[House Hearing, 116 Congress]
[From the U.S. Government Publishing Office]
U.S. BIODEFENSE, PREPAREDNESS,
AND IMPLICATIONS OF
ANTIMICROBIAL RESISTANCE.
FOR NATIONAL SECURITY
=======================================================================
HEARING
BEFORE THE
SUBCOMMITTEE ON NATIONAL SECURITY
OF THE
COMMITTEE ON OVERSIGHT
AND REFORM
HOUSE OF REPRESENTATIVES
ONE HUNDRED SIXTEENTH CONGRESS
FIRST SESSION
__________
June 26, 2019
__________
Serial No. 116-41
__________
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COMMITTEE ON OVERSIGHT AND REFORM
ELIJAH E. CUMMINGS, Maryland, Chairman
Carolyn B. Maloney, New York Jim Jordan, Ohio, Ranking Minority
Eleanor Holmes Norton, District of Member
Columbia Justin Amash, Michigan
Wm. Lacy Clay, Missouri Paul A. Gosar, Arizona
Stephen F. Lynch, Massachusetts Virginia Foxx, North Carolina
Jim Cooper, Tennessee Thomas Massie, Kentucky
Gerald E. Connolly, Virginia Mark Meadows, North Carolina
Raja Krishnamoorthi, Illinois Jody B. Hice, Georgia
Jamie Raskin, Maryland Glenn Grothman, Wisconsin
Harley Rouda, California James Comer, Kentucky
Katie Hill, California Michael Cloud, Texas
Debbie Wasserman Schultz, Florida Bob Gibbs, Ohio
John P. Sarbanes, Maryland Ralph Norman, South Carolina
Peter Welch, Vermont Clay Higgins, Louisiana
Jackie Speier, California Chip Roy, Texas
Robin L. Kelly, Illinois Carol D. Miller, West Virginia
Mark DeSaulnier, California Mark E. Green, Tennessee
Brenda L. Lawrence, Michigan Kelly Armstrong, North Dakota
Stacey E. Plaskett, Virgin Islands W. Gregory Steube, Florida
Ro Khanna, California
Jimmy Gomez, California
Alexandria Ocasio-Cortez, New York
Ayanna Pressley, Massachusetts
Rashida Tlaib, Michigan
David Rapallo, Staff Director
Daniel Rebnord, Subcommittee Staff Director
Amy Stratton, Clerk
Christopher Hixon, Minority Staff Director
Contact Number: 202-225-5051
------
Subcommittee on National Security
Stephen F. Lynch, Massachusetts, Chairman
Jim Cooper, Tennesse Jody Hice, Georgia, Ranking
Peter Welch, Vermont Minority Member
Harley Rouda, California Justin Amash, Michigan
Debbie Wasserman Schultz, Florida Paul Gosar, Arizona
Robin L. Kelly, Illinois Virginia Foxx, North Carolina
Mark DeSaulnier, California Mark Meadows, North Carolina
Stacey E. Plaskett, Virgin Islands Michael Cloud, Texas
Brenda L. Lawrence, Michigan Mark E. Green, Tennessee
C O N T E N T S
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Page
Hearing held on June 26, 2019.................................... 1
Witnesses
Dr. Helen Boucher, Director, Tufts Center for Integrated
Management of Antimicrobial Resistance, Tufts Medical Center
Oral Statement................................................... 4
Dr. Asha George, Executive Director, Blue Ribbon Study Panel on
Biodefense
Oral Statement................................................... 7
Mr. Chris Currie, Director, Emergency Management, Disaster
Recovery, and DHS Management Issues, Homeland Security and
Justice Team, U.S. Government Accountability Office
Oral Statement................................................... 9
Dr. Cham E. Dallas, University Professor and Director, Institute
for Disaster Management, University of Michigan
Oral Statement................................................... 11
Written opening statements and statements for the witnesses are
available on the U.S. House of Representatives Document
Repository at: https://docs.house.gov.
Index of Documents
----------
Documents entered into the record for this hearing are listed
below, and are available at: https://docs.house.gov.
* Statement by California Life Association; submitted by Rep.
Lynch on behalf of Rep. Rouda.
U.S. BIODEFENSE, PREPAREDNESS,
AND IMPLICATIONS OF
ANTIMICROBIAL RESISTANCE
FOR NATIONAL SECURITY
----------
Wednesday, June 26, 2019
House of Representatives
Subcommittee on National Security
Committee on Oversight and Reform
Washington, D.C.
The subcommittee met, pursuant to notice, at 4:11 p.m., in
room 2247, Rayburn House Office Building, Hon. Stephen Lynch
presiding. Present: Representatives Lynch, Hice, and Welch.
Mr. Lynch. Good afternoon. This subcommittee will come to
order, and without objection the chair is authorized to declare
a recess of the committee at any time.
This hearing is entitled, ``U.S. Biodefense, Preparedness,
and Implications of Antimicrobial Resistance for National
Security.'' And I want to apologize, first of all, to my
witnesses, our witnesses, and to our guests. As you know, as I
explained earlier, to most of our guests, there is rule in the
house that a subcommittee hearing such as ours cannot convene
while there is a full committee hearing ongoing, and so that is
where my colleague, Mr. Hice, was. There is also a rule that a
subcommittee cannot begin unless one Democrat and one
Republican are present to constitute a quorum. So I have to say
I have never been so happy to see a Republican in my life, so
we will begin.
Today's hearing will examine whether the United States is
prepared to respond to various biological threats to our
national security. These include natural pandemic outbreaks
such as influenza, Ebola, or diseases yet unknown, as well as
biological attacks which are perpetrated by foreign
adversaries, terrorist organizations, and other non-State
actors. We will also focus on the growing threat of
antimicrobial resistance, which, according to the Center for
Disease Control and Prevention already contributes to the
deaths of about 23,000 Americans each year.
In the two decades since September 11, 2001, amazing
developments in biotech, including synthetic biology, gene
editing, and genomic engineering have led to remarkable
breakthroughs in health care, clean energy, and sustainable
nutrition. However, actors with maligned intent can also
exploit those same technologies to develop biological weapons
or agents and deploy them across our Nation and the
battlefield, with potentially devastating effect.
Director of our National Intelligence, Dan Coats,
underscored this risk in his 2019 Worldwide Threat Assessment,
when he stated, and I quote, ``These technologies hold great
promise for advances in precision medicine, agriculture, and
manufacturing, but they also introduce risks, such as the
potential for adversaries to develop novel biological warfare
agents, threaten food security, and enhance or degrade human
performance,'' close quote.
A previous assessment issued by former Director of National
Intelligence, James Clapper, identified gene editing as a
potential weapon of mass destruction, the basic ingredients of
which can be bought online today for as little as $60.
Similarly, the nonpartisan Government Accountability Office
has also highlighted the dangers posed by naturally occurring
infectious disease that could easily become pandemics in view
of global climate change and mass human migration. These
official warnings demand our continued attention. Although we
are fortunate not to have experienced a biological attack here
in the United States since the anthrax attacks post September
11th, the threat remains very real. Foreign adversaries have
already demonstrated an interest in developing genetic and
biological weaponry. According to official reports, North
Korean leader Kim Jong-un is pursuing advanced bioweapons
research and production capabilities.
Andrew Weber, the Assistant Secretary for Nuclear,
Chemical, and Biological Defense Programs under President Obama
recently commented that ``North Korea is far more likely to use
biological weapons than nuclear ones. The program is advanced,
underestimated, and highly lethal.''
Terrorist organizations and other non-state actors also
have started to develop and deploy biological weapons. A laptop
discovered from ISIS fighters in northern Idlib, Syria, in
2014, reported contained a 19-page document with instructions
on how to develop biological weapons and weaponize the bubonic
plague from infected animals. It also highlighted the
relatively low cost of biological weapons and their potential
to inflict mass casualties.
To their credit, both Democratic and Republican
administrations have taken some steps to strengthen our
national biodefense. Most recently, in September 2018, the
Trump administration released the National Biodefense Strategy
in compliance with a congressional directive, included in the
Fiscal Year 2017 National Defense Authorization Act. The
President has also established a multi-agency biodefense
committee to be chaired by the Secretary of Health and Human
Services.
Congress has also sought to enhance our national biodefense
and preparedness. Earlier this month, the House passed a
bipartisan legislation that will reauthorize critical funds for
bioterrorism and pandemic preparedness, including $7.1 billion
for the BioShield Special Reserve Fund for the development of
biothreat medical countermeasures. The bill, which the
President has signed this week, also includes $685 million in
annual grant funding to states and localities through 2023, to
assist them in responding to infectious diseases, biological
events, and other public health threats.
Nevertheless, there are key gaps that remain. As reported
by GAO, our national biodefense framework is still, and I
quote, ``fragmented and lacks coordination among multiple
agencies.'' Moreover, GAO has identified persistent challenges
facing two primary biosurveillance programs operated by the
Department of Homeland Security to detect and monitor
biological threats. Both the BioWatch program and the National
Biosurveillance Integration Center have been hampered by
technical performance deficiencies in the absence of clearly
stated mission.
Our biodefense efforts must also adapt to the emergence of
new biological threats, including deadly antimicrobial-
resistant diseases that render existing antibiotics,
antifungal, or antiviral medications virtually useless.
According to an April 2019 New York Times report, the spread of
a resistant fungus known as Candida auris has led the CDC to
designate it as a serious global health threat. The CDC has
already documented nearly 700 cases of this life-threatening
infection in the United States. American servicemembers in Iraq
and Afghanistan have also contracted drug-resistant, superbug
infections threatening overall troop readiness and morale.
Robust and continued congressional oversight will be
essential to enhancing our national biodefense going forward.
To this end, I look forward to discussing these and other
topics with today's witnesses, and I now yield to the ranking
member of this subcommittee, the gentleman from Georgia, Mr.
Hice, for five minutes for an opening statement.
Mr. Hice. Thank you very much, Mr. Chairman, and I am
honored to be the one Republican that you are very thrilled to
see today, and the feeling is mutual toward you.
I also want to take a moment to say thank you to our
witnesses for your patience today, and all who are attending.
Sometimes our schedules get turned upside down, and the fact
that you have exhibited great patience with us and
understanding, and that means a lot, so thank you for that.
I also want to extend a very personal welcome to Dr. Dallas
from the University of Georgia, a good friend and a wonderful
family that you have. It is good to see you here. Dr. Dallas is
recognized as a great leader on this topic as well as a
phenomenal professor at the University of Georgia. And with
there being about two months before football season we will
just publicly say ``Go Dogs,'' and let's get that rolling.
But we are here today to discuss how our country prepares
for, responds to, and recovers from potential catastrophic
biological incidents and naturally occurring pandemics.
Historically, our country has faced a number of significant
biological incidents. For example, shortly after 9/11, and the
terrorist attacks then, envelopes containing infectious anthrax
spores were deliberately mailed through the U.S. postal system.
Many of you will remember that. Some 22 people were infected
and five deaths occurred.
In 2009, our country faced a pandemic virus that first
emerged in the U.S., resulting in a worldwide death toll of
between 150,000 to 575,000, according to the CDC. In 2014,
there was an unprecedented Ebola outbreak in West Africa. The
outbreak resulted in more than 28,000 cases and about 11,000
deaths. Eleven individuals were treated in the U.S., one of
which died.
In September 2018, President Trump's administration
released a comprehensive National Biodefense Strategy, as the
chairman mentioned. It built on lessons learned from the past
biological incidents, like the 2001 anthrax attacks and the
2009 influenza pandemic and the 2014 Ebola outbreak. President
Trump has also released a National Security Presidential
Memorandum to support the National Biodefense Strategy. For
instance, it established a Biodefense Steering Committee, which
is chaired by the Secretary of Health and Human Services, to
coordinate implementation of the strategy.
These actions demonstrate the Administration's commitment
to strengthen America's defense against biological threats to
health and safety.
So before us today, as I have already mentioned, each of
you are experts in this field and we welcome you here to deal
with the biodefense issue. We have a Blue Ribbon Study Panel
representative, Government Accountability Office, and as I
mentioned, representatives from both the University of Georgia
and Tufts, and we are honored to have each of you here.
So we look forward to hearing your testimony, and on this
side of gaining some of your expertise on this topic. So again,
we welcome you here, we thank you for being here, and with
that, Mr. Chairman, I will yield back.
Mr. Lynch. Thank you. Today we are joined by an all-star
panel of witnesses, and very patient witnesses. Dr. Helen
Boucher is the Director of--she is my homie, Massachusetts. She
is the Director of the Tufts Center for Integrated Management
of Antimicrobial Resistance at Tufts Medical Center. We also
have Dr. Asha George, Executive Director of the Blue Ribbon
Study Panel on Biodefense; Chris Currie, Director of Emergency
Management, Disaster Recovery, and DHS Management Issues,
Homeland Security and Justice Team, within the U.S. Government
Accountability Office--his business cards are about this big--
and Dr. Cham Dallas, a Georgia native, University Professor and
Director, Institute for Disaster Management at the University
of Georgia.
Mr. Hice. Go Dogs, if I failed to mention that earlier.
Mr. Lynch. Go Dogs. On the record, without objection, Go
Dogs is entered into the record.
Mr. Hice. Thank you very much. Thank you, sir.
Mr. Lynch. All right. Now, it is the custom of the
committee to ask the witnesses to rise and be sworn in. Please
raise your right hand.
[Witnesses sworn.]
Mr. Lynch. Let the record show that the witnesses answered
in the affirmative.
Thank you. Please be seated.
The microphones are sensitive so please speak directly into
them. Without objection, your written statements will be made
part of the record, and with that I welcome Dr. Boucher. You
are now recognized for five minutes to give an oral
presentation of your testimony.
STATEMENT OF DR. HELEN BOUCHER, DIRECTOR, TUFTS CENTER FOR
INTEGRATED MANAGEMENT OF ANTIMICROBIAL RESISTANCE, ON BEHALF OF
TUFTS MEDICAL CENTER
Dr. Boucher. Good afternoon Chairman Lynch, Ranking Member
Hice, and distinguished members of the subcommittee. On behalf
of the Infectious Diseases Society of America, or IDSA, thank
you for holding today's hearing and inviting me to testify.
I am an infectious disease physician at Tufts Medical
Center in Boston, director of the Tufts CIMAR that was
mentioned, and the treasurer of IDSA. I also have the privilege
to serve on the Presidential Advisory Council for Combatting
Antibiotic-Resistant Bacteria. My comments today are my own and
delivered on behalf of IDSA, and do not reflect the views of
the U.S. Government.
As I am a clinician, I would like to start by telling you
about two patients we recently treated. The first is a young
lady with a history of injection drug use, who had two prior
heart valve infections related to opioid use. Over the course
of two to three years, she had two separate heart valve
infections, the second of which was due to methicillin-
resistant S. aureus, or MRSA, and involved her tricuspid valve
that had been previously surgically repaired. Her treatment was
complicated by kidney failure due to an antibiotic called
vancomycin and prolonged hospitalization. Her course was
further complicated with a chest wound infection, also due to
MRSA.
We saw her again when she was 22 weeks pregnant, and the
MRS infection had extended from chest bone into her chest. She
had to have several surgeries and received another long course
of antibiotic therapy while she was pregnant. She had several
more hospitalizations, including some time spent in the ICU,
but ultimately delivered a healthy full-term baby. Her problems
have continued, however, and she may require yet another heart
valve replacement.
Sadly, hers is not an isolated case. We, and most other
health care facilities in the United States care for a large
number of patients with drug-resistant infections related to
opioid use.
The second patient is a middle-aged lady I took care of in
the hospital recently. She had undergone chemotherapy for
leukemia and was in remission, so there was no cancer in her
body. We were called when she developed pneumonia and a
bloodstream infection due to a Gram-negative bacteria that was
resistant to every drug tested by our lab. When I sat down to
deliver this news to her she said, ``How can this be? Surely
you are going to find something to treat this.''
We did succeed in doing a lot of fancy testing in the lab
and getting help from the FDA and collaborating with a company
to get an investigational drug called cefiderocol, and gave her
a combination of antibiotics, but she ultimately died 10 days
later. So this lady, in the prime of her life, who had overcome
cancer, died from an antibiotic-resistant infection.
It is also important to point out that with our best
efforts and help from many people around the country, including
here in Washington at FDA, it took four days to get the
emergency use antibiotic to her, and it sort of emphasizes how
important it is for us to have effective drugs in our hospital
pharmacies, ready to use when our patients need them.
These and many other experiences motivate me and my
colleagues to fight for solutions to this crisis. As many as
162,000 people in the United States lose their lives every year
to multidrug-resistant infections. CDC also estimates that
antibiotic-resistant infections result in $20 billion in excess
health care costs annually, due, in large part, to longer
hospital stays for patients in whom these infections are not
easily treated.
Antibiotic-resistant infections pose a significant threat
to our national security, as was mentioned. Resistant pathogens
complicate our soldiers' combat wounds, increasing the risk of
limb loss and death, and compromise our military's combat
readiness and effectiveness. Between 2004 and 2009, over 3,300
American soldiers in Iraq and Afghanistan became severely ill
from a single resistant Gram-negative pathogen called
Acinetobacter, which has become even more resistant to
treatment over time.
Alarmingly, as was also mentioned, resistant pathogens are
a prime candidate for weaponization. The former Soviet Union
successfully weaponized multidrug-resistant strains of both
plague and anthrax. Studies have concluded that the aerosolized
release of a weaponized, resistant pathogen in just a single
incident of bioterrorism in the Washington, DC. area would
result in a death toll of over 3 million. Any mass casualty
event is likely to result in severe wounds and burns, which can
quickly become infected and further complicated by resistance.
Antibiotic resistance also puts our health security at
risk, both in the U.S. and around the world. An outbreak of a
serious resistant infection with limited or no treatment
options could overwhelm health systems, harm economies, and
even destabilize communities and countries.
Antibiotic resistance importantly threatens to undo decades
of medical progress. Many lifesaving procedures, like cancer
chemotherapy, organ and bone marrow transplants, and other
complex surgeries are only possible with the support of
effective and safe antibiotics.
While bacteria develop resistance in nature, the use of
antibiotics places selective pressure on bacteria, leading them
to develop resistance even faster. Antibiotic use in animals,
agricultural settings, and the environment also contribute to
resistance. We must curtail inappropriate antibiotic use to
limit the development of resistance. But even appropriate
antibiotic use causes resistance, so we must develop a robust,
renewable pipeline of new antibiotics to address our current
and future threats.
Unfortunately, our toolbox of antibiotics is shrinking.
Nearly all large pharmaceutical companies have left the
antibiotic development field. The small companies that remain
responsible for most of the antibiotic innovation are
struggling to stay in business. In April, one small company,
Achaogen, filed for bankruptcy, despite having received Federal
support to develop and launch an important new antibiotic.
Others have recently announced massive layoffs.
There are currently 42 antibiotics in development. Of
these, only 16 have the potential to treat our worst
infections, the Gram-negative infections, and most drugs in
clinical development do not ultimately achieve FDA approval.
Factors very unique to antibiotics make it extremely
difficult for companies to earn a return on investment in
antibiotic R&D. Antibiotics are taken for a limited duration of
time, and new antibiotics must be used judiciously to preserve
their effectiveness. Incentives are needed to make antibiotic
R&D feasible for companies.
Congress and the Federal Government have taken many
important steps to address antibiotic resistance and spurring
antibiotic R&D, and we are very appreciative. Current efforts
must be maintained and new policies are needed. The problems
are complex and will require multifaceted solutions that cut
across multiple congressional committees.
We encourage you to support the DISARM Act, which will soon
be introduced in the House. This bill will help stabilize the
antibiotic market for companies and investors by boosting
Medicare reimbursement for important new antibiotics. It will
also help curb resistance by requiring hospitals to implement
stewardship programs and report antibiotic use and resistance
data to CDC.
While reimbursement reform would be an important step
forward, it alone is highly unlikely to deliver the antibiotic
pipeline we need. A new incentive not linked to sales volume,
to provide a predictable return on investment, is necessary. We
also call for increased investments in research and public
health interventions to address resistance.
Once again, please accept my deepest thanks on behalf of my
colleagues at IDSA, and most of all, our patients, to the
subcommittee for holding this hearing and for inviting us to
participate. We look forward to continued collaboration to
address the problem of antibiotic resistance.
Mr. Lynch. Thank you.
Dr. George, you are now recognized for five minutes.
STATEMENT OF ASHA GEORGE, EXECUTIVE DIRECTOR, BLUE RIBBON STUDY
PANEL ON BIODEFENSE
Ms. George. Thank you, Mr. Chairman, Ranking Member Hice,
and to the congressional staff, thank you for inviting us here
today to talk about these issues.
I am the Executive Director for the Blue Ribbon Study Panel
on Biodefense. In addition to having a doctorate in public
health and having spent 30 years in the biodefense arena, I am
also a Desert Storm veteran, and I bring that up really only
because I know what it feels like to be operating in an arena
under the specter of biological warfare. I know what it feels
like to be wearing chemical protective overgarments and wonder
if they are going to protect me from a biological agent. I know
what it feels like to be taking a vaccine that just the week
before got emergency use authorization for me to take. And I
know what it feels like to be standing on a battlefield
wondering if antimicrobial-resistant anthrax or some other
biological agent have been loaded into a Scud missile and are
coming my way.
I mention all of this because I don't want anybody in this
country, particularly in this country, geographically, to ever
have to feel any of those things, and I know that you don't
either.
I will just add one other point here, and that is while we
haven't had any other biological attacks since the anthrax
events of 2001, we still have all these white powder events. I
believe it was today that the DeKalb County Courthouse had to
evacuate for what seemed to be a rather significant white
powder event that turned out not to be anthrax, from what I
understand. But just imagine how all those people felt. That is
a highly busy courthouse. There are a lot of people in there,
all affected at once.
I have submitted my longer written statement for the
record, but I just want to make a few points here.
The Blue Ribbon Study Panel on Biodefense addresses the
entire spectrum of biodefense, so we are looking at prevention
and deterrents in terms of the State Department and the Defense
Department and the intelligence community, and then we look at
everything beyond that as well--preparedness, detection,
response, attribution, recovery, and mitigation.
And when you hear that list you think about what that must
mean in terms of the government. This is a huge governmental
set of activities. All of the Federal departments, eight of our
independent agencies, and one independent institution, that we
know about, all contribute to biodefense. That makes
jurisdiction and oversight here in the House and in the Senate,
obviously, extremely difficult and challenging. But I think
that it points very directly to this particular committee and
the need to exert oversight from here, because you have the
entire picture, and look at the entire government.
We issued a report in 2015 called the Blueprint for
Biodefense. In it we have 33 recommendations and 87 action
items. And we assessed the state of biodefense here in the
country looking at strengths and weaknesses and
vulnerabilities. And the Nation remains vulnerable to this day.
In short, the Nation is not prepared for biological outbreaks,
acts of bioterrorism, biological warfare, or accidental
releases, with catastrophic consequences, and I think that is
where the national security issue comes into play, not to say
that the onesy-twosy events are not worthy of our concern, but
we are talking about catastrophic events that would affect the
effective functioning of our entire society.
The National Biodefense Strategy that was mentioned earlier
is actually one of our recommendations from our blueprint, as
was this Coordination Council, although you wanted to see both
of those activities run out of the White House. When you have
so many governmental agencies involved we believe you need
somebody above them all to run them all.
The strategy has come out, as you said, Mr. Chairman, but
the implementation plan for that strategy is still pretty thin.
The Department of Health and Human Services has been charged
with working on that implementation plan, but they face the
challenge of trying to get information out of all the other
departments and agencies to inform that plan. I hope it doesn't
take as long to produce that as it did to produce the
implementation plan for the National Strategy for Pandemic
Influenza. President Jimmy Carter issued that requirement to
the Department of Health, Education, and Welfare for the
strategy and the implementation plan, yet it was only released
by President George W. Bush, however many decades later, and
pulled away from the Department of Health and Human Services.
Just quickly about antimicrobial resistance. The panel is
very concerned about antimicrobial resistance. AMR would
exacerbate all the types of threats that I mentioned earlier.
Our national policy, which seems to focus quite a bit on
hospitals and health care, looks at these individuals, these
patients, and then says we have to get them out of the hospital
as soon as we can, because we are trying to reduce their
exposure to these resistant organisms within these hospitals.
I would leave it to my colleagues to discuss how effective
that actually is, but it is not a national security policy. It
is not good national policy. If we were to be attacked or
experience a naturally occurring disease that has become
resistant, that affects a large population or populations here
in the United States, we would have no place to discharge them
to. There would be no place for them to go.
So thank you very much for your time and letting me go over
a minute, Mr. Chairman. I appreciate the opportunity.
Mr. Lynch. Thank you very much, Doctor, and thank you for
your service.
Ms. George. Thank you.
Mr. Lynch. Next up, Mr. Currie, you are now recognized for
five minutes.
STATEMENT OF CHRIS CURRIE, DIRECTOR, EMERGENCY MANAGEMENT,
DISASTER RECOVERY, AND DHS MANAGEMENT ISSUES, ON BEHALF OF
HOMELAND SECURITY AND JUSTICE TEAM, U.S. GAO
Mr. Currie. Thank you, Chairman Lynch, Ranking Member Hice.
It is an honor to be here today to talk about GAO's past work
on biodefense. A lot of what I was going to talk about has been
said, so I will try to alter this a little bit.
Biodefense is a very unique threat, and biothreats are very
unique in this country. We look at lots of different threats
across the government at GAO. And I think unlike cyber threats
and mass shootings and things that are in our face every day,
it is very difficult because the perception is that these are
low-likelihood events, and thus, it makes it very difficult to
maintain focus and maintain resources on these types of events.
But clearly it doesn't mean that these are not serious threats
and very scary threats.
The other challenge, that Dr. George mentioned, is
fragmentation across the Federal Government and across all
levels of government, and the private sector. We have
identified, for almost a decade now, that fragmentation across
large and small departments--DHS, USDA, Department of Defense--
I think we said before there are almost two dozen
Presidentially appointed officials that have some sort of
responsibility for biodefense. They make this very, very
difficult to tackle, because departments cannot tell other
departments what to do, and they can't tell them how to spend
their money. They also can't tell them how much money to
request. This also cuts across congressional committees of
jurisdiction too. It just makes it a very big challenge.
Because of this, for almost a decade, we have recommended
that the Federal Government needs a large, overarching national
strategy and focal point to address this issue, similar to what
we have done in other areas, like cybersecurity.
In addition to the strategy itself, at the high level, we
have also done work at GAO on a number of more specific
biodefense-related programs across the government, and I would
like to talk about just a few of those things.
In the area of biodetection, as was mentioned in the
opening statement, we have done work looking at Department of
Homeland Security's BioWatch program. This is the only system
we have in this country that has a goal of detecting a
biothreat that is released into the air. But frankly, the
system has struggled since the very beginning to do what it was
intended to do. It has never done what it was intended to do
and never worked as well as we have wanted it to work.
So we have made a number of recommendations over the years
to try to address these issues, ultimately leading to the
cancellation of this program in different ways. It is currently
still in use but is going to be phased out by DHS, but the
replacement situation is very uncertain and very unclear at
this point, in terms of biodetection.
In the area of situational awareness, which is extremely
important, which is basically how do we know what threat we are
facing, how quickly, and who knows it, DHS and HHS have both
struggled. On the DHS side, we have found that the National
Biosurveillance Integration Center has struggled to get the
data it needs and the information it needs, frankly, to be
useful to its partners. We heard from the people that use it
that it doesn't provide new and useful information.
And on the HHS side, it has been almost 13 years since
there has been a requirement for a public health situational
awareness network. That still has not been implemented. We have
done work on it three or four different times in that 13 years,
and recommended ways to try to implement that program. Most
recently, in the recently passed legislation, required, set a
deadline for its implementation again and required that HHS
implement our recommendation. So HHS has just continued to
struggle to implement that situational awareness program.
Laboratory safety and security, another huge issue that we
and many others have identified problems with. This is an area
that we have identified problems across the biodefense
enterprise with all of these departments. We looked at almost
every department that oversees or has laboratories and we found
widespread challenges in their policies and oversight. Some
policies were out of date. Some suspicious incidents were not
even being reported. So we made over 33 recommendations at that
time, which is a huge number, across departments. Twenty-one
are still open. So some departments have made progress; others
are still lagging behind.
I would also like to talk about what Dr. George mentioned,
about the catastrophic incidents, and I will throw in there
situations like Zika in 2016 and Ebola in 2014. What we see in
these situations, and even those were not as severe as the ones
we are really worried about, is it is not clear who is in
charge when these situations happen, and it also not clear
where the funding comes from.
We have done some work in the past looking at development
of a response fund. This would be similar to what FEMA has, for
example, to handle disasters when they occur. I think people
vary on their views of this issue, but some people thought
there needed to be some sort of fund, so we deal with these
issues when they come up, and we know exactly who is in charge
of these situations, so we don't have to wait months for
supplemental appropriations and things like that.
So those are just a few of the issues. I have many more
things to talk about but thank you for the invitation.
Mr. Lynch. Thank you.
Dr. Cham Dallas, you are now up for five minutes.
STATEMENT OF CHAM DALLAS, UNIVERSITY PROFESSOR AND DIRECTOR,
INSTITUTE FOR DISASTER MANAGEMENT, ON BEHALF OF UNIVERSITY OF
MICHIGAN
Mr. Dallas. The potential for biological attacks and other
naturally occurring pandemics is real, and of substantial
national impact, and I applaud this subcommittee for addressing
this issue, and thank you for inviting me here today.
It seems appropriate for my testimony to address the area
of biodefense preparedness at the local level, where an
appreciation of the likely in-the-field response can be
discussed.
Over the last 20 years, the University of Georgia and the
Medical College of Georgia--I am a professor in public health
in the first and a professor of emergency medicine in the
second--we have been active in research and training in
biodefense emergency preparedness and response. As a result, we
have had the unique experience of helping and evaluating over
700 institutional stakeholders within the state of Georgia in
their relative ability to respond to a biodefense challenge at
the grassroots level.
So this program in biodefense was ongoing at the turn of
the century, and we got a CDC Center for Public Health
Preparedness at UGA, and now is the Institute for Disaster
Management that I direct.
The last 13 years, this institute has had--we have led the
planning, organization, and conduct of tabletop and full-scale
exercises for virtually all the hospitals, 140 of them, and
then, just as important, or maybe more important, the hundreds
of additional supporting institutions--the nursing homes, law
enforcement, public health departments.
And so, how are we doing? One of the most important
developments in this process, we have seen in Georgia, and is
mimicked elsewhere in the country, is the development of health
care coalitions to better coordinate biodefense response,
between so many disparate institutions. It was very hospital-
based for so long and now we are getting all these support
institutions involved. That has been a success story.
And this was initially started in New York, quite frankly,
and the success they have had there has been now duplicated in
Georgia, and we hope elsewhere.
For instance, there have been many epiphanies where we get
these organizations, and for the first time they divulge their
plans to each other. You have got to realize these people are
in competition with each other, in most cases, and all of a
sudden we discover they are depending on the same resources,
and they are going to be fighting over them if these events
ever occurred. And so we hopefully helped them work this out in
advance.
Starting in 2015, the Ebola crisis occurred, and Georgia
received a lot of these patients from West Africa. And so we
had to ramp up pretty quick, and we quickly realized, in our
initial evaluations, that the 17 service providers, who
volunteered to provide these services, were not ready. It is a
pattern that expect would happen nationwide. It is just that we
experienced it because we had these patients coming in.
These EMTs and docs are very bold and they are willing to
go in, but you have got to train them right. For instance, we
just had a tabletop last week, at the Institute in Athens,
where we had all the people from all around the state that
would be the actual people that would respond. And there has
been progress in that. It just shows that training can work.
Now one of the most vulnerable populations in these
anticipated biodefense scenarios we have found is increasing
elderly populations, especially the ones in institutions, in
nursing homes and assisted living facilities. There are
thousands of them in Georgia alone. The vulnerabilities that
have been seen in natural disasters, for vulnerable
populations, very highly publicized in the recent hurricanes,
as severe as they are, we can expect those to be exacerbated
further, much further, when considering biodefense issues, and
particularly with agents that are coming in that are
microbially resistant.
Now the current system is not robust in dealing with the
background. If you have ever been to these institutions they
have background problems with isolating infectious disease
people. And then there is evacuation. The evacuation is a
nightmare. We have designed evacuation plans for many of these
facilities. Nationwide it is a big problem. In fact, in most
cases they are just going to shelter in place, because of the
complications in trying to get them out of there.
We have researched new approaches. We have gone into the
back of these ambulances and tried to ramp them up. A success
story there is Georgia EMS, they were going to take three hours
to transport a patient. Now we can do it in 30 minutes. That is
a standard that should be expected nationwide. If we can do it
in Georgia, certainly we can do it elsewhere.
Now I will tell you, if you look at a top-flight problem,
and that is going to be--and we are looking at it now, is the
backup power for these long-term care facilities. There are
some real nightmare stories with that. Efforts are greatly
needed now to prioritize and close those gaps in power backup
capabilities. They have been talking about it a long time and
it hasn't happened. I will just tell you, I am really worried
about that one.
We have reviewed hundreds of after-action reports
throughout the state, and we keep those at the Institute. Two
common themes emerge--the need for additional research and
training and incident command--Who is in charge? How are
commands given out?--and the need for additional research in
communication methodologies.
I will close with just a couple of examples. For instance,
emergency codes are coming out of all of these hospitals. We
found, throughout the system, they don't know what they mean.
They have no idea. It is unbelievable but they don't. And we
have some plans to get off this color-code system and let's
make the visitors and patients responders, instead of panicked
people.
And then I will close with the mortality issue. We wrote
the mass fatality plan for the state. I tell you, these rural
hospitals, for them, a morgue is a little room with an air
conditioner, a window unit. A lot of these facilities only have
maybe a couple of weeks of money on hand. They will collapse
under this pressure. And I might point out that they are also
the ones that are already hard hit. This will fall hardest on
the vulnerable populations.
So we have come a long way, and there is little doubt that
with the increasing biological threat matrix we have a long,
and I think difficult, work ahead of us.
Thank you.
Mr. Lynch. Thank you very much.
I will now turn to questions and I yield myself five
minutes for questions.
So I think because of the anthrax attacks on September
11th, I think our response was to that type of event, where
terrorists or maligned actors might try to inject something
like that into the population, but more recently--and I don't
know, over time that has become sort of a low--there has been a
probability bias that works against us focusing on that
problem, because nothing has happened since 2001.
The more recent manifestations, though, are, you know, this
antimicrobial resistance that we have seen in some of the
hospitals. Dr. Boucher, I think you mentioned that in your
remarks.
So there have been a number of assessments in terms of--the
New York Times did a very, very good piece on that. It made my
skin crawl--and we had a report from the Secretary-General of
the United Nations that estimated that drug-resistant diseases
cause at least 700,000 deaths worldwide each year, and the
report noted that that figure, and I quote, ``could increase to
10 million deaths per year by 2050.'' And all the reports say
that the figures that they are putting out are very
conservative assumptions.
What is your assessment of the threat here? You know, we
have heard about our preparedness, which is severely lacking,
but in terms of trying to quantify the magnitude of the threat
here, what are your thoughts?
Dr. Boucher. Thank you very much, Mr. Chairman. I think the
main message is that the crisis is here, so antibiotic
resistance is real, it is at all of our hospitals, it is in the
community, and it is no longer if it comes. It is here. So
those patients I told you about, there are more, and all my
colleagues across the country are treating patients like this,
and we are having the sad duty to have to send people to
hospice because we have infections we can't treat. This is
happening all across the country.
Mr. Lynch. Yes.
Dr. Boucher. So I think that is one thing.
In terms of our response, through at least, you know, my
involvement with our society for the past 15 years and the
Presidential Council now for the past five years, there
certainly are efforts with the National Action Plan for
Combating Antibiotic-Resistant Bacteria to coordinate the
efforts across the U.S. Government, and I think there has been
some progress. We certainly still have a ways to go, and, you
know, the National Action Plan set out targets for what would
happen by the year 2024, how resistance would decrease, how
antibiotic overuse would decrease, you know, a number of hard
targets, which we have not met.
We have a meeting coming up in July and we will have
another report released, sort of looking ahead to the next five
years as to what are the big needs, and I think that we still
have some really big needs. Probably the biggest need, if we
had to pick one, would be to make stewardship programs for
antibiotics a condition of participation for CMS, to finalize
that rule. So that rule is under consideration. I think a week
or so ago it was sort of continued for another year, but we are
very, very hopeful that that will be finalized. The Joint
Commission has mandated that, so all Joint Commission hospitals
have to have stewardship programs, and we have seen great
increase across the country in the presence of stewardship
programs, and it is making a difference. We need to see more.
We also have stewardship needs in the outpatient arena and
CMS has a condition of participation for long-term care
facilities, which are real breeding grounds for antibiotic
resistance.
So those a couple of high-level thoughts, in terms of where
we are.
Mr. Lynch. Well, let me ask you about the pipeline for
antibiotics, because that has to be part of the answer here,
right? You mentioned how even the 42 or 46 that are in the
development now, a very small number of those might address our
needs. How do we incentivize that? How do we, on our end,
incentivize the research and development that needs to happen?
Dr. Boucher. Great question. So it is true that the
antibiotic pipeline is thin, and we have been making efforts
for the last at least 10 years to work on, you know,
resurrecting it a little bit. And while we had a little bit of
good news and a few more antibiotics approved recently, we have
this sort of terrible situation where the market really seems
to be broken, and the bankruptcy of a company. So we are
finding that the return on investment for antibiotics is just
not what it needs to be, and some of the reasons are that
antibiotics are given for short periods of time, we hold them--
people like me hold them as much as possible to be used only
when we need them for the worst infections, and, you know, the
societal sort of standards are that the cost is just not that
high.
So we, unfortunately, have come to the point where this
company who developed an antibiotic that we really needed
couldn't even afford to continue to manufacture it so we could
have it on the shelf in our pharmacy for the time we need it.
So that gets to incentives.
We sort of break down incentives into two groups. Push
incentives are those that happen before the drug is FDA
approved, and we have a good example, I think, in CARB-X, which
is a public-private partnership between BARDA and several other
global partners, including the Wellcome Trust and some other
academic and government groups. They have successfully funded a
number that at the end of this year it will be over 60
different medicines and diagnostics for antibiotic-resistant
infections, and that is really great and that is helping that
early phase.
The other sort of part of the story are so-called pull
incentives, which cover the time after a drug is approved by
the FDA, and that is the area where we are seeing this big
problem now, with the bankruptcy and maybe some more. And so
there is where the DISARM Act comes in, and that is one idea of
a pull incentive to carve out the cost of the new antibiotic
from the diagnosis-related group, the kind of bundled payment
that we get in the hospital, and could be a kind of short-term,
small step in the right direction.
Very importantly, that incentive is tied directly to
antibiotic stewardship, so it has to be used in hospitals that
have antibiotic stewardship programs, and takes it one step
further, to actually requiring reporting on use of antibiotics
back to the CDC, so that we will know that these drugs that are
incentivized are used in the best way possible.
Mr. Lynch. Yes.
Dr. Boucher. We know that more is going to be needed in the
pull side, and so the concept of delinkage, that is taking the
return on investment away from the volume of sales, this
concept has really gained traction in ideas like a market entry
reward that might be awarded to the maker of a drug that
targets a really great unmet need at the time of licensing and
guarantees a certain amount of return on investment over a
period of, say, five years, again, tied to good stewardship and
appropriate use, could be enough to kind of help get this----
Mr. Lynch. Yes, prime the pump.
Dr. Boucher [continuing]. yes, get us back into a
functional situation.
Mr. Lynch. Yes. Okay. Thank you very much.
I now yield five minutes to the ranking member for
questions.
Mr. Hice. Thank you very much, Mr. Chairman.
Dr. Dallas, the biodefense preparedness, and then the
defense management. How is that best coordinated on a local or
state level?
Mr. Dallas. The best thing for them to respond--and first,
we have made a lot of progress. Exercises help a great deal.
The one gap--I like to go back to gaps, how we improve
further--is getting the physicians to come. It is hard to get
them. They are busy. To get them involved in the exercise is a
key factor for us. I think the key to that is through the CEOs
of the hospitals. They can tell them what to do, and if they
did, that would help a great deal.
Like I said before, the infrastructure support--I didn't
even mention it but these things that make everything worse--
the cyber vulnerability of the health care system is stunning.
Just there in our local vicinity there, in your district, there
have been a bunch of ransomware attacks that have taken down
these health care institutions for millions of dollars. And all
of this robs the infrastructure. So I would say bolstering the
public health infrastructure is the answer to this, so that
when it occurs--and I agree with my colleagues here that this
is coming--we were talking about it before. When you say
something is a low-likelihood event, it is not a straight line
that we are talking about. It is low likelihood and then all of
a sudden you are logarithmic and you are shooting up.
Mr. Hice. Yes. When it happens you have got to be prepared
at that point.
Mr. Dallas. You have got to be ready.
Mr. Hice. And you mentioned the health care coalitions. I
am curious about that in reference to what you are talking
about now, with the exercises, assuming that means not just the
hospitals and doctors but the entire health care coalition that
you are talking about, which would include enforcement and a
host of others involved. Is that----
Mr. Dallas. That is right, like volunteer groups, and how
to mobilize people. They can't show up at the time and help. We
have to train the people. Medical Reserve Corps units. There
are all sorts of ways, but it has got to be the community
working together.
New York showed us the way on this, and it was really
phenomenal, because it is a false multiplier of all your
resources there, working together. We have seen--I saw it in
Georgia, just in the last 10 years, it really explodes the
capabilities, but in the end if we don't have the drugs, if we
don't have the new antibiotics--I will add to the testimony
that was just said, drug development is pretty big at the
University of Georgia, and yet we are now telling the students
coming up that the odds of you running a drug all the way
through the system is 10 percent. And so these youngsters--they
all look young to me now--are coming up and they are going, ``I
am never going to run a drug through?'' And so there is just a
lot of disincentivization with that, and that is a major issue.
So on the pharmaceutical end we have got to fix it. On the
health care coalition we have got to continue to build it,
particularly the weak links, like the nursing homes and
assisted living facilities and the power backup.
Mr. Hice. And in addition to that I would think there would
have to be partnership between Federal, state, and local. I
mean, this is everyone working together.
Mr. Dallas. Yes. Like we say, all disasters are local, and
we sure appreciate the Federal Government's support, because
the resources are massive and awesome and really impressive,
although some of them, like you were describing, haven't been
very efficient. But when it comes to being on the local level,
it is all local, and we have to depend that they can meet these
demands at the local level.
Mr. Hice. All right. Mr. Currie, let me ask you real
quickly, I am sure all of you are aware that DHS has determined
that fentanyl poses a significant material threat to our
security. Do you agree with that assessment, by the way?
Mr. Currie. Yes, sir.
Mr. Hice. All of you, I am assuming, would agree with that?
So can something like fentanyl be used as a broader mass
attack on the U.S.?
Mr. Currie. Sir, I think--I am not sure I would be
comfortable answering that in a public setting. We are not
actually doing any work on that specifically, but the issue of
fentanyl as a drug and some of the drug concerns versus its use
as a weapon of mass destruction, those are kind of two separate
issues and the latter gets into classified information pretty
quickly.
Mr. Hice. Okay. I totally respect that.
And my last question for now, Dr. George, you mentioned the
blueprint, with 33 recommendations. Who has received those 33
recommendations, and ultimately, who is responsible to
implement them?
Ms. George. So we had distributed the report throughout
Congress. We issued it in 2015, though, so it has been a while.
We wrote recommendations for various Federal entities, for the
Administration, meaning the White House specifically, and for
Congress to execute. So it depends on the recommendation.
But, you know, sir, it depends on what the topic is too. I
don't think we should be leaving it to just one entity all by
themselves. If the White House is not going to pick up on
something, Congress certainly should. If Congress is not going
to pick up on something, then the rest of the Federal
Government can. You know, it is one of the beautiful things
about our government. So that would be my----
Mr. Hice. That is one of the messy things about our
government. Like you said, Mr. Currie, we have got like 12
different overlapping--nobody knows who is in charge, and it
seems like this is something that needs to be addressed.
Thank you, Mr. Chairman. I yield back.
Mr. Lynch. Okay. Let me stay with you, Dr. George. I know
that most nations, or most all have signed this, you know,
Biological Weapons Convention, basically a treaty not to
purchase these agents. However, it is a different story with
some of these non-state actors. And the technology has really
come down in terms of the cost of acquiring or developing
yourself.
What level of risk do you think that our military face,
say, you know, we have got folks in Syria, we have got folks in
Afghanistan, Iraq. What is the level of risk that you think is
presented, for them to face what you faced in uniform?
Ms. George. Yes, sir. I, of course, think it depends on the
geographic area that they are located in, but I think that they
are at great risk. I think these countries, and our troops, and
everybody else's troops, are at enormous risk. When you look at
Syria, for example, Syria had a vibrant biological weapons
program. North Korea is suspected of engaging in biological
weapons development as well. And al Qaeda, ISIL, and other
terrorist organizations have been very vocal about their desire
to obtain or produce and use biological weapons, and they are
not talking about doing that, you know, out in the country
somewhere where nobody is. You have to take their desires to
use biological weapons and look at who they are fighting at the
same time. That puts those populations at risk and it puts our
troops at risk as well.
Mr. Lynch. Let me ask, Mr. Currie, and also Dr. Dallas. So
the response in its initial phase will be local, so that means
my local community health center in my neighborhood, and in a
lot rural communities it is probably a local community health
center. It is our docs and nurses, EMS, first responders--that
is the front line of the program we have right now.
So how do we engineer our response so that we push out some
of the countermeasures to that population, to our first
responders, to our local health centers, to the people that are
going to have to respond to this in the first instance?
Mr. Currie. Well, I think one thing I would like to say,
this is where I think health situational awareness becomes so
important. So you are right, the nurses and docs are the ones
that are going to see the information the fastest and right
away, but at the Federal level this is why these information
networks that DHS and HHS have been developing are so critical,
because the idea is that we need to have them tied into all the
state and local information, to get that information as quick
as possible, not just to diagnose it and understand what is
going on but then quickly communicate to everybody at all those
levels that need to come in and help surge and respond.
Otherwise it is going to remain localized for a long period of
time before the word trickles up to whoever it needs to trickle
up to, and then trickles down very slowly. And that is our
concern about the lack of progress on these situational
awareness networks.
Mr. Lynch. So Dr. Boucher, you are at Tufts, and, you know,
we have an event like this, and, you know, as Dr. Dallas points
out and Mr. Currie, the initial impact is really on the street
level. How well are we equipped to connect what you are doing
and the resources that you have? Are there exercises that go on
here that we coordinate, you know, the local community health
center with, you know, Tufts or, you know, your research arm,
and, you know, the labs that are working on this?
Dr. Boucher. Well, I guess I can speak to what happens at
the hospital. So we certainly have exercises that are ongoing
and we work with the city and state Department of Public
Health, which are tied into CDC. So I think we learned a lot
from the Ebola experience, and it wasn't smooth when it
started, but certainly I think that we have these tabletop
exercises regularly and there is participation with community
partners as well as a hospital like ours. You know, we are
quaternary referral center, but we also communicate across
town. And you know we have lots of different players in the
medical world. But the state and local health departments
really are the center and do a great job. And so both in sort
of this really kind of dreaded disaster preparedness but also
in things like the opioid epidemic, you know, we are working
together in that way too.
So I think that is the vision from our CDC colleagues, is
that it works local, state, health departments up to CDC and
back, at least for surveillance and initial response in that
regard.
Mr. Lynch. Can you comment on that? I mean, in your initial
testimony, I meant to go back to that, where you talked about,
you know, opioid use contributes to this vulnerability of
antimicrobial resistance. What is the connection there? I
missed that.
Dr. Boucher. Okay. So people who inject opioids get
infections because they are injecting through their skin. Even
if their skin was clean they would have an increased risk of
infection. And we know that patients who use opioids have a 16-
times-higher risk of having an MRSA infection, which is a
resistant kind of bacterial infection.
And so what we are seeing are patients like this,
unfortunately----
Mr. Lynch. Is that shared needles? Is that----
Dr. Boucher. It is not even. I mean, it could be. It could
be worse with shared needles, but just injecting. Every time
you inject in your skin----
Mr. Lynch. Okay.
Dr. Boucher [continuing]. even if it is sterile there is
still a risk. Skin is our most important barrier to infection.
So these people are injecting over and over again, usually not
in such a sterile way. But we know from good studies that these
patients have a 16fold higher risk of MRSA, and that is just
one kind of resistant bacteria.
But our hospitals are full of these patients, and treating
them is incredibly difficult. It is heart-wrenching. These are
young, otherwise healthy people, and you are talking about
doing a heart valve replacement and another one and another
one. It is incredible, the burden of that morbidity and
mortality that we see. And so our society now has a whole group
dedicated to infections in people who inject drugs, because it
is such a big problem. It is almost a little bit like at the
beginning of the AIDS epidemic, in terms of what we are seeing,
and the burden of it, the stigma of it, and the challenges, the
sort of multidisciplinary challenges in treating it.
Mr. Lynch. Great. All right. I want to yield to the
gentleman from Georgia for five minutes.
Mr. Hice. Thank you, Mr. Chairman.
Dr. George, I know that the Blue Ribbon Panel has had some
meetings and has published some stuff involving the private
sector being involved in the preparedness efforts, and what Dr.
Dallas was talking about. Just comment a little bit of how the
partnership works between the private sector and government.
Ms. George. So it depends, of course, on the topic, I
guess, and I know I keep saying that.
Mr. Hice. Just an example.
Ms. George. Well, I think when it comes to pharmaceutical
development, for example, the Federal Government has identified
various threats, various biological threats that we would need
antibiotics and other antimicrobials to address, and they need
to fund those things that we don't have a market for. So that
would be on the one hand.
On the other hand, the U.S. Government is not in the
business of producing antimicrobials by itself, so it has to
work with the private sector, and together they have to produce
what is needed for the country.
Mr. Hice. Okay. So in that scenario you are talking private
sector would be the corporate business sector.
Ms. George. Mm-hmm.
Mr. Hice. Okay. Coming back, Dr. Dallas, to you, the
National Biodefense Structure that the President has come out
with, do you see a pathway in that for better collaboration
between the Federal Government, Federal agencies and state and
local?
Mr. Dallas. Yes, like what was said earlier, it was a good
start and it was a long time coming, but it is a good start and
I am encouraged by it, frankly. We have got to do something to
bolster the private sector's incentivizations. For instance,
vaccine development is a perfect example. We have almost chased
the vaccine development out of the country, even when we
provide incentivizations to these companies. Do you know what
is their main objection? It is lawsuits. They say, ``Look, we
can make Tylenol or some other agent and make lots of money.
The liability here is too high.'' And we say, ``We will protect
you,'' and they say, ``I don't believe you.'' And they have
just withdrawn, even when offered what they say is legal
protections.
Yes, I am encouraged by it. I would like to see it move
forward. Like was said in other testimonies here, there are
often some real latent periods. Some of them go on a long time
before we see a response. But yes, I am encouraged by it. I
would really like to see us incentivize these companies to move
forward, and I mean right away.
Mr. Hice. Good suggestion.
All right. I want to come back to earlier you mentioned one
of the things--you didn't phrase it this way--that keeps you up
at night is the vulnerabilities that we have, in particular
with the elderly senior community.
All right. So we have got all these facilities out here. We
have got hundreds of thousands, millions of seniors living in
them, and private homes, a host of different places. What is
needed to bring these facilities up to standard? I mean, it
sounds like an enormous task.
Mr. Dallas. It helps that most of these facilities have
isolation capabilities now, okay. It is just that they are
operating on the edge. They are operating in a margin, and they
don't have the incentives either to further develop these
isolation capabilities. So we ought to take the isolation
capabilities we have now and exercise them. Otherwise, what we
will end up doing is if they get to the hospital, they will get
care, and if they don't, they won't get care. And that is
really dangerous.
Mr. Hice. Okay. For my help, all right, what are we talking
about, isolation capabilities?
Mr. Dallas. Well, that usually means--they are laughing
over here with me--that usually means we have a little room we
stick them all in.
Mr. Hice. All right. That is what I had pictured in my
mind.
Mr. Dallas. And we a $10-an-hour person that has no
training that is expected to keep them from infecting the other
people, and they don't succeed, and then it spreads, and then
we can't move them, because if we move them we will then
contamination the bus driver and who knows who else, the
personnel.
So, yes, it is to take that simplistic, very basic, almost
19th century--I shouldn't have said that--system that we have
and advance it. Let's bring it up to 21st century.
Mr. Hice. Yes, I mean, and that has got to be an enormous
thing. I think a little room as well. If you got an entire
facility, a senior citizen facility where you have got
something spreading, they are not all going to fit in one room.
I mean, this is yet another disaster waiting to happen.
Mr. Dallas. And the rural areas are where the real issues
are, because they are on the edge. These are the vulnerable
people. They are already on the edge, I mean, frankly, on the
edge of health care access. And, boy, when this comes it is
going to hit them the hardest, because they are on the edge.
And then, like Mr. Currie was just saying, you know, we are the
front-line people and we can't really tell what is going on. We
have got to have a central organizing people to say, ``Look,
there is the problem,'' and then they come back and tell us
what to do.
But I am telling you, these nursing home and assisted
living facilities, particularly the ones that are on the edge
now, there is where things are going to explode out of there.
Mr. Hice. Well, we would appreciate if you would fix that
problem real quickly. Thank you, Mr. Chairman.
Mr. Dallas. We will do our best.
Mr. Hice. All right.
Mr. Lynch. I mean, that goes back to my question regarding
the community health centers, because I know a lot of rural
communities love their community health centers, but I am not
sure that anybody on the ground within that health center is
thinking about this problem, and I am not sure we have
incentivized them to, you know, do that.
Mr. Dallas. We have a lot of highly motivated people in
public health departments, and people forget about them. And
they are really motivated. They are just do-gooders par
excellence.
Mr. Lynch. Yes.
Mr. Dallas. But they don't have the knowledge. Somebody at
the central level has got to shoot information back to them and
say, ``You have got to watch. You have got to isolate, or you
have got to move them out.'' They have got to be told, and then
somebody better get down there to help them, and we are going
to have to force them to have evacuation plans, and then back
them up.
Mr. Lynch. Yes. Actually, you know, so we had a suicide
cluster in my neighborhood, my local neighborhood. We lost 14
young boys over about 18 months. And it was my local health
center, it was the Massachusetts Department of Public Health,
and then we reached out to CDC in Atlanta. So it was that whole
network, sort of what you are describing, for a different type
of problem, but it was very much a scramble until we got the
right people in place and had an opportunity to address it.
I want to ask each of you--so you each have got about a
minute and 15 seconds--what else do you think is important for
the ranking member and I to know, and members of the committee
to know? What else do you think is very important for us to
understand? And, I mean, we have your written statements so I
know you have got your top five ideas, but what else is out
there that you think is lacking that we might need to address,
or something that might not have percolated up in our
discussion already today?
Dr. Boucher.
Dr. Boucher. Thank you very much. I will comment on a
couple of things quickly. We didn't really hit that much on
diagnostics, but an area where we really are on the edge, I
think, of making some big advances are on diagnostic tests. So
that is the ability to know if a patient has a virus or a
bacteria causing their infection, or if it is a bacteria, which
bacteria? If we knew that we could impact this problem of
resistance, we believe, in a really meaningful way.
And so there are efforts going on in that public-private
partnership I mentioned. It is funding some diagnostic
companies. But there is still work to do on the path to
approval and marketing and using them in our hospitals.
Another area that I don't think we probably highlighted
enough was the One Health approach. So we understand that the
problem of antibiotic resistance really flows between humans,
animals, and the environment, and we, in the United States,
have made some good progress with our food animals, with the
Veterinary Feed Directive that was passed sort of banning the
use of antibiotics as growth promoters in food animals, but
this problem, on a global scale is huge.
The amount of people in the world who are going to be
eating meat is going up and up and up, and we know that a lot
of resistance comes from the developing world to us, so this
interrelationship is very important in the way we address this
problem, and this is something that we are focused on in our
center, in terms of research.
We are studying things like passing a resistance from your
pet dog or cat to the family, and back and forth, and there are
a number of issues here as well as in the environment. So I
think we want to highlight that.
And then the last thing I will mention is the work force.
We need a robust work force to solve this problem. We need
doctors, of course, which is my bias, but also we need nurses
and pharmacists and others. So we at IDSA, and others are
highly engaged in things that will help us recruit and retain
the best and the brightest in this field and ensure that they
are remunerated adequately to stay in the field.
So thank you.
Mr. Lynch. Excellent. Dr. George?
Ms. George. Sir, I would just mention two things in
particular. We talked about information flow earlier. I think
it is important for you to realize that there is an
intelligence issue here as well. The intelligence community has
not dedicated a whole lot of resources to this particular
threat since we shut down our own offensive biological weapons
program back in the 1970's. They have to step up.
But we are talking about diseases and activities that are
occurring on the nonclassified side as well, so that
information intelligence fusion has to happen and then
information has to go up and down, so that it is usable by
state and local folks.
I would also mention that it is important for you to know,
if you didn't already, that the public is actually very
concerned about the biological threat. One of the reasons is
almost everybody has had some issue with antimicrobial
resistance, of course, but many know people who have received
white powder letters and packages. And also, I think it is
important to understand that Hollywood has picked up on this
and they keep churning out these movies that put the biological
threat front and center to the public, and keeps it on their
minds.
So we owe it to the constituents to actually do something
about this and move, you know, the stick forward so that they
feel better protected.
Mr. Lynch. Very good.
Mr. Currie?
Mr. Currie. Yes, sir. I know we are running out of time so
I will just limit it to----
Mr. Lynch. No, no. You have got time.
Mr. Currie. Okay. I have two things. So the first thing I
will say, just for you as the chairman and the ranking member,
you mentioned congressional oversight. I think Dr. George
mentioned congressional oversight. We think the strategy--we
are looking at it right now and we are going to report on it
later this year. I think it is one of the best efforts we have
seen so far, and we have been looking at this for a long time,
to better coordinate biodefense.
But consistent oversight is going to be critical to keep
this moving forward. We see, across government, we look at
everything there is in government, at GAO, and where there is
heavy oversight and heavy emphasis, progress gets made. And I
think the execution of the strategy is going to be critical.
And there are going to be some really difficult things in
that execution. I mentioned the prioritization of resources and
budgets across so many departments. It is going to be a huge
challenge to be able to look at that holistically.
Mr. Lynch. Mr. Currie, you are actually--isn't the GAO
currently reviewing the report that Dr. George referred to
earlier?
Mr. Currie. Yes, sir. We are currently reviewing the
National Biodefense Strategy to both ensure that it met the
legislative requirements and also to see if it is going to be
successful when it is implemented.
Mr. Lynch. Okay.
Mr. Currie. And so that is exactly what I am talking about,
is that, you know, it has got to be successful in the execution
but it is going to be a major challenge, and it is not going to
get implemented successively just by the departments without
consistent congressional oversight.
Mr. Lynch. Excellent. All right. Is that all you have got?
Mr. Dallas. Yes, sir.
Mr. Lynch. Okay. Dr. Dallas.
Mr. Dallas. Yes. I want to jump right on that, along with
Mr. Currie. He mentioned about congressional oversight. I will
give you the perfect example, and the progress that we made in
Georgia, you know, we had this influx of Ebola patients coming
in, the way we were able to make progress was because there was
congressional oversight language that we could get back to,
that controlled how the Ebola funding was done.
Now, as we all know in here, you know, when there is
government appropriations people want to send it off in all
sorts of directions. But since there was very firm
congressional oversight language it really made a path for us,
and that is probably more than any other single factor, other
than our enthusiasm and running around in the back of
ambulances, was the fact that there was congressional language,
and every time we got lip service, ``No, the congressional
language says this.'' And then that made us--and that is why I
saw, in person, that is how we made the progress we did.
Mr. Lynch. I do know that on the Ebola issue that we had
asked a certain number of institutions to raise their hand and
say, if we are in this situation, we are in. And so, you know,
to those courageous institutions that volunteered their
services and said, you know, ``we want to be part of this and
we want to step up,'' the only problem was when it did happen
many were unprepared. They were very willing but they were
woefully unprepared. And that is sort of the gap between where
we want to be and where we actually are.
I also have a--I have got some housekeeping here.
Mr. Hice. Do you have----
Mr. Lynch. Yes, yes. Absolutely. Go right ahead. I yield to
the gentleman for five minutes.
Mr. Hice. I won't need five minutes. Dr. Boucher, I just
have not been able to ask you the question, and I guess the one
that I have remaining for you is how can we reduce the rate of
unnecessary prescribed antibiotics?
Dr. Boucher. That is a great question. So we believe that
there are a number of ways to do this. And so antibiotic
stewardship, this programmatic approach to the most optimal use
of antibiotics, is a great way, and it involves, you know, a
program that exists in a hospital or health care system to
ensure that antibiotics are used appropriately, that is, they
are not used when they are not needed, and used in the best way
possible when they are needed. And that is really important
because using them in the best way has better outcomes.
We have learned a lot, I would say, in the first five years
of the National Action Plan about what impacts behavior, why
physicians give antibiotics to people with colds. We have
learned that--good studies have shown that if a patient comes
into the doctor's office late in the day, they are more likely
to get an antibiotic than if they come early in the day. You
know, there are a lot of issues at play.
And so, actually, we have recommended, at the Presidential
Advisory Council, more work on implementation science. How do
you actually get it to happen? How do you get people to change
their behavior? And I think we are making strides. There has
been some good progress in pediatrics. There was just a study
this week about emergency rooms, having stewardship programs in
emergency rooms. That is a place where a lot of antibiotics are
handed out, and then urgent care centers are other target
places.
So there is a lot of work to do, but I think that probably
it is going to take a little bit of carrot and stick to make it
actually work, and some better science to know what will not
only work but be sustainable, because that is the other thing
that we have observed, is that some programs and you get the
numbers down for a while and then they trickle back up.
So I think that clearly physicians, other prescribers, all
of us have a role. And then every patient has a role. I
encourage patients to ask, ``Do I need this antibiotic?'' If
every patient asked that we would be a lot further along in the
trajectory.
Mr. Hice. Well, listen, I just want to personally, again,
to every one of you say thank you for being here. This has been
extremely informative to me, personally, and I am glad no one
sneezed in here today. But this has been great and your
expertise, bringing that here to Congress is very helpful. And,
Mr. Chairman, to you as well, thank you for calling this
hearing and putting this together. I appreciate it, and I yield
back.
Mr. Lynch. I thank the gentleman, and I would like to just
followup on your excellent question.
I spent a little time, a while ago, in Honduras and in
Guatemala and in El Salvador, and it was on the immigration
issue, but during my visit there I learned that many of the
antibiotics that we use, the most popular ones here in the
United States, penicillin and others, are available over the
counter in those countries. So they sort of buy them like we
buy aspirin. And so, you know, it provides a training ground
for some of these germs, and it just reduces the efficacy of
those antibiotics.
Is there any sort of international or regional cooperation
going on with some of those countries where we could work with
their health departments and maybe try to educate everyone on
our effort here and how they might sort of get on the same
page, and maybe we can help them with some of their issues as
well.
Dr. Boucher. Huge issue, the over-the-counter availability
of antibiotics, in much of the world. And I think the plan is
the Global Action Plan for Combating Antibiotic-Resistant
Bacteria. I came out of the U.N. meeting a couple of years ago.
And the good news--and the WHO is sort of leading that charge,
we are very much committed to, and part of that. The good news
is that many countries now have an action plan. The challenges
are that in many developing countries access to antibiotics is
a much bigger problem than anything else. They have babies
dying because they don't have access to antibiotics, and they
don't have a health care infrastructure to have doctors,
nurses, anybody prescribing.
Mr. Lynch. I see.
Dr. Boucher. So I think it is going to take a lot to change
this. Certainly our efforts in every country as part of this
action plan has to have some kind of a stewardship program. It
is going to be very different, right, and for some countries it
might be taking antibiotics away from over-the-counter status.
But it is a huge issue, that access piece, globally, is very
different than what we have here in the United States.
Mr. Lynch. Right. More complicated than I thought.
I have a little bit of housekeeping here. I want to ask
unanimous consent to enter into the record a statement from the
California Life Science Association that was offered by Mr.
Rouda, right?
Without objection, so ordered.
Mr. Lynch. Last, I would like to thank you all for your
patience and your very, very helpful testimony and the good
work that you do on a regular basis in your official capacity.
Without objection, all members will have five legislative
days within which to submit additional written questions, for
you, the witnesses, through the chair, which will be forwarded
to the witnesses for responses. And I ask if you do receive any
of these questions could you please respond as promptly as you
are able.
With that this hearing is now adjourned. Thank you.
[Whereupon, at 5:32 p.m., the subcommittee was adjourned.]
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