[House Hearing, 108 Congress]
[From the U.S. Government Publishing Office]
BIOSHIELD: LESSONS FROM CURRENT EFFORTS TO DEVELOP BIO-WARFARE
COUNTERMEASURES
=======================================================================
HEARING
before the
SELECT COMMITTEE ON HOMELAND SECURITY
HOUSE OF REPRESENTATIVES
ONE HUNDRED EIGHTH CONGRESS
FIRST SESSION
__________
JUNE 6, 2003
__________
Serial No. 108-9
__________
Printed for the use of the Select Committee on Homeland Security
Available via the World Wide Web: http://www.access.gpo.gov/congress/
house
__________
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SELECT COMMITTEE ON HOMELAND SECURITY
CHRISTOPHER COX, California, Chairman
JENNIFER DUNN, Washington JIM TURNER, Texas, Ranking Member
C.W. BILL YOUNG, Florida BENNIE G. THOMPSON, Mississippi
DON YOUNG, Alaska LORETTA SANCHEZ, California
F. JAMES SENSENBRENNER, JR., EDWARD J. MARKEY, Massachusetts
Wisconsin NORMAN D. DICKS, Washington
W.J. (BILLY) TAUZIN, Louisiana BARNEY FRANK, Massachusetts
DAVID DREIER, California JANE HARMAN, California
DUNCAN HUNTER, California BENJAMIN L. CARDIN, Maryland
HAROLD ROGERS, Kentucky LOUISE McINTOSH SLAUGHTER,
SHERWOOD BOEHLERT, New York New York
LAMAR S. SMITH, Texas PETER A. DeFAZIO, Oregon
CURT WELDON, Pennsylvania NITA M. LOWEY, New York
CHRISTOPHER SHAYS, Connecticut ROBERT E. ANDREWS, New Jersey
PORTER J. GOSS, Florida ELEANOR HOLMES NORTON,
DAVE CAMP, Michigan District of Columbia
LINCOLN DIAZ-BALART, Florida ZOE LOFGREN, California
BOB GOODLATTE, Virginia KAREN McCARTHY, Missouri
ERNEST J. ISTOOK, JR., Oklahoma SHEILA JACKSON-LEE, Texas
PETER T. KING, New York BILL PASCRELL, JR., New Jersey
JOHN LINDER, Georgia DONNA M. CHRISTENSEN,
JOHN B. SHADEGG, Arizona U.S. Virgin Islands
MARK E. SOUDER, Indiana BOB ETHERIDGE, North Carolina
MAC THORNBERRY, Texas CHARLES GONZALEZ, Texas
JIM GIBBONS, Nevada KEN LUCAS, Kentucky
KAY GRANGER, Texas JAMES R. LANGEVIN, Rhode Island
PETE SESSIONS, Texas KENDRICK B. MEEK, Florida
JOHN E. SWEENEY, New York
JOHN GANNON, Chief of Staff
UTTAM DHILLON, Chief Counsel and Deputy Staff Director
STEVEN CASH, Democrat Staff Director
MICHAEL S. TWINCHEK, Chief Clerk
(II)
C O N T E N T S
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Page
STATEMENTS
The Honorable Christopher Cox, Chairman, Select Committee on
Homeland Security, and a Representative in Congress From the
State of California............................................ 1
The Honorable Jim Turner, Ranking Member, Select Committee on
Homeland Security, and a Representative in Congress From the
State of Texas................................................. 2
The Honorable Robert E. Andrews, a Representative in Congress
From the State of New Jersey................................... 4
The Honorable Donna Christensen, a Delegate in Congress from the
U.S. Virgin Islands............................................ 10
The Honorable Jennifer Dunn, a Representative in Congress From
the State of Washington........................................ 3
The Honorable Bob Etheridge, a Representative in Congress From
the State of North Carolina.................................... 8
The Honorable Barney Frank, a Representative in Congress From the
State of Massachusetts......................................... 10
The Honorable Duncan Hunter, a Representative in Congress From
the State of Massachusetts..................................... 4
The Honorable Sheila Jackson-Lee, a Representative in Congress
From the State of Texas
Oral Statement................................................. 6
Prepared Statement............................................. 7
The Honorable James R. Langevin, a Representative in Congress
From the State of Rhode Island
Oral Statement................................................. 9
Prepared Statement............................................. 11
The Honorable John Linder, a Representative in Congress From the
State of Rhode Island.......................................... 5
The Honorable Karen McCarthy, a Representative in Congress From
the State of Missouri.......................................... 5
The Honorable Kendrick Meek, a Representative in Congress From
the State of Florida........................................... 9
The Honorable Pete Sessions, a Representative in Congress From
the State of Texas............................................. 5
WITNESSES
Dr. Ali Khan, Chief Science Officer, Parasitic Diseases, National
Center for Infectious Diseases, Center for Disease Control and
Prevention, Department of Health and Human Services
Oral Statement................................................. 12
Prepared Statement............................................. 15
Joseph M. Henderson, Associate Director for Terrorism
Preparedness and Response, Center for Disease Control and
Prevention, Department of Health and Human Services............ 23
Dr. John Ring LaMontagne, Deputy Director, National Institute of
Allergy and Infectious Diseases, National Institutes of Health,
Department of Health and Human Services
Oral Statement................................................. 17
Prepared Statement............................................. 19
APPENDIX
Materials Submitted for the Record
Questions for the Record--for National Institute of Allergy and
Infectious Diseases (NIAID).................................... 62
BIOSHIELD: LESSONS FROM CURRENT EFFORTS TO DEVELOP BIO-WARFARE
COUNTERMEASURES
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FRIDAY, JUNE 6, 2003
U.S. House of Representatives,
Select Committee on Homeland Security,
Washington, D.C.
The committee met, pursuant to call, at 10:06 a.m., in Room
345, Cannon House Office Building, Hon. Christopher Cox
[chairman of the committee] presiding.
Present: Representatives Cox, Dunn, Hunter, Sessions,
Turner, Frank, Slaughter, Andrews, McCarthy, Jackson-Lee,
Christensen, Etheridge, Langevin, and Meek.
Chairman Cox. Good morning. A quorum being possibly
present, the Select Committee on Homeland Security will come to
order. The committee is meeting today to hear further testimony
relating to Project BioShield. I would like to welcome the
members in attendance this morning and thank our witnesses for
agreeing to appear before this committee on such short notice.
This initiative is moving quickly. I am grateful to be able to
hear your testimony before we mark up the legislation next
week.
The Secretary of Homeland Security is given a very
important role in Project BioShield. This role is primarily one
of threat assessment. Legislation requires the Secretary to
assess existing and potential threats from chemical,
biological, radiological and nuclear agents and to determine
which of those threats presents a material threat against the
United States population.
Countermeasures to agents so identified by the Secretary
will be eligible for purchase for the strategic national
stockpile using BioShield's special funding mechanism.
The Department's pivotal responsibilities under BioShield
are part and parcel of its broader threat assessment
responsibilities under the Homeland Security Act. There is a
virtually infinite universe of potential threats, of course
only a finite amount of resources to deal with them.
Conducting the kind of analysis and assessment that will
allow us to set security priorities and focus our efforts on
the most pressing threats is one of the most important
functions of the Department of Homeland Security. Quality
threat assessment is absolutely critical in order to prevent
attacks on our homeland. This is nowhere more true than in the
case of bioterrorism. To best protect against attacks on the
U.S. population, our efforts must be concentrated fully on the
agents that pose the greatest danger. Assuring this is the
Department of Homeland Security's responsibility.
Yesterday, the Subcommittees on Emergency Preparedness and
Response and Intelligence held a joint hearing examining the
infrastructure already in place and the infrastructure that is
now being built at DHS for performing the threat assessment
required for the success of BioShield.
I want to thank Chairmen Shadegg and Gibbons for holding
that hearing. This hearing is intended to bring the benefit of
the valuable experience of other existing biothreat programs to
our discussion of BioShield and the role of DHS. This hearing
will help us understand the challenges the Department of
Homeland Security will face and the capabilities that it must
develop.
We have witnesses with us from the National Institutes of
Health and the Center for Disease Control, both within the
Department of Health and Human Services. HHS already performs
threat assessment that is closely related to the kind of
analysis that DHS will be required to perform for the BioShield
legislation. The Secretary of Health and Human Services is
required by the Bioterrorism Preparedness Act of 2002 to
maintain a list of agents and toxins that could potentially
pose a severe threat to the public health. This list is then
used to set research and response priorities within the Federal
Government
In order to be successful, DHS must perform these
assessments and more. The Secretary must be able to combine a
determination of which agents are most intrinsically dangerous
with an intelligence assessment of terrorist capabilities. I
hope this hearing gives us an idea of what this entails and
whether there is anything that we in Congress must do as we
consider this legislation to help the Department fully meet its
mandate.
I look forward to hearing from our witnesses.
The Chair would now recognize the ranking member, Mr.
Turner, for his opening statement.
Mr. Turner. Thank you, Mr. Chairman. I want to thank you
for your leadership on this issue of the biological threat that
we face as a nation. I appreciate that this committee has been
aggressive in trying to schedule hearings on this important
piece of legislation and attempting to delve into some of the
tougher issues that we all know exist.
Our hearing yesterday revealed to us information that I
think all of us on both sides of the aisle consider to be quite
disturbing with regard to the progress of the Department of
Homeland Security, and its ability to carry out the
responsibilities that we will be giving it under the BioShield
legislation. And I am hopeful that we can move forward in
urging the President and the Secretary of the Department to
further strengthen that portion of the Department's function
and responsibility.
Our hearings on Project BioShield have demonstrated, I
think to all of us, that to solve the problem of bioterrorism,
we are going to have to form a strong relationship between the
public and the private sectors. The BioShield legislation is
designed to give our pharmaceutical industry incentives to do
what they do best, and that is, to take a potential medicine or
vaccine against a biological agent and bring it to the stage
where it can be mass produced.
But the difficult work of basic research and drug
development is being done elsewhere. It is being done in
government research laboratories, in the biotech industry and
in our research universities. The seriousness of the
bioterrorism threat and the sophistication required to develop
adequate defenses requires, in my view, a sustained long-term
and extremely focused research and development effort. We
simply cannot leave this responsibility to the uncertainties of
the market and sit back and hope that all the drugs and
vaccines will be developed.
The federal government must play a role in funding the
basic research and development work needed for an adequate
biodefense. The administration has recognized this as well.
That is why the proposed funding for biodefense at the National
Institute for Allergies and Infectious Diseases has risen from
$180 million since September 11th to the proposed $1.6 billion
in next year's budget, an 800 percent increase. This funding
increase is dramatic, and I wholeheartedly support it.
Still, the task of developing countermeasures is so
difficult and so vitally important, there are many other issues
besides the amount of resources that need to be addressed.
First, the National Institute for Allergy and Infectious
Diseases, commonly referred to as NIAID, has traditionally
focused, as I understand it, on pure scientific research. Now
it is being asked to become more involved in a related but
distinct task of drug development. I will be interested to
learn from our witness today what the leadership of NIAID is
doing to implement this change of culture within your own
organization, and I hope to hear assurances that we are making
the proper investments to ensure that we get not only good
research but also countermeasures that we can use to protect
the American people.
Secondly, we have heard extensive testimony about the
effectiveness of Project BioShield. There is a distinct
possibility that the private sector may not participate in
bringing promising drugs from the development stage toward
final production, and I would like to know from our witnesses
whether the government has or could build that capacity in the
event the incentives in the BioShield legislation are
insufficient.
I am particularly interested to learn more about NIAID's
Vaccine Research Center as it relates to the biodefense effort.
I am pleased that we have excellent witnesses from both the
NIAID and CDC here today. You have a very important job to do.
We want to support you in it, and be sure that you are
successful.
I thank you, Mr. Chairman. I look forward to hearing from
both of our witnesses.
Chairman Cox. Thank you.
The Chair recognizes the vice chairman of the full
committee, the gentlelady from Washington, Ms. Dunn, for her
opening statement.
Ms. Dunn. Thank you, Mr. Chairman, and welcome, gentlemen.
Thank you for being here with us today. As members of this
committee will agree, the downside of serving on a brand new
committee is that we don't have a space to call our own. This
is just a temporary problem. We will find a space of our own
very soon, but I am very happy that you were able to join us
here in the Cannon Caucus Room today.
Providing the Department of Homeland Security the necessary
resources to protect Americans from biological attacks is a
very important goal for this committee, and I look forward to
your input on implementing the BioShield Project.
As we found during the anthrax attacks in the fall of 2001,
very small amounts of biological agents can wreck havoc on our
livelihood, affecting our work, our home and the Nation's
economy. All of us in Congress were affected by the discovery
of anthrax in office buildings in the House and the Senate. As
we will recall, all staff were exposed--there were some staff
who opened the mail who were, in fact, exposed to anthrax, and
we experienced and continue to experience today delays in
receiving our mail, and of course many of our offices were
quarantined during those days.
With the havoc the anthrax attacks caused, we all learned
that we will need to be better prepared if a biological attack
occurs to a greater population. Project BioShield will be a
very important part of our homeland security efforts, yet its
successes will not be dependent solely on how much money we are
able, as Members of the Congress, to provide, but on developing
the coordination, the infrastructure and the leadership within
DHS and among other Federal agencies and our public health
system.
Today we will hear about the role of the Centers for
Disease Control and the National Center for Infectious Diseases
in helping to prevent and respond to potential bioterrorism
attacks. I look forward to hear how the CDC and the NIH will
work together to ensure the safety of the American people.
BioShield, if implemented successfully, will have a
profound effect on mitigating the effects of a biological
attack as we are preparing to mark up this legislation toward
the end of next week, I, too, look forward to hearing from you
and to gleaning something from your experience today.
Thank you, Mr. Chairman.
Chairman Cox. Thank you. The gentleman from the great State
of New Jersey, whose Devils were successful last evening, Mr.
Andrews, is recognized for his opening statement.
Mr. Andrews. Thank you, Mr. Chairman. I look forward to the
testimony of the witnesses, and--the specific time
measurements--and what I want to do on behalf of my
constituents is know what benchmarks I should be evaluating. I
am quite satisfied that you have laid the initial groundwork
that you ought to lay, and I commend you for it. What I am
interested in is learning ways that we can measure your
progress in this very important mission. Thank you, Mr.
Chairman.
Chairman Cox. The gentleman from California, the chairman
of the Committee on Armed Services, Mr. Hunter, is recognized
for his opening statement.
Mr. Hunter. Well, thank you, Mr. Chairman, and likewise I
don't have a lengthy opening statement, but I want to thank my
colleagues. Thank you and Mr. Turner and all my colleagues for
the hearing, and simply say that in the end, we are going to
have to translate these disparate agencies and all of the
players in what I would call this maybe three-part chain, that
is, detection, analysis and protection, into an apparatus that
can move very quickly, meaning that if there is a disease or a
substance that is threatening, whether it is troops in theatre
or civilians in this country, a single team that can move
quickly to capture some of that substance or that disease, move
it quickly to an analytical team, and from there, take it
quickly to a team that can put together a defensive measure and
then apply that, whether it--it has to be applied in
inoculation to the civilian population or to the uniform
services, and sometimes in this country, resolving fragmented
and disparate agencies into a focused effort that involves
action, and in this case, I think it is going to have to be
action that can take place very rapidly is sometimes one of our
biggest challenges.
So I am interested in knowing how we are going to put that
team together, and how it is going to be integrated with the
efforts that are already ongoing.
Obviously in the military, we have as the operation in Iraq
has reflected, the capability of analyzing some of the obvious
challenges and dangers and taking action to prevent those from
becoming damaging to our troops, and so we have the--at least
the embryonic apparatus of a BioShield in place with respect to
the military already, but I am interested in knowing how we are
going to be able to make this thing work together, the domestic
and the military elements, and bring them--meld them into a
single apparatus that can get the job done. So thanks for the
hearing, and gentlemen, thanks for being with us
Chairman Cox. The gentlelady from Missouri is recognized
for her opening statement. Ms. McCarthy is recognized for 5
minutes.
Ms. McCarthy. Thank you, Mr. Chairman. My mike is having
problems. I thank you for calling this meeting. I don't
think--.
Chairman Cox. If the gentlelady would suspend, it occurs to
me that because we have so much space up here behind the dais,
that if members would like to relocate, they would be welcome
to do so, but at least you might want to relocate to a
microphone that works.
Ms. McCarthy. Thank you very much, Mr. Chairman. I don't
know of an issue more critical, more timely or more important
than the biodefense of our country, and I am so grateful to you
for calling this hearing. And ranking member Turner, thank you
as well. And Dr. Khan and Dr. LaMontagne, I look forward very
much to your input, and I know you look forward to our
questioning and our thoughts as well as we work together as a
team to address this very vital issue.
Thank you very much. I would yield back my time, and I look
forward to continuing the hearing.
Chairman Cox. The gentleman from Georgia wishes to waive
his opening statement?
Mr. Linder. I have no comment, Mr. Chairman.
Chairman Cox. The gentleman from Texas is recognized for an
opening statement.
Mr. Sessions. Thank you, Mr. Chairman. Dr. Khan, Dr.
LaMontagne, we appreciate you being here before this committee
today. I am particularly interested in your comments as they
relate to the legislation that deals with the ability to take
from what I would say in the lab ideas and serums or answers to
problems and bringing them directly out on an expedited basis.
Now more than ever, this country and this world is faced
with new viruses, new problems, new plagues that confront us,
and I don't know that it is necessarily bioterrorism, but it is
certainly things that emanate as a result of people and animals
and things all around the world. And so in particular, I would
look today to hear from you about how we take those things as
they are identified in the world as problems, threats to
civilization, how we can mature that process very quickly in
the laboratory and then make them generally available to
people, and generally speaking, our process has been, I
believe, slow. While I am satisfied that our pharmaceutical
community does a very good job, I am concerned about rules and
regulations that inhibit the introduction of those drugs on a
more widely available and quicker basis.
So I will look forward to that testimony and hearing that
from you today, and want to thank both of you for being before
this great Select Committee today. I yield back, chairman.
Chairman Cox. Thank you. The gentlelady from Texas, Ms.
Jackson-Lee, is recognized for an opening statement.
Ms. Jackson-Lee. Thank you very much, Mr. Chairman and the
ranking member, for holding a very important hearing this
morning, and I am pleased to join my colleagues on this
committee. I would ask, Mr. Chairman, unanimous consent that my
entire statement be allowed to be submitted into the record in
it entirety.
Chairman Cox. Without objection, and the chairman would
note that all members will have the opportunity to submit
further opening statements for the record.
Ms. Jackson-Lee. Before their testimony even, I would like
to thank the witnesses and just to make note that for a moment
I have to testify in the Senate for a moment, but I will look
forward to reviewing, as I have, their statements and look
forward to participating in the questions.
We realize that terrorism is alive and well. In light of
the tragic incidents in Riyadh, Saudi Arabia on May 12th, and
of course, the tragedy in Morocco where 43 people were killed,
it makes this hearing even more important, because we realize
that the threat of bioterrorism remains with us, and the fact
that biological weapons are highly portable and difficult to
detect. Positive strides have been made in securing our borders
and presenting unwanted materials from entering our country,
but it is unrealistic to expect no biological weapons to enter
the United States or maybe even to be created here.
Last year alone, 30 million tons of cocaine was smuggled
into the United States. If we can't stop 30 million tons of
cocaine, then we know the difficult charities, if you will, of
dealing with the issue of bioweapons. Your position here or
your testimony here will be helpful to us and insightful and
encouraging as to how we might further enhance the security of
America.
We are trying to educate our citizens with the color
system. I believe now more and more they are sensitive to the
fact that when we make note of the various levels of threat,
that they will pay attention, but look, for example, to the
worldwide SARS outbreak. No, it is not a biological terrorist
effort, but we do know it has been difficult to deal with. The
inability of many foreign countries to adequately deal with
that outbreak raises questions about our own preparedness. What
about other infectious diseases, like tuberculosis? Just last
summer the country was faced with the West Nile virus. Of
course, that was not a biological threat or terrorist act, but
I can tell you in my community, we faced real challenges in
educating the community about how to protect themselves.
We must do better in the area of biological weapons and the
threat that they pose.
The ease with which biological weapons can be manufactured
is also a danger. The equipment and ingredients needed to
manufacture many biological agents can be purchased over the
Internet. Additionally, as our failure to apprehend those
responsible for the 2001 anthrax attacks illustrates,
biological terrorists can operate with more secrecy than
traditional terrorists. We must be concerned. The provisions of
Project BioShield provide a good start to protecting Americans
from bioterrorist attack, but work remains.
It is important, of course, to realize the provisions in
this legislation grants the National Institute of Health new
powers, good powers through grants and contract awards to speed
effective research and development efforts on bioterrorism
countermeasures. I am interested in making sure that all of
America, all of America's research specialists, all of
America's universities, Hispanic serving universities,
historically black universities, small universities and
colleges understand this process so that those who have
capacities, no matter where they are, will reach out and
participate in the research and grant efforts.
In addition, I might want to raise a question, as I close,
about the 40 million uninsured Americans who do not have health
care. They do not have established relationships with
physicians. How do we get them in the line of prevention,
immunization? How do we work with some of the failures of this
Nation so that we can ensure that every single person within
our boundaries remains safe and secure as we fight collectively
the war against terrorism. I am delighted that this hearing is
proceeding, and I know that we will have good instructions that
we should. And I yield back, Mr. Chairman.
[The information follows:]
PREPARED STATEMENT OF THE HONORABLE SHEILA JACKSON LEE, A
REPRESENTATIVE IN CONGRESS FROM THE STATE OF TEXAS
Mr. Chairman and Mr. Ranking Member, I thank you for convening this
vital hearing to hear testimony from government experts on their
efforts to assess the bioterror threat, develop countermeasure to
bioterror attacks, and coordinate with Project BioShield.
The Al Qaeda terrorist network remains a threat to Americans and
peaceful people worldwide. The recent suicide bombing attacks have
confirmed that terrorist cells are still planning and executing deadly
attacks. In Riyadh, Saudi Arabia, on May 12th, nine suicide bombers
attacked three residential compounds. The attacks took the lives of 35
innocent people including 9 Americans. Another suicide bombing attack
in Morocco killed 43 people. Despite Homeland Security Department
Secretary Tom Ridge's decision to lower the terrorism threat on May
30th, American's are still at risk. Our nation's elevated level of
vigilance may protect us from attacks like suicide bombing, but there
are many other terrorist threats that put American lives at risk.
Bioterror attacks are a perfect example.
The threat of bioterrorism must be one of our chief concerns as we
continue our work of protecting our homelands from terrorist attacks.
Biological weapons pose a particularly dangerous threat. Biological
weapons are highly portable and difficult to detect. Positive strides
have been made in securing our borders and preventing unwanted
materials from entering our country, but it is unrealistic to expect no
biological weapons to enter the United States. Last year alone 30
million tons of cocaine was smuggled into the United States. If we
can't stop 30 million tons of cocaine from crossing our borders, how
can we expect to stop a vile filled with anthrax, botulism, or small
pox? A vile that could kill hundreds or possibly thousands.
Bioterrorism attacks not only pose a danger to human lives, they
also have the ability to cripple the operation of our society and
severely harm our economy. We all recall the primary and secondary
impact of the anthrax attacks in 2001. The attacks involved a series of
letters mailed in pre-stamped envelopes to media outlets in Florida and
New York and to the offices of Senators Thomas Daschle and Patrick J.
Leahy (D-Vt.). The anthrax attacks killed five Americans and left 13
others severely ill. The five people who died from inhalation anthrax
included two postal workers at the Brentwood postal facility in
Washington, a Florida photojournalist, a New York hospital worker and a
94-year-old woman in Connecticut. Thousands more were exposed to the
lethal bacteria. The letters passed through various post offices and
postal distribution centers along the East Coast leaving a trail of
contamination. Buildings from the Brentwood mail facility, to the
Congressional office buildings, to NBC headquarters had to cease
operations.
The threat of bioterrorism did not end in September of 2001. As
recently as April 22nd of this year in Tacoma, Washington we had a
bioterrorism scare. A white powder was found in two envelopes, and 94
people had to be evacuated from a mail distribution facility. Initial
tests of the powder tested positive for biotoxins that cause bubonic
plague or botulism. Four people at the facility had to be
decontaminated. The same day, a suspicious powder was found in a
Federal Express cargo area at Southwest Florida International Airport,
in Fort Myers, Florida. Six people were taken to a hospital for
possible decontamination, including one who suffered burning eyes and
nose.
We are presently faced with the threat of a worldwide SARS
outbreak. The inability of many foreign countries to adequately deal
with that outbreak raises questions about our own preparedness. What
about other infectious diseases like tuberculosis? There are many
ailments that our medical professionals are struggling to control. We
must do better in the area of biological weapons.
The ease with which biological weapons can be manufactured is also
a danger. The equipment and ingredients needed to manufacture many
biological agents can be purchased over the Internet. Additionally, as
our failure to apprehend those responsible for the 2001 anthrax attacks
illustrates, biological terrorists can operate with more secrecy than
traditional terrorists.
These are but a few concerns we face as we consider Project
BioShield. The provisions of Project BioShield provide a good start to
protecting Americans from a bioterrorist attack but work remains.
Presently Project BioShield's provisions grant the National Institute
of Health new powers, through grants and contract awards, to speed
effective research and development efforts on bioterrorism
countermeasures. Project BioShield also creates a long-term funding
mechanism for the development of medical counter measures, and empowers
the government to purchase safe and effective vaccines. Finally,
Project BioShield authorizes the Food and Drug Administration to use
promising, yet uncertified, biological treatments in the case of
emergencies.
Mr. Chairman and Ranking Member, I believe these are good first
steps in protecting Americans from biological attacks. However, I feel
that many questions remain. I look forward to the testimony of our
witnesses today, and I hope that their guidance can help us make all
Americans less vulnerable to bioterrorism.
Chairman Cox. I thank the gentlelady. The gentleman from
North Carolina, Mr. Etheridge, is recognized for purposes of an
opening statement.
Mr. Etheridge. Thank you, Mr. Chairman. Thank you for
holding this hearing. I am going to be rather brief, but I do
want to say based on the hearings we held yesterday and the
information concerning--or the lack thereof, of information as
it relates to biochemical weapons and others, I am somewhat
disturbed, so I hope this morning you can--even though this is
not part of your testimony, that your information will be more
inclusive and helpful, because I think from what I heard
yesterday, I am quite aware and concerned that the level of
threat may be higher than we even think.
But I hope you will discuss or share with us, even though
the responsibility is on a broader scope--you know, most people
live in local communities, you know, and the concern is what
about the local community. Local health departments for a lot
of people is where they receive their services. Depending on
where you are in the United States, if you are in a rural area,
that those departments are absolutely overloaded. We have
people who aren't even taking smallpox shots now to be able to
provide services if something should happen.
So I hope you will share some of that with us this morning
and talk about two very critical issues to local folks. That
is, the safety of water and the food. We have the safest food
supply in the world, but I can see if there is an area where
you would want to have some problems, you could create turmoil
very quickly there. And I think that is important and as we
look at the global movement of people. It may be, as has
already been stated this morning, something someone
intentionally puts in a system. It may be something that is
started in nature that moves because we move so quickly from
one part of the world to the other. Historically, you have
dealt with those issues in a very positive way, and I would
congratulate you on it, but I think as we look out into the
21st century, those challenges are going to increase even more.
So I hope you will touch on that this morning.
Thank you, Mr. Chairman.
Chairman Cox. Thank you. The gentleman from Rhode Island,
Mr. Langevin, is recognized for his opening statement.
Mr. Langevin. Thank you, Mr. Chairman, and I too will have
a more formal statement to submit for the record, but, Mr.
Chairman, I want to thank you and the ranking member for
organizing this hearing, and I would like to thank the
gentlemen for their presence and look forward to their
testimony today.
I noticed in my briefing memo that we had attempted to get
witnesses from DOD and DHS but were unable to do so. I would
hope that DOD and DHS would follow the lead of CDC and NIH in
being more forthcoming with this committee in the future.
The areas that I hope the gentleman will address and things
that I am concerned with--and I agree with the gentlelady from
Missouri that the bioterror threats that are facing this
country are significant, and there is no greater a priority we
should have than addressing and dealing with these issues.
I will be most concerned with knowing if you have adequate
resources to do the job that you are facing. I would also be
interested in hearing the degree to which you are coordinating
efforts, both with nongovernmental and governmental agencies,
particularly DOD and DHS, and also I am interested in knowing
how you are setting priorities in terms of what types of
bioterror threats we need to address, both terrorist threats or
natural emerging pathogens that are antibiotic and drug
resistent. But I thank you for your presence today and look
forward to your testimony. Thank you, Mr. Chairman.
Chairman Cox. Thank the gentleman. The gentleman from
Florida, Mr. Meek, is recognized for an opening statement.
Mr. Meek. Thank you, Mr. Chairman, and I would like to not
only welcome our witnesses, but also thank the leaders in this
committee, including yourself, for having this very important
hearing. You heard some reference to yesterday. You had nothing
to do with yesterday. Today is today, and I am glad that you
are here, and I am more interested in understanding more about
our potential threat level and how y'all have worked with other
agencies, both of your agencies work with other agencies to--
the agencies abroad of efforts that they have to fight against
as it relates to bioterrorism, will we be the leader in this
effort, or are there other countries that are--taking
countermeasures against bioterrorism?
What we are asked in this proposed legislation when we
start to mark it up is to relax acquisition procedures, and we
are going to be asked to do many things that we are not doing
now, to give great discretion to members of the administration
and future members of future administrations to be able to
protect Americans in the future. I think that is so very, very
important. We deal with bioterrorism from my reading and from
what I have been briefed about, and something is going to be
very difficult--I don't know if we can legislate the
countermeasures totally, so what you do in the research
community is going to be vital.
Intelligence will be vital also, and I know that, Mr.
Chairman, as we go through this process, that we will discuss
and iron out many of those issues, but I know that in this
particular area, that preventive maintenance through discussion
and also allowing many people within the field of helping us
find countermeasures towards bioterrorism is going to be
important. So I look forward to the discourse, and I want to
thank both of you for being here this morning.
Chairman Cox. I thank the gentleman.
The gentlelady from the Virgin Islands is recognized for an
opening statement, Mrs. Christensen.
Mrs. Christensen. I will submit my opening statement for
the record, Mr. Chairman, and do we get 8 minutes if we don't
do an opening statement?
Chairman Cox. Yes. In fact, I think the Chair will be able
to be very liberal today because of the good attendance of
those who are here.
Does any other member wish to make an opening statement?
The gentleman from Massachusetts, Mr. Frank, is recognized
for an opening statement.
Mr. Frank. Thank you, Mr. Chairman. To begin, I want to
thank you for the role the committee has been playing recently.
I think yesterday's hearing, although painful was very useful,
and this is exactly the role we should be playing and I am
pleased to be part of it.
On this issue as I read Dr. Khan's statement, I was struck
by his appropriate reference on several occasions to the role
of State and local government, and we should be clear here. The
role of the Federal Government in this situation is to direct
the research to an overall coordinator, but the delivery of the
service, whatever it is in terms of dealing with bioterrorism,
is going to be overwhelmingly State and local. We don't have a
core of Federal officials that we are going to dispatch.
And this is what troubles me about our current situation.
While we are appropriately building up at the Federal level our
capacity to deal with terrorism at that level, we are seeing an
erosion at the State and local level of our capacity to carry
out these policies. The fact is that there are not two separate
public health systems and two separate police departments and
two separate fire departments, one of which at the State and
local level exists to deal with terrorism outbreaks and another
of which just exists to deal with ongoing activities, and what
we have got, because of the fiscal policies being followed at
the Federal and State level, is a serious erosion in many cases
of the capacity of the State and local public safety people,
public health, police, fire and others, to respond. And we are
building up this structure at the same time that we are seeing
the base weaken, and I do not think that it is a very sensible
policy.
So I think it is important for us to go ahead with these
preparations at the national level, but it is a mistake to
think that we can do this. And as I said--read Dr. Khan's
statement, he talks appropriately about working with State and
local agencies. The actual execution of many of these plans is
going to have to be carried out by local people, and as I said
before, we were asked during anthrax whether the American
public health system was ready for an outbreak of bioterrorism,
and I can tell you from what I know of the cities, the American
public health system isn't ready for Friday night.
I mean, by midnight tonight in many American cities, the
emergency rooms are going to be closed. So to think we can then
expect them in an emergency to take advantage of all this work
that we hope we are going to be able to do is a mistake, and so
I just urge that we treat--keeping the local public health, the
local hospitals, the police, the fire and other responders in
emergencies, keeping them in good shape overall is as important
to this fight against any potential terrorism outbreak than
anything else.
Chairman Cox. I thank the gentleman.
Does the gentlelady from New York wish to make an opening
statement?
Ms. Slaughter. Thank you, Mr. Chairman. In the interest of
time, I will withhold. I do have some questions, however, at
the proper time. Thank you.
Chairman Cox. Does any member wish to make a further
opening statement?
PREPARED STATEMENT OF THE HONORABLE JIM LANGEVIN, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF RHODE ISLAND
Thank you, Mr. Chairman. I would like to welcome our two witnesses,
Dr. LaMontagne and Dr. Khan, for what I expect will be a very
informative and productive hearing. I appreciate your willingness to
come before us. I would also like to note that it is my understanding
that the Committee sought witnesses from the Departments of Defense and
Homeland Security to join you today, but none were forthcoming. It is
my sincere hope that in the future, these agencies will show the same
willingness as CDC and NIH to make their representatives available for
participation in these important hearings.
Mr. Chairman, bioterrorism represents a major threat to our
national security, and I believe it is our job as members of this
Select Committee to instill confidence in the American people that a
coordinated, concerted effort is being made to combat bioterror.
Unfortunately, I do not think we have reached that point yet, but I do
think that hearings like today' are important steps towards that goal.
I' very interested to hear from our witnesses about whether the
resources they have are sufficient to handle the significant tasks for
which they are responsible. In addition, I hope to learn what, if any,
coordination exists between health-focused entities like CDC and NIH,
and the Department of Homeland Security and Department of Defense in
identifying threats and directing efforts appropriately to address the
most pressing dangers we face.
Specifically, I will be looking forward to hearing about what kind
of formal procedures exist for information-sharing between members of
the intelligence community and our federal medical researchers. If
there is currently no formalized process, I would be interested to hear
whether our witnesses think such a process would be helpful in
determining where and how to direct their efforts, and how we on the
Committee might be helpful in creating such a relationship.
I would also like to know whether our experts in the medical and
public health areas of bioterror are working with peers in the
intelligence community to determine threats and prioritize activities,
or whether the intelligence agencies lack analysts with the appropriate
medical expertise. Finally, I am interested in knowing whether DHS has
sought the input of agencies like CDC and NIH as they set up their
system for intelligence analysis of bioterror threats.
Again, Dr. Khan and Dr. LaMontagne, I greatly appreciate your
presence here today. This is a vital issue, and I look forward to
hearing from you both.
If not, I would like again to welcome our witnesses. We
have two witnesses with us this morning, Dr. John Ring
LaMontagne is the Deputy Director of the National Institute of
Allergy and Infectious Diseases. And Dr. Ali Khan is the Chief
Science Officer for parasitic diseases at the National Center
for Infectious Diseases in the Center for Disease Control and
Prevention.
Chairman Cox. We have both of your written statements, and
appreciate your submitting them. You are welcome to summarize
and expand upon those statements in the 5 minutes that are
dedicated to your formal testimony before we proceed to
questions. I would like to begin, Dr. Khan, with you.
STATEMENT OF DR. ALI KHAN, CHIEF SCIENCE OFFICER, PARASITIC
DISEASES, NATIONAL CENTER FOR INFECTIOUS DISEASES, CENTER FOR
DISEASE CONTROL AND PREVENTION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
Dr. Khan. Good morning. Thank you.--se attention.
Chairman Cox. Dr. Khan, I wonder if you could pull that
microphone closer to you.
Dr. Khan. Is that better? You have stated my current title.
Let me start by saying that I was previously the scientific
director for CDC's initial bioterrorism program and helped
craft the framework for our national preparedness activities,
including formulating our critical agent list to facilitate
coordinated planning. Biologic agents on this list remain the
basis for our State and local public health preparedness
programs, formulary decisions for the national strategic
stockpile, and the diagnostic reagents we distribute through
our laboratory response network.
This list has also been--.
Mr. Frank. Excuse me, Mr. Chairman. This room makes it hard
to hear anything other than a horse, so if you could pull the
mike closer and speak louder, I would appreciate it
Dr. Khan. Is that better?
Chairman Cox. Yes. Much better.
Dr. Khan. The critical agent list has been embraced by the
NIH for their research purposes and the medical community--.
Mr. Frank. I hate to be picky, but a little too much--.
Dr. Khan. I have been invited to discuss the process used
to determine which biologic agents were selected for the list.
However, let me state up front that my current activities
center on global emerging infectious diseases and malaria
prevention activities worldwide.
However, I am joined by Mr. Joe Henderson, CDC's associate
director for Terrorism Preparedness and Emergency Response,
sitting on my right. He is the gentleman who is currently
responsible for our bioterrorism preparedness program and is
available for questions the committee may have about our
current program.
I would like to go over two things briefly, first, how
these certain biologic agents were selected and prioritized to
make up the critical agent list and then the three categories
of agents. In June of 1999, CDC convened a meeting of academic
infectious disease experts, national, State and local public
health authorities and civilian and military intelligence and
law enforcement officials. They were asked to review and
comment on the potential public health impact to civilian
populations of various biologic agents. Four criteria were used
to assess this public health impact. The first was the
anticipated amount of illness and death do to an agent. The
second was a delivery potential to a large population based on
a combination of the stability of the agent, the ability to
mass produce and distribute the agent and its potential for
person-to-person spread.
The third criteria was the public perception of the agent
in terms of arousing public fear and causing civil disruption.
And the fourth criteria was the special public health
preparedness needs relating to detecting and responding to the
deliberate dissemination of a biologic agent in our communities
based on their surveillance requirements, their diagnostic
tools, stockpile needs, preparedness needs.
And these last two criteria are actually unique futures of
the public health list, compared to many other lists that do
occur for preparedness and other specific purposes.
Now, the participants I just discussed, they identified
these four criteria and reviewed previously identified
biological warfare agents in light of these four criteria. Once
that was done, CDC personnel identified objective indicators in
each of these categories, used a risk matrix analysis process
to go ahead and further prioritize all of these agents that
were initially discussed. The overall rating process in these
four areas was used to assign agents to Category A, B and C,
based on the priority of public health preparedness that would
be required, and essentially the public health impact of these
agents.
This risk matrix analysis in the final listing was
subjected to an external peer review process and published for
wide dissemination in the public health and medical
communities. I believe all the members of the committee have a
copy of that published paper that discussed the analysis and
what agents eventually came out in that analysis.
And I will quickly go through those three categories.
Agents in Category A have the greatest potential for adverse
public health impact with mass casualties and essentially
require the most broad-based public health preparedness
efforts, be they be in surveillance, laboratory diagnosis, and
again for the stockpile needs for specific medications. These
agents have the most risk of dissemination to a large group of
people, generally small particle aerosols in the air, and are
most likely to cause civil disruption.
The diseases that these agents cause include smallpox,
anthrax, plague, botulism, tularemia and some select
biohemorrhagic fever such as Ebola hemorrhagic fever.
Now, it is because of this list and the presence of the
anthrax on this list that we had Cipro and Doxi available in
the national pharmaceutical stockpile. We had diagnostic tests
for anthrax at all the local and State health departments in
October of 2001 during the anthrax attacks. So it was because
of that process that these preparedness measures were in place.
Now, the Category B agents have some potential for
widespread dissemination, but do not pose the same threat
potential or have the same degree of preparedness needs as
Category A agents. Agents in this category required some
focused improvements in surveillance and diagnostic, but
generally the way these lists are structured, for the moment
that you get to Category B, most of your stockpile and drug
needs have already been met by Category A agents. So there is
less need by the time you get to the second set of agents. And
the agents on this list include brucellosis, typhus, various
viruses that cause encephalitis and certain agents of concern
for water and food safety issues, bioterrorism issues.
In the category C agents are not currently believed to
present the high bioterrorism risk to public health, but they
could emerge as future threats. Threat of these agents will be
addressed by our general bioterrorism preparededness efforts
and the ongoing development that is necessary for the public
health infrastructure for detecting and responding to new
diseases of unknown etiology or new emerging infectious
diseases.
And the above category of agents should not be considered
definitive. Agents in each category may change as we get new
information or we obtain new assessment methods on how they may
be used. However, fortunately, to date these lists--this list
has not warranted being changed.
To meet the ever-changing response in preparedness
challenges presented by bioterrorism, a standardized and
reproducible evaluation process similar to the one I just
outlined to you and is described in much more detail in the
paper and the written testimony will continue to be used to
evaluate and prioritize the current agents on the list and new
agents that may emerge as threats to our civilian population
and our national health security.
In conclusion, CDC is committed to working with other
Federal agencies, academia and other partners, as well as State
and local public health departments to ensure the health and
medical care of our citizens. We have made substantial progress
to date in enhancing the Nation's capacity to prepare for and
respond to a bioterrorism event. The best strategy, however,
that remains to protect the health of our civilians against a
biological attack is the development, organization, and
enhancement of our public health prevention systems, tools and
research. Not only will this approach ensure that we are
prepared for deliberate bioterrorist threats, but will also
ensure that we are able to recognize and control naturally
occurring and reemerging diseases such as West Nile a couple
years ago, SARS this year, and pandemic influenza when it will
reoccur.
A strong and flexible public health infrastructure is our
best defense against any disease outbreak, and I believe many
members have already mentioned this. Thank you very much for
your attention. I will be happy to answer any questions you may
have.
[The statement of Dr. Khan follows:]
PREPARED STATEMENT OF DR. ALI S. KHAN
Good morning, Mr. Chairman and Members of the Committee. I am Dr. Ali
Khan, Associate Director for Medical Science, Division of Parasitic
Diseases, National Center for Infectious Diseases, Centers for Disease
Control and Prevention (CDC). I am accompanied today by Mr. Joseph M.
Henderson, CDC's Associate Director of Terrorism Preparedness and
Emergency Response. Thank you for the invitation to participate today
in this hearing on the challenges and progress made in identifying
agents that could be used as biological weapons. I will outline the
overall selection and prioritization process used to determine the
biological agents for CDC's public health preparedness activities.
As part of a Congressional initiative begun in 1999 to upgrade national
public health capabilities for response to acts of biological
terrorism, CDC was designated the lead agency for overall public health
planning. An Office of Terrorism Preparedness and Emergency Response
has been formed to help provide strategic direction across CDC,
targeting areas to enhance preparedness activities, planning, improved
surveillance and epidemiologic capabilities, rapid laboratory
diagnostics, communications, and the delivery of medical therapeutics
stockpiling. To focus these preparedness efforts, however, the
biological agents toward which the efforts should be targeted had to be
first formally identified and prioritized according to the level of
threat posed. These agents make up CDC's critical agent list. This list
is used as the framework for guidance to the state and local
preparedness programs, determining the formulary for the Strategic
National Stockpile, developing public health response plans and
determining reagents and protocols for the Laboratory Response Network
(LRN). The presence of anthrax on this list led to the focused
preparedness efforts on drug stockpiles and diagnostic tests that were
available during the 2001 anthrax attack.
A number of similar lists do exist such as the military's formal
assessment of multiple agents for their strategic usefulness on the
battlefield; an international list of agents for export control; a list
of agents that have been processed for biowarfare; and classified
lists. Most of these lists focused on biowarfare, but for public health
preparedness purposes, CDC needed a list of agents that could have
significant impact on the U.S. population. To guide the national public
and medical health bioterrorism preparedness and response efforts, we
devised a method for assessing potential biological threat agents that
would provide a reviewable, reproducible means for standardized
evaluations of these threats. Identifying these priority agents helps
facilitate coordinated planning efforts among federal agencies, state
and local emergency response and public health agencies, and the
medical community.
Overview of Agent Selection and Prioritization Process
In June 1999, CDC convened a meeting of academic infectious disease
experts, national public health experts, Department of Health and Human
Services agency representatives, civilian and military intelligence
experts, and law enforcement officials to review and comment on the
threat potential of various agents to civilian populations. While
biological agents can cause illness in humans, not all are capable of
affecting public health and medical infrastructures on a large scale.
The following four general criteria were used to assess this public
health impact: 1) the anticipated amount of illness and death with an
agent; 2) the delivery potential to large populations based on
stability of the agent, ability to mass produce and distribute a
virulent agent, and potential for person-to-person transmission; 3) the
public perception as related to fear and potential civil disruption;
and 4) the special public health preparedness needs based on stockpile
requirements, enhanced surveillance, or diagnostic tools necessary to
respond to a deliberate dissemination of an agent. These last two
criteria were the unique features of the public health critical agent
list.
Participants discussed and identified these four criteria and reviewed
available lists to subjectively place agents they felt had the
potential for high impact. Participants with appropriate clearance
levels also reviewed intelligence information regarding classified
suspected biological agent threats to civilian populations. Genetically
engineered or recombinant biological agents were considered but not
included for final prioritization because of the inability to predict
the nature of these agents and thus identify specific preparedness
activities for public health and medical response to them. In addition,
no information was available about the likelihood for use of one
biological agent over another. This aspect, therefore, could not be
considered in the final evaluation of the potential biological threat
agents.
After the meeting, CDC personnel then attempted to identify objective
indicators in each category that could be used to further define and
prioritize the identified high impact agents and provide a framework
for an objective risk-matrix analysis process for any potential agent.
The agents were evaluated in each of the general areas according to the
objective parameters. Final category assignments (A, B, or C) of agents
for public health preparedness efforts were then based on an overall
evaluation of the ratings the agents received in each of the four
areas.
Categories of Agents
Based on the overall criteria and weighting, agents were placed in one
of three priority categories for initial public health preparedness
efforts: A, B, or C. Agents in Category A have the greatest potential
for adverse public health impact with mass casualties, and most require
broad-based public health preparedness efforts (e.g., improved
surveillance and laboratory diagnosis and stockpiling of specific
medications). Category A agents also have a moderate to high potential
for large-scale dissemination or a heightened general public awareness
that could cause mass public fear and civil disruption.
Most Category B agents also have some potential for large-scale
dissemination with resultant illness, but generally cause less illness
and death and therefore would be expected to have lower medical and
public health impact. These agents also have lower general public
awareness than Category A agents and require fewer special public
health preparedness efforts. Agents in this category require some
improvement in public health and medical awareness, surveillance, or
laboratory diagnostic capabilities, but presented limited additional
requirements for stockpiled therapeutics beyond those identified for
Category A agents. Biological agents that have undergone some
development for widespread dissemination but do not otherwise meet the
criteria for Category A, as well as several biological agents of
concern for food and water safety, are included in this category.
Biological agents that are currently not believed to present a high
bioterrorism risk to public health but which could emerge as future
threats (as scientific understanding of these agents improves) were
placed in Category C. These agents will be addressed nonspecifically
through overall bioterrorism preparedness efforts to improve the
detection of unexplained illnesses and ongoing public health
infrastructure development for detecting and addressing emerging
infectious diseases.
Agents were categorized based on the overall evaluation of the
different areas considered. For example, smallpox would rank higher
than brucellosis in the public health impact criterion because of its
higher untreated mortality (approximately 30 percent for smallpox and
less than or equal to 2 percent for brucellosis); smallpox has a higher
dissemination potential because of its capability for person-to-person
transmission. Smallpox also ranks higher for special public health
preparedness needs, as additional vaccine must be manufactured and
enhanced surveillance, educational, and diagnostic efforts must be
undertaken. Inhalational anthrax and plague also have higher public
health impact ratings than brucellosis because of their higher
morbidity and mortality. Although mass production of Vibrio cholerae
(which causes cholera) and Shigella species (which cause shigellosis)
would be easier than the mass production of anthrax spores, the public
health impact of widespread dissemination would be less because of the
lower morbidity and mortality associated with these agents and because
of some of the preparedness efforts implemented for other agents such
as drug stockpiles.
The above categories of agents should not be considered definitive.
Agents in each category may change as new information is obtained or
new assessment methods are established. To date, changes to these lists
have not been warranted. Disease elimination and eradication efforts
may result in new agents being added to the list as populations lose
their natural or vaccine-induced immunity to these agents. Conversely,
the priority status of certain agents may be reduced as the identified
public health and medical deficiencies related to these agents are
addressed (e.g., once adequate stores of smallpox vaccine and improved
diagnostic capabilities are established, its overall rating within the
risk-matrix evaluation process might be reduced). To meet the ever-
changing response and preparedness challenges presented by
bioterrorism, a standardized and reproducible evaluation process
similar to the one outlined above will continue to be used to evaluate
and prioritize currently identified biological critical agents, as well
as new agents that may emerge as threats to civilian populations or
national security.
Conclusion
In conclusion, CDC is committed to working with other Federal agencies,
academia, and other partners, as well as State and local public health
departments, to ensure the health and medical care of our citizens. We
have made substantial progress to date in enhancing the Nation's
capability to prepare for and respond to a bioterrorist event. The best
public health strategy to protect the health of civilians against a
biological attack is the development, organization, and enhancement of
public health prevention systems and tools. Priorities include
strengthened public health laboratory capacity; increased surveillance
and outbreak investigation capacity; and health communications,
education, and training at the Federal, State, and local levels. Not
only will this approach ensure that we are prepared for deliberate
bioterrorist threats, but it will also ensure that we will be able to
recognize and control naturally occurring new or re-emerging infectious
diseases such as SARS or pandemic influenza. A strong and flexible
public health infrastructure is the best defense against any disease
outbreak.
Thank you very much for your attention. I will be happy to answer any
questions you may have.
Ms. Dunn. [Presiding.] Thank you very much, Dr. Khan. And
next we will hear from Dr. LaMontagne, who is the deputy
director of the National Institute of Allergy and Infectious
Diseases for the National Institutes of Health. May I just
suggest to you, Dr. LaLantagne, the speakers are not aimed in
our direction, and if you could speak slowly and precisely, we
will give you the extra time you need, but it is very difficult
to hear. The acoustics in this room are terrible. Go ahead, Dr.
LaMontagne.
STATEMENT OF JOHN RING LaMONTAGNE, PH.D., DEPUTY DIRECTOR,
NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES, NATIONAL
INSTITUTES OF HEALTH, U.S. DEPARTMENT OF HEALTH AND HUMAN
SERVICES
Dr. LaMontagne. Thank you very much, Madam Chair and
members of the Committee. Thank you for giving me the
opportunity to discuss the comprehensive and accelerated
process for developing medical countermeasures against
bioterrorist threats. As you know, the National Institutes of
Health, particularly the National Institute of Allergy and
Infectious Diseases, of which I am Deputy Director, is engaged
in a vigorous effort to ensure homeland security and protect
the American people against potential agents of bioterrorism,
as well as emerging and reemerging infectious diseases.
Integral to this effort is the enactment of Project
BioShield which will increase the authority and flexibility of
the NIH to expedite research towards the development of
critical medical countermeasures for biodefense.
Today I will describe for you, one, how the NIAID has set
up its research priorities to develop vaccines and therapeutics
against bioterrorist threats; two, why NIAID has identified
certain biological agents as its top research priorities and,
third, what NIAID is doing to ensure that medical
countermeasures, particularly vaccines and therapeutics, are
developed as rapidly as possible to protect homeland security.
The NIAID set its research priorities for defense against
bioterrorism through a comprehensive and systematic process.
Since February of 2002, we have convened four multi-
institutional panels of scientific experts and developed a
strategic plan and a strategic research agenda based on their
recommendations. For example, based on advice of the Blue
Ribbon Panel on Bioterrorism and Its Implications for
Biomedical Research, we developed the NIAID Strategic Plan for
Biodefense Research and the NIAID Research Agenda for CDC
Category A Agents.
Strategic plan emphasizes, first of all, basic research on
microbes and host defenses; second, targeted milestone-driven
development of drugs, vaccines, other interventions and
diagnostics.
The NIAID defense research agenda emphasizes the short-
term, intermediate, and long-term goals for research in
Category A agents, a group of microbes and toxins that you have
just heard about identified by the CDC as the most dangerous.
These include anthrax, smallpox, plague, botulinum toxin,
tularemia, and hemorrhagic fevers caused by viruses such as
Ebola.
Thus, the initial focus of our biodefense research effort
has been to develop new and improved vaccines, therapeutics and
diagnostic tests against Category A agents. An essential
component of this program is enhancing the Nation's capability
to conduct research on these agents. This requires that
additional high-containment research facilities known as BSL 3,
or biosafety level 3, and BSL 4 laboratories be constructed and
made accessible to government-supported scientists. Also
required to fulfill the goals of our research program are other
specialized research resources such as centers for sequencing
the genomes of these microbes and skilled scientists and
technicians who are trained to handle dangerous microbes and
toxins.
In addition to research on Category A agents, NIAID is also
spearheading efforts to develop new and improved vaccines,
therapeutics, and diagnostics for Category B and C agents as
well.
Again, based on the recommendations of a blue ribbon panel,
we developed the NIAID biodefense Research Agenda for Category
B and C Priority Pathogens. These agents include a diverse
array of viruses, bacteria and bacterial toxins that are
carried by insects, livestock, and other vectors; can be
inhaled; or are spread through contaminated food and water.
I have indicated that the NIAID biodefense program
emphasizes research on Category A agents: anthrax, smallpox,
plague, botulinum, tularemia, and Ebola and other hemorrhagic
fever viruses. Why are these viruses, bacteria and toxins
considered the more dangerous potential agents of bioterrorism?
Many of the microbes, such as those that cause measles, mumps
or even AIDS cause serious illness that are not in a Category A
list.
Simply put, the high priority Category A agents include
organisms that can pose a risk to national security, because
they, first of all, can be easily disseminated and transmitted
from person to person. They result in higher mortality rates
and have a potential for major public health impact. They might
cause public panic and social disruption. They require special
action for public health preparedness.
In Category B agents are considered to have the second
highest priority in terms of the bioterrorist threat potential.
These agents are moderately easy to disseminate, result in
moderate morbidity rates and low mortality rates and require
specific enhancements of our diagnostic capacity and enhanced
disease surveillance.
Category C agents, the next highest priority, include
emerging microbes that could be engineered for mass
dissemination in the future because of their availability, ease
of production and dissemination and potential for high
morbidity and mortality rates, and obviously a major health
impact.
In general, the NIAID has three broad goals in vaccine
research. The first is to identify new vaccine candidates to
prevent disease for which no vaccines currently exist, improve
the safety and efficacy of existing vaccines and, third, to
design novel vaccine approaches such as the use of new vectors
or adjuvants.
To achieve these goals, NIAID supports basic research to
understand the biology of the microbes that cause disease and
to determine how humans and other animals respond to infection
with these microbes. Key to our understanding of microbial
biology is identification of the nucleic acid sequence of their
genomes. With this information in hand, we will be better
poised to identify molecular targets to use in the design of
vaccines and therapeutics.
Another primary objective of the NIAID biodefense research
program is to attract the long-term interest and support of
academia and industry in the efforts needed to develop
effective bioterrorism countermeasures.
NIAID's biodefense research program facilitates the
involvement of academic scientists through the use of all
available funding mechanisms including the development of a
network of Regional Centers of Excellence for research on
bioterrorism and emerging and reemerging infectious diseases.
Our biodefense strategic plan and research agenda has
required an expansion of investigator-initiated and institute-
initiated grants and contracts. In Fiscal Year 2002 and 2003,
NIAID developed a total of 46 different biodefense initiatives
to stimulate research in this area. Thirty are totally new, and
16 are significant expansion. During this time, NIAID has also
seen a 30 percent increase in the number of grant applications.
The vast majority of these are in response to our biodefense
initiatives.
In closing, thank you again for giving me opportunity to
testify today before you about NIAID's biodefense research
agenda. I would be pleased to answer any questions you might
have.
Ms. Dunn. Thank you very much, Dr. LaMontagne.
[The statement of Dr. LaMontagne follows:]
PREPARED STATEMENT OF DR. JOHN R. LaMONTAGNE
Mr. Chairman and Members of the Committee, thank you for giving me the
opportunity to discuss the comprehensive and accelerated process for
developing medical countermeasures against bioterrorist threats. As you
know, the National Institutes of Health (NIH), particularly the
National Institute of Allergy and Infectious Diseases (NIAID), of which
I am Deputy Director, is engaged in a vigorous effort to ensure
homeland security and protect the American people against potential
agents of bioterrorism as well as emerging and re-emerging infectious
diseases.
The destruction of the World Trade Center, the attack on the Pentagon,
and the anthrax attacks in the fall of 2001 starkly exposed the
vulnerability of the United States to acts of terrorism. At the NIH,
and particularly at the NIAID, these events triggered the development
of an aggressive, broadly based research program designed to provide
the American people with vaccines and therapeutics against a range of
bioterrorist threats.
Integral to this effort is the enactment of Project BioShield, which
will increase the authority and flexibility of NIH to expedite research
toward the development of critical medical countermeasures for
biodefense. Project BioShield would also establish a secure funding
source for the purchase of critical medical countermeasures, and would
give the Food and Drug Administration (FDA) an Emergency Use
Authorization for these countermeasures. Thus, the accelerated research
and development program of the NIH, and the NIAID in particular, would
work in concert with Project BioShield to provide the American people
with safe and effective vaccines and therapeutics to protect them
against a range of biological threats.
Today, I will describe to you: (1) how the NIAID has set its research
priorities to develop vaccines and therapeutics against bioterrorist
threats; (2) why NIAID has identified certain biological agents as its
top research priorities; and (3) what NIAID is doing to ensure that
medical countermeasures--particularly vaccines and therapeutics--are
developed as rapidly as possible to protect homeland security.
Overview
For years, civilian agencies such as the NIH, the FDA, the Centers for
Disease Control and Prevention (CDC), as well as the U.S. Army Medical
Research Institute of Infectious Diseases (USAMRIID) in the Department
of Defense (DoD), have addressed the threat of bioterrorism. The
research has been directed at viruses, bacteria, and bacterial toxins
that could emerge or re-emerge spontaneously in nature, or that could
be intentionally released as biological weapons into human populations.
However, the anthrax attacks of 2001 revealed significant gaps in our
overall preparedness against bioterrorism, and gave a new sense of
urgency to our biodefense research efforts.
We realized quickly that it was no longer adequate to do business as
usual. A primary goal of the NIH has always been to support research
efforts that generate new knowledge about disease and to translate
these findings into vaccines, therapeutics, and diagnostics that
protect public health. But, to develop safe and effective products for
biodefense as quickly as possible, we needed to intensify and
accelerate this process. Thus, we sought creative ways in which to
modify NIH's traditional process of research and development, while
continuing to preserve the excellence that is a hallmark of NIH
research. The NIAID biodefense research program is directed primarily
toward the needs of civilian populations, although interventions
emerging from it may logically also have application in military
settings.
How has NIAID set its research priorities to develop vaccines and
therapeutics against bioterrorist threats?
Bioterrorism is defined as the intentional use of microorganisms that
cause human disease, or of toxins derived from them, to harm individual
people or to elicit widespread fear or intimidation of society.
The NIAID set its research priorities for defense against bioterrorism
through a comprehensive and systematic process. Since February of 2002,
we have convened four multi-institutional panels of scientific experts,
and developed a strategic plan and strategic research agendas based on
their recommendations. Based on advice from the Blue Ribbon Panel on
Bioterrorism and Its Implications for Biomedical Research, we developed
the NIAID Strategic Plan for Biodefense Research and the NIAID Research
Agenda for CDC Category A Agents. The Strategic Plan emphasizes: 1)
basic research on microbes and host defenses; and 2) targeted,
milestone-driven development of drugs, vaccines, other interventions,
and diagnostics. The NIAID Biodefense Research Agenda emphasizes the
short-term, intermediate, and long-term goals for research on Category
A agents, a group of microbes and toxins identified by the CDC as the
most dangerous. These include anthrax, smallpox, plague, botulism,
tularemia, and hemorrhagic fevers caused by viruses such as Ebola.
Thus, the initial focus of our biodefense research effort has been to
develop new and improved vaccines, therapeutics, and diagnostics
against Category A agents. An essential component of this program is
enhancing the Nation's capability to conduct research on these agents.
This requires that additional high-containment research facilities,
known as BioSafety Level-3 (BSL-3) and BSL-4 laboratories, be
constructed and made accessible to government-supported scientists.
Also required to fulfill the goals of our research program are other
specialized research resources such as centers for sequencing the
genomes of these microbes, and skilled scientists and technicians who
are trained to handle dangerous microbes and toxins.
In addition to research on Category A agents, NIAID is also
spearheading efforts to develop new and improved vaccines,
therapeutics, and diagnostics for Category B and C agents. Again, based
on the recommendations of a blue ribbon panel, we developed the NIAID
Biodefense Research Agenda for Category B and C Priority Pathogens.
These agents include a diverse array of viruses, bacteria, and
bacterial toxins that are carried by insects, livestock, or other
vectors; can be inhaled; or are spread through contaminated food and
water. They include the bacteria that cause typhus and cholera, and
viruses such as West Nile virus, which is carried by mosquitoes, and
tick-borne encephalitis virus. As is the case for the Category A
agents, NIAID research on Category B and C agents is designed to
understand the biology of the microbe and the host response to the
microbe, and to use that knowledge as the basis for developing safe and
effective vaccines and other medical countermeasures.
Why has NIAID identified certain biological agents as its top research
priorities?
I have already indicated that the NIAID biodefense program emphasizes
research on Category A agents: anthrax, smallpox, plague, botulism,
tularemia, Ebola and other hemorrhagic fever viruses. Why are these
viruses, bacteria, and toxins considered the most dangerous potential
agents of bioterrorism? Many other microbes, such as those that cause
measles, mumps, or even AIDS, cause serious illness but are not on the
Category A list. Simply put, the high-priority Category A agents
include organisms that pose a risk to national security because they:
Can be easily disseminated or transmitted from person to
person
Result in high mortality rates and have the potential for
major public health impact
Might cause public panic and social disruption
Require special action for public health preparedness
Category B agents are considered to have the second highest priority in
terms of their bioterrorist threat potential. These agents are
moderately easy to disseminate, result in moderate morbidity rates and
low mortality rates, and require specific enhancements of our
diagnostic capacity and enhanced disease surveillance. Category C
agents have the next highest priority. They include emerging pathogens
that could be engineered for mass dissemination in the future because
of their availability, ease of production and dissemination, and
potential for high morbidity and mortality rates and major health
impact.
What is NIAID doing to ensure that vaccines and therapeutics are
developed as rapidly as possible to protect homeland security?
The process by which NIAID is developing safe and effective
countermeasures for biodefense is complex and multifaceted. I would
like to describe, in general terms, how we develop vaccines. I will
relate this process to the specific development of vaccines and
therapeutics for biodefense.
In general, the NIAID has three broad goals in vaccine research:
Identifying new vaccine candidates to prevent diseases for
which no vaccines currently exist.
Improving the safety and efficacy of existing vaccines. (NIAID
researchers are collaborating with colleagues at USAMRIID, and with
private industry, to develop and test safer, next-generation vaccines
for smallpox and anthrax.)
Designing novel vaccine approaches, such as new vectors and
adjuvants (Scientists at the NIAID Vaccine Research Center are working
to develop gene-based vaccines for Ebola and related viruses.)
To achieve these goals, NIAID supports basic research to understand the
biology of the microbes that cause disease and to determine how humans
and other animals respond to infection with these microbes. Key to our
understanding of microbial biology is identifying the nucleic acid
sequence of their genomes. With this information in hand, we will be
better poised to identify molecular targets to use in the design of
vaccines or therapeutics. Recently, for example, two teams of NIAID-
funded researchers at The Institute for Genomic Research in Rockville,
MD, reported the complete genetic sequence of the strain of Bacillus
anthracis used in the 2001 anthrax mail attacks, and the complete
genomic sequence of the Q-fever pathogen and Category B agent, Coxiella
burnetii.
In addition to understanding how a microbe causes disease, it is also
important to understand how animals and humans respond to microbial
infection. NIAID supports research on innate and adaptive immune
responses in a range of animal models and in humans. We also are
working to understand how certain pathogens evade immune surveillance
and use this information to design ways to trigger a protective immune
response. We are investigating new immunostimulatory agents that boost
the effectiveness of vaccines. Additionally, we need to understand how
immune responses vary in different individuals according to age,
general health status, genetic makeup, and treatment with
immunosuppressive drugs.
Developing new and improved vaccines and therapeutics also requires a
strong clinical infrastructure. NIAID supports Vaccine and Treatment
Evaluation Units, which conduct human clinical trials to determine the
safety and efficacy of candidate vaccines for infectious diseases,
including several caused by Category A, B, and C agents. This network
has served as a national resource for the independent evaluation of
vaccines since 1992.
Another primary objective of the NIAID biodefense research program is
to attract the long-term interest and support of academia and industry
in the efforts needed to develop effective bioterrorism
countermeasures. NIAID's biodefense research program facilitates the
involvement of academic scientists through the use of all available
funding mechanisms, including the development of a network of Regional
Centers of Excellence for research on bioterrorism and emerging and re-
emerging infectious diseases.
Key to the development of safe and effective medical countermeasures
for biodefense are collaborations with private industry. Since the Fall
of 2001, we have strengthened and expanded our interactions with the
private sector, including biotechnology companies and pharmaceutical
manufacturers. Many biodefense products will not provide sufficient
incentives for industry to develop on their own, because a profitable
market for these products cannot be guaranteed. Therefore, NIAID has
developed public-private partnerships to overcome these obstacles.
Also, the passage of Project BioShield, which would authorize the
purchase of biodefense countermeasures, would provide a much-needed
incentive to participate in this effort.
Our biodefense strategic plan and research agenda has required an
expansion of investigator-initiated and Institute-initiated grants and
contracts. In Fiscal Years 2002 and 2003, NIAID developed a total of 46
biodefense initiatives to stimulate research: 30 are new initiatives
and 16 are significant expansions. During this same time period, NIAID
has seen a 30 percent increase in the number of grant applications; the
vast majority of these are in response to our biodefense initiatives.
Still another important element in our biodefense research program is
an enhancement of Intramural research. Of note, the NIAID Vaccine
Research Center, is working on the development of new and improved
vaccines against a range of bioterrorist threats, including the Ebola
virus, as well as a next-generation vaccine against smallpox.
Related to our biodefense preparedness research program is a more
recent, NIH-wide effort to develop effective countermeasures against
chemical and nuclear/radiological weapons. We recognize the NIH may not
necessarily have a predominant role in developing countermeasures for
these threats, although we must still be prepared for any eventuality.
Dr. Elias Zerhouni, the director of NIH, has established the NIH
Biodefense Research Coordinating Committee to facilitate and coordinate
the development of a research agenda and to implement R&D programs that
address relevant aspects of chemical and nuclear/radiological threats.
Dr. Anthony S. Fauci, the director of NIAID, serves as committee
chairman.
That concludes my testimony. I would be happy to answer any questions
you may have.
Ms. Dunn. It was a little difficult to hear, and so I would
like to know from you, both you gentlemen, the list that we
talked about, the categories A, B and C that are current
priorities, how will they compare, do you believe, over what
you expect to recommend to the Secretary as your bioterrorism
threat prioritizations as we move into the future?
Dr. LaMontagne. Well, I would say that we strongly believe
the Category A agents represent the major threats, and within
that list three major targets, I think, for which there is
probably unanimous agreement is smallpox, anthrax and botulism,
but all of the agents on that list--all seven of the category A
agents, I think, are considered to be important targets.
Dr. Khan. Let me state that the list that we are talking
about are the identical lists, so NIH at least has coordination
between CDC and NIH on these same lists. And, again, our State
and local health departments and the medical community agree on
the nature of those lists and how they were put together. The
criteria to put together those lists and the agent remain valid
currently, and the agents within them and the way they were
prioritized also appear to remain valid. The Agency already
reevaluates this process on a yearly basis as they provide new
guidance to State and local health departments to verify that
the lists are valid.
Ms. Dunn. Thank you. Yesterday we had a hearing in which we
discussed these issues with the man in charge for the
Department of Homeland Security, and I think we all had some
question that over the next 10 years we are going to be
spending $5.6 billion on this program. We want to make sure
that DHS can handle it. A few months ago, the SARS epidemic
struck North America and the rest of the world. Not knowing at
the beginning whether this was a biological attack, how did the
Department of Homeland Security work with both of your
organizations in responding to the outbreak? What
organizational structure was established? And were you
effectively able to work through that problem?
Dr. LaMontagne. Well, I think in response to the question
about interaction or communication with homeland security, I
think that given the youth of the organization and the idea of
homeland security, that is, I think that our interactions have
been actually quite good. We do have frequent meetings with
them. There are meetings at the departmental level as well, but
I am not perceiving that there is an inability to communicate
with them pretty effectively on these issues. I think we do.
Dr. Khan. Let me make a comment about SARS. I just came
back from 5 weeks in Singapore assisting them with the SARS
outbreak, and I asked for consultation with Mr. Joe Henderson
about this question in preparation for this question, and, yes,
CDC did work with DHS to discuss the SARS outbreak.
Let me state that we have been doing this for a number of
years. We did it for the West Nile outbreak when it was
originally identified in the United States to verify that it
was not bioterrorism. There are also published guidelines on
how we evaluate epidemics, coauthored by CDC and the FBI to go
through the epidemiologic and laboratory criteria on how to
investigate an outbreak and say whether or not you think it is
bioterrorism.
For specific comments about our current relationships and
structure with DHS, if you would allow me, I believed defer to
Mr. Henderson who can talk about our specific relationships.
Mr. Henderson. Thank you for the opportunity to make a few
additional comments on what Dr. Khan had mentioned regarding
our work with homeland security. It is a new forming
organization, and we are working with them closely. When SARS
first appeared, of course the first thing we were concerned
with was that it was, in fact, potentially a terrorism event.
Since September 11th, that is the way our thinking has been in
relation to emerging diseases and outbreaks globally. We have,
I think, additional room to work with homeland security to make
sure that we have a process in place to rapidly analyze
information regarding potential terrorist threats, but we do
have a routine communication with homeland security on these
issues.
Ms. Dunn. Thank you, gentlemen. Dr. Khan, you mentioned in
your statement that both civilian and military intelligence
experts were parts of the panel that the CDC established in
1999 to help formalize and prioritize the categories A, B, and
C biological agents and you also mentioned that participants
with appropriate clearance levels also reviewed the
intelligence information regarding classified suspected
biological agent threats to civilian populations.
Can you tell us what agencies within the Intelligence
Community participated on your panel generically and at an
unclassified level can you explain how this information was
analyzed? For example, is the information a product or raw or
analyzed information. Is this collaboration still ongoing?
Dr. Khan. We can submit to the committee a complete list of
agencies and individuals who were present at that briefing if
they would request. As far as putting the list together, the
purpose of the list was actually to try to develop something
that would not be classified and be available for the whole
public health and medical community. So we took the information
that was available on the biowarfare agents and extrapolated
that to what would happen in specific categories if they were
used on civilian populations. That allowed us to go from what
would essentially be considered some sort of classified
information to unclassified public use information that would
be used for preparedness purposes.
Ms. Dunn. Looking forward to that list. Thank you very
much, gentlemen. And now, Congressman Turner, would you like to
ask your questions for 5 minutes?
[The information follows:]
Participants in CDC Critical Biological Agents for Public Health
Preparedness Meeting, June 3-4, 1999
Donald A. Henderson, M.D., M.P.H.
Director,
Johns Hopkins Center for Civilian Biodefense Studies
Thomas Inglesby, M.D.
Johns Hopkins Center for Civilian Biodefense Studies
Dennis Perrotta, Ph.D.
Chief, Bureau of Epidemiology,
Texas Department of Health
Mike Osterholm, M.D., M.P.H.
Chair and CEO
Infection Control and Advisory Network, Inc.
Kenneth Bernard, M.D.
Special Advisor to the Assistant to the
President of the United States on National Security
Kathy Zoon, Ph.D.
Director, Center for Biologics Evaluation and Research
Food and Drug Administration
Mark Elengold
Deputy Director, Center for Biologics
Evaluation and Research
Food and Drug Administration
George Hughes
Special Agent
Office of Criminal Investigations
Office of Regional Affairs
Food and Drug Administration
John Taylor
Senior Advisor for Regulatory Policy
Office of the Commissioner
Food and Drug Administration
Martha Girdany
Biological and Chemical Group
DCI Nonproliferation Center
Kathleen Kuker
Director, Weapons of Mass Destruction Operations
Federal Bureau of Investigations
Howard Stirne, M.D.
Consultant, Medical Coordinator, SWAT EOD
Federal Bureau ofInvestigations
Jeff Mazanec
Supervisory Special Agent,
Joint Terrorism Task Force
Federal Bureau ofInvestigations
Arlene Reidy
Department of Justice
Ted Plasse, M.S.
Defense Intelligence Agency
Biological Warfare Group
LTC Ted Cieslak, M.D.
US Army Medical Research
Institute of Infectious Diseases
William Raub, Ph.D.
Deputy Assistant Secretary for Science Policy
Department of Health and Human Services
Amandeep Matharu
Scott Lillibridge, M.D.
Director, Bioterrorism Preparedness and Response Program
National Center for Infectious Diseases
Centers for Disease Control and Prevention
Steve Ostroff, M.D.
Associate Director for Epidemiologic Science
National Center for Infectious Diseases
Centers for Disease Control and Prevention
James LeDuc, Ph.D.
Associate Director for Global Health
National Center for Infectious Diseases
Centers for Disease Control and Prevention
Ali Khan, M.D.
Deputy Director, Epidemiology and Surveillance
Bioterrorism Preparedness and Response Program
Centers for Disease Control and Prevention
C.J. Peters, M.D.
Chief, Special Pathogens Branch
Division of Viral and Rickettsial Diseases
National Center for Infectious Diseases
Budget Examiner for Bioterrorism and Food Safety
Office of Management and Budget
Department of Health and Human Services
RADM Robert Knouss, M.D.
Director, Office of Emergency Preparedness
Department of Health and Human Services
CDR Kevin Tonat, Dr.P.H., M.P.H.
Special Assistant to the Director
Office of Emergency Preparedness
Department of Health and Human Services
John La Montagne, Ph.D.
Deputy Director, National Institute of
Allergy and Infectious Diseases
National Institutes of Health
James Hughes, M.D.
Director
National Center for Infectious Diseases
Centers for Disease Control and Prevention
Centers for Disease Control and Prevention
Robert Craven, M.D.
Chief, Epidemiology Section,
Arbovirus Diseases Branch
Division of Vector-Borne Infectious Diseases
National Center for Infectious Diseases
Joseph Esposito, Ph.D.
Chief, Poxvirus Section, Viral Exanthems and
Herpesvirus Branch
Division of Viral and Rickettsial Diseases
National Center for Infectious Diseases
Centers for Disease Control and Prevention
David Ashford, D.V.M., M.P.H.
Meningitis and Special Pathogens Branch
Division of Bacterial and Mycotic Diseases
National Center for Infectious Diseases
Centers for Disease Control and Prevention
David Swerdlow, MD
Foodborne and Diarrheal Diseases Branch
Division of Bacterial and Mycotic Diseases
National Center for Infectious Diseases
Centers for Disease Control and Prevention
Steve Bice
Chief, National Phannaceutical Stockpile Branch
Division of Emergency and Environmental
Health Services
National Center for Environmental Health
Centers for Disease Control and Prevention
Lisa Rotz, M.D.
Bioterrorism Preparedness and Response Program
National Center for Infectious Diseases
Centers for Disease Control and Prevention
Peg Tipple, M.D.
Assistant Director of Medical Science,
Office of Health and Safety
Office of the Director
Centers for Disease Control and Prevention
Bryan Hardin, Ph.D.
Deputy Director
National Institute for Occupational Safety and Health
Centers for Disease Control and Prevention
Scott Deitchman, M.D.
National Institute for Occupational Safety and Health
Centers for Disease Control and Prevention
Arnold Kaufmann, Ph.D.
Emergency Response and Coordination Group
National Center for Environmental Health
Centers for Disease Control and Prevention
DDonald Shriber, M.P.H.
Associate Director/Washington
Centers for Disease Control and Prevention
Martha Katz
Deputy Director for Policy and Legislation
Office of the Director
Centers for Disease Control and Prevention
Mr. Turner. Thank you, Madam Chairman. Dr. LaMontagne, I
want to start with you and ask a couple of questions.
Under the BioShield legislation that is before this
committee, the funding that has been talked about so much and
has been modified as it has moved forward through the process
of congressional hearings, is dedicated to ``security
countermeasures'' which are defined under the bill as
``approved drugs or drugs that have sufficient clinical
experience or research data to qualify for approval or
licensing at a later date.'' Now, one of the concerns that I
have had about BioShield is that the much talked about funding
is limited to that stage at the end of the process after the
vaccine has been discovered, after it has been tested at an
applied research level, after all that is done. Only then is
the BioShield funding available to contract with the private
company to go through the final stages of clinical trials and
production of the vaccine. That is what is referred to
oftentimes by Dr. Fauci as the pull side of the equation. I am
more interested in, because of the area that you work in,
understanding the push side of this process. And I know that
the creation of the Center for Vaccine Research deals with a
broad category of potential threats. I think it was originally
created to try to deal with AIDS. But you obviously have
expanded it and it is now the entity that would deal with the
basic research, the applied research, and developing the
vaccines necessary to meet these biological threats that we
have talked about.
I am very interested in how you view the capability that
you currently have, even with the expanded funding, to provide
the leadership that is necessary to do the basic research and
the applied research to come up with the vaccines that can be
moved to the final stages, develop as and produced the private
sector. Could you give us some feel for your capacity to
accomplish that task?
Dr. LaMontagne. Well, I will try. That is a complicated set
of questions. But let me begin by clarifying something about
the Vaccine Research Center, which, as you said, is the unit
which is on the NIH campus which is part of our Institute
dedicated to the development of vaccines. And it was created 4
years ago or so with the express notion that it would focus on
AIDS vaccines. It has expanded its agenda in a clear reflection
of the pressures and priorities that the Nation is facing to
add to its activities some very important work in other
vaccines, particularly Ebola virus and West Nile, which are two
very interesting projects that it has currently underway.
The process of vaccine development or countermeasure
development, however you want to phrase it, particularly for
biodefense agents, is a very complex one because for one thing
the marketability of these products at the end of the process
is limited. Secondly, the ability to test these materials in
the traditional randomized clinical trial settings that we have
become accustomed to, for example, for AIDS drugs or for other
vaccines is simply not available. There are not enough anthrax
cases, for example--anthrax, fortunately is not a common
disease, plague is not a common disease, Ebola is not a common
disease. To satisfy the standards for efficacy and safety that
one might require under normal circumstances, we have had to
adapt to what the FDA is now referring to as the two-animal
rule. In other words, we will seek to gain evidence of the
efficacy of these materials by testing them in a very rigorous
manner. There is not going to be any compromises here in terms
of their ability to elicit protective responses in at least two
different animal model systems. We will then use that
information in addition to information obtained in clinical
trials of the antigenicity of these or the immunogenicity, the
ability of these vaccines, for example, to elicit protective
immune responses in humans and compare those to what we see in
the animal model systems. Based on that information we should
be able to assess whether or not a particular vaccine is of the
quality that will provide the kinds of protection that are
needed to prevent disease following a challenge from whatever
source.
I should just conclude my remarks by saying there is
another very difficult aspect to this, and that is what you can
do in a laboratory; for example, the Vaccine Research Center
can make candidate vaccines in the 10,000 to 20,000 dose range.
When you are talking about vaccines that are going to be
required in the millions or tens of millions of dose ranges,
you require an amplification of production capacity that really
only exists in the private sector. So we have to develop
methods or ways of attracting and bringing the private sector
into this process early on so that they can then take the
handoff when it is appropriate and move those vaccines into the
level of production that is going to be required to meet a
national challenge such as the one we are facing.
I hope that answers your question.
Mr. Turner. I will follow up with you on my next round of
questioning. Thank you, Doctor.
Chairman Cox. [Presiding.] Thank you. The Chair recognizes
himself for 5 minutes. What we are interested in here today, in
particular, is to propose the role for the Department of
Homeland Security because nothing that gets funded under
Project BioShield for ultimate stockpiling and use can go
forward unless there is a materiality determination by the
Secretary of Homeland Security under the terms of the proposed
statute; that is, the statutory scheme, so very literally the
determination, responsibility exercised by the Secretary of
Homeland Security is the linchpin of all of the scientific work
that proceeds and all the monies that get spent in support of
it and in support of the stockpile.
I have every confidence that CDC, NIAID, are competent to
determine the relative lethality of the different agents that
might be used against our human population, against American
people as the result of a terrorist attack or military threat.
But the job of Homeland Security encompasses more than that. We
have to have some notion of what are the capabilities of
terrorist groups, what are the capabilities of states or other
individuals or organizations; second, what are the means that
these states or terrorist groups or individuals might use to
deploy those weapons; and, third, perhaps most important, what
is the probability of that happening given their capabilities
and given the means of deploying the weapons. Ultimately, of
course we have to go back then to the science and say if they
are going to deploy in this fashion, given their capabilities
what would be the relative lethality, what would be the effect
and, summing it all up, is that material?
I first want to ask you whether or not either of your
organizations has any analytical capability with respect to
identifying terrorist groups, states, individuals or
organizations who possess these agents or the capacity to
manufacture and deploy them and, second, whether or not you
believe that that is something that if you can't do, that
Homeland Security will be able to get its arms around and
interface with you so that you can do the crosswalk because you
have information that their analysis is dependent upon and vice
versa?
Dr. Khan and Dr. LaMontagne, in either order.
Dr. Khan. Let me start by saying that as we devise these
critical agents lists, it was--the criteria that were put
together were more than the lethality and the mortality of the
agent. We tried to integrate in what was known about whether
these agents had been weaponized and previously used
potentially and how these agents would be transmitted.
Chairman Cox. What is the source, Dr. Khan, for that
information? Is that an input for you or is that something that
you can develop yourself based on resources that you possess?
Dr. Khan. A lot of it was from input from our intelligence
experts. Some of it is from--.
Chairman Cox. You say our intelligence experts, you mean?
Dr. Khan. Our civilian and military intelligence experts
who provided input into the process of putting together the
list. I promised a copy of all the individuals who participated
in the--.
Chairman Cox. Does ``our'' refer to CDC?
Dr. Khan. No, I am sorry, the United States.
Chairman Cox. So those are outside inputs for CDC? Is the
same true for NIAID?
Dr. LaMontagne. Absolutely. We don't have any internal
ability to do that kind of analysis
Chairman Cox. And then once you have those inputs and you
are taking that information and running with it, do you then go
back to those sources with the question of how might these
agents be weaponized and dispersed?
Dr. Khan. That information was used in deriving the list.
And we took into account the worst case scenario, which would
be that these agents would be well produced and distributed by
large particle aerosols. And then when you integrate that in
with what we know about the morbidity and mortality, then you
get a set of agents, the seven that we have mentioned, that
would likely cause the most public health impact given all the
right conditions for how the agent is manufactured, produced
and distributed.
So that list is not just the most lethal diseases because
if you put a list together of what the most lethal diseases is
you would start with rabies potentially at the top and Ebola
and HIV and other diseases before you would get down to the
seven that we are talking about. So it is more than just what
is likely to kill you, it is what is likely to be produced and
manufactured, what is their data and that if it is disseminated
deliberately would cause a lot of public health damage.
Chairman Cox. Dr. LaMontagne.
Dr. LaMontagne. I would agree with what Ali has said but I
also would comment that, yes, if we need additional information
about whether some agent can be weaponized and how, we would
have to ask for advice or information or input from the
intelligence agencies. That is the only way we would know how
to get that information. We have done that. I mean, they do
communicate with us on these issues as well.
Chairman Cox. I think that my time has expired and I look
forward to pursuing this line of questioning further. I believe
that the gentleman from New Jersey, Mr. Andrews, is next to ask
questions.
Mr. Andrews. Thank you, Mr. Chairman. I would like to thank
the witnesses and follow up on the chairman's line of questions
about inputs from intelligence sources and then outputs from
your research work and management work to other groups. I
assume that if they have not already done so, that terrorist
organizations and enemy states are going to gain some knowledge
of our vaccine potential or treatment potential and begin
efforts to alter bacterial agents in a way that would defeat
those vaccine efforts. I think it is a fair assumption that
someone is going to try to do that.
How would you find out that such an effort to alter had
taken place? Would you have to ask the intelligence agencies or
is it your experience that they would volunteer that
information to you?
Dr. Khan. If I could defer this question to our current
director of the CDC program who deals with these agents.
Mr. Henderson. Thank you. Basically we do have some--.
Chairman Cox. I am sorry. Excuse me, sir. As you prepare to
answer this question could you identify yourself for the
record?
Mr. Henderson. My name is Joe Henderson. I am the Associate
Director for CDC's Terrorism Preparedness and Emergency
Response Program. We do have a scientific capability to look at
organisms that we fear may have been genetically manipulated.
One of the first tests we did with the anthrax events of 2001
was determine its antibiotic susceptibility. If we see that the
organism is not susceptible to those antibiotics that it
normally would be susceptible to, we would be suspicious. Then
we have other laboratory tests working with the NIH and the
military to determine if in fact we could tell with some
certainty that an organism has in fact been manipulated.
Mr. Andrews. Let me use this example. Let's assume that our
Intelligence Community discovered research being done on a new
strain of synthetic anthrax and they had some information about
that. It was taking place somewhere else in the world. What
procedure exists for them to brief and notify you about that so
you can begin to reassess your matrix of threats that you have
to address?
Mr. Henderson. I would say that prior to September 11th,
2001 it virtually didn't exist. Since then I think our ability
to work with the Intelligence Community has improved
considerably. For example, if we were to hear about--if there
was in fact known intelligence that either the CIA or the FBI
or the National Security Council or even DOD's intelligence arm
found to be credible they clearly would work through the
Department of Health and Human Services through--the structure
we use is through the Secretary's command center to communicate
to CDC this known threat. This has happened several times, most
recently prior to the war with Iraq where we were concerned
about retaliation.
Mr. Andrews. I appreciate the answer. Mr. Chairman, what I
find instructive about the answer, which is entirely candid and
accurate, is that the Department of Homeland Security never
emerged anywhere in the answer to the question, which I think
tells us something about the intelligence problem that we have,
not you.
Second question is about outputs from research. I assume
that if you are successful in identifying the--I may not
pronounce this correctly--nucleic acid sequences of some of the
biological agents, that that research might also have some
usefulness or viability in the technology of detection. I
assume right now it is impossible to know that someone is
bringing in a vial of smallpox in a suitcase through an
airport. It would be impossible to screen and identify that in
any kind of technological way. I assume, though, that the more
you learn about the makeup of these biological agents the more
possibilities there are for research to detect the presence of
the particular characteristics of these agents so they could be
screened, they could be detected, they could be prevented from
being brought into the country.
What mechanism exists for to you share the research that
you have done at NIH about the makeup of these agents with
others that might use that research for purposes other than
creating vaccines but, for example, for purposes of creating
detection technology that might detect the presence of such
agents?
Dr. LaMontagne. Well, I think we use a lot of traditional
methods for that kind of transmission of information. Meetings,
workshops, publications, are very commonly used for that
purpose, and I think we would exploit all of them to try to get
that moving into that direction.
Mr. Andrews. Here again I think it is interesting that what
we need is some kind of institutionalized connection between
your agency and the Department of Homeland Security since if
such a technological gain were possible, and it isn't today,
but if it became possible we would want to see an
institutionalized mechanism where you would report that
information to the DHS so they could begin the practical
application research to do something with it. I offer no fault
or criticism of you. I think it shows a disconnect in the
structure that we have created that could fully exploit the
research that you are doing.
I see my time is up, Mr. Chairman. Thank you.
Chairman Cox. Thank the gentleman. The gentleman from
California, Chairman of the Armed Services Committee, Mr.
Hunter, is recognized for 5 minutes.
Mr. Hunter. Thank you, Mr. Chairman. I want to thank my
colleague from Texas here for letting me take the next
question. Gentlemen, it looks to me like we have been looking
at this from the defense aspect. At some point we have to have
in place a mechanism that would have maybe four parts to it:
First, the ability to detect bad stuff quickly; secondly, the
ability to analyze that stuff; thirdly, the abilities to
quickly fabricate vaccines; and lastly, the ability to
vaccinate the people who might be victims of that, whether it
is uniform folks or folks in the population. And bringing into
focus or focusing all this weight of talent that we have spread
out across our institutes, our educational system, our private
sector and the elements that are in DOD, bringing them, the
weight of that talent into focus against those four elements
that I just laid out looks like is a major challenge. And so
maybe we are going to have two types of programs that we have
to run. One is for what I would call anticipated problems and
those are the major threats that you have listed in your
categorization from A in descending order, things that we know
are out there and that we are going to have to deal with but,
secondly, the ability to deal with unanticipated stuff.
So I would like to ask you your thoughts on whether you
think we can do this, knit together a mechanism that can
rapidly--and I think the key here is time is going to be of the
essence--rapidly detect, analyze, fabricate inoculation or a
medicine that will handle this particular problem and, lastly,
protect our folks; that is, get the inoculations to them. You
think we are going to be able to draw together from all these
disparate elements this capability?
Dr. Khan. Let me talk to the first two elements of that.
Mr. Hunter. Pull that thing up close because I have trouble
hearing. I would rather have you louder than softer in here.
Dr. Khan. The detection and analysis part is very much a
function of what we do domestically with our State and local
health departments working with CDC to try to figure out what
new diseases or emerging diseases may be out there, quickly
figure out that that disease is out there, find the agent,
characterize the agent, and then move to step three, which is
your step about fabricating vaccines, et cetera. That also
works in the international arena.
Let me just use SARS as an example of how that worked.
Working with WHO, we discovered that there was a new disease
out there which had never previously seemed to have been
described as causing a lot of infection among health care
workers who were dying. It was mainly focused in the health
care setting. Working with our partners in WHO, and that meant
putting staff out there in countries, we got hold of this
agent, uncharacterized, brought it into the agency, quickly
were able to isolate it and identify that this was a brand-new
virus which was a type of corona virus, sequence the agent
within weeks to help develop diagnostic tests.
Now part of that process was that we shared what materials
we got with NIH and other members in the private community and
academic community and said, look, this is what we have, this
looks like it may be a new corona virus. Can you help us
develop diagnostic tests, can you help us develop new
countermeasures against these agents? That happened extremely
fast in this case. We would like that to be a model of how we
look at not just new and emerging infectious diseases, but BT
is part of that broader pallet of emerging infectious diseases
that if somebody did release something like anthrax or plague
that quickly that identification would occur in the local and
public health departments, that agent would be very quickly
characterized to say we have looked at the genes, none of these
genes have been swapped, it doesn't look like it is abnormal or
it does look like it is abnormal, there seems to be new genetic
markers in there, it seems to be resistant to everything, why
is that, that shouldn't happen naturally, and then move it to
the next step with NIH to get us forward from there.
Dr. LaMontagne. I think I would add to what Ali has said,
Mr. Hunter, that actually in the field of infectious diseases
there is actually a lot of communication among investigators
out there. There has also been historically--I have been at the
NIH for 27 years--a lot of very positive interactions between
DOD agencies and CDC and NIH on many, many of these issues. So
we have a track record of really sorting through these
problems, I think, pretty effectively.
The latter two points that you made in terms of developing
the vaccines or countermeasures and actually deploying them
effectively are really formidable challenges though that
require considerable amount of investment in research and in
infrastructure to accomplish successfully. I think that that is
one of the areas that we really need to work most actively on
because it is the most difficult.
Dr. Khan. If I could pick up from number 3 and 4 from John
to go to 4, which is you get the vaccine but that is only
partway there. You have to get it into people's arms or the
drug, you have to get it into somebody's body. Then you have to
monitor for the side effects, you have to maintain registries
of those people. And that applied public health research is
where CDC comes back into the picture to say, okay, there is
actually some public health research involved in that part of
the process. There was obviously research involved in the first
part, the surveillance methodologies. The diagnostic methods we
have out there didn't come de novo. It took a lot of work and
research to say these are the best strategies to find out what
is going on, these are the best diagnostic tests. So research
infuses the whole process.
Chairman Cox. Does the gentleman have further questions?
Mr. Hunter. No, Mr. Chairman. I appreciate it.
Chairman Cox. The gentlelady from Missouri, Ms. McCarthy,
is recognized for 5 minutes.
Ms. McCarthy. Thank you, Mr. Chairman. Thank you for your
thoughtful presentation as well as your thoughtful responses to
the committee's questions. I would like you to elaborate a
little bit. When Ms. Dunn was inquiring you talked with us
about how the agencies have been coming together to work with
you. But I wonder if you would expand a little bit on how the
Intelligence Community is helping you assess what biological
issues are priorities for us so that we can further direct you
not only in your research but in your ability to help our local
responders and communities all over America be adequately
prepared.
When I visit with my local responders out in the heart of
America, their biggest fear is that they do not have the means
to both coordinate with the hospitals and emergency centers in
the case of a biological incidence but that even if there are
drugs or other materials available that they won't have them or
the ability to disseminate them. While I know that you are
primarily involved in the research end of this, please know
that whatever comfort you can bring in your work to those on
the front line 24/7 would be of great help to us and to our
work and how we might better serve you in accomplishing that
goal.
Dr. Khan. If you would permit, let me ask that question of
the current Director of our CDC Bioterrorism Program, who deals
with these local and State preparedness needs all the time.
Mr. Henderson. Thank you, Dr. Khan. Excellent question, two
parts of your question I see. One is how do we take the
intelligence that we are currently getting at CDC and then
translating that down to our State and local colleagues. I do
want to mention a bit about our grant program from CDC that as
at the end of August of this year we will have funded $2
billion to State and local health agencies, which has been a
huge infusion into the public health system to assure they can
in fact respond to these terrorism events. The intel piece, the
challenge for us at CDC and the Department of Health and Human
Services is the fact that our method of looking at information
and data to determine how it might trigger an outbreak of an
infectious disease or some other type of public health
emergency is different than what the Intelligence Community
does to analyze intel that comes in. We basically in public
health like to investigate every possible event that could lead
towards some type of illness, injury, death, even if it only
affects one person. Intel we are finding out and becoming more
knowledgeable about this process and gathering information from
the Intelligence Community is a bit more of an art than a
science we are finding, and it is difficult for us to really
weed through all that to find out what in fact is credible
information that needs to be relayed to the State and local law
enforcement officials and public health so we can have a
unified response in addressing the threat.
So we continue to work on that to try to improve that. But
again since September 11th we have done a lot with our health
alert network to disseminate information to State and local
health colleagues and through governors' offices and State
emergency management officials so that they are constantly
aware of what we find throughout the Nation and globally that
they need to know about that could potentially impact and
affect their populations.
The grant program we always say at CDC and with our
colleagues at the National Association of County and City
Health Officials that all response is local. We know that. For
a terrorism event we know that regardless of the event the
first 48 hours is going to fall on the backs of State and
local, really the local public health officials to respond
effectively to mitigate the consequences and recover from that
event.
We are building capacities at all levels. We know we need
to continue to focus on the local level. Our grant program
looks for meaningful collaboration between State and local
health officials to ensure they have that capacity. We will
continue to improve this program to assure we see that local
response capacity.
Ms. McCarthy. I thank you for that information and would
like to suggest that if we on this committee can be of further
assistance to you in reaching that goal you just described of
adequately preparing our local first responders you must make
us aware of that so we can be your advocates in the Congress. I
know that my community--I have the greater Kansas City area on
the Missouri side and suburbs--did receive a homeland security
grant recently for training and equipment for our local
emergency responders. For example, in Independence, Missouri,
Harry Truman's hometown, my police chief, my fire chief can't
communicate with each other. Equipment doesn't talk to each
other. When we had the tornado incidents recently they used
their cell phones for as long as they could before those went
out in order to meet the needs of the community and the
surrounding communities. So you know, that grant money is
helpful but still not enough. And I am thinking $2 billion, I
applaud you for that on the efforts to help our first
responders on the bioterrorism aspect of it, but I would like
to say that that is not enough money either for what is needed
locally all over this country. And we need to be sure we
educate everyone to the fact that you know we aren't going to
leave them out there with great expectations but without the
means to carry out their work. They want to do what is right.
They are training and preparing to do so and we at the Federal
level must be willing to help be that partner.
So to the degree you can continue to advocate among the
executive branch for better funding, for full funding, for
adequate funding to carry out the goals you have established
through your research and your intelligence and your work, then
we can all be partners in seeing that the people's needs are
met in a crisis anywhere in America. Let's hope that we never
need to, but I do know that it is a very real concern out there
in the heart of America, I would expect in all the communities
represented here today on the committee.
And I want to, Dr. Khan, thank you for your work with the
intel officials that you have been meeting with and continue to
do so, please, because it is critical that we all have the best
information possible and to the degree that we can anticipate
and be prepared the public will be better served.
Mr. Chairman, I would like to yield back the rest of my
time. I thank the witnesses and experts here today for
responding to my questions.
Chairman Cox. Thank the gentlelady. The gentleman from
Texas, Mr. Sessions, is recognized for 5 minutes.
Mr. Sessions. Thank you, Mr. Chairman. I don't know who to
direct this to on the panel, but I am sure each of you would
have an opportunity to make a comment. I believe as a result of
precaution in the last few months we have gone about
inoculating first responders, nurses, doctors, other people in
the community who would come upon a potential of smallpox. A
lot of people were given the inoculation. And I am interested
in hearing from you about how that worked, lessons learned,
things about not only giving the vaccination but people
receiving it, whether it was based upon a threat, whether it
was based upon, you know, just the best information that we
had. I am interested in an evaluation of how that process went
and has taken place because--and whether it was an actual
threat or whether it was just something we did as a precaution.
Mr. Henderson. Sir, I will take that question since at CDC
it is my primary responsibility to manage the National Smallpox
Program. It has been since August of last year. We have been
very involved with working with our State and local colleagues
on this issue. So I can touch on several aspects of your
question.
One, I want to mention the smallpox preparedness activity.
You seem to indicate in your question as though we have done
something and we are done with it and now we are looking back
to see whether or not we have actually succeeded. I have to say
that from CDC's perspective we have done an awful lot in the
past 8 to 10 months in improving overall focus on smallpox
preparedness, which is more than just offering the opportunity
to vaccinate individuals. It is also a focus on assuring there
are plans and employees that should you see a case of smallpox
in your emergency department you can mobilize your resources to
investigate that case, confirm that it is in fact smallpox
disease, isolate that patient, hopefully minimize the spread.
Those plans a year ago today, 10 months ago today, frankly
weren't in place. They are in place now.
Also having plans in place to assure you can protect your
population that hadn't really been exposed yet if you see
disease in your community through mass vaccination campaigns.
Those are extremely labor intensive plans that require a lot of
thinking, a lot of partnering at the State and local level with
a whole variety of stakeholders. Those plans are in place now.
They weren't a year ago today.
So even though there has been this focus on smallpox
vaccination there has been a much more broader focus on
smallpox preparedness in general.
I have to say that the vaccine program itself has been
relatively successful because we have people vaccinated now
that we will call upon to evaluate those first cases of disease
in the emergency department and to be called upon to
investigate cases of disease in the community through our
public health system. It is not the numbers that we had planned
for initially but it doesn't make the program a failure. We
think it still makes the program a success because we have over
270,000 doses of vaccine forward deployed that should we see a
case of smallpox we have people who are trained to vaccinate,
we have clinics set up to vaccinate people, to screen them
appropriately to assure we are not putting people in harm's way
who may be contraindicated.
So overall we see this program as being a success. It is a
success today and will continue to be a success as our State
and local colleagues are now developing plans to focus on their
supporting and maintaining smallpox preparedness into the
future.
Mr. Sessions. Well, I am glad to hear that it was a
success. I think what you are saying to me was it was necessary
to make sure we had a cadre of people who received the
inoculation so that if they do come into contact or once it is
recognized as smallpox is that, as Duncan Hunter said, that
thing that is out there, that we are able to then have a group
of people who are able to come into contact with those, and I
think that is wise management.
Secondly, I heard you say that you think it is at least
reasonably successful, and that makes me happy. I think this is
part of the preparedness that we are looking to CDC and this
administration to be in those sorts of positions.
I see my time is nearing an end. I would hope that at some
point also we are able to have some discussion about--Dr.
LaMontagne, you began to speak about it--but allowing the
private sector once whatever this thing is that is identified
but getting it to private sector companies, I am interested in
knowing how we can more effectively unleash them so that
bureaucratic rules, regulations do not hinder their ability to
properly function.
Dr. LaMontagne. If I could comment briefly on this in
relationship to the question on smallpox. We have actually been
managing an effort that involves various agencies of the
government, including CDC, FDA, USAMRIID and others, on the
development of a next generation smallpox vaccine that is
expected to be much safer. And that is a process that does
engage the private sector and our approach in that process has
been to generate milestone-driven initiatives where we will
evaluate over a period of time how the private sector that we
are providing resources to is actually performing against some
standards.
Mr. Sessions. Thank you. I thank our great chairman for his
leadership in today's wonderful meeting.
Chairman Cox. I thank the gentleman from Texas. The great
gentlelady from Texas, Ms. Jackson-Lee, is recognized for 5
minutes.
Ms. Jackson-Lee. Thank you, Mr. Chairman. I will work with
this microphone this morning again. I thank the witnesses very
much and I appreciate the testimony that I had a chance to
review and would like to raise several questions following the
line of some of my colleagues, but specifically I want to
acknowledge that all of us deal with the national security
question but certainly must deal with the securing of our
respective constituencies and the boundaries thereof. And in
particular, I serve an urban area, Houston, Harris County,
Harris County, one of the largest counties in the Nation,
Houston, the fourth largest city in the Nation, extremely
diverse, many individuals coming through for trade and other
reasons and as well coming from all parts of the world to live
in that community. So we have our respective challenge, but we
have a very strong base of resources because we have the Texas
Medical Center present, but also we have stakeholders like
Riverside Hospital, which is a historically black hospital and
we have the Lyndon Baines Johnson Public Hospital in the public
hospital system that has a very large clientele, patient base,
if you will, but not large enough.
So I want to raise the question that I raised earlier in my
opening statement and that has to do with the 40 million
uninsured individuals in America, those that don't have health
coverage. I raise that because individuals who have health
coverage are used to going to facilities, either have a
physician relationship, used to knowing where a health facility
or they know where a hospital is because they have a
relationship there. What is the planned response if a situation
arises where millions of people in an area need to go in for
consultation, then inoculation, then follow-up and there are so
many people without this good working relationship? How are
aspects of your agencies looking at the questions of facilities
to be in place for distribution that are not necessarily health
facilities? Would be the follow-up with these facilities then
continue or would you expect the normal public health system to
assist? How will the resources be distributed to take this
extra burden of people who don't have a standing relationship
and how will they know where to go?
One of the questions that I have been raising with the--I
have a homeland security task force in my community that I
convene and I include institutions of learning, public school
systems, as well as community groups because the question
always becomes how will they be secure, how will they be
apprised of the threat. So that is one question.
The other question comes with accountability. Six billion
dollar, part of the responsibility is of course to--I think the
language is push and pull, push for vaccines to expedite
research and pull by providing a market. What is the
accountability of the pharmaceutical companies in terms of
whether they will create the research, whether they will
provide for the actual creation of the drug, what oversight do
we have in doing that?
My last question involves this whole issue. I think your
testimony noted that there were certain bioterrorist entities
or drugs--not drugs but creations that we are aware of for at
least diseases rather, smallpox, anthrax, plague and botulism
as the top ones. What are we doing with respect to getting
ahead of that? And how soon do we think, for example, smallpox
will be available for everyone in the United States of America?
Dr. LaMontagne. Let me try to answer the question on the
accountability issue, which I think is an important concern. I
think there are a number of safeguards in the process that are
nested in the regulatory process that we go through for drugs
and vaccines that will ensure that whatever is available at the
end of the day is satisfactory and meets the highest standards
that we can achieve for a product to prevent or treat a
disease. I don't think there is any compromise in that at all.
So we will--I am pretty sure that--that is an important
safeguard. In addition, I think the--as I mentioned, there is
more of an attempt to use milestones, performance milestones in
the award of these kinds of contracts to make sure that
progress is at an appropriate level with the investment being
made.
Ms. Jackson-Lee. The uninsured?
Dr. Khan. Let me answer that from the aspect of local
preparedness. Your point is well taken and was actually one of
the foundations of the Bioterrorism Program when it was laid
out a couple years ago. All response, all detection occurs
locally. Nobody from the Federal Government is going to come
into your community and say, okay, I know where your hospitals
are, I know where your gyms are, I know where your facilities
are. This is where these people need to go. This is how this
needs to get set up. All that preparedness has to occur
locally. It is the local communities that will have to identify
where their hospitals will be, where their facilities will be,
what will be put up, what will be put down, and how they will
try to integrate in the national resources as they come in for
a response. And essentially the essence of our local
preparedness and response program is to get those communities
up and running with some guidance from the agency.
So, again, it is the local response that we are all
dependent on, all the Federal agencies that the local community
is ready and knows if this pharmaceutical stockpile comes with
100 billion doses of X, how do we move it from this gigantic
pallet into people's mouths. It is again the local community.
Ms. Jackson-Lee. On the smallpox immunization, what efforts
are we making to be able to immunize everyone in the United
States?
Mr. Henderson. Our plans right now are from the Department
of Health and Human Services, looking at where we are in the
clinical trials from the AKM products. First of all, I should
mention we do have enough vaccine right now that should we have
to vaccinate the entire population we can dilute existing
quantities of vaccine to do that. But we are looking for the
new product to be available in probably early to mid-2004.
Ms. Jackson-Lee. Let me just say thank you very much. Let
me say, Mr. Chairman, I thank these witnesses very much. I want
to make sure that the program of BioShield does not overlook
small hospitals, small research centers, historically black
colleges, Hispanic serving colleges where there are research
elements, native American institutions. I just simply in
closing would like to say that I would like someone to get with
my office in particular about exposing these other, maybe other
level entities about the research opportunities.
Can I just conclude by saying is there any foreclosure
precluding any of those kind of entities, smaller entities
being involved in the research of research grants that are
under your jurisdiction?
Dr. LaMontagne. Not at all. Actually we encourage that and
are trying hard to reach out to that community as well.
Dr. Khan. Same at our agency.
Ms. Jackson-Lee. If I could encourage that and also, as was
noted, these small and the local government areas, county
health clinics and city health clinics, that we can work
together to make sure that they are well informed and well
involved.
Thank you, Mr. Chairman.
Chairman Cox. The gentleman from North Carolina, Mr.
Etheridge, is recognized for 5 minutes.
Mr. Etheridge. Thank you, Mr. Chairman. And again thank you
for being here. Let me, Dr. Khan, go to you first if I may,
please, sir. Obviously all of us are concerned as we talk the
BioShield and the funds available here and it has been alluded
to already and several have asked questions, but let me follow
the question a little bit as it relates to districts because
all of us represent different districts. Mine is one that has
urban, suburban, rural, one large military base and a small
one. So it is a little unique and we have some of the large
institutions. Most of our responders, first responders are
volunteer, many of the areas as you can appreciate.
You said in your prepared testimony that a strong and
flexible public health infrastructure is the best defense
against any disease outbreak. That being said, the four areas
that I have talked about, the cities, the suburban areas, rural
areas and the military, which one is the weakest link in our
public health infrastructure and why? And what is the best way
to address these weaknesses as we see them and, finally, which
of these four areas is most vulnerable to attack?
Dr. Khan. They all, sir, have their own unique weaknesses
from a public health standpoint. I can't comment on the
military, but we do know based on the anthrax attacks in 2001
that our civilian population, and a previous attack using a
food borne agent, that our civilian populations are vulnerable
to attack using biological agents. And I will go back to your
comment about, I guess, what I originally started as my
comment, is our agency's comment about the public health system
requiring to be flexible.
Marcy Layton, who is the health director up in New York, is
the first person to admit that her response to West Nile virus
was better and was a more focused response because of her
activities for bioterrorism preparedness. That is very much
true if you look today at our response for SARS. Our response
to this international outbreak is a lot better than it would
have been based on our response to anthrax in 2001.
So, again, the bioterrorism preparedness activities are
helping to improve basic public health infrastructure. But we
need to remember that the broader pallet of what we need to be
doing is improving the ability not just for anthrax, which may
or may not happen again, or smallpox, but there continues to be
routine infectious diseases every day that need attention at
the domestic level and also many diseases that need attention
at the international level that we need to stay engaged in. And
within that milieu we will then find out about these new
diseases. But if we don't stay engaged in what is going on
every day, we will never fine anything new because we are
having trouble finding the old stuff and taking care of it.
Mr. Etheridge. You don't want to identify the weakest link
in each one, because each one has their weak links. The reason
I raise that question is because a lot of our States right now
are really pressed, a lot of our health facilities are woefully
inadequate and, to be very candid, because of the number of
years we haven't done the funding. I think as we look at this
whole issue of BioShield the weakest link is where we have the
greatest problem and we have to be prepared for that.
Mr. Henderson. Can I just follow up on that and add a
couple of things? You hit on a very important question, one
that drives us in looking at our State and local program, as
far as people ask us all the time are we prepared, who is
prepared, who is not prepared, et cetera. It is a really
difficult question to answer. There are three things that we
see that impact the success criteria. One is political will.
The second is leadership. And the third is resources. We have
seen local jurisdictions with very little resources but strong
leadership and political will that have done amazing things. We
have seen some jurisdictions with a lot of resources, but don't
have the political will, are struggling with leadership and
they are probably not as far along as their citizens would like
them to be.
It is trying to find ways to combine those three strengths
so we can assure we have a network of systems across the
country that can in fact prepare and respond to these events.
That is what we are doing in developing our evaluation criteria
for our State and local cooperative agreements, is to provide
the standards to assure we can develop those three success
criteria so we can improve preparedness.
Mr. Etheridge. Thank you. Let me go very quickly to the
next question because you testified, Dr. LaMontagne, about the
30 percent increase in the number of grant applications to
develop bioterrorism countermeasures. With the existing
personnel you now have and the resources, are you able to keep
up with the application in grants and are most of them
applications for basic research or are they actually for
development of vaccines and other countermeasures? And,
finally, do you believe that the BioShield funding is
absolutely critical to the development of the most dangerous
countermeasures?
Dr. LaMontagne. The question is a very important one, Mr.
Etheridge. I think that--just to give you an analysis of the
response that we have received--it is across the board. It is
not only basic research which we have encouraged, but also we
encouraged programs in very targeted and focused initiatives to
try to generate the kind of vaccine or drug that we would like
to have for a particular disease. One can always use more
resources. That is always true, as you know. But I think it is
moving along pretty well. So we will see how this evens up in
the next year or so, I think. We will have a better indication
of how well we have titrated our own resources with what is
coming in.
Chairman Cox. Thank the gentleman.
The gentleman from Rhode Island, Mr. Langevin, is
recognized for 5 minutes.
Mr. Langevin. Thank you, Mr. Chairman. Again thank you for
your testimony today, gentlemen. It has been very enlightening
and informative. I guess I would start off by saying that
clearly what we need to do and various aspects of government
need to do is inspire confidence in this question and, more
importantly, inspire confidence in the minds of the public that
there is a coordinated and comprehensive process and effort
that exists with respect to dealing with bioterrorism and the
threat of bioterrorism. I don't think that we are there yet. I
don't think that in the mind of the public that we can say that
we have inspired that level of confidence. I think CDC and NIH
are off to a very good start. I think that is one of the bright
spots in this whole effort. But we clearly have more work to
do.
I would like to turn to the line of questioning that the
chairman had started with in dealing with how you are getting
your information and intelligence. Clearly identifying the
pathogens, for example, that NIAID should be working on depends
on assessments of the bioterrorism threat. And I am curious to
know, in exploring again the chairman's line of questioning,
the level of interaction that you are having with the
intelligence communities. In particular, it sounds like this is
more of an informal process than a formal process. So I would
like to you explain that interaction a little more thoroughly
if you could.
And also, I would like to know where the Intelligence
Community is deriving its data set; for example, where are they
getting their intelligence? And are you dealing with peers
within the Intelligence Community when you are talking to these
individuals or are they lay people?
And also, since DHS is going to have a major role in this
process, I would like to know if DHS has contacted either CDC
or NIH to ask for your input as they are setting up their
internal structure for dealing with the bioterror threat?
Dr. Khan. That question, sir, let me turn that again to Mr.
Henderson, who deals with our current day-to-day programming.
Mr. Henderson. Just again reflects on the intelligence and
formalizing the process. I should say that for my particular
agency, just to be selfish for a moment, we would love to have
a one-stop shop where all the intel is coming in, they are
analyzing it and they are handing us stuff and they find it to
be credible that they are looking for us and our State and
local colleagues to respond to. Right now, that is in fact the
concept of homeland security and we are working with them in
trying to decide how best to do that. We still though have our
peer relationships and contacts in the agencies I mentioned
earlier, the NFC and the CIA and the FBI. We actually at CDC
have an FBI analyst who is stationed at CDC to help us with any
potential threats that may be coming into CDC as a facility
since we managed to secure select agents, and so that is a sea
change in thinking in how we dealt with this prior to September
11. The only way that happened was through a coordinated
approach working with the Department of Homeland Security.
I also want to mention that in formalizing this arrangement
with Homeland Security to understand how we will take this
intelligence and respond appropriately, and accurately, it
played out pretty well in the TOPOFF II exercise where we were
looking at plague in Chicago and a dirty bomb scenario in
Seattle. We saw through that exercise scenario how the future
will look as far as how CDC will get information that we will
act upon, and we liked what we saw. It made sense to us. It was
logical. We could react faster and we had a higher degree of
confidence in the information that was coming to us. Again that
was a scenario that was artificial. But it showed us what the
future held and I have to say that Homeland Security played a
strong role in that activity.
Mr. Langevin. And they are reaching out to you and asking
for your input as to how they should set up their internal
infrastructure with respect to bioterrorism?
Mr. Henderson. Yes, they have asked us because you have to
remember it's not a one-way street. As much as they are going
to give us intelligence information they are looking for CDC to
also provide them intelligence information. And SARS is a good
example. We have people over the globe we are working with and
as we collect all the information the only way for them to get
it is through CDC. So it does open a two-way channel of sharing
of information.
Dr. LaMontagne. I would completely agree with what Joe has
said. I mean I think we have experienced a sea change in our
ability to interact and work with the intelligence agencies not
only at the NIH, but obviously, as Joe has pointed out, with
CDC, and I think the Department of Homeland Security and before
it the Office of Homeland Security have been very helpful in
making sure that that conversation takes place.
Mr. Langevin. I see my time has expired, so I thank you for
your--.
Chairman Cox. The gentleman from Florida, Mr. Meek, is
recognized for 5 minutes.
Mr. Meek. Thank you, Mr. Chairman. I want to go back to
some of the statements I made in the opening dealing with
working with other countries, and I know that the Dutch have
worked in many areas of research and have found, been
discoverers of vaccines. I know that both agencies work with
the international community as it relates to finding vaccines
and sharing research information. I believe bioterrorism here--
and there are three categories, A, B and C--is something that
could be a reality in any city or small town. How are we
working with those other countries that are out there that may
be facing some of the same threats that we are facing? And the
reason why I am asking the question, the fact that I think that
we would see some activity abroad maybe not here in the
homeland, but we would see activity abroad first and then we
can pretty much expect that that is just a test or the training
area, just to bring a homeland attack here in the United
States.
Dr. Khan. Thank you very much for that question, sir, and
actually it is a major focus of what I do on a day-to-day basis
these days. We have a number of activities in place
internationally. So I am working with the World Health
Organization directly and their smaller subsets of WHO. We have
relationships with regions. We have relationships with specific
countries to do various projects and systems. We have also set
up something called international emerging infectious disease
programs. We have one such program we would be delighted to
expand that worldwide. These are areas where there are a couple
of CDC specific people in country who help build up their
surveillance capacities and their response capacities and it
would allow the country to find what is going on, be it
bioterrorism, other emerging diseases, a lot faster because
that is truly what the delay is.
You know, once the countries recognize it we generally have
good relationships to get those agents to the United States and
other countries for development of vaccines and diagnostics,
but often the countries don't have the ability to recognize
what is going on in their own country, and that delay is
deadly, especially for bioterrorism, because you may only have
a couple of days to actually treat patients or get your set of
countermeasures ready before the agent comes to you. So we
would like to expand that international emerging infection
program and it has been--let me give SARS as an example.
Again this was not bioterrorism, but we had one of these
programs in Thailand that provided us the opportunity to help
Thailand, Taiwan, Cambodia and Laos based on this handful of
people who were based out in Thailand, and it would have been
nice to have done that in additional countries.
Mr. Meek. And, Dr. Khan, one of the other concerns or
things that I think that we need to know if it is something
that is going on somewhere in the globe that any of you on the
panel may be very concerned about, that could potentially
happen here in the United States as it relates to bioterrorism.
And I can tell you right now, since 9/11 everyone is trying to
focus on issues that you have been working on your entire
careers. Now, all of a sudden you are front stage. Everyone
wants to pay attention. But still when we start looking at
local communities, States, they are also fighting for funding.
They are fighting for the flexibility that is being asked for
in this piece of legislation, and I think Americans as we look
at legislation that has been passed through this Congress,
PATRIOT Act I, with the potential PATRIOT Act II, and the
misallocation or appropriation of that legislation, it set us
back. And one, do you see an area in the country or in the--not
in the country but in this world that because of your
individuals that are out there from the CDC, something that
potentially that is raising your eyebrows, something that we
need to pay close attention in, something that you are right
working with--what you have now to work with that you are
moving in that direction to find a vaccine to make sure that it
doesn't become a problem for Americans? That is one.
Two, as it relates to dissemination of a vaccine, if
something was to happen here in the United States, do we have
better functions in being able to get that vaccine and being
able to make sure that we have enough of it to deal with a
wide-scale bioterrorism activity? We have had several exercises
or two or three recently. How did things turn out there as it
relates to the response?
Dr. LaMontagne. I could start on one aspect of your
question, Mr. Meek. I think that, yes, there are diseases that
we are quite concerned about overseas that might come here. The
one that I might mention that I have had a professional
interest in for a long time is influenza. And as a matter of
fact, we have a considerable interest in looking at influenza
in many parts of the world, including the Far East, Hong Kong
and China in particular, through projects that we have
supported for surveillance of animal influenza viruses in the
Hong Kong, area in particular. I think that was, as it turned
out, that group, because of its enhanced capacities, I think it
was quite helpful in dealing with the SARS outbreak that
occurred recently.
So, yes, we do have groups out there doing that kind of
work all the time.
Dr. Khan. Let me follow up on those comments that we do
have a number of people stationed overseas who look at emerging
infectious diseases, and pandemic influenza is a major concern
for us. Again the influenza outbreak of 1918 was the largest
epidemic in the world, killed probably over three-quarters of a
million Americans based on that population. And we know without
a doubt pandemic influenza will happen again and we need to be
prepared and the only way to be prepared is to have a presence
overseas.
So it is important and I think, Mr. Meek, this is where
your question was coming from, it is important to maintain our
focus internationally as we think about bioterrorism also.
Because people may practice potentially outside the U.S. first,
or for a disease that is spread by person-to-person
transmission, there is no reason to start in the U.S. If it is
spread by person-to-person transmission you put it anywhere in
the world it will make it is way to the U.S., and there is
numerous diseases that are examples of that. West Nile is an
example of that. Wasn't in the United States. SARS is an
example of that. Wasn't in the United States. We continue to
get imported cases, 1,500 cases of malaria every year into the
United States.
So importations, translocations of disease are a common
process. Another reason why we can't forget the international
arena for bioterrorism is you know John said they are trying to
develop countermeasures, anthrax, plague, tularemia. There
aren't that many cases in the U.S.; however, there are such
cases abroad and if we have good relationships with countries
where these are still problems we would have a place to use our
countermeasures. You know as we develop new smallpox vaccines
if we have good relationships with countries where monkey pox
is still an issue, potentially that could be a model that could
be used for vaccines and therapeutics that would then prepare
us domestically and help our counterparts internationally.
Dr. LaMontagne. Just to add to what Ali has said, in terms
of the availability of the vaccine or the intervention that
might be desired, I think there is still much work to do to
make sure that we have adequate supplies of these vaccines, and
I think that is where the complementarity associated with
BioShield could be very helpful.
Mr. Meek. Mr. Chairman, I believe that when we start to
move forth this legislation, not only communications, not only
statutory direction to the departments, because we have a
number of agencies and departments working together, what we
find in the law enforcement community everyone talks about, oh,
we are working together and they come here and they walk in the
room hand in hand and hugging each other and then after they
walk out the room, they don't talk to one another. I call it
bleacher democracy. I mean, they would be together only in a
time that they need to be there. But communications is very,
very important. And in the area that y'all are working in, this
is front seat. To get vaccines, to be able to get preventive
measures countermeasures out there in a timely manner with
local health agencies, working with them, making them feel a
part of what is going on is going to be key. I don't know if we
can legislate that. That is something that I think that works
within the professional community of making sure that that
happens. Anything to the end of helping us, well, anything to
helping us in this legislation work with other nations that are
ally nations that share a common threat, a common loss, it is
very, very important and I think that we reflect that, and I am
pleased to hear that you are out sharing and looking and trying
to detect that information. Hopefully that is going across to
the law enforcement segment of this effort against terrorism.
Chairman Cox. The distinguished gentlelady from the Virgin
Islands, Dr. Christensen, is recognized for 5 minutes.
Mrs. Christensen. Thank you, Mr. Chairman, and I just want
to start out by saying how much we appreciate both, all three
of you being here and the work that you have been doing, as
evidenced I am sure only in small part by your testimony and
your responses. We want to make sure that you have the
resources and the support to continue to do it and to improve
upon it.
I want to ask--my first question kind of piggybacks on the
last one my colleague Mr. Langevin was asking, and it is one
that has been asked before. There are coordinating councils,
there seems to be a very good but informal working relationship
between the different parts of the Department of Health and
Human Services and the other agencies. Would it, as we look at
the act and look towards some possible amendments, is there
something that we ought to be doing to put all of this into one
umbrella agency with one director? Would that improve, would
that be an improvement over the relationship we have now? Would
it be easier? Would the communication be better or do you feel
that the way it is working now is working at its best, all of
the research and development of countermeasure?
Dr. LaMontagne. Well, I think considering the fact that for
many of us it is a new role, this I think actually works pretty
well. And I am not sure that a new entity as such is really
required. I think the big challenge for us, which is a comment
that I think Joe alluded to in one of his responses a little
while ago is that you are dealing with different cultural
aspects to these different agencies, and I think developing
ways in which we can communicate is going to be something that
is perhaps iterative and takes a while. But I actually think
that it is quite positive from my perspective. I don't really
have any reasons to complain.
Mr. Henderson. I agree, John. One of the things I think
that you are probably hearing on this particular committee, you
probably heard it yesterday, you may be getting a sense of it
today, is that it has only been 7 months since they passed the
Homeland Security Act, and so 7 months employing this large
organization, and we are working very hard with Homeland
Security because we want to develop the right relationships.
What are the right relationships? And you know where are we
seeing the true leadership? Where are we seeing the resources
in the political world that I mentioned before? What we are
asking State and local health colleagues to consider we need to
consider at the Federal level. I think if we give the current
situation a chance and a little bit more time we will pull it
together. But in the meantime there should be some confidence
that we are engaging and we are developing these relationships.
We can continue to improve communication, but we are working at
doing that. I think hearings like this are very helpful to
bring this to light for us to just remind us that we need to
continue to make this investment in time and building
relationships.
Mrs. Christensen. And apropos of the issue of time and the
time it takes to do this right, and to get it where it needs to
be, the Institute of Medicine has been asked to look at Project
Bioscience to assess, investigate it and come up with some
recommendations which won't come out until later on this year.
The recent interim report says that they really need more time
because this is a very complex, bioscience is a very complex
initiative and with far reaching implications. And I heard, and
I read in your statement, Dr. Khan, something that I have asked
many questions about in previous hearings, the importance of
focusing on the public health system. We hear that there are
laboratories still to be built, B-3, B-4 laboratories still to
be built. What is the danger in waiting until we--and
especially given the fact that many of our hearings have not
been as informative as this one. What is the danger in waiting
until we get a very informed assessment of bioscience before
moving ahead? Can't we be doing more with our public health
system, doing more with basic research, putting the facilities
in place that we know need to be in place now? And wait until
we get a report and do it right?
Dr. LaMontagne. Well, I think one danger would be--in my
mind the fact that there are lots of things that are going on
right now in the research arena, the sort of push thing that
Dr. Fauci refers to. There is a big investment being made in
this field. We are pushing research very aggressively to
develop the vaccines and the drugs we need. We need to get the
pull components. So that pull component is I think very
important. It is a complement to the push. So the sooner that
we can do that I think the more effective the program will be
in its total capability.
Mrs. Christensen. That was the shortest 5 minutes I have
ever seen, Mr. Chairman.
Chairman Cox. The gentlelady is recognized for an
additional 2 minutes.
Mrs. Christensen. Okay. Thank you. Thank you. Project
BioShield--thank you, Mr. Chairman--presumes basic research
being done, promising countermeasures being identified and then
incentives being given as you just described. What is the
status of the basic research? Do we have a lot of basic
research done ready to go to the private sector to be taken to
the final product?
Dr. LaMontagne. I think the short answer to that question
is that it depends on the agent. In some cases we have very
good basic information, for example, in anthrax. But for a lot
of the other diseases that are in the Category A list, basic
research has not been--they haven't been easy to study so we
don't have a lot of basic information. We do need it in order
to get the kinds of things that we will need at the end of the
day.
Mrs. Christensen. And for those that you have the basic
research ready to go, how--can it be done under the current
processes? Even with the incentives, the private sector has
some concern that they will spend significant amounts of their
own money and not be able to put this on the private market. So
can it be done now with what we have?
Dr. La Montagne. Well, I think that is the dilemma. We can
take it through the basic research and I am going to include in
that some developmental research. We can do clinical trials
perhaps and learn how to produce something in large amounts,
and so forth, and have a very mature product. But the risk is
that there won't be anything, any entity, a corporate entity
which--and they are really the ones where the expertise exists
to produce vaccines and medications at high quality reliably in
large amounts. And unless you have the capacity to basically
hand it over to them in some effective way, you are not going
to be able to get the material that you need in the amount you
need. That is the risk.
Mrs. Christensen. Thank you, Mr. Chairman. I appreciate the
extra time.
Chairman Cox. I thank the gentlelady. Our witnesses, we do
have additional questions for the panel. We'd like to let you
go before noon if that is at all possible. You have been at the
witness table for nearly 2.5 hours, and so I would invite you,
unless you want to just press on, to stretch your legs and take
a recess. But it is up to the panel.
Dr. Khan. We will press on, sir.
Chairman Cox. We could adjourn for 5 minutes and come back
at 11:30 if that would work for you. We will recess for 5
minutes, and that I think would put us at 11:25. At 11:25 we
will resume.
[Recess.]
Chairman Cox. I would like to welcome our members and our
witnesses back. Dr. Khan and Dr. LaMontagne, I hope you are
ready for the second round of questions. We have four members
present. We hope to be sparing of your time. You have been very
generous with your time. I want to thank you once again, as I
did at the outset, for being with us here today and for your
outstanding assistance to this committee as we prepare to mark
up legislation perhaps as early as next week to create the
Project BioShield, a multibillion dollar program.
The Chair would recognize himself for 5 minutes. Right off
the bat, let me ask whether either of you have familiar with
the program of the former Soviet Union, Biopreparat. Is either
of you familiar with that?
Dr. LaMontagne. Yes, somewhat.
Chairman Cox. Dr. LaMontagne, Scott Becker, who is the
Executive Director of the Association of Public Health
Laboratories has stated, quote, we do not have a national plan
or a lead agency for many of the laboratory activities. Did the
U.S. have such a thing as Biopreparat?
Dr. LaMontagne. Well, I mean my understanding of the
genesis and the purpose of Biopreparat was as an organization
that was designed for the production of basically biological
munitions, so I don't see any need for us to be in that
business necessarily.
Chairman Cox. But I am sorry. I mean only organizationally,
a lead agency with overarching responsibility. I don't mean to
draw the analogy beyond that.
Dr. LaMontagne. I am really not sure whether we would need
something quite like that. As I tried to illustrate in my
responses to various questions through the morning, I think
there is actually very good interaction and communication
within the agencies that are responsible with this activity.
There are entities such as the Homeland Security Council and
other groups that are, I think, bringing together these
agencies in a coordinated manner. So I am not sure that it is
needed at this point.
Chairman Cox. Dr. Khan.
Dr. Khan. Let me specifically talk about Scott's comments.
There actually is a laboratory response network in the United
States working with APHL, which is how we get diagnostic
reagents out to all States and local health departments. And if
you expand that laboratory response network one more step, you
realize why it is difficult to take all terrorism response
activities into a single entity from a public health standpoint
because you can't separate out the routine public health
responsibilities from what potentially could be terrorism.
Terrorism doesn't wave a red flag saying hi, I happen to be
anthrax. It is somebody walking in the emergency room short of
breath who has a large middle of his chest on his chest x-ray
and you look at the chest x-ray, you look at the symptoms and
you go, okay, this may potentially be anthrax. Or somebody
walking in with a rash and you need a clinician to say, no, I
don't think this is chicken pox, I actually think this
potentially could be smallpox.
So you can't separate out those pieces of the public health
response. They are an integrated public health response. And
going back to the APHL and the relationship with the laboratory
response network, this laboratory response network, it was
originally set up specifically for bioterrorism purposes. It
was set up to say these are the critical agents, these are the
reagents and the tools you will be using to monitor for these
agents. We just sent SARS reagents through that network. We
have sent West Nile reagents through that network. It is too
interconnected, it is extremely interconnected.
Chairman Cox. I want next to go to the report that you
submitted with your testimony. Dr. Khan, you were one of the
authors of this report which is summarized for us, titled
``Public Health Assessment of Potential Biological Terrorism
Agents.'' \1\ It describes how in June of 1999 experts got
together to review general criteria for selecting the
biological agents that pose the greatest threat to the
population.
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\1\ Rotz, Lisa D., Khan, Ali S., Lillibridge, Scott R., Ostroff,
Stephen M., and Hughes, James M., ``Public health assessment of
potential biological terrorism agents'' Emerging Infectious Diseases,
Volume 8, No.2, 225-230, February 2002, Centers for Disease Control and
Prevention.
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Reading this, and then reading testimony that you provided
today covering some of the same ground, it is not clear to me
just how much classified information went into the preparation
of this evaluation of this review. In the CDC report summary,
it stated that the following unclassified documents containing
potential biological threat agents were reviewed. The Select
Agent Rule List, the Australian Group List, the Unclassified
Military List, the Biological Weapons Convention List and the
WHO Biological Weapons List. Participants with appropriate
clearance levels reviewed intelligence information regarding
classified suspected biological agent threats to civilian
populations. No information was available about the likelihood
for use of one biological agent over another. Because this
assessment that we are after is meant to rank the threats
according to materiality, I am in the dark about what
classified information, if any, was directed towards the
likelihood of these threats.
Dr. Khan. Sir, the list in the acknowledgment section are
some of the participants and we have promised to provide the
committee the specific names and the agencies CIA, FBI,
National Security Council, et cetera, who participated in
developing the list and did provide classified information in
terms of what agents had been weaponized and mechanized for
potential use. So that data was integrated into the final risk
analysis matrix.
Please recognize that the reason for the matrix was that we
needed to try to get some of the information that may have been
classified into an unclassified setting because that is the
only way to prepare a public health and medical community. You
can't tell them there is something I can't tell you that may be
a problem. You have to tell them we think based on the risk
matrix there are six or seven diseases we need to pay lots of
attention to. Make sure you know their clinical signs. Make
sure you have surveillance, make sure you have diagnostic
tests.
Chairman Cox. I am just trying to understand the
representation in both the testimony and the report summary
that no information was available about the likelihood for use
of one biological agent over another. So I am inferring from
this that classified, unclassified or otherwise, there was no
information, is that right?
Dr. Khan. At the time of that meeting we were not
specifically provided information that said agent X is the
likely agent. And the list, the way it is structured, is not a
probability list.
Chairman Cox. Right. Now, June of 1999, that is when this
was done, is that right? There was no information. Has this
analysis, this ranking, or the composition of the list, been
updated since 1999?
Dr. Khan. Let me take that from one aspect and then I am
going to turn it over to our current Director who deals with
this on a day-to-day basis. The list, the set of the criteria
was peer reviewed after 1999 before publication in 2001 and to
make sure those criteria were stable.
Chairman Cox. And does the peer review include the
Intelligence Community?
Dr. Khan. No, sir. It includes the process to say that this
is the right way to put together the list.
Chairman Cox. That is, the scientific community?
Dr. Khan. The scientific process to put together the list.
And then since that time, and, Joe, maybe you can take the
question from this point of our ongoing interactions with the
Intelligence Community.
Mr. Henderson. At this point we at CDC have to consider
that this list is still viable and it is still a useful tool to
provide our framework based upon the criteria.
Chairman Cox. Well, just pause right there. My question was
whether it has been updated since 1999 and what I am hearing
you say is that we have to still consider that it is
applicable.
Mr. Henderson. Yes, sir. It has not been changed since
1999.
SUBMITTED FOR THE RECORD BY THE HONORABLE CHRISTOPHER COX
The Washington Times
www.washingtontimes.com
CIA says al Qaeda ready to use nukes
By Bill Gertz
Published June 3, 2003
Al Qaeda terrorists and related groups are set to use chemical,
biological and nuclear weapons in deadly strikes, according to a new
CIA report.
``Al Qaeda's goal is the use of[ chemical, biological, radiological
or nuclear weapons] to cause mass casualties,'' the CIA stated in an
internal report produced last month.
``However, most attacks by the group--and especially by associated
extremists probably will be small-scale, incorporating relatively crude
delivery means and easily produced or obtained chemicals, toxins or
radiological substances,'' the report said.
Islamist extremists linked to al Qaeda leader Osama bin Laden
``have a wide variety of potential agents and delivery means to choose
from for chemical, biological and radiological or nuclear (CBRN)
attacks,'' said the four-page report titled ``Terrorist CBRN: Materials
and Effects.''
The unclassified report was produced by the CIA's intelligence
directorate, and a copy of it was obtained by The Washington Times.
The report identifies several deadly toxins and chemicals that al
Qaeda could use to conduct the attacks, including nerve gases, germ and
toxin weapons anthrax and ricin, and radiological dispersal devices,
also known as ``dirty bombs.''
Disclosure of the CIA report comes as the agency is under fire over
its reports on Iraq's chemical, biological and nuclear weapons, none of
which has been uncovered. Several lawmakers from both parties,
including Sens. John W. Warner, Virginia Republican, and John McCain,
Arizona Republican, have called for hearings into the intelligence
about Iraq that the Bush administration received.
In the latest report, the CIA said terrorist success would depend
on planners' technical expertise. However, one likely goal of any
attempted attack would be ``panic and disruption,'' the agency stated.
Several groups of al Qaeda tried to conduct ``poison plot'' attacks
in Europe using chemicals and toxins in assassinations and small-scale
attacks, the CIA said.
``These agents could cause hundreds of casualties and widespread
panic if used in multiple, simultaneous attacks,'' the report said.
Also, al Qaeda is developing bombs with radioactive material from
industrial or medical facilities, and an al Qaeda document obtained in
Afghanistan revealed that the group had sketched out a crude device
capable of causing a nuclear blast, the report said.
``Osama bin Laden's operatives may try to launch conventional
attacks against the nuclear industrial infrastructure of the United
States in a bid to cause contamination, disruption and terror,'' the
report stated.
Al Qaeda's plans for chemical arms were revealed in a document
obtained in summer 2002 that ``indicates the group has crude procedures
for making mustard agent, sarin and VX,'' the report said.
Mustard is a blistering agent, and sarin and VX are nerve agents
that can kill humans in small amounts.
The report also states that Mohamed Atta, ringleader of the
September II attacks, and Zacarias Moussaoui, who is on trial in
Virginia on charges related to the attacks on the World Trade Center
and Pentagon, studied methods of delivering biological weapons.
Both men ``expressed interest in crop dusters, raising our concern
that al Qaeda has considered using aircraft to disseminate [biological
warfare] agents,'' the report said.
According to the report, al Qaeda and other terrorists also could
produce what the CIA calls an ``improvised nuclear device'' capable of
causing a nuclear blast.
Such a bomb is ``intended to cause a yield-producing nuclear
explosion,'' the report said.
Terrorists could produce a nuclear device in three ways, including
a bomb made trom ``diverted nuclear-weapons components,'' a nuclear
weapon that had been modified, or a new, indigenously designed device,
the report said.
A homemade nuclear bomb would be one of two types: either an
implosion device that uses conventional explosives to create a nuclear
blast, or a ``gun-assembled'' device. Making a nuclear bomb would
require that terrorists first obtain fissile material such as enriched
uranium or plutonium as fuel for creating a nuclear blast.
A more likely type of terrorist attack is the use of such nuclear
material with conventional explosives to create a ``dirty,'' or
radiological, bomb, the report said.
``Use of a [radiological dispersal device] by terrorists could
result in health, environmental and economic effects as well as
political and social effects,'' the report said. ``It will cause fear,
injury, and possibly lead to levels of contamination requiring costly
and time-consuming cleanup efforts.''
Among the materials that are available to terrorists for this type
of bomb are cesium-137, strontium-90 and cobalt-60--materials used in
hospitals, universities, factories, construction companies and
laboratories.
A security notice made public by the State Department yesterday
stated that ``al Qaeda and sympathetic terrorists groups continue to
demonstrate their interest in mass-casualty attacks using chemical,
biological, radiological, and nuclear (CBRN) weapons.''
The notice said no information proves the group now is planning an
attack in the United States with a weapon of mass destruction, but
noted that ``such an attack cannot be ruled out.''
The FBI also distributed a bulletin recently to law-enforcement
agencies identifying the chemical, biological and nuclear weapons
available to al Qaeda and other terrorists.
The CIA report contains photographs of a training video obtained in
Afghanistan from an al Qaeda training camp showing chemical agents
being tested on dogs.
Agents available to the group include toxic cyanides that can kill
in high doses and less lethal industrial chemicals such as chlorine and
phosgene.
Biological agents al Qaeda could use include anthrax, a bacteria
that can cause mass casualties, and botulinum toxin. The CIA stated
that methods for producing botulinum have been found in terrorist
training manuals.
Another toxin weapon, ricin, ``is readily available by extraction
from common castor beans,'' the report said.
``There is no treatment for ricin poisoning after [the toxin] has
entered the bloodstream,'' the report said. ``Terrorists have looked at
delivering ricin in foods and as a contact poison, although we have no
scientific data to indicate that ricin can penetrate intact skin.''
2003 News World Communications. Inc. All rights reserved.
Chairman Cox. It has not been changed since 1999. There is
a report that was referenced in the newspaper on June 3 from
the CIA titled ``Terrorist CBRN Materials and Effects. '' That
includes a report that al Qaeda terrorist and related groups
are said to use chemical, biological and nuclear weapons in
deadly strikes. Quote, Biological agents al Qaeda could use
include, and then they are listed. Now this is obviously more
recent. The list that you are working off of dates 2 years
before 9/11. Is that right?
Mr. Henderson. Yes, sir.
Chairman Cox. And even then at the time it did not include
information concerning the likelihood for use of one biological
agent over another. The reason I ask this question and I am
pursuing this line of inquiry is that in the legislation that
we are considering right now the Secretary of Homeland Security
is going to be responsible for making this ranking. He is going
to be responsible for doing it on an ongoing basis and a
current basis and we are trying to understand what facility,
what resources are available to the Department and to the
Secretary to accomplish this. Based on our joint subcommittee
hearings of yesterday, I think it is very clear that this
capacity does not exist in the Information Analysis Directorate
and that we have to go outside for it, and so we are becoming
intensely interested in how this process is working with you
and the Intelligence Community and in any way that we can we
want to make sure that you have opportunities to be current, to
get the intelligence that you need, and to adjust the science
accordingly.
So since my time has expired I will just leave you with
this question. We are in fact moving forward on marking up this
legislation. What could we do in this legislation to improve
your life, to improve your capacity to do these things? So, for
example, you are no longer working off a 1999 list. I would
address that to any of the three of you.
Mr. Henderson. I will start and I am sure John has a
comment. One thing I would recommend is that when we make a
decision to include something on the list, whatever the disease
is and how the disease is transmitted, understand that provides
a framework for a whole variety of other decisions that then
have to be made at the State and local level, the Federal
level, et cetera, including for us and the Department of
Homeland Security the formulary for the strategic national
stockpile. We know we need to have a routine review, whether it
is annual or every 2 years, of the formulary for the stockpile
and that is all based upon what we consider to be those agents
where there is a higher likelihood that they could potentially
be used by terrorist organizations. There is nothing right now
that mandates the review by any form of a committee. So if you
were to recommend something that could be seen as very helpful
for us in pulling together all the resources that we would look
at as being our scientific and law enforcement advisory body
that could help advise on what we need to do with our programs
to stockpile, et cetera.
Chairman Cox. Well, the legislation does mandate an ongoing
review, and it places that responsibility with the Secretary of
Homeland Security. But it is very abstract about how in the
world this is going to be accomplished and since it is going to
be apparently accomplished with a great deal of outside
resources, I think we need to think through in a little more
detail how we can make this work.
Mr. Henderson. I should mention that even in the absence of
the legislation we at CDC are still, we will drive ahead and
try ro pull this together for our own purposes.
Chairman Cox. The other members have been very generous
with the chairman, and the Chair recognizes the ranking member
from Texas, Mr. Turner.
Mr. Turner. I thank you, Mr. Chairman. Dr. LaMontagne, I
want to follow up on our earlier line of questioning. As I had
shared with you, and I know you are aware, the statute that is
being proposed, the so-called BioShield legislation, deals not
with the development of the drug, but with the production phase
of a vaccine. And in your testimony earlier you said that the
most difficult area in the development of a vaccine is the
research and development and infrastructure piece. Can you
expand upon what that is briefly?
Dr. LaMontagne. Well, what I was alluding to was that for
many of the drugs and vaccines that we use in everyday use
today, you need to have basically, fundamentally a dedicated
facility almost that can produce these things in the quality
and the quantity that is needed. That is not something that
occurs in the context of a research entity necessarily. But let
me give you an example.
For many years the NIH and CDC and other agencies worked on
the development of a meningitis vaccine for children called
Haemophilus influenzae type B. This vaccine has been so
successful it has eliminated the disease in the United States.
But to produce it in the quantities that were required to
deliver it to every child in the United States required a huge
investment in the manufacturing sector. That is what I am
talking about, that there is a need at the pull end of the
process to have the resources available that can facilitate
that translation from the basic clinical research finding to
broader use in the population.
Mr. Turner. If you had a promising vaccine and you brought
it through the basic research and applied research stage, I
believe you testified that in your center you could actually
produce about 10 to 20,000 doses of some vaccine?
Dr. LaMontagne. Yes, we can. That facility, however, I
should emphasize is a research facility. It is not a
manufacturing facility and there is an important difference
between the two.
Mr. Turner. All I was trying to determine is if you are in
a position where you have developed a vaccine through the
centers of excellence that are being created through the
university research centers, and you have a vaccine that has
produced 10--or 20,000 doses currently, you could actually go
out, if you had the dollars appropriated to you, and you could
contract with a pharmaceutical manufacturer to produce that
vaccine?
Dr. LaMontagne. I suppose we could, yes, sir. We could
contract it if we had the resources to do that. I should
caution that many of the amounts I have seen would be quite
huge. You are talking hundreds of millions of dollars to do
that.
Mr. Turner. Right. So it would be a large sum of money. But
you could currently, under current law you could contract for
that if you were appropriated the funds to do it. Assuming you
have the resources available to you and the appropriations,
then basically if there is a vaccine that your efforts, grants
program and centers of excellence developed, and you were at
that stage where you know it is ready to go into the final
stages of development and production, we could get those
vaccines done.
Now, under Project BioShield we are envisioning some kind
of guaranteed level of funding. Based on your knowledge of
where we are in the development of vaccines for these category
A pathogens--and I think you mentioned there are three that
really are uppermost on your mind: anthrax, smallpox and
botulism--if we pass this legislation tomorrow, what contract
would you suggest to Dr. Fauci and Tommy Thompson that we enter
into immediately? And with what company?
Dr. LaMontagne. Well, I think that the vaccines that are
currently being developed are not at the stage, unfortunately,
where one could expand them into large production at the
present time. But I think the ones that you have cited,
anthrax, a new smallpox vaccine, perhaps, antitoxin for
botulism, other vaccines in that general category, even an
Ebola vaccine, these are all viable candidates for this
expansion process if one had it available.
Mr. Turner. Is there anybody out there right now at the
door that you are aware of?
Dr. LaMontagne. There is no large vaccine manufacturer at
the door saying that they are ready to produce any of these
vaccines in large amounts.
Mr. Turner. I just wanted to be sure we shouldn't continue
to meet through the weekend here to be sure we don't delay this
at all. One other question that I have before my time expires:
When we talk about the biological threat, we have got all these
possibilities of different strains of anthrax and we have been
told that you may develop a vaccine and then find out somebody
has altered the strain and it is not effective. How are we
going to deal with that kind of threat? Because once you
contract for the production of some particular vaccine it seems
to me that if somebody is smart enough to alter the strain,
then the contract you just entered into is basically useless
and you have to go back and do another one. Is that the reality
of the bioterrorist threat that we face?
Dr. LaMontagne. Well, I think there is an element of that
reality in all the decisions that we are facing, but I am not
sure I would paint it quite that starkly. I mean, I think that
there is utility to these vaccines from a biological, technical
perspective. I think a vaccine that induces antibodies to the
protective antigen, which is in the case of anthrax the most
important constituent that can first protect, would be useful
no matter what kind of interventions or changes one might make
in the organism itself. I am not aware that one can develop a
vaccine that would escape the neutralizing capacity of the
immune response generated by that antigen. That may be
possible, but I think it is a very difficult technical problem
for someone to do. But you are right. There is a risk in all of
these. This is not the same thing as a vaccine for a
traditional public health problem like measles or rubella. We
are dealing with a problem where a manipulation by some
external forces might actually influence the outcome quite
dramatically. So we do have to have a nimble response if we
can.
Mr. Turner. My time has expired. I have a couple of other
questions. I will reserve them. Thank you.
Chairman Cox. The gentlelady from Texas, Ms. Jackson-Lee,
is recognized.
Ms. Jackson-Lee. Thank you, Mr. Chairman. Thank you very
much. And again the witnesses should be certainly acknowledged
for their willingness to continue with us in what I think is a
very important hearing. On 9/11, we saw the utilization of
common, if you will, vehicles and an accelerated utilization of
entities that we are comfortable with. Airplanes filled with
fuel. Prior to 9/11 most Americans would not be threatened by
an airplane that lifts off to the destination of which they
choose. We saw those now vehicles and fuel source be turned
into a terrorist act that was devastating. One of the aspects
of your testimony included the listing of smallpox, anthrax I
think most of us had not heard of prior to the time that was
used as a terrorist threat and vehicle as well. The plague and
botulism many of us have read about.
What about tuberculosis, which is highly infectious? And if
utilized by the infected person to be a terrorist vehicle, if
you will, where are we in terms of either providing for that
under the bioscience effort, doing greater research, and
preventing that infectious person from becoming a threat from a
terrorist perspective. I assume it is like going into a crowded
theater and being infected possibly. And if tuberculosis is a
wrong example, if you could utilize any other example, and how
are we prepared for that kind of threat? Also, if you would
expand on the response you gave to Chairman Cox about how we
could be helpful. Did I hear you say that an advisory committee
or a group that would provide insight, greater insight to how
you can use your resources would be helpful? If that is the
case I would like that expanded on.
And I have two specific questions, one to Dr. LaMontagne.
You are used to--in NIAID I would be interested in how you
define biodefense work, but more particularly how do you
balance the work that is going to be necessary between basic
research which traditionally has concentrated on an applied
research which can find more directly, which can lead more
directly to the production of a specific vaccine or other
countermeasure? The question is how are you going to balance
the work that you already do with new work that will be
required by this legislation? I think that would be more clear.
And to Dr. Khan, the FDA has used the two animal route for
testing. We are going to be moving fast and furious, I hope. I
hope our pharmaceuticals who may be engaged will pierce the
issue of transparency or will make sure it is transparent and
they will in fact be accountable, which is one of the things I
would like you to further respond to. But will we have the
capacity as we are moving fast and furiously to be able to test
these drugs so that they can be utilized as quickly as
possible? We have a rule against using humans and we understand
that. But will we have the capacity to meet the test, the
challenge that we are going to face when we are truly trying to
secure the homeland?
Dr. LaMontagne. Well, let me start first of all with the
issue of how the institute is trying to balance its biodefense
with non-biodefense research responsibilities and then talk a
little bit about TB in response to your question. I think we
have tried very hard to maintain our focus, not only on the new
responsibility of biodefense, but also we haven't lost, I
believe, any momentum in our research activities related to
AIDS, particularly AIDS vaccine development and other
activities in the non-biodefense area, and we are very strongly
committed to maintaining that kind of balanced portfolio. The
basic research that you refer to is fundamentally--I just want
to clarify that the way we look at it and what we are trying to
achieve is we think basic research is essential to gain
fundamental information about these bioterrorist agents. That
basic information is critical for us to be able to move into
the next step, which is the development of the drugs, the
vaccines and the diagnostic tests that can be used just
generally. I think in closing the consensus on the utility of
tuberculosis as a bioterrorist agent is that it is probably
very remote. This is a disease that, while certainly an
important focus of our attentions in the non-biodefense area,
is not something that occurs in an acute manner. It is a long-
term, chronic, lifelong infection, as you know, and there are
effective approaches to try to control it.
Dr. Khan. Let me expand on those comments and go back to
sort of how the list was derived. Tuberculosis is a severe
public health--it remains a severe public health problem. It is
also a severe disease if you are unfortunate to get it, and
there are numerous such diseases besides tuberculosis, rabies,
HIV, ehrlichiosis, toxoplasmosis, et cetera, that didn't make
it on the list, at least A and B. Those would generally be
covered under the category C agents, and the reason is that to
derive these priority lists wasn't just a function of whether
or not it was a public health problem or whether or not the
disease was severe but it was additional information on whether
or not this agent could be spread to a large group of people,
what percentage of those, what proportion of those people would
become sick, and how effective that spreading process would be,
and then what special preparedness needs would be required, and
that is why a number of agents remained in this emerging
infectious category C. But that I think goes back to the
broader thing that these bioterrorism agents are just part of
this bigger issue of emerging infectious diseases and we are
always looking for the flexibility to be able to deal with all
of this as a group because you do not know what tomorrow's
threat may potentially be or what may show up that you didn't
think about 2 or 3 years ago.
Mr. Henderson. Just to follow up on your question about the
advisory body. Because you are talking about several Federal
agencies that are involved in some decision model here, there
is three things that I think we would benefit from and again we
will pursue this regardless. And one is informing. You know,
this is an advisory body of government nongovernmental
officials. Inform us of the threats. Then help us prioritize
our decision making around the type of research that we would
do, and the development of the appropriate countermeasures. I
think that would be helpful. And the third thing is just having
an advisory body that can enable effective communication
between and among the Federal agency. That, I think, would be
something that we would find to be extremely valuable and we
are pushing that now.
Ms. Jackson-Lee. I got your two. You said inform us of the
threat and then an advisory body, but what was the other?
Mr. Henderson. Enable the communication between and among
Federal agencies.
Ms. Jackson-Lee. Thank you. The question about the
capacity, the two animal capacity in terms of keeping up with
the fast pace of research, the testing. Anyone have a comment
on whether we do have that adequate capacity? There is a two
animal test I understand, and as we are trying to move as
quickly as possible and efficiently as possible, do we have the
capacity in that kind of process to keep up with the kinds of
drugs that are being discovered that we are pushing to be
discovered?
Dr. LaMontagne. I think that we don't have the capacity
yet, but we are rapidly building it. In the next couple of
years I think we will have expanded our research laboratory
capacity to be able to do many of the two animal test protocols
that would be required. One thing to keep in mind is that these
studies by their nature will require containment facilities for
many of these agents. So as soon as that capability is
expanded, which is part of our plan currently, then we expect
we will have sufficient capacity to do much of this.
Ms. Jackson-Lee. I thank you very much. In my earlier
questions, as I close on this one, I indicated the interest of
stakeholders like small hospitals and I indicated in my
community Riverside Hospital and other public hospitals, other
institutions. I mentioned Texas Southern University, Prairie
View A&M only because they are in my area, but there are
others. I imagine that research can be done if you do it in
partnership offsite from your respective locations and that you
can have collaborative partnerships with institutions like that
that may be helpful in some of the testing in other areas that
you are working in particularly basic research.
Dr. LaMontagne. That is absolutely correct and we would
encourage that.
Ms. Jackson-Lee. Thank you. I hear a loud yes. All right.
Thank you very much. Thank you very much, Mr. Chairman.
Chairman Cox. Mrs. Christensen is recognized once again.
Mrs. Christensen. Thank you, Mr. Chairman. My first
question is a relatively simple one I think. How long does it
take--and I hope it wasn't asked before--how long does is take
to develop a vaccine to a not seen before agent? Because the
bioscience has a 5-year bring to completion time frame and
there was some concern raised about that limit, that time
limit.
Dr. LaMontagne. That is a very hard question to answer, but
a very important question. I think it depends entirely on the
agent in question. I mean, some vaccines have moved actually
very rapidly through the developmental process in the absence
of the current pressures we are feeling in terms of biodefense.
But I think depending on where you stand, let's say you have
the essential components of the vaccine identified, you can
probably do it in that 3 to 5-year confine. If you have to
start at a fundamental level without identifying what will work
as a vaccine, it will take much longer, perhaps 2 or 3 years
beyond that.
Mrs. Christensen. And Dr. LaMontagne, back to you again,
too. You responded to a question about safeguards in the
process a while back. And Project Bioscience uses a lot of
expedited procedures and really puts a lot of authority in one
person, the Secretary of Health and Human Services. There are
already expedited procedures I believe at NIH and the Food and
Drug Administration that can be used. Do you see the--can
existing expedited procedures be used to better protect the
public especially since some of the approvals can be extended
if needed and we still have some questions about how best to
provide compensation for injury?
Dr. LaMontagne. Well, I think that in response to your
question, that most of the--or virtually all of the expedited
capabilities that we have have been engaged. I think that what
we are talking about is a need for an enhancement of that
capability. The safeguards that I mentioned earlier on have to
do as much with the safeguards that currently exist in the
system, which are actually quite robust, to ensure that the
vaccines and the medications and the drugs that we are
providing are produced consistently at high quality and do what
we intend them to do.
Mrs. Christensen. And one last question. We have had three
or four hearings on Project Bioscience. There hasn't really
been brought to us a Project Public Health. And I know $2
billion, and that is just part of it. Let me ask the CDC, how
is that--if you were asked to--knowing the state of local and
State public health agencies, areas where high disparities
exist and perhaps what that 2 billion is going to be used for
now, how much more should we be providing or did you ask for
when you put together a proposed budget? Where was it?
Mr. Henderson. Just one second. We would like to provide a
more comprehensive response back for the record if that is okay
because the public health system is a complicated situation and
it really requires a more detailed response.
Mrs. Christensen. Yeah. And we really want to be assured
that the public health system that is going to deliver the
services, the vaccines, all these wonderful medicines that we
are going to develop, countermeasures, is going to be in place
and it is going to be in place everywhere. And so we would
really appreciate your response, what the needs really are.
Thank you, Mr. Chairman.
Chairman Cox. The gentleman from Texas, Mr. Turner.
Mr. Turner. Thank you, Mr. Chairman. Dr. LaMontagne, let's
follow up again on my earlier thoughts. Recognizing the
limitation in the BioShield bill, dealing with the tail-end of
the process--that is the final stages of its development,
production--would you have any objection to making the
BioShield legislation and its funding mechanism available for
basic and applied research even perhaps just in the event of a
national emergency where there was a determination made that
there was a material threat to the U.S. population?
Dr. LaMontagne. Well, that is an interesting and
provocative question, Mr. Turner. I am not sure if, in the
current situation, that is necessarily needed. That is my own
opinion. I mean, I think that there is a quite healthy funding
stream going into the basic research elements of the research
agenda for all of these countermeasures. What is really needed
is that pull component that we have talked about. However, is
that going to be an absolute? Should there never be a
circumstance in which we might--which I think is at the heart
of your question--where one might want to do this. I really
can't predict that. I don't foresee it currently. But it is
certainly possible that one might want to entertain that
prospect sometime in the future.
Mr. Turner. Well, as you know, the BioShield legislation
itself says that the funding is not triggered until there is a
finding that there is a material threat to the U.S. population.
So I wouldn't really be suggesting that what you are doing now
is not likely to be sufficient. I am talking about that
circumstance where we are confronted with a biological threat,
where the determination is made as provided for under the
legislation. If there is a material threat to the United States
population, would you have any objection to giving the
authority to the President or to the Secretary of HHS or DHS
the power to make the determination that the funding that is
there could be applied on an emergency basis through the
applied research to finding a vaccine that we need to address?
Dr. LaMontagne. In the scenario you are asking about it
would be a situation--I just want to make sure I understand
what exactly you are asking me. And as I understand the
scenario, you are talking about a situation in which a new and
novel agent appears as a validated threat to the citizens of
the United States. Under those circumstances I think we should
take all options available to us. So I suppose in a sense the
answer might be yes, but I am not sure that that is the wisest
use of those resources. I think the intention of them, as I
understand the bill, is to provide that kind of pull component
to engage the private sector in some of this research activity
as well as the developmental activity. So to the extent that it
could be covered under that kind of a rubric I think it is
probably acceptable.
Mr. Turner. Well, I would hope that if we did determine
that there was a material threat to the U.S. population that we
would be in a position of doing everything we possibly could to
address it. And as you know, under the legislation there is no
funding going to be made available to any of these private
sector companies for the production of a vaccine unless there
is a finding that there is a material threat to the U.S.
population. I think it is a pretty high standard that is in the
bill already unless I misunderstand the intent of the language
of a finding of a material threat.
Dr. LaMontagne. I would have to get back to you on that,
sir. I am not exactly sure what the standards are because I
have not been that engaged in those discussions frankly.
Mr. Turner. The budget request from NIH is for $1.6 billion
for the various research, basic research, applied research
activities, both internal, external grants that you may give to
universities and others. Could you tell me how those funding
streams will break down in actual practice, assuming that $1.6
billion is appropriated by the Congress, among the grants or
the research by universities and others versus the monies that
you will apply internally on this activity?
Dr. LaMontagne. I don't have those figures in front of me,
Mr. Turner, but I will be happy to provide that for the record
in writing. But we do have an organized plan to address those
issues.
Mr. Turner. I don't mean to confuse you by my line of
questioning. I am just one who believes we need to do more and
we need to do it faster than we are doing. I want to be sure
you are equipped to the extent to which you need to be to
accomplish the task of discovering the vaccines, which
currently the BioShield legislation, in my understanding, has
little to do with. I think that side of the equation also
deserves the attention of this committee and of this Congress.
Thank you very much for your testimony today.
Chairman Cox. I want to thank the panel very much. You have
been exceptionally generous with your time, your knowledge and
your expertise, very helpful to this committee as we move
forward to mark up the BioShield legislation.
I want to ask one question as we wrap up. It is by
inference from what I have listened to throughout the morning
that both of you, for NIAID, for CDC, it would be helpful to
have as much information from the Intelligence Community as
possible for you to continue to prioritize your work. Is that
correct?
Dr. LaMontagne. Absolutely. Yes, Mr. Chairman.
Chairman Cox. That the more information that you have,
respectively, about the actual capabilities of terrorists and
states, the better; the more information that you have about
the modalities that might be employed to disperse
microorganisms the better off we will be; and the more
information that you have about the relative likelihood of the
use of one biological agent over another the better, is that
correct?
Dr. LaMontagne. Yes, sir.
Dr. Khan. Yes, sir.
Chairman Cox. It is my reading of the draft legislation
that would create the bioscience program that the
responsibility for seeing to it that that happens would rest
with the Department of Homeland Security and the Secretary of
Homeland Security. I think we need, as we move forward, to make
sure that this legislation and that other authorities of the
Department are adequate so that this actually happens. I don't
think we want to find ourselves perpetually in a circumstance
where you are relying on a 1999 list or the communication with
the Intelligence Community is episodic. Assure that is an
ongoing responsibility that would be placed in law for the
Secretary of Homeland Security and that the Secretary's
exercise of these authorities would be enormously consequential
for you, for the funding that bioscience would make available
and none of it would be made available without the Secretary's
prior determination. So making sure that those determinations
are based on good information both good science and good
intelligence is of vital importance.
So I know you are going to be partnering with other parts
of the government in this as we go forward. I want to
compliment you on what you have achieved already over the years
and have mercy and let you go without continuing to praise you
so long that you can't have lunch. Thank you very much for
being with us.
The hearing is adjourned.
[Whereupon, at 12:10 p.m., the committee was adjourned.]
APPENDIX
Materials Submitted for the Record
QUESTIONS FOR THE RECORD--FOR NATIONAL INSTITUTE OF ALLERGY AND
INFECTIOUS DISEASES (NIAID)
(NIAID)--BioDefense Research
How does NIAID's biodefense research compare to what takes
place within other government agencies, such as the Centers for Disease
Control, the Department of Defense, and the private sector?
How should NIAID balance its work between basic research,
which it traditionally has concentrated on, and applied research which
can lead more directly to the production of a specific vaccine or other
countermeasure?
Should NIAID be more actively involved in such applied
research? If so, how should it transition to a better balance between
basic and applied research?
NIAID's Vaccine Research Center (VRC)
How successful has the Vaccine Research Center been in
developing needed vaccines? How many vaccines has the Center been
responsible for producing since it was first created?
Does the Vaccine Research Center partner with the private
sector to accomplish its work? If so, who does what? What is the
division of labor between NIAID and the private sector?
How does the work to be carried out by the private sector
under Project BioShield compare to the work already being done by the
Vaccine Research Center?
What is the capacity of the Vaccine Research Center? Is it--or
can it be--the government's alternate to Project BioShield if Project
BioShield does not result in procuring needed vaccines and other
medical countermeasures?
Should the Government Do More to Produce Vaccines?
If Project BioShield does not succeed in procuring needed
vaccines, should the government do more--apart from the pharmaceutical
or biotechnology industry--to develop vaccines and other medical
countermeasures?
If government efforts should be expanded, how should we go
about doing so? Should NIAID or another government entity be in charge
of such work? What resources will be required?
NIAID Lessons Learned
What, in your view, are the principal lessons learned from
ongoing government efforts to research and produce countermeasures
against the highest priority biological agents? What has worked well,
and what hasn't?
How important is the private sector been in researching and
developing medical countermeasures against biological threats? How do
the private sector's efforts complement similar efforts underway within
the government?
Testing of vaccines
Is there sufficient capacity--either in the government or in
the private sector--to test vaccines using the Food and Drug
Administration's ``two animal rule?''
If not, what plans exist, or what efforts are currently
underway, to boost testing capacity? Will NIAID's ``facilities
improvement'' initiative for this fiscal year help in alleviating any
problems?