S. Hrg. 110-558
SIX YEARS AFTER ANTHRAX:
ARE WE BETTER PREPARED TO RESPOND
TO BIOTERRORISM?
=======================================================================
HEARING
before the
COMMITTEE ON
HOMELAND SECURITY AND GOVERNMENTAL AFFAIRS
UNITED STATES SENATE
ONE HUNDRED TENTH CONGRESS
FIRST SESSION
__________
OCTOBER 23, 2007
__________
Available via http://www.gpoaccess.gov/congress/index.html
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COMMITTEE ON HOMELAND SECURITY AND GOVERNMENTAL AFFAIRS
JOSEPH I. LIEBERMAN, Connecticut, Chairman
CARL LEVIN, Michigan SUSAN M. COLLINS, Maine
DANIEL K. AKAKA, Hawaii TED STEVENS, Alaska
THOMAS R. CARPER, Delaware GEORGE V. VOINOVICH, Ohio
MARK L. PRYOR, Arkansas NORM COLEMAN, Minnesota
MARY L. LANDRIEU, Louisiana TOM COBURN, Oklahoma
BARACK OBAMA, Illinois PETE V. DOMENICI, New Mexico
CLAIRE McCASKILL, Missouri JOHN WARNER, Virginia
JON TESTER, Montana JOHN E. SUNUNU, New Hampshire
Michael L. Alexander, Staff Director
Aaron M. Firoved, Professional Staff Member
Brandon L. Milhorn, Minority Staff Director and Chief Counsel
Asha A. Mathew, Minority Senior Counsel
Trina Driessnack Tyrer, Chief Clerk
C O N T E N T S
------
Opening statements:
Page
Senator Lieberman............................................ 1
Senator Collins.............................................. 3
Senator Akaka................................................ 21
WITNESSES
Tuesday, October 23, 2007
Hon. Jay M. Cohen, Under Secretary for Science and Technology,
U.S. Department of Homeland Security........................... 5
Gerald W. Parker, D.V.M., Ph.D., M.S., Principal Deputy Assistant
Secretary, Office of the Assistant Secretary for Preparedness
and Response, U.S. Department of Health and Human Services..... 9
Keith A. Rhodes, Chief Technologist, Director, Center for
Technology and Engineering, Applied Research and Methods,
Government Accountability Office............................... 12
Tara O'Toole, M.D., MPH, Director and Chief Executive Officer,
Center for Biosecurity, University of Pittsburgh Medical Center 14
Alphabetical List of Witnesses
Cohen, Hon. Jay M.:
Testimony.................................................... 5
Prepared statement........................................... 29
O'Toole, Tara, M.D., MPH:
Testimony.................................................... 14
Prepared statement........................................... 71
Parker, Gerald W., D.V.M., Ph.D., M.S.:
Testimony.................................................... 9
Prepared statement........................................... 42
Rhodes, Keith A.:
Testimony.................................................... 12
Prepared statement........................................... 54
APPENDIX
Slides submitted for the Record from Mr. Cohen................... 38
Questions and responses for the record from:
Mr. Cohen.................................................... 80
Mr. Parker................................................... 87
Mr. Rhodes................................................... 103
Dr. O'Toole.................................................. 105
GAO Report to Congressional Requesters, ``Project Bioshield--
Actions Needed to Avoid Repeating Past Problems with Procuring
New Anthrax Vaccine and Managing the Stockpile of Licensed
Vaccine,'' GAO-08-88, October 2007............................. 116
SIX YEARS AFTER ANTHRAX: ARE WE BETTER PREPARED TO RESPOND TO
BIOTERRORISM?
----------
TUESDAY, OCTOBER 23, 2007
U.S. Senate,
Committee on Homeland Security
and Governmental Affairs,
Washington, DC.
The Committee met, pursuant to notice, at 10:01 a.m., in
Room SD-342, Dirksen Senate Office Building, Hon. Joseph I.
Lieberman, Chairman of the Committee, presiding.
Present: Senators Lieberman, Akaka, and Collins.
OPENING STATEMENT OF CHAIRMAN LIEBERMAN
Chairman Lieberman. Good morning and welcome to our hearing
today where we will assess whether the Federal Government has
developed the tools that we need in the post-September 11,
2001, world to respond to bioterrorist attacks on the United
States and also to the effects of pandemic events.
Six years ago--just one week after the September 11 attacks
traumatized America--we were shaken again by a string of
anthrax attacks that, over the course of 2 months, killed five
people, sickened 22, and drove more than 10,000 others to take
powerful antibiotics as a precautionary measure. Postal Service
workers were hit the hardest as the attack came in letters
through the mail, but I will say, it also hit close to home. In
Wallingford, Connecticut, a wonderful woman, Ottilie Lundgren,
was one of those who died because she opened a letter
containing the deadly substance.
I know that we all certainly here in the Capitol remember
those days because a mailroom employee of then-Majority Leader
Tom Daschle opened a letter containing the deadly white powder.
The Hart Building was evacuated, closed for months while
environmental HAZMAT teams scoured the building.
Regrettably, whoever was responsible for the anthrax
attacks, has remained unknown and, therefore, unfortunately,
unpunished. But we do know that a catastrophe can strike
Americans in their homes or places of work or places of
assembly as a result of bioterrorism or naturally occurring
diseases such as pandemic flu. And, therefore, we must be
ready.
So 6 years after those anthrax attacks, are we better
prepared to respond to bioterrorism than we were then? My
answer, unfortunately, is yes, but not much, and certainly not
enough. And I base that on the testimony and the GAO report
that we will hear today.
We have a lot to do in the area of medical readiness. Last
week, the Administration finally produced its National Strategy
for Public Health and Medical Preparedness. It covers the range
of emergency responses that would be required after various
types of biological attacks. As I read it, I became
increasingly concerned that right now we are far from capable
of achieving many of those requirements as stated in the
National Strategy. For instance, we are still not able to
monitor biological incidents and their effects on people in
real time. We cannot reliably field sufficient medical surge
capacity to respond to either a bioterrorism attack or a
naturally occurring pandemic. We cannot dispense drugs to
entire populations or track the spread of disease through a
community. These are essential requirements of national health
security post-September 11, 2001, and they are today,
unfortunately, unmet. So we will ask why we have not met those
requirements and how together we can do so as soon as possible.
Today's hearing will also consider how well the government
is protecting its citizens from biological threats through
medical countermeasures and technologies, and here I
specifically mean a 21st Century anthrax vaccine, a system of
biological sensors in cities throughout the Nation, and better
standards for anthrax field tests to speed response and reduce
false alarms.
In these areas, the status of our government's activities I
think has been mixed. On the up side--and there is an up side
here--the Strategic National Stockpile has been enlarged with
additional doses of an anthrax vaccine, new antidotes to
counter the toxins it produces, antibiotics for over 40 million
people, and countermeasures to other diseases such as smallpox
and botulism toxins that can be spread by a terrorist attack.
As a result, the ability to treat victims of biological
attacks with medical countermeasures has genuinely improved
since 2001. Our research is also getting better as a result of
centers that have been established specifically to study
bioterrorism agents, their compositions, capabilities, and
provenance.
On the down side, however, the Department of Health and
Human Services' efforts to develop a second-generation anthrax
vaccine have, in a word, failed. This is a very disappointing
breakdown that has put us back at square one after 4 years of
work, a lot of it apparently misguided, to improve on the 30-
year-old technology that we now have in the stockpile.
Today, this Committee is releasing a report by the
Government Accountability Office,\1\ the first of a series in
related topics that reviews HSS' missteps, describes the
Department's failure to minimize waste of the stockpiled
vaccine, and provides recommendations for how to avoid similar
mistakes in the future.
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\1\ GAO Report to Congressional Requesters, ``Project Bioshield--
Actions Needed to Avoid Repeating Past Problems with Procuring New
Anthrax Vaccine and Managing the Stockpile of Licensed Vaccine,'' GAO-
08-88, October 2007, appears in the Appendix on page 116.
---------------------------------------------------------------------------
I must say that I am particularly concerned about this
problem because the Department of Health and Human Services is
preparing to seek bids on a new contract for an anthrax vaccine
without, according to GAO, having conducted a thorough
postmortem of its errors with regard to the awarding of the
first contract.
The brief history of this vaccine began after Congress
passed the BioShield legislation in 2004 to establish a method
for the Federal Government to buy medical countermeasures to
biological agents. The first contract was awarded later that
year to a small company called VaxGen. They were to develop a
next-generation vaccine to replace the current one, which,
though safe, is often painful, requires six injections to be
effective, and has had problems maintaining required purity.
Multiple problems arose, as we know, in the VaxGen
contract, and they have been well documented in previous
congressional hearings so we need not go over them here. The
contract was eventually canceled, and, needless to say, the
second-generation vaccine was never produced.
Today in its report, GAO points out that HHS has not yet
fully examined its BioShield failure, much less adopted
measures to avoid a repeat of it. So I will ask our HHS witness
this morning how the Department expects to avoid similar
failure the next time around.
Beyond countermeasures, we are also going to look at
detection technologies under development and those already
being implemented. And there is some encouraging news here,
too, including the Department of Homeland Security's BioWatch
system, a network of sensors placed in over 30 cities to test
the air for anthrax and other biological agents. How successful
has that program been and should it be expanded further? I am
going to ask the Department of Homeland Security also for an
explanation of why it has not yet adopted standards it and
other stakeholders created for anthrax field tests so that new
technologies will be as effective as possible.
To say the obvious, we are very fortunate that during the
last 6 years we have not experienced another attack from
biological agents or any other form of weapon of mass
destruction. And so far we have, fortunately, also managed to
avoid the major pandemics that seem to sweep the globe
naturally every few decades. But that obviously does not mean
that we will be so lucky in the future.
The Departments of Homeland Security and Health and Human
Services, working in coordination with State and local
governments and the private sector, have very awesome
responsibilities here to protect the public from deadly
biological attacks, awesome in the sense of the scope of the
responsibility and what has to be done to meet it. This
Committee wants to work with both Departments to get it right
because the consequences of failing to do so would obviously be
catastrophic.
I look forward to the testimony of our witnesses today. I
thank you for being here, and now I am pleased to call on
Senator Collins.
OPENING STATEMENT OF SENATOR COLLINS
Senator Collins. Thank you, Mr. Chairman.
Six years ago, anthrax-laced letters resulted in the deaths
of five people, widespread concern about the safety of postal
workers and the U.S. mail, the treatment of thousands of people
with powerful antibiotics, and the evacuation of the Hart
Senate Office Building.
Today's hearing concerns two matters of great importance
for this Committee and for all Americans: Our preparedness for
bioterrorism and efficiency in government operations.
Unfortunately, the report that Senator Lieberman and I
requested from the GAO makes clear that the Federal attempt to
procure an improved anthrax vaccine has yielded not a new
vaccine but instead a textbook example of prodigious waste.
As the GAO also discovered, taxpayers stand to lose $128
million in 2008 as the stocks of the current vaccine expire.
The Department of Health and Human Services currently has no
system to transfer them for use by the Department of Defense,
the only large-scale user of anthrax vaccine, before the stocks
expire.
In 1996, former Army Chief of Staff Gordon Sullivan wrote a
wise book on a systematic approach to management in settings of
uncertainty and change. Its title alone offers a kernel of
wisdom: ``Hope Is Not a Method.''
The story of the now canceled $877 million procurement
contract between HHS and VaxGen demonstrates the danger of
relying on hope for progress. The Department hoped that a small
company could not only develop an effective vaccine, but also
could obtain approval for it and manufacture 75 million doses
all on an unrealistically fast track.
VaxGen officials hoped that they could meet the terms and
deadlines of a contract that lacked specific requirements and
was critically vulnerable to future decisions by the Food and
Drug Administration.
VaxGen also hoped that its small staff, lack of expertise
in vaccine formulation, and limited access to additional
capital would not impede the required rapid progress to
contract fulfillment.
Not one of these hopes survived the collision with reality.
The reality is that HHS' contracting practices for Project
BioShield have displayed many of the same problems that this
Committee has observed in procurements in other departments and
agencies related, for example, to Hurricane Katrina and to
reconstruction work in Iraq and Afghanistan--flaws that we hope
to correct through contracting reform legislation.
HHS was responding to a crisis in the wake of the September
11, 2001, terrorist attacks and the anthrax mailings. No one
knew how soon or in what number follow-on attacks might appear.
But the risks, uncertainties, and vulnerabilities revealed by
the anthrax attacks made a methodical approach to vaccine
procurement more, not less, important.
A methodical rather than a hopeful approach to Project
BioShield contracts might have included a more realistic
evaluation of the suitability of using a small vendor with
limited experience, a vendor that had been de-listed from the
NASDAQ securities market 3 months before the November 2004
contract signing.
A methodical approach would have included a fact-driven
assessment of vaccine development prospects and production
capabilities--an assessment that GAO's interviews with industry
experts suggest would have been bleak indeed.
And perhaps most important, a methodical approach would
have identified and specified contract requirements up front.
I have no doubt that many lessons could be drawn from this
very troubling story. But as the GAO notes, HHS has yet to
conduct a formal lessons-learned study.
We will spend additional time today discussing two other
disturbing issues outside the immediate ambit of the VaxGen
contracts--the lack of a process to move the stocks of current
anthrax vaccine to the military before they expire, and the
reported willingness of HHS to deploy the vaccine even if it
has expired.
I look forward to hearing the testimony of our witnesses
today on the procurement and the other challenges we must
address to ensure that our Strategic National Stockpile
fulfills its purpose of maintaining readily available stocks of
vital medical supplies for victims of major disasters. I am
particularly interested in hearing Admiral Cohen's thoughts on
how the findings from the GAO report can be applied to the
important work he is leading at DHS.
The only good news in the GAO report was the obvious
observation that we have suffered no new anthrax attacks since
2001. If we had, our hearing could have unfolded in the wake of
another tragedy. We must apply the lessons learned from the
failures documented by the GAO to improve our preparations for
a possible terrorist attack using biological weapons before it
is too late.
Chairman Lieberman. Thanks, Senator Collins, for that
excellent opening statement.
We appreciate the four witnesses before us who can help us
answer the questions we have. We will begin with Jay Cohen,
Under Secretary of the Department of Homeland Security for the
Science and Technology Directorate, Retired Admiral of the U.S.
Navy. Good to see you. This is actually your first appearance
before the Committee since assuming this role. We welcome you.
I think you know that the Science and Technology Directorate is
one of the totally new entities created at the Department of
Homeland Security effectively by this Committee. So just to
make you feel younger, we take a paternalistic interest in what
you are doing. Admiral Cohen?
TESTIMONY OF HON. JAY M. COHEN,\1\ UNDER SECRETARY FOR SCIENCE
AND TECHNOLOGY, U.S. DEPARTMENT OF HOMELAND SECURITY
Mr. Cohen. Well, good morning, Chairman Lieberman, Senator
Collins, and distinguished Members of the Committee. I am
honored to appear before you on this solemn occasion of the
sixth anniversary of the anthrax attacks against our Nation to
report on the progress made by the Department of Homeland
Security's Science and Technology (S&T) Directorate. Those
events of 6 years ago served as a wake-up call that an
adversary could produce or obtain biological agents to use
against this country.
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\1\ The prepared statement of Mr. Cohen appears in the Appendix on
page 29.
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Thank you for entering my formal written statement into the
record. I will quickly summarize it here. But before I do, I
wanted to thank the Congress, this Committee, and your very
professional staff for the strong bipartisan leadership and
support you have given me and the dedicated, hard-working men
and women of the Department of Homeland Security Science and
Technology Directorate as they work to make the Nation safer.
Thomas Jefferson said, ``The price of freedom is eternal
vigilance.'' And vigilant we must be.
I am humbled to appear alongside such distinguished panel
members. The Congress and the American people want to know, 6
years after anthrax, are we better prepared to respond to
bioterrorism? And I will tell you the answer is yes, and I
would like to give you a few examples.\1\
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\1\ The slides submitted by Mr. Cohen appear in the Appendix on
page 38.
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Prior to the anthrax attack, the Nation lacked a
comprehensive understanding of the risks posed by acts of
bioterrorism. We did not have a dedicated research and
development capability for addressing those risks, civilian
attack warning systems to know if we had been attacked,
dedicated forensic analysis capabilities and adequate capacity
to rapidly characterize samples from the attack to help others
in trying to identify who might have perpetrated the attacks,
plans and tools for cleaning up after such an attack, and focus
on the additional significant threats posed by bioterrorism.
In the intervening 6 years, DHS S&T, in collaboration with
its interagency partners, represented here and in the audience,
conducted formal risk assessments of 28 biological agents. This
analysis is guiding the prioritization of the Nation's
biodefense efforts and has resulted in nine additional material
threat determinations, a list of key agents to be detected by
warning systems, and identification of key vulnerability and
research gaps.
We established a National Biodefense Analysis and
Countermeasures Center to provide a dedicated capability for
conducting both unclassified and classified biodefense
research; developed and operated the Nation's first bioattack
warning system, which has already been referred to here, known
as the BioWatch system. This system, first fielded in 2003--and
I am very pleased that Dr. John Vitko, who is my Director of
the Chemical and Biological Division, is largely responsible
for that development and deployment. It was fielded in 2003 and
is operating in more than 30 cities, as has already been
stated, and has conducted some 4 million tests to date without
a single false positive.
We have conducted development of the next-generation fully
autonomous detection systems to significantly increase the
BioWatch capabilities, and I know your interest in that, and
those systems are now entering field tests; developed standards
and processes for biodetection tools to be used by first
responders; in partnership with HHS, DOD, Department of
Justice, the Postal Service developed a coordinated national
biomonitoring architecture; established a National Bioforensic
Analysis Center, and we are conducting operational bioforensic
analysis today in partnership with the FBI.
This provides the Nation with its first dedicated
contamination-free biocontainment laboratory space for forensic
analysis and the necessary analytic tools and chain of custody
control for conducting that analysis. We have worked with the
EPA, HHS, and State and local authorities to develop protocols
and tools for cleaning up complex transportation hubs following
a biological attack, and we are working closely with the U.S.
Department of Agriculture to better characterize the existing
veterinary countermeasures for agro-defense and to develop
next-generation countermeasures.
In the future, I am pleased to tell you that we will extend
the formal risk assessments to include all of chemical,
biological, radiological, and nuclear threats. We will complete
construction and occupy the new National Biodefense and
Analysis Countermeasures Center (NBACC) facility at Fort
Detrick, Maryland, and that should occur at this time next
year. And working with our colleagues on the National
Interagency Biodefense Campus at Fort Detrick, we will provide
the Nation with the understanding it needs to identify and
prioritize threats and the tools it needs to defend them.
We will develop the understanding and tools to defend
against enhanced and advanced biological threats. We will
complete testing of the next-generation BioWatch systems and
work with the DHS Office of Health Affairs--and thank you for
establishing that customer for me, critically important--to
transition BioWatch III into operation. We will develop an
expanded range of detection systems and tools for use in
facility protection, protection of the food supply, and first
responders. We will partner with the EPA, HHS, and State and
local governments to develop the framework, plans, and tools
for restoring entire city neighborhoods in the event of a
biological attack. We will partner with the U.S. Department of
Agriculture to develop next-generation veterinary
countermeasures. And, finally, we will design, construct, and
operate the National Bio- and Agro-defense Facility (NBAF), to
provide the Nation with state-of-the-art biocontainment
laboratory space to accelerate the development of veterinary
countermeasures against foreign animal and zoonotic diseases.
And you know we look to have that down-select at this time next
year.
And so before I conclude, I am pleased to be joined here
today, as I said, by Dr. John Vitko, and also Jamie Johnson,
who is my Director of the Office of National Labs in the S&T
Directorate, who will help this shade tree engineer with your
more technical questions.
Additionally, my DOD partners have brought examples of
devices that we have developed together for our first
responders. You see a new chem/bio suit that our firemen can
use.
So, in summary, DHS S&T has taken the wake-up call of the
2001 anthrax events very seriously. Much has been accomplished.
However, because of the evolving nature of the threat, much
also remains to be done. We look forward to continuing to
support the Nation in responding to this challenge. I welcome
your oversight, and I welcome your questions. Thank you so
much.
Chairman Lieberman. Thanks, Admiral. Do you want to take a
minute to describe the chem/bio outfit?
Mr. Cohen. Yes, sir. In today's world, where we ask our
heroes, our first responders--the enabling legislation that you
so eloquently put in place, I am reminded that it is 183 pages
of which 17 pages are DHS S&T. I just completed 6 years as
Chief of Naval Research, and the legislation in Title X for the
Office of Naval Research, 1946, is half a page. It says there
will be an Office of Naval Research, it will be led by an
admiral, you will do good S&T, and you will report to the
Secretary of the Navy.
Here, 60 years later, we have 17 pages, and it shows you
the impact of word processing on the legislative process. But
it is very well thought out.
Chairman Lieberman. You and your predecessors made a lot
out of that half-page. [Laughter.]
Mr. Cohen. And we continue to, I can assure you. But
everyone is well represented. It is very well thought out, and,
of course, the support I got from your Committee and from all
of the Congress the first 3 weeks I was on board a year ago, in
August, in getting the new organization in place and the new
investment portfolio was because I xeroxed those 17 pages, I
highlighted them, and we organized to fulfill your vision,
which I think was very thoughtful.
But today, and I think you are very wise in this, I am not
to re-create National Institutes of Health, National Science
Foundation, DOD or DOE labs. But you have given me the
authorities to leverage them and take my precious dollars and
add on top.
So we deal with the Technology Support Working Group
(TSWG), which is a very strong, very proactive, and very
innovative Department of Defense group, and working together
with them, what you see here is an ensemble for our firemen
where, when they go into a hazardous situation--and, as you
have indicated, Chairman, they may not know initially that
there are biological or chemical hazards. It provides the
additional protection because we know they do not only have to
worry about smoke and worry about the heat and the fire, but we
know that when they come out we can monitor them, and they will
not have been exposed internally to chemical and biological
threats. And we do that through filters, the self-contained
breathing apparatus, even the gloves--and there are two
different variations because I am a big believer, as is TSWG,
in competition of ideas. The gloves have magnetic seals, so
when you put the glove on, even at the glove area you do not
get the leakage. And so these are, in fact, in operation today.
We have an iris scanner. Now, this is really expensive. It
is about $15,000 a copy. But it will give us detection against
your face of biological and chemical threats. If we were to
deploy these in the hundreds, it would be $10,000 to $15,000 a
copy, but you can imagine--and this is a wonderful thing about
America, our innovation, the Bayh-Dole Act that you provided.
In thousands, we would drive the price down, and this would be
an export for American technology.
Chairman Lieberman. What would you do with that? Just take
a minute.
Mr. Cohen. You would just put it--I am the first responder.
Chairman Lieberman. Yes, you want to make sure that the
first responder has not been compromised.
Mr. Cohen. Or a victim.
Chairman Lieberman. Or a victim, right.
Mr. Cohen. It does not matter. It is the human subject. We
put it there, we press the button, and it will give us a
readout for the various biological and chemical contamination
and give us a high confidence level.
Chairman Lieberman. That is great.
Mr. Cohen. This is in the final stage of testing.
And, finally--and you are very kind to give me this extra
time, Chairman--this little device, I thought it was a
chocolate wafer. I was really pleased that my staff had
provided that for me. I am a chocoholic. But it is actually
this disposable mask. You can carry this in your back pocket.
And, again, this provides the near-term--not against smoke, but
against biological and chemical hazards so that you can
evacuate the area of contamination.
This is just a small example. We filled up the Cannon
Caucus Room last spring, DHS and TSWG, showing the kind of
progress that we have made in all these areas. Thank you so
much.
Chairman Lieberman. Thanks, Admiral. I am glad you did
that. Look, part of why Senator Collins and I wanted to put the
S&T Directorate in DHS was because we in our service on the
Armed Services Committee had seen the power of putting Federal
money into research when there is, in that case, national
security, and now here, homeland security. And, of course,
there is tremendous spillover into commercial applications as
well. So it has been very encouraging to see the combination of
American innovation or American entrepreneurship come together
to try to meet the needs that we have now. You are going to
give that first responder the rest of the morning off?
Mr. Cohen. Yes, sir. We will give him gangway liberty.
[Laughter.]
Chairman Lieberman. OK.
Dr. Parker, welcome. Thank you for being here. Principal
Deputy Assistant Secretary, Office of the Assistant Secretary
for Preparedness and Response at the U.S. Department Health and
Human Services. We welcome your testimony. Obviously, GAO had
some tough things to say about HHS, so this is your opportunity
to respond.
TESTIMONY OF GERALD W. PARKER, D.V.M., PH.D., M.S.,\1\
PRINCIPAL DEPUTY ASSISTANT SECRETARY, OFFICE OF THE ASSISTANT
SECRETARY FOR PREPAREDNESS AND RESPONSE, U.S. DEPARTMENT OF
HEALTH AND HUMAN SERVICES
Mr. Parker. Thank you and good morning. Chairman Lieberman,
Ranking Member Collins, and distinguished Members of the
Committee, I am honored to be here today to discuss the
development and acquisition of medical countermeasures to
address the threat of bioterrorism.
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\1\ The prepared statement of Mr. Parker appears in the Appendix on
page 42.
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I would like to make it clear that medical countermeasures
development and acquisition is only one component of our
overall preparedness efforts that range from research,
development, and acquisition of medical countermeasures to
response delivery platforms that support State and local
authorities in dealing with the medical aspects of major
disasters.
Today I will focus on three themes related to how HHS has
made significant progress in our medical preparedness
activities.
First, we have made significant progress; we have made
significant acquisitions for the stockpile against the most
serious threats facing the Nation.
Second, as a result of the lessons learned from previous
acquisition successes and setbacks, and with the help of
Congress, we have changed the way we do business at HHS.
Third, we have taken an all-hazards approach to public
health preparedness. The gains we make against each threat will
help us across the spectrum of public health emergencies and
disasters.
HHS has already achieved a significant level of
preparedness against a number of threats using all authorities
available to us. For example, we have a stockpile of
antibiotics that provides a substantial level of preparedness
for bacterial threat agents, including anthrax, plague, and
tularemia. This includes enough antibiotics for the first-line
defense against anthrax to provide a 60-day post-exposure
prophylaxis for over 40 million people. We also have enough
smallpox vaccine for every American. That includes a new
vaccine, ACAM-2000, developed by Acambis, that was just
licensed by the FDA this year. Project BioShield, enacted in
2004, authorized the $5.6 billion Special Reserve Fund for the
procurement of security medical countermeasures.
During the first 3 years of implementation, Project
BioShield awarded procurement contracts for the current and
next-generation anthrax vaccines, anthrax antitoxins, a next-
generation smallpox vaccine, botulism antitoxins, and two
medical countermeasures for radiological threats. Additionally,
we have made great progress in improving our Nation's ability
to respond to an influenza pandemic.
Since December 2005, HHS has awarded over $3 billion to
support the first stage of our pandemic preparedness
activities, including expanding and diversifying domestic
influenza vaccine production and surge capacity, increasing
H5N1 vaccine and antiviral stockpiles, and supporting advanced
development of cell culture and antigen-sparing influenza
vaccines, antivirals, and diagnostics.
While we have achieved successes, we have also learned
lessons. The discovery and development of new medical
countermeasures is complex and an inherently risky endeavor.
The termination of the contract to procure an rPA anthrax
vaccine exemplifies the multifactorial challenges encountered
in implementation of Project BioShield. We have observed
several lessons in implementing Project BioShield:
First, contract terms dictated by the BioShield statute
were challenging, particularly for less experienced companies.
Second, it is critical that developers establish effective
relationships with the FDA to gain a clear understanding of the
regulatory requirements with respect to their product for the
stockpile.
And, third, or finally, absence of a robust advanced
development program placed too much risk on BioShield projects.
In response to these lessons, in July 2006, HHS established
the Public Health Emergency Medical Countermeasures Enterprise
to coordinate the range of work being done to develop and
procure countermeasures against terrorist and naturally
occurring threats and to define priority requirements and make
more efficient decisions.
We have established the Biomedical Advanced Research and
Development Authority (BARDA), as called for in the Pandemic
and All-Hazards Preparedness Act. And we are working to improve
and accelerate medical countermeasures advanced research and
development using these new authorities. We also are building
on the successes of the pandemic influenza program to support
an advanced development portfolio of new products and
technologies across the threat spectrum.
We have requested $189 million for advanced development for
fiscal year 2008 to increase the maturity of potential Project
BioShield products, bridging the Valley of Death gap between
NIH and other research and development programs in Project
BioShield procurements.
I cannot overstate the importance of advanced development,
and the fiscal year 2008 request for advanced development
funding is critical to BARDA implementation and effective
utilization of the Special Reserve Fund for Project BioShield.
We are using new BARDA authorities, such as advanced and
milestone payments, in the new BioShield contract for the next-
generation smallpox vaccine and have recently awarded a number
of advanced development contracts. These include advanced
development contracts for anthrax antitoxins, rPA anthrax
vaccine, a smallpox antiviral, novel antibiotic formulations,
and radiological/nuclear medical countermeasures.
We are facilitating stakeholder discussions with the FDA to
establish a better understanding of the regulatory requirements
for countermeasures. We will continue to insist on and verify
demonstrated understanding of those requirements by
manufacturers.
Last spring, we released the enterprise strategy and
implementation plans which identified the top priority medical
countermeasures development and acquisition thrust and
requirements. These plans were informed by significant
stakeholder input. The strategy and implementation plan
reaffirms and further identifies our commitments to the
development and acquisition of anthrax vaccines, anthrax
antitoxins, and therapeutics for radiological and nuclear
threats. It also identifies the need for the continued
development and acquisition of broad spectrum antibiotics,
antivirals, and diagnostics against the high-priority threats
identified by the Department of Homeland Security.
The National Biodefense Science Board was established last
May to provide expert advice and guidance to the HHS on all
matters related to preparedness and response to public health
emergencies resulting from current or future threats, whether
naturally occurring, accidental, or deliberate. These and other
efforts signal our commitment to greater transparency,
predictability, and partnership with our stakeholders. We will
build on past successes, lessons learned, and new authorities
to continue to improve implementation of all BARDA programs,
including Project BioShield.
This concludes my testimony, and I would be happy to answer
any questions. Thank you.
Chairman Lieberman. Thanks, Dr. Parker. We look forward to
the questions.
Our next witness is Keith Rhodes, who is the Chief
Technologist of the Government Accountability Office and
Director of the Center for Technology and Engineering. In this
capacity, Mr. Rhodes provides assistance throughout the
Legislative Branch, throughout Congress, on issues requiring
significant technical expertise.
Mr. Rhodes, we welcome your testimony. As I mentioned in my
opening statement, one of the things that I found most
troubling in your testimony was the conclusion that the folks
at HHS had not done a thorough postmortem of the failed VaxGen
contract, which was particularly troubling since they are in
the process of going to a second try at it. Dr. Parker has just
used the phrase ``lessons learned'' and mentioned some things,
and I welcome your response as to whether that is adequate to
meet the concerns that you expressed in your report.
TESTIMONY OF KEITH A. RHODES,\1\ CHIEF TECHNOLOGIST, CENTER FOR
TECHNOLOGY AND ENGINEERING, APPLIED RESEARCH AND METHODS,
GOVERNMENT ACCOUNTABILITY OFFICE
Mr. Rhodes. Thank you, Mr. Chairman. I will try and address
that as quickly as I can.
---------------------------------------------------------------------------
\1\ The prepared statement of Mr. Rhodes appears in the Appendix on
page 54.
---------------------------------------------------------------------------
Chairman Lieberman and Senator Collins and Members of the
Committee, thank you for asking us here to discuss our findings
on Project BioShield's first major procurement contract for the
new rPA anthrax vaccine and the potential for waste in the
Strategic National Stockpile. My statement is based on our
report,\2\ which we are releasing today, and will focus on the
following two issues that you asked us to address: One, factors
that contributed to the failure of ASPR's first Project
BioShield procurement effort with VaxGen for an rPA anthrax
vaccine; and, two, potential for waste in the licensed anthrax
vaccine BioThrax in the Strategic National Stockpile.
---------------------------------------------------------------------------
\2\ The report by GAO appears in the Appendix on page 116.
---------------------------------------------------------------------------
In November 2004, ASPR awarded VaxGen a procurement
contract for $877.5 million. Two years later, in December 2006,
ASPR terminated VaxGen's contract for failure to meet a
critical contractual milestone. We identified three major
factors that contributed to the failure of this effort:
First, ASPR awarded the first BioShield procurement
contract to VaxGen when its product was at a very early stage
of development, when many critical manufacturing issues such as
stability and scale-up production had not been addressed.
Similarly, the requirement to deliver 25 million doses of rPA
anthrax vaccine within 2 years was not based on objective data.
This requirement, according to industry experts, would have
been unrealistic even for a large pharmaceutical firm, given
that the product was at such an early stage of development.
Second, VaxGen took unrealistic risks in accepting the
contract terms. According to VaxGen officials, they understood
that their chances of success were limited. Nonetheless, they
accepted the contract terms in spite of the aggressive delivery
timeline, their lack of in-house technical expertise and
stability in vaccine formulation, and their limited options for
securing additional funding should the need arise for
additional testing to meet regulatory requirements.
Third, important FDA requirements regarding the type of
data and testing required for the rPA anthrax vaccine to be
eligible for use in an emergency were not known to FDA, NIAID,
ASPR, and VaxGen at the outset of the procurement contract. The
requirements for use of the new anthrax vaccine were defined
later when FDA introduced new general guidance on emergency use
authorization and specifically in January 2006, after VaxGen
asked FDA for clarification. In addition, ASPR's anticipated
use of the rPA anthrax vaccine was not articulated to all
parties clearly enough and evolved over time.
Finally, according to VaxGen, the purchase of BioThrax for
the stockpile as a stopgap measure for post-exposure situations
increased the requirements for using the VaxGen rPA vaccine.
All of these factors created confusion over the acceptance
criteria for VaxGen's product and significantly diminished
VaxGen's ability to meet contract timelines.
According to industry experts, the lack of clear
requirements is a cause of concern to companies asked to
partner with the government since they invest significant
resources in just trying to meet government needs. These
companies are now questioning whether the government can
clearly define its requirements for future procurement
contracts.
With regard to potential for waste in the stockpile, we
identified two issues:
First, ASPR lacks an effective strategy to minimize waste.
Vaccine valued at more than $12 million has already expired and
is no longer usable. Without an effective management strategy
in the future, over $100 million per year could be lost over
the life of the licensed anthrax vaccine currently in the
stockpile. ASPR could minimize such potential waste by
developing a single inventory system for BioThrax in
conjunction with the Department of Defense, with rotation based
on a first-in, first-out principle.
Second, ASPR plans to use expired vaccine in violation of
FDA's current rules. According to CDC, ASPR told CDC not to
dispose of the three lots of BioThrax vaccine in 2006 and 2007.
ASPR officials told us that the agency's decision was based on
the possible need to use the lots of vaccines in an emergency.
However, FDA rules prohibit the use of expired vaccine. Thus,
ASPR's planned use of expired vaccine would violate FDA's
current rules and could undermine public confidence because
ASPR would be unable to guarantee the potency of the vaccine.
Mr. Chairman, in our May 2006 testimony, we concluded that
ASPR's procurement strategy for rPA anthrax vaccine had been
very aggressive. We stated that, ``It is important to
understand the unique issues at stake in this early phase of
implementation for the biodefense strategy. The rest of the
biotechnology sector will be watching to see whether the
industry and the U.S. Government can make this partnership
work.''
And so, Mr. Chairman, Senator Collins, as you have said, 6
years after the anthrax attacks of 2001, the government does
not have a new, improved anthrax vaccine for protecting the
public. The failure of this procurement effort has raised large
questions regarding our country's ability to build a
partnership between pharmaceutical and biotechnology firms and
the government to develop both new vaccines and a robust and
sustainable biodefense industrial base. This goes beyond just
this individual vaccine procurement and could have an impact on
how the biotechnology industry responds to government overtures
in the future for tools to counter the many biothreat agents
still to be addressed.
Finally, given that the amount of money appropriated to
procure medical countermeasures for the stockpile is limited,
it is imperative that ASPR develop effective strategies to
minimize waste. This point is the basis for maintaining public
confidence. Since vaccines are perishable commodities that
should not be used after their expiration dates, it is prudent
for ASPR to destroy the expired lots to ensure the public that
they will not be given an expired vaccine in case of an
emergency. In addition, ASPR should find users for the
stockpiled products before they expire to minimize waste.
Regarding your question on lessons learned, we have seen no
formal lessons learned. We have seen no documentation. If Dr.
Parker's statements are credible, that is fine, but we have not
seen a formal document explaining what I just explained to you
and what we have stated in our report and in the testimony.
Mr. Chairman, Senator Collins, this concludes my summary. I
will be happy to answer any question you or other Members of
the Committee may have.
Chairman Lieberman. Thanks, Mr. Rhodes.
Dr. Parker, during the question-and-answer period, we will
give you a chance to respond.
Our final witness on the panel, returning by popular
demand, Dr. Tara O'Toole is the CEO and Director of the Center
for Biosecurity at the University of Pittsburgh Medical Center
and a professor of medicine at the University of Pittsburgh.
The center conducts policy analyses and works to prevent the
development and use of biological weapons, among other
challenges it takes on.
It is very good to see you, and I look forward to your
testimony now.
TESTIMONY OF TARA O'TOOLE, M.D., M.P.H.,\1\ DIRECTOR AND CHIEF
EXECUTIVE OFFICER, CENTER FOR BIOSECURITY, UNIVERSITY OF
PITTSBURGH MEDICAL CENTER
Dr. O'Toole. Thank you, Mr. Chairman, Senator Collins, and
Members of the Committee. Thanks for the opportunity to be here
today and thank you for this Committee's continuing dedication
to homeland security and biodefense issues.
---------------------------------------------------------------------------
\1\ The prepared statement of Dr. O'Toole appears in the Appendix
on page 71.
---------------------------------------------------------------------------
I would like to start by thanking the Federal employees who
have worked so hard on these vital programs, including Admiral
Cohen and his team and Dr. Parker and his colleagues. I have
been amongst the sternest critics of both of these programs,
and at this point, after studying biodefense issues since 1998,
I think my colleagues and I have concluded that the scale of
the challenges we face in constructing an adequate biodefense
exceeds all our expectations as of 2001. The challenges are
technical, they are organizational, and they are political.
I will also say that I think that our narrow gauge and
focus of some of these programs and the absence of what I would
call a biodefense strategy has led us to miss some
opportunities that we might take advantage of in our efforts to
create a biodefense.
What we are going to have to build is systems, not just
technologies and vaccines, but systems for getting and
deploying and using technologies and countermeasures, and those
take a long time to build and, frankly, a lot more money than
we have invested in biodefense so far. But I would like to
start by reviewing why we are having this hearing and why we
are worried about this problem.
The Defense Science Board said in 2000, 6 months before the
anthrax attacks, that there are no technical barriers to
terrorist groups or individuals building and disseminating a
devastating biological attack. That is even more true today. In
2005, the National Intelligence Council Report said that of all
the terrorist attacks and challenges facing U.S. security, they
were most worried about a biological attack, which they thought
was more likely than a nuclear attack. Those are the only two
types of assaults that could really destabilize the United
States of America.
Chairman Lieberman. We are more worried--excuse me for
interrupting--because of the relative ease with which a
devastating amount of bioterrorist agents can be brought into
the country.
Dr. O'Toole. I think it was the ease of carrying out a
biological attack, because these organisms live naturally in
the world and are available in hundreds of gene banks across
the world, and also because these are replicating organisms. So
if you can mount one attack, you can make enough anthrax, for
example, if you are patient, to do two or ten attacks. So
everyone is going to feel vulnerable after the first attack.
The whole country is going to want anthrax vaccine. That is why
sitting here today with enough anthrax vaccine to cover only
about 3 million people is so worrisome and, I suspect, part of
the reason behind HHS' reluctance to get rid of expired
vaccine. It might not be perfect, it might not be what you
would use on a good day, but it might be a lot better than
nothing in the breach.
So we need to take, I believe, a much more strategic look
both at these two programs that we are discussing today--and
they are both vital programs--as well as at our overall
biosecurity strategy.
I think there is a lot of complacency and misinformation
abroad in the leadership of the country about the biothreat and
biodefense. I think people think the threat is much more remote
and much less potentially destabilizing than is the case, and I
think they believe we are more prepared than is the case
because we have done a lot. We have worked hard and spent about
$40 billion since 2001 on civilian biodefense.
But the problem is that drugs and vaccines are a lot harder
and trickier to make and a lot more expensive than sensors or
engineering products. I do not think that when we embarked on
the BioShield program in 2004, the complexity of this endeavor
was fully realized either by the Congress or by HHS.
The fact is that the $5.6 billion in BioShield is a
fraction of what we are going to need, and part of the delay on
HHS' part is trying to figure out how do we get countermeasures
for all the possible CBRN threats within that sum of money. We
are not asking, ``What do we need to defend the country against
bioattacks?'' We are, in effect, asking, ``What countermeasures
can we get for this amount of money?'' We are basically
shopping at Costco. This is part of the reason why big
pharmaceutical companies do not want to get into the game. It
is also why we are dependent upon small, daring biotech
companies who have never made anything before, and making a new
drug or a vaccine is a lot more art than science. That is just
where we are. We are in the midst of a revolution in
bioscience. There are lots of very tempting possibilities
coming down the pike in terms of new drugs and new vaccines.
But at the current pace, it is going to take us about 10 years
to get there.
So the whole problem of trying to get what we need for a
fairly paltry sum of money when you compare it to other
national security expenditures is one of the big problems with
countermeasures.
There have also been real process problems, as HHS staffed
up and figured out how to do what it was trying to do. Some of
these process problems are very well documented in the GAO
report. I think some of these problems have been improved upon.
The BARDA legislation that the Congress passed last year
attempts to fix a lot of these process problems, but Congress
has not appropriated any money for BARDA yet. And that is
sending, I think totally unintentionally but very loudly, a
message to the biotech and pharmaceutical companies who are in
this game that Congress does not really take biodefense
seriously. I know that is not the truth as far as this
Committee is concerned, but that is how it is being read. I
would be happy to talk more about that, but I think one of the
vital tasks before this Congress is to appropriate some money
for BARDA.
Finally, I think the BioWatch program has made tremendous
progress over the years. I think it is good technology. It is
not clear to me that it is the right technology given our
choices. It may be that we could make more strategic purchases,
particularly in obtaining situational awareness, the
information we need once an event is underway, through other
investments. My recommendation is that DHS or an interagency
process steps back and takes a strategic look at what we are
doing across the board in biosurveillance and sets out clear
goals for what we want to be able to do in 5 years and 10
years. Thank you.
Chairman Lieberman. Thanks, Dr. O'Toole. As usual, very
good testimony.
Let me go back briefly to the discussion between Mr. Rhodes
and Dr. Parker. Dr. Parker, obviously there is a lot of concern
here on Capitol Hill and generally about the VaxGen experience
because we ultimately have spent hundreds of millions of
taxpayer dollars with nothing to show. Mr. Rhodes in his report
is upset that HHS did not do a very thorough postmortem at all,
or lessons learned. Today you cited some lessons learned in
your testimony. Mr. Rhodes said he is not satisfied with that.
He would like to see, particularly as you go on and try to do
this, something more formal about what you put in place to
avoid repeating the mistakes. So tell us what you are doing and
what you are going to do to make sure that the next millions of
dollars get something for that.
Mr. Parker. Thank you, Senator, and actually, if I may, I
may also pick up on a couple themes that Dr. O'Toole picked up,
because I think that is important.
Chairman Lieberman. Yes.
Mr. Parker. There are some themes that she mentioned as
well, in addition to Keith's comments.
Chairman Lieberman. So just respond to Mr. Rhodes first,
and then you can----
Mr. Parker. Yes, I will, but a little bit about my history.
I joined the Department just a little over 2 years ago--
actually just before Hurricane Katrina, and so I was completely
engrossed for about 3 months in Hurricanes Katrina, Rita, and
Wilma. And when I began to then take a look at Project
BioShield and the progress and the potential setbacks that were
already kind of looming there, it became obvious that there
needed to be some corrections and fixes.
I think Dr. O'Toole properly described it as a young
program, setting up a new organization. So we actually looked
at some of these things, and we kind of categorized these
issues as internal, interagency, and external with our
stakeholders. And, yes, internal within the Department, within
our office, did we have a large enough staff to effectively
manage this, particularly when the experience was that we did
not have large pharmaceutical companies, that we were dependent
upon the up-and-coming, energetic biotechnology industry. We
needed a larger staff because this was going to require greater
government oversight and hand-holding, so to speak, to be
successful in this endeavor.
So, we had to go and get the budget resources and the
direct management of budget line items so we could build the
staff of qualified professionals, and we are doing that.
Chairman Lieberman. So you feel that is one lesson learned
that you are beginning to make better.
Mr. Parker. Yes, sir. We are building a highly qualified
acquisition and scientific staff so we can provide much better
oversight of all of our BARDA programs, not only Project
BioShield but pandemic influenza and the advanced development
program authorities that we just got in the Pandemic and All-
Hazards Preparedness Act.
Interagency: If you are not really familiar with the
BioShield--most people do not understand the details of the
BioShield statute and the legislation, and the fact that
contracts--there are really fixed-cost procurement contracts,
and you can build some of the R&D into that development cycle.
But there is so much uncertainty in R&D that the earlier you
let a contract for a procurement under Project BioShield, the
higher the risk. And so that was a recognized need that we
needed to bring products further into the pipeline,
developmental, and mature them before we would bring them into
Project BioShield. But also associated with that interagency is
it is a very complex, also, approval process to make any
acquisition decision. We need two Cabinet Secretaries and the
President--now it has been delegated down to the OMB Director--
to make a decision on individual procurements.
Chairman Lieberman. So the decisionmaking process has been
better streamlined now.
Mr. Parker. The decision has been better streamlined, and
then the other part was transparency in working with industry.
Chairman Lieberman. Let me interrupt you there because I
have only got about a minute and 45 seconds. Let me suggest
first that you and the Department present your responses of
lessons learned in writing to GAO so they can respond to it,
also for the benefit of the Committee. But I wanted to give you
a little bit of time on another topic because I noticed you
were shaking your head when there was reference to the vaccines
that may be distributed that have expired. So why were you
shaking your head?
Mr. Parker. First, we totally agree with the GAO report
that those expired products need to be destroyed, and we would
do so. HHS never had an intention to use expired vaccine in an
emergency use, so those products will be discarded. But it is
also important to note--I think it has come up--but medical
products, medical countermeasures, particularly biologics, they
have a discrete shelf life.
Chairman Lieberman. Sure.
Mr. Parker. And so we are always going to be in a position
that as they expire, they need to be discarded.
Now, in regard to can we do a better job working with the
Department of Defense to look at inventory management, sure,
and we had begun, before the GAO began looking at this, talking
to DOD about this. We have some particular challenges involved
that include contracting, legal, and liability and so forth,
but we are redoubling our efforts with the Department of
Defense to see how we can better overcome some of those
challenges so that we can minimize--we will never completely
eliminate it, but perhaps minimize some that has to get
discarded.
Chairman Lieberman. OK. My time is just about up. I do want
to say very briefly that Dr. O'Toole made a good point, and
part of the problem that led HHS to enter into this enormous
contract with really an untested start-up company, VaxGen, was
because you could not get the big pharmaceutical companies
interested in it. And part of the problem here is still us,
Congress, in the sense--it is not that it is an easy problem,
but we have to find a way literally to entice the big
pharmaceutical companies to get into this because there is not
an obvious typical market incentive to do it. And we have tried
various ways to try to create that incentive for the public
good. They all run into some interest group that does not like
the incentive. But, meantime, the Nation remains vulnerable to
a bioterrorist attack, and the strongest part of our country to
present an answer--a vaccine, a treatment--is essentially not
on the playing field, and we have got to find a way to get them
out there.
My time is up. Senator Collins.
Senator Collins. Thank you, Mr. Chairman.
Dr. O'Toole, you made a very interesting comment when you
said that we need to be building systems that can deliver the
countermeasures or the technologies, and then you went on to
make a very interesting comment about the BioWatch project.
This is the project that deploys sensors in some 30 cities. I
have always thought that it was an excellent idea, an early-
warning system. But I think you are causing us to take a second
look at how we are deploying our resources.
If there is a biological agent that is detected by Project
BioWatch, how prepared do you think State and local first
responders and emergency managers are to respond? In other
words, we may have a great technology in place to detect a
biological agent's release. But if we do not have the system in
place to respond to that detection, are we any further ahead?
Dr. O'Toole. Yes, well, that is the question, Senator, and
I cannot directly answer your query as to how the public health
officials who are charged with triggering response would react.
But I can tell you that at a meeting called by the White House
last spring, which included about 60 public health officials
and emergency response experts, there was quite a widespread
articulation of skepticism about BioWatch. And I have heard in
other hearings of users being very critical of the resources
BioWatch takes, of the lack of coordination in some places--not
all--between those who operate the BioWatch system and those
who are charged with public health. I am sure those kinds of
problems are fixable, but they do need attention because this
complaint litany has been going on for years now.
My concern is that we cannot afford to put sensors in every
nook and cranny of every city or every town in the country, so
the first question is: Will the BioWatch sensors detect a
release? The second question is basically the hinge point upon
which BioWatch, at least its efficacy, depends. The whole idea
of BioWatch is that early warning gets you an earlier and hence
a better response. But it is not clear that public health is
going to be willing to pull the trigger to respond--to move the
stockpile, to tell everybody we have had an anthrax attack,
etc.--until they have clinical evidence of an attack, meaning
someone who is sick with symptoms or a lot of people who are
sick with symptoms similar to a bioterror agent, or clinical
diagnostic tests--cultures, PCRs, saying, yes, this person is
infected with anthrax. That has been the case so far.
Now, in practice, if they do get a BioWatch alert, public
health starts actively querying emergency rooms and so forth
for people who are sick and fit the description of this
disease. Would we be better off--if it is a zero sum game--
investing some money in rapid point-of-service diagnostic tests
so that a doctor could tell you immediately or within an hour
that you have anthrax or you do not? Would we be better off
making electronic links between hospital emergency rooms and
public health, which more or less do not exist in most places
today? Are we spending too much of our attention on detecting a
bioattack based on the unproven and untested assumption that
early detection improves response? Or would we be better off
investing in systems that are going to give us more situational
awareness during an attack? Situational awareness is going to
be critical to managing an attack effectively and to mitigating
the consequences. We are spending almost nothing on situational
awareness right now comparatively in terms of energy, talent,
and money, and I think that would be a very important part of
the strategy.
Senator Collins. Thank you. Admiral Cohen, I am going to
ask you to comment on Dr. O'Toole's comments. I know that you
are working on second-generation technology that is going to
shorten the time involved in issuing an alert, and I have
always thought the idea of sensors in key places in key cities
was an excellent idea. But I think Dr. O'Toole also raises a
very good point about what happens next.
What is your response? Are we prepared in terms of public
health authorities, emergency managers, medical personnel,
first responders, to react quickly when you issue a report
based on the BioWatch sensors?
Mr. Cohen. Well, Senator, first of all, I think your
question is right on the mark, and I think Dr. O'Toole's
comments are very articulate, very thoughtful, and get right to
the heart of the issue.
Now, in my prepared statement, I told you that the existing
BioWatch sensors have processed over 4 million samples, and we
have had no false positives. But we have had close to two dozen
positives in that same period of time. All of those positives
that were determined to be valid, they were environmentally
based. In the 14 months that I have been on board in this
position, I have had an opportunity to see how different
cities, different health organizations at the State, city, and
local level, respond to the report of those valid positives.
And I must tell you it varies significantly.
In some of our larger metropolitan areas, they go, as we
say, to battle stations. They take it very seriously. They
bring in secondary sensors. They do surveys. They check the
pharmacies to ensure that the Tylenol shelves are not emptied.
They check with the emergency rooms. They do all of the things
that you and Dr. O'Toole indicated would be necessary as part
of a system, a systems approach. In other areas, well, it is a
time-late sample, and if something is going to develop, we will
know about it anyway.
The Founding Fathers were very wise. Those powers not
specifically given to the Federal Government are retained by
the States and locals. So we wanted an inefficient and
confrontational form of government, and the good news is that
is what we have, and the bad news is that is what we have.
In defense, it was quite easy. We can tell medical doctors
and we can tell the patients what to do, what vaccines you are
going to take, when to report to sick bay. It is not that
simple or straightforward in health care, certainly the
distributed health care or public service health care that we
have throughout.
So as we go forward, I do think Dr. O'Toole has one thing
especially right. The more ubiquitous the sampling, the less
expensive the sampling, the more responsive, meaning short time
and accuracy, the sampling, whether it is at point of care or
it is distributed throughout a city or it is on mobile trucks,
or one of the things we are working on in my high-risk
portfolio is what we call ``Cell-All.'' There are 2.8 billion
cell phones today. Now, a cell phone is no longer just a phone.
It is a mini-computer that has computing power that exceeds
what a super-computer had 10 years ago. It has voice, it has
video, it can take pictures, it has GPS in it. So if we could
have even a single sensor, whether it is radiological or
biological, every one of us would have a sensor and would then
report through 911 the location, the fact there was a
radiological or a biological event occurring. We are not
talking about a CO, carbon monoxide, monitor that has numbers.
It is a 1 or a 0. Did it hit the trip point that was
established by HHS, CDC, etc.? And then if we have multiple of
these in a metro station or in a hospital, etc., we know an
event is occurring.
Now, this is on the high end. This is the 9/11 Commission,
not suffering from a lack of imagination, but I can tell you we
are actively pursuing this. And coupled with BioWatch III,
which will be more near term, wireless, more digital than
BioWatch II, and because it will be cheaper, we will be able to
put it, we hope, in four times as many cities. But we have got
to go in the direction that Dr. O'Toole has said in the area of
the response, in the linking of emergency rooms, etc.,
critically important, but I really do think that this is an
HHS, CDC, and congressional area. We can give the tools. We
cannot mandate their use.
Senator Collins. Thank you.
Chairman Lieberman. Thanks, Senator Collins. Senator Akaka,
good morning. Thanks for being here.
OPENING STATEMENT OF SENATOR AKAKA
Senator Akaka. Thank you very much, Mr. Chairman. I want to
congratulate you and the Ranking Member for having this
hearing. It is fascinating for me to sit here and listen to all
of this and to hear from our experts what they have been facing
in dealing with the crisis.
I was interested, Secretary Cohen, in some of the new
equipment that you have been holding up here, and I
specifically wanted to ask you about the iris scanner that you
have. I wonder how accurate it is. Can it detect specific
chemical or biological agents?
Mr. Cohen. Well, Senator, aloha.
Senator Akaka. Aloha.
Mr. Cohen. The short answer is yes, it does select specific
agents, both chemical and biological. That is why we have an
LED screen so that when you hold it up to the face and you
press the button, it identifies to you which specific agent you
might be looking at.
We are refining its accuracy, its false alarms, etc. This
is cutting edge technology. It is in the final test phases. I
am glad to come by and give you a demonstration, or your staff,
or take for the record the specific sensitivities that it has.
I was in your lovely State 2 weeks ago with Major General Bob
Lee, your Adjutant General. Of course, Maine suffers from
nor'easters, and Connecticut has the occasional influx where
they lose all their beautiful elm trees about every 17 years--I
remember that. But in Hawaii, you have not only the terrorist
threats in the middle of the Pacific Basin, but you have a
variety of natural threats, be it earthquakes or tsunamis,
flooding, etc. And I am reminded of the loss of power on Oahu
just months ago from the earthquake. And I am so pleased that
we are able to work closely with your Adjutant General and all
the Adjutants General in providing these kinds--initially in
small numbers on an experimental basis so they can work with
the first responders to make the people of Hawaii and the
Nation safer.
Senator Akaka. As these are developed, it is important that
there is training down the line to the first responders so that
it can be applied and used wherever it is necessary.
Secretary Cohen and Secretary Parker, going back to the
earlier discussion on anthrax, why is anthrax vaccine the only
near-term anthrax BioShield procurement priority? What other
near-term or non-antibiotic therapies is HHS focusing on?
Mr. Parker. Well, anthrax vaccine is not the only near-time
priority, and anthrax vaccine is not the only component of our
strategy to have therapeutics for anthrax. The first line of
defense is antibiotics; vaccine is important for post-exposure
use in conjunction with antibiotics; but, also, anthrax
antitoxins to treat symptomatic anthrax. And so it is important
that we pursue that continuum and that complete tool chest for
the medical countermeasures against anthrax.
But we also have other priorities, and they tier from the
DHS threat assessment and the material threat determinations,
but they include antitoxins and botulinum neurotoxins. They
include the need to pursue medical countermeasures for the
radiological and the nuclear threat. They also include the need
to have medical countermeasures against smallpox. And as I
mentioned in my opening remarks, we have a vaccine now for
every American, and we are also under a Project BioShield
contract pursuing a modified and a second-generation smallpox
vaccine that could be particularly useful in certain
populations, at-risk populations. But we also need an antiviral
for smallpox, and we just continued and extended an advance
development contract to continue the development of a smallpox
antiviral. But with the list of threats that we do face, we
need to be turning our attention--and we are--to looking at
more broad spectrum, both antibiotics and broad spectrum
antivirals.
One other category for which we actually have no medical
countermeasures yet are the viral hemorrhagic fevers, but there
has been a great deal of research and development in the
discovery phase, and there is actually some reason for optimism
that there may be some countermeasures for some of the viral
hemorrhagic fevers that are maturing out of the tech base that
could go into early development.
So there are a number of projects that we have underway,
and, again, I must emphasize the need for advanced development
to bring those out of the tech base and mature those in a way
that will ultimately make them more suitable for a Project
BioShield type procurement.
Senator Akaka. Thank you very much, Mr. Chairman.
Chairman Lieberman. Thanks, Senator Akaka.
I think we can do another round before a round of votes is
called on the floor. I want to go back to the conversation
about situational awareness. This Committee in our extensive
investigation of Hurricane Katrina found that one of the great
problems was that the responders did not have situational
awareness. They could not talk to each other. They could not
talk to their superiors. Here we are talking about something
else, so I wanted just to ask you, Dr. O'Toole, give us a real
brief definition of what you mean by situational awareness in a
bioterrorist context or a pandemic context.
Dr. O'Toole. Well, imagine yourself mayor of a city that
has been attacked with anthrax. You may have knowledge of half
a dozen or a dozen people who are in the hospital sick, and
what you know is there is more to come. What you are going to
want to know is, for example, how many people are sick, how
many people are at risk, where are the sick people. Are the
hospitals caring for them about to collapse because they are
being overwhelmed, both by people who are infected and people
who fear they might be? Do they have the resources they need,
whether they be drugs, equipment, ventilators, whatever? If
not, where are those resources and how could I get them to
where they are? And this situation of confusion and of active
management is not going to be over in a day or a week. It is
going to go on for weeks and months.
In 1918, in Baltimore, the Public Health Department
completely lost its credibility overnight during the pandemic
flu epidemic by saying we are seeing fewer and fewer reports
from doctors of new patients with flu. At that time, as now,
doctors submitted little green cards saying ``I have seen a
case of flu'' via the mail to the Health Department. And what
was happening at the time was that the doctors were so busy
taking care of the surge in patients that the little green
cards were not getting filled out.
Chairman Lieberman. Let me stop you there. That is an
excellent introduction. I want to now turn to Admiral Cohen and
Dr. Parker and ask them to respond because obviously it is
almost 90 years after the Baltimore situation, so this is the
question that we want to ask, which is that if a biological
agent has been distributed in a population by terrorists or if
a pandemic is beginning, what systems are in place for the
authorities, locally and then nationally, to know quickly
enough that this is happening? I mean, obviously, we have
enormous electronic capacity, telecommunications capacity that
did not exist in 1918. Still, I fear--as I mentioned when I
read the National Strategy for Public Health and Medical
Preparedness--that a lot of the requirements in the strategy I
do not think we have yet.
Tell me where we are and what we are doing to try to close
whatever gaps exist.
Mr. Cohen. Well, Chairman, I will start at a macro level,
and in terms of the detail of the health care, I will leave
that, of course, to Dr. Parker.
Chairman Lieberman. Let me ask you, if you can from your
position at DHS, to respond to that type of situation, not 1918
but to the mayor of a present-day city. Anthrax has been
released in a city, a town, and it is beginning to turn up. Are
we going to know about it quickly enough?
Mr. Cohen. Well, the short answer is if we are monitoring
for it in BioWatch, we have a high probability of knowing about
it. Of course, there are many other ways to detect the anthrax.
There is a great sense of awareness and alertness today in the
general population, whether you go on a plane or you open a
letter, you do it carefully. You know there are many reports
that we get of white powder. Some turn out to be false. We have
had some naturally occurring anthrax, as you know, from
untanned animal hides over the last several years.
Chairman Lieberman. Right.
Mr. Cohen. It is a naturally occurring disease. But I have
a higher confidence that in the near term, before we depleted
the stocks of Tylenol, in major population areas we would know
that there was a medical emergency occurring and that we would
quickly know that it was anthrax.
Chairman Lieberman. Would we know because of the monitors
that you have set up or because there is a system where doctors
will feed into some electronic process to let us know something
is spreading rapidly?
Mr. Cohen. Well, for us it is the monitors, for us it is
the number of sick people. You both are very familiar with our
operations center, which has come an awfully long way.
Chairman Lieberman. Right.
Mr. Cohen. You are aware that we do these exercises like
TOPOFF. In fact, 2 weeks ago, we just did one in Phoenix. While
it was a nuclear/radiological exercise, the dispersion models,
etc., are very similar. We learned a lot about shelter in
place, especially school children, the effect that the parents
would worry about wanting to go out and get them. The doctor
will talk much more about how you transmit these various
diseases. Radiological is not biological. But there is a
general awareness that, I think, works to our benefit. You then
have to go into all of the other interoperability coordination
issues and authorities that are necessary. And right now, last
night we had with Secretary Chertoff a late-night phone call,
all of the leadership, on how we are going to respond and help
with the terrible tragedy that is occurring in California right
now, with 250,000 people who have been displaced--Qualcomm
Center, the convention center, working with the Red Cross,
getting planes, cots, etc., there.
So while biological may be very threatening and unique and
have medical aspects to it, these kinds of events tend to
replicate in how they develop and how we respond.
Chairman Lieberman. OK. Dr. Parker, I am over my time, but
just take a moment and tell us whether there is an electronic
system in place.
Mr. Parker. Yes, if I can add to that, the CDC is
developing an electronic system--they have several surveillance
systems that are very effective and active and serve local and
State public health communities. And one of the surveillance
systems that they have been developing is called BioSense. And,
in fact, we refocused it recently to make sure that it is
focusing on some of the high-consequence bioterrorism
pathogens. But it is designed to build that electronic bridge
between the public health community and the medical community
and to help speed the flow of information electronically.
Now, frankly, though, our vision really for the future to
much better improve our situational awareness from a medical
perspective is the electronic health record and to be able to
use that in an improved way. But we are not there yet.
Chairman Lieberman. We are not where we need to be there
yet, are we? I would really challenge you to--I know a lot
comes down to money, but to come back to us with a proposal for
what we could do to facilitate that.
Mr. Parker. I would be glad to.
Chairman Lieberman. Because that will become the first line
of defense.
Mr. Parker. It is. And another thing with the Pandemic and
All-Hazards Preparedness Act (PAHPA), recently, we have begun
to also make sure that the Poison Control Centers are part of
this because they are an important component in our real-time
disease detection and monitoring.
But I also have to emphasize this is part of our all-
hazards approach, and we have made a lot of accomplishments, I
believe, in our pandemic influenza preparedness activities and
working with State and local communities on these very issues,
and that will have implication for a bioterrorism event as
well.
Chairman Lieberman. OK. Senator Collins.
Senator Collins. Dr. Parker, I want to go back to the issue
of the stockpiled anthrax vaccine. It seems so logical to me
for you to have a joint effort with DOD whereby, as your
vaccine is getting closer to the expiration date, you rotate it
out to DOD to use, and then you buy new and repeat the process
over and over again. And if that kind of system does not occur,
we know from GAO's estimates that it is going to cost the
taxpayers $128 million in 2008, and then each year another $100
million.
Now, you said you are working with the Defense Department
on such a plan, but you alluded to certain obstacles. What are
those obstacles? Are they legislative obstacles? Are they
funding? What is the problem? It just seems like a common-sense
solution to a problem that otherwise is going to cost the
taxpayers hundreds of millions of dollars.
Mr. Parker. Well, first, it does seem like a common-sense
solution, and we are working to try to find that common-sense
solution. But there are realities in the contracting issues
because we use two different contracts, and we are working on
that, too. That is another issue because we have worked very
closely with the Department of Defense, particularly on all of
our medical countermeasures, but even more specifically on
Anthrax Vaccine Absorbed. But there are liability issues
associated with each individual contract, and all that is
associated with some legal issues. Both the Department and I,
though, feel pretty optimistic that we can work through those
issues. I have not identified that there is any need for
legislative help on this, but we will be looking for that if it
comes up. But so far, we will do everything we can to work
through that and overcome it.
But let me just talk also about the expense. I am not quite
sure I agree with the $100 million figure in 2008, but that is
something we can talk offline and work on that. Fortunately, we
have not had to use these medical countermeasures--hopefully we
will never have to use these medical countermeasures. They are
part of our preparedness activities. But as medical
countermeasures expire, though, we will have to discard medical
countermeasures.
I am not sure if I would want to couch the fact that we
have to discard expired medical countermeasures in our
stockpile because they passed their expiration and we cannot
use them as wastage. That is part of our cost of being
prepared. We know we are going to have to lose some of that. We
will work and redouble our efforts with the Department of
Defense to try to do everything we can to minimize what has to
be discarded and make sure it can be appropriately utilized.
But just knowing the requirements, what the Department of
Defense does, and how our stockpile is going to grow, we can
never eliminate it. We are always going to be in a position
that some will have to be expired.
Senator Collins. Mr. Rhodes, do you see a potential for
saving literally hundreds of millions of dollars over the next
decade if we are able to come up with an integrated system
whereby the BioShield vaccines are rotated to DOD to use?
Mr. Rhodes. Yes, ma'am. I know Dr. Parker and I will
probably always disagree on the exact number, and that is fine.
But I think this also gets to the larger discussion that leads
back to Dr. O'Toole's point about strategic vision. It is one
thing to store vaccine in a vial. It is another to store it in
bulk. It is one thing to rotate vials out of the Strategic
National Stockpile and into DOD usage, the coordination between
there. But it is also a function of how are we going to use it.
Dr. O'Toole is absolutely right. A series of vaccines that
have gone a certain period of time beyond their expiration date
may indeed be better than nothing. But that is the discussion
that needs to take place at the strategic level based on
scientific data so that we can maintain the public's confidence
in our Nation's ability to respond.
Dr. Parker is absolutely right. Biologics expire. They get
old. They die. They lose their efficacy. The point is to make
certain that we have the strategy in place tied to the systems
that Dr. O'Toole is describing where we can deliver the
countermeasure and that we do have a pipeline for the
countermeasure and we understand how the countermeasure is
going to be used for emergency use. Is it directly in its most
effective time of life? Can we rotate it to DOD? That is
ultimately the message we are trying to deliver, is that
broader view, whether it is looking at what is the next
generation of anthrax vaccine going to be and how are we going
to procure it, or how are we going to store what we already
have.
Senator Collins. Mr. Rhodes, my time is almost expired. Let
me just ask you one final question. We still need an improved
anthrax vaccine, one that is easier to administer, less
painful, etc. How prepared do you think HHS is at this point to
award a new contract for the development of a new vaccine that
does not have the same very unfortunate and expensive ending
that the previous one had?
Mr. Rhodes. I appreciate the Committee asking Dr. Parker to
put together the lessons learned. Based on documentation that
we have, I cannot give you the assurance here now that the next
contract will be successful because I do not know that the
lessons have been learned and incorporated directly into the
process for acquiring the next version, letting the next
contract.
While we were having discussions this summer, we were told
that there was internal analysis about the lessons learned. We
have not seen it. And at the same time, the contract was being
let. So I have to go with what I have, and what I have does not
counter the position--the track record that I have already
seen.
Senator Collins. Thank you. Mr. Chairman, it looks like Dr.
Parker wants to respond.
Chairman Lieberman. Go ahead, Mr. Parker.
Mr. Parker. I have just three major points as far as the
lessons learned on individual contracts.
One, we have moved away from a performance-based contract,
which was basically deliver the product, to one that has very
detailed milestones and deliverables along the way to
delivering the product. And so that way we ensure that there is
complete understanding by all parties at the beginning of what
are the specific milestones that must be met.
Two, we verify and ensure that there is early, often
communication with the Food and Drug Administration; and as the
science matures and the information matures, that the product
continues to develop, it is critical that the manufacturer
engage early and often with the FDA.
And then, finally, our ability now to have advanced
development through the BARDA is just absolutely critical that
we can take products further down the developmental pipeline
and experience some of the setbacks that you are going to have
and that you will have in R&D with the appropriate type of
funding and advanced development and have those products so
they are more mature before they do go into a Project BioShield
procurement.
Senator Collins. Thank you, Mr. Chairman.
Chairman Lieberman. Thank you very much, Senator Collins.
Dr. Parker, have you agreeded to respond in writing and
present a kind of lessons learned plan to GAO?
Mr. Parker. Yes, Senator.
Chairman Lieberman. I appreciate that very much. The roll
call has gone off, so Senator Collins and I have to go over to
the Senate. We will have to close the hearing.
I do just want to draw attention to something Dr. O'Toole
said in her testimony, and perhaps we will form a question to
the panel on it. But it is that a concept of operations to
counter another anthrax attack is lacking. And by coincidence,
Senator Collins and I last week sent a letter to Secretary
Chertoff in which we said that we know he is working on the
National Response Framework, which is the groundwork for
planning efforts, but there is no substitute for actual
operational plans. In some of the materials we read here, I got
the feeling that the vaccine might be able to be delivered to a
general area, but then it was not clear how it would get to the
people who really need it. And this is a critical factor to
stress.
As you know, everyone talks about what keeps you up at
night post-September 11, 2001. This keeps me and a lot of other
people up at night for the reasons we have discussed. The ease
of bringing biological agents into the country or actually
preparing them here, and then the propensity they have to
multiply and spread has devastating consequences.
So the Committee is going to stay on this. We are going to
look over your shoulder at DHS and HHS. We do not consider
ourselves to be antagonists, but we are representing the public
that we all serve. We are also going to say to you, tell us
what you are not getting that is standing in the way of you
achieving what we need to achieve as soon as possible. And I am
pleased to say that Mr. Rhodes and the Committee and GAO are
going to be working together. We have agreed that the excellent
report issued today is the first of a series that will be
issued with regard to the bioterrorist threat to our country.
Admiral Cohen, do you want a last word?
Mr. Cohen. Yes, sir. I know you are facing a vote. I just
want to make one clarification. On the retinal scanner, what we
are looking at are the physiological effects on the human,
which we then track back to various chemical and biological
agents. And I wanted to correct that record. And you asked is
there anything you could do to help. I think your staff is
aware that wisely you sunsetted many of the provisions of the
initial Homeland Security Act, but one that is coming up on
January 25, 2008, is the other transaction agreements. This is
a critically important tool that we use, especially in the
BioWatch and biodefense areas, and I would just with great
respect ask that if there is any thing that its renewal could
be attached to before it expires, we would greatly appreciate
that and will not abuse it.
Thank you so much for your leadership.
Chairman Lieberman. Time flies. That is quick. Thank you.
The record of the hearing will remain open for 15 days for
any additional comments that the witnesses would like to submit
or for us to ask you additional questions. This has been a very
productive, direct hearing with, I think, the appropriate sense
of urgency to it, and I thank you for all that you have all
contributed.
Senator Collins, would you like to add anything?
Senator Collins. Thank you to our witnesses and to you, Mr.
Chairman, for holding this very important hearing.
Chairman Lieberman. Thank you. The hearing is adjourned.
[Whereupon, at 11:40 a.m., the Committee was adjourned.]
A P P E N D I X
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