[House Hearing, 113 Congress]
[From the U.S. Government Printing Office]
[H.A.S.C. No. 113-63]
BIODEFENSE: WORLDWIDE THREATS
AND COUNTERMEASURE EFFORTS FOR
THE DEPARTMENT OF DEFENSE
__________
HEARING
BEFORE THE
SUBCOMMITTEE ON INTELLIGENCE, EMERGING THREATS AND CAPABILITIES
OF THE
COMMITTEE ON ARMED SERVICES
HOUSE OF REPRESENTATIVES
ONE HUNDRED THIRTEENTH CONGRESS
FIRST SESSION
__________
HEARING HELD
OCTOBER 11, 2013
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
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SUBCOMMITTEE ON INTELLIGENCE, EMERGING THREATS AND CAPABILITIES
MAC THORNBERRY, Texas, Chairman
JEFF MILLER, Florida JAMES R. LANGEVIN, Rhode Island
JOHN KLINE, Minnesota SUSAN A. DAVIS, California
BILL SHUSTER, Pennsylvania HENRY C. ``HANK'' JOHNSON, Jr.,
RICHARD B. NUGENT, Florida Georgia
TRENT FRANKS, Arizona ANDRE CARSON, Indiana
DUNCAN HUNTER, California DANIEL B. MAFFEI, New York
CHRISTOPHER P. GIBSON, New York DEREK KILMER, Washington
VICKY HARTZLER, Missouri JOAQUIN CASTRO, Texas
JOSEPH J. HECK, Nevada SCOTT H. PETERS, California
Peter Villano, Professional Staff Member
Mark Lewis, Professional Staff Member
Julie Herbert, Clerk
C O N T E N T S
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CHRONOLOGICAL LIST OF HEARINGS
2013
Page
Hearing:
Friday, October 11, 2013, Biodefense: Worldwide Threats and
Countermeasure Efforts for the Department of Defense........... 1
Appendix:
Friday, October 11, 2013......................................... 29
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FRIDAY, OCTOBER 11, 2013
BIODEFENSE: WORLDWIDE THREATS AND COUNTERMEASURE EFFORTS FOR THE
DEPARTMENT OF DEFENSE
STATEMENTS PRESENTED BY MEMBERS OF CONGRESS
Langevin, Hon. James R., a Representative from Rhode Island,
Ranking Member, Subcommittee on Intelligence, Emerging Threats
and Capabilities............................................... 2
Thornberry, Hon. Mac, a Representative from Texas, Chairman,
Subcommittee on Intelligence, Emerging Threats and Capabilities 1
WITNESSES
Bennett, Dr. Bruce W., Senior Defense Analyst, RAND Corporation.. 6
Giroir, Dr. Brett P., M.D., Interim Executive Vice President,
Texas A&M Health Science Center, Texas A&M University.......... 9
Russell, MG Philip K., USA (Ret.), Sabin Vaccine Institute....... 7
Smithson, Dr. Amy E., Senior Fellow, Monterey Institute of
International Studies.......................................... 4
APPENDIX
Prepared Statements:
Bennett, Dr. Bruce W......................................... 42
Giroir, Dr. Brett P.......................................... 65
Russell, MG Philip K......................................... 61
Smithson, Dr. Amy E.......................................... 33
Documents Submitted for the Record:
[There were no Documents submitted.]
Witness Responses to Questions Asked During the Hearing:
[There were no Questions submitted during the hearing.]
Questions Submitted by Members Post Hearing:
[There were no Questions submitted post hearing.]
BIODEFENSE: WORLDWIDE THREATS AND COUNTERMEASURE EFFORTS FOR THE
DEPARTMENT OF DEFENSE
----------
House of Representatives,
Committee on Armed Services,
Subcommittee on Intelligence, Emerging Threats and
Capabilities,
Washington, DC, Friday, October 11, 2013.
The subcommittee met, pursuant to call, at 11:11 a.m., in
room 2118, Rayburn House Office Building, Hon. Mac Thornberry
(chairman of the subcommittee) presiding.
OPENING STATEMENT OF HON. MAC THORNBERRY, A REPRESENTATIVE FROM
TEXAS, CHAIRMAN, SUBCOMMITTEE ON INTELLIGENCE, EMERGING THREATS
AND CAPABILITIES
Mr. Thornberry. The subcommittee will come to order.
Mr. Langevin, I am sure, is on the way, and he will be here
in just a moment, but we will go ahead and get started.
Today's hearing is a reminder that the national security
threats to our Nation do not go away or wait patiently while we
try to straighten out our budget woes. There are very real and
very significant dangers in the world, and the foremost target
is America and Americans.
Part of our job on this subcommittee is to look ahead for
the threats coming down the road and for those that may loom
larger in the future. Biological threats must be at or near the
top of that list.
For example, while the world's attention has been focused
on Syria's chemical weapons, DNI [Director of National
Intelligence] Clapper testified earlier this year that Syria's
biological program may be more advanced than we previously
thought. We believe that other nations, such as North Korea,
have such capability, as well.
David Hoffman's book, The Dead Hand [The Dead Hand: The
Untold Story of the Cold War Arms Race and Its Dangerous
Legacy], discusses the Soviet program, which engineered a
pathogen within a pathogen so that victims got sick, seemed to
get better, and then got hit with a second pathogen and quickly
died. In other words, there seems to be an endless number of
biological threats, from the crude to the sophisticated.
And then, of course, there are terrorists. The former chief
technology officer for Microsoft, Nathan Myhrvold, recently
published a paper on the Lawfare Web site, entitled ``Strategic
Terrorism,'' that has been generating a fair amount of
discussion in national security circles. He argues,
convincingly I think, that technology gives small groups more
lethality than ever, that the incentive for more spectacular
attacks will grow, that biological weapons may be the most
dangerous form of attack, that terrorists using such weapons
cannot be deterred, and that we are not adequately prepared.
We are anxious to get our witnesses' perspectives on these
issues, and they are well qualified to provide that. We want to
examine the threat, the Department of Defense's (DOD) role in
meeting the threat, and other Government and national resources
that should also play a part.
I would yield to Mrs. Davis for any opening comment she
would like to make at this moment on behalf of Mr. Langevin.
Mrs. Davis. Mr. Chairman, thank you very much.
This is important. And part of it is under what
circumstances we believe our most pressing threat in this area
might be. So I look forward to the discussion, and thank you
very much.
And I believe Mr. Langevin is here, and we will give him an
opportunity when he comes in. Thank you.
Mr. Thornberry. Excellent timing for an entry. And I yield
to the distinguished ranking member for any opening comments he
would like to make.
STATEMENT OF HON. JAMES R. LANGEVIN, A REPRESENTATIVE FROM
RHODE ISLAND, RANKING MEMBER, SUBCOMMITTEE ON INTELLIGENCE,
EMERGING THREATS AND CAPABILITIES
Mr. Langevin. Thank you, Mr. Chairman.
And to our witnesses, I appreciate you being here today on
this very important topic. It is obviously very timely and a
timely
hearing.
And I want to thank the chairman for focusing the Nation's
and the subcommittee's attention on this issue of biowarfare.
Biowarfare is obviously a very troubling prospect,
something that weighs heavily on all of us. And while less
prevalent in the news than nuclear or chemical warfare, it is
an extraordinarily lethal capability that poses a significant
threat to the United States, including from terrorism.
Now, there are also many unknowns and problems unique to
biowarfare, including, most obviously, the unlikelihood of an
attack warning and the difficulty in crafting effective
countermeasures, if they can be created at all.
And these organisms can be incredibly lethal, as Major
General Russell highlighted in his written testimony. Tularemia
is one of the most infectious agents know, with an infectious
dose containing less than 10 bacteria, an infinitesimal amount
when one considers that a simple powder aerosol can deliver
hundreds of thousands of those organisms.
Further, other agents such as botulinum toxin, plague, and
many viral hemorrhagic fevers lack approved vaccines at the
present time.
These difficulties are put into stark relief when we look
at the use of weapons of mass destruction in Syria. Although
the nerve agent sarin was used as opposed to a biological
agent, the attacks in Syria nonetheless demonstrated the
reality of the WMD [Weapons of Mass Destruction] threat to U.S.
and allied forces. Even more troubling, given Syria's past
biological warfare capability and the instability, to put it
mildly, in the country, the threat of proliferation is real and
serious.
Now, that is the background for today's hearing, and it
should add some urgency to the issue. This is not an academic
discussion. And I certainly look forward to what our panel has
to say about proliferation risks from Syria and elsewhere.
Now, within the United States Government, the problem is
obviously compounded by the wide spectrum of agencies with a
piece of the biodefense puzzle. Outside of DOD's [Department of
Defense] Chemical and Biological Defense Program, the
Department of Health and Human Services, Agriculture, Homeland
Security, and the Food and Drug Administration each have a
role, and each has their own specialties, capabilities, and
responsibilities in addressing biothreat preparedness and
response. I remember well the complications of this
interdependency from my time chairing the Homeland Security
subcommittee with oversight of biodefense.
Since my departure from that subcommittee, we have seen the
GAO [Government Accountability Office] report that showed the
Governmentwide biodefense enterprise as being fragmented and
sometimes duplicative as well as lacking strategic oversight
mechanisms. Now, this committee and the Congress have acted to
ameliorate those concerns and enhance the interagency process.
And I certainly look forward to hearing from our witnesses on
what progress has been made and how far we still have to go.
So, with that, Mr. Chairman, in the interest of time, I
want to leave it there. I want to thank you again for convening
the hearing. And I want to thank, obviously, our witnesses for
appearing this morning. And I look forward to a very
informative and interesting discussion.
With that, I yield back.
Mr. Thornberry. I thank the gentleman.
And before going to our panel, I ask unanimous consent that
other committee and non-committee members be allowed to
participate in today's hearing after all subcommittee members
have had a chance--have had the opportunity to ask questions.
Is there
objection?
Without objection, it is so ordered.
Let me now turn to our witnesses.
Thank you all for being here.
We have--everybody is a doctor--Dr. Amy Smithson, Senior
Fellow at the Monterey Institute of International Studies; Dr.
Bruce Bennett, Senior Defense Analyst for RAND; retired Major
General Dr. Philip Russell, who is a retired Army medical
officer and professor emeritus at Johns Hopkins School of
Public Health; and Dr. Brett Giroir, Interim Executive Vice
President, Health Science Center, Texas A&M University.
Again, thank you all for being here.
Dr. Smithson, please proceed.
STATEMENT OF DR. AMY E. SMITHSON, SENIOR FELLOW, MONTEREY
INSTITUTE OF INTERNATIONAL STUDIES
Dr. Smithson. Good morning. And thank you for the
opportunity to testify before the committee on matters of vital
importance to the defense of this Nation.
Mr. Thornberry. Dr. Smithson, if you would hit the
microphone. And try to get it up kind of close to you. Some----
Dr. Smithson. All right.
Mr. Thornberry. They work better that way.
Dr. Smithson. Sorry about that faulty start.
Mr. Thornberry. Thank you.
Dr. Smithson. I thank you for the opportunity to testify
before the committee on matters of vital importance to the
defense of this Nation.
As you have already noted, the number of known biological
weapons proliferators is relatively small today. I would add to
that list North Korea, which I am sure Dr. Bennett will
address. And over the past two decades, terrorists have wreaked
havoc with bombs and bullets far more frequently than with
disease. But no one should be complacent about the biological
weapons threat.
Regrettably, states and subnational actors alike can co-opt
the fruits of the life sciences revolution for germs weapons
programs, which are always shrouded in the utmost secrecy.
Proliferators can use synthetic biology to create from scratch
notorious killers like the 1918 influenza virus and even
smallpox virus. And they can highjack other new life sciences
technologies to manipulate and control human behavior.
One of our other problems is that we don't know what we
don't know. The intelligence community's performance assessing
the biological weapons threat leaves a great deal to be
desired. I will give you an idea why.
Prior to the 1991 gulf war, U.S. intelligence did not
identify Iraq's principal biological weapons production
facility at Al Hakum, nor did they pick up on Iraq's purchase
of an astounding 30 metric tons of growth media, which is used
to grow biowarfare agents.
Moreover, public health authorities, not law enforcement or
intelligence officials, connected the dots in a 1984 surge in
gastrointestinal illness in Oregon to the Rajneesh cult, which
sickened 751 people when it decided to test its plot to foil an
election by sprinkling salmonella on restaurant salad bars.
U.S. intelligence agencies admitted in 1996 testimony that
they were oblivious to Aum Shinrikyo's unconventional weapons
programs until after the cult's infamous attack in the Tokyo
subway on March 20th, 1995. Fortunately, Aum failed when it
tried to acquire and disperse on several occasions biowarfare
agents.
And last but not least, the FBI [Federal Bureau of
Investigation] turned to Dr. Bruce Ivins, a 26-year veteran of
the U.S. Army Military Research Institute for Infectious
Diseases, USAMRIID, to help them investigate the 2001 anthrax
attacks, only fingering him as the culprit in 2008.
Now, the Select Agent Rules, the centerpiece of the U.S.
biosecurity approach, would not have stopped Bruce Ivins, who
was mentally unstable and abusing drugs and alcohol. These
rules do not require substance abuse screening, and they
address mental health issues tangentially. Moreover, a 2001
inventory of USAMRIID's culture collection turned up an amazing
9,220 vials not listed in the facility's computerized
inventory, including vials of botulinum neurotoxins and the
Ebola virus. USAMRIID's inventory saga illustrates just how
misapplied the paradigm of nuclear controls is in a life
sciences world.
With all of this in mind, I offer the committee three
recommendations to consider.
The concept and practice of biosecurity is in serious need
of an overhaul, in part because evidence indicates that the
Select Agent Rules have important opportunity costs for
biodefense. Top scientists in laboratories have apparently
opted out of work with high-risk pathogens already. Therefore,
Congress should require the executive branch to prepare a cost-
benefit study of the Select Agent Rules and alternative
approaches to biosecurity.
Second, far, far too often, scientists' knowledge of
important biosafety, biosecurity, and research oversight
procedures falls to the inclinations and sometimes shoddy
practices of their laboratory supervisor. No time should be
wasted in correcting this ad hoc situation. Congress should
consider how mandatory education and competency demonstration
requirements could be instituted in all colleges and
universities granting life sciences degrees in all institutions
working with high-risk pathogens
Third, the United States needs to go back to the drawing
board on data-collection strategies, tactics, and tools that
can be used to assess the biological weapons threat. Among
other things, a congressionally mandated study would evaluate
the limitations and prospective contributions of intelligence
and inspections to the detection and deterrence of bioweapons
proliferation.
The United States Government appears to have done little to
learn from the incredible experience of the United Nations
Special Commission. With ordinary inspection tools and old-
fashioned, gumshoe detection work, UNSCOM [United Nations
Special Commission] inspectors collected considerable evidence
that Iraq was hiding a bioweapons program behind the facade of
civilian activities. UNSCOM compelled Iraq to admit this.
Inspections can work. And this experience stands as a
direct challenge to the conventional wisdom that the Biological
and Toxin Weapons Convention is inherently unverifiable. This
study would be a springboard to identify alternatives to give
U.S. policymakers more data of a more reliable quality about
suspected biological weapons activities, which would, in turn,
inform U.S. biodefense programs.
With that, I would be pleased to answer any questions about
my testimony.
And I would also add a note of today's news that the OPCW,
the Organization for the Prohibition of Chemical Weapons, has
been awarded the Nobel Peace Prize. These inspectors are
undertaking an unprecedented task, but for 17 years they have
been going around the world monitoring the destruction of
chemical weapons. And it is something that, perhaps, if you
would also like to ask questions about the situation in Syria,
I would be delighted to entertain them.
Thank you for your time and attention.
[The prepared statement of Dr. Smithson can be found in the
Appendix on page 33.]
Mr. Thornberry. Great. Thank you.
Dr. Bennett.
STATEMENT OF DR. BRUCE W. BENNETT, SENIOR DEFENSE ANALYST, RAND
CORPORATION
Dr. Bennett. Thank you very much, Chairman Thornberry,
Ranking Member Langevin, and members of the subcommittee. Thank
you for inviting me to testify at this hearing.
While there are many evidences of the North Korean
biological weapons, North Korea has been very effective at
hiding that information, denying us information in the world
about its biological weapons programs and making the threat
very uncertain. Still, because biological weapons pose a
fearsome threat, South Korea
and the United States need to be prepared, hedging against the
uncertainties.
I will discuss that threat and then turn to means for
countering that threat, though I will focus on the nonmedical
counters, given the expertise of my colleagues.
In my written testimony, I have provided several open
descriptions of the North Korean biological weapons program. To
summarize, most observers believe that North Korea has pursued
a serious biological weapons development program focused on a
dozen diseases, to include anthrax, cholera, smallpox, and
plague, the latter two being contagious diseases.
It is not known whether these agents are currently
weaponized, though there are a number of testimonies of North
Korea testing these agents against people in its prison camps.
Thus, even if these agents are not currently weaponized, the
north should be able to weaponize them once it decides to
prepare for war.
North Korean special forces are a likely means of
delivering biological weapons. The North has some 200,000
special forces, some of whom could deliver devastating
biological attacks against South Korea, Japan, and even the
United States. Depending upon wind, atmospheric conditions, and
population density, these forces could infect perhaps 500--or
50,000 people per kilogram of anthrax used. Alternatively, with
contagious diseases like smallpox, even if only 1,000 people
were initially exposed, thousands more could be infected as the
disease spreads.
Biological effects are not limited to casualties and
fatalities. As in the case of the anthrax letters, biological
agents can deny the use of facilities, potentially for years.
They can put overwhelming demands on the medical system. They
can force people to use protective measures, measures that
would particularly degrade military operations. They can cause
psychological reactions like the 600,000 people who fled a city
in India one night in 1994 after what turned out to be 167
cases of plague.
And how many cases of smallpox would have to be brought
back into the United States, for example, among evacuated
noncombatants, combat casualties, or aircrews, before the
United States would face substantial economic and psychological
impacts?
So how can we prepare for and respond to these potential
attacks? We must prepare to counter the effects of biological
attacks. Such capabilities would also help deter the attacks in
the first place, and deterrence is clearly the preferred
option. As noted above, I will focus here on the useful
nonmedical counters.
In peacetime, North Korean special forces seeking to
covertly introduce biological weapons for future attacks could
be stopped at South Korean or U.S. borders if immigration was
connected to the passport databases of Asian countries and able
to detect falsified passports. In crisis and conflict, the U.S.
and South Korea could use robust air and missile defenses if
they are deployed in Korea against North Korean military
aircraft or missiles that might carry biological weapons.
With contagious diseases, exposure can be prevented in
various nonmedical ways. Schools can be closed, public
activities suspended, those sick can be physically isolated,
and those exposed could be subjected to quarantine if the laws
exist to facilitate these arrangements.
People arriving at international air and sea ports should
be scanned for a fever. Those with fever should be isolated
until their fever subsides or testing determines they are not
contagious. This procedure continues in South Korea, for
example.
The United States and South Korea should buy respirators
now that they would use to block disease should there be an
outbreak of biological agents. And collective protection should
be provided with us building military facilities in Korea now
at Camp Humphreys, as they were provided when we built those
facilities--similar facilities at Osan Air Base.
In conclusion, the North Korean biological weapons pose
potentially serious though uncertain threats to South Korea and
to the United States. This threat should press the United
States and South Korea to pursue more complete protections.
Thank you.
[The prepared statement of Dr. Bennett can be found in the
Appendix on page 42.]
Mr. Thornberry. Thank you.
General Russell.
STATEMENT OF MG PHILIP K. RUSSELL, USA (RET.), SABIN VACCINE
INSTITUTE
General Russell. Thank you, Mr. Chairman, members of the
committee. I appreciate the opportunity to discuss an issue
that has been--I have been concerned about for about 35 years
or more. And I would like to present my views on what I believe
is a significant unaddressed threat to our Armed Forces and to
our national security.
Over the past two years, my colleagues Mr. Joel McCleary
and Dr. Keith Wells and I have conducted a study of the
impressive achievements of the U.S. offensive biowarfare
program to learn what that means in terms of modern threat
assessment. We conducted a parallel study of how advancement in
pharmaceutical manufacturing can benefit and enable our
adversaries. Our study of the offensive program was based on
existing unclassified documents and on the oral history of one
of the scientific leaders of the program, Mr. Bill Patrick. A
parallel study of classified materials by Dr. Robert Kadlec
supported our findings.
The U.S. offensive biowarfare program was very large, very
well-funded, and very successful. By 1969, when the program was
terminated, it had achieved the ability to deliver lethal and
incapacitating agents in a dry powder aerosol over very large
areas, up to hundreds of square miles. The effectiveness of the
program was conclusively demonstrated in large-scale field
tests such as Red Cloud, Watch Dog, and Speckled Start. These
were enormous trials, many of them conducted over the Pacific.
The two agents chosen by the program after years of
research to be the most effective were tularemia and
staphylococcal enterotoxin B, or SEB. Tularemia is one of the
most infectious agents known and, when delivered by aerosol in
high doses, causes a severe respiratory disease that can be
fatal. Tularemia is widely disseminated in nature and easily
obtained. SEB causes rapid incapacitation and is also lethal in
high concentrations.
These agents, along with delivery systems, were
manufactured and stockpiled. There were plans to use them in
combination, one for rapid effect and one for lethality. Both
of these agents are readily available to anybody who can
isolate a bacterium.
Very few of our present Government officials understand the
achievements of that program and what it means to our current
security. Our analysis of the advances in biologic
manufacturing technology and bioprocessing leads to the
conclusion that it is now possible for a small group of
adversaries to produce these same weapons in quantities large
enough for a strategic attack. Advances in aerosol delivery of
therapeutics have provided our adversaries with greatly
enhanced capability.
We now have no specific licensed preventive medical
countermeasures for these two agents. We rely on antibiotic
therapy for tularemia and supportive care for SEB. The
deficiencies in our national medical countermeasures
development programs have been very well documented. The
Department of Defense created a joint program for advanced
development of medical countermeasures for biodefense in 1996.
The joint vaccine acquisition programs, I think started in
1997, was a major component of this.
A tularemia vaccine was at the top of the requirements
list, which included several other biodefense vaccines
against--most of them up against viruses. It is now 17 years
later and no new licensed products have been developed.
Several independent reviews of the DOD programs, including
one directed by Congress and two by the Institute of Medicine,
were highly critical of the management of the program. To my
knowledge, the recommendations of outside panels have been
largely
ignored.
In summary, I believe that a significant national
vulnerability exists that will persist unless action is taken
to improve our countermeasures development efforts.
I thank you for your attention to this issue. I will be
happy to answer questions.
[The prepared statement of General Russell can be found in
the Appendix on page 61.]
Mr. Thornberry. Thank you.
Dr. Giroir.
STATEMENT OF DR. BRETT P. GIROIR, M.D., INTERIM EXECUTIVE VICE
PRESIDENT, TEXAS A&M HEALTH SCIENCE CENTER, TEXAS A&M
UNIVERSITY
Dr. Giroir. Chairman Thornberry, Ranking Member Langevin,
members of the committee, Congressman Flores, thank you for the
opportunity to be here today.
I am here as the principal investigator for the Texas A&M
Center for Innovation in Advanced Development and
Manufacturing, a public-private partnership with the Biomedical
Advanced Research and Development Authority, also known as
BARDA, of the U.S. Department of Health and Human Services.
This partnership is designed to enhance the Nation's
preparedness against pandemic influenza as well as chemical,
biological, radiological, and nuclear threats.
My previous experience includes Government service as the
director of DARPA's [Defense Advanced Research Projects Agency]
science office and also as chair of the Chemical and Biological
Defense Panel of the Threat Reduction Advisory Committee at
Defense Threat Reduction Agency (DTRA).
At DARPA, we identified a critical national need for core
biomanufacturing facilities that would be low-cost, flexible,
adaptable, capable of simultaneously producing multiple
products to support biodefense, while maintaining the ability
to surge to a single product during a national emergency. In
2008, when my assignment at DARPA was completed, I joined the
Texas A&M system, secured a $50 million investment from the
State of Texas to demonstrate those flexible manufacturing
capabilities originally envisioned at DARPA.
Beginning in 2009, Texas A&M designed, developed,
constructed, and is now operating a revolutionary first-in-
class, 150,000-square-foot facility that has pioneered highly
flexible, adaptable, and even mobile manufacturing platforms at
a capital cost of about 80 percent less than the current state
of the art. This project, called the National Center for
Therapeutics Manufacturing, is a primary infrastructure asset
for the HHS [U.S. Department of Health and Human Services]
center, which I will now describe.
The Texas A&M Center for Innovation is one of three
national centers competitively awarded by HHS in June of 2012
and is the only one led by an academic institution. It is found
on an initial 5\1/2\-year base period contract consisting of
$176 million in funding from HHS and a $109 million cost-share
by our center's academic, commercial, and State of Texas
partners. The total potential duration of the contract is 25
years, with options for an additional $2.4 billion in readiness
stipends and task orders.
The high-level objectives of our center are: first, to
provide a national vaccine response against pandemic influenza,
defined as 50 million doses delivered in 4 months, with initial
doses available to the U.S. Government in 12 weeks; second, to
perform what is called the advanced development and
manufacturing of vaccines and medical countermeasures against
chemical, biological, radiological, and nuclear threats as
tasked by HHS; and, third, and very importantly, to train the
future domestic U.S. workforce.
To achieve these objectives, Texas A&M is leading a
multidisciplinary team with expertise spanning from research
through clinical trials, including GlaxoSmithKline, or GSK,
Vaccines, the world's largest vaccine developer, with over 1.4
billion vaccine doses distributed worldwide annually and 11
vaccines in the United States.
The center is also actively expanding domestic U.S.
infrastructure. First, our preexisting facility is undergoing a
capabilities upgrade that will be completed in March of 2014.
Second, we are building a new, dedicated pandemic influenza
vaccine facility to meet our 50-million-dose requirements.
Construction and facility commissioning will be completed in
the third quarter of 2015. Third, we are building a new live-
virus vaccine facility to produce vaccines up to the BSL-3
biosafety level. Construction and facility commissioning will
also be completed in the third quarter of 2015.
I would like to finish my remarks highlighting
opportunities for collaboration with the Department of Defense.
First, Texas A&M is highly motivated to continue our
distinguished history of service to the Nation by supporting
the DOD and supplying improved vaccines and countermeasures to
the warfighter. Of particular interest would be DOD
partnerships to develop and manufacture products for their
stockpile and special immunizations programs and, perhaps more
importantly, to be the cornerstone for an emergency response to
genetically modified, or chimeric organisms as well as other
unexpected agents that we believe are a growing real threat to
our national security and public health.
According to our contract with HHS, at least 50 percent of
our center's capabilities are available for non-HHS projects.
Therefore, there is an immediate opportunity for the DOD to
utilize our center's capacity and expertise, which has already
been funded by HHS. We believe such collaborations would not
only reduce DOD operational risks but would also reduce DOD
expenditures, potentially by hundreds of millions of dollars
that could then be reallocated to provide additional vaccines,
countermeasures, and capabilities to our warfighters.
Thank you very much for this opportunity, and I am pleased
to answer any questions.
[The prepared statement of Dr. Giroir can be found in the
Appendix on page 65.]
Mr. Thornberry. Thank you.
And, without objection, you all's full written statement
will be made part of the record as well, but I appreciate the
oral comments from each of you.
Let me just begin with one question that I would invite
each of you to address, and that is referencing back to the
paper I mentioned on terrorists' use of biological weapons.
And I would just--you all were not asked to testify as
experts on terrorism, but I would be interested in whatever
thoughts you may have about the likelihood of such a thing,
what some of the challenges would be, you know, whatever you
feel comfortable in commenting on a terrorist attack using
these sorts of weapons.
Dr. Smithson.
Dr. Smithson. I have looked at the statistics of terrorist
activity, and it is clear that, for the time being at least,
they are far more interested in bombs and bullets over the past
couple of decades. But it is also equally clear, by the
attempts to acquire substances and the uncovering of plots,
that there is increasing interest among terrorists.
The other thing that I think brings this within the reach
of not just terrorist groups but individuals is the de-skilling
of equipment. In other words, things that used to take Soviet
bioweaponeers thousands and thousands of man-hours can now be
accomplished by a piece of equipment in a fairly short time.
They are currently working on desktop printers for DNA
[Deoxyribonucleic Acid ].
So it is a very fast-moving technical situation that will
allow terrorist groups to acquire this capability. And we know
that there are terrorist groups out there, like al Qaeda, that
have the intent to kill indiscriminately.
So I am very concerned about the prospects for the future.
I don't know exactly when, but I do believe we will see
bioterrorism again.
And in my prepared remarks, I quote another individual who
agrees with this study cited, and it is Martin Shubik, who
views this situation in an equally grave manner.
Dr. Bennett. I think we have to face the fact that some of
the state actors we look at look a lot like terrorists when
they actually go out. Some of my colleagues in the South Korean
military believe that they have been subjected to testing by
the North Korean special forces in recent years. Anthrax,
probably several other diseases, they believe, have been tested
in their territory to see what kind of reaction there would be
and the ability to cope. That is clearly a terrorist kind of
action.
I think we also have to recognize that some of these state
actors are very closely tied to Iran, to Syria, where you have
the potential for state-sponsored terrorists and would be quite
pleased to see terrorists also using these capabilities and
have done a fair amount of transferring of technology and
capability to other states. We don't know about to specific
terrorist groups, but you have to wonder if that isn't coming,
if it hasn't already occurred.
General Russell. Unfortunately, some of the best potential
bioweapons exist in nature and are readily available, so
locking up bacteria and viruses is not going to solve the
problem.
The advances in biologic manufacturing that I mentioned
include the drying methodologies and production of aerosol
powders. This information is widely available on the Internet.
The equipment is for sale on the Internet. I think we have seen
a tremendous shift of advantage to the adversaries in this
regard because of the ability of a very small group of people
with the expertise to manufacture these weapons. And the
weapons are very, very dangerous.
Dr. Giroir. I certainly share the other witnesses'
concerns.
And I will reemphasize what Dr. Smithson said, is I believe
the barrier to entry into this has dramatically decreased, both
because of the biomanufacturing advances that General Russell
has said but also the ubiquitous nature of DNA technology,
recombinant DNA technology, synthetic DNA technology.
Literally, what took me weeks during medical school to produce
in a multimillion-dollar laboratory can be done in an afternoon
on a benchtop by someone with a relatively less degree of
scientific training. So the barriers to entry have decreased.
I share General Russell's concern about the known threats.
As a critical care physician, I have treated both SEB and
tularemia, and the thought of having hundreds or thousands of
such patients cannot even be comprehended by the medical
community, much less addressed.
And, third, I share the concern about some of your remarks,
sir, about masked or chimeric organisms that I think leverage
current vaccine technologies that are developed for the
betterment of mankind. These are very, very concerned to mask
very dangerous organisms within infectious aerosol organisms.
So, again, I share the threat and wanted to re-echo some of
their themes.
Mr. Thornberry. Mr. Langevin.
Mr. Langevin. Thank you, Mr. Chairman.
Again, thanks to our panel. This is obviously a very
sobering discussion. And I am reminded that there are obviously
many threats that we face, particularly from terrorism, and as
horrific as a nuclear attack on the country would be,
thankfully Mother Nature didn't make it easy to make weapons-
grade plutonium or highly enriched uranium. However, developing
bioweapons and using them against our population is something
that terrorists could do not just once but again and again and
again, and it poses great risk.
This is something, as I mentioned in my opening statement,
I spent quite a bit of time on when I chaired the Subcommittee
on Emerging Threats, a subcommittee on Homeland Security.
And I would like to just start by asking your concerns
about what are the more likely pathogens that we have to worry
about. I know we talked about tularemia. Would you put that as
number one on the list? Or is it weaponized aerosolized
anthrax? Where should we be targeting our resources to develop
countermeasures?
These are obviously important discussions for us to
contemplate. And it is also important to remember that people
would be kidding themselves or grossly misinformed if they
thought that terrorists and the various groups and forms that
they take are uneducated. These are actually highly educated
people, in many ways, in the STEM [Science, Technology,
Engineering, and Mathematics] fields, in the biosciences. And
this issue of threat of bioweapons attack on the country is
something that, it is one of those things that does keep me up
late at night.
But I would like to talk about, in terms of prioritization,
what do you think are highest on the list? We can go right down
the line.
Dr. Smithson. Thank you, Congressman. And I am afraid my
answer may disappoint you somewhat.
Yes, everything on the list is a problem, but so are things
that aren't on the list. And this is one of the things that I
learned from the inspectors of the United Nations Special
Commission. We tend to look at these problems through the lens
of our past program and of what we know about other past state-
level programs. And then along comes a country like Iraq, and
they choose to weaponize an agent that causes liver cancer and
something that causes gas
gangrene.
So when you go in looking for something that you expect--
and I guess my message in this case is that things that are not
on the list could be very problematic. They can be genetically
engineered to increase their lethality and contagiousness. We
know that the Russians did a lot of this work. I have been in
over 20 of the facilities that were part of the former Soviet
program.
So, in considering what is a problem, I know we have to
prioritize, but I would encourage everyone to keep in mind that
it is not just about a list. It is about a world of potential
problems.
Thank you.
Dr. Bennett. I think we have to recognize the fact that it
depends upon what the target is. If someone is trying to attack
the civil population, which could happen in this country, they
can use almost any of the agents. Whatever is easiest to
produce could cause the effects.
If they are trying to go after our military, and we are
properly vaccinated in certain areas, they are going to go
after things that are different. And their knowledge, which is
pretty well-established on what kind of protections we have
fielded, will lead them to some differences. But those
differences, as Amy has just said, are pretty easy to come by.
There are lots of alternatives out there.
General Russell. I have a slightly different view of that
because if you look at the characteristics of biologic agents,
microbial agents, and their suitability for use of weapons,
there is a hierarchy. Some are easily manufactured. The
bacteria are much more easily manufactured than viruses, for
example. It takes a lot of expertise to grow viruses in cell
culture. Bacteria are easy. The stability of the organism, both
in growth and in aerosol, is a huge issue and one that was
solved by the two programs. And the availability, I do not have
a high level of concern about chimeric agents, about engineered
agents, simply because Mother Nature is a much better
bioengineer than anybody has published so far. But there is a
hierarchy.
Tularemia came to the top of the list from the two
offensive programs. Anthrax is ten-thousand-fold less
infectious, but it is a persistent agent and it is very, very
dangerous. But there is a hierarchy. I think we have a pretty
good posture in terms of smallpox, a pretty good posture in
terms of anthrax, but I think we have a couple more on the list
that we need to take off as major concerns. And then we can
worry about downstream engineered organisms.
Dr. Giroir. I certainly agree that the likely existential
threats, such as smallpox, likelihood of anthrax, et cetera,
need to be taken off the table very early.
I don't share the opinion that the genetically modified or
chimeric organisms are lower down the list. And I think that is
based on good information about what is capable and what was
thought of. That is not to say that nature doesn't always throw
something at you naturally; I completely agree with you. But I
do believe that the genetic modifications and chimeric
organisms are an important threat.
The last thing I would say is a prioritization on the list
needs to be the unknown unknown, what were not expected for.
And we, at least I believe, nationally need to take a lot of
lessons from the DOD in exercising the capability and doing
tests and exercises that, if we see something we don't know of,
how does this actually happen? How does my center interact with
other centers? How does the DOD interact with HHS? How do we do
it and distribute it in a very short timeframe? Which is a very
different problem than taking 10 years to make your next
anthrax product and stockpiling it.
Mr. Langevin. Thank you, Mr. Chairman.
Mr. Thornberry. Mr. Nugent.
Mr. Nugent. Thank you, Mr. Chairman.
And I want to thank this panel. I don't feel very
comfortable. Thank you so very much in doing that.
And, particularly, you know, there was a GAO report out in
regards to biodefense efforts being somewhat fragmented. And,
obviously, there are a lot of different takes on what we should
address and what we should look at, so that makes it even more
difficult, I am sure.
I would love to hear your input in regards to what you
think--I mean, there has been some legislative, I guess, tries
to fix, but what do you think we need to do to try to
coordinate and use best practices or--you know, when we are
spending money, let's get the best bang for our buck.
Dr.--right? Doctor, doctor, doctor, but Dr. Smithson.
Dr. Smithson. Apologies. A group like us does tend to be,
shall we say, the skunk at the cocktail party. But we are all
here in the service of defense and peace.
I think the coordination of a government as large and
unwieldy as ours is a never-ending challenge. And the only
surefire way to ensure that more, as opposed to less, of that
happens is to have White House attention and dedicated
responsibility on issues just like this and to have, quite
frankly, the whip cracked from that location frequently in
terms of oversight and coordination.
Otherwise, I think there are organizations and even
scientists that have their own preferred solutions, and you
don't get too much of an agreed agenda. And so, yeah, I would
put a strong vote for more attention from the White House.
Mr. Nugent. Dr. Bennett.
Dr. Bennett. I think what we have to recognize--I think the
medical responses are extraordinarily important, but there are
a lot of nonmedical responses that also have to be coordinated
in here. Our legal framework for doing things like quarantine
and isolation is not really there.
In the 1970s, when you had the outbreak of smallpox in
Yugoslavia, they forcefully vaccinated almost 90 percent of the
population, even though it was already vaccinated, to try and
get it under control. They threw over 10,000 people into
quarantine for several weeks. They took very extreme measures.
Now, they got it under control relatively quickly as a
result, but it was a combination of the medical and the
nonmedical actions. And, as Amy has suggested, somebody needs
to be looking at that combination and making sure we have the
full package of tools so that we can proceed.
Mr. Nugent. General.
General Russell. In our Government, everybody is in favor
of coordination, but nobody wants to be coordinated. It is a
very, very difficult issue, one I struggled with when I was in
the Army, when I was at HHS.
And the fundamental answer is senior leadership and
direction. If there is strong central senior leadership, the
agencies will respond and work together. If there is not, they
will not; they will go their own way. And there is a lot of
history to support that view.
And Dr. Bennett has it absolutely correct, medical
countermeasures are only a piece of the issue. We need a focus
on biologic terrorism and the threat, and we need a coordinated
across-the-Government effort to do it, but that takes
centralized leadership to do it.
Mr. Nugent. Doctor.
Dr. Giroir. I am going to echo, centralized leadership is
key. I think some structures have been made in the last few
years that are very positive. The so-called PHEMCE, the Public
Health Emergency Medical Countermeasures Enterprise, where
everyone is at the table--DOD, DHHS, FDA [Food and Drug
Administration], NIH [National Institutes of Health], et
cetera--I think that is very, very positive. It is done at a
high level, Assistant Secretary, then at a level below that
where the work gets done.
But, again, everyone around the table. There is no
substitute by having someone calling the leadership of that
group and helping people who may not want to be coordinated to
be coordinated.
I only give you my experience when I was at DARPA. The day
that Dr. Kadlec took a special assistant to the president
position, in terms of biosecurity, the world changed
instantaneously, because everyone was around the table and
someone told us all what was expected of us and held us
accountable to that. And I thought that was a very important
lesson that I learned.
Mr. Nugent. Seems like a key theme across the board,
though, is about leadership from the top.
Thank you so very much.
I yield back.
Mr. Thornberry. Mrs. Davis.
Mrs. Davis. Thank you, Mr. Chairman.
And I am glad we are having the interagency discussion. And
as I know the chairman knows, it has been an issue, of course,
on the Armed Services Committee.
I actually recall that when I first came to Congress, NDU,
National Defense University, did a lot of those simulations.
And, you know, we had one biological attack and, you know,
another week came over, and you see the map and the changes.
And it is actually something that is not being done anymore, I
don't believe. And I thought it was educational. It was scary,
but it did give us a sense.
And having everybody around the table, the difficulty, as
you say, is, where does the leadership come from, and how do we
actually move forward with that? You have all basically talked
a little bit about that. You see that in the executive branch.
Could you help us understand? I mean, how often do you think
these issues come up? How prevalent is--you know, how much a
part of the discussions do we have biowarfare?
And, also, in terms of public-private partnerships, Dr.
Giroir, you were talking about Texas A&M and the fact that, in
terms of research and development, you are kind of asking the
question, is there something more that could be done? DARPA led
some of those efforts, but then it moves over to the private
sector or at least the academic sector.
How do you see that working better together? Are there
authorities that are needed? Is there something else that
perhaps Congress should be doing to facilitate that? How good
an idea is that? And are we putting our efforts into R&D
[Research and Development], and whether it is DARPA or ARPA,
whatever, that should be more focused in this regard,
preventative as well as the others?
Dr. Smithson. Thank you for your question.
As somebody who has specialized in chemical and biological
weapons nonproliferation for over two decades, I can tell you
that it can be a lonely place in a very nuclear, nuclear-
centric world.
Look, it is understandable that decisionmakers and think
tanks and everybody else worries perhaps first and foremost
about these things. And I think if there is something positive
to be taken out of the anthrax letter attacks in 2001, it is
that biological is now part of that conversation more
frequently. It is on people's minds.
But it is an incredibly complicated thing to parse.
Sometimes what you do that has a benefit in one instance--for
example, increasing the disease surveillance capacities of
overseas laboratories so that they can detect an outbreak
before it reaches U.S. shores--might also have a downside if
you don't properly train those laboratory technicians in the
biosafety precautions they need and must have. And if they
don't have a concept of security and responsibility for the
work that they do--they are not even aware, often, that agents
have been weaponized and even used in war in this field.
So it is a very complicated situation to get decisionmakers
to focus on. And sometimes, quite frankly, they just throw up
their hands, ``What are we to do,'' in these circumstances.
Get more people like us in the room with you more
frequently. And if you would like another thrilling scenario
exercise, I can provide one of those, in terms of even the
challenges of attributing a biological weapons attack, which is
the first part of a response.
Dr. Bennett. Let me give you an example along the lines you
are talking about. Let's say that there is a collapse of the
North Korean Government, that some of the factions decide that
they are going to use some of the smallpox, which they may well
have, and they simply sprinkle it among the American
communities in Seoul.
But, of course, in that kind of situation, we would want to
evacuate the noncombatants, because a civil war might break out
in the North and difficult situation develop, and we evacuate
them back to the United States. And, of course, smallpox takes
12, 15, 20 days to develop. Those people come back to the
United States and you get the disease once they are back here,
and it is already spreading. So where is our concept for
quarantine of those people we would be evacuating out if there
really is a risk?
Part of the problem is we need to be discussing these
things more to recognize where those vulnerabilities are. Those
discussions, I don't see them going on. And I think that is the
kind of thing, exactly as you suggest, where we need to raise
the consciousness in order to address it.
General Russell. The biologists are a minority in the--in
this discussion. Most of the discussion is so dominated by the
nuclear and the chemical communities, that the--and the
leadership thinks along the lines that they are used to dealing
with those threats, and they are so very, very different from
the biologic threat, that the medical countermeasure
development has always struggled because to a large extent, the
leadership in the Department of Defense doesn't understand the
vaccine industry, doesn't understand the biology, and it
doesn't understand the science.
That expertise has been largely developed and stayed within
the medical departments of the armed services, but the Defense
Department is quite separate from that and has not benefited
from the transfer of that information. I hope that things will
change in the future, because we do have a really major
problem.
Dr. Giroir. Just want to make a comment or two about the
coordination, and there is an analogous side on the DOD, but I
will stick to DHHS since I am now one of the centers. I think
it is important to understand how things link. The National
Institutes of Health, particularly NIAID [National Institute of
Allergy and Infectious Diseases], is responsible for doing the
basic work that sets the groundwork for all the countermeasures
in vaccines that are actually done. They bring it to a certain
level, either late preclinical, or what is called phase one,
and then it is transitioned to BARDA, the Biomedical Advanced
Research and Development Authority, to do what is called
advanced development in manufacturing, the scale-up, the
readiness. This is very, very expensive; the later stage
clinical trials to bring them.
So the first set of coordination is within the agencies
themselves. And personally I am seeing that being very
positive, that the NIH and BARDA are working very closely
together. People like me from the academic community on the
advanced development side are being invited to all the critical
meetings on the NIH side, so we know what is coming down the
pike back and forth. So I just wanted to make that kind of
clear about how this works. And there is an analogous situation
on the DOD side between basic research and acquisition.
Two things you asked for specific suggestions, so I will
give them to you. At least on the advanced development side, it
is critical to have commercial partnerships in this venture,
because the expertise, the critical mass, the knowledge
primarily resides in large or even medium companies who do this
for a living every day, and in order to be cost-effective but
also reduce the risk, we have got to bring commercial partners.
Again, this was a major effort of BARDA, and we brought in GSK,
who is working with us primarily on pandemic influenza.
I think anything that could be done to incentivize
commercial pharma to get in this area, which is not profitable
and is of high risk, would benefit us very much. And I think
one thing that can be done is ease of Government contracting
and lack of administrative burden imposed on companies who,
quite frankly, don't have the time, willingness or ability to
take that risk that Government contracts put on them.
The third thing I would say is I would have Congress
encourage agencies like BARDA on the contracting side to use
the flexible authorities that they were given to expedite
contracts and make them more goal-oriented except--instead of
cost-based contracts where basically every nut or bolt has to
be justified and there is a margin put on that. I think the
contracting authority that was given is plenty sufficient, but
it needs to be exercised in a more rigorous way. If you ask me
what I think you could do, I would have Congress encourage them
to use the authorities that were already given. And maybe
General Russell disagrees with that, but----
General Russell. I do not.
Dr. Giroir. Okay.
General Russell. I heartily agree with that.
Mr. Thornberry. Well, that is a story we have heard in
other places, as you can imagine. Federal contracting is one of
our biggest problems. And I remember some of those exercises
you were talking about dealing with anthrax, for example, which
got to be in my part of Texas, and it just shut down the
country once you start quarantining places off. It really does
open your eye. We have got our own doctor, Dr. Heck.
Dr. Heck. Thank you, Mr. Chairman. Thank you all for that
excellent review of where we are at and the discussions of the
needs for physical and medical countermeasures and the
importance of addressing the genetic and chimeric organisms,
but I think, in my mind, Dr. Bennett hit it on the head, which
our underlying issue is the lack of discussions and how are we
going to address the issues that we face? I remember in 1997
when then-Secretary of Defense Bill Cohen was on ABC's ``This
Week'' and held up the 5-pound bag of sugar and said, if this
was anthrax and spread over D.C., it would take out half the
population.
So we are about 16 years later and still waiting for
meaningful discussions to take place. And while the things that
you talked about are important, critically important, I think
there are a lot of other simpler things that we have yet to
talk about, like the identification of dual-use technology and
how we are going to figure out if what they are doing is for
licit purposes or illicit purposes.
The chronic underfunding of public health infrastructure in
this Nation, who actually will be the first responders, as Dr.
Smithson pointed out, was the group that figured out what was
going on in The Dalles, Oregon, salmonella outbreak.
And, of course, Dr. Giroir, you mentioned the overwhelming
of our healthcare system by mass casualties. And you look at
the statistics that in most mass incidents, it is about a
seven-to-one ratio of those who are actually affected versus
those who are unaffected but show up just because--I am an
emergency medicine doc--just because they want to get checked,
and they are concerned, the psychological fears.
So how would you address those things? Dual use; figuring
out who is good, who is bad; the chronic underfunding of public
health, or how do we enforce public health infrastructure; and
how are we going to prepare our healthcare system to deal with
the casualties?
Dr. Smithson. I always love a simple question. Thanks for
that. I could not agree with you more that investment in public
health is always a sound idea. And in this case, it doesn't
necessarily matter, in terms of casualty care, whether it is
Mother Nature or a deliberate attack, so that is always a good
idea.
In terms of identifying dual-use technology, this is
something that concerns me greatly, because of how quickly
this--the equipment and knowledge is--is advancing at this very
time. And there are tools like the Australia Group, which was
formed in the mid 1980s in response to the attempts of Iran and
Iraq to acquire chemical weapons precursors from a variety of
supplier nations, and so we began to harmonize our export
controls. And that group now also addresses biological
materials and dual-use biological equipment, but it is tough
for the Government to agree how to address some of these
issues, in part, because there are so many things happening,
and there are so many different opinions about what is most
important.
So here is what I would encourage us to do, and that is
actually to get industry into that equation as well, because
there are some very constructive things that can be done in
terms of public-private partnerships with regard to control of
dual-use equipment. Name me a company that wants to have its
piece of equipment end up on the front page of The New York
Times or some other media outlet as being part of a terrorist
attack or a state-level biological weapons program. So we need
to work with industry to provide them with some access to the
information that we collect and get their cooperation in terms
of screening customers more effectively than perhaps even the
Government can accomplish.
Dr. Bennett. Let me turn to the military in particular and
some things we could be asking the military to do. I think we
need to recognize the fact that this kind of threat could
overplay any kind of future contingency, whether it is a
challenge like a provocation in North Korea or some major
conflict. So do we ask all of our soldiers that are deployed in
the field to report in as soon as they are sick with any kind
of virus or whatever? Most of them are typical military
personnel. They are a little reluctant to do that until they
are sure they are really sick, just like many of us are. Rules
on that kind of thing could be very important.
Similarly, let's think about the military. If we can't
evacuate casualties from the theater, our current concepts for
military medical care are very much challenged. We may have to
plan to do much more medical care in a theater in order to take
care of our personnel who have become casualties, conventional
casualties, if there is the threat of contagious disease coming
back with them. So this is all a matter of starting to think in
this context of if this really is a threat, let's take it
seriously.
General Russell. Shortly after 9/11 and the anthrax
attacks, there was a huge investment in the public health
infrastructure of this country. A lot of manpower was added and
a lot of capability, both for surveillance and for first
response. I believe that that has seriously deteriorated over
the succeeding years, and our public health infrastructure, I
think, needs a lot of attention.
One of the operational aspects of military medicine has
been the overseas laboratories of the armed services, and they
have provided both an enormously effective base for research in
the epidemiology of infectious diseases in various parts of the
world, and they are also good listening posts. They interact
with the medical and public health communities of their
countries. And I think that one thing we could do to improve
our ability to understand what is going on in the rest of the
world in terms of infectious diseases is to increase our
investment in the overseas laboratories.
Both the Army and the Navy have very good labs that have in
recent years not been very well supported.
Dr. Giroir. I am in the enviable position to be last, so I
can agree a lot, but the public health system will likely be
tasked to handle such an outbreak. I think it is also very
likely that it will be the first detectors of an outbreak, the
first responders, the emergency room physicians, the infectious
disease physicians, so any investment into public health is an
investment in national security in this regard, and I feel that
very, very strongly.
I also agree that industry involvement is very important in
this, both from the dual-use technologies, to bring them
onboard and help solve the problem, and as the dual-use
technologies do proliferate, I think it is important to
understand that they are all computer-based technologies,
digital-based technologies, so quite aside from what we are
talking about, I would hope that the intelligence communities
have avenues into collaboration with biologists to understand
what those signals can be, which may be very, very rich.
I do want to say that as hard as all this is, and as much
as we are sort of laying crate today, I think these are all
tractable problems. These are all solvable problems if there is
coordination and leadership. There is not--as a critical care
and ER [Emergency Room] doctor, there is not a day in the
winter that you don't have 100 patients more than you deal
with--that you can deal with comfortably. So people on the
front lines, whether it be military or health responders, know
how to handle this problem, but they need some help, they need
some coordination, they need to be involved and educated to
help solve this problem. And it is solvable. These are solvable
problems. They may not be 100-percent solvable, but 80- or 90-
percent solvable is a whole lot better than where we are right
now.
Dr. Heck. Thank you. Thank you, Mr. Chairman.
Mr. Thornberry. Mrs. Hartzler.
Mrs. Hartzler. Thank you, Mr. Chair. This has been very
enlightening and disturbing all at the same time, but it is
good that we are starting--not starting the discussion, but
bringing it up today. But I wanted to go back to part of your
testimony, Dr. Smithson, about Syria, and we haven't really
touched on that. Could you give us an update on what is really
taking place there and how likely you believe will be the
ultimate success, will we be able to identify and access all of
the different chemical sites, will we be able to do away with
these weapons? Can you give us an
update?
Dr. Smithson. Thank you. And I think we have got a
tremendous challenge on our hands with Syria, in part because
of Bashar al Assad's track record with regard to cooperation
with nuclear inspectors. If you will recall, in 2007--or 2006,
Israel bombed a nuclear reactor there, which the Syrian
government built in secret, but they were a member of the
Nuclear Non-Proliferation Treaty since 1968. And after they
built this place, they tried to disguise it with an outer
building that didn't make it look like a nuclear reactor. And
after it was bombed, they immediately cleaned up the site and
then delayed the inspectors from getting in there. And even
when they found evidence of manmade uranium, they simply
pointed to that as the fault of the Israelis who bombed the
site and said it was part of the bomb particles.
The track record in collaborating with the chemical
inspectors, yes, we have all seen the footage of the chemical
inspectors inside a facility, and methinks perhaps he is
really, really trying to persuade us that he is going to
cooperate, but keep in mind that already he has shot at the
chemical investigators that Secretary General Ban Ki-moon sent
in there, he tried to bomb away the evidence of the attacks of
August 21st. It is a very mixed track record.
And it is an incredibly difficult thing that they are going
to attempt to do. I am not confident that U.S. intelligence or
any other intelligence has identified all of the sites involved
in this program. And I am very appreciative that the Defense
Department has assets, as do the Russians, which can be brought
into this equation to hydrolyze and degrade the agent if it is
stored in bulk quantities, as well as to literally blow up in
boom boxes in a contained situation munitions.
Getting there is going to be tough, because if you have got
to try to move these things, oh, my gosh. Think about the
security environment: Hezbollah, Hamas, Al Qaeda are in the
neighborhood. So these are very, very early days, and I think
it would be a tremendous thing if indeed the Assad government
does want to really forfeit its weapons. I am just not
convinced that that is the case yet.
And I think that the Nobel Prize money that will now come
to the OPCW is sadly needed. We need to provide resources to
this organization so that they can attempt to do this job. So
stay tuned. There could be some bumps in the road ahead, and it
could be
also an incredible victory for international peace and chemical
disarmament.
Mrs. Hartzler. I haven't read extensively at all about
this, but isn't like the sarin gas in different components and
then they have to mix it? And so if the theory is they are
going to take it out, they could take it out in separate stages
and so they are--all the components wouldn't be together, or
can you kind of explain, and then how do they actually give--I
remember you said something about hydrolyze.
Dr. Smithson. Yes. Certainly. There are two different types
of chemical weapons basically when it comes to the form that
they are in. One is a unitary agent, and they are mustard gas,
which is a World War I agent that was first used in World War I
is thought to be already mixed.
Mrs. Hartzler. Okay.
Dr. Smithson. And whether it is stored in bulk containers
or in a munition that is already mixed. But you have probably
heard the term binary chemical weapon.
Mrs. Hartzler. Uh-huh.
Dr. Smithson. In this case, the last two chemicals that
would be used to make the warfare agent is sarin or VX [nerve
agent] are going to be combined, either right before they are
filled into the munition or, in the case of the U.S. program,
which was rather advanced and the Soviet program, they would
literally be mixed inside the munition on the way to the
target. So at this point, we are not exactly sure, although a
lot has appeared in the media, about the character of what the
stockpile is.
It is reasonable to expect that some of this will be in
bulk quantity, others will be in munitions. And when it is
munitions, keep in mind that the U.S. chemical weapons program,
the destruction program, as well as the one in Russia, put
their destruction facilities right beside the storage sites,
because it is considered a safety hazard just to transport
these things a short distance even to destroy them.
And so transporting them through a civil war is--really,
again, it boggles the mind to think about the courage that
these inspectors are going to have to exercise in order to get
this job done.
And, so the destruction process, there is a capability
called the U.S. field hydrolysis system, which literally is
transportable, there are two units that I believe are probably
headed to Syria, or off the coast as we speak. And this system,
you would use hot water or other chemical reagents, depending
upon what you put in there, to degrade the bulk agent down to
99 percent or even better. So that is definitely a step in the
right direction.
And the boom boxes, we have a couple of different systems
that have also been used in the United States where you can put
a munition of a certain size inside the boom box and it will
literally heat up over the course of 2 days, destroy the agent
and decontaminate the remaining parts of the weapons system.
So these are some of the options, but right now, we really
don't have a concrete idea of the condition of this stockpile
or exactly what the game plan is to getting this very difficult
job accomplished.
Mrs. Hartzler. Thank you very much. Thank you, Mr.
Chairman.
Mr. Thornberry. Thank you. Let me ask General Russell and
Dr. Giroir about the relationship between DOD and HHS, because
some folks believe that DOD has got to focus on protecting
soldiers, HHS focus on protecting the civilian population, and
so we have basically two different missions that need to be
conducted separately. Other folks think that there could be
much more interaction and collaboration. You heard Mr. Nugent
ask about fragmentation of effort. So I would just be
interested in y'all's view about how the two perspectives work
together and could and should there be more, or is it just two
different missions and it is not going to work to do more?
General Russell. The medical countermeasures requirements
for DOD are quite different from HHS. They do overlap in some
areas, and--but the basic research and the underlying biologic
research that is needed to develop the countermeasures is
fundamentally universal. And so I think the DOD historically
has drawn on research done at NIH and in the civilian
community, as well as in its own labs.
I think the coordination historically has been fairly good.
There are interagency committees that meet regularly and
exchange information and discuss how they can work together. I
know the DOD is using the HHS stockpile for rolling over the
anthrax vaccine, and if necessary, smallpox vaccine. There are
interagency agreements that are working.
On the other hand, there are requirements that the DOD has
for immunizations, because protecting the warfighter with
immunization is an important issue, and these are requirements
that HHS does not have. So there has to be some separate
activities at the advanced development and purchasing level,
but the--on the other hand, the military laboratories have
focused on the problems of the military and have provided the
important basis for moving ahead. All of the advances in
tularemia vaccine that have been made came out of military
efforts. The rPA [Recombinant Protective Antigen] Anthrax
vaccine came out of USAMRIID, and the military laboratories,
especially USAMRIID, are still doing very, very good basic
research that are underpinning the development efforts that are
needed.
Dr. Giroir. I will just add to that by saying, although
there are different mission requirements and clearly more of an
emphasis on vaccines and certain types of vaccines, programs
such as our HHS center is fully capable of performing the
advanced development and manufacturing on both military or
civilian measures. The technologies are all the same, the
platforms are all very similar. So there is a great ability at
that level specifically, once they are out of the basic
laboratory or out of USAMRIID, this very expensive
infrastructure critical manufacturing piece can certainly be
shared to a really great degree, because the technologies for
making military or civilian are all about the same. There is
nothing that the DOD needs to produce that can't be done with
the technology that we are developing or have developed with
HHS at that manufacturing stage.
Mr. Thornberry. And that infrastructure you talked about
has been paid for largely by HHS, right?
Dr. Giroir. Yes, sir. There are three centers, and they all
have different developments. Our center will be fully developed
in 5\1/2\ years, but we are ready to take on task orders now.
Novartis, which is the second center, will be fully developed
in 4 years,
and Emergent Biosolutions, I believe they are in a 7- or 8-year
contract, but there will be a rolling set of improving,
increasing
capabilities.
And, again, our contract is cost shared. We have a lot of
skin in the game, $176 million from the Government and $109
million from our partners, but all of our centers are ready to
start working today. We will be fully ready within a few years
to meet all of the requirements that were brought to us by HHS.
Mr. Thornberry. Okay. Thank you.
Dr. Smithson, I am not sure if I got this exactly right,
but I think part of your testimony talked about who had access
to certain agents and the screening for individuals who worked
in certain situations. Obviously, security clearance reform is
a very significant issue these days, as it should be. Can you
elaborate just briefly on--you talked about a cost benefit
study for select agent rules or something like that. Can you
just elaborate for a second what you are talking about? Are we
talking about basically a security clearance for people who
have access to these pathogens or am I misinterpreting?
Dr. Smithson. It is not sometimes just about the security
clearance. In the case of Bruce Ivins, who brought the notion
of an insider threat to everyone's attention, it is about
whether or not the people who were working in these very high-
pressure environments, and quite frankly, I have never worked
with an agent where if I pricked my finger, there is no medical
treatment or vaccine, and basically I am a dead woman walking,
so I think this is a very high-stress environment. And in the
case of Bruce Ivins, yes, he did incredible work on the anthrax
vaccine, but he was also apparently, according to the FBI,
mentally unstable, he had made death threats and he was abusing
substances. And this is what is not addressed in the select
agent rules in a comprehensive manner. For example, the
screening that the FBI does, according to the select agent
rules, asks if you have ever been adjudicated mentally
deficient. It doesn't say, ``are you off your rocker now?''
And we need to make sure, quite frankly, that the people,
first and foremost, who are handling these substances and doing
the work that we all very much want and need them to do have--
have sound judgment exercised. And so that is what I am asking
for, is to kind of shift the emphasis away from trying to count
things that are found in nature and that can be replicated, you
know, on an incredible scale in fermenters toward a system of
mutual accountability in the laboratory and sound judgment in
the laboratory. I think these are going to be better defenses
than trying to lock up pathogens that you can find in Mother
Nature.
Mr. Thornberry. Thank you. Mr. Langevin.
Mr. Langevin. Thank you, Mr. Chairman. And, again thanks,
to our panel. As often happens, the chairman and I often are on
the same wavelength on a lot of these issues, and I would like
to go back to the question that he asked on DOD and HHS
resources. And I want to ask, I think, a slightly different
way, just a different spin on it, but obviously, DOD and HHS,
in particular, have unique capabilities when it comes to
biowarfare. To what extent does DOD leverage HHS resources? And
is it reasonable to expect greater efforts here? And how do DOD
priorities affect HHS's work? Are we properly leveraging the
resources of the other, going both ways?
Dr. Giroir. I am just going to say from our standpoint in
the HHS center, I can't comment on Novartis or Emergent, but we
have had a visit from the joint program executive officer with
all of his staff to look at our facility probably about 7
months ago. We have had no direct interaction funding task
orders requests from DOD specifically. We are obviously highly
motivated to support, because we have tremendous infrastructure
now and being built. I think HHS is certainly willing to do
that. Even in our facility, we could dedicate capacity to DOD
should that be wanted.
So I would say the conversation, at least in terms of our
facility, which I could speak definitively about, has started
to--has begun with high level visits. Where that leads, we
really don't know.
Mr. Langevin. Is there anything that you can recommend that
we do to encourage that?
Dr. Giroir. I think there should be expectations that where
resources can be shared, they need to be shared, because I
believe, as--I would much rather several hundred million
dollars be put into a tularemia vaccine that achieves the
capability than duplicating what HHS and the taxpayer has
already funded.
Mr. Langevin. I agree. Anybody else want to add anything,
or I will go to another question?
General Russell. I have worked on both sides of the fence,
and the requirements of Department of Defense, although
somewhat different, are--do overlap tremendously, and as Dr.
Giroir said, the manufacturing base is fundamentally the same.
I think we can expect in the future to--DOD requirements
may benefit by the HHS investments. Whether that is effectively
coordinated and maximized is, I think, going to be up to the
senior leadership of the Government.
Mr. Langevin. I think that is something we have got to
spend more time focusing on, because we will definitely be able
to yield better outcomes if we are properly resourced.
Let me turn to another area. Given the difficulty and the
time requirements of developing effective countermeasures for
biological weapons, obviously intelligence plays a critical
role in identifying potential threats.
So can you explain the interplay of the intelligence
community with the biodefense enterprise? And what can be done
to better identify biological weapon threats that adversaries
might be developing? And do you see DOD's ability to mitigate
threats hindered by intelligence capabilities, particularly
HUMINT [Human Intelligence]?
General Russell. I think the difficulties that the
intelligence community has had in dealing with the biologic
threat is a matter of history. They have not distinguished
themselves greatly, partly because of a very, very difficult
intelligence target, probably the single most difficult target
there is. And in the past, the attention of the intelligence
community has been on other threats, and the internal
capability and knowledge about biology has just not been there.
I think it is improving to some extent.
Your question about HUMINT, I think, is right on, because I
think the only way we are going to get decent intelligence
regarding the biologics threat is by accentuating the human
side. The other intelligence-gathering methods don't seem to
work very well against a biothreat.
Dr. Smithson. The Biological and Toxin Weapons Convention,
which is the treaty that bans biological weapons doesn't have
any verification provisions, and that is largely, I think, at
this point because people refuse to consider the experience of
the United Nations Special Commission, which I referred to in
my testimony. What is quite astonishing there is that a very
small group of inspectors, working off of scant, incomplete,
and sometimes inaccurate intelligence about Saddam Hussein's
biological weapons program and working against a government
that had a game plan to hide that biological weapons program at
all costs were able to go in and uncover it.
So the conventional wisdom, again, needs to be rethought.
And it is far better to have eyes inside a facility, to have
inspectors engaging with the scientists there, literally
looking at what they are doing. And, yes, they may not always
be able to catch everything that is going on, but you are far
better informed from inside a facility than you are from 3
miles above the ground with satellite
images.
And having asked any number of former biological weapons
scientists what they would do if they were to get back into the
game, they would aim for the incapacitating agents that I
referred to earlier, the things that control human behavior,
because this is considered amongst the weapons scientists to be
the brave new frontier.
And last but not least, on the wisdom of relying on human
intelligence, let's keep in mind the case of ``Curveball,'' and
this is the Iraqi defector that simply made it up. And he made
up the whole shebang about Iraq having mobile biological
weapons production capabilities. If anyone had bothered to ask
the UNSCOM inspectors at that time whether or not that was a
realistic scenario, they would have explained that when Iraq
talked about mobile, they meant moving one part of the program,
doing one part of the program in one location and another part
of the program here, and not putting things like that on
wheels.
So conceptually to them, both in terms of the way that the
Iraqis did both chemical and biological weapons programs and
also from a scientific standpoint and a safety standpoint, the
idea of putting mobile biological weapons production out there,
even if you are a desperate proliferator, just didn't make
sense. Just a few thoughts for consideration.
Mr. Langevin. Very good. Thank you. Thank you, Mr.
Chairman.
Mr. Thornberry. Mrs. Davis.
Mrs. Davis. Thank you, Mr. Chairman. This has been very
interesting. It is always a difficult question. We all could
like to see more resources, but if I guess the first question
is, do you think that the resources match the need as we know
it today and as we are planning in terms of if--perhaps if we
were better coordinated, but if not, is there any consensus
among the four of you that there is a place particularly that
those resources should be going to that would make it--that
would make a difference overall in terms of the ability to
leverage those resources for a better outcome? Any consensus?
Dr. Smithson. The increase in U.S. biodefense programming
after 2001, some would say, and I would agree, was long, long
overdue. There are a lot of resources being put into this
arena.
At this point, I would rather have us do it smarter, as a
taxpayer, than simply plus up budgets without having the types
of discussions and decisions that this panel is talking about.
Let's do it smarter first.
Mrs. Davis. I think I did hear that. Okay.
Dr. Bennett. I would suggest, though, much as you were
suggesting earlier, the military has to pay attention, and they
are not paying a whole lot of attention to this threat at this
stage. They are not trained in it, they don't understand in
many cases at the senior level of the theater commanders, for
example, the implications it would have for them, that sort of
thing. So a small investment in the education, I think, and
focus in requiring it in planning and so forth would make a
huge impact, at least as far as the military is concerned.
Mrs. Davis. Thank you.
General Russell. Yeah. I don't think it is the total amount
of resources that is as important as the way it is being
managed and distributed. I think there has been an enormous
amount of wasted effort in some of these programs, and I think
better management would accomplish more than just plussing up
the budget. I think attention to the problem at the highest
levels is probably more important right now than other aspects
of it.
Dr. Giroir. I agree that resources need to be spent
smarter; the first of that is eliminate all duplication of
resources across the agency, and I think there is very
significant ability to do that with sort of upper-level
management and leadership.
Secondly, I will say it again, I think efficiency in the
contracting process and being more outcomes-oriented and less
micromanagement would certainly improve our efficiency probably
20 or 30 percent within our center.
Third, I think the Government should explore more public-
private partnerships where there is cost-sharing. I think there
can be tremendous alignment with the pharmaceutical industry
for which their research and development budgets are dwindling,
to align priorities so there is a little skin on both sides so
you get more out of the Government dollar than you would
otherwise, and enable industry to do that.
And the fourth point I would make is the only area that I
really think needs more quantitative instead of just smart
investment is to prepare for the unknowns, and you heard me say
that before, to try to get a system to understand if something
we don't expect that we haven't stockpiled for 15 years come
down the pipeline, what is our capabilities? How do the DOD and
DHHS work together? How do we attack it, maybe not 100 percent,
but 80 percent, 90 percent enough to stop the major outbreak? I
think more resources need to go to that type of threat. The
others, I think you'd be smarter and you would go a long way.
Mrs. Davis. Thank you.
Mr. Thornberry. Well, thank you all. Needless to say, we on
this committee have limited jurisdiction dealing with DOD, and
this is not a problem that will be solved within DOD, but on
the other hand, it seems to me your central point is we need to
pay more attention to this stuff and DOD can help us do that as
a Government. And that and a number of other suggestions, I
think, are helpful to us.
Again, thank you all for being here. I thought it would be
good to have a distraction from a budget discussion, but you
all may drive me back to it, so--but I really do appreciate
your time and expertise. Thank you again.
With that, the hearing is adjourned.
[Whereupon, at 12:48 p.m., the subcommittee was adjourned.]
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A P P E N D I X
October 11, 2013
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PREPARED STATEMENTS SUBMITTED FOR THE RECORD
October 11, 2013
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