ENGINEERING BIO-TERROR AGENTS:
LESSONS FROM THE OFFENSIVE U.S. AND
RUSSIAN BIOLOGICAL WEAPONS PROGRAMS
=======================================================================
HEARING
before the
SUBCOMMITTEE ON PREVENTION OF NUCLEAR AND BIOLOGICAL ATTACK
of the
COMMITTEE ON HOMELAND SECURITY
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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COMMITTEE ON HOMELAND SECURITY
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
______
SUBCOMMITTEE ON PREVENTION OF NUCLEAR AND BIOLOGICAL ATTACK
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)
(II)
C O N T E N T S
----------
Page
STATEMENTS
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
WITNESSES
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
Institute:
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
ENGINEERING BIO-TERROR AGENTS:
LESSONS FROM THE OFFENSIVE U.S. AND RUSSIAN BIOLOGICAL WEAPONS PROGRAMS
----------
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
country.
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
ourselves.
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
tasks.
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
bioweapons.
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
here.
Mr. Linder. Dr. Alibek, you may begin.
STATEMENT OF DR. KENNETH ALIBEK, EXECUTIVE DIRECTOR, CENTER FOR
BIODEFENSE, GEORGE MASON UNIVERSITY
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
pathogens.
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
manufactured.
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
microorganisms.
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
article.
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
pigs.
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
IA.
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
pathogens.
Mr. Linder. Dr. Brent.
STATEMENT OF DR. ROGER BRENT, DIRECTOR AND PRESIDENT, MOLECULAR
SCIENCES INSTITUTE
Dr. Brent. Well, I am grateful to Chairman Cox, Chairman
Linder and Ranking Member Langevin for being asked to testify
here.
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
years.
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
today.
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
weaponization.
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
catastrophe.
(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
shift.
(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.
STATEMENT OF DR. MICHAEL V. CALLAHAN, DIRECTOR, BIODEFENSE &
MASS CASUALTY CARE, CIMIT/MASSACHUSETTS GENERAL
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
well.
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
inventories.
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
poisonings.
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
terrorist:
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
infected.
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
run.
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
laboratory.
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
point.
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
person.
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.
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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
questioning.
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
forth.
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
much.
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
individuals?
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
not.
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
discussion.
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
pathogens.
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
defenses.
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
it.
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
month.
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
intent.
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
paradigm.
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
explore.
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
virus.
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
forth.
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
minutes.
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
choice.
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
possible.
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
minutes.
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
world.
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
this.
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
approach.
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
things.
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
slack.
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
south.
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
difference.
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
consequences?
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
laboratories.
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
countries.
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
saying?
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
cost?
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
source?
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
biology.
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
development.
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
horrific.
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
that.
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
war.
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
it.
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
one.
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
quick.
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.]