developed a good committee or group of 
very, I would say, respected people, knowledgeable in the field 
of biological weapons threat.
    Unfortunately again, many people try to pretend that they 
know biological weapons threats. But in many cases we have, I 
would say, a number of people inside the United States who have 
firsthand knowledge of the field of biological weapon threat, 
and they understand what kind of agents could be the more 
threatening agents and what types of threats we need to handle.
    In this case, you establish such a panel, working either 
for Congress or any kind of agency, and they will determine 
first, for example, the level of threat coming from different 
pathogens. We do have many, many projects of this type.
    But when we see that kind of standard, not very 
comprehensive, not very sophisticated knowledge, if we want to 
start this work, we need to stop for a second, we need to do 
this work. It is not going to take much time, 3 months, 6 
months, and it could be done.
    Next, after we define the threat, we will start working 
with a bigger group of scientists and figure out what kind of 
technologies we have available to mitigate each type of threat, 
specific technologies, and what kind of prospective 
technologies we have at different stages of development to meet 
prospective threats.
    As soon as we have got this done, in my opinion the picture 
is becoming absolutely clear. But at some point--we discussed 
this in 1998, in 2000, immediately after 2001-2002, and now it 
is 2005 and already 8 years, and we still aren't there.
     Mr. Linder. Mr. Shays, do you wish to inquire further?
    Mr. Shays. Thank you very much. This is a great panel. 
Frankly, this is a terrific committee. If you had said 6 years 
ago that we would be in the Ways and Means Committee Room 
talking about the issues that we are talking about, I look at 
these old pictures of former chairmen and I think this is a 
strange world we are in.
    But the one thing that is fairly clear to me is, the 
technology is going to continue to advance, and I use that with 
quotes, so that less sophisticated operatives will be able to 
do horrific things.
    One of the hearings that I had in my National Security 
Subcommittee before September 11 that blew me away was a noted 
doctor of a major medical magazine, and he ended the hearing by 
saying, ``My biggest concern is that a small group of dedicated 
scientists will be able to create an altered biological agent 
that could wipe out humanity as we know it.''
    That is why I think, Mr. Chairman, the work that you are 
doing is essential. The likelihood of this happening is smaller 
than a conventional attack; the consequences, though, are 
    I want to know if I should dispose quickly of this issue. 
In 1972, the U.S. and more than 100 nations signed a Biological 
and Toxin Weapons Convention, which basically barred possession 
of deadly biological agents except for defense research. 
However, and this is the issue, no mechanism was set up to make 
sure people abided by it; and the city inspector I saw in 
Russia proved that no one was paying attention to it.
    Do you think it is conceivable that we will be able to have 
a convention process that will enable us to look at biological 
sites and be somewhat assured that bad things are not 
happening, or do you think it is almost pointless because folks 
can be in garages and elsewhere?
    Nodding heads will not be on the record here. I will start 
with you, Dr. Brent. What is the answer?
    Dr. Brent. I think that having conventions that track down 
technologies and look for particular things might well give a 
false sense of security, so I don't think you can do it like 
    I think there is a great deal of value to be had in not 
only criminalizing, but stigmatizing, maybe even hyper-
stigmatizing, deliberate research in biological weapons in the 
U.S. and worldwide, the idea being to create a moral climate in 
which if somebody down the hall was doing something sinister 
and you were worried about it, you might drop a dime to your 
local enforcement agency.
    So I think there is some value in conventions prohibiting 
things. I don't think there is going to be security in 
surveilling sites and stuff.
    Mr. Shays. Thank you.
    Dr. Alibek. I would absolutely agree in my opinion, because 
terrorist groups, they don't sign agreements. Of course, 
whatever we decide, they are not going to follow the rules of 
    Mr. Shays. They are not going to tell us where they are 
making it either.
    Dr. Alibek. At the same time, what I would like to say, 
what we are missing now when we talk about a threat is coming, 
what kind of threat and so on and so forth, and what we can do 
about this, in my opinion there is one more important piece 
missing, and this piece is so essential in my opinion, if we 
don't pay strong attention to this issue, we are going to 
suffer again.
    Dr. Alibek. Because what we don't have, for example, in the 
field of any kind of discipline--science, technology--we have 
got special, let me say, programs; universities which are 
teaching, let me say, special extras--
    Mr. Shays. What is your bottom-line point? What is the 
point you want to make?
    Dr. Alibek. What I want like to say, we need to establish a 
national educational program for biodefense extras in the field 
of nonproliferation, counterterrorism, investigation--
    Mr. Shays. So your point is that in the United States we 
don't have enough qualified people going into this area?
    Dr. Alibek. We don't have enough qualified people who would 
be able, let me say, to deal with the more, let me say, 
sophisticated threat.
    Mr. Shays. Let me go to you, Dr. Callahan.
    Dr. Callahan. My only two points in response to that is, 
with regard to the treaties, we can use all of our other 
benefits and attributes of the United States, such as our 
health care, to get out there and to penetrate into the 
countries of concern. Using Russia as a specific example, is 
that we are in almost all the nooks and crannies of the open 
programs in the Ministry of Health, kept out only of the 
Ministry of Defense programs and a couple little shops out in 
the far east of Russia.
    The key point is that those have been driven by strong 
incentives for sustainable value and economic development, 
quite frankly, because we bring Merck and Pfizer with us rather 
than the Department of Defense. We bring money and we bring 
autonomy, and we bring the ability for them to work in a 
private market.
    It is that second group that you talked about, the Ted 
Kaczynski bioweaponeer, someone in the basement who is 
supported by novel technologies, who is going to be the more 
dramatic of the two and make a loud bang in a small place. That 
can happen behind national lines in university laboratories, 
and then there are smaller biotech shops. And that is where the 
intelligence community needs to intersect with the biodefense 
community to provide steering and guidance, because those 
communities remain largely disengaged because of the need for 
clearances and the need to keep your subject matter experts 
operating in open source. Some mechanisms to get a large number 
of people informed for informed research and development to 
mitigate against these threats is absolutely critical.
    Mr. Shays. Thank you. Thank you, Mr. Chairman
    Mr. Linder. Does Mr. Thompson wish to inquire?
    Mr. Thompson. Yes, Mr. Chairman. And let me say that I am 
absolutely appreciative of the three gentlemen and their 
testimony. It has been quite enlightening, and I do appreciate 
    One thing I would like to kind of get your individual 
thoughts on, everybody pretty much agrees anthrax is kind of 
number one on the list, or something like that--
    Mr. Shays. No. You have got a shaking head here.
    Mr. Thompson. Well, all right. Then give me number one and 
number two, and then I will ask for number three.
    Mr. Shays. Yeah, I want to know that, too.
    Mr. Thompson. So if it is not--
    Dr. Callahan. These are probability estimates. And we are 
all products of our experience in a formal weapons program, in 
molecular biology and technology, and in the remote developing 
countries where you see these diseases all the time.
    I do actually put anthrax up there because of the technical 
challenges; you don't have to store it, it lives forever, and 
you don't have to feed it. It is also easy to get because it is 
found in almost every neotropical country that is available. So 
I do actually put anthrax up there. And there is also a great 
cache with it right now; it is easy to recognize in all of the 
cultures in the world, including terrorist cultures. And also 
it has huge public health importance in countries of concern 
because it kills a lot of meat stock. It is a huge pathogen in 
veterinarian populations. It happens in areas there.
    After that, I am going to go to avian influenza. And this 
is another wild-type agent, meaning naturally occurring agent, 
which could be commandeered and used for ill purposes. And it 
is a great example where you will have tremendous impact in 
undermining of confidence, for which you do not have an 
effective disease, and for which you will have guaranteed 
contagion and transmission, so that would be number two.
    Third would be the moderately engineered pathogens, those 
that are hardened to survive in sunlight and survive in low-
halogen environments. They make them difficult to decon.
    And after that, we are going to get into much more 
complicated agents, and then go back to those zoological 
pathogens, such as Glanders and those that will affect your 
agriculture reserves and meat stocks.
    Dr. Brent. I think Dr. Callahan just made the key point, 
which is that in my mind a potential adversary might go with 
what they knew and felt comfortable with. So Dr. Callahan can 
run around the world picking clinical isolates out of disease 
outbreaks and prioritize things that way. Dr. Alibek worked in 
a successful Soviet program which had anthrax as one of its 
major weapons.
    If I were, you know, doing things, I might do what I know. 
I might resynthesize SARS, put a toxin on it, infect myself, 
and cough on people. I don't know that it is worth while to 
prioritize the risk if every expert who imagines an attack 
imagines things through the prism of what they would find to be 
easy and devastating.
    Dr. Alibek. What I would like to say, yes, when we talk 
about terrorist groups, in many cases they have no scientific 
ability or technological sophistication, for example, just to 
work on 5, 10, 15 different pathogens and to choose the best 
one just to deploy.
    In this case, it is the issue of what they can have access 
to or what they can achieve and so on and so forth. But 
unfortunately, even if we proceed from this point, 
unfortunately anthrax is becoming first. And too, the ability, 
technological and so forth, anthrax is there. In this case, 
whether or not we like it, anthrax is the weapon of choice, and 
we need to get rid of anthrax. I am not saying that we 
shouldn't prepare for other agents. There is a huge network of 
agents and we need to have preparation, but in terms of 
probability, actual ability, anthrax is taking place number 
    Mr. Thompson. Thank you, Mr. Chairman.
    Mr. Linder. Thank you, gentlemen. This has been an eye-
opening experience, and I expect we are going to do this again. 
It makes me wonder if we have blown the $20 billion I talked to 
you about, and if we should keep that money and be flexible and 
    I have one question to each of you. What would you say if I 
told you a scientist from Sweden said that Iranian children 
emigrating with their parents from Iran to Sweden have all been 
vaccinated for smallpox; what would that mean to you?
    Dr. Alibek. It is very hard to say. They are two different 
ways of explaining it. First, analyzing the Iranians, I have 
noticed they still believe that smallpox could come back. And 
they do some vaccinations of smallpox and some development and 
so on and so forth. That is why if, for example, when they 
vaccinate against smallpox, meaning that it could come back 
without having actual knowledge, or it could be a special 
agent, because if they have some information that Iran is 
working with smallpox virus.
    Talking about Iran, I am finishing some analytical work, 
and hopefully I will deliver it quite soon to one of the 
government departments. I see that Iran is having a very big 
interest in military-type biotechnology and medical biology. In 
this case, I didn't see smallpox, but what I saw, actually, is 
quite disturbing. In this case, looks like there is some 
biological weapons activity in Iran.
    Mr. Linder. Thank you very much. This hearing is adjourned.
    [Whereupon, at 12:10 p.m., the subcommittee was adjourned.]