[Senate Hearing 116-518]
[From the U.S. Government Publishing Office]
S. Hrg. 116-518
COVID-19: LESSONS LEARNED TO
PREPARE FOR THE NEXT PANDEMIC
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HEARING
OF THE
COMMITTEE ON HEALTH, EDUCATION,
LABOR, AND PENSIONS
UNITED STATES SENATE
ONE HUNDRED SIXTEENTH CONGRESS
SECOND SESSION
ON
EXAMINING COVID-19, FOCUSING ON LESSONS LEARNED TO PREPARE
FOR THE NEXT PANDEMIC
__________
JUNE 23, 2020
__________
Printed for the use of the Committee on Health, Education,
Labor, and Pensions
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]
Available via the World Wide Web: http://www.govinfo.gov
__________
U.S. GOVERNMENT PUBLISHING OFFICE
45-223 PDF WASHINGTON : 2022
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COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS
LAMAR ALEXANDER, Tennessee, Chairman
MICHAEL B. ENZI, Wyoming PATTY MURRAY, Washington
RICHARD BURR, North Carolina BERNARD SANDERS (I), Vermont
RAND Paul, Kentucky ROBERT P. CASEY, JR., Pennsylvania
SUSAN M. COLLINS, Maine TAMMY BALDWIN, Wisconsin
BILL CASSIDY, M.D., Louisiana CHRISTOPHER S. MURPHY, Connecticut
PAT ROBERTS, Kansas ELIZABETH WARREN, Massachusetts
LISA MURKOWSKI, Alaska TIM KAINE, Virginia
TIM SCOTT, South Carolina MARGARET WOOD HASSAN, New Hampshire
MITT ROMNEY, Utah TINA SMITH, Minnesota
MIKE BRAUN, Indiana DOUG JONES, Alabama
KELLY Loeffler, Georgia JACKY ROSEN, Nevada
David P. Cleary, Republican Staff Director
Lindsey Ward Seidman, Republican Deputy Staff Director
Evan Schatz, Minority Staff Director
John Righter, Minority Deputy Staff Director
C O N T E N T S
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STATEMENTS
TUESDAY, JUNE 23, 2020
Page
Committee Members
Alexander, Hon. Lamar, Chairman, Committee on Health, Education,
Labor, and Pensions, Opening statement......................... 1
Murray, Hon. Patty, Ranking Member, a U.S. Senator from the State
of Washington, Opening statement............................... 4
Witnesses
Frist, William, M.D., Former U.S. Senate Majority Leader,
Nashville, TN.................................................. 7
Prepared statement........................................... 8
Summary statement............................................ 15
Khaldun, Joneigh S., M.D., MPH, FACEP, Chief Medical Executive
And Chief Deputy Director For Health, Michigan Department of
Health and Human Services, Lansing, MI......................... 16
Prepared statement........................................... 18
Summary statement............................................ 22
Gerberding, Julie L., M.D., MPH, Executive Vice President And
Chief Patient Officer, Merck & Co., Inc., Co-Chair, CSIS
Commission on Strengthening America's Health Security,
Kenilworth, NJ................................................. 23
Prepared statement........................................... 24
Summary statement............................................ 28
Leavitt, Michael O., Former U.S. Secretary of Health And Human
Services, Salt Lake City, UT................................... 29
Prepared statement........................................... 30
Summary statement............................................ 36
ADDITIONAL MATERIAL
Statements, articles, publications, letters, etc.
Senators Schumer and Murray, testing letter.................. 69
ASM Statement letter......................................... 71
Health Equity Principles for State and Local Leaders in
Responding to, Reopening, and Recovering from COVID-19,
Robert Wood Johnson........................................ 75
Bill Frist:
A Storm For Which We Were Unprepared......................... 80
Pandemic; The Economy's Silent Killer, Bill Frist Remarks
Dec. 8, 2005............................................... 86
COVID-19: LESSONS LEARNED TO
PREPARE FOR THE NEXT PANDEMIC
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Tuesday, June 23, 2020
U.S. Senate,
Committee on Health, Education, Labor, and Pensions,
Washington, DC.
The Committee met, pursuant to notice, at 10:03 a.m., in
room SD-430, Dirksen Senate Office Building, Hon. Lamar
Alexander, Chairman of the Committee, presiding.
Present: Senators Alexander [presiding], Burr, Collins,
Cassidy, Roberts, Murkowski, Romney, Braun, Murray, Baldwin,
Murphy, Warren, Kain, Hassan, Smith, Jones, and Rosen.
OPENING STATEMENT OF SENATOR ALEXANDER
The Chairman. The Committee on Health, Education, Labor,
and Pensions will please come to order. First, the usual
administrative matters. This is a little like the theater
announcements that we used to receive. We are getting used to
those. We follow the advice of the attending physician and the
Sergeant-at-Arms who have consulted with all the right people.
We are seated at least six feet apart. That means there is no
room for the public or the media here, but the media is
participating, we hope, and we hope the public is as well.
www.help.senate.gov is our website.
Our witnesses are participating by video conference, which
is a real change for the U.S. Senate and in some ways a very
welcomed one because I think it makes it possible for us to be
able to attract witnesses who have very busy schedules on the
same day such as today. Some Senators are participating by
video conference.
Senators may remove their masks since we are 6 feet apart.
I am grateful to the Rules Committee, the Sergeant-at-Arms, the
Press Gallery, the Architect of the Capitol, the Capitol
Police, our Committee staffs, and Chung Shek and Evan Griffis
for all their hard work to help keep us safe. Senator Murray
and I will each have an opening statement and then we'll turn
to our witnesses who we thank very much for being with us
today.
Each witness, we would ask that you summarize your remarks
in five minutes, which will allow more time for the large
number of Senators who we expect to participate to present
their testimony. We will have one round of questions for a five
minute round.
Less than four months ago, on March 1, the coronavirus
situation was about this. At the end of February, there were
79,000 cases around the world. Only 14 in the United States,
except for 39 who had been brought home from overseas with the
virus. By March the 2nd, there were two deaths in the United
States. By March the 3rd, when we had a hearing, there were six
deaths. And on March the 1st, on Sunday in the New York Times
on the front page it said this, that most experts were far from
certain that this virus would carry to all parts of the United
States, and that with its top-notch scientists, ``modern
hospitals and sprawling public health infrastructure, most
experts agree the United States is among the countries best
prepared to prevent or manage such an epidemic.''
Well, even six weeks after the first virus was found in the
United States, even the experts underestimated the ease of
transmission and the ability of this coronavirus to spread
without symptoms. These qualities made the virus, in the words
of Dr. Fauci, ``my worst nightmare.'' In the period of four
months, he said, it has devastated the world. This Committee is
holding this hearing today because even with an event as
significant as COVID-19, memories fade and attention moves
quickly to the next crisis. While the Nation is in the midst of
responding to COVID-19, the U.S. Congress should take stock now
of what parts of the local, state, and Federal response to this
crisis worked, what could work better and how, and be prepared
to pass legislation this year to be better prepared for the
next pandemic which will surely come.
On June 9, I released a white paper outlining five
recommendations for Congress to prepare Americans for the next
pandemic. They were these. No. 1, tests, treatments and
vaccines. Accelerate research and development. No. 2, disease
surveillance. Expand our ability to detect, identify, model,
and track emerging infectious diseases.
No. 3, stock piles, distributions, and surges. Rebuild and
maintain Federal and state stockpiles, and improve medical
Supply surge capacity and distribution. No. 4, public health
capabilities. Improve state and local public health
capabilities. And finally, who is on the flagpole, who is in
charge. Improve coordination of Federal agencies during a
public health emergency. I have invited comments and responses
in any additional recommendations for the Senate Committee on
Health, Education, Labor, and Pensions to consider. I will
share this feedback with my colleagues, both on the Democratic
and the Republican side.
This is not a new subject for any of the witnesses that we
have today. 15 years ago the then Majority Leader of the U.S.
Senate Bill Frist said in a speech at the National Press Club
that a viral pandemic is no longer a question of, if but a
question of when. He recommended what he calls a six-point
public health prescription to minimize the blow,
communications, surveillance, antivirals, vaccines, research,
stockpile surge capacity. Senator Frist is one of our witnesses
today and I am including in the record two of his speeches.
Our next witness, Dr. Joneigh Khaldun serves as Chief
Medical Executive and Chief Deputy Director for the Michigan
Department of Health and Human Services, where she has worked
to coordinate the state's response to COVID-19. Our third
witness is Dr. Julie Gerberding, who served as Director of The
Centers for Disease Control and Prevention under President
George W. Bush. She helped lead preparedness efforts on the
response to SARS, West Nile Virus, H5N1 Avian Influenza, and
the rise of multi-drug resistant bacteria like MRSA.
Another witness is Governor Michael Leavitt. He was
Governor of Utah. He was Secretary of Health and Human Services
and an Administrator of the EPA under George W. Bush. Following
the emergence of H5N1 Avian Flu, Governor Leavitt increasingly
focused his efforts on pandemic preparedness. As Secretary in
2007 he said this 13 years ago, everything we do before a
pandemic will seem alarmist, everything we do after a pandemic
will seem inadequate. That is the dilemma we face, but it
should not stop us from doing what we can do to prepare.
Congress has passed legislation to prepare for pandemics
before.
During the last 20 years, four Presidents, Clinton, Bush,
Obama, Trump, and several Congresses have enacted nine
significant laws to help local, state, and Federal Governments,
as well as hospitals and health care providers, to prepare for
a public health emergency including a pandemic. Congress
provided over $18 billion to States and Hospital Preparedness
Systems over the last 15 years to help them prepare as well.
In writing those laws, Congress considered many reports
from Presidential commissions, offices of Inspectors General,
the Government Accountability Office, and outside experts. The
reports contained all sorts of warnings that the United States
needed to address the following familiar issues, familiar by
now, better methods to quickly develop tests, treatments, and
vaccines, and scale-up manufacturing capacity, better systems
to quickly identify emerging infectious diseases, more training
for the health care and public health workforces, better
distribution of medical supplies, better systems to share
information within and among states and between states and the
Federal Government. Many reports also warned that while states
play the lead role in a public health response, many states
didn't have enough trained doctors, nurses, and healthcare
professionals, had inadequate stock piles, and struggled with
funding challenges.
In some instances, over-reliance on inflexible Federal
funding contributed to these problems. Looking at lessons
learned from the COVID crisis thus far, many of the challenges
that Congress has worked to address during the last 20 years
still remain. Additionally, COVID-19 has exposed some gaps that
had not been previously identified. These include unanticipated
shortages of testing supplies and sedative drugs which are
necessary to use ventilators for COVID-19 patients.
Memories fade, attention moves quickly to the next crisis.
Four months ago, five months ago we were in the midst of the
impeachment of a President. Today, that seems like ancient
Roman history. That makes it imperative that Congress act on
needed changes this year in order to better prepare for the
next pandemic. I look forward to hearing from our witnesses and
I would also appreciate the feedback we are receiving on the
white paper. I will set a deadline for June 26 on that feedback
so the Committee has time to consider it and to draft and pass
legislation this year.
Senator Murray.
OPENING STATEMENT OF SENATOR MURRAY
Senator Murray. Well, thank you very much, Mr. Chairman,
and I also want to thank all of our witnesses for joining us
today. And of course thank our staff for wrangling the
technology to make this hearing possible. I said before, we
need to understand fully and exactly everything that has gone
wrong in our response to COVID-19. Why and how we work to make
sure we are never in this situation again. But I want to be
absolutely clear from the start, reflecting on how we prepare
for the next crisis is no substitute for responding to the
crisis at hand, which has infected over 2 million people in our
country, killed over a 120,000, and which continues to spread.
Unfortunately, the White House is pretending this pandemic
is over. President Trump has said it is fading even as several
states see record case increases. Vice president Pence wrote an
op-ed saying we are winning the fight and there isn't a second
wave while experts like Dr. Fauci warn we aren't even through
the first wave yet. Admiral Giroir has stepped down from his
role leading testing efforts without being replaced, and
President Trump is calling for less testing, even though we
don't have anything close to the testing and tracing capacity
we need to safely reopen our communities. It is not just
officials in the White House who are sticking their heads in
the sand.
Leader McConnell and some Republicans have suggested there
is less urgency to take further action since we gained some 2.5
million jobs after losing more than 20 million jobs. You know,
as a former preschool teacher, I can tell you even some of our
younger students know that map doesn't add up. So I hope we
don't just spend our time today talking about how to avoid
mistakes in the next pandemic, but instead address the mistakes
this administration is still making during this one and the
ones they are at risk of repeating as the response to COVID-19
continues. One lesson we have already learned, this crisis is
no great equalizer, but rather a force which perpetuates and
deepens the injustices that black communities, latino
communities, tribal communities, people with disabilities, and
so many others face.
We have known for decades that our healthcare system treats
some communities much worse than others, especially communities
of color. Those disparities are caused by a long history of
systemic racism and underfunding, and those in charge have a
responsibility to acknowledge the problem and do everything
they can to close that gap. This administration has not taken
that responsibility seriously. At best, they turned a blind eye
to the problem. At worst, they seem determined to make it worse
as we have seen in the administration's irresponsible rule to
allow discrimination in health care.
We have also seen once again how desperately we need a
national universal paid sick leave policy so workers can stay
home and do what is best for their health and for public health
without fear of losing their job or their paycheck. And we have
learned how important it is the Department of Labor's
Occupational, Safety and Health Administration is. They need to
stop dragging their feet and finally make clear safety isn't
optional by immediately issuing an emergency temporary
standard. There are also several lessons We need to apply
regarding vaccines.
We cannot allow the Trump administration to bungle this
like they have so much else. This pandemic will not end until
we have a vaccine that is safe, effective, that we can widely
produce and equitably distribute and that is free and
accessible to everyone. So when it comes to developing a
vaccine, we don't just need a fast process, we need a thorough,
transparent, and science driven one. We need to know the
process is free of political interest influence, especially
after the hydroxychloroquine debacle. And the final COVID-19
vaccine or vaccines truly meet the gold standard families have
relied on for so long, which is why the administration needs to
commit now to being fully transparent about the vaccine
development and review process and about the data that is
ultimately used to evaluate safety and effectiveness.
We also need the administration to detail how it will
produce and distribute vaccines everywhere to everyone. Even
the incomplete data we currently have shown black, latino and
tribal communities are disproportionally impacted by COVID-19
and have significantly less access to testing than white
communities. This is an injustice that we cannot repeat when it
comes to vaccines nor can we afford to repeat delays like those
the Trump administration caused by refusing to take
responsibility for resolving coordination problems in the
national supply chain.
Instead, the Trump administration must work now to draft
and release a comprehensive COVID-19 vaccine plan, the type of
comprehensive plan we still haven't gotten on testing. One that
addresses all of these questions and other barriers, like how
do we fight misinformation and vaccine hesitancy? How do we
strengthen our immunization infrastructure to ensure it is
ready to meet this unprecedented challenge? How do we build
global partnerships in this effort, instead of turning our back
on the rest of the world, which not only betrays our American
values but also puts people here at home directly in harm's
way.
Mr. Chairman, these are not questions we need to answer
before the next pandemic starts, they are questions we have to
answer before the current pandemic can end. I look forward to
hearing our witnesses perspectives on all of these urgent
issues today, and Mr. Chairman I hope in the future, very near
future, this Committee will also be able to get the
perspectives of several important members of this
administration we have not heard from yet, Secretary Azar,
Secretary Scalia, and Secretary DeVos.
It is clear we have a lot more work to do to respond to
this pandemic and I urge our Republican colleagues to come back
to the table so we can work on this together because the
challenges our Nation is grappling with right now, the public
health crisis of COVID-19, the economic crisis this pandemic
has set in motion, and of course the persistent systemic
inequities driven by racism that this crisis has only
exasperated are urgent. Our Nation cannot keep waiting. Thank
you, Mr. Chairman.
The Chairman. Thank you, Senator Murray. Each witness
will--I would ask you to summarize your statement in five
minutes so we will have more time for questions. I welcome our
witnesses. It is a distinguished panel. We look forward to
hearing from each of you. It is my privilege to introduce the
first one. Senator Bill Frist, with whom I served and many of
us served. He represented Tennessee for two terms in the
Senate. He was the Majority Leader of the U.S. Senate. He
served on this Committee in the U.S. Senate. He is a heart and
lung transplant surgeon by training. First practicing physician
to serve in the Senate since 1928.
He now serves on several boards including the Robert Wood
Johnson Foundation. He is senior fellow at the bipartisan
policy center and chairman and founder of Health Nashville. In
2005, and I am sure he will talk about this, he gave many
speeches on the inevitability of a global pandemic and the
importance of preparedness. I have submitted two of those
speeches to the record during this Committee's May 7th hearing.
Next, after Dr. Frist, we will hear from Dr. Joneigh
Khaldun. Dr. Khaldun serves as the Chief Executive and Chief
Deputy Director for Health of the Michigan Department of Health
and Human Services. In this position she oversees the
Population Health Medical Services, Aging and Adult Services,
and Behavioral Health and Developmental Disabilities
Administration for the State of Michigan. Dr. Khaldun has
extensive experience in state and local Governments. Prior to
her current role, she served as Director and Health Officer for
the Detroit Health Department. She is a practicing emergency
medicine physician.
Our third witness is Dr. Julie Gerberding. She is Executive
Vice President and Chief Patient Officer at Merck & Company,
and serves as a Co-Chair of the Commission on Strengthening
American Health Security at the Center for Strategic and
International Studies. Dr. Gerberding served as the Director of
the Centers for Disease Control, the CDC, from 2002 to 2009.
Under her leadership CDC coordinated preparedness efforts
and responses to several public health threats including SARS,
West Nile Virus and Avian Flu. She played a key role in the CDC
response to Anthrax attacks in 2001. Senator Romney will
introduce our final witness, Governor Mike Leavitt.
Senator Romney. Thank you. Mr. Chairman. I am happy to
introduce my friend Mike Leavitt. Mike is actually the one who
is most responsible for freeing me from the golden chains of
the private sector. He got me to leave my position at Bain
Capital and to come out help run the Olympic Winter Games of
2002 in Salt Lake City. As such, he was my boss. He was the
Governor of the State of Utah at the time and we became since
then dear friends. He also was kind enough when I was running
for President to lead my transition team.
I am not sure I would have been a great president, but I
would have had a great administration because he put together
an extraordinary team and laid out a pathway to help our
Country in numerous ways. Mike Leavitt, as you also have
indicated, was a three-term Governor of Utah in the Bush
administration. He served as Administrator of the EPA and then
for several years as a Secretary of Health and Human Services.
One of his priorities was to focus on pandemic preparation.
He secured some $7 billion in funding with the Administration--
through the Administration and Congress to prepare for
pandemics. Since leaving Government, he has founded a firm
called Leavitt Partners. It is the premier healthcare
consulting firm in the country, with hundreds of employees
under his management as well as a private equity firm that he
has built. It set an extraordinary record and he continues to
contribute to our Country, my friend Mike Leavitt.
The Chairman. Thank you, Senator Romney. Now we will begin
with Senator Frist. Welcome, Senator Frist, back to your old
Committee.
STATEMENT OF WILLIAM FRIST, M.D., FORMER U.S. SENATE MAJORITY
LEADER, NASHVILLE, TN
Dr. Frist. Good morning, Chairman Alexander and the Ranking
Member Murray, Members of the Committee. And it is great to be
back to the halls in the Senate even if only remotely and to
see so many old friends and colleagues. I do want to commend
the Committee for placing a focus now on preparing for the
inevitable biological and infectious diseases that absolutely
will come in the future. As you mentioned, in December 8th of
2005 at the National Press Club, I said in the very same speech
I gave, in this body 15 years ago and repeatedly all across the
country, I said a viral pandemic is no longer a question of if
but a question of when.
I even said it would come from China at the time. Grounded
deeply in my own experiences as a physician in the Senate,
being in China with a Senate delegation during the SARS
pandemic in 2003, personally treating HIV, AIDS patients,
responding to the Anthrax attacks, it was crystal clear then we
were woefully unprepared for what was to inevitably come. In
those talks, I proposed a specific six-point plan called a
Manhattan Project of the 21st century to prepare the Nation.
And during my time in the Senate, we laid the foundation with
the Bioterrorism Act of 2002, Project Bioshield 2004, the PREP
Act 2005, the Pandemic and All-Hazards Preparedness Act of
2006, and subsequently, as you have outlined in your white
paper, we have done more but this was not enough nor will it be
enough.
A little bit disappointingly, most of what I recommended in
2005 remains undone. So for my recommendations, I use the exact
same six categories I used then. No. 1, communication. We have
got to clarify who is in charge in an emerging pandemic. Only
then will we be consistent and be coordinated. The Federal
response must be led at the National Security Council level to
facilitate this whole of Government approach. CDC, the trained
and experienced experts, should regain its position as the
Nation's apolitical voice of public health.
No. 2, surveillance. We must modernize our real-time
domestic and international surveillance and threat detection
system. This pandemic has laid bare our inability at the
Federal level to track outbreaks with testing and reporting
across the country. We must engage globally, diplomatically and
economically.
An outbreak anywhere in the world is a risk everywhere. It
is a risk to every community in America. The ability of
developing nations to detect, track and contain a novel virus
will be inextricably tied to their capacity of their public
health infrastructure, which is vitally dependent on U.S.
support. Categories three and four were agents and vaccines,
and as in 2005, we have a dangerously inadequate vaccine
manufacturing base here within the United States. We must
establish public, private partnerships with industry that are
and can be sustained. For our supply chains including testing
and vaccine development, the Federal Government must be re-
engineered to serve as a sort of control tower function.
No. 5, I said then and now research and development. In my
words in 2005, I called for massive R&D investment to create a
biologically based Manhattan Project to help better defend us
against naturally occurring, like we are seeing now, or
accidental or intentional bioterror threats, including
infectious disease. Categories of stockpiling and surge
capacity were No. 6. The Federal Government should take the
lead role serving as overlaying central repository paired with
a well-structured surveillance system that would accurately
track outbreaks to ensure that supplies are responsibly and
appropriately distributed where the risk is greatest.
In telemedicine, with which this Committee has dealt, I
echo Chairman Alexander's recommendations that we, ``ensure the
United States does not lose the gains made in telehealth.'' We
must make permanent the majority of regulatory changes, with
some modifications, in order to unleash this revolutionary
power of virtual care delivery in America. I want to quickly
touch on two other important areas, public health funding and
vulnerable populations.
For the funding, observing closely for the past 25 years, I
conclude like our armed services defense, we must have
predictable, consistent base funding for our public health
security programs. Yes, health security is National Security so
let's treat it as such. That is why I joined. Dr. Tom Friedman
and others to advocate for the creation of a specific new
health defense operations budget designation. This
discretionary approach, with exempt from spending caps, a small
number of critical pre-existing health security funding lines.
Lastly, this whole concept of vulnerable populations of
health equity, any pandemic preparedness response needs to
comprehensively consider how to protect and care for the most
valuable here at home and globally. And real quickly, I
encourage the Committee to underscore this vital connection
between the health of the world's most vulnerable and the
security of Americans here at home, especially as you soon
consider global access to immunization. Members of the
Committee, thank you for having me here today. The work you are
doing now will literally save lives in the future.
[The prepared statement of Dr. Frist follows:]
prepared statement of bill frist
Good morning Chairman Alexander, Ranking Member Murray, and Members
of the Senate Health, Education, Labor, and Pensions Committee. Thank
you for inviting me to testify at today's hearing, ``COVID-19: Lessons
Learned to Prepare for the Next Pandemic.'' It is great to be back in
the halls of the U.S. Senate--even if only remotely--and to see so many
old friends and colleagues.
I want to commend Chairman Alexander and Ranking Member Murray for
placing a focus now on preparing for the biological and infectious
diseases threats of the future. For too long, we have lurched from one
public health crisis to another--retroactively appropriating emergency
funds and so avoiding a large-scale pandemic through a great deal of
American ingenuity and, sometimes, an even greater dose of good luck.
But with COVID-19, our luck has run out.
In 2005, in a series of speeches I predicted a global pandemic
arising from China and proposed a six-part plan to prepare the Nation
focused on: 1. Communication; 2. Surveillance; 3. Antiviral Agents; 4.
Vaccines; 5. Research and Development; and 6. Stockpiling and Surge
Capacity.
On June 5, 2005 at Harvard University, I called for and outlined a
greater than ``Manhattan Project'' for the 21st Century with ``no less
than the creation, with war-like concentration, of the ability to
detect, identify and model any emerging or newly emerging infection,
natural or otherwise; for the ability to engineer the immunization and
cure, and to manufacture, distribute and administer whatever may be
required to get it done and to get it done in time. For some years to
come, this should be the chief work of the Nation, for the good reason
that failing to make it so would be to risk the life of the Nation.''
On December 8, 2005 at the National Press Club, I said, ``A viral
pandemic is no longer a question of if, but a question of when. We
know--depending upon the virulence of the strain that strikes and our
capacity to respond--that the ensuing death toll could be
devastating.''
My reasoning then for recommending a bold, comprehensive
preparedness plan was first and foremost, to protect human life. But my
second, as captured in my December speech's title: ``Pandemic: The
Economy's Silent Killer,'' was to preserve economic stability when a
pandemic inevitably came. I had the Congressional Budget Office study
the impact of a severe pandemic on our economy, and they estimated a 5
percent reduction in GDP. Tracking almost exactly, the International
Monetary Fund's World Economic Outlook released in April estimated a
5.9 percent decline in U.S. GDP for 2020--over a trillion dollars in
losses.
I share this not because my remarks were prescient of what was to
come 15 years later, but as Majority Leader of the Senate, I failed to
sufficiently make the case, and truly comprehensive pandemic
preparedness legislation never passed. I had seen SARS firsthand on the
ground (with a Senate delegation) in China in 2003, personally treated
patients suffering the ravages of HIV/AIDS in Sub-Saharan Africa and
here at home in my medical practice, lived through and helped navigate
our response to the 2001 Anthrax attack on the U.S. Senate and our
postal workers, and at the time of this 2005 proposal, shared global
concerns about the deadly H5N1 avian influenza. But now that we all are
living through what once was a predicted threat, my hope is the smart
work of this Committee and others, combined with the will of the
people, will make these needed changes a reality. I can assure you that
new, more deadly viruses will raise their heads in the future. It's
biology. They know no borders. And they kill.
But we are not starting from scratch. As Senator Alexander's recent
White Paper, ``Preparing for the Next Pandemic,'' clearly outlines,
Congress has not wholly ignored this threat. Indeed, during my time in
the Senate and as Senate Majority Leader, we enacted:
The Public Health Security and Bioterrorism
Preparedness and Response Act of 2002 (``Bioterrorism Act,'' PL
107-188)
The Project BioShield Act of 2004 (PL 108-276)
The Public Readiness and Emergency Preparedness Act
of 2005 (``PREP Act,'' PL 109-148)
The Pandemic and All-Hazards Preparedness Act of 2006
(PL 109-417)
But these and all the well-intended legislation that followed
failed to protect us. While 9/11 and the Anthrax attacks were a wakeup
call, and while our Nation's leaders did respond and put in place
funding and new important public health authorities, we didn't fully
prepare for a pandemic--a simultaneous nationwide, indeed a worldwide,
assault on every one of our citizens, our underfunded public health
infrastructure, and our economy. We took some important steps and in
many ways, the basic foundations from which we need to respond to a
pandemic are in place. Now, we need to establish a clear chain of
command coupled with a more systematized, coordinated response
structure and power it with robust, sustained financial resources to
enable our public health leaders to keep Americans safe.
Most of what I recommended in 2005 in those speeches delivered
around the country and in this body remains undone today, thus I
outline my recommendations along the exact same six categories.
1. Communication
As I said then, ``Number one is communicating with the public.'' To
allay irrational fear, communication--of accurate, reliable, consistent
information--must be the bedrock of every public policy response.
From the outset of the COVID-19 crisis and continuing today, we
have had mixed and contradictory messages on the severity of the
outbreak, the differing roles of Federal, state and local government,
the availability of tests, potential treatments, the appropriateness of
masks, and timelines and approaches for reopening. This has
unquestionably led to unnecessary viral spread, duplication of efforts,
gaps in response, and loss of life. It's fixable.
First, we must clarify who is in charge in a pandemic. The current
response structure is broken. The Federal response should be led at the
National Security Council level to facilitate a ``whole of government
approach'', re-establishing the NSC'S Directorate for Global Health
Security and Biodefense. The NSC should set out guidelines and ensure
seamless coordination between and among departments, with regular and
consistent pressure testing.
Second, the CDC should regain its position as the Nation's
apolitical voice of public health. The CDC has 20,000 health
professionals who dedicate their lives to protecting Americans. The
National Center for Immunization and Respiratory Disease has more than
700 FTE staff who are experts in this area. They have spent decades
working on the public health control of respiratory viruses. This
Administration has sidelined the entire agency from their role in
briefing the public, which has had a chilling effect on the information
that could leave the agency and reach the public. CDC guidance has had
to go through dozens of levels of review which in many cases took weeks
instead of days. This led to confusion and uninformed improvisation at
the state and local levels without strong Federal leadership.
Third, we must make sure what is said at the Federal level
coordinates and integrates well with the more regional needs, abilities
and resources of state and local municipalities. This can be
accomplished in part by strengthening the relationship between CDC and
the Association of State and Territorial Health Officials (ASTHO). In
times of infectious disease outbreak or pandemic, predetermined,
clearly delineated emergency channels of communication, authority and
action should immediately be implemented.
2. Surveillance
Every moment counts. The sooner we detect, identify, and contain a
viral threat, the better the health and economic prognosis will be.
This pandemic has laid bare our inability, at the Federal level, to
detect and track outbreaks across the country, and provide real-time,
consistently formatted data to states and localities that can help them
understand the threat, and in turn inform Federal and regional
allocation of supplies and personnel. Compared to 2005, the tracking
tools are much more sophisticated. But, just like then, we have waited
until after an outbreak to develop and deploy much of this technology.
Valuable time is lost as the virus aggressively continues to
exponentially infect the world. Here we must think global to protect
the safety and security of our families in our neighborhoods.
That's why we need a real-time domestic and international threat
detection system. Some experts have recommended a new epidemic
forecasting center similar to the National Hurricane Center, which
would function as a government-academic partnership to help guide
decisions from National Strategic Stockpile needs and disbursements, to
informing travel restriction decisions as novel viruses emerge, to
providing states and localities real-time information to guide their
public safety decisions in an outbreak.
While not necessarily intuitive, a huge part of effective
infectious disease surveillance is maintaining Federal support of
global health. The next zoonotic disease transmitted from animals to
humans will likely come out of Asia or Africa. The ability of
developing nations to detect, track and contain a novel virus will be
inextricably tied to the capacity of their own public health
infrastructure, something that is vitally dependent on U.S. support.
And their willingness to mutually share that critical infectious
disease surveillance information and allow our scientists to reliably
participate in its interpretation will depend on the integrity and
trust of our diplomatic relationships.
Our national health, when it comes to recurrent deadly viruses and
pandemics, depends on global health.
We typically commit about 1 percent of Federal resources to
international assistance, but in our COVID-19 emergency packages, only
one-tenth of 1 percent of funds have gone to help low-and middle-income
countries in their COVID fight. We must recognize containing COVID
globally is essential to halting its spread in the U.S., particularly
as we begin to reopen our country for travel and business. (Indeed, New
Zealand had just announced the eradication of COVID-19 when two
infected U.K. travelers potentially reintroduced the virus, coming in
contact with as many as 320 people.) To ensure a comprehensive Federal
approach to global health security, Congress's fractured global health
jurisdiction (which spans at least 10 different committee and
subcommittee structures across both chambers) should be rectified by
the establishment of separate bipartisan special committees or formal
working groups that provide a coordinating, overarching vision for the
regular committees of jurisdiction.
The White House Office of Management and Budget should establish a
senior staff role to ensure consistency of health security funding and
management decisions across all agencies and accounts--domestic and
international--as the George W. Bush administration did effectively.
We cannot close our borders until a vaccine is developed and all
300 million Americans are inoculated. Nor can we completely shut down
our economy and livelihoods. So, while protecting our own people is
first and foremost, supporting global response efforts are essential to
keeping Americans safe.
Viruses are indifferent to a country's borders. Surveillance must
be global as well as domestic.
3. & 4. Antiviral Agents and Vaccines
The development of a COVID-19 vaccine has quickly become the Holy
Grail, and after record genome sequencing, our private sector is
tackling this challenge with unprecedented innovation and remarkable
speed.
(In my personal opinion, I believe that the rapidly developing
treatments of COVID-19 via anti-viral agents, monoclonal antibodies,
and convalescent serum, coming this late summer and fall, will have the
most dramatic impact on re-opening our economy, equal to or possibly
more so than the long-awaited vaccine.)
But had we invested years ago in speeding up the ``bug-to-drug''
development timeframe for the vaccines, it's possible this record
timeline could have been halved. To that end, I strongly agree with
Chairman Alexander's assessment that, ``Only the Federal Government can
fund research at the scale necessary to create tests, treatments, and
vaccines for a pandemic . . . '' It will take partnerships.
What was true in 2005 is still true today: we have a dangerously
inadequate vaccine manufacturing base in the United States. This must
be rectified. Bottom-line: there's so little profit and so much
uncertainly in vaccine manufacturing today. We must establish
longstanding public-private partnerships with industry that are
sustained and are not at risk of disappearing with each Appropriations
cycle. We cannot expect the private sector to independently invest
billions of dollars developing antivirals and vaccines for novel
viruses that we hope we'll never need to use. That's not a sustainable
business model.
One approach that should be considered here is a model adopted
recently by Civica Rx--an innovative, new nonprofit pharmaceutical
entity that partners with health systems, insurers, and the Federal
Government to prevent generic drug shortages by establishing stable
supply chains, expanding domestic manufacturing, and entering into
long-term supply contracts. Though its success is yet to be fully
demonstrated, the model of shared responsibility among all stakeholders
might be considered with drug and vaccine development and distribution.
We should also consider options like the continuous manufacturing
provisions in Senator Blackburn's Securing America's Medicine Cabinet
Act, which would strengthen our ability to more quickly manufacture
certain drugs at a lower cost and with better quality controls.
Beyond investing in the science to create future treatments and
vaccines for unknown threats, it is imperative that we act now to
address the very real challenge we are about to face when a vaccine is
developed. The same supply chain shortages and equity issues we
witnessed with personal protective equipment (PPE) and testing
components are about to be magnified when every nation in the world is
simultaneously seeking the vaccine and the components needed to package
and administer it, to protect their people.
The Federal Government should serve a ``control tower'' function to
address these inevitable, pending domestic supply chain issues. It must
clarify which agency will be responsible for this vital function,
boldly prepare them for it, and then give that agency the full
authority and resources to act.
Additionally, we must recognize when it comes to competing global
interests, it is not a zero-sum situation. Today, exactly as we said in
2005, we simply do not have the domestic manufacturing capacity in this
country necessary to cover our own needs. The greater the capacity to
produce a vaccine globally, the better off we are. Access must be
addressed proactively before it is a politically explosive as well as
economically and ethically catastrophic.
While the World Health Organization Access to COVID-19 Tools (ACT)
Accelerator has little chance of really corralling every player to
share ``equitably'' before meeting their own needs, participation or
cooperation now will at least be the point on which countries will
judge one another. China will exploit the hole in U.S. engagement in at
least two ways: providing products and access directly to countries and
by pressing the idea that the global rules-based, capital system is the
cause of any vaccine access failure. We should consider constructive
ways to engage globally to counter this narrative, including
participating in the Coalition for Epidemic Preparedness Innovations.
5. Research and Development
I previously called for a massive R&D investment to create a
``Manhattan Project for the 21st Century'' to help us better defend
against naturally occurring, accidental, and intentional threats--
including infectious diseases. We must make long-term, multi-year
investments here.
For example, Project BioShield when it was enacted in 2004 was
intentionally an advance ten-year appropriation, established to allow
the government to guarantee a market for chemical, biological,
radiological, and nuclear (CBRN) medical countermeasures. But since
2014, there hasn't been an advance appropriation, and instead it is
reliant on the annual appropriations cycle. That doesn't send a
powerful message to the private sector.
A meaningful investment here could, for example, go toward standing
up public-private partnerships to ensure robust and timely diagnostic
testing development to avoid repeating the test development mistakes of
this spring.
6. Stockpiling & Surge Capacity
This is unequivocally an area where we fell short. There was
unnecessary confusion about Federal, state, and even hospital-level
responsibilities in procuring PPE and testing supplies, which led to
hoarding, drove up market prices, and pitted states and even hospitals
against one another. And most importantly, our failure here put the
lives of our frontline workers at risk. We would never ask our soldiers
to go into battle without armor, and we should never send our
healthcare first responders into a pandemic without PPE and other vital
supplies.
It is easy to point the finger, but the reality is our Natio1nal
Strategic Stockpile--its contents, relationships between state and
Federal, its distribution policy--has been neglected over the course of
multiple administrations. States and health systems should make a good
faith effort to create their own stockpiles, but realistically we must
acknowledge that competing, short-term, state budget priorities will
always win out over long-term preparedness planning. The Federal
Government must take the lead role here, serving as a central
repository. Ideally, paired with a well-structured domestic and global
surveillance and wisely managed distribution system, our Nation could
appropriately fortify our stockpile at early signs of a threat, and
also accurately and sensitively track outbreaks to ensure supplies are
rapidly distributed to those in greatest need. Stockpile resources
should be stored regionally, with a transparent and operationally
capable plan for distribution to local municipalities.
In strengthening our Strategic National Stockpile framework, the
Federal Government should stand up capabilities to map supply chain
data--including where it is and how much there is (a Federal registry).
Ideally, we would onshore some of these manufacturing capabilities, and
for others preplan resilient measures to convert existing factories to
supplies that may be needed. These will require Federal incentive or
partnership to keep domestic production lines at the ready.
Additionally, there needs to be more coordination between BARDA and
the Stockpile. We need a resilient system that involves more ongoing
input from experts on what is needed for the future, so we can
strategically invest and fortify the Stockpile for the next, most
probable threat, not the last one. Furthermore, both BARDA and the
Stockpile would benefit from more financial resources.
Being prepared also means training first responders, and ensuring a
civilian volunteer corps to step in and help handle the surge. It means
allocating adequate surge facilities--vaccination sites, treatment
centers, laboratories, and morgues. I have specifically advocated for
funding for an expanded contact tracing workforce and voluntary self-
isolation facilities, if needed utilizing vacant hotels, with Andy
Slavitt, Scott Gottlieb and other public health leaders, recognizing
that our ability to immediately trace and self-isolate at the sign of
illness are of utmost importance today to public safety as we reopen.
The current pandemic will rapidly accelerate tracking and tracing
technology for the future, and it will improve with time though it's
still just a bit too early in its development, practical application
and general acceptance.
The recommendations within each of these six categories are by no
means exhaustive, and I know my colleagues on this panel will have much
to add. A few additional areas I want to touch on are: (1) Public
health funding; (2) Vulnerable populations and health equity; (3)
Virtual care, and (4) Establishing a Coronavirus Commission.
Public Health Funding
In just a few short months, we already spent more in the four COVID
response packages than we have on the Iraq War.
Researchers estimate that there is a $34 per capita gap between
what is needed to assure the conditions that populations are healthy
and our Nation's current public health investment--approximately a $10
billion deficit. It is time we look at public health as part of our
Nation's defense.
Last month, I joined with Dr. Tom Frieden, former Senator Tom
Daschle, Dr. Tom Ingelsby and others to advocate for the creation of a
Health Defense Operations budget designation.
Health Defense Operations--HDO--provides an increased, sustained,
predictable base funding for public health security programs that
prevent, detect, and respond to outbreaks like COVID or pandemic
influenza.
Congress is to be commended for the quick response to COVID-19 by
providing critical emergency supplemental funding during the pandemic.
But this funding in response to emergencies will not sufficiently
protect us for the future. Supplemental appropriations are by their
nature temporary. Future health and economic security can best be
protected by changing the way we allocate funds to protect us all from
health threats. We have all seen the limitations that caps and
sequestrations cause for discretionary funding. We have seen that even
mandatory funding doesn't ensure stable support as those funds are
often siphoned off during calm periods when outbreaks are out of the
news.
We propose a new approach for specific public health programs that
are critical to prevent, detect, and respond to health threats. We call
this the Health Defense Operations (HDO) budget designation, and it
would exempt critical health protection funding lines at the CDC, NIH,
FDA the office of the Assistant Secretary for Preparedness and Response
from the spending caps so our public health agencies can protect us.
Specifically, Health Defense Operations programs will:
be exempted from the Budget Control Act budget caps
not be sequesterable for the length of the fiscal
year
and be required to submit bypass budgets (Program-->
Agency--> Congress) ensuring there is an unvarnished look at
preparedness needs.
This does not exempt these identified programs from the
appropriations process, but rather exempts them from budget mechanisms
that have eaten away at public health. We propose an $11 billion annual
increase in funding for specific funding lines at CDC, NIH, FDA and
ASPR, a comparatively small investment compared to prior COVID
supplementals and our annual defense budget.
The detailed recommendations I have outlined require a dependable,
consistent funding source, and the Health Defense Operations budget
designation can create a thoughtful cross-agency approach to funding
diverse needs over time.
An alternative approach would be to establish a Public Health
Infrastructure Fund that would provide a mandatory stream of resources
to states and localities to build public health capabilities while
ensuring accountability. Ultimately, our public health infrastructure,
as has become apparent to all over the past four months, has been
woefully underfunded for years and we need a new budgetary approach to
combat funding shortfalls.
While I recognize that the HELP Committee does not appropriate
these funds, robust public health infrastructure funding will be
necessary if we are serious about effectively preparing for the
inevitable next pandemic with incumbent loss of life.
Vulnerable Populations and Health Equity
The greatest strains of a pandemic fall on particular demographics
because of specific economic, or social or health status. With COVID-
19, we continue to see a disproportionate burden of illness and death
among racial and ethnic minority groups. Theses populations
disproportionately work in front-line jobs that prevent them from
staying home, are more likely to be uninsured or underinsured, live in
densely populated areas and in multi-generational homes that make it
harder to isolate when sick, rely on public transportation, and have
serious underlying medical conditions. Any pandemic preparedness
response needs to comprehensively consider how to protect and care for
the most vulnerable. I recommend:
States and the Federal Government collect and share
data on confirmed cases by race, ethnicity, disability and
income to understand what populations are being hit hardest and
why;
States, in consultation with Federal health agencies,
establish protocols for intensifying testing in the highest
risk settings and among the highest risk individuals to ensure
early detection paired with contact tracing;
States and Federal health agencies include
representatives from communities of color and other
marginalized groups to inform and shape pandemic response
decisions.
We are living through a singular time in our Nation's history, and
our preparedness policies should seek to end the barriers to health and
well-being for communities of color, with the goal of health equity.
Virtual Care
Necessity is the mother of all invention, and the explosion of
telehealth and virtual care has been one of the most constructive
advances to emerge from this crisis. I want to echo Chairman
Alexander's recommendation that we ``Ensure that the United States does
not lose the gains made in telehealth.'' The gains for the patient
include convenience, affordability, and rapid access to quality care
that is needed. The field of virtual health care, delivered from a
remote location by text, phone or video has been accelerated by five
years or more. And patients and the country will benefit in a
transformative way.
I am heavily involved in virtual care, beginning with my days 30
years ago taking care of over a hundred transplant patients remotely.
Today I serve on the board of two virtual health care companies,
Teladoc Health (physical and mental health) and Smile Direct Club
(dental health). Teladoc Health delivers care via telemedicine in 175
countries and in more than 40 languages, partnering with employers,
hospitals, and health systems. I have seen firsthand how our recent
policy changes at the Federal and state levels have in an
overwhelmingly positive way unleashed private sector innovation--
stepping in to address care gaps created by the pandemic's stay at home
orders.
To continue this progress, I recommend:
1. Allow telehealth access regardless of patient and provider
location: Congress must act to modernize 1834(m) by removing
the geographic and originating site restrictions. By doing
this, all Medicare patients can access care outside of specific
geographic locations and outside specific brick-and-mortar
facilities.
2. Allow HHS to determine appropriate telehealth services and
providers: Congress should give the Secretary of HHS the
ability to expand the list of eligible telehealth practitioners
and ensure the Secretary has the authority to determine
eligible telehealth services. Additionally, Congress should
make permanent the 80 new telehealth services that can be
reimbursed by Medicare.
3. Allow federally Qualified Health Centers and Rural Health
Clinics to offer telehealth after COVID: 1834(m) limits the
types of ``distant sites'' for a provider to use telehealth.
The law does not allow FQHCs or RHCs, critical safety net
providers, to be reimbursed as distant sites. The CARES Act
changed this during the pandemic, but action must be taken to
ensure FQHCs and RHCs can reach their patients via telehealth
and receive appropriate reimbursement for their services.
While the Administration has done a good job, there is a risk that
broad telehealth deployment if not carefully designed could actually
replicate barriers in place in the traditional health system that
produce disparities. One glaring example is a bias in some of the new
authorities that have been authorized for two-way video communications.
We should treat all forms of communications equally, as long as doctors
are able to meet the same standards of care. If we discriminate against
telephone (without video) users, for example, we will leave behind
rural communities without access to broadband as well as minority and
other lower-income populations that may not have more expensive smart
phones with two-way video capabilities. I urge CMS to continue to allow
patient choice and physician discretion when it comes to technology
post COVID. And as we move forward, we need to ensure that patient
privacy and security are protected.
Additionally, we have learned that in order to deploy vast networks
of physicians to where they are needed, we must have a mechanism to
address state physician licensure. Many states did that by waivers of
various kinds, but it was a steep learning curve with no consistency.
Finally, while I believe the majority of regulatory changes made to
advance telehealth and virtual care during COVID should be made
permanent, parity in payment is one that should be revisited following
the crisis. Undoubtedly it was a needed change to motivate physician
engagement and participation, but since some of the overhead costs are
eliminated in virtual transactions, it will likely make sense to
reimburse closer to 70 to 80 percent of in-person visits. Reimbursement
parity laws completely remove telehealth savings to the patient.
Coronavirus Commission
In closing, I have one final recommendation. After September 11,
2001, we recognized that our country faced a new threat that required a
new approach to our national defense. Without a doubt, the massive
disruption caused by the COVID-19 pandemic makes clear we need to
recalibrate again. A deadlier virus will cause devastation on an even
more frightening scale.
To further examine what parts of the local, state, and Federal
response worked, and what could work better and how, we should form the
coronavirus equivalent of the 9/11 Commission. We must do everything in
our power to make sure our imperfect response is not repeated. It's a
matter of saving lives.
Thank you Chairman Alexander, Ranking Member Murray, and Members of
the Committee for having me here today. The work you are doing now will
literally save lives in the future--thank you for your tireless
commitment to improving health in the spirit of bipartisanship.
______
[summary statement of bill frist]
In 2005, in a series of speeches I predicted a global pandemic
arising from China and proposed a six-part plan to prepare the Nation
focused on: 1. Communication; 2. Surveillance; 3. Antiviral Agents; 4.
Vaccines; 5. Research and Development; and 6. Stockpiling & Surge
Capacity. Much of what I recommended in 2005 remains true today.
1. Communication
We must clarify who is in charge in a pandemic. The
Federal response should be led at the National Security Council
level to facilitate a whole of government approach.
The CDC should regain its position as the Nation's
apolitical voice of public health.
We must make sure what is said at the Federal level
coordinates and integrates well with the more regional needs,
abilities and resources of state and local municipalities.
2. Surveillance
This pandemic has laid bare our inability, at the
Federal level, to track outbreaks across the country, and
provide real-time data to states and localities. That's why we
need a real-time domestic and international threat detection
system.
3. & 4. Antiviral Agents and Vaccines
We have a dangerously inadequate vaccine
manufacturing base in this country. We must establish public-
private partnerships that are sustained and are not at risk of
disappearing with each appropriations cycle.
Furthermore, the Federal Government should serve in a
``control tower'' function now to address pending supply chain
issues for when a vaccine is developed.
5. Research and Development
I previously called for a massive R&D investment to
create a ``Manhattan Project for the 21st Century'' to help us
better defend against naturally occurring, accidental, and
intentional threats--including infectious diseases. We must
make long-term, multi-year investments here.
6. Stockpiling & Surge Capacity
The Federal Government should take the lead role,
serving as a central repository. Ideally, paired with a well-
structured domestic and global surveillance system, our Nation
could fortify our stockpile at early signs of a threat, and
also accurately track outbreaks to ensure supplies are
distributed to those in greatest need. Stockpile resources
should be stored regionally, with a transparent and
operationally capable plan for distribution to local
municipalities.
Being prepared also means training first responders,
and ensuring a civilian volunteer corps to step in and help
handle the surge.
Public Health Funding: Last month, I joined with Dr. Tom Frieden,
former Senator Tom Daschle, Dr. Tom Ingelsby and others to advocate for
the creation of a Health Defense Operations budget designation to
provide an increased, sustained, predictable base funding for public
health security programs. It would exempt critical health protection
funding lines at the CDC, NIH, FDA, and ASPR from spending caps so our
public health agencies can protect us.
______
The Chairman. Thank you, Dr. Frist.
Dr. Khaldun, welcome.
STATEMENT OF JONEIGH S. KHALDUN, M.D., MPH, FACEP, CHIEF
MEDICAL EXECUTIVE AND CHIEF DEPUTY DIRECTOR FOR HEALTH,
MICHIGAN DEPARTMENT OF HEALTH AND HUMAN SERVICES, LANSING, MI
Dr. Khaldun. Yes. Chairman Alexander, Ranking Member
Murray, and Members of the Committee, thank you for the
opportunity to speak with you today about Michigan's response
to COVID-19 and how we can prepare for future pandemics. COVID-
19 has infected at least 61,000 and killed over 5,800 adults
and children in Michigan. At our peak in April we identified
over 1,500 cases and there have been 180 deaths each day. Due
to the decisive and necessary actions of our Governor Gretchen
Whitmer, as well as the sound judgment of our residents and the
work of our local Health Departments, those numbers have
declined by more than 80 percent. But let me be clear, this is
not the time for victory laps.
COVID-19 is still very present in Michigan and across the
country. We simply cannot let our guard down on COVID-19. More
than ever, leaders must be laser focused on protecting our
communities and addressing the inadequacies in our public
health infrastructure. So the greatest tragedy of this pandemic
is how it has ravaged communities of color. Michigan was one of
the first states to release COVID-19 data by race and
ethnicity. In Michigan, just 14 percent of our population is
African-American and they represent 31 percent of COVID-19
cases and 40 percent of deaths. This is not unique to Michigan.
Racial and ethnic minorities are disproportionately being
inspected by and dying from COVID-19 across the country. These
disparities cannot be explained by genetics. They exist because
of institutional and structural racism that has deprived
communities of color of adequate resources and opportunities
for prosperity and optimal health. Indeed, racism is a public
health crisis that must be met with urgency, funding,
elimination of policies that perpetuate health inequities. If
we truly care about the health of every individual in this
country, we must ensure that there is equitable access to
testing, treatment and vaccines for COVID-19 at no cost.
We also need consistent and accurate messaging from the
highest levels of the Federal Government. As a practicing
emergency medicine physician and public health leader, I rely
on swift, scientifically sound guidance from our Nation's
leaders during the crisis. We need accurate and clear messaging
from the White House about the true threat of the disease, how
and when to get a test, and the importance of wearing masks and
social distancing. Next, we must develop and implement a
national testing strategy infrastructure.
As a country, we did not expand access to COVID-19 testing
at the rate needed to identify cases quickly with tragic
consequences. Michigan has now built a testing network of
nearly 70 labs and 250 testing sites and we conduct about
14,000 test per day with the capacity to do more. I am grateful
for the support of our Federal partners, but we still struggle
with the limited number and types of supplies we receive from
HHS and FEMA. To fill in the gap, we work non-stop to procure
testing materials from the private market but supply
constraints remain a limiting factor.
A national procurement and testing strategy would have
prevented state and local Governments from competing with each
other and avoid one of the most outrageous realities of this
pandemic, turning people away who should have been tested.
Finally, we must invest in public health infrastructure at the
Federal, state and local level. More than 25 percent of local
public health physicians have been eliminated in recent years
and Federal spending on public health and prevention is minimal
and declining. These cuts hinder our ability to adequately
respond to public health threats. I have experienced this
firsthand.
In my former role as Detroit's Health Commissioner, I lead
the city's response to the largest hepatitis A outbreak in
modern history, pulling a limited staff away from other
critical public health work to quickly ramp up vaccination
infrastructure. As Michigan's Chief Medical Executive, I
scrambled to respond to the state's outbreak of Eastern equine
encephalitis, a mosquito borne illness that infected and killed
a record number of people and animals. Simultaneously, I had to
pull together a team within weeks to respond to a mysterious
vaping related illness without any additional funding or staff.
My experience with COVID-19, unfortunately, is no
different. Since March, we have had to take extraordinary
measures to build data systems, armies of contact tracers, and
set up testing infrastructure. To ensure the U.S. can
adequately respond to this crisis and the next, we need long-
term investments in our public health departments and programs.
Now is not the time to celebrate or to turn our focus away from
COVID-19. If anything, we must get more aggressive, more
aggressive in addressing health inequities, expanding testing
and contact tracing, and ensuring our public health
infrastructure is strong. Thank you for the opportunity to
share Michigan's experience today.
[The prepared statement of Dr. Khaldun follows:]
prepared statement of joneigh s. khaldun
Chairman Alexander, Ranking Member Murray, and Members of the
Committee, thank you for the opportunity to speak with you today about
Michigan's response to COVID-19, what steps need to be taken to protect
the public health from this devastating disease, and how we can prepare
for future pandemics.
COVID-19 continues to ravage communities across the country, and
Michigan has not been spared. Michigan identified its first two cases
of COVID-19 on March 10, 2020, the same day that our Governor, Gretchen
Whitmer, declared a state of emergency. By April 1, 2020, Michigan had
identified 9,334 confirmed cases and 334 deaths from the disease.
Governor Whitmer has taken a series of appropriate and decisive actions
to protect the health of Michigan residents, including restricting
gatherings and travel unless they were necessary to sustain or protect
life, limiting healthcare activities that were not time-sensitive, and
aggressively building up testing and contact tracing to contain the
disease.
As of June 20, 2020, Michigan had 61,084 confirmed cases, and 5,843
deaths due to COVID-19. It has tragically killed people of all ages in
our state, from as young as 5 up to 107. While our road has not been
easy, we have made progress. Due to the Governor's actions, the sound
judgment of most of our businesses and residents, and the work of our
local health departments, Michigan has seen a significant decline in
cases and deaths over the past several weeks. Our hospital systems,
particularly those in southeast Michigan who were hit hardest during
this pandemic, are now stable in bed availability, supply of personal
protective equipment (PPE), and resources available to take care of
their sickest patients. As of last week, Michigan was one of four
states in the country on track to contain the disease, according to the
public health experts at Covid Act Now. \1\
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\1\ https://covidactnow.org/?s=53768.
Because of this, Michigan is cautiously reopening the economy with
robust safety protocols in place. \2\ But let me be clear: this is not
the time for victory laps. COVID-19 is still very present in Michigan
and we continue to respond to outbreaks across our state. There is no
vaccine and much of the population has likely not been infected,
meaning most people are not immune to the disease. There is no FDA-
approved antiviral treatment. And many states are still seeing
increasing numbers of cases. In Michigan, I am preparing for the real
possibility of a resurgence of cases in the fall during influenza
season, which would be devastating for the health of our residents and
could stretch our hospital capacity once more.
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\2\ MI Safe Start Plan. May 7, 2020.
For these reasons, we cannot let our guard down now on COVID-19.
The COVID-19 pandemic is not over. As we move forward with fighting
this disease, Federal, state, and local leaders must be laser-focused
on protecting our communities from COVID-19 and addressing the
inadequacies in our public health infrastructure.
Health Inequities
The greatest tragedy of this pandemic is how it has ravaged
communities of color. Michigan was one of the first states to release
data on cases and deaths by race and ethnicity. In Michigan, a state
where just 14 percent of the population is African American, 31 percent
of COVID-19 cases, and 40 percent of deaths, are African American.
Governor Whitmer swiftly responded to this information by establishing
the Michigan Coronavirus Task Force on Racial Disparities, chaired by
Michigan's Lieutenant Governor Garlin Gilchrist. \3\ I have the
pleasure of serving on this task force alongside several other
community, academic, and government leaders, and the task force has
moved swiftly to identify causes and promote solutions to address these
inequities.
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\3\ Executive Order 2020-55.
The racial disparities in the effects of COVID-19 are not unique to
Michigan. African Americans, Hispanics, and other racial and ethnic
minorities across the country are disproportionately being infected by
and dying from COVID-19. \4\ This is no surprise. Health disparities
and inequities have plagued this country since its inception. To be
clear, these disparities cannot be explained by genetics. Instead, the
disparities exist because of institutional and structural racism that
has deprived communities of color of adequate resources and
opportunities for prosperity and optimal health. Indeed, racism is a
public health crisis that must be met with urgency, funding, and the
elimination of policies that perpetuate health inequities: policies
like redlining, lack of investment in schools, and both implicit and
explicit bias in the healthcare system.
---------------------------------------------------------------------------
\4\ Garg S, Kim L, Whitaker M, et al. Hospitalization Rates and
Characteristics of Patients Hospitalized with Laboratory-Confirmed
Coronavirus Disease 2019--COVID-NET, 14 States, March 1-30, 2020. MMWR
Morb Mortal Wkly Rep 2020;69:458-464. DOI: http://dx.doi.org/10.15585/
mmwr.mm6915e3.
These policies have caused communities of color to be more likely
to live in poverty, have inadequate housing, have poor access to
healthcare, and work in lower paying jobs. \5\ This means that due to
the nature of their employment, people of color have disproportionately
been deemed ``essential'' during the COVID-19 pandemic, needing to
leave their homes and interact with the public instead of having the
privilege of safely working from home while maintaining health and
other fringe benefits. Homelessness, multi-generational households, or
unsafe living conditions make it difficult to effectively self-isolate
and quarantine, allowing COVID-19 to rapidly spread. People of color
are also more likely to have underlying health conditions that are
often undiagnosed or poorly treated, putting them at higher risk of
being severely affected and dying from COVID-19.
---------------------------------------------------------------------------
\5\ US Bureau of Labor Statistics, Report 1082, Labor force
characteristics by race and ethnicity, 2018. October 2019. https://
www.bls.gov/opub/reports/race-and-ethnicity/2018/home.htm.
Strategies to fight COVID-19 and future pandemics must focus on
eliminating barriers in access to healthcare. No one should worry about
paying out of pocket for testing or treatment of COVID-19. Everyone
should have access to health insurance, and our healthcare safety net
which cares for the most vulnerable must be adequately funded. Vaccine
distribution strategies should be data-driven and focus on those who
are at highest risk of severe disease, with clear guidance in place to
ensure communities of color have equitable access. Strategies should be
employed that embed testing and vaccination distribution in
communities--not only in doctor's offices or hospitals. The strong
partnerships that state and local health departments have cultivated
with communities over the years should be leveraged to address ongoing
challenges with access to care. These partnerships will also be
critical to overcoming the mistrust of the healthcare system that often
exists in communities of color, fueled by historical inequities in
treatment. \6\
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\6\ Armstrong, K et al. Distrust of the Healthcare System and Self-
Reported Health in the Unites States. J Gen Intern Med. 2006 Apr;
21(4): 292-297. Available from: https://www.ncbi.nlm.nih.gov/pmc/
articles/PMC1484714/.
We also have to ensure access to adequate housing. Housing policy
is health policy. In the short term that means safe places where people
who have COVID-19 can self-isolate and longer term making sure people
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have access to affordable, healthy housing in safe neighborhoods.
Finally, we must address implicit and explicit bias in our
healthcare system. Research has shown that, once care is accessed, both
implicit and explicit bias by healthcare providers contributes to
health care disparities. \7\ One of the factors associated with
implicit bias is how we are socialized. We all have implicit biases but
often do not realize that they exist--assumptions about individuals and
groups can cause medical providers to not use a patient's individual
circumstances or objective data to guide clinical management. Explicit
biases include those that are more explicitly racist, that may also not
be fully recognized. This bias is known to impact health outcomes in
communities of color and COVID-19 is no different. Implicit bias
training should be a mandatory part of all health professional
training, and medical schools and residency training programs should
accelerate efforts to increase diversity in their classes.
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\7\ Institute of Medicine (US) Committee on Understanding and
Eliminating Racial and Ethnic Disparities in Health Care; Smedley BD,
Stith AY, Nelson AR, editors. Unequal Treatment: Confronting Racial and
Ethnic Disparities in Health Care. Washington (DC): National Academies
Press (US); 2003. Available from: https://www.ncbi.nlm.nih.gov/books/
NBK220358/.
Consistent and Accurate Messaging
I have the utmost respect for my colleagues at the U.S. Centers for
Disease Control and Prevention (CDC), and I have been grateful for
their support since we first began building up Michigan's response to
COVID-19 in January 2020. However, we have been challenged by the lack
of consistent, science-based strategy and messaging from the White
House. I am a practicing emergency medicine physician and have had the
honor of serving as Baltimore's Chief Medical Officer, Detroit's Health
Commissioner, and now as Michigan's Chief Medical Executive. As
frontline clinicians and public health leaders, we rely on swift,
scientifically sound guidance and messaging from our Nation's leaders
and Federal public health experts during a crisis. This has not been
the case since the beginning of this outbreak, with inconsistent and
inaccurate messaging from the White House about the true threat of the
disease and potential treatments. There should be a clear, accurate,
and consistent message at the national level alerting people to the
risks of the disease, how and when to get a test, the importance of
contact tracing, and basic public health messaging relaying the
benefits of wearing masks and practicing social distancing. As with
previous outbreaks such as Ebola, or H1N1, we must make sure our
Nation's top public health leaders are the face of this pandemic and
are given full authority to swiftly implement the most scientifically
sound practices and to communicate this information to the public.
National Testing Strategy and Infrastructure
As a country, we did not expand access to COVID-19 testing quickly
enough. In the early stages of the pandemic in Michigan, individuals
had to meet strict criteria, including having severe symptoms, or a
clear history of travel to an impacted country, to access testing. Once
they met that strict criteria and were tested by a healthcare
professional, state and local public health leaders had to subsequently
arrange for packaging and shipment of the patient's sample to the CDC
lab, where the CDC then prioritized which samples were run. By early
February, Michigan was working through the process to be able to run
samples in our state laboratory, but that process was then halted as
the CDC had to work through unexpected inconsistencies in the testing
platform.
By the end of February, Michigan's public health laboratory was the
only laboratory in Michigan able to perform COVID-19 testing. On March
10, 2020, when Michigan confirmed its first case of COVID-19, our
laboratory only had enough supplies to run a few hundred tests a day
for a few days. Weeks of delays and restrictions in testing meant we
were not able to identify cases at the level and speed needed--with
tragic consequences--as there were likely hundreds, if not thousands of
cases in Michigan well before they were identified by testing.
Since that time, through painstaking work, Michigan has built a
testing system that now conducts about 14,000 tests per day. We are
working toward a goal of 30,000 tests a day, or about 2 percent of
Michigan's population per week, in line with recommendations of
national public health experts. Nearly 70 laboratories in the state
have validated testing for COVID-19, and about 250 test sites are
currently operating. With this expanded capacity, Michigan has
broadened testing criteria significantly, and we are focused on testing
anyone who has symptoms, may have been exposed, or is most vulnerable
to disease. The assistance of Michigan's National Guard and funding
from the Paycheck Protection Program and Healthcare Enhancement
(PPPHCE) Act as well as the Coronavirus Aid, Relief and Economic
Security (CARES) Act have been vital supports in the state's testing
strategy.
I have greatly appreciated the support we've received from our
Federal partners including, but not limited to those at the U.S.
Department of Health and Human Services (HHS), the CDC, the Assistant
Secretary for Preparedness and Response (ASPR), and the Federal
Emergency Management Agency (FEMA). They have consistently answered our
calls and Michigan is now regularly receiving testing supplies.
However, we still struggle with the lack of detail provided on the
timing, quantity, and type of supplies coming to the state, and often
the supplies we receive are not compatible with the laboratory systems
that exist in the state. This makes planning and coordination
challenging.
Early identification of cases and testing should have been an early
priority at the Federal level. When it was clear in other countries
that the disease could rapidly spread, the U.S. should have swiftly
established a national testing strategy and set up clear testing
criteria and infrastructure for state and local governments to easily
obtain testing supplies. Instead, state and local governments were left
to compete for limited supplies and people who likely had the disease
were turned away from testing, resulting in the disease spreading like
wildfire in our communities. Even today, Michigan is unable to meet its
testing goal of 30,000 tests per day. Laboratories still struggle with
a fragmented and inconsistent supply of test kits and laboratory
reagents. Our hospital laboratories frequently run low on reagents and
are still only able to test the sickest patients. Going forward, the
Federal Government should institute a national supply chain strategy to
resolve bottlenecks that no state alone can address--and ensure an
ample supply of test kits and reagents.
Invest in Public Health Infrastructure at the Federal, State, and Local
Levels
In its 1988 report, ``The Future of Public Health'', the Institute
of Medicine expressed concern that, ``this nation has lost sight of its
public health goals and has allowed the system of public health
activities to fall into disarray.'' \8\ Despite this grave warning, our
public health systems continue to struggle for the support and funding
needed to ensure there is a robust, versatile, and flexible system
available to protect and promote the health and well-being of our
residents. Public health departments across the country are
continuously asked to do more, with less. Between 2008 and 2017, more
than 56,000 local public health positions were eliminated, which
accounts for almost 25 percent of the workforce. \9\
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\8\ Institute of Medicine 1988. The Future of Public Health.
Washington, DC: The National Academies Press. https://doi.org/10.17226/
1091.
\9\ Trust for America's Health. What we are learning from COVID-19
about being prepared for a public health emergency. Issue Brief, May
2020. Accessed 18 June 2020 file:///C:/Users/HUdsonn2/Downloads/
TFAH2020CovidResponseBriefFnl.pdf.
Nationally, less than three percent of the annual $3.6 billion
spent on health is dedicated to public health and prevention, and this
proportion has been decreasing since 2000. \10\ Funding from the CDC
for public health preparedness and response has been cut by over half
in the past decade. \11\ In fiscal year 2016, Michigan's per capita
state funding from the CDC was $18.80 compared to the national average
of $21.31. \12\ This places Michigan 43rd in CDC funding. \13\ These
cuts have had a significant impact on our ability to adequately fund
and respond to public health threats.
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\10\ Trust for America's Health. The Impact of Chronic Underfunding
on America's Public Health System: Trends, Risks, and Recommendations,
2020. Accessed 17 June 2020 https://www.tfah.org/report-details/
publichealthfunding2020/.
\11\ Ibid.
\12\ Citizens Research Council of Michigan. An Ounce of Prevention:
What Public Health Means for Michigan. Report 403, August 2018.
Accessed 17 June 2020 https://crcmich.org/wp-content/uploads/rpt403-
public-health-2.pdf.
\13\ Citizens Research Council of Michigan. An Ounce of Prevention:
What Public Health Means for Michigan. Report 403, August 2018.
Accessed 17 June 2020 https://crcmich.org/wp-content/uploads/rpt403-
public-health-2.pdf.
I have experienced this first-hand. As Detroit's Health
Commissioner, I led the city's response to the largest Hepatitis A
outbreak in modern history, pulling my limited staff and funding away
from other critical public health work to quickly set up pop-up
clinics, and worked with federally Qualified Health Centers and
hospitals to make sure patients were appropriately screened and those
at highest risk were vaccinated. In my role as Michigan's Chief Medical
Executive, last year I had to quickly respond to the state's worst
outbreak of Eastern Equine Encephalitis (EEE) ever recorded. This
debilitating mosquito-borne illness infected many and ultimately killed
six people and dozens of animals across the state. I had to scramble to
set up a surveillance and mitigation strategy coordinated across 45
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local health departments in a matter of weeks.
My experience with COVID-19 is no different. Since March 2020, our
state and local health departments have had to take aggressive and
extraordinary measures to expand contact tracing infrastructure--the
bread and butter of any communicable disease response. We set up a new
technological infrastructure that enables more effective management of
contacts. We built our own contact tracing army--over 10,000
Michiganders have volunteered to be contact tracers, approximately 500
are deployed today, and we are moving quickly to hire surge staffing
embedded in local health departments, using funds from the PPPHCE Act
and the CARES Act.
But the ability to respond to crises like these should be built
into the public health system, not jerry-rigged as a global pandemic
spreads like wildfire. We should not have to rely on volunteers or take
staff away from other critical public health work to respond to
emerging public health threats. Lack of ongoing investment in
technology, surveillance, and staffing infrastructure means that state
and local health departments are constantly improvising and building
these systems during a response, resulting in dangerous delays in
understanding disease spread and swiftly controlling it. To ensure the
U.S. can continue to respond to COVID-19, safely reopen and sustain our
economy, and respond to the next emerging threat, we need long-term
investments in our public health departments and programs.
Public health experts have been gloomily warning of our lack of
preparedness for a global infectious disease pandemic for years.
Unfortunately, COVID-19 has turned those warnings into a real-life
public health nightmare, killing over 120,000 people in the U.S. and
leaving under-resourced public health departments scrambling to provide
a coordinated and robust response. It has further unveiled the tragic
injustice of racial inequality in our society. But it is not too late
to save the lives of hundreds of thousands more. We have an opportunity
to make the next chapter in this crisis a success story brought about
by strong Federal leadership making serious and sustained investments
in public health infrastructure.
Now is not the time to celebrate or turn our focus away from COVID-
19. We must still aggressively fight this pandemic and if we do not
redouble our efforts many more people will unnecessarily die. As a
country we must urgently address health inequities, expand testing and
contact tracing, and make sure our public health infrastructure is
strong. We must remain vigilant, hopeful, and committed to protecting
the public's health.
Thank you for the opportunity to share Michigan's experience.
______
[summary statement of joneigh s. khaldun]
COVID-19 has and continues to ravage communities across the
country. As of June 20, 2020, Michigan had 61,084 confirmed COVID-19
cases and 5,843 deaths. While we have made tremendous progress in
slowing the spread of this disease in Michigan, we recognize that now
is not the time for victory laps. COVID-19 is still very present in
Michigan and we continue to respond to outbreaks across our state.
Nationally, this destructive virus has killed over 120,000 people so
far with no end in sight and has left under resourced public health
departments scrambling to provide a coordinated and robust response in
the absence of Federal leadership. It has also further unveiled the
tragic injustice of racial inequality in our society. But it is not too
late. With strong Federal leadership and strategic policy, we have the
opportunity to turn this crisis around and prevent additional suffering
and death.
Health Inequities
Across the country, communities of color are disproportionately
being infected by and dying from COVID-19. For example, despite making
up only 14 percent of Michigan's total population, African Americans
represent 31 percent of COVID-19 cases and 40 percent of deaths. This
cannot be explained by genetics and has everything to do with
institutional and structural racism that has consistently left
communities of color without adequate resources and opportunities for
prosperity and optimal health. Strategies to fight COVID-19 and future
pandemics must focus on eliminating policies that perpetuate inequities
and should ensure equitable access to health care, vaccines, education,
employment, and housing.
Consistent and Accurate Messaging
Since the beginning of the COVID-19 outbreak, Michigan has been
challenged by the lack of a consistent, science-based Federal strategy
and message about the true threat of the disease, mitigation
strategies, and potential treatments. A clear, accurate, and consistent
message is needed at the national level alerting people to the risks of
the disease, how and when to get a test, the importance of contact
tracing, and basic public health messaging relaying the benefits of
wearing masks and practicing social distancing.
National Testing Strategy and Infrastructure
As a country, we were not prepared for COVID-19. We did not have
the testing capabilities, testing supplies, or personal protective
equipment needed to adequately respond. Governments and hospitals have
had to compete for resources, often against the Federal Government.
Combined with delayed and sometimes unusable supplies from our Federal
partners, this created unneeded uncertainty in an already difficult
situation. While things have improved, many of these issues continue to
be a concern. We need a national strategy and leadership to ensure a
smooth supply chain that makes sure the right supplies are arriving
when and where needed.
Public Health Investment
Nationally, less than three percent of the annual $3.6 billion
spent on health is dedicated to public health and prevention, and this
proportion has been decreasing since 2000. COVID-19 has shown the
problems with this disinvestment. To ensure the U.S. can continue to
respond to COVID-19 as well as the next emerging threat, we need to
invest long-term in our public health departments and programs.
______
The Chairman. Thank you, Dr. Khaldun.
Dr. Gerberding, welcome.
STATEMENT JULIE L. GERBERDING, M.D., MPH, EXECUTIVE VICE
PRESIDENT AND CHIEF PATIENT OFFICE, MERCK & CO., INC., CO-
CHAIR, CSIS COMMISSION ON STRENGTHENING AMERICA'S HEALTH
SECURITY, KENILWORTH, NJ
Dr. Gerberding. It has been a long time since I have
testified in front of the HELP Committee and it is good to be
back, but I also thank you for your incredible leadership and
all you do to protect the health of Americans. There is a lot
of media claiming that this pandemic is the pandemic of a
century, but I agree with Dr. Frist. I think this pandemic is
the harbinger of things to come.
While we focus on how we can mitigate its harm right now,
we do have to peer into the future and accelerate our
preparedness efforts and really take seriously this time what
needs to be done to truly create a health security agenda for
America. Now, I would like to just start with what we know for
sure because we are still in a learning phase here. We know for
sure this virus is incredibly transmissible. We know it causes
great harm, serious morbidity and mortality especially among
vulnerable people, and we know that it is going to continue to
spread for many months to come.
We are nowhere near the end of the mitigation phase of this
crisis. We also know that shelter in place and quarantine can
be successful in slowing down transmission, but that comes at a
tremendous price to individuals and families as well as
economies and global macroeconomic forces simply because it
shuts down business and people don't have livelihoods and the
economies don't have a base. Now, what don't we know? We don't
know what we need to know about the virus, its interaction with
the host, and how it is going to evolve over time. We don't
know really how to calibrate our balance between opening our
societies and resuming some important business functions and at
the same time continuing social distance so that we can slow
down spread. We don't know to what extent daycare, schools, and
colleges contribute to community transmission and transmission
of this virus to other more vulnerable people in society.
Last but not least, we don't know if we can stop this
pandemic with a vaccine. So let's talk a little bit about
vaccine. If we want to end a pendemic, we are going to need a
vaccine that is feasible and produced at large scale. We need a
vaccine that ideally is successful in a single dose and we need
a vaccine that we can reasonably predict will likely be
effective and safe.
Let me talk about why this is a stern taskmaster, the
science of vaccinology in the context of COVID-19. First, with
respect to efficacy. We need a vaccine that produces effective
immunity, neutralizing the virus, preventing infection even
among vulnerable, older or immunosuppressed people, and we need
a vaccine that is durable so that protection lasts beyond a few
weeks or months. And finally, of course, ideally, we would like
to have a vaccine that is robust if the virus does change or
evolve over time. But as high a bar as efficacy sets, we also
need a higher bar for safety because we are going to be using
this vaccine in some of the most healthy people as well as some
of the most vulnerable people, including children and
potentially even infants.
We must not sacrifice safety for the sake of speed and I
think that is going to be a very important component of our
communication about the vaccine opportunity because people need
to trust that the vaccine will be safe. We already have
concerns that myths and lies about the safety of the products
that are in progress are a deterrent to people's willingness to
step up and accept immunization.
While I am cautiously optimistic about the prospects for a
vaccine, we are a long way from being able to promise the
delivery date or the characteristics of what I suspect will be
several vaccines that will have different effectiveness in
different populations. So, Senator Frist outlined an incredible
historic list of the six things that we need to do for future
pandemics. That has been echoed in your white paper, Senator
Alexander. It has been presented in various forms by the
bipartisan Blue Ribbon panel, by the CSS Commission that you
referenced earlier, as well as many after-action reports filing
ongoing outbreaks during my tenure at CDC.
All of these perspectives have some common themes, and
first and foremost is the theme of sustained National
leadership at the level of the National Security Council. But I
want to highlight one other theme that Senator First brought up
and that is the critical importance of sustained, long-term
budgetary investment, ending the cycle of complacency in crises
that we have been in for so many years and instead creating a
budget process for our Nation's preparedness, and particularly
for the CDC, which you characterized as an independent
scientific organization that needs to function in an apolitical
environment.
We need to make sure that we find a budget mechanism that
allows the sustained funding to not be subject to budget caps
and not be something that gets involved in horse-trading when
the budget balancing process rolls around every year. That
alone would help us secure an ongoing progressive investment in
preemptive preparedness that truly will change the game for
Americans. So thank you for allowing me to testify and I look
forward to your questions.
[The prepared statement of Dr. Gerberding follows:]
prepared statement of julie l. gerberding
Chairman Alexander, Ranking Member Murray, and other Members of the
Committee, thank you for the opportunity to appear today. Reviewing the
lessons learned from COVID-19 and other past pandemics and preparing
for the next pandemic is critical. Unfortunately, we can't expect this
pandemic to be a ``once in a century'' event; it is a sobering
harbinger of things to come. Thank you for your leadership in this
critical area.
Experts have predicted for years that a pandemic of this magnitude
would occur, and significant progress has been made over the last
decade in increasing our capabilities and readiness. Now that we are in
the midst of the experience, while we must focus on the immediate task
at hand, we can already see some of the vulnerabilities in our system
that need to be addressed for the future. We must increase our posture
of readiness for future infectious disease threats, with science,
capability, and capacity in the U.S. and across the globe. We must
ensure there is a robust market for innovation and continue
collaboration, partnership, and strategic investments across the
public-private continuum.
As one of the very few companies that have continued to invest in
both vaccines and anti-infective medicines, at Merck we know we have a
special responsibility to help advance both vaccine and antiviral
therapies as part of our overall COVID-19 response. We have been fully
committed to developing an effective response to the COVID-19 pandemic
since it was first recognized, and we know that success will require
global collaboration among countries, companies, and other key
stakeholders. Despite the unprecedented, rapid collaboration and
investment from the biopharmaceutical industry, we will continue to
have more lives lost to COVID-19.
The development of a new vaccine is complex, time intensive, and
carries no guarantees. It is estimated that only six percent of vaccine
candidates get to the finish line and that is why only a small number
of companies have continued to operate in this space.
Manufacturing and distributing a vaccine under normal circumstances
is exceedingly complex, requiring hundreds of steps, thousands of
complex tests, all validated to ensure that every single vial has the
identical high quality and safety. When we think about what will be
needed to address the pandemic, we are talking about orders of
magnitude beyond what we as an industry are currently doing and which
truly exceeds the current global capacity.
In order to meet this need, we must all appreciate that the
biopharmaceutical collaborators are working at risk. In other words, we
are making considerable investments in key elements such as
manufacturing capacity before we typically would, before we know
whether we even have a successful product--in many cases building a
factory before we have fully developed the process at a smaller scale.
As a result, we have to think carefully about how these decisions will
impact other development programs and allocation of investments,
including considering the inevitable opportunity costs.
In the short-term, we can expect many more months of ongoing
transmission risk, with many people at risk. This will be further
complicated as we expect influenza season to confound the impact of
COVID-19 on communities and health systems. Sheltering in place and
social distancing have proven effective mechanism to slow the
transmission of the virus and protect the health care capacity;
however, it comes at a huge price. The economic, individual/family, and
community hardships are real. At the same time, communities with less
social distancing are beginning to demonstrate more transmission.
I believe we need to find the right evidence-based balance between
sufficient social distancing, including masks and avoidance of crowds,
with prudent steps to resume business activities and more normal
activities of daily life. This is imperative.
We also need to address escalating levels of misinformation related
to the pandemic and the public and individual health impact of future
vaccines. We are continuously seeing dissemination of information that
is inaccurate and/or misguided. This can be quite dangerous as it leads
to questioning the safety and efficacy of vaccines, which we know are
critical to containing this pandemic and preventing future ones. We
have seen the erosion of trust in governments and health care workers,
who will be conducting vaccination programs. Ultimately this
misinformation and mistrust can lead to a troubling reduction in people
choosing to receive vaccines.
The current pandemic has only further emphasized the value of
vaccines in preventing illnesses. We know that it is better to prevent
an illness rather than treat it, but we are now living a stark example
of that principle. As we look forward to a time when new vaccines and
treatments are widely available, we must do more to ensure the adequate
funding of prevention and immunization infrastructure in our health
system more broadly. As this pandemic has shown very clearly, these are
critical for health protection but also for national and economic
security.
Testing protocols for future pandemics will also be critical. The 6
key priorities for testing are as follows:
1. Test people with symptoms for diagnosis;
2. Test people exposed to known/suspected cases;
3. Test people in ``hotspots'' where transmission is
increasing;
4. Routinely test people in locations known to be or likely to
be high risk (nursing homes, health care settings, prisons,
meat packing plants, etc.);
5. Test to understand patterns of transmission risk and improve
policy decisions (e.g., in daycares, schools, campuses, etc.;
using antibody testing)--this is the essence of public health
surveillance;
6. Deprioritize other ``general'' testing to unclog the system,
especially until the reliability of tests improves.
Accelerating and enhancing health care surge capacity planning is
also essential. This includes a multitude of critical activities, such
as:
1. Conducting a thorough supply chain assessment to understand
and address vulnerabilities;
2. Examining how to best strengthen the Strategic National
Stockpile performance to be the most effective and efficient
during a pandemic (e.g., consider expansion of personal
productive equipment, ventilators, and other durable medical
equipment);
3. Augmenting supplies of antibiotics, intravenous fluids, and
other medicines to sustain critical care;
4. Formalizing augmented health care workforce contingency
plans (credentials across states, retirees, volunteers,
Department of Defense) and updating training;
5. Institutionalizing telehealth and payment reforms; planning
for needed in-person primary care, maternal health, mental
health, substance abuse, and dental care clinics;
6. Creating an interoperable pandemic health data network
(instead of local and state stand-alone networks);
7. Engaging and incentivizing the private sector in planning
efforts;
8. Exercising and improving plans with accountability from
partners to follow through on lessons learned.
As we look forward, it is important to understand the key lessons
that can and should be applied to help us better prepare for and
respond to future pandemics. Vaccine development is complex and carries
no guarantees; for this reason, we need to support the pursuit of
multiple approaches.
While the first step is clearly finding the one or more effective
vaccines, we can't underestimate the challenges of successfully
deploying those vaccines. The complexity of the situation on the ground
and challenges faced by vaccinators in the Democratic Republic of Congo
(DRC) with our Ebola vaccine have been unparalleled. The scope and
scale of the vaccine distribution, delivery, and administration
challenges for COVID-19 will be significantly greater and will require
unprecedented partnerships amongst manufacturers, supply chain and
logistics professionals, governments, community leaders, health care
workers, and individual citizens.
Key lessons we learned through our experience with Ebola that we
can leverage moving forward include:
1. Public-private partnerships can be very powerful and
effective, but also exceptionally complex and resource
intensive. Bringing a diverse set of collaborators together
requires trust and an ``eyes wide open'' effort with clear
roles, expectations, and accountability defined for each
collaborator.
2. Regulatory requirements and regulatory-manufacturing
interplays are highly complex, requiring approval of both the
product and the manufacturing process at each manufacturing
facility for licensure. Accounting for these complexities
requires more standardization and rightsizing specifically for
preparedness goals, as well as better pre-work and
harmonization when moving forward.
3. Numerous non-regulatory policies, such as trade, GMO, and
BSL requirements can act as barriers to the free flow of raw
materials and other component parts needed for vaccine
manufacturing and quality testing. If these can be identified
in advance, manufacturers and government officials can work
actively to address them before they result in manufacturing
delays.
Preparing for tomorrow's pandemic requires a new health security
doctrine. For the past two years, I have co-chaired with former Senator
Kelly Ayotte the Center for Strategic International Studies (CSIS)
Commission on Strengthening America's Health Security. Senators Murray
and Young are part of the Commission. Other congressional Members
include: Representatives Bera, Brooks, Cole, and Eshoo, in addition to
several security experts. In November 2019, the Commission released the
Ending the Cycle of Crisis and Complacency report. The report lays out
several key steps that the Administration and Congress should take to
create a sustainable basis for strengthening the health security of
Americans.
We began the Commission's work with a simple understanding: health
security is national security, in a world that is increasingly
dangerous and interdependent.
Biological threats--outbreaks from natural, intentional, and
accidental causes--are occurring more often and at the same time, the
world is increasingly insecure, violent and disordered, and it is
exactly in these danger zones where an increasing number of biological
outbreaks occur.
Globalization and the rise of international trade and travel mean
that an outbreak in a disordered setting with a compromised health
system can quickly become a pandemic, threatening the United States and
the rest of the world. Policymakers increasingly recognize these
threats can undermine the social, economic, and political security of
nations.
Unfortunately, this recognition occurs when a health crisis
strikes--COVID-19, measles, MERS, Zika, dengue, Ebola, pandemic flu--
and U.S. policymakers rush to allocate resources in response. Yet all
too often, when the crisis fades and public attention subsides, urgency
morphs into complacency. Investments dry up, attention shifts, and a
false sense of security takes hold.
That realization led us to conclude: the U.S. Government needs to
break the cycle of crisis and complacency and replace it with a
doctrine that can guarantee continuous prevention, protection, and
resilience. The Commission advocates for a package of strategic,
affordable actions to advance U.S. health security.
First and foremost, we recommend permanent health security
leadership as a central pillar of the National Security Council (NSC)
by a credentialed and qualified expert.
Second, we need to invest directly and consistently, over the next
decade, in the capacities of low-income countries. The best approach to
protect the American people is to stop outbreaks at the source. The
Global Health Security Agenda has a proven track record in building
health systems and health security preparedness in low-and middle-
income countries, financed through a $1 billion Ebola emergency
supplemental funding. We recommend sustaining that success, not
disrupting or curtailing it.
Create a new non-discretionary budget authority that assures
sustainable investments independent of budget caps or the necessity of
annual budget trade-offs.
We recommend that the U.S. Government expand DTRA's geographic
authorities to operate in all continents where health security threats
exist. Furthermore, support for military overseas infectious research
laboratories should be sustained. DOD biological research and
development programs often focus on diseases not studied in other
venues and result in medical countermeasures that would otherwise be
delayed or not developed at all.
Congress should require national, state, and local governments to
conduct regular preparedness exercises with updates to Congress on
strengths and identified gaps in capacity.
The Commission also advocates that the U.S. Government strengthen
and adapt programs and capacities to deliver health services in fragile
settings that meet the special needs of acutely vulnerable populations,
elderly, women, and children.
It is also importation to prioritize a ``one health'' research
agenda, including significantly augmenting research to understand the
intersection of human, animal, and ecosystem factors that promote the
emergence and spread of infectious diseases and how to reduce and
contain these threats. This would include expanding the investment in
animal and environmental health surveillance for infectious diseases,
modernizing global public health infectious diseases data systems and
tools, and seeking predictive insights and preemptive interventions,
not just counter-measures and emergency response capabilities.
The last area of priority concern is to plan strategically, with
strong private-sector partners, to support targeted investments that
will accelerate the development of new technologies for epidemic
preparedness and response. We assert that the U.S. Government should
directly invest in the Coalition for Epidemic Preparedness Innovations,
or CEPI, an international alliance that finances and coordinates the
development of new vaccines to prevent and contain epidemics.
Again, thank you for the opportunity to testify in front of you
today, and it is my sincere hope that we can work closely together to
advance the U.S. health security agenda, so we are better prepared for
the next pandemic.
______
[summary statement of julie l. gerberding]
We must increase our posture of readiness for future infectious
disease threats, with science, capability, and capacity in the U.S. and
across the globe. We must ensure there is a robust market for
innovation and continue collaboration, partnership, and strategic
investments across the public-private continuum.
Unfortunately, recognition of the health security vulnerabilities
tends to occur when a crisis strikes--COVID-19, measles, MERS, Zika,
dengue, Ebola, pandemic flu--and U.S. policymakers rush to allocate
resources in response. All too often, when the crisis fades and public
attention subsides, urgency morphs into complacency. Investments dry
up, attention shifts, and a false sense of security takes hold.
The U.S. Government should examine package of strategic actions to
advance U.S. health security:
Permanent health security leadership as a central
pillar of the National Security Council (NSC) by a credentialed
and qualified expert.
Invest directly and consistently, over the next
decade, in the capacities of low-income countries.
Create a new non-discretionary budget authority that
assures sustainable investments independent of budget caps or
the necessity of annual budget trade-offs.
Expand DTRA's geographic authorities to operate in
all continents where health security threats exist. Sustain
support for military overseas infectious research laboratories.
Congress should require national, state, and local
governments to conduct regular preparedness exercises with
updates to Congress on strengths and identified gaps in
capacity.
U.S. Government must strengthen and adapt programs
and capacities to deliver health services in fragile settings
that meet the special needs of acutely vulnerable populations,
elderly, women, and children.
Prioritize a ``one health'' research agenda,
including significantly augmenting research to understand the
intersection of human, animal, and ecosystem factors that
promote the emergence and spread of infectious diseases and how
to reduce and contain these threats.
Support targeted investments that will accelerate the
development of new technologies for epidemic preparedness and
response.
It is also essential to accelerate and enhance health care surge
capacity planning, including:
Conducting a thorough supply chain assessment to
understand and address vulnerabilities.
Examining how to best strengthen the Strategic
National Stockpile performance to be the most effective and
efficient during a pandemic.
Augmenting supplies of antibiotics, intravenous
fluids, and other medicines to sustain critical care.
Formalizing augmented health care workforce
contingency plans (credentials across states, retirees,
volunteers, Department of Defense) and updating training.
Institutionalizing telehealth and payment reforms;
planning for needed in-person primary care, maternal health,
mental health, substance abuse, and dental care clinics.
Creating an interoperable pandemic health data
network (instead of local and state stand-alone networks).
Engaging and incentivizing the private sector in
planning efforts.
Exercising and improving plans with accountability
from partners to follow through on lessons learned.
______
The Chairman. Thank you, Dr. Gerberding.
Welcome, Governor Leavitt.
STATEMENT OF GOVERNOR MICHAEL O. LEAVITT, FORMER U.S. SECRETARY
OF HEALTH AND HUMAN SERVICES, SALT LAKE CITY, UT
Mr. Leavitt. Thank you, Chairman Alexander, and Ranking
Member Murray, and the Members of the Committee. A special
thank you to Senator Romney for that generous introduction.
Only months into my service at the Department of Health and
Human Services, Dr. Gerberding and I participated in an
emergency briefing on the H5N1 Avian Influenza. We were told it
was a virus with pandemic potential.
The next morning a colleague of mine entered my office
carrying a book. The book was entitled ``The Great Influenza: A
History of the Pandemic of 1918'' written by John Berry. As he
handed it to me, he delivered a message. It was, you need to
understand this. He was right, not just for me, but for all of
us. As I read the book and several others, as I saw briefings
and learned from others, it quickly became evident to me that
ultimately a pandemic would occur. And that is true today. We
have it but we will have another and we need to be prepared.
And at that point in time our country was unprepared. As the
H5N1 continued to spread, as you indicated earlier Mr.
Chairman, Congress was alerted and appropriated $7.4 billion.
Several Members of this Committee will remember that well.
Over the next three years, we undertook an aggressive
effort to heighten our Nation's readiness for a pandemic. We
sought to develop vaccine manufacturing inside the territorial
boundaries of the United States. We wrote the national pandemic
response plan. Congress passed legislation that has become a
foundation of that plan, the PREP Act of 2005, Pandemic All-
Hazards and Preparedness Act of 2006.
Those two bills, when added to Project Bioshield, which was
passed in 2004, contain many of the legislative authorities
that have been actually used in recent months. 54 pandemic
summits were held in partnership with the Governors of each
state and territory. There were three messages that were
delivered at those summits, all three still critical even in
the midst of a pandemic and certainly in the future. The first
was just a reminder that pandemics happen. They are a biologic
fact and a certainty. Pandemics occur, and when they do they
obviously bring death and suffering and sweeping change.
The dilemma is that they happen far enough apart that we
forget, as people have made the point already. The second
message was that pandemics happen and every generation has to
prepare on their own or they will be complacent as well. And
finally, everyone needs a pandemic plan. States need a plan,
local Governments need a plan, businesses, churches, schools,
hospitals, because a pandemic is different than any other
disaster that we deal with. It is intensely local.
In a terrorist event like 9/11 or a natural disaster like
Katrina, the Federal Government's response is to call on
unaffected states to send people and equipment to the disaster
area. In a pandemic, those resources are to a large degree
unavailable because they are needed at home. The message is
clear that any state or any community that fails to plan
thinking that somehow the Federal Government will ride to its
rescue will be tragically mistaken, not because the Federal
Government lacks the will, not because it lacks the wallet, but
because the Federal response plan is based on focusing
primarily on localized disasters.
Gratefully, the H5N1 Avian Influenza did not become a
pandemic but the process has taught us a lot and the lessons we
need to learn are still true today. I will just highlight four.
First, the need to clarify roles between states and national
Governments in advance. Second, having a vaccine is critical,
but it is only the beginning. While we have manufacturing
capability, fill, finish and distribution priorities will
inevitably be a problem and they still need planning.
Third, providing situational awareness is a critical role
of the Federal Government and principally CDC. The disease
gathering--information gathering capability of the Federal
Government needs investments and it needs modernization. And
last, I will echo what my colleagues have said, pandemic
preparation requires investment every year. Mr. Chairman, I
look forward to our conversation.
[The prepared statement of Mr. Leavitt follows:]
prepared statement of governor michael o. leavitt
Good Morning, Chairman Alexander, Ranking Member Murray, and
Committee Members.
Thank you for the invitation to appear before the HELP Committee
again and for accommodating my remote participation.
The topic of this hearing is of great importance to me personally
and to the Nation. I am pleased that this Committee has the foresight
to recognize that even while we are still in the midst of responding to
COVID-19, now is, in fact, the right moment to be capturing the lessons
we are learning through this public health emergency, so we haven't
long forgotten them by the next one and to be looking ahead to how to
prepare for the next pandemic.
Before we turn to talk about the future, I want to acknowledge the
significant losses we've experienced across this country over the past
several months. For the families that have lost loved ones, I convey my
greatest sympathies to you. For those who have felt the economic pain
of job or income loss, I hope you are soon on the path to recovery. And
to the heroes in the public and private sectors who have helped us
respond to this emergency and keep essential businesses open to serve
our communities, I thank you for your efforts. This pandemic has
affected us all in profound and different ways, which is why we must
learn from what we are experiencing today and take steps to set
ourselves up for the best possible outcomes in the future.
The Foundation of Preparedness is Laid Long Before an Emergency
Shortly after becoming Secretary of the U.S. Department of Health
and Human Services, the H5N1 avian influenza appeared to have pandemic
potential. With support from President George W. Bush and Congress, my
colleagues and I initiated an aggressive pandemic planning process.
Part of our efforts involved energizing local and state preparedness by
holding pandemic summits in 54 states and territories. These summits
were full-throated efforts to sound the alarm and remind states and
local communities that pandemics happen. When they do, there are no
other natural or manmade disasters that can compare to their
disruption. It was also an attempt to assure states understood that
because the pandemic would unfold across the country at the same time,
states and local communities also needed to prepare.
The experience reminded me that pandemic planning is made even more
difficult because anything you do to prepare in advance of a pandemic
seems like an overreaction, and anything you say sounds alarmist. But
after a pandemic starts, anything you have done to prepare seems
inadequate.
We are, as a Nation, understandably focused right now on mitigating
the health and economic harm caused by COVID-19. However, while we
focus on the pandemic in front of us, we can't miss this opportunity to
reflect on the lessons of COVID-19 and apply those lessons, so we are
more prepared for the next pandemic or public health emergency.
Unfortunately, time is of the essence since the next pandemic event
might be the second wave of COVID-19 this fall.
As Chairman Alexander points out in his white paper, ``Preparing
for the Next Pandemic,'' action often only comes in response to a
threat. That is human nature. It can be challenging to focus citizens
and policymakers on public health preparedness when they are focused on
other pressing issues of daily life. If a snake isn't at your ankle,
then you aren't thinking about it.
The terrorist attacks on the United States on September 11, 2001,
and the subsequent anthrax attacks ushered in a period of heightened
awareness that homeland security and domestic preparedness are just as
crucial to the Nation's safety as foreign policy and a combat-ready
military. In the subsequent five years alone, Congress passed, and the
President signed into law, the Bioterrorism Act (2002), Project
BioShield (2004), the Public Readiness and Emergency Preparedness Act
or ``PREP Act'' (2005), and the Pandemic All-Hazards and Preparedness
Act (2006). Collectively, these laws provided necessary tools that have
been deployed in the years since, and some specifically in response to
COVID-19, including;
Preparedness grants to help states and health care
providers prepare for and respond to public health emergencies;
Authority for HHS to waive certain Medicare or
Medicaid requirements during national emergencies to provide
flexibility for hospitals and states to respond to a public
health emergency;
Establishment of a multi-year Special Reserve Fund
and authority for HHS to enter contracts to procure medical
countermeasures before they are approved;
The Hospital Preparedness Program, which to helps
hospitals buy tangible resources like ventilators, mobile
medical units, and pharmaceutical caches;
Authority to the FDA to issue emergency use
authorizations, which allow the use of medical countermeasures
before FDA approval;
Liability protections for companies, health care
providers, and others involved in the distribution and
administration of medical countermeasures in a public health
emergency, except in cases of willful misconduct;
The Covered Countermeasures Process Fund to
compensate eligible individuals who suffer injuries as a direct
result of a countermeasure administered or used under a PREP
Act declaration.
Establishing the Secretary of HHS as the lead Federal
authority for the public health and medical components of
responses to emergencies under the National Response Framework;
Creating the position now known as the Assistant
Secretary of Public Health Emergency Preparedness (ASPR) to
coordinate HHS efforts to prepare for, respond to, and recover
from disasters and public health emergencies; and
Creating the Biomedical Advanced Research and
Development Authority (BARDA) to fund the advanced research and
development of medical countermeasures.
Cooperation by Federal and State Governments is Key to Response
It is my perception that Members of this Committee, in general
terms, share an aspiration for the United States to be prepared to
prevent, mitigate, respond, and recover from a public health emergency,
whether deliberate, accidental, or natural. I also sense there is
consensus that both the states and the Federal Government have an
essential role in that effort. So, the age-old dilemma of how to divide
responsibility between state governments and the Federal Government
seems to be very much at play.
Having served as a Governor and a Cabinet Officer, I have come to
understand that both the states and the Federal Government have
different capabilities and roles to play. I dealt with this dynamic
regularly because both the Department of Health and Human Services and
the EPA had important missions and were heavily dependent on state
partnerships to carry them out.
On matters related to public health emergencies, I view the Federal
Government as excelling in two areas. First, the Federal Government
collects and distributes money. While public health is a core function
of states, the Federal Government is a significant supporter of this
state-based infrastructure. Second, the Federal Government provides
leadership, support, and coordination to the states and local agencies
that are the front lines of any response. As a practical matter,
however, the Federal Government is challenged to execute uniformly
across the entirety of this vast, diverse nation, and thus roles should
be assigned with care. With those limitations, the Federal Government
is highly dependent on states to meet emergency response needs.
I saw this very clearly when Hurricane Katrina struck in 2005. Our
Department's role was to aid victims after their evacuation or rescue.
I quickly understood that the Federal Government's emergency response
system is in no small measure the aggregation of multiples state
emergency response capacities operating under Federal coordination.
Emergency response was done differently in Arkansas than in Texas or
Florida. But each in their way, the states got it done. If we had
insisted on absolute uniformity, the effort would have failed.
Shortly after Hurricane Katrina, we were required to prepare the
Nation for a potential pandemic influenza. Once again, it became
evident that the Nation's public health capacity was the aggregation of
state and local public health organizations, acting with Federal
coordination. Each state deployed its assets. Were some better than
others? Yes. But the Federal Government simply does not and should not
have sufficient capacity to deploy everywhere.
All disasters are local. When it is a hurricane or flood,
particular areas of the country become the focus. While the response is
led at the local level, the Federal Government is needed, as noted
above, to step in to provide funding as well as leadership and
coordination in some cases. But a pandemic imposes a unique strain on
our system of response since the emergency is happening on such a wide
scale all at once and requires resources and coordination in different
magnitudes of scale. Because of this, pandemic preparedness requires
special preparation and attention, and so I offer up five
recommendations for your consideration.
Define the Division of Duties Between States and the Federal Government
in Advance
Because of the Federal Government's involvement in many state
domains, it should not surprise anyone that states have expectations
that the Federal Government comes to the rescue, even in areas that are
clearly state responsibilities. In a pandemic, there are times when the
Federal Government cannot come to the rescue. Not because the Federal
Government lacks a will or the wallet, but because many of the
resources they would typically call on belong to the states. In a
natural disaster like Hurrican Katrina, Federal emergency managers call
other states and pay them to deploy their emergency response assets to
the disaster area. In a pandemic, state resources are not deployable
because they are needed at home.
In the current pandemic, at times there was confusion by some on
matters such as the purposes of the Strategic National Stockpile (SNS),
the procurement of personal protective equipment (PPE), and who had the
authority to make public health decisions. In the middle of a pandemic,
emergency finger-pointing is unproductive and costly. Roles and
responsibilities must be communicated clearly before an emergency
occurs to encourage swift decisionmaking and response.
In my view, there are some duties only the Federal Government can
accomplish. For example:
Support the research, development, and manufacture of
vaccines and medical countermeasures, and approve safe and
effective products;
The stabilization of the economy through fiscal and
monetary policy;
Managing relationships with other countries;
Supplementing states and local governments with
emergency funding;
Creating situational awareness by collecting data and
research from the states and giving it a big picture
perspective;
Providing general guidance and assurance to the
American people; and
Interstate and intercontinental transportation.
There are also duties better handled by states and local
authorities. Most of the state duties are execution-oriented. For
example:
Managing public health functions such as inspection,
data collection, workforce;
Making risk framework decisions (e.g., Red, Orange,
Yellow, Green) in various areas;
Management of health care delivery capacity;
Communicating local conditions and guidance;
Regulation of health care delivery;
Conducting testing and contact tracing; and
Public health enforcement.
The Federal Government Must Ensure and Maintain Domestic Capacity to
Manufacture Vaccines for the Entire U.S. Population Within Six Months
of the Emergence of a Virus With Pandemic Potential
Due to the unparalleled impact that a pandemic has on the health,
economy, and security of the entire country, the Federal Government
must ensure the capacity to domestically manufacture enough vaccines to
protect all Americans. A pandemic virus does not stay within state
lines. Just as the Federal Government must prepare to deploy military
assets such as the Army Corps of Engineers when the U.S. homeland is
attacked or devastated by a natural disaster, it must also prepare to
develop and deploy life-saving countermeasures and vaccines. This
understanding led President George W. Bush to make domestic vaccine
manufacturing capacity a key pillar of the National Strategy for
Pandemic Influenza.
Unlike seasonal vaccines or routine immunizations, there is no
commercial market for most medical countermeasures outside of a public
health emergency. No state alone, or even a group of states, can create
and sustain such demand. Only the Federal Government has the financial
and practical capacity to lead this effort.
Over the last two decades, Congress has taken steps to de-risk
vaccine research and development by funding pre-clinical, clinical, and
advanced research, giving the Federal Government authority and
dedicated funding to procure countermeasures, and establishing
liability protections.
On November 1, 2005, President George W. Bush requested $7.1
billion in emergency funding for pandemic influenza preparedness
activities, of which $6.7 billion was for implementing the HHS Pandemic
Influenza Plan. Over the next year, $5.6 billion of that request was
funded by Congress and allocated to HHS. In June 2007, HHS used some of
these funds to retrofit existing domestic manufacturing facilities of
U.S.-licensed biologics for pandemic influenza vaccine production. Over
the years, additional funding has gone to support the Centers for
Innovation in Advanced Development and Manufacturing (CIADM) to build
warm base manufacturing capacity through both new and converted
facilities.
These investments must be sustained over time, and unfortunately,
they were not. As a result, we do not have the robust, warm base
capacity we need for this and future pandemics. After initial Federal
construction support, manufacturers bore the full cost and risk of
maintaining these facilities. Several of the facilities were eventually
sold and used to produce seasonal vaccines or as contract manufacturing
facilities. They may eventually be made available for COVID-19 vaccine
manufacturing.
HHS has announced contracts with manufacturers to buildup domestic
manufacturing capacity for both COVID-19 vaccines and therapeutics
using funds recently appropriated by Congress. This is the right move,
and I'm glad to see it's being done. But we need to take a longer-range
view and not wait until a pandemic has already hit our shores before
making these kinds of investments. This approach should be a
centerpiece of a long-term preparedness strategy.
There are several things that the Federal Government can do to
increase and sustain domestic vaccine manufacturing capacity,
including:
Support the research, development, and domestic
manufacturing of seasonal influenza vaccines. Domestic seasonal
influenza vaccine platform technologies and manufacturing
facilities are the foundation of domestic pandemic vaccine
capacity. Increased domestic seasonal flu vaccine
infrastructure investments can be leveraged to produce pandemic
vaccines with similar scientific and platform technology
profiles. The Federal Government can further support the U.S.
domestic seasonal flu vaccine market through tax incentives,
reimbursement strategies, research, development, and
procurement contracts, and other public-private partnerships.
Utilize a federally Facilitated Vaccine Portfolio
Strategy. A successful pandemic vaccine strategy is not ``one
shot, and you're done.'' Once a virus with pandemic potential
is identified, the Federal Government must utilize a portfolio
strategy to support parallel research, development, and
manufacturing of multiple vaccine candidates. To execute this
strategy, the Federal Government must have access to pre-
designated domestic manufacturing facilities for each type of
vaccine candidate technology (such as Messenger RNA (mRNA),
cell, or egg-based) in multiple regions of the country. The
Federal Government can expand beyond the current CIADM program
by:
Y Funding the warm base maintenance required to keep
domestic vaccine manufacturing facilities, their
personnel, and their technology up-to-date and
pandemic-ready;
Y Entering into cost and risk-sharing agreements with
commercial and academic partners to co-manage domestic
vaccine manufacturing facilities;
Y Identify and pre-certify non-traditional contract
manufacturing facilities, such as animal vaccine and
agricultural biotech facilities, which can quickly
convert to a vaccine or vaccine-component manufacturing
facility in the event of a pandemic. Participating
facilities could receive additional compensation for
operating losses from forgoing manufacturing of their
traditional business lines.
Leveraging Federal Contracting Authorities in New
Ways. While the Federal Government must ensure domestic vaccine
manufacturing capacity, it cannot do it without the cooperation
and innovation of the private sector. Most government contracts
to support medical countermeasures are quite simple. The
Federal Government gives money to one company for the research,
development, or procurement of a specific medical
countermeasure with demonstrated safety and efficacy for
delivery on a particular schedule. Producing a nationwide
supply of domestically manufactured pandemic vaccines requires
the support of more complex business relationships. For
example, the government may have several options for vaccine
components, manufacturing facilities, and fill and finish
capabilities. They need the flexibility to ``mix and match'' as
science and needs evolve. If a vaccine manufacturer's vaccine
candidate fails in clinical trials, there must be an ability to
use that same manufacturer's facility, and perhaps even their
personnel and supply chain to produce vaccines from other
manufacturers with successful vaccine candidates. HHS can use
their Other Transactions Authority (OTA), a widely used
mechanism by other agencies, to enter into contracts with a
consortium of companies to spread risk over several different
vaccine candidates. \1\ Other useful authorities exist under
DOD programs with similar interests.
---------------------------------------------------------------------------
\1\ See generally, ``Rapid Medical Countermeasure Response to
Infectious Diseases: Enabling Sustainable Capabilities Through Ongoing
Public-and Private-Sector Partnerships: Workshop Summary (2016.)''
available at https://www.nap.edu/catalog/21809/rapid-medical-
countermeasure-response-to-infectious-diseases-enabling-sustainable-
capabilities.
Recruiting Federal Employees with Vaccine
Manufacturing and Procurement Experience. Every day of my
tenure as Secretary of Health and Human Services, I was
impressed by the knowledge, expertise, and commitment to health
and public service of the HHS staff. They each bring valuable
expertise to their roles. One area that needs additional focus
is ensuring that the team tasked with managing and executing
the Federal domestic vaccine enterprise have technical
experience in vaccine manufacturing and procurement. A further
area of required expertise is familiarity with flexible and
complex contracting and procurement authorities that may
involve other departments and sophisticated performance
---------------------------------------------------------------------------
metrics.
Understand That the U.S. Isn't the Only Vaccine Game
in Town. With the increase in global partnerships to develop
vaccines for use overseas, U.S. vaccine manufacturers have
several potential government and non-government partners to
choose to do business with. One executive from a COVID-19
vaccine manufacturer stated that they did not seek Federal
funding because ``Our focus was to move as quickly as possible,
and we really didn't want to . . . spend a month negotiating
with the U.S. Government.'' \2\ The domestic vaccine supply of
the United States is put at risk when U.S. vaccine
manufacturers begin to see contracts to manufacture vaccines
for foreign countries and global NGO's as more reliable options
than partnering with the Federal Government. The U.S.
Government needs to be a consistent, efficient, and transparent
contracting partner.
---------------------------------------------------------------------------
\2\ See generally, ``BIO: What's the ROI on a COVID-19 vaccine? We
have no idea, says Pfizer.'' by Arlene Weintraub, FiercePharma, June
11, 2020. Available at https://www.fiercepharma.com/pharma/bio-what-s-
roi-a-covid-19-vaccine-we-have-no-idea-says-pfizer.
We Need Modern Day Data Collection and Aggregation to Guide Our
Response
Detailed and accurate data is essential for the Federal Government
to coordinate and states to execute a response to a public health
emergency. The lack of an established process to share near real-time
data electronically leads to duplicative, time-consuming processes at
CDC and other Federal health agencies, to aggregate and organize data
already stored electronically at the state, local, tribal, and
territorial levels.
There are currently two major types of datasets tracking the COVID-
19 outbreak: a Federal dataset run by the CDC, and state-based data
sets. A recent survey showed substantial differences between state and
Federal data on COVID-19 testing. According to the survey,
28 states and the District of Columbia's test numbers
reported by the CDC fall within 10 percent of the total test
numbers reported by the states and only a few match precisely;
22 states' test numbers reported by the CDC fall
outside the 10 percent range--and some of the discrepancies are
very large; and
13 states' total test numbers reported by the CDC
diverge from state reporting by more than 25 percent. \3\
---------------------------------------------------------------------------
\3\ See generally, ``Assessment of the CDC's New COVID-19 Data
Reporting'' The COVID Tracking Project, May 18, 2020. Available at
https://covidtracking.com/documents/CDC-Report-CTP.pdf.
Some of this confusion comes from conflicting reporting
requirements for laboratories and states, while a critical element is
the lack of interoperable software capacity to collect and aggregate
---------------------------------------------------------------------------
test results.
While Congress appropriated $500 million to support improved public
health data systems as part of the recent CARES Act (PL 116-136), money
alone will not solve the problem. HHS should work with the private
sector to acquire the software capacity to collect and aggregate test
results submitted by state and local public health agencies but
coordinated and maintained by the CDC. HHS should give guidance and
technical support to the states so they can each collect and submit
their data in a manner compatible with CDC's, to establish the near-
real-time biosurveillance system that is necessary to detect, identify,
and model emerging infectious diseases.
Better data faster means a better public health response. It also
allows Federal and state governments to quickly predict how a disease
will impact different populations and help identify high-risk
individuals and communities that need additional interventions.
We Should Modernize and Sustain Our Public Health Infrastructure
The public health function of our state and local governments is
being tested in many ways through the current public health emergency,
and it is clear that it is in desperate need of modernization. In part,
this is due to budget pressure at the state level to prioritize
Medicaid spending or other health priorities over investments in public
health. Public health is often a forgotten function of government,
working quietly behind the scenes and not drawing attention to the part
it plays when things are going well. But the COVID-19 pandemic has
thrust public health into the spotlight, and it is now getting the
attention it warrants.
The CARES Act included funding to make essential upgrades to our
public health infrastructure, and I hope that this funding is used
wisely to help states and local agencies make long-term improvements. I
believe that upfront investments in public health modernization at the
state and local level save the Federal Government money over time. For
example, if state and local public health agencies maintained the
capacity to trace contacts for emerging infectious diseases and surge
that capacity as necessary, Congress wouldn't need to come up with such
large emergency supplemental appropriations to respond to every
emergency. With a strong foundation of well-trained personnel, IT
infrastructure, and surge capacity steadily funded, it wouldn't be as
great of a strain to respond to a pandemic or any other health
emergency.
This is not just an issue for governments. Right now, many
employees of large and small businesses alike are having their
livelihoods threatened by the economic impact of COVID-19. There can be
no real economic recovery until we have public health risk mitigated.
This connection between public health and financial well-being provides
strong incentives for employers and the business community to step up
in new ways to partner with and support state and local public health
agencies.
Preparedness Needs to Have the Same Urgency as Response
Finally, one of the goals of preparedness should be to identify
potential threats and responses before they happen. Preparedness
exercises must be done regularly at the Federal, state, and local
government levels, as well as by the private sector, communities, and
families. In many places, these exercises are a standard practice
already, and I think that they should become more widespread, more
frequent, and should focus on known and unknown threats. One of the
things we did at our business was develop a continuity of operations
contingency plan for a pandemic or economic downturn. We didn't know if
either or both would happen, but when they did it allowed us to
transition to remote work and take other quick measures to mitigate the
impact of COVID-19 on our clients and employees. Similarly, I reached
out to family members and encouraged them to develop preparedness
plans.
Right now, it feels a bit like we are walking out onto an icy lake.
We're not sure how thick the ice is. So, you walk a few feet, stop, and
pause, and get a sense of whether you feel comfortable or not, whether
you hear cracking sounds. If you do, you move back, but if you don't,
then you move forward. And that's where we are as a country. We have
seen individuals and institutions scramble over the last few months to
develop risk frameworks to guide public health and economic decisions--
essentially frameworks for how we safely walk across the icy lake.
These are the ``Red, Orange, Yellow, Green'' and ``Phase 1, Phase 2,
Phase 3'' decisions that Governors and Mayors must make. After the
pandemic, these officials should be encouraged to preserve these risk
frameworks so they can build on them in future emergencies. The
specific details of any given plan may need to change, but the mindset
of thinking in advance and gaming out a response should not.
Conclusion
Thank you for the opportunity to address this Committee. I agree
with Chairman Alexander that now is the time not just to respond, but
to prepare. This pandemic is not over. New cases are still rising in
some locations, and others that have seen a decrease may have a second
wave in the fall or next year. That means we still have time to prepare
for what this disease may bring and for future public health
emergencies. As the Committee looks at different policy
recommendations, I remind you to consider how the Federal, state, and
local governments, as well as the private sector, communities, and
individuals, can all play a role. We are ``all in this together'' in
pandemic response and recovery but must now extend this mentality to
preparedness as well.
I look forward to answering any questions you have.
______
[summary statement of michael o. leavitt]
This pandemic has affected us all in profound and different ways,
which is why we must learn from what we are experiencing today and take
steps to set ourselves up for the best possible outcomes in the future.
All disasters are local. When it is a hurricane or flood,
particular areas of the country become the focus. While the response is
led at the local level, the Federal Government is needed to step in to
provide funding as well as leadership and coordination in some cases.
But a pandemic imposes a unique strain on our system of response since
the emergency is happening on such a wide scale all at once and
requires resources and coordination in different magnitudes of scale.
Because of this, pandemic preparedness requires special preparation and
attention, and so I offer up five recommendations for your
consideration.
1. Define the Division of Duties Between States and the Federal
Government in Advance.
There are some duties only the Federal Government can accomplish:
Support the research, development, and manufacture of
vaccines and medical countermeasures, and approve safe and
effective products;
The stabilization of the economy through fiscal and
monetary policy;
Managing relationships with other countries;
Supplementing states and local governments with
emergency funding;
Creating situational awareness by collecting data and
research from the states and giving it a big picture
perspective;
Providing general guidance and assurance to the
American people; and
Interstate and intercontinental transportation.
There are some duties better handled by states and local
authorities:
Managing public health functions such as inspection,
data collection, workforce;
Making risk framework decisions (e.g., Red, Orange,
Yellow, Green) in various areas;
Management of health care delivery capacity;
Communicating local conditions and guidance;
Regulation of health care delivery;
Conducting testing and contact tracing; and
Public health enforcement.
2. The Federal Government Must Ensure and Maintain Domestic
Capacity to Manufacture Vaccines for the Entire U.S. Population Within
Six Months of the Emergence of a Virus with Pandemic Potential.
3. We Need Modern Day Data Collection and Aggregation to Guide Our
Response.
4. We Should Modernize and Sustain Our Public Health
Infrastructure.
5. Preparedness Needs to Have the Same Urgency as Response.
______
The Chairman. Thank you, Governor Leavitt. And thanks to
each of you. We will now begin a five-minute round of
questions. I would ask the Senators and the witnesses to try to
observe the five-minute limit. We have a lot of Senators who
want to talk to these very distinguished witnesses. I will
begin.
When we are through, I am going to ask each of the
witnesses to answer this question, if you were the king or the
queen and you could do two or--let's say three things to be
ready for the next pandemic, what would those three things be?
Now, Dr. Frist I only have five minutes, but let me start with
you with this question. Someone might ask, why are you taking
time in the midst of this pandemic to talk about planning for
the next one? How would you answer that question?
Dr. Frist. Yes, I think the points are made. We need to end
this pandemic. But, we don't know even when a second surge is
going to come. So as much as we can do to prepare that
infrastructure and the structure itself for the next pandemic,
the next emerging threat, it will apply to what we are doing
now.
The sense of urgency is simply that we have identified
pretty quickly in the last several months the needs that are
out there, which we have talked about in this hearing thus far,
and now is the time to go ahead in a parallel fashion, pass
legislation, and I would add things like the telehealth hearing
that you had the other day, good things you can do now which
will make either a second surge preparation more adequate or
another pandemic which will occur more tolerable in the future.
The Chairman. Thank you. And as each of you said, memories
are short and we will move on to the next issue if we don't
deal with this one now. Now, let me go to Dr. Gerberding and
Governor Leavitt first. Let's talk about manufacturing. Let me
drill down on that a little bit. We dealt with manufacturing
before. We built three manufacturing plants.
Today, we have 10, 12, 14 of vaccines that are racing
toward trying to produce several hundred million doses by early
2021. Ideally, what sort of manufacturing capacity should the
Federal Government have on hand, ready to produce these doses
and to distribute them properly? Can we just rely on the
private sector to do that or should we have our own
manufacturing plants? I thought we did that with three
manufacturing plants. Are they adequate? What happened,
Governor Leavitt?
Mr. Leavitt. As time has gone on and the urgency has
diminished, we have seen the ongoing funding of those,
particularly in the area of maintenance and keeping them warm--
we invested and I think properly invested in partnerships to
enhance it. What I think we did not do adequately as a country
over the course of time is maintain them in a way that they
were warm and could be stood up quickly. I will also mention
that we have a big challenge in being able to fill and finish
and distribute that infrastructure.
Yes, the private sector can in fact be very important in
that process because that infrastructure exists, but planning
how it will be distributed, who will get it first, etc. is a
big need and it is one that will need to deal with, to Senator
Murray's point, even now. So if we have time, and I know that
the Department is likely working on this, but that is a
critical need.
The Chairman. Dr. Gerberding, you have seen it from both
sides, the Government and now the private sector. Should we
build manufacturing plants or pay for the private sector to
build manufacturing plants for the future, or can we remodel
those we now have? What should we do? What is a smart strategy
in manufacturing for the Federal Government?
Dr. Gerberding. One thing Senator to point out about the
manufacturing that has been built in these partnerships is that
was primarily targeting influenza, and influenza vaccine is a
dual-purpose vaccine because of course we have seasonal flu
every year and the idea would be they can call upon those
seasonal flu operations to flex in the case of a pandemic as we
did in 2009 when we were experiencing H1N1 pandemic. Broadly
speaking, the few large manufacturers of vaccines that are
still in business are nearly at capacity just to create the
vaccines that we need for day-to-day purposes and immunizing
our population against known threats.
We clearly need an emergency capacity buildup. And in my
view that is best done in private, public partnerships. We may
get to a point, as we experiment with these 130 products that
are in various stages of development for this pandemic, where
we understand the concept of a platform approach, meaning that
we can repurpose a given facility easily for the next problem
that comes along and that we don't have to go back to ground
zero and build a new each time a new and unfamiliar need for
vaccine arises.
I think a partnership model works best and we must not
remove the incentives for the biopharmaceutical industry to
continue to innovate. It is that innovation that has gotten
this far this fast in this particular pandemic, but at the same
time we can't invest at scale for 130 candidates. We have to
make choices. And that is where the NIH----
The Chairman. My time is up and I want to respect the five-
minute limit as interesting as the comments may be. Thank you.
Senator Murray.
Senator Murray. Thank you, Mr. Chairman. Thank you to all
of our witnesses. Really appreciate your testimony today. Dr.
Khaldun, the United States COVID-19 response has failed to keep
black and latino families, Indian tribes, and other people of
color healthy and safe. Disproportionately high numbers of
people of color are becoming seriously ill or dying from COVID-
19.
This tragic reality is driven in part by long-standing
systemic racism and underinvestment in communities of color,
which have contributed to significant health disparities, but
it is also a result of this administration's failure to take
these disparities seriously and devote attention and resources
to the communities most in need of assistance. I am going to
ask you today, what can we do to address the immediate impact
of the pandemic on communities of color?
Dr. Khaldun. Thank you, Senator Murray, for that question.
So we in the state of Michigan have identified these
disparities very, very early. The Governor actually announced
quickly a task force to really understand why these disparities
exist and then to develop specific recommendations for how we
address them. So some of the things that we have done is making
sure that testing is accessible in minority communities.
We actually worked with the communities to bring testing to
places where they normally wouldn't have access to care. We
have also eliminated costs for a lot of our testing sites so
you don't have to worry about it if you don't have insurance or
even if you don't have a primary care doctor. A lot of our
sites in Michigan for testing, you don't have to have a
doctor's order in order to be able to get a test done.
Then we have to think about all of the people who have been
deemed essential during this pandemic and been coming out of
their homes to have to work and how we can protect them. So
making sure they are not allowed to lose their jobs and that
they get supports at home so that they can be able to be as
safe as possible.
Senator Murray. Thank you. Obviously, we have to work on
this. We can't ignore it as we have been doing and I think this
is a really important point we need to think about not just for
today, but moving forward, so thank you. Dr. Gerberding, we
have a very robust system for evaluating vaccines.
Unfortunately, we have seen some concerning polling already
suggesting some Americans would not be willing to get a COVID-
19 vaccine. So the time to build that confidence is right now
and a number of experts are expressing concern that President
Trump's vaccine acceleration process known as Operation Warp
Speed could undermined confidence in COVID-19 vaccine,
particularly, if the public perceives that a vaccine was rushed
out for political reasons or without rigorous review. What
specific commitments should the administration make right now
to build public confidence in a vaccine?
Dr. Gerberding. There are two things that I would
recommend, one is transparency about exactly what the safety
assessments are and that involves the participation of the ACIP
at the CDC, the FDA, and several of the other scientific
organizations that have an oversight of that. The second thing
that I would propose is that the safety be monitored by the
National Academy of Medicine.
This is something that has happened many years over the arc
of childhood immunizations and when I for example had
responsibility for administering the smallpox vaccination
program for First Responders, it was the National Academy of
Medicine that monitored the safety of that program and helped
us identify very early that there was a safety signal. So I
think involving the scientific community, credible experts,
apolitical and orientation is really going to be a very
important part of building this trust.
Senator Murray. Okay. And a comprehensive plan, I would
assume you would agree?
Dr. Gerberding. Absolutely. Yes, absolutely.
Senator Murray. Senator Frist, good to see you again. You
have repeatedly emphasized the importance of strong public
health funding and argued that insufficient public health
investments have met state and local public health departments
are responding to COVID-19 with, ``one hand tied behind their
backs'' and you have argued for the creation of a $4.5 billion
mandatory annual investment in public health infrastructure. I
think this is something that is critically important and I want
to ask you, if we were to create such a fund, how do you
predict the U.S.'s response to the next infectious disease
outbreak would look different than what we currently have?
Dr. Frist. Well, I think all or many of the panelists have
empathized this importance of the sustained funding and the
public health infrastructure fund is one option to do that, one
that I do support.
A strong public health system can quickly alert us to
problems. You can build resilient communities that are healthy
and socially connected. It creates a reserve capacity to
respond to an emergency of any kind which is why I co-authored
that op-ed with Senator Daschle and the FDA Commissioner Andrew
Von Eschenbach in support of what was a $4.5 billion public
health infrastructure fund. It is really interesting.
We have not consistently provided the type of funding this
needed to build an ongoing strong public health system. If you
look back at the Great Recession, frontline state and local
health departments have lost more than 56,000 positions due to
funding cuts. These are the people we need whether for contact
tracing or epidemiology. They have been lost now over the last
about 10 years.
Strong predictable investments from the Federal Government
will ensure that public health departments here on the ground,
in your community are fully staffed and resourced and able to
handle the needs of today's demand for things like the contact
tracing force.
Senator Murray. Okay. Thank you. Thank you, Mr. Chairman.
The Chairman. Thank you, Senator Murray. Senator Burr is
next and for 17 years he has been busy writing many of the laws
we are talking about today.
Senator Burr.
Senator Burr. Chairman, thank you. Thank you for that
recognition. Senator Frist, Secretary Leavitt, Dr. Gerberding,
Dr. Khaldun, welcome. We value the ability to pick your brain
on this. I think this is probably the most important period in
this pandemic it is when we begin to do the after action review
and figure out what worked, what didn't work, what needs to be
changed, and it is important that Congress go through this
process.
When we moved the last PAHPA reauthorization bill out of
this Committee, I reminded my colleagues at that time, this was
by no means the finish line and much work remained for us to be
better prepared. Dr. Gerberding, you were in a unique situation
at CDC and now in the private sector, but in your testimony,
you advocate for a greater use of public-private partnerships.
During our last HELP Committee hearing on the pandemic, I urged
the CDC to put these types of collaborations in place so that
we could leverage innovative technology companies and our
ability to detect, to identify, and detract threats including
emergency infectious disease.
Given your experience at the helm at the CDC, why was the
agency so ill-equipped to put these types of agreements in
place before the pandemic and what would you recommend to CDC
going forward as it relates to public, private partnerships?
Dr. Gerberding. Thank you, Senator. And I must say I don't
know what the CDC was or was not doing in collaboration with
private sector partners. Just seeing it from the outside
looking in, there has been a tradition of recognizing the
importance of the private sector when I was there. We had desks
in the Emergency Operation Center for a number of private-
sector entities that we recognized as important in the supply
and stockpiling logistics and testing, etc.
But I will also say that there are some complexities of
working with the private sector and Government. And I just go
back to what Governor Leavitt said in the context of planning
for influenza pandemic where we recognized that the Federal
Government has a critical role but we had learned then and what
I think we are seeing now is that the private sector is
powerful, and leveraging that power and those resources is
essential to being able to scale a national response.
Senator Burr. Well, I thank you for that. I think that the
deficiency was most evident in testing and the inability for
CDC to reach out to the private sector. Thank goodness PAHPA
reauthorization allowed greater expansion of authorities by the
directorate FDA to use emergency use authorizations to set up
these public-private partnerships, and we have probably more
capacity than is being utilized in testing nationwide today.
One of the areas where efficiencies can be gained in vaccine
manufacturing and production is through the use of platform
technology, Dr. Gerberding.
For example, Merck licensed the Ebola vaccine platforms
being used to develop coronavirus vaccine. How can we enhance
the coordination between innovators, BARDA, FDA to ensure that
these platforms against these threats is as efficient as
possible when the need arises? In other words, how do we keep
these platforms as an approved entity and we only do the
clinical proof on what we are trying to treat off the
platforms?
Dr. Gerberding. I think BARDA is well on its way to being
able to accomplish that. I think CEPI is another model, the
Coalition for Epidemic Preparedness Innovation. But what needs
to happen is not necessarily having a focus on efficiency. We
need to have a broader expectation that will invest in a lot of
things that won't pan out. If we aim for efficiency, we are
going to be slow and miss the boat. We need to be prepared to
experiment, to try a broader array of things, and I continue to
think that BARDA is critical to the coordination of all of
that.
Senator Burr. Thank you for that, Dr. Gerberding. This
question is to my good friend, Mike Leavitt and Bill Frist. We
did what I thought was revolutionary at the time with the
investment in three flex manufacturing facilities for vaccines.
And the testimony has been correct that they were designed for
the annual influenza or some variation, at the time H1N1, H5N1,
and they are very difficult to program over and surge in front
of that vaccine for coronavirus. Can both of you give us what
you think this Committee should do legislatively to encourage
the creation of some type of multi-manufacturing facilities
that can be utilized when the Federal Government feels a
national need?
Mr. Leavitt. I will respond quickly. First, just annual
appropriation, supporting it when there is not a crisis is the
first thing that has to happen because it is keeping facilities
warm and keeping access to them during those periods that makes
it possible when there is a need.
Senator Burr. Senator Frist.
Dr. Frist. Yes, and Senator Burr, again, thank you. I just
17, 18 years ago I remember all the nights in the majority
leader office as you helped put together BARDA so thanks for
that. You know, I think it is going to come down a little bit
to what Senator Murray asked about increased funding and how we
do it. I am on record as supporting a mandatory appropriation
about $4.5 billion fund but also I mentioned my testimony the
HD, which is an annual appropriation which really comes to what
Governor Leavitt talked about.
An annual appropriation in a sort of an advanced category
would allow you to fund it to BARDA individually, to NIH
individually, discretionary funding, and to the NIH all three,
but it would be annual and it would be annual appropriations
with oversight by the U.S. Senate, by the Congress itself. That
does have the advantage of this timeliness of incorporating
science, what is needed at a particular time and guarantees
that funding in a sustained way. So I would also encourage
looking at that because that immediacy of what is needed to
years from now is going to be very different as we just saw
with flu vaccine manufacturing versus the current
manufacturing.
It is going to have to be flexible and it is going to have
to be nibble, and you might consider, even though it is not
directly in your Committee, that sort of annual appropriation
oversight be able to support the type of public-private
partnerships in this area of manufacturing.
Senator Burr. Thank you, Mr. Chairman.
The Chairman. Thank you, Senator Burr. Senator Casey is
next and he too has been very involved being the principal
Democratic co-sponsor of the last reauthorization of the PAHPA
bill, I believe.
Senator Casey.
Senator Casey. Mr. Chairman, thank you very much. And thank
you for noting that, and I am grateful for the testimony of our
witnesses and the wisdom and experience they bring to bear on
these issues for this hearing. I wanted to start with Dr.
Khaldun regarding what you have seen in a lot of what is in
your testimony with regard to the challenges faced in the state
of Michigan like so many other states. I know that Detroit,
obviously one of the hardest hit cities in the country, just
like all major cities, like Philadelphia have been hit,
especially in the black community and that is true in so many
of our urban areas.
I know that in your testimony, I guess when you compare the
percent of the population of African-Americans in Michigan,
about 14 percent but 40 percent of the deaths and more than 30
percent of the cases. In our state the death number, percent
might be a little lower, but it far outstrips the percent of
the population. We have had to date at least 1,368 deaths of
black Pennsylvanians from COVID-19. So I have two questions,
the first one is, how have the social determinants of health
impacted people's ability to protect themselves and their
families from the virus and from the COVID-19 disease?
Dr. Khaldun. Well, thank you, Senator Casey. So absolutely,
when you talk about the health disparities that we are seeing
not just in Michigan, but across the country, those social
determinants of health, so housing, transportation access to
healthcare, poverty, those are things that we believe are
really contributing to the disparities in COVID-19 as they
contribute to other health disparities.
Again, people who are of color are more likely to live in
poverty. They have been more deemed as essential workers coming
out of their house instead of being able to safely work from
home, needing to take public transportation, living in crowded
or perhaps unsafe living conditions making them more likely to
spread COVID-19. So those are some of the things that we have
seen in Michigan that we believe are contributing to the
disparities.
Senator Casey. I guess as well some, many I should say,
African Americans are the ones who are on the frontlines and
often the very front of the front line. Is that correct?
Dr. Khaldun. Yes, that is correct, Senator Casey. So again
going back to the fact that people of color are more likely to
live in poverty and therefore more likely to have those lower
wage jobs, some of our grocery store workers, bus drivers,
those types of jobs. And those are the exact people that when
across the country we had stay home or stay safe orders, a lot
of those people were unable to stay at home. They had to come
out and I believe that contributed to the disparities and the
disparate numbers of deaths that we have seen.
Senator Casey. Thank you, doctor. The second question I
have is, we know that public health is driven at a very much a
state and local level. But obviously this pandemic has reminded
us that all levels of Government need the help of the Federal
Government. And I guess when you step back and look at where we
have been, what parts of the response so far do you believe
require coordination and the convening power of the Federal
Government?
Dr. Khaldun. Yes, so I think that very early on, and first
let me actually start by saying I really appreciate the support
of my Federal colleagues at the CDC who since January has been
really supportive of us at the state and local level in
Michigan. But I do think that we should have had, as I said in
my testimony, a more urgent testing response in our
communities.
Early on in my state labs, we were preparing in January
actually to be able to perform the test, but we ran into delays
and I am sure that in Michigan because of those delays, there
were people who weren't tested and the disease was spreading
before we even knew it. So I believe that a coordinated
strategy at the Federal level would have helped us in that way.
Also with PPE, we had to fight other states and even local
Governments in being able to get access to PPE and it really
delayed us and I think exposed many more people to the virus in
Michigan.
Senator Casey. Finally, Dr. Gerberding, I want to thank you
for your help in Pennsylvania helping our citizens and our
state to better understand what we have been up against and am
particularly grateful for that. I guess in the 30 seconds we
have, you spoken about an immunization infrastructure. Could
you fill in for us, I know your testimony spoke to this, the
kind of the who, what, when, where, the mechanics of that, who
should be involved and what role the Federal Government should
play?
Dr. Gerberding [continuing]. Are just beginning to improve
that for adolescents and adults but it is fragile and I think
one of the most important things that is not getting enough
attention right now is the fact that distributing this vaccine,
even in the United States, is going to be incredibly
challenging, making the decision about who goes first, how to
allocate doses as they become available, and how to sustain
that atmosphere of trust and willingness to step forward and
receive it.
The infrastructure for that is going to be local and that
means that we need to support our local and State health
officials in getting ready to make those really hard decisions
and implement that really macro-program.
Senator Casey. Thank you. Thank you, Mr. Chairman.
The Chairman. Thank you, Senator Casey.
Senator Collins.
Senator Collins. Thank you, Mr. Chairman. Dr. Frist, it is
great to see you again. We have missed you. One of the lessons
from the COVID pandemic is that our country is far too
dependent on foreign manufacturing of drugs, diagnostics, and
medical supplies. For example, about 80 percent of the basic
components used in medicines, the active pharmaceutical
ingredients, are coming from China and India for our U.S.
market. The exact dependence remains unknown since there is no
API registry. Well, what happened is just about the time that
the COVID-19 epidemic hit the United States, India stopped
exporting 26 APIs and finished drugs.
The CARES Act includes portions of legislation that I
introduced with Senator Tina Smith, the Meds Act, that includes
greater reporting requirements on the sources of APIs as well
as redundancy plants and tended to deal with shortages, but are
there specific incentives that the Senate should consider
specifically to encourage domestic manufacturing, including
perhaps tax incentives or greater investment in FDA's emerging
technology program?
Dr. Frist. Thank you, Senator Collins. I think this whole
coordination of procurement is huge and in the Committee's
white paper, you talked about coordination, procurement as
being a very clear and important Federal responsibility. As you
pointed out, we have been inadequately prepared here. We have
seen it day in and day out and we can do so much more to
establish this resilient domestic right here at home
manufacturing lines, detracting of supply chains, ensuring a
robust support of the national strategic stockpile.
The incentives will have to be financial. The real problem
in these public, private, or the real challenge in these
public, private partnerships is this lack of continued funding
over time to adjust to the market, where on the private sector,
they will be generous and they will be patriotic but at the end
of the day, they do need to report fiscal responsibility. So we
have to step in and whether it is with direct tax credits,
whether it is with a funding stream by an artificial market
that is set up over time, we do have to keep a revenue stream
out there that is dependable, it is sustainable, and that is
long term, and that is flexible because it will change year to
year in terms of what those manufacturing, the specific
manufacturing needs are.
As for the testing itself, the tests are remarkable right
now between the public-private partnerships and the private
sector moving ahead and is being revolutionized before eyes in
a very quick fashion. Now, it came too late. It came too late
but now there is an encouraging more and more of that with some
sort of financial incentive.
Senator Collins. Thank you. Dr. Gerberding, last month the
Aging Committee held a hearing on the impact of the coronavirus
on older adults living in nursing homes. And that hearing
reaffirmed my belief that a baseline test for all residents and
staff, not just those that are symptomatic, is necessary to
prevent outbreaks. COVID-19's impact on long-term care settings
directly intersects with the stark racial disparities have we
are seeing, and unfortunately, remarkably Maine has the
Nation's worse COVID-19 racial disparity.
Many of the worst outbreaks that have occurred in Maine are
in nursing homes and the CDC reports that some 40 percent of
those health care workers that have tested positive were
identified as black or African Americans. As a former director
of the CDC, what do you recommend as the best way for Congress
to help address this racial disparity among those that are the
frontline workers in our nursing homes?
Dr. Gerberding. Thank you, Senator. Obviously we need to
test symptomatic people and their context but to me the third
most important reason to test are the people who are working in
these known high-risk environments and clearly nursing homes
are among those at the top of that list. Those are intrinsic
hot spots and we need to test often and test everyone who comes
and goes from those centers until such time that we can
demonstrate that transmission has been contained.
I can't say enough about how critical it is to not overlook
the most vulnerable people and that includes the elderly people
but also those who are vulnerable on the basis of underlying
conditions and often that tracks with the racial and ethnic
disparities that you are alluding to. It is a very difficult
challenge. The solution to it is multifactorial.
It really is a reflection of the social determinants of
health as much as anything else and that is a long answer, and
I know I have a short period of time, but the first step is to
make the measurement clear and transparent so that we all have
to stare it in the face and recognize that we are not
successful until we deal with that challenge.
Senator Collins. Thank you.
The Chairman. Thank you, Senator Collins.
Senator Baldwin.
Senator Baldwin. Thank you, Mr. Chairman, having trouble
with my mute button here.
The Chairman. You are on now.
Senator Baldwin. Great. Thank you. So I wanted to start by
just reflecting that every Member of this Committee would love
to be able to turn the page on the current pandemic and start
planning for the next one, but the cases of COVID-19 and
hospitalizations continue to rise and we can't divert our
attention from the ongoing crisis. And I think it is very clear
that the administration has not yet learned a critical lesson
particularly about worker safety. Without enforceable worker
safety standards, workers and their families are needlessly put
at greater risk when they go back to work.
Guidelines from the CDC have not been enough, and yet the
Occupational Safety and Health Administration has failed to
move forward with mandatory and meaningful rules for employers.
In response to disturbing widespread reports of safety concerns
leading to preventable illnesses and deaths, I introduced the
COVID-19 Every Worker Protection Act. This bill would require
OSHA frankly to do its job and to issue an emergency temporary
standard that establishes a legal obligation of all workplaces
to implement infectious disease exposure control plans that
would keep workers safe during the COVID-19 pandemic.
Dr. Khaldun, do you believe that giving employers clear and
mandatory rules through an emergency temporary standard would
help improve our public health response by protecting workers,
their families, and their communities during a pandemic? And
correlated with that, why is a focus on worker safety
particularly important for communities of color and others who
have been disproportionately impacted by COVID-19?
Dr. Khaldun. Thank you, Senator. So, absolutely. The health
and safety of our frontline workers has been incredibly
important. I think it is really unfortunate that a lot of our
frontline workers have been infected by or even died from
COVID-19. In the state of Michigan, our Governor did issue an
executive order that established robust protections for our
workers so that is incredibly important. It goes back to these
social determinants of health and the fact that communities of
color are more likely to live in poverty and have these lower
wage jobs. So again, they have had to come out of their homes
instead of being at home during this pandemic, so it is
incredibly important.
The Chairman. Senator Baldwin, we have lost your signal and
we will wait just a moment. See if we can regain it. If not, we
will go back to you--why don't we move on to Senator Cassidy
and then we will come back to Senator Baldwin, let her reclaim
her time when ever she regains her internet signal.
Senator Cassidy.
Senator Cassidy. Thank you all for being here. I appreciate
your service in the midst of an epidemic. I have got questions
to begin with, with Mr. Leavitt and Dr. Gerberding. Let's kind
of reflect on your past history, if you will.
Dr. Gerberding, all of you are recommending lots more money
for the Centers for Disease Control and public health,
mandatory spending almost most of you. If you are not saying
that specifically, it seems as if you wish it to be mandatory.
There is a lot of folks out there that feel as if the CDC has
not responded to the challenge with the money that they have
been given and before significant more dollars are given, would
like to see some sort of recommendations for reform. So some of
the criticisms made, which I have made some of them by the way,
whether it is right to make them are not, a little bit slow to
the mark, laborious contracting with lots of red tape, a loss
of focus, afraid to take bold action, and they misjudged
terribly the rapidity by which the virus would spread
throughout our community.
Now, if we are going to ask to give them another $4 or $5
billion and more and more and more, I think it is fair to say,
is there reform that could be instituted, that you are just not
putting more money into a system which is inherently not
working well, but rather more money in system which is
streamlined so that it can work better? What are your thoughts
on that, may I ask?
Dr. Gerberding. You know, I have known the CDC for a long
time before and after I worked there and I can say that the
scientists who are there are national treasures and the
scientists who are there leading this pandemic are the same
scientist that were there when I dealt with SARS. So I don't
think it's a deterioration of the science or the scientific
capability of the agency.
I do think the scale of this response would test any public
health agency as it has around the world, but I also do think
that modernization is a word that really needs to be the
framework for considering where do we go from here. One of the
things that I would acknowledge, and maybe Governor Leavitt
would like comment, is that when we did extensive rehearsal for
influenza pandemic preparedness, again involving some of the
very same people, we rehearsed everything except one thing, we
didn't rehearse testing because in influenza you don't rely on
the test to make the diagnosis and make the decisions. So the
whole apparatus necessary to scale test to 300 million people
was not something that we practiced and we made----
Senator Cassidy. Let me ask, and I can concede that
although it seems as if there could have been--because I
understand in different times people were concerned about
bubonic plague and other kind of exotic infectious diseases
coming in, so it seems that testing could have been imagined as
an issue, but there has so far not been a plan I have seen to
actually go beyond mitigation into actual suppression. And so
we have communities that have moved beyond litigation that
should be in suppression, but again, we don't see the plan for
that. So what would be your response to that?
Dr. Gerberding. Well, I am not sure I could agree with you
on the we have ended the mitigation phase and are into
recovery. This virus is still not----
Senator Cassidy. I am not speaking nationwide. I am
speaking particular communities.
Dr. Gerberding. But in every community the vast majority of
people remain susceptible so they are only one visitor when
travel away from exposure.
Senator Cassidy. Which is why you need the suppression, I
guess. Let me go to you, Dr. Leavitt--Mr. Leavitt, I am sorry.
The defenders of the CDC said it actually put good stuff out
there, but there is a review process that squashes it, and yes,
they actually have thought ideas that would say Montana you are
so low, we can move to a suppression strategy, but they float
it, it gets killed.
Now, I look at the interaction between CDC and HHS and the
White House as a black box, but someone told me that the
Congress should demand recommendations without review. Meaning
that we get the recommendations for those, what that means, I
didn't. That we get the recommendations unvarnished, not if you
will kind of looked at through the political lens or through
the lens of that which the administration wished to have. It is
the pure scientists that Dr. Gerberding just kind bragged on.
What are your thoughts on that?
Mr. Leavitt. I am inclined to believe that Congress getting
the facts in an unvarnished way is a good thing and that good
ideas will be held up under scrutiny. I will point out that
there are times when even within a Department or the Government
there are conflicting missions. Testing is a good example. CDC
had the mission of being able to get testing out quickly. FDA,
it was about being accurate. Sometimes accurate and quick don't
align, and in a situation like that, in an emergency situation
that occurred. I too agree with.
Dr. Gerberding, CDC is a treasure not just in the United
States, but around the world in dealing with disease around the
world. If you look at international organizations and lift up
the hood, you will see at the heart of that are the scientists
in CDC, and I know you are not intending to diminish that but
it is--in an emergency, it is easy to be critical in an
emergency. The reality is they need support.
Senator Cassidy. I accept that but I think with Dr.
Gerberding said about modernization, if we don't have
modernization, it is going to be difficult to get people to
support the more financially. I yield back.
Mr. Leavitt. I totally agree with that, particularly in the
data infrastructure. Our data infrastructure, the ability to
collect data from the states in an almost real-time, be able to
create situation situational awareness, that is one of the
fundamental important duties of the Federal Government in a
pandemic situation is to provide situational awareness.
Senator Cassidy. Thank you.
The Chairman. Senator Cassidy.
Senator Murphy.
Senator Murphy. Thank you very much, Mr. Chairman. Thank
you to all of our witnesses. Senator Cassidy knows the high
regard in which I hold him and he is not wrong that there needs
to be reform at the CDC going forward and admission of the ways
in which they didn't measure up. But let's just be a hundred
percent clear here, the CDC is trying to do good work here.
They are sending out regular guidance on the importance, for
instance, of wearing masks as maybe the most evidence based
method of preventing the spread of this disease.
The President of the United States refuses to wear a mask.
His top advisors refuse to wear masks. He says it is an attack
on him politically for people to wear masks. The CDC develops
guidance for individual industries and businesses to reopen.
The White House then prevents that guidance from being
dispensed to states because the White House doesn't want to
take responsibility for the decisions made to reopen the
country.
I think the CDC needs to do some hard looking internally,
but I also think that they have been prevented from doing the
best work they could by this administration, this President. I
appreciate the focus of this hearing moving forward, but any
good fire department that has a house on fire and a house next
door that is in danger of catching on fire does both, they put
out the fire at the house that is engulfed in flames and they
try to do work next door to prevent the next house from
catching fire. We are not doing both in the Senate right now.
We are holding a hearing on getting ready for the next pandemic
and we are not taking up any legislation this work period in
order to address the existing pandemic.
I want to frankly direct some of my questions to our
witnesses with respect to what we could be doing now, which I
think also probably is part of the conversation about what to
do moving forward. Dr. Gerberding, you referenced how important
it was for us to join the international vaccine effort, CEPI.
The Coalition for Epidemic Preparedness Innovations is a
multinational public, private sector collaboration to develop a
vaccine for COVID-19.
It is also working on other vaccines as well. I agree with
you. We should join CEPI as a mechanism to get ready for the
next pandemic but we should join CEPI right now, correct? There
is no reason to wait, especially given that they are doing most
of their work as we speak on a vaccine for COVID-19.
Dr. Gerberding. I completely agree with you, Senator.
Senator Murphy. Just underscore why that is important. Why
is it important for us to be in CEPI right now as they develop
a COVID-19 vaccine?
Dr. Gerberding. Well, CEPI is already funding many of the
biopharmaceutical entities that are working on vaccines. So
they have already reviewed and invested, but they also are
positioned uniquely right now on a global basis to help
adjudicate the allocation and the planning for how we are going
to solve this global problem because we are not safe until
everyone is safe.
That means we have to be thinking about vaccine in the
billions of doses not in the hundreds of millions of doses. So
right now CEPI is probably the leading organization, together
with many other partners, to provide the credibility and the
scientific oversight to try to make sure we do that right.
Senator Murphy. It is pandemic response malpractice for the
United States not to be part of CEPI. All of our allies, all of
our friends are part of this organization. And while we hope
that it is our funding and our domestic programs that develop a
vaccine, if it is a CEPI partner develops the vaccine, we want
to be at that table. That is something we can do right now.
Dr. Khaldun, we talked a little bit about supply chain and
what we do moving forward to try to prevent the problems that
happened this time around. But in my state, the supply chain
crisis isn't history, it is present. We still can't get PPE at
our nursing homes. I was just at a hospital testing site last
week and they don't have enough cartridges to be able to do
their quick turnaround tests. I just want to be clear, Dr.
Khaldun, the supply chain crisis isn't fixed is it?
Dr. Khaldun. That is correct. We still in our state have
lab capacity to be able to do at least twice as many labs as we
are doing now, but we are limited by the number of swabs and
reagents. So that is absolutely still a challenge.
Senator Murphy. I think this discussion is really
important. I have argued from the beginning that you can't wait
for the next pandemic to hit us in order to get ready, but we
have not beat this pandemic. On Sunday, there were one 183,000
new cases reported globally. That was the highest number of
cases on any single day since the beginning of this pandemic.
And that was Sunday.
It was Sunday and we are going to break for a very nice
July 4th recess for Members of Congress who still have jobs,
who are largely still healthy without having passed any
legislation to try to help states, help local, public health
districts address an epidemic that is still present. We need to
be able to do both and my worry, Mr. Chairman, is that we are
not at least during this work period. Thanks for the
opportunity to ask questions.
The Chairman. Thank you, Senator Murphy.
Senator Roberts.
Senator Roberts. Thank you, Mr. Chairman. And thanks to all
of the witnesses. I would like to thank Chairman Alexander,
Senator Burr for working with me over the years to help address
this issue, particularly during our work on something called
Pandemic All-Hazardous Preparedness Act and response to the
COVID-19 pandemic. We are making progress and in March Congress
passed the CARES Act which included the Priorities Zoonotic
Animal Drug Provision or PZAD. Everything has to be an acronym.
This provides a pathway at FDA for expedited approval of animal
drugs that have the potential to prevent or treat a zoonotic or
vector-borne disease.
This isn't new, Mr. Chairman. It isn't as if the dogs
haven't been barking about this back in the day when I had the
privilege of being chairman of the Emerging Threats Committee
on the Armed Services Committee. We were in charge of the Nunn-
Lugar Program and we were allowed into secret cities in Russia
at that particular time. Obviously, we are not now. But there
was one that I visited called Obokensk. It is about 60 miles
north of Moscow and it was there that we had a whole range of
scientists and I saw warehouses full of pathogens. It was
stunning. It was shocking.
Everything from Ebola to Smallpox where there was no
preparedness or no treatment, but the big one was hoof and
mouth disease and these scientists were trying to weaponize
these pathogens for an attack on a Nation's food supply. Well
now we have seen that with COVID-19. Not exactly with regards
to the livestock that we have but we have seen it in the
packing houses and what it does to the food supply chain. So,
and back at that particular time when Bill Frist was our
Majority Leader, he was also our doctor with regards to every
Senator.
Bill, I still want to thank you for what you did for me
with one malady that I was suffering from. Bill had no patience
for patients that were a little reluctant and so he took me by
the arm, arched me into the cloakroom, got Dr. Cameron on the
line up at Johns Hopkins and made an appointment for me, not
the next day but the following Monday at 7 o'clock in the
morning.
I then had the wonderful experience of enjoying 10 days of
my life at Johns Hopkins. The view was nice in terms of
Baltimore, but I didn't particularly want to end my days there
which was not the case. Bill, thanks for everything that you
have done for me and for a lot of Senators. The question I have
is what are we doing now? One thing I want to point out, we
have the National Bio Agriculture Facility, the replacement for
Plum Island, at a level 4 lab at Kansas State University. It is
a Consortium with other land-grant schools.
Again, we are making some progress. That facility will be
open in 2022, but it is open right now doing some work and
additional work at Kansas State. Now, the question I have is,
we used to have exercises and I know of three. The first one, I
played the role of the President. We had a hoof and mouth
disease outbreak. Started in Texas. By the time Oklahoma
figured out, it was in North Dakota. All of our exports
stopped. Our entire food supply chain stopped. We had to
euthanize millions of head of cattle. It was something we never
experienced before. I know that leaves two others.
I am not sure we are doing that today and I don't know why
we are not now. Now, we have a wonderful exercise with COVID-
19, it just happens to be real. Senator Frist I am going to ask
you this question. What can we do, and this is for all the
witnesses, to continue facilitating coordination between public
health and agriculture sectors and improving our surveillance
in these areas before we have an outbreak? Dr. Frist, please.
Dr. Frist. You know, it is--one of the things that these
pandemics bring out is a reason I was able in 2005 to be so
certain that we would have an infection and I mentioned, I
predicted it coming out of China or it could have come out of
these congested areas in Africa, is this integration, this
assimilation between human and animal. And if you look at the
layout for the future, almost certainly the next virus will
emerge through this chain of anergenic shifts and drifts to
come between animals coming to humans. I didn't first
appreciate it.
But in 2001 when Anthrax hit our Capitol and about a third
of Senate was moved out of their offices for a year, this
symbiotic relationship and this focused understanding, this
important understanding of the veterinary world with human
health and I would also add with environmental health. It is
all one health.
We in our own ways are very isolated and insular and
thinking silos. The only way to bring people together, to
expand their thinking, their diversity of thinking in real time
are these exercises in each should be built into every
administration. It should be done on an annual basis. And from
that we will be able to predict in almost exponential type
thinking things like this need for testing, which we have
missed in the past.
Senator Roberts. I appreciate it. Thank you, Mr. Chairman.
The Chairman. Thank you, Senator Roberts.
Senator Warren.
Senator Warren. Thank you, Mr. Chairman. No, I have to be
honest. I am puzzled by the topic of today's hearing which asks
us to start preparing for ``the next pandemic.'' The next
pandemic. What about the pandemic that is going on right now.
You know, the last time I checked the U.S. was still fighting
coronavirus and losing. Cases are rising rapidly over 20 states
and hundreds of people are dying every single day. In
Massachusetts, we learned firsthand just what happens when the
Federal Government isn't prepared for a pandemic.
Back in March, we asked the Federal Government for medical
supplies. Weeks later, only a fraction of those supplies had
arrived and the Federal Government was reportedly seizing
shipments that were headed our way. Now, even as the cases have
come down, supply chain problems persist. Doctors in Milton are
using construction goggles as PPE and Massachusetts General
Hospital told the Boston Globe that its supply chain was,
``fragile.'' If we don't apply the hard lessons learned in
Massachusetts, states like Florida and Texas and Arizona where
cases are now rising are going to pay the price.
Dr. Khaldun, Michigan has also experienced some of these
supply chain problems. Since March, the Federal Government has
implemented systemic ways to try to ensure that states with
rising COVID caseloads will have all the masks and gowns and
testing kits and other supplies that they need. Is that right?
Is that what has actually happened in Michigan?
Dr. Khaldun. I am grateful and thank you, Senator, for that
question. I am grateful for the support of my colleagues at HHS
and FEMA. They have been regularly sending us supplies. But
quite frankly, they have not been enough. Some of the supplies
that we have received have been expired. And so we still are
working aggressively to try to make sure we have enough PPE for
now and the potential second wave that we will probably see in
Michigan come the fall.
Senator Warren. Yes, it sounds like the very clear supply
chain lessons that were learned by the states that were hit
hard early on are just simply not being applied even though we
are now more than three months into fighting this virus. So
here is another one to focus on. As Massachusetts fought to
reduce the spread of COVID-19, it developed a robust contact
tracing program that is now the model for the Nation.
Experts agree that contact tracing is essential to
successfully contained coronavirus. So Dr. Khaldun, Michigan
has also invested in contact tracing and tracking information,
and 500 Michiganders, as I understand it, are already working
on tracking these infections, but the state could use more
support. So let me just ask you, do you need more resources for
this work and do you think that we should have a nationwide
contact tracing program to help states that are dealing with
COVID-19 cases?
Dr. Khaldun. Absolutely, Senator. So, yes, absolutely. I
think we should have a Federal strategy for contact tracing. We
have over 10,000 Michiganders who have volunteered to do this
contact tracing, more than 500 of them are already deployed. We
have additional paid staff throughout the state. What has been
a hodgepodge of local, state and Federal Governments trying to
support this. Some more support would actually be welcomed from
the Federal level.
Senator Warren. Well, I think--it is important for all of
us to hear your voice on this. I appreciate it, Dr. Khaldun.
You know we are nowhere near close to a national contact
tracing program. The House has passed key provisions of the
contact tracing legislation that I introduced with Congressman
Levin from Michigan, but Republicans in the Senate have refused
to provide states with the funds they need to trace coronavirus
infections. So let's have one more turn of this.
Let's talk about who is going to be hit the hardest if we
don't learn the lessons of the past few months. In
Massachusetts, we already know data. Data show that black and
Hispanic people in the commonwealth are three times more likely
than white people to contract COVID-19. So, Dr. Khaldun, if the
Federal Government fails to right the wrongs of its early
response to COVID-19, how will its failure impact people of
color and other vulnerable communities that are at risk for the
coronavirus infection?
Dr. Khaldun. I think if we don't aggressively address those
social determinants of health, so adequate housing, making sure
people have access to health care, no out-of-pocket costs for
testing, absolutely. African-American communities, latino
communities, our tribal communities are going to be the ones
that are hit the hardest so it is something that is very
concerning for me.
Senator Warren. Well, thank you very much, Dr. Khaldun. And
thank you for your work. You know, there is going to be a time
and place to take the lessons from this pandemic and apply them
to the next one.
But right now as COVID-19 cases top 2.3 million nationwide,
our country can't look at the coronavirus pandemic as if it is
an event from the past. 120,000 Americans are already dead and
more are dying every day. We must expand contact tracing. We
must secure our supply chain. We must protect communities of
color and we must stop pretending that this pandemic is over.
Thank you, Mr. Chairman.
The Chairman. Thank you, Senator Warren. We will go to
Senator Murkowski, I believe, and then we will go back to
Senator Baldwin. Let her reclaim her time when we lost internet
contact with her.
Senator Murkowski.
Senator Murkowski. Thank you, Mr. Chairman. I so appreciate
this hearing. I happen to think it is very timely and I am not
one that thinks that we are beyond this pandemic we are in the
midst of it. But even while we are in the midst of an active
pandemic, it is important to not only understand where we have
been but where we are going.
Governor Leavitt, I really appreciate the comment that you
made in 2007 while serving as Secretary and you have repeated
some of it in your opening testimony, everything we do before a
pandemic will seem alarmist, everything we do after a pandemic
will seem inadequate. This is the dilemma we face, but it
shouldn't stop us from doing what we can to prepare and prepare
every day for what we really don't know.
Back home in Alaska, we have heard from our state officials
and just from Alaskans around the state, what are the
priorities as we are dealing with the here and now. It is still
supplies and manufacturing, making sure that we have what it is
that we need. Testing capacity continues to be a challenge, but
we have been aggressive with that which I credit our state
teams with but worrying about supplies.
Consistent messaging, no different in Alaska than what we
are seeing around the country. Levels of confusion, though when
you are having mitigation strategies that are perhaps
conflicting, that causes an issue of distrust from the public
and we need to pay attention to that. But the one that I want
to speak to and have questions about is the public health IT
infrastructure. Our state reports that IT infrastructure for
contact tracing is still lacking. What we are using is Excel
spreadsheets and faxes as our main tool for their contact
tracing efforts. We have 761 cases as of this morning. Over 250
of those are active. Our teams have been working and staying on
top of it but the article in the newspaper just yesterday is we
are close to being maxed out.
As we are thinking about that and recognizing that there
are several proposals out there for a national contact tracing,
TTSI, that the contact tracing, diagnostic testing, supported
isolation, and the need to suppress or mitigate. So the
question that I would have is, is whether or not we need to
have a national contact tracing program or do you believe that
we can focus our attention on bolstering the funding and the
capacity of public health departments at the state and locality
level.
Because as I talk to Alaskans, they are saying, we think we
have this. We want this support, financial support, but we
don't know that we want a national program. So I would--I guess
I would ask you, Dr. Frist and you Governor Leavitt for your
views on that role with contact tracing because I think going
forward this is going to be a key aspect to how we can stay on
top of what we are dealing with. Your thoughts.
Dr. Frist. Thank you, and just to prefix what I am saying,
I think our second pandemic may come in about three months and
that is why I do think it is important to do exactly what we
are doing. Learn very quickly and then probably can but right
now and then an after-action review will I am sure occur next
year or two years or three years. On the contact tracing
workforce, there has been a whole bunch of estimates out there
as to what is needed.
We know it is the most effective action at this standpoint
and the workforce does operate under state and local
management, even if it is a Federal program and it needs to
expand to help control COVID-19. We have to. All of these
studies have concluded that we must expand it. It is about
180,000 people that are needed and can states do that? Probably
not because states have had their public health infrastructure
underfunded at the state and local level.
A lot of them don't even have epidemiologist to the local
communities much less contact tracers. And so I think we have
to go out for Federal support this time around, maybe not next
time around, until we have an effective vaccine that is on the
market. If we see new cases, we are going to have to increase
it.
Massachusetts has done a great job. They hired and trained
applicants quickly, got them out there. So Dr. Gottlieb and I
and Andy Slavitt have proposed for this pandemic a Federal
workforce, federally funded, and then allocation of that
funding to the state so they can get it up and running today
and we have that on record----
Senator Murkowski. Thank you, Dr. Frist.
Mr. Leavitt. Senator, I believe that a national strategy is
required. It will require some local execution. Let me be
deliberate about that. Clearly, we will need to have national
funding to support this in the way that Senator Frist has
articulated. Second, there has to be a national system that
local input feeds into where standards are used and how data is
collected so it can be rolled up quickly.
There are components of local execution that are required
but there is a clear need for national funding on this
pandemic, as I agree with Senator Frist, public health has been
malnourished over the course of the last almost 40 years, and
we need to buildup that infrastructure. We can have a national
system but it will require some execution by the local level,
but ought to be done according to a set of national standards.
Senator Murkowski. Thank you. Thank you both.
The Chairman. Thank you, Senator Murkowski.
Now, we will go back to Senator Baldwin.
Senator Baldwin. Thank you, Mr. Chairman, and I apologize
for the interruption in internet service, but I am glad to be
back with the panel. My first question, of course, related to
urging OSHA to issue an emergency temporary standard that would
be enforceable and mandatory as workplace reopen. And I think
especially about schools that are preparing to start in-person
classes again, K through 12 and higher education and their
needs. But I want to move to the companion issue of these
shortages that we have been seeing in the very things that
would likely be contained in an emergency temporary standard
that OSHA should promulgate.
Just as the administration has failed to issue these
enforceable standards to protect workers, they have also failed
to provide the leadership needed to take decisive action. For
example, ramping up production of testing and testing supplies,
other needed equipment, PPE here in the United States. Some
have touched on this already, but it is why I introduced with
Senator Murphy the Medical Supply Transparency and Delivery
Act.
What it does is unlock full authority of the Defense
Production Act to increase the production of critical supplies
including PPE as well as the supplies needed for testing. So
Dr. Khaldun, I directed my first question to you and I will
follow-up also with you. Can you describe how shortages of
testing supplies or PPE have hindered your state's efforts to
respond to the current pandemic?
Dr. Khaldun. Yes. So, as I said earlier Senator, in the
beginning we had to delay testing in our state even when our
state lab was able to do tests initially. We could only do a
few hundred and then there were very strict criteria at the
beginning were only the sickest could actually get access to a
test while the disease spread in our state.
We still have, for example, our hospital labs. They are
still only able to test the sickest patients because they have
challenges with reagents and a lot of our community testing
sites also still have challenges with reagents and testing
swabs. Again, I am grateful for what we have received, but
often when we receive supplies from the Federal Government,
they actually don't match up with that what our labs are
actually able to run so we can't even use them. So it is still
absolutely a concern.
Senator Baldwin. Thank you, Mr. Chairman.
The Chairman. Thank you, Senator Baldwin. Sorry that we
lost you there for a while. But thank you for sticking with us.
Senator Romney.
Excuse me, Senator, Kaine.
Senator Kaine. Thank you, Mr. Chairman. Thanks to the
witnesses, especially to Secretary Leavitt. When I was Governor
of Virginia, we were dealing with H1N1 and then Secretary was a
great partner with the administration. I associate myself with
comments of all my colleagues that we got a current challenge,
we have to plan for the future one. Just the magnitude of the
current challenge, last week in the United States the number of
new COVID-19 cases increased by 25 percent over the previous
week. And that shows that the current challenge is getting
worse not better, but we do have to plan for the future.
One of the things I want to do is take advantage of this
experience to talk about the future. So first topic to the
witnesses, every pandemic would likely be a little bit
different but it seems like there is a template that the
successful nations have used to deal with COVID-19. And the
template is aggressive early testing and contact tracing to
find those who are ill, the isolation of people who have COVID-
19, and immediate treatment of those folks.
Do you agree that those four elements early testing,
contact tracing, isolation, treatment should be a template that
we should prepare to use in future pandemics?
Mr. Leavitt. I will respond Senator Kaine. Those are--what
we have collectively come to know as social distancing
measures. They are they constitute the only medical
intervention that we have absent a pandemic--or absent a
vaccine, excuse me. And the reality is that is likely to be the
case in any pandemic situation. We will be without a vaccine
for a time. So that is a fundamental. It is a public health
basic. What we do have to remember is that any medical
intervention has side effects and this has side effects.
If I were to take pain medication, for example, I would be
told you can't use this too long and you can't use too much of
it or you are going to have other problems develop. We are
obviously trying to find the balance now in this medical
intervention that we have used, absent having no vaccine.
The answer is yes, but there is going to be a limit to
which we can use them as a practical matter without having the
side effects of the economy that we have experienced, the side
effects of the social logic damage that is becoming more
evident.
Senator Kaine. You have anticipated my next question,
Secretary Leavitt. The side effects on the economy. I was
having this conversation with Chairman Rich in the Foreign
Relations Committee last week because we had a similar hearing
about the global aspects of the pandemic. And he pointed out
that the aggressive testing and contact tracing, some nations,
some cultures accepted maybe a little bit better than would be
accepted here. We were talking about South Korea.
I responded and I said that is true, it might be hard for
people here to accept contact tracing but because South Korea
did that early they didn't then have to use the heavy hand of
Government to shut the economy down. South Korea's unemployment
rate has gone up by about 1 percent. Because they isolated sick
people, they didn't have to do the large economic shutdown that
the United States had to. So the basic measures we talked about
are not only good public health measures, they are also
measures to protect the economy.
I want to move to one element of these basics and that is
testing. I am very concerned about this and you have all talked
about it, particularly Dr. Khaldun, the difficulty of doing
testing and mission because of an adequate supplies and mixed
messaging. Over the weekend, the President said he had
instructed his administration to slow down testing because he
thinks increased cases is bad.
I am going to be clear about this, increasing number of
cases is bad, increasing deaths is bad, increasing
hospitalizations is bad, but the idea that you would slow down
testing because you didn't want to find out if people are sick
is just grotesque. The Chairman, the Ranking Member of the
Committee, Senator Murray and Senator Schumer, wrote a letter
to Secretary Azar that I would like to introduce for the
record, Mr. Chairman, if I could.
The Chairman. So ordered.
[The information referred to can be found on page 69 in
Additional Material.]
Senator Kaine. Pointing out that $14 billion that has been
provided by Congress for testing has yet to be obligated by the
Administration. I am deeply worried that there is a bias
against testing because we don't want to know bad news. I have
been puzzled, we are in the fifth month of the pandemic, why
hasn't the Administration issued national guidance about how
many tests we should do. The website of the CDC, instructions
to colleges doesn't even mention the word testing and I believe
there is either a fear of finding out how bad this is or a
desire to not be held accountable for falling short of testing
guidelines.
As I conclude, I will just point out, we heard from Admiral
Giroir a month ago, May 12, and we sort of had to drag out of
him, what would be an appropriate national testing goal for the
beginning September when schools are going back in and he said
40 to 50 million tests a month, which is 1.3 to 1.7 million
tests a day. At that time in May 12 we were doing between
300,000 and 400,000 tests a day. Now more than a month later we
are at 500,000 test a day.
If Admiral Giroir is right and we have to do between 1.3
and 1.7 million tests today in September and many experts say
it is higher, I have grave doubt about whether this
administration is going to enable our country to do that if we
are only at 500,000 on June 23. With that, thank you, Mr.
Chairman.
The Chairman. Thank you, Senator Kaine.
Senator Hassan.
Senator Hassan. Well, thank you, Mr. Chairman, and thank
you to all of the witnesses for being here today. As I looked
at your bios, I am realizing that the combined years of public
service sitting before us is extraordinary and I thank you all
for your service. There will be time for thorough review of
everything that went wrong with the Administration's response
to the current pandemic.
Our Nation can better prepare for future pandemics by
reversing cuts to public health and preparedness funding, re-
engaging with international partners, and ensuring that key
Federal positions are occupied by qualified staff. However, we
are in the middle of a pandemic now. COVID-19 continues to
spread quickly through the United states even as many European
nations have gotten their outbreaks under control. America has
4 percent of the world's population yet 25 percent of the
overall deaths from this endemic and 20 percent of new daily
cases being reported.
In my home state, the toll in our nursing homes continues
to be extraordinary, 80 percent of the deaths in New Hampshire
have been in long-term care facilities. Our primary focus must
be on strengthening the Federal response to the current
pandemic that is still raging across our country.
I want to start with a couple of questions to Dr. Khaldun.
Dr. Khaldun, in the early stages of the pandemic Michigan's per
capita testing for COVID-19 was below the national average.
Since then, you have been able to not only ramp up testing and
become one of the few states that have an infection rate of
less than 1 percent among those being tested.
What specific steps were critical to addressing those
initial challenges in your state and what Federal support is
needed to help other states replicate your approach by
expanding testing capacity, improving demographic data
collection from testing sites, and using that data to quickly
respond to potential outbreaks?
Dr. Khaldun. Thank you for that question, Governor. It has
certainly been a massive effort and response not only from our
state and local health departments but our procurement team in
the state, our Michigan National Guard. There are many, many
people who have contributed to us being able to respond, going
from just a few hundred tests today to now about 14,000 a day.
We have focused on how after we bring in testing into
communities.
Working with community partners. We have made sure that
when we do our contact tracing, we have updated and have to do
again, building the plane while we are flying it, updating our
contact tracing platforms so that we can effectively isolate,
understand who has potentially been exposed and isolate them as
quickly as possible.
Again, it has been a massive effort but I would not say
that we are necessarily winning in Michigan. We are still
seeing outbreaks across the state and we continue to work hard
to expand testing.
Senator Hassan. Well, that is helpful. Are there particular
things you think the Federal Government can do?
Dr. Khaldun. Yes, I again I have been really pleased that
we have been working with our Federal partners on testing
supplies, but often we don't know when those testing supplies
are going to come, and when they come with their less than what
we expected to get or they are not even useful. So we need
really a clear strategy from the Federal Government on
supplies, when we will get them, so that we can actually plan
on the state and local level for how we will get those supplies
out.
Senator Hassan. Well, thank you. I also wanted to follow-up
with you on another issue. In April, you wrote a letter to
clinicians across Michigan highlighting the fact that African
American residents comprise 40 percent of COVID-19 deaths
statewide despite making up only 14 percent of the state's
population.
This is a disparity that you have talked about a little bit
today and it is a disparity we have seen across the Nation
during this pandemic and in overall health care and outcomes.
What types of dedicated investments from Congress are needed to
give state and local Governments across the country the support
they need to improve health and wellness in communities of
color and work toward eliminating these health disparities
during the pandemic and beyond?
Dr. Khaldun. We really have to focus upstream and talk
about those social determinants of health. So housing policy is
health policy. We have to make sure communities of color who
are disproportionately living in poverty have access to healthy
and safe housing. Making sure they have access to health
insurance and expanding Medicaid across the country would be
important.
No one should have to pay out-of-pocket costs for testing
or treatment or a vaccine. And to make sure there is equitable
distribution across this communities to make sure that we are
addressing disparities. I also talked about implicit and
explicit highest in our health care system. Again, many people,
it has been well documented that these disparities exist, that
is why I sent the letter as well.
Senator Hassan. Thank you very much and thank you, Mr.
Chairman.
The Chairman. Thank you, Senator Hassen.
Senator Smith.
Senator Smith. Thank you, Mr. Chairman and Ranking Member
Murray, and to all of you for being here today. I want to start
by associating myself with the comments of my colleagues who
made on the really important point that we have so much work
right now to address the existing pandemic that we are dealing
with and living through right now. And I especially am
concerned about how COVID-19 is exacerbating existing health
disparities and the systemic racism that is literally deadly
for black and Hispanic and native communities in my state and
all around the country. But here is one example that really
shows what this means in real life.
Recently an obstetrician in Minnesota shared a story about
a black Minnesotan a Liberian immigrant, a pregnant woman who
went to the emergency room because she thought she had
complications with her pregnancy related to COVID-19. So she
goes to the emergency room and not once, not twice, not three
times, but four times. The first three times she is turned away
because even though she is COVID positive, it was determined
that she wasn't sick enough to be admitted to the hospital. Two
days later, she returns for a fourth time and she is so sick
that an emergency cesarean is performed in a last-ditch effort
to save her and her child and they both died. She wasn't
believed and she died.
Now, implicit bias healthcare is kind of a policy wonkish
term, but this is what it means when bias and racism and
disparity kills people. I know that we have talked a lot about
what this disparity means when it comes to COVID, but Dr.
Khaldun, I want to ask you this question. What can we do so
that black women are not turned away from getting the health
care that they need when it comes to COVID?
Of course, I have to acknowledge that we know that maternal
mortality rates for African American women in our country are
three or four times higher than they are for white women even
without the complexities of COVID. What can we do to address
that problem?
Dr. Khaldun That is right. We experience that disparity
when it comes to maternal and infant mortality in the state of
Michigan. Even an African-American baby is twice as likely to
die before its first birthday than a white baby and in the
state and some of the things that we can do is really make sure
that, I believe that we should have mandatory implicit bias
training for all health professionals students.
I think that our health professional schools should all
work to expand diversity in their students. I also think, and
this is some of the work we are working on with our partners in
Michigan, we have to make sure that those best practices when
it comes to hemorrhage bundles and just the top quality care
for OB care really implemented across hospitals, even those
hospitals that take care of the most impoverished women, we
have to make sure there are high standards set and that
everyone has access to equitable care.
Senator Smith. Thank you for that. I agree with you on
that. I think that those are the kinds of things we need to do
all of the work we need to do to diversify our health care
system. And also make sure that we have community based care
available for women and that would be I would think would be
the same when it comes to COVID. Let me ask you this question,
Dr. Khaldun. What should we be doing better in order to make
sure that our public health messages are reaching communities
of color and are relevant and appropriate for black and brown
latino communities, indigenous communities who are a very
important part of our, my work here in Minnesota also.
For messaging, those community partnerships are incredibly
important. That is some of the work we have done here in
Michigan. Again, with our coronavirus racial disparities task
force, we are working very closely with community members to
make sure that the messages that we are putting out are
resonating and that we use those community like those trusted
community leaders to get accurate messaging out into the
community. Those partnerships are critical. We can't do this
alone and we shouldn't be only doing it from a state and local
Government perspective.
Senator Smith. Right. I think that is so right and it
brings me to my last point here, which is that in order for
that to work, those community organizations and need to have
capacity and local public health agencies need to have
capacity. And I know that you worked at the local level as well
at the state level.
Right now in Congress, we are having a debate about how
urgent it is that we get emergency resources to state and local
Governments right now in order to help make sure that this
response happens. And so could you just answer briefly, I just
have a second left, on how important it is you think from where
you sit that we get that state and local aid to Governments
right now as we are dealing with this epidemic.
Dr. Khaldun. That is right. Our state and local Governments
absolutely have been underfunded for her decades, especially
our local health departments. They often don't have even one
epidemiologist. So funding at the state and local level are
incredibly important for COVID-19 and other critical public
health work.
Senator Smith. I think it is why so many of us supporting
the Heroes Act funding to get emergency aid to state and local
Governments. Thank you, Mr. Chairman.
The Chairman. Thank you, Senator Smith. Senator Jones. We
will go back to Senator Jones. Senator Rosen.
Senator Jones. I am sorry. I had problems with the mute
button. Mr. Chairman, can I go forward?
The Chairman. Okay, we will go to Senator Jones.
Senator Jones. Thank you. Thank you, Mr. Chairman. I really
appreciate this hearing and I hope we have more to be honest
with you. I don't think this is a topic that can be handled in
just one hearing and I hope our other committees in the Senate
will likewise have hearings on their respective jurisdictions
about lessons learned from this pandemic. I would like to first
go to my Northern neighbor, Tennessee neighbor, Senator Frist
and talk a little bit more about manufacturing. I know Senator
Alexander asked about it.
Senator Collins, Senator Murphy mentioned it as well. But
the focus I want to talk about is really on PPE, masks, gowns,
those kind of things. We have--I really--it seems to me that we
have had not only a shortage now, we are going to continue to
have a shortage in the future. We have got to rebuild our
national stockpile, but also keep that replenished as our
stockpile ages. We have seen in Alabama supplies sent from the
national stockpile that were 10 years past expiration dates,
that were rotted. So it seems to me that one of the things that
we can do is try to incentivize, and you mentioned that in your
testimony.
I have a bill pending called the Build Healthcare Equipment
and In America Act to try to give those tax incentives to
companies to either repurpose existing facilities, stand up new
facilities, and also give some help or infrastructure such as
broadband in areas that might not have it.
In addition to the tax incentives, I was caught by your
statement that we have got to help with markets, long-term
markets, maybe even I can't remember the exact phrase, might
have been artificial markets. So in addition to the tax
incentives like I have got in my bill, what can we do to create
those markets? Because I just think we are going to be, even
when we are out of this pandemic, we are going to be living in
a new world in which more masks, more gowns, more shields are
going to be needed for businesses, schools, and healthcare
workers going forward. So, how can we do that in addition to
the incentives?
Dr. Frist. Thank you. We deal in pandemics, remember virus
occur. They don't all become pandemics. So when we talk about
pandemics, we were talking about something that explodes and
then it goes around the country to multiple places. That is the
global emphasis of if there is an outbreak anywhere, it is
important here. The markets does come in part to stockpiling
but in addition it extends this whole concept of what we are
dealing with is a rare but certain event, a rare but certain
event.
The rarity is hard for Congress to deal with because of the
attention span of Congress, having spent a lot of time in the
room that you are in, and that is where it is important to have
timelines that are 10 years or 15 years. Markets tend to look
day-to-day and therefore this will artificial market means that
we have to have some side, sort, of the tax credits could do
it, but some sort of public funding that will guarantee a
market over that 10, 15 year period when that certain event,
that certain pandemic will occur. Your higher point is on the
stockpiling and it too, and the CDC we talked about
modernization which I agree with, but we also need to modernize
the stockpile.
There is still a lot of debate. Is it a Federal
responsibility or do we push it upon the states? States,
because they have to balance their budgets, are not--because of
the immediate demands of the constituents, is not going to be
able to do it. So the stockpiles need to be not just
implemented at one point in time, but they, just like we have
to have these exercises every year, have to be looked at year
to year as to the current threats or risks that are being
determined by our communities of science, those scientist at
the CDC.
If we do that, we can have regional stockpiles coordinated
with an overlay at the Federal Government, with great
coordination, better coordination, going back to Governor
Leavitt's plans with the states is to the immediacy of what
needs to be in that stockpile and then the markets design
around that. The Federal Government itself can't go out and
build these factories. It has got to have to be people who are
in the business who can change with science, change with the
time, change with the biology in real-time.
Senator Jones. Great. Thank you, Senator, I appreciate
that. Governor Leavitt, let me ask you real quick in my
remaining seconds here, I completely agree that we need to do
more investing in public health, but in your testimony you
mentioned that Medicaid funding crowds out state budgets for
public health funding and I would like for you to just explain
briefly what you mean by that. Are you suggesting that we
should cut Medicaid and that would help public health funding
because it seems to me in my state more Medicaid is better for
public health than less.
Mr. Leavitt. Senator, let me just say that public health
generally has been starved for resources for probably 30 or 40
years and the budgets have just continued to go down. There is
a direct correlation, it is just a fact, I am not making--
drawing the causation. I am just saying there is correlation
here that Medicaid budgets have dramatically gone up.
When I was first Governor I think Medicaid was 6 percent of
the budget. It would probably be 20 percent in the state that I
was Governor now. Public health as a percentage of that is gone
down. We have just undernourished it and I am worried about
that. I don't think that every--it is a local function. It is a
state function. Right now it is being driven and funding
primarily by Federal dollars. I think that is not a good idea
in the long term. So I am just advocating that states need to
be to pay attention to their public health infrastructure as
well.
Senator Jones. Right. Thank you. Thank you, Mr. Chairman.
The Chairman. Thank you, Senator Jones.
Senator Rosen.
Senator Rosen. Well, good morning everyone and thank you,
Mr. Chairman for bringing this important hearing and of course
Ranking Member as well and everyone on the panel for all of
your work in the past and your comments about how we can plan
for not just a global pandemic but all those smaller kinds of
prices that we may have that we have to plan for you even if
they are regional.
I do believe that it is really important to keep up with
research in order to understand this virus because scientists
around the globe are frantically working to gain a better
understanding of COVID-19. How the virus specifically attacks a
patient's immune system, what treatments work, how to best
prevent infection. To make sure we do not have gaps in research
and information in how the virus impacts a wide range of
patients, I introduced along with Senator Rubio the Ensuring
Understanding of COVID-19 to Protect Public Health Act.
This bipartisan bill would direct the NIH to conduct a
longitudinal study of patients that includes diversity among
gender, race, ethnicity, geography, and age, and many other
things. We are looking at both the short-term and long-term
impacts along with interventions.
This would be reported publicly on a regular basis so that
all researchers and public health officials have the latest
information. So Dr. Khaldun, as a public health official
directly dealing with the current pandemic, what challenges
have you faced in getting comprehensive information about the
latest research on COVID-19, and could you please speak to how
not having robust data available hurts not only ongoing
research but patient care?
Dr. Khaldun. Yes. So we all are learning about this virus.
Obviously, it is a new virus. So we are all learning how it
responds in the human body and who is the most impacted, but
absolutely it would be great to have more research to look at
the disparities and why those disparities exist, to look at how
it even impacts children. We are seeing this mysterious disease
in children as well. So absolutely the research and the data
would be incredibly important to advancing this response.
Senator Rosen. Building on that, what recommendations would
you have for us, maybe in Congress or others, how can we make
it easier for doctors and public health officials to get this
comprehensive data? Updates are coming in rapidly. I want to
avoid, what--I really want to avoid these gaps that we seem to
be having in the data between states and counties and cities,
etc., etc.
Dr. Khaldun. Yes, I think we need uniform surveillance and
data systems across the country. We at the state, we have our
own data system, the locals often are doing their own, and then
we have kind of a hodgepodge of ways that we get data to the
CDC and we have recently updated that.
We absolutely need more data. It would be great to have, I
would say, more coordination and updating when the CDC does
come out with guidance or research to make sure that our state
and local Governments get that as quickly as possible. Some
more coordination and better surveillance will be important.
Senator Rosen. From the CDC?
Dr. Khaldun. The CDC.
Senator Rosen. Thank you. I want to move on and talk a
little bit about telehealth. Of course last week we had a great
hearing on telehealth. It showed how vital this tool is for
caring for patients not only during the pandemic but also
after. So of course along with many of my colleagues, we
support continuing the flexibilities for telehealth
reimbursement that we have allowed through Medicare through the
passage of the CARES Act, and I want to tell you I think it has
been fantastic in Nevada. We have a model health company that
will send a paramedic or a nurse to a patient's home and use
telehealth to connect with the physician to treat the patient.
They do a history and physical, they take the vital signs,
they may do blood work right there, and then can speak with the
physician. If the situation is more serious, they can get the
patient to a hospital or to a follow-up kind of an urgent care
situation. So again, Dr. Khaldun, from your experience during
this pandemic, how do you think that telehealth has really
improved patient outcome and people's ability to receive care?
Dr. Khaldun. Telehealth has been incredibly important to
maintaining our health care system during this response, and I
actually hope that we don't go backward, that we continue to
use the lessons we have learned with this response as we move
forward. We have expanded access in our state to telemedicine
and telephonic visits, including authorization for
teledentistry, OT, PT, speech therapy as well.
It has been incredibly helpful with our health care system,
and I hope we learn from those lessons.
Senator Rosen. I hope we do too. Thank you. I appreciate
you being here today.
The Chairman. Thank you, Senator Rosen. If the witnesses
will stay with us another 10 minutes, we will conclude the
hearing. Senator Murray, do you have closing remarks?
Senator Murray. Well, thank you, Mr. Chairman. You know, I
just have to say COVID-19 has killed more than 120,000 people
in the country and sickened more than 2 million. None of us
would have said that 4 months ago. And we just have to just say
this is stunning. I mean, especially when I heard Vice
President Pence last week, ``our whole of America approach has
been a success and the Nation's response to COVID-19 is a cause
for celebration.''
I mean, we are in a pandemic that has just stunned this
Nation and we should not be ignoring that or talking
nonchalantly about it. I will ask Dr. Khaldun to just comment,
based on your experience in Michigan, would you characterize
the Federal Government's response as a cause for celebration?
Is it time to declare mission accomplished?
Dr. Khaldun. Absolutely not, Senator. We are in the middle
of a pandemic. We are still seeing outbreaks across the country
and increasing cases. So we definitely should not be
celebrating right now.
Senator Murray. Yes, and I don't think so either. So Mr.
Chairman, thank you for this hearing. I really do appreciate
all of our witnesses for taking the time to join us today and
share your expertise. While it is clear we still have a lot of
work to do to prepare for the next pandemic, it is even more
apparent to me that there is a lot more that has to be done
right now to respond to this one, because despite what we heard
from the White House, this crisis is far from over.
Several states are seeing record setting new case counts.
There are many steps that we need to be taking as soon as
possible to fight COVID-19. We need to increase testing not
decrease it like we continue to hear President Trump suggest.
We need to take steps to pave the way for a safe, effective
vaccine that is free and accessible nationwide. And we need to
take steps to address the harmful health disparities that are
being compounded by this crisis.
Of course we have to address racial injustice not just in
health care but in so many other ways as well. So as we
continue to focus on that, I would like to ask consent to
submit for the record an outline of health equity principles
from the Robert Wood Johnson foundation, Mr. Chairman.
The Chairman. So ordered.
[The information referred to can be found on page 75 in
Additional Material.]
Senator Murray. I really hope we continue to talk about
this and build on this conversation today not just with future
hearings and discussions but we need to take, Congress needs to
take, immediate action so our country can deal with the crisis
at hand. Thank you.
The Chairman. Thank you, Senator Murray. And thanks for
your cooperation and that of your staff in scheduling the
hearing. In a moment, I am going to ask each of our four
witnesses if they can summarize in about 60 seconds the top
three things they would do now to prepare for the next pandemic
if they were the king or the queen of the United States, but
first, let me make a couple of comments. Several of my
colleagues have wondered why in the middle of a pandemic we
would be thinking about how to prepare for the next one.
Well, I think Senator Frist made that argument very
eloquent, as eloquently as did other witnesses. It is because
our experience has been, we haven't been able to adequately
take the steps that we need to take to prepare for the next
pandemic if we wait till the current one is over. Over the last
20 years, we have had four Presidents, two Republicans, two
Democrats, several Congresses earnestly working on this
subject. They have passed nine different major laws.
I mentioned what those were before, but it was after
Anthrax and after SARS and after the flu pandemic and after
Ebola, the attention of Congress on difficult issues was on
other matters. The same thing happened in the states where
hospitals and states allowed their stockpiles to be diminished
because other matters demanded more budgetary considerations.
So I would ask my colleagues, when do you think would be a
better time to ask the U.S. Congress, for example, to build a
manufacturing plant for vaccines that we for many years might
not even use. Probably during this pandemic is the best time to
get the attention of the Congress for such a use.
Or when would be a better time to accelerate research for
testing and treatments, if we can think of ways that would
speed and accelerate those testing and treatment for the next
pandemic? Or when will be a better time to do the appropriate
funding for the Centers for Disease Control to do data
surveillance? Or when would be a better time to look at our
stockpiles and our Hospital surges than while we are in the
midst of them? When would it be a better time to talk about
strengthening funding for state and local public health
departments, which Governor Leavitt said have been going
downhill for 40 years in terms of funding? Well if we haven't
been able to do it for 40 years, why not try doing it in the
midst of a pandemic. When would be a better time to consider
who ought to be on the flagpole?
It is not going to be easy to accept the recommendation of
Dr. Gerberding and the commission that recommended putting
someone in the NSC in charge or to improve coordination of
Federal agencies in other ways. And when would be a better time
to do what is probably the most difficult recommendation that
many of you have made which is create a funding stream that is
automatic, that is mandatory at a time when the Federal
Government has such a big deficit.
The reason we are doing this today is because we are in the
midst of these problems and our eyes will be clearer on what
the solutions may be and our wills will be better and we have
an notoriously poor record of short memories when it comes to
doing everything we need to do. We have tried but we have not
obviously done some of the things that we need to do. So in my
view, and I think in the view of at least several of the
witnesses and many others, now is the time to do those few
things that we know must be done for the next pandemic while
our attention is focused on these matters.
A couple of other comments before I ask our witnesses for
their concluding remarks, one was I appreciate Dr. Gerberding's
comment about asking the National Academy of Medicine to become
involved in transparency for the vaccines. I think that is a
very good idea. And that is what they are for. And I think
their opinion about the safety of a vaccine would go a long way
toward dispelling any worries about it. And the other comment I
want to make was on contact tracing. Of course contact tracing
is essential and of course Federal funding is essential but we
have already done the Federal funding.
I mean Congress gave states $150 billion, all of which
could be spent on contact tracing. In addition to that, that
was a month ago. And then in addition to that, Congress gave
states another $11 billion as part of a $25 billion testing
package that was expressly for the purpose of contact funding
if the state chose to use it that way. We specifically decided
not to tell states to use it that way but they could use it
that way.
That is plenty of money to hire all the contact tracers
that you need. I mean according to one estimate by professional
firm, an average salary for a contact tracer might be $37,000.
And if that were the case, the cost of a 100,000 would be $3.7
billion, a lot less than the $11 billion that was specifically
allocated to states for the purpose of hiring contact tracers
if they chose to use it.
Senator Blunt, who is the Chairman of the Appropriations
Committee for Health and I wrote a letter to CDC asking to make
that clear to Governors that they have that money and many
states have not spent their $150 billion that we gave them
earlier. This is an allowable expense there.
Yes, we need Federal funding for contact tracing. Yes, they
are important. Yes, it might be 100,000, 150,000, 180,000 but
we have already appropriated that money and states ought to use
it and many already are now. To conclude the hearing, let me
ask the four witnesses, even though they have already said this
in their testimony, if they were in charge and they could do
three things this year to get ready for the next pandemic, what
would those three things be? Senator Frist, maybe begin with
you.
Dr. Frist. Thank you, Mr. Chairman. The pandemic is growing
around the world. And as I said, an break anywhere is a risk
everywhere so we got to think globally. We need to test more.
Continue to focus on the vulnerable populations as we talked
about here and around the world. I too endorse Senator Murray's
under underscoring of the Robert Wood Johnson Foundation
principles.
My three things are No. 1, we need to establish to invest
in long-term partnerships. Age and partner with the private
sector to develop the diagnostic tests and treatments,
vaccinations. No. 2, put in place a budget mechanism to ensure
public health funding does not disintegrate when memory of this
pandemic fades.
I mentioned the health defense operations budget in my
prepared statement. And No. 3, telehealth. It works. It allows
social distancing and clinical care to be delivered. And for
the future, it is convenient. It is affordable. And for the
future of health, it will be transforming.
The Chairman. Thank you, Dr. Frist.
Dr. Khaldun.
Dr. Khaldun. Thank you, Chairman, for the opportunity to
speak today. The three things I would focus on are one,
disparities, two, surveillance, testing, and tracing, and
isolation. And then, funding of state and local health
departments. When we talk about disparities, we have to talk
about housing. Everyone should have access to affordable and
healthy housing. We have to invest in communities of color, so
education and jobs, access to healthcare we have to focus on,
so funding for the health care safety net, our federally
qualified health centers who provide this care in these
communities. We have to buildup, as has already been talked
about, the testing capabilities, the contact tracing
capabilities.
We are grateful for the funding that we received in the
State of Michigan but it also needs to be long-term funding and
not just come up when we have an emergency. And then finally,
we must invest in long-term infrastructure in our state and
public health departments.
As has been said before, many of them only have one
epidemiologist or no epidemiologist, and we are always building
these responses on the fly. This needs to be something that is
long term as far as funding for state and local health
departments. Thank you.
The Chairman. Thank you.
Dr. Gerberding.
Dr. Gerberding. Thank you. I certainly support what Senator
Frist said and stand by the recommendations of the CSIS report
as well. I will emphasize three things one is a national
vaccine plan that includes not only the science and the
development and the manufacturing piece in collaboration with
the private sector, but also the allocation, uptake, and
monitoring piece because we know this is in our future and we
are not ready for it yet.
The second thing I would say is that we are coming into a
high probability of jointness of ongoing COVID in the context
of influenza, and we need to exercise health care surge under
that scenario. Again, including the supply chain and the
private sector in that process so that we can understand how to
create more robust supply and hopefully really improve
immunization rates for influenza this season at a time when we
need it now more than ever.
The last thing I would just re-emphasize is the importance
of the budgetary authority that allows for sustained investment
not just at the Federal level and CDC, but through our state
and local health departments. You can't plan for preparedness
in one year cycles any more than you can plan for the
Department of Defense to be prepared for that kind of security
in a one-year timeframe. We need long-term, sustained,
progressive accountability and measures for progress. Thank
you.
The Chairman. Thank you.
Governor Leavitt.
Mr. Leavitt. Unless you think I cannot count, I am going to
give you four. The first is to advance in clarity on the
division of labor between state and Federal Government and the
pandemic. States need to be with that, armed with a clear
understanding of their role and the Federal Government, its
role. Second, rejuvenating the public health infrastructure, as
others have stated, is not only important in a time of pandemic
but in the health system where working toward value of the
social determinants of health will play a dual role and an
important role, and will have ongoing benefit in both in and
out of a pandemic. Third the HHS, CDC data modernization.
It is a critical piece of infrastructure that needs to be
put in place in advance. We should be working on it now. It can
be valuable in three months from now as well as in three years
from now. and finally, again the echo, annual appropriation on
emergency management not just episodic funding.
The Chairman. Thank you, Governor Leavitt. Thanks to each
of our four witnesses. As I listened to the priorities, I am
reminded again, most of those recommendations will help with
the current pandemic, all will help with the future pandemic,
and in my opinion, they will all be easier to pass and turn
into law during this current pandemic then they will be if we
wait a year or two and try to compete with other priorities of
the moment.
The hearing record will remain open for 10 days. Members
may submit additional information for the record if they would
like. I have also invited comments and responses and any
additional recommendations in response to my white paper
preparing for the next pandemic for our Committee to consider.
I will fully share those recommendations that I receive with my
colleagues, both Democrat and Republican. The deadline for
submitting those comments is 5 p.m. this Friday, June 26.
Comments may be sent to pandemic preparedness at
help.senate.gov.
[The information referred to can be found on page 69]
The Chairman. This is our fourth hearing this month on the
COVID-19 pandemic. We have had one on going back to school, one
on going back to college, we have had one on telehealth, we
have had this one, and then we will meet again at 10 a.m. on
next Tuesday, June 30th for an update on progress toward safely
getting back to work and back to school and our witnesses will
be Dr. Fauci, Dr. Hahn, Admiral Giroir and Dr. Redfield. Thanks
again to our distinguished panel of witnesses, to the Senators
who participated, to the staff who helped put this together.
The Committee will stand adjourned.
ADDITIONAL MATERIAL
Letters of Support
United States Senate
June 21, 2020
The Hon. Alex Azar, Secretary
U.S. Department of Health and Human Services,
200 Independence Avenue,
Washington, DC.
Dear Secretary Azar:
We write to express concern regarding the distribution of funds
Congress allocated for COVID-19 testing and contact tracing, including
for providing testing to the uninsured. Congress provided more than $25
billion to increase testing and contact tracing capacity \1\ and $2
billion to provide free COVID-19 testing for the uninsured by paying
providers' claims for tests and associated items and services (such as,
office or emergency room visits needed to get an order for or to
administer a test). \2\, \3\ While it has been months since these funds
were first appropriated, the Administration has failed to disburse
significant amounts of this funding, leaving communities without the
resources they need to address the significant challenges presented by
the virus. The United States is at a critical juncture in its fight
against COVID-19, and now is the time for an aggressive and fast
response. This Administration will put our country at grave risk if it
tries to declare an early victory, leave lifesaving work undone, and
leave resources our communities desperately need sitting untouched.
---------------------------------------------------------------------------
\1\ https://www.Congress.gov/bill/116th-congress/house-bill/266/
text.
\2\ https://www.Congress.gov/bill/116th-congress/house-bill/6201/
text.
\3\ https://www.Congress.gov/bill/116th-congress/house-bill/266/
text.
Regarding funding for ramping up testing and contact tracing
capacity, the Administration has full discretion to spend, as it sees
fit, more than $8 billion of the $25 billion provided by Congress. With
COVID-19 cases spiking in numerous states, the Administration has not
released a plan to distribute this funding. It is critical that the
Administration disburse the $8 billion immediately with an emphasis on
addressing two major unmet needs: contact tracing and collecting data
---------------------------------------------------------------------------
on COVID-19 racial and ethnic disparities.
The country's current contact tracing workforce is inadequate to
deal with the new spike in COVID-19 cases. Leading public health groups
say state and local governments need $7.6 billion to quickly scale up
contact tracing, including $4.8 billion to hire at least 100,000
contact tracers. \4\ Meanwhile, other experts believe the country needs
closer to 300,000 contact tracers. A bipartisan group of experts
proposed last month that $46.6 billion is needed to contain the spread
of COVID-19--including $12 billion for expansion of the contact tracing
workforce. \5\
---------------------------------------------------------------------------
\4\ https://www.naccho.org/uploads/full-width-images/Joint-Public-
Health-Contact-Tracing-Workforce-Request-4.30.20-FINAL.pdf.
\5\ https://apps.npr.org/documents/document.html?id=6877567-
Bipartisan-Public-Health-Leaders-Letter-on.
Dr. Scott Gottlieb, who served as Commissioner of the Food and Drug
Administration under President Trump, said recently that, ``Right now,
we haven't been able to trace [spread of the virus] back to the source
because we don't have all that track and trace work in place. And so
that's a challenge for public health officials.'' \6\ Yet despite this
urgent need, the Centers for Disease Control and Prevention (CDC) has
not even awarded nearly $4 billion in funding at its disposal that
could be used for public health surveillance, and state, local, tribal
and territorial surveillance and contact tracing efforts.
---------------------------------------------------------------------------
\6\ https://www.washingtonpost.com/news/powerpost/paloma/the-
health-202/2020/06/15/the-health-202-u-s-isn-t-ready-for-the-contact-
tracing-it-needs-to-stem-the-coronavirus/5ee6528b602ff12947e8c0d7/.
Additionally, the effort to gather COVID-19 data on race and
ethnicity is woefully inadequate. Recent reports found that 52 percent
of reported cases are missing information on race or ethnicity,
preventing public health officials from knowing where to target
interventions in communities of color. \7\ Even with these low
reporting frequencies, the data we do have indicates that the
disparities are vast. By its own admission, the Trump administration
must change its approach to this issue. CDC Director Robert Redfield
acknowledged that the Administration's paltry initial report to
Congress on demographic data fell short, saying that ``I want to
apologize for the inadequacy of our response.'' \8\ Brett Giroir, HHS
Assistant Secretary for Health and former coronavirus testing czar,
said ``We're flying blind until this comes in. We can't develop a
national strategy to reach the underserved, or know how well we're
doing, until we have the data that shows us if we're reaching them or
not.'' \9\ Communities of color ravaged by COVID-19 cannot afford to
wait any longer for a better approach.
---------------------------------------------------------------------------
\7\ https://www.politico.com/news/2020/06/14/missing-data-veils-
coronavirus-damage-to-minority-communities-316198.
\8\ https://www.politico.com/news/2020/06/04/coronavirus-robert-
redfield-racial-disparity-cdc-301223.
\9\ https://www.politico.com/news/2020/06/14/missing-data-veils-
coronavirus-damage-to-minority-communities-316198.
Regarding funding to provide free testing for the uninsured, to
date, media reports note that ``only $10.8 million, or 0.5 percent of
the $2 billion Congress set aside to help providers pay for COVID-19
testing for uninsured patients, has been approved to be paid during the
first two weeks of the program's operation.'' Recent news reports note
that slow distribution of these funds may be caused by technical flaws
with the portal for submitting claims, a lack of awareness about the
availability of the funds, and coding issues. No patient should avoid
seeking medical care because they are worried they cannot afford it--
especially in the midst of a pandemic, in which reluctance to seek care
because of cost endangers the health of others. Congress appropriated
these funds in large part because we know that patients often forego
recommended tests and treatments because of cost. \11\ The need for
these funds is made even more acute by the Trump administration's
sabotage of our health care system, leaving increasing numbers of
Americans uninsured. Even before the pandemic began, the U.S. Census
Bureau reported that the number of Americans without health insurance
rose by about 2 million in 2018. Even the number of uninsured children
increased. \12\
---------------------------------------------------------------------------
\11\ https://www.norc.org/PDFs/
WHI%20Healthcare%20Costs%20Coverage%20and%20Policy/
WHI%20Healthcare%20Costs%20Coverage%20and%20Policy%20Issue%20Brief.pdf.
\12\ https://khn.org/news/number-of-americans-without-insurance-
rises-in-2018/.
The pandemic has exacerbated this trend. After the start of the
pandemic, the Kaiser Family Foundation estimates that as many as 27
million people may have lost employer-sponsored insurance between March
1 and May 2, many of whom may be eligible for an automatic special
enrollment period. \13\ Further, the Trump administration has refused
to open a national special enrollment period to make it easier for
patients and families to sign up for comprehensive coverage, while
continuing to promote ``junk'' short-term plans that are allowed to
discriminate against people with pre-existing conditions and are not
required to cover the essential health benefits, like prescription
drugs.
---------------------------------------------------------------------------
\13\ https://www.kff.org/coronavirus-covid-19/issue-brief/
eligibility-for-aca-health-coverage-following-job-loss/.
This funding is also important to addressing health disparities. As
of 2018, nonelderly Black, Hispanic, American Indian and Alaska Native,
and Native Hawaiian people and Pacific Islanders are more likely to be
uninsured than white people. \14\ This lack of access to care is one
factor that contributes to the worse health outcomes experienced by
communities of color with respect to COVID-19. \15\
---------------------------------------------------------------------------
\14\ https://www.kff.org/disparities-policy/issue-brief/changes-in-
health-coverage-by-race-and-ethnicity-since-the-aca-2010-2018/.
\15\ https://www.cdc.gov/coronavirus/2019-ncov/need-extra-
precautions/racial-ethnic-minorities.html.
Funding to cover the cost of testing for the uninsured is also
critical to support health care providers. The American Hospital
Association estimates that, over a 4-month period from March 1 to June
30, hospitals will experience $202.6 billion in losses. The rise in the
uninsured population contributed to a 13 percent increase in bad debt
and charity care in March of this year compared to the prior year. \16\
---------------------------------------------------------------------------
\16\ https://www.aha.org/guidesreports/2020-05-05-hospitals-and-
health-systems-face-unprecedented-financial-pressures-due#:-
:text=Discussion,of%20%2450.7%20billion%20%20month.
We call on you to immediately disburse the remainder of the $25
billion in funds to ramp up testing and contact tracing capacity, as
well as to make sure providers are aware of and able to easily access
the $2 billion that Congress appropriated to provide testing for the
---------------------------------------------------------------------------
uninsured. Thank you for your urgent attention to this matter.
Sincerely,
Charles E. Schumer,
United States Senator.
Patty Murray,
United States Senator.
______
Statement from the American Society for
Microbiology
June 23, 2020
On behalf of our 30,000 members in the United States and around the
world, the American Society for Microbiology (ASM) thanks Chairman
Lamar Alexander, Ranking Member Patty Murray, and Members of the Senate
Health, Education, Labor, and Pensions (HELP) Committee for holding
this hearing to review lessons learned from past global infectious
disease outbreaks and the current COVID-19 pandemic, and to discuss how
we can better prepare for future pandemics. We also wish to express or
appreciation to the Chairman for issuing a white paper on this subject
with a call for comments. This is an important first step to ensuring a
better response in the future, and ASM looks forward to providing more
specific comments to the Committee.
As soon as the public health emergency subsides, Congress and the
Administration must initiate a high-level, broad-based, comprehensive
and scientific review of the COVID-19 response through either a Federal
commission or a qualified, nonpartisan entity such as the National
Academies of Science, Engineering, and Medicine. This process should
also be forward-looking and make cross-cutting recommendations on how
the United States can better prepare for future public health
emergencies, including funding needs and policy changes. By fully
understanding what went well and what did not during this most recent
pandemic, we can help thwart, or at the very least minimize, the
effects of the next pandemic.
Attached is a stakeholder letter dated March 30, 2020 spearheaded
by ASM and signed by 38 additional national and international
organizations, calling for a science-based review. ASM believes a high-
level, comprehensive pandemic response review should make
recommendations to do the following:
Ensure global collaboration and open lines of
communication with our international partners;
More rapidly scale up laboratory testing capacity in
order to get tests to those who need them;
Ensure a steady supply chain of materials to labs and
hospitals to mitigate shortages;
Clearly and effectively communicate practical, science-
based information and guidance to stakeholder entities and to the
public; and
Reduce patient access barriers so that all who need
testing can get testing.
The current crisis has brought to light a number of barriers,
challenges and shortcomings in our ability to respond to a public
health emergency. Some of these were the results of ``real-time''
decisionmaking, while others exposed systemic breakdowns, chronic
underfunding, and a lack of resources that were years--if not decades--
in the making. These cut across multiple agencies and span levels of
government from Federal, to state, to local authorities.
While ASM members in clinical laboratories have the most immediate
connection to the current crisis, our members work in several areas
that will be critical to a long-term strategy to head off future
pandemics. These include conducting basic biomedical research, vaccine
development, and service delivery in clinical laboratory settings.
ASM stands ready to work with you to help improve the systems we
have in place today and to develop the solutions that will help address
tomorrow's challenges.
ASM reiterates our commitment to assisting the Committee, its
Members, the Congress, the White House Coronavirus Task Force and the
agencies as the U.S. continues to respond to the COVID-19 pandemic.
More information from ASM on nCov2019: https://asm.org/Press-Releases/
2020/COVID-19-Resources.
The American Society for Microbiology is one of the largest
professional societies dedicated to the life sciences and is composed
of 30,000 scientists and health practitioners. ASM's mission is to
promote and advance the microbial sciences.
ASM advances the microbial sciences through conferences,
publications, certifications and educational opportunities. It enhances
laboratory capacity around the globe through training and resources. It
provides a network for scientists in academia, industry and clinical
settings. Additionally, ASM promotes a deeper understanding of the
microbial sciences to diverse audiences.
March 30, 2020.
The Hon. Richard Shelby, Chairman
Committee on Appropriations,
U.S. Senate,
Washington, DC.
The Hon. Patrick Leahy, Vice Chairman
Committee on Appropriations,
U.S. Senate,
Washington, DC.
The Hon. Roy Blunt, Chairman
Subcommittee on Labor, HHS, Education,
Committee on Appropriations,
U.S. Senate,
Washington, DC.
The Hon. Patty Murray, Ranking Member
Subcommittee on Labor, HHS, Education,
Committee on Appropriations,
U.S. Senate,
Washington, DC.
Dear Chairman Shelby, Vice Chairman Leahy, Chairman Blunt and
Ranking Member Murray:
We, the undersigned organizations representing millions of
individuals working to address the unprecedented challenges SARS-COV-2
has presented to our society, our healthcare system, and our economy,
are committed to working with Congress and the Administration to
address the pressing needs associated with the novel coronavirus (SARS-
COV-2) and COVID-19.
We are writing to request that, as soon as the immediate public
health emergency subsides, Congress and the Administration initiate a
high-level, comprehensive review of the COVID-19 response through
either a Federal commission or a qualified, nonpartisan entity such as
the National Academies of Science, Engineering, and Medicine. This
process should also be forward-looking and make cross-cutting
recommendations on how the United States can better prepare for future
public health emergencies, including funding needs and policy changes.
By fully understanding what went well and what did not during this most
recent pandemic, we can help thwart, or at the very least minimize, the
effects of the next pandemic.
Specifically, such a review should recommend the most effective
ways to:
Ensure coordination and collaboration across and amongst
Federal agencies and with state and local authorities;
Clearly and effectively communicate practical, science-
based information and guidance to stakeholder entities and to the
public;
Build public health capacity, including at the local,
state and tribal health department levels;
Rapidly scale up laboratory testing capacity in order to
get tests to those who need them;
Ensure a steady supply chain of materials to labs,
clinics, hospitals and workplaces to mitigate shortages;
Protect the most vulnerable in our communities by
reducing patient access barriers to testing and health care services;
and,
Facilitate global collaboration to ensure that responses
are based on real-time, accurate information.
The current crisis has brought to light a number of barriers,
challenges and shortcomings in our ability to handle a public health
emergency. Some of these were the results of ``real-time''
decisionmaking, while others exposed systemic breakdowns that were
years--if not decades--in the making. These cut across multiple
agencies and span levels of government from Federal, to state, to local
authorities.
While public health professionals, health departments, clinical
laboratories, clinics and hospitals have the most immediate connection
to the current crisis, a comprehensive, well-planned approach will be
critical to a long-term strategy to head off future pandemics. A
comprehensive approach includes medical research and development,
social, behavioral and economic considerations, corporate partners to
ensure product and service delivery, small businesses, universities and
research institutions, as well as healthcare professions.
We stand ready to work with you to help improve the systems we have
in place today, and to develop the solutions that will help address
tomorrow's challenges.
Sincerely,
1,000 Days
AABB
American Academy of Pediatrics
American Association for Clinical Chemistry
American Association for the Advancement of Science
American Association of Colleges of Pharmacy
American Association of Immunologists
American Institute for Medical and Biological Engineering
American Public Health Association
American Society for Clinical Pathology
American Society for Microbiology
American Society for Nutrition
American Society for Pharmacology and Experimental
Therapeutics
American Society for Virology
American Society of Hematology
American Society of Tropical Medicine and Hygiene
Association for Professionals in Infection Control and
Epidemiology
Association of American Cancer Institutes
Association of American Universities
Association of Maternal & Child Health Programs
Association of Population Centers
Association of Public Health Laboratories
Association of Public and Land-grant Universities
Biophysical Society
Coalition for the Life Sciences
Federation of Associations in Behavioral & Brain Sciences
Foundation for Vaccine Research
Global Health Technologies Coalition
Infectious Diseases Society of America
National Association of County and City Health Officials
National Safety Council
OSA, The Optical Society
Population Association of America
Research!America
Society of Infectious Diseases Pharmacists
Susan G. Komen
The Society for Healthcare Epidemiology of America
Trust for America's Health
Vaccinate Your Family
______
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A Storm for Which We Were Unprepared
Bill Frist, M.D.
The American Mind
Essay--04.13.2020
Senator Bill Frist saw it coming years ago.
Senator William Frist, M.D. is a nationally acclaimed heart and
lung transplant surgeon and the former Majority Leader of the U.S.
Senate. In 2005, during his tenure in Congress, he delivered the
Marshall J. Seidman Lecture for the Department of Health Care Policy at
Harvard University. In this strikingly prescient speech, he foretells
the possibility of a viciously deadly pandemic and calls for action to
defend against that eventuality on a vast scale. Though his warnings
went unheeded, we are honored to publish his words now as part of our
ongoing efforts to understand and counteract COVID-19 and its effects.
I am a physician and a surgeon who by accident of fate finds
himself in the halls of power at a time of dangers for his country and
the world, the most compelling of which are exactly those a physician
is trained to recognize and fight. To me it seems no more natural to be
a United States Senator, and in my case the majority leader of the
Senate, than it did to Harry Truman, who spent so many hard and
unambitious years as a farmer and then found himself in such a place
and at such a time as he did. And, like him, as someone who comes from
the outside, and for whom the perquisites of power appear strange and
irrelevant, I have asked myself what my purpose is as a public servant,
what my obligations are, and what high precedents I should follow.
After some thought, I have determined my purpose, I know my duty
and obligations, the precedents to honor, and why--neither history nor
life itself being empty of example. Just as a surgeon must follow a
purely objective course and a general must look at war with a cold and
steady eye, a statesman must operate as if the world were free of
emotion. And yet, to rise properly to the occasion, the surgeon must
have the deepest compassion for his patient, the general must have the
heart of an infantryman, and the statesman must know at every moment
that the cost of his decisions is borne, often painfully, by the
sovereign population he serves--all as if the world were nothing but
emotion. The difficulty in this is what Churchill called the
``continual stress of soul,'' the rack upon which the adherents of
these professions, if they meet their obligations well, will of
necessity be broken.
In balancing objectivity with emotion, the practical with the
moral, the smooth operation of power with its homely and human effects,
one is driven to consider first things and elemental purposes, and this
consideration makes clear that the guiding star of statesmanship is not
aggrandizement of the state or the furtherance of a philosophy or
ideology, and neither glory nor ambition nor accumulation of territory
or riches. Rather, the guiding star must be the fact of human
mortality, and the first purpose of a public official a simple watch
upon the walls. We are charged above all with assuring the survival of
the Nation and protecting the lives of those whom we serve and who have
put us in our place, entrusting us with this gravest of
responsibilities.
Whether leading a small nomadic band, captaining a ship, or at the
head of a huge industrial nation, the task is the same. It is not
merely that which can be accomplished with sword and shield, but,
rather, the exercise of courage, sacrifice, and judgment, in the
preservation of the life of a nation in its people as families and
individuals. And as if by design, this task becomes in its execution a
principle that unites the powerless and powerful in an unimpeachable
equality.
Clear and Present Danger
In times of peace and prosperity, whole nations sometimes willfully
forget that we are mortal, and the forgetfulness then can rule beyond
its natural life even in the face of war and pestilence, when by all
accounts the star of mortality shines in air cleared of the luminous
distractions of peace.
Like everyone else, politicians tend to look away from danger, to
hope for the best, and pray that disaster will not arrive on their
watch even as they sleep through it. This is so much a part of human
nature that it often goes unchallenged. But we will not be able to
sleep through what is likely coming soon--a front of unchecked and
virulent epidemics, the potential of which should rise above your every
other concern. For what the world now faces it has not seen even in the
most harrowing episodes of the Middle Ages or the great wars of the
last century. And not only are we unprepared for rampant epidemics, we
have not taken sufficient note of the fact that though individually
each might be devastating, they are susceptible of either purposeful or
accidental combination, in which case they could be devastating almost
beyond imagination.
The history of pathogens advances in parallel with and is no more
static than our own, with which it is always intertwined, even if at
times invisibly. Sometimes it rushes forward with great speed and
breathtaking evolutionary vigor, and sometimes it rests in slow
backwaters. When, in 1967, the U.S. Surgeon General declared that we
had won the war on infectious diseases, we thought the slack water
would last forever. But that war had never ended other than in wishful
thinking.
Even now we accept as normal, because it is normal, that more than
a quarter of all deaths--fifteen million each year--are due to
infectious diseases. Three million children die every year of malaria
and diarrheal diseases alone, one child every 10 seconds. As sobering
as this may be, we have been nonetheless in a quiescent stage of the
mutability of pathogens, a hiatus from which they are now poised to
break out. When viral diseases evolve normally--such as in the typical
course of the human influenza virus undergoing small changes in its
antigenicity and killing an average of 500,000 people annually
throughout the world--it is called an antigenic drift. When they emerge
with the immense power derivative of a jump from animal to human hosts
followed by mutation and/or recombination with a human virus, as in the
influenza pandemic of 1918-1919, in which 500 million people were
infected and 50 million died, including half a million in the United
States, it is called an antigenic shift.
To have believed with the Surgeon General forty years ago that the
great advances of biological science were capable of permanently
suppressing infectious disease was to have been unaware that these
triumphs were appropriate only to one phase in the life of a
continually evolving enemy whose natural rate of evolution and
adaptation is far greater than our own. Shifts are the result of
random, fortuitous, and unavoidable changes. Human population increase,
concentration, and spread, intensification of animal husbandry, and
greater wealth in developing countries bring animals both wild and
domestic into closer contact with ever-larger numbers of people. War,
economic catastrophe, and natural disasters subdue active measures of
public health. The unprecedented use of antibiotics builds
unprecedented resistance. Travel, trade, and climate change bring into
contact disparate types and strains of disease. And as a consequence of
all this, microbes evolve, mutate, and find new lives in new hosts.
The annual toll of infectious diseases worldwide--including four
million from respiratory infections, three million from HIV/AIDS, and
two million from waterborne diseases such as cholera--is a continuing
and intolerable holocaust that, while sparing no class, strikes hardest
at the weak, the impoverished, and the young. But this is just a
beginning, in that the evidence strongly suggests that we are at the
threshold of a major shift in the antigenicity of not merely one but
several categories of pathogens, for never have we observed among them
such variety, richness, opportunities for combination, and alacrity to
combine and mutate. HIV, variant Creutzfeldt-Jakob disease (mad cow),
avian influenzas such as H5N1, and SARS are merely the advance patrols
of a great army forming out of sight, the lightning that however silent
and distant gives rise to the dread of an approaching storm--a storm
for which we are entirely unprepared. How can that be? How can the
richest country in the world, with its great institutions, experts, and
learned commissions, have failed to make adequate preparation--when
preparation is all--for epidemics with the potential of killing off
large segments of its population?
Precedent and Presage
To see what lies on the horizon one need only look to the
relatively recent past. I have a photograph of an emergency hospital in
Kansas during the 1918 influenza pandemic. People lie miserably on cots
in an enormous barn-like room with beams of sunlight streaming through
high windows. It seems more crowded than the main floor of Grand
Central Station at five o'clock on a weekday. In this one room several
hundred people are in the throes of distress. Think of 2,000 such rooms
filled with a crush of men, women, and children--500,000 in all--and
imagine that the shafts of sunlight that illuminate them for us almost
a century later are the last light they will ever see. Then bury them.
That is what happened.
How would a nation so greatly moved and touched by the 3,000 dead
of September 11th react to half a million dead? In 1918-1919 the
mortality rate was only 10 percent, which seems merciful in comparison
to the near 100 percent rate common to hemorrhagic fevers. Nor is
influenza nearly as infectious as, for example, smallpox. How, then,
would a nation greatly moved and touched by 3,000 dead, react to five
or fifty million dead?
Smallpox is just one of many threats. During the cold war, the
Soviet Union, which stockpiled 5,000 tons annually of biowarfare-
engineered anthrax resistant to 16 antibiotics, also produced massive
amounts of weaponized smallpox virus just as universal immunization had
come to a halt. As a result of conditions prevalent during the
dissolution of the USSR, it is impossible to rule out that quantities
of this or other deliberately manufactured pathogens such as anthrax,
pneumonic plague, tularemia, etc. may find or may have found their ways
into the possession of terrorists such as bin Laden and al-Zarqawi.
Although the United States has put up enough--questionable--smallpox
vaccine for the entire population, it has neither the means of
distribution nor the immunized personnel to administer it in a
generalized outbreak, nor the certainty that the vaccine would be
relevant to a specific weaponized strain of the virus. Ring vaccination
would be useless if the pathogen were released at many sites
simultaneously, and in such a circumstance hospitals and the now
nonexistent auxiliary means of relief would be quickly overwhelmed.
Panic, suffering, and the spread of the disease would intensify
as--because people were dead, sick, or afraid--the economy ceased to
function, electrical power flickered out, and food and medical supplies
failed to move. Over months or perhaps years, scores of millions might
perish, with whole families dying in their houses and no one to
memorialize them or remove their corpses. Almost without doubt, the
epidemic would spread to the rest of the world, for in biological
warfare an attack upon one country is an attack upon all. Every vestige
of modernity would be overturned. The continual and illusory flirtation
with immortality that is a hallmark of scientific civilization would
shatter, and we would find ourselves looking back upon even the most
difficult times of the last century as a golden age. Despite the common
wisdom, humanity has not moved beyond this kind of scenario. Of late it
has moved unnecessarily and gratuitously toward it.
Any number of unknown viruses for which at present there is neither
immunization nor cure are at this moment cooking in Asia and Africa,
where they arise in hotbeds of densely intermingled human and animal
populations. We are in unexplored territory. Economic and environmental
changes in Asia have forced wilderness-deprived waterfowl to alight to
feed amid farm animals in newly dense populations due to recently
acquired wealth and dietary expectations, in a culture in which live
poultry is brought to market. The reassortment of viral DNA as a result
of this mingling is so frenzied that it is only a matter of time until
the emergence of a virus unequaled in transmissibility and virulence.
The epidemiological calculus of flu is notoriously volatile due to the
unknowns of rapid reassortment. We do know now, however, that the
incidence of H5N1 has been underestimated, that North Korea may be at
the cusp of an Avian Flu crisis, and that we are woefully underprepared
even for a virus that we can foresee, much less for one that we cannot.
No such viruses have yet reached critical mass or leapt from the
channels imposed by their inherent limitations, environmental
obstacles, and deliberate actions to contain them. But the evidence I
have seen, the patterns of history, and new facts such as rapid,
voluminous, and essential travel and trade; the decline of staffed
hospital beds; and a now heavily urbanized and suburbanized American
population dependent as never before upon easily disrupted networks of
services and supply, lead me to believe that--especially because
vaccines, if they could be devised, would not be available en masse
until six to nine months after the outbreak of a pandemic--the
imminence of such viruses might result in the immensely high death
tolls to which I have alluded.
It is true that none of these viruses has yet spread
geometrically--instantly and irrevocably overcoming health care systems
and pulling us backward across thresholds of darkness that we long have
believed we would never cross again. And yet this they might do--either
entirely on their own or as a result of intentional human intervention.
No intelligence agency, no matter how obsessively and repeatedly
rearranged, and no military, no matter how powerful and dedicated, can
assure that a few technicians of middling skill using a few thousand
dollars' worth of readily available equipment in a small and apparently
innocuous setting cannot mount a first-order biological attack. It is
possible, for example, to unite the prairie-fire infectiousness of
smallpox with the almost absolute fatality of Ebola fever. It is
possible simply and inexpensively to synthesize virulent pathogens from
scratch, or to engineer and manufacture prions that, introduced
undetectedly over time into a nation's food supply, would after a long
delay afflict virtually the entire population with a terrible and
uniformly fatal disease. Unfortunately, the permutations are so various
that the research establishment as now constituted cannot set up lines
of investigation to anticipate even a small proportion of them. Never
have we had to fight such a battle, to protect so many people against
so many threats that are so silent and so lethal.
But is it reasonable to assume that anyone might resort to
biological warfare? Indeed it is. Al-Qaida has declared that, ``We have
the right to kill four million Americans--two million of them children
. . . [and] it is our right to fight them with chemical and biological
weapons.'' In Al-Istiqlal, the weekly of Islamic Jihad, we read that
``it is the duty of Muslims to act in any possible way to acquire
weapons of mass destruction, starting with nuclear weapons and ending
with chemical and biological weapons.'' It is hardly necessary,
however, to rely upon stated intent. One need only weigh the logic of
terrorism, its evolution, its absolutist convictions, and the evidence
in documents and materials found in terrorist redoubts.
Those who equate terrorism with its targets and take false comfort
in attributing to the terrorist the moral status and restraint of his
victim should consider that for more than half a century at least eight
countries have possessed a collective arsenal of, at times, not only
scores of thousands of nuclear warheads but the virtually ineluctable
means of delivering them. Still, apart from the first and only use of
nuclear weapons, in every trying condition, in crisis and in war, in
victory and in defeat, not one has been detonated except in test. Who
would gamble that if the terrorist enemy possessed even a single
nuclear charge, he would fail to devote all his resources to its
detonation in the midst of the maximum number of innocents? And though
not as initially dramatic as a nuclear blast, biological warfare is
potentially far more destructive than the kind of nuclear attack
feasible at the operational level of the terrorist, and biological war
is itself distressingly easy to wage.
Rising to Meet the Day
I ask again how it is that nowhere is anyone prepared either for
naturally occurring epidemics of newly emergent diseases or those that
are deliberately induced? It would take whole encyclopedias to dwell on
what has not been done and the inadequacy of what little has been done,
but a hint may be accurately conveyed by the fact that the Nation's
largest biocontaminant unit with fully adequate quarantine and negative
air is a ten-bed facility in Omaha, or by the absurdity of a recent
announcement from the Washington Hospital Center that in ``implementing
plans for handling any disaster that might effect our capital,'' and
``to deal with the worst in biological, chemical, and natural
disasters,'' it has built, ``a multi-use, 20-bed ready room'' (emphasis
mine).
We may have built a 20-bed ready room, but there is on the horizon
a silent wave that is coming at the world, and, if we do nothing, it
will sweep over us invincibly. My duties as physician and public
official having fused, I propose that we take the measure of this
threat and make preparations to engage it with the force and knowledge
adequate to throw it back wherever and however it may strike. It need
not be invincible and we need not fall to our knees before it. Means
adequate to the success of a defensive plan are present in great
profusion. Whereas the approaching biological shift is gathering force
like a massing army, providence has massed an army to meet it. Having
themselves expanded geometrically, the life sciences have come to the
threshold of a great age, and to cross it they need only encouragement
and a signal from the body politic to put their resources in play.
We are not without weapons in this war. They are present in the
stupendous material and intellectual wealth of the civilized world,
which, despite current divisions of action and opinion, has everything
to lose in common. They are present in the approximately $30 trillion
per annum combined gross national products of just NATO and Japan. They
are present in the great stores of science and technology amassed over
thousands of years of civilization; in the many hundreds of
universities, advanced research institutions, and hospitals; in the
private sector's ruthless focus, which, though frequently condemned for
its lack of humanity, may yet be the instrument that saves humanity.
They are present in the special temperament and brilliance of
individual scientists; in the magnificent light that comes of the
surprising and ingenious application of new technologies; and in the
vigor, intelligence, and decency of free and unoppressed peoples.
The nature of the threat being mortal and reaction to it heretofore
irresponsible and inadequate, I propose--entirely without prejudice to
the necessity and absent the diminution of the means to disrupt,
defeat, and confound the aggressor by force of arms--an immense and
unprecedented effort. I see not an initiative on the scale of the
Manhattan Project, but one that would dwarf the Manhattan Project; not
the creation of a giant, multi-billion dollar research institution, but
the creation of a score of them; not merely the funding of individual
lines of inquiry, but of richly supported fundamental research, a
supreme effort in hope of universal application; not the fractional
augmentation of medical education but its doubling or tripling; not a
wan expansion of emergency hospital capacity, but its expansion, as is
necessary and appropriate, by orders of magnitude; not to tame or
punish the private sector, but to unleash it especially upon this task;
not the creation of a forest of bureaucratic organization charts and
the repetition of a hundred million Latinate words in a hundred million
meetings that substitute for action, but action itself, unadorned by
excuse or delay; not the incremental improvement of stockpiles and
means of distribution, but the creation of great and secure stores and
networks, with every needed building, laboratory, airplane, truck, and
vaccination station, no excuses, no exceptions, everywhere, and for
everyone.
I call for no less than the creation, with war-like concentration,
of the ability to detect, identify, and model any emerging or newly
emerging infection, natural or otherwise; for the ability to engineer
the immunization and cure, and to manufacture, distribute, and
administer whatever may be required to get it done and to get it done
in time. For some years to come, this should be the chief work of the
Nation, for the good reason that failing to make it so would be to risk
the life of the Nation.
It could be very costly, yes, but it is the kind of thing that,
once accomplished, is done. And it is the kind of thing that calls out
to be done, and that, if not done, will indict us forever in the eyes
of history. In diverting a portion of our vast resources to protect
nothing less than our lives, the lives of our children, and the life of
our civilization, many benefits other than survival would follow in
train, not least the satisfaction of having done right. If the process
of scientific discovery proceeds as usually it does, diversions of
money, energy, and effort into the construction of a vast public and
private research and medical system capable of intercepting and
defeating the worst natural or terroristic epidemics would very likely
bring as well a magnificent offshoot--understanding diseases that we do
not now understand and finding the cures for diseases that we cannot
now cure. If the laws of supply and demand have not been repealed--and
they have not--the heretofore unequaled abundance of medical goods and
services would contribute to solving the problems of financing health
care--and it would do so the old-fashioned way, by paying for it. And,
as always, disciplined and decisive action in facing an emergency can,
even in the short run, compensate for its costs--by adding to the
economy both a potent principle of organization, and a stimulus like
war but war's opposite in effect, which would power the productive life
of the country into new fields, transforming the information age with
unexpected rapidity into the biotechnical age that is to come--and all
this, if the Nation can be properly inspired in its own defense and
protection, perhaps just in time.
Rest for a moment what may be your astonishment at the scale of the
initiative I have proposed, and allow a conservative Republican from
Tennessee, who is by nature skeptical of government action, to affirm
the root conservative principle that if the life of the Nation is
potentially at risk no effort should be judged too ambitious, no price
too high to pay, no division too wide to breach.
We have built great cities, dams, and aqueducts. We have built the
interstate highway system, bridges, canals, fleets, armies, and a world
of structures the cost of which defies expression. We have decided upon
going to the moon and then done so in a few short years. Can we not,
then, build this thing, and take these steps, to protect our lives and
the lives of our children, to evade mass death and alleviate the
greatest suffering that man has ever known, that comes to all classes,
all races, all ages? Have we been so blinded and confused that we
cannot see the single most important challenge before us, and the
single greatest opportunity?
I am aware that what is now required has not been asked since the
eighth of December, 1941. And I am aware of the difficulties. But I
know as well that however much it may be shunted aside by the ordinary
and the profane, a deep understanding of mortality, second to none, is
present in the people--who are not superficial, who are not to be
dismissed, and from whom an almost miraculous collective wisdom has
arisen whenever it has been needed. It arose at the time of the
American Founding, to create a republican democracy despite the
militant opposition of the world's greatest empire. It arose when the
premise of the founding, that all men are created equal, was turned
into reality even though to do so meant the bloodiest war in the
Nation's history. It arose in the world wars and the cold war, when the
Nation fought and persevered for a century, with patience, devotion,
and generosity, not merely for the sake of its narrow interests--which
some could not even see--but out of principle. I believe that despite
their imperfection the sinews of the American people are intact, and I
believe that the sinews of our allies and their great civilizations are
intact as well.
America on the Front Lines
Especially since September 11th, awareness of mass biological
warfare has been at the edge of the popular imagination, but seems to
have escaped political will. Blind and chattering elites have dismissed
the concerns of the public, or failed to hear them, as if there were a
set of facts, a certitude of result, or some infallible wisdom with
which to support this dismissal. But no such facts exist and the
certitude of those who would discount the danger is just a pose spun
from thin air. Failure to foresee, to prepare for, and to forestall
bioterrorism and a biological shift is a failure of statesmanship that,
until remedies are found and action taken, is also a personal failure
for everyone in a high and responsible position--even the highest,
especially the highest, including the president, and including me. In
this regard the people are ahead of their leaders and possessed of more
common sense. They know, quite frankly, that we are as vulnerable as
hell, and that no one is really doing anything about it.
The persistent inaction is especially gratuitous in light of the
fact that the magnitude of the issue should have the power to heal many
a breach and cross many an ideological chasm. For those who hold that
attention to moral questions is illusory and impractical, and for those
who protest that devotion solely to practical matters is amoral, here
is the urgent fusion of both, that cannot be dismissed as either, even
if until now it has been perceived and neglected as if it were neither.
As in crises of times past, left and right, modernists and
traditionalists, the old world and the new, can agree that the
protection and preservation of human life on a massive scale is the one
goal in their philosophies that will enable their every other principle
to seek its every other action.
Conservative predilection and purely empirical observation lead me
to believe that what I have proposed, though universal in effect,
cannot be brought to fruition as a universal scheme. The World Health
Organization is essential, but it works best as an expression of the
power and resolution of nations. For the Nation is yet the highest
level of effective organization, and, paradoxical as it may seem, a
worldwide defense against biological catastrophe would be strongest
were it erected at the national level, in a loose confederation with
unavoidable duplications but with, nonetheless, the organic development
among countries of an efficient division of labor.
In this the United States is as blessed as it has been since its
beginnings. We are the wealthiest, freest, and most scientifically
advanced of all societies, the first republican democracy, the first
modern state. And although we have suffered criticism of late and to no
small degree because of our awkwardness as a young nation, we have been
willing since our Founding and are willing still to pursue certain
ideals. Though not infrequently condemned from the precincts of
cynicism, America has mostly left cynics in its wake, sometimes after
saving them from floods that they themselves have unleashed.
Do not discount America or dismiss its resolution. Our
imperfections are accompanied by fine qualities and beliefs of which we
will never be ashamed and from which we have no intention of recoiling.
We believe in government with the consent of the governed, and in the
sanctity of the individual. We have as a nation by and large rejected a
mechanistic view of human nature in favor of a belief in the soul and
the grace it may be granted. (If there is no soul, what is the basis of
human equality in law or morals, given that we are unequal in all other
ways?) This belief to which we hold firm is descended from our
founding, which occurred at a time of miraculous poise in human history
when science and reason were in uncontradictory balance with faith;
when in America the freshest optimism the world has ever known was
tempered by a view of human nature unsurpassed in its clarity and
caution.
Lest this seem too abstract, consider that when we found ourselves
in violation of our elemental principles we suffered through many years
of fratricidal warfare to put them right. Both sides fought with
inimitable courage, and the side--of which I am a son--that was reduced
to waste and ash, rose from its ruins to fight a greater battle, a
battle with itself, finally to embrace the principles it had opposed.
From the blood of my fathers and in my blood itself I have not
merely a vision of ruin, waste, and ash, but the certain knowledge, a
vivid memory that has of late been refreshed and confirmed. This is not
the last time you will hear from me, but today I have tried to impress
upon you the urgency I feel in the matter of the immediate destiny not
only of America but of the world, for pandemics know neither borders,
nor race, nor who is rich nor who is poor, they know only what is
human, and it is this that they strike, casting aside the vain
definitions that otherwise divide us.
It is my pre-eminent obligation as a public servant and my sacred
duty as a physician to ask you to support the essence of my proposal.
In respect of human mortality, for the sake of your own families and
children, for the honor and satisfaction of doing right, and to sweep
away the inexcusable prevarication that has accumulated since the great
shock of September 11th, I bid you join in this declaration. May God
preserve us all, and may our actions and foresight make us worthy of
His preservation.
______
remarks as prepared for majority leader bill frist, m.d.
Pandemic: The Economy's Silent Killer
National Press Club
December 8, 2005
Introduction
Imagine a cigarette carelessly flung on the edge of a scorched and
brittle forest. Un-extinguished, the cigarette smolders in the leaves
until it catches flame. The winds blow in, sparks are carried afar, the
thirsty limbs ignite. A forest fire is born.
When the elements are aligned, the path of a global pandemic is
similar.
Think of a fast-moving, highly contagious disease that wipes out 50
million people. Half a million in the U.S. The killer pandemic claims
more victims in 24 weeks, than HIV-AIDS has claimed in 24 years.
In the United States--the most developed nation in the world--
bodies pile up in the streets. There aren't enough morticians to bury
the dead. Nor are there enough doctors and nurses to tend to the sick.
Normal life stops. The churches close, the schools shutter.
Communications and transportation grind to a halt.
The public succumbs to hysteria and panic. Police protection fails.
Order decays. Productivity dives.
Sounds like science fiction, doesn't it? But what if I told you, it
already happened? What if I told you it was the pandemic flu that swept
across America and around the globe in 1918?
Or if I told you that this glimpse into the past might just be a
preview to our future?
***
A viral pandemic is no longer a question of if, but a question of
when.
We know--depending upon the virulence of the strain that strikes
and our capacity to respond--that the ensuing death toll could be
devastating.
In recent weeks, the growing death toll of the avian flu and the
mounting drumbeat of discussion have placed the virus under the
microscope of the public eye. Yet--like all stories--it too will shift
from center stage. The public will have had their fill. The danger will
seem removed.
But while the story may recede from the cover of Newsweek or the
centerfold of Time, I know that a threat that strikes at our very
mortality--as this does--must not recede to the backdrop of public
concern.
As a physician, a heart surgeon, my life has centered on
mortality--the preservation of life.
Similarly, as public officials, the mortality of mankind should be
our first, and if necessary, only concern. Measured against everything
we consider from day to day--budgeting, taxes, judges, pensions--your
mortality, the care and protection of human life, is the most
fundamental responsibility entrusted to us.
Which is why we will not look away from what may come.
Today I ask you to walk forward with me to a future where an avian
pandemic strikes. (It's almost Christmas . . . think of the Ghost of
Christmas Future.) As we look to that future, let's zero in on a
critically important aspect that has received almost no focus to date--
the pandemic's impact on our economy.
``When a pandemic strikes, exactly how devastating will the
economic fallout be?''
That is the question I'll answer today.
But before we fast-forward to the future, let's quickly rewind.
``Exactly what is this avian influenza?''
The year is 1997. The place, Hong Kong.
The culprit: the H5N1 strain of the avian flu, a highly contagious
virus primarily affecting wild waterfowl. The birds are a natural
breeding ground for the virus--they can carry the virus without
symptoms, spreading it far and wide.
In 1997 the dynamics shift. The virus that has affected only
animals so far spreads to 18 people in Hong Kong. A third of them die.
By slaughtering the region's entire poultry stock--1.5 million
birds--Hong Kong authorities quickly stem the spread of disease.
But to scientists and public health officials, it is the first shot
heard round the world. The Hong Kong outbreak signaled that the H5N1
strain had satisfied two of three prerequisites for a pandemic:
1st: the H5N1 strain was a novel type of virus, to which no
human being has any pre-existing immunity.
2nd: The virus could reproduce in humans and cause serious
illness.
The only remaining requirement--not yet fulfilled--is human-to-
human transmission.
For the final element to fall into place, it will require little
more than the shuffling of a few genes between the animal and human
forms of a virus (--a phenomenon known as an antigenic shift.)
The resulting mix will be totally unfamiliar to the human immune
system which normally fights infections--meaning that human beings will
have no natural immunity to it. More alarming, the right mix of genes
could allow for sustained human-to-human transmission: an avian
pandemic would launch to life.
***
Since the 1997 outbreak, the avian flu has progressively and
relentlessly spread across 16 countries. From Hong Kong, the virus has
stretched its tentacles into Thailand, South Korea, Vietnam, Japan,
Cambodia, Laos, Indonesia, China, Malaysia, Russia, Kazakhstan,
Mongolia, Turkey, Romania, and Croatia--infecting 135 humans, and
killing 69 (in five countries--Cambodia, China, Indonesia, Thailand,
Vietnam). \1\
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\1\ From 2003 to present. Deaths have occurred in Cambodia, China,
Vietnam, Thailand, and Indonesia.
With each outbreak, the signs are increasingly clear that a
---------------------------------------------------------------------------
pandemic is looming.
1st: it's found a permanent ecologic niche among domestic ducks
in rural Asia.
2nd: it's increased the range of species it can infect--moving
to cats and tigers.
3rd: it's grown more robust, rendering itself resistant to 1 of
2 types of anti-flu drugs.
4th: it's shown the ability to mutate rapidly, with the
propensity to acquire new genes.
Last, it's demonstrated that it can infect humans directly.
With each person that the virus infects, the more likely it is that
genetic re-assortment will occur, and a pandemic will arise.
Possible Pandemic Scenarios
A second fundamental question: ``How severe will that pandemic
be?''
To forecast the economic impact, it's a question we must answer.
The most frequently cited, deadliest pandemic in recent history was
the 1918-1919 Spanish influenza.
The flu infected between a quarter and a third of all Americans,
and killed half a million (2-3 percent of those infected). Worldwide,
40 to 50 million people died.
Unlike the seasonal flu, the 1918 influenza preyed on and killed a
younger, healthier demographic, the most productive segment of our
population--as opposed to the elderly, the weak, and the very young. In
the United States, the pandemic was so acute that the average lifespan
was shaved-off by 10 years.
``So, will an avian pandemic today be more severe or less severe
than the 1918 avian flu?''
We don't know.
Scientists who believe that the coming pandemic will be LESS severe
cite the dramatic 20th century advances in science and medicine. We
have far more sophisticated tools for surveillance, the ability to
design vaccines, and better treatment options like antibiotics for
secondary bacterial infections.
Those who believe that we're MORE vulnerable today argue (perhaps
even more persuasively) that the world is much more densely populated
which facilitates rapid spread. They cite that the population is
comprised of a higher proportion of elderly; that our dependence on
just-in-time delivery systems would wreak greater disruption; and last
that a million people living today with preexisting compromised immune
systems (by cancer therapy) means a more susceptible host.
This line of reasoning--that a pandemic would be worse--is
compounded by the fact that the world today is so tightly
interconnected through travel, trade, and on-line communication--a
factor that could greatly amplify the spread of fear, panic, and even
the virus itself.
Whatever the outcome, this latter argument speaks to an undeniable
truth. When facing the prospect of a modern pandemic, no longer are we
battling the rapidly spreading virus alone, but the repercussions of
disease in a world where everything is interdependent.
``But,'' you say, ``1918 is a long time ago.''
``Is there a modern example of a viral outbreak that we can learn
from?''
And the answer is yes--the 2003 outbreak of the SARS virus.
SARS is our Best Benchmark
SARS, though not a pandemic, demonstrated--for the first time
ever--the profound sensitivity of the modern global economy to a
contagious, spreading, infectious disease.
The SARS virus infected only 8,000, and killed just 774 (remember
the annual seasonal flu kills 30,000 in America every year). BUT what
we learned was that the global reaction to this newly emerged virus was
disproportionately greater than the actual virulence of the disease.
\2\
---------------------------------------------------------------------------
\2\ Economic Risks Associated with an Influenza Epidemic, Bio-Era.
From an economic standpoint, SARS taught us that when a modern
---------------------------------------------------------------------------
pandemic emerges, it will generate two waves of reaction.
The first economic wave leads to the INDIRECT costs to the economy.
It will be propelled by fear, confusion and misunderstanding, and a
lack of confidence in the authorities' ability to respond.
In the early stages of the SARS outbreak, fear and
uncertainty led to a dramatic 30-80 percent decline in tourism in East
Asia in the spring of 2003. GDP fell by an astounding 2 percent in the
second quarter.
In Hong Kong, airline passenger arrivals dropped by two-
thirds in April 2003. (as compared to the month before). Retail sales
fell 8.5 percent for the quarter.
Foreign direct investment in Asia plummeted.
And in Canada--where fewer than 500 people were
infected--the country suffered more than $1 billion in economic losses.
\3\
---------------------------------------------------------------------------
\3\ Economic Risks Associated with an Influenza Epidemic, Bio-Era.
The second economic wave is caused by the DIRECT impact of the
disease. It represents the hit the economy takes from hospitalizations,
deaths, lost productivity, and a consequent slowdown in the flow of
goods and services. In SARS, these DIRECT economic losses--from the
medical treatment costs and lost productivity--accounted for only 1-2
percent of the $30-50 billion in total damages. \4\
---------------------------------------------------------------------------
\4\ Economic Risks Associated with an Influenza Epidemic, Bio-Era.
SARS taught us that the indirect impacts--from fear,
misunderstanding, and a lack of confidence in a community's (or a
nation's) ability to respond--must be addressed when forecasting the
economic impact of a pandemic.
CDC Study
``What current economic studies have looked at the impact of a
modern avian pandemic on the US economy?''
The data are very limited.
The most cited--and until today--the most recent study is the 1999
report by the CDC (Centers for Disease Control and Prevention). The
study, however,--conducted 4 years before the SARS outbreak--was
incomplete. It measured only the DIRECT medical and health costs to the
economy: hospitalizations, outpatient visits, and deaths.
Assuming an attack rate of 15-35 percent, the CDC predicted that:
38-89 million people would become clinically ill;
18-42 million would require outpatient care;
314,000-734,000 people would be hospitalized; and
89,000-207,000 people would die.
Their conclusion: The estimated cost to the U.S.
economy would be a 1 to 2 percent drop in GDP ($71-$166 billion
loss in 1995 dollars).
Projected Economic Effects
But that's just the DIRECT costs.
``What would the TOTAL economic impact be?
To shed light on that answer, I asked my economic advisers, the
Congressional Budget Office, to provide a comprehensive analysis of the
economic impact of a pandemic on the U.S. economy.
Our CBO study looked at two scenarios--a severe pandemic (much like
the 1918 pandemic) and a mild pandemic. For a severe scenario, the CBO
assumed a 2.5 percent case fatality rate, and for a mild scenario they
assumed a 0.1 percent case fatality rate.
I will focus my remarks on the severe scenario:
30 percent of the population is infected (90 million
Americans)
2 million people die.
CBO assumed that:
The pandemic would last for 3 months.
And 30 percent of the workforce would become ill and
miss 3 weeks of work
The supply side economic impacts would include:
A shrinking of the labor force due to illness and the
death of 1 million labor force participants;
A disruption of the supply chain due to shutdowns in
transportation; and
A shortage of health care personnel and quality
medical care for flu-and non flu-related illnesses.
The supply side impacts can be roughly correlated to direct
losses--from lost productivity, illness, and death.
CBO concluded that these supply side impacts would cause the
Nation's GDP to decline by a full 3 percent in the year the pandemic
occurs.
And then there is the demand side of the equation.
The impacts to demand would also be astounding:
Voluntary quarantining would reduce turnout at
restaurants, shopping malls, sporting events, churches and
schools.
Demand would fall by 80 percent in entertainment,
arts, recreation, restaurants, and lodging (for 3 months).
Retail trade would fall by 25 percent.
The demand for medical and hospital services would
surge.
And, a fear of travel, coupled with government-
imposed restrictions, would lead to a dramatic decline in
domestic and international travel.
These demand-side impacts can be roughly characterized as indirect
economic losses, (and they reflect the public's fear, misunderstanding,
and lack of confidence in authority). CBO concluded that these indirect
losses would cause the Nation's economy to fall by an additional 2
percent!
Thus, together, the supply and demand impacts would result in a 5
percent reduction in GDP.
This is a $675 billion hit (in 2006 dollars) to the U.S. economy.
These are huge numbers. This scenario suggests that a severe
influenza pandemic would have an impact on the U.S. economy that is
slightly larger than the typical recession experienced since World War
II. On average those recessions lowered real GDP 4.7 percent.
(The CBO study also reports results for a milder pandemic of the
1957 and 1968 variety. The analysis found that the impact on the
economy would be a 1.5 percent drop in GDP--1 percent on the supply
side and 0.5 percent on the demand side.)
Similar to what the SARS experience brought to light, the CBO
scenarios suggest that fear, misunderstanding, and a lack of confidence
and trust in authority may have almost as much impact on the economy as
the direct toll of sickness and death.
Public Health Prescription
A $675 billion hit to the economy is--without question--a grim
prognosis. But our hands are not tied. In fact, the policy implications
become crystal clear. By immediately outlining and implementing a
specific policy prescription, we can minimize not only the direct
economic effects of a pandemic, but perhaps more significant, greatly
reduce the costly indirect effects of panic, fear and paralysis.
There are 6 steps we must take.
1. Communication
Number #1 is communicating with the public.
To allay irrational fear, communication must be the bedrock of
every public policy response. Communication--of accurate, reliable,
consistent information--isn't an option--it is the antidote--the
vaccine for irrational fear. (Think Katrina.)
Failing to effectively communicate with the public--both before and
during the pandemic--would be analogous to having a fire escape plan
for your home, but neglecting to share the plan with your family. You
don't want your family jumping out the window when there's a ladder
under the bed. To minimize losses, you not only create an emergency
plan, you tell people about it--again and again and again..
Prior to the pandemic--today--we must organize a communications
structure with representatives from public health, law enforcement,
military, and government to serve as the liaison to the public. It must
be grounded in trust and reliability. During an outbreak, the
communications structure should update the public every 6-8 hours on
what they need to know--educating them on symptoms, cases, deaths,
outbreak locations, and when and where to find care.
2. Surveillance
Second is surveillance. Remember the forest fire? We must stomp on
the sparks before they ignite. The sooner we detect, identify and
contain avian flu--in animals and in humans--the better the economic
prognosis will be. That's why we need a real-time international threat
detection system. And that's why I've proposed $1 billion to build it.
By developing rapid testing technology, by training more
epidemiologists, by enhancing our global partnerships, and by helping
developing nations compensate farmers for livestock culled we can
contain the flames before they spread.
3. Antiviral Agents
Third are antiviral agents. Antiviral agents (and believe it or not
there are only two) are the only front-line therapeutic tool we
currently have to treat the avian flu, and slow its spread. But the bad
news is, our current supply is inadequate. Today we have 4.3 million
courses of Tamiflu stockpiled. That's enough to treat less than 2
percent of the U.S. population. We must increase that number to provide
Tamiflu for at least 25 percent of the population. A five-day course of
Tamiflu for 75 million Americans would cost approximately $1.35
billion--a tiny fraction of the economic impact of a full-blown
pandemic.
4. Vaccines
Vaccines are our best line of defense--for prevention. Yet,
unfortunately, until we identify the strain--which we can do only when
sustained human-to-human transmission occurs--we cannot begin to
produce a targeted, fully effective vaccine. With our current grossly
inadequate vaccine manufacturing capacity, it could take as long as a
whole year to achieve ``bug to drug''--that's the window of time
between first identifying the specific strain and manufacturing a
vaccine available for distribution. In a time of pandemic, that's an
unacceptable wait.
We have a dangerously inadequate vaccine manufacturing base in this
country. Why? Bottom-line: there's so little profit and so much
uncertainly in vaccine manufacturing today.
30 years ago there were 24 vaccine manufacturers. Today there are
only 5 . . . and only 1 on U.S. soil (Sanofi Pasteur).
In the United States we have 18,000 (not millions) doses of a test
vaccine stockpiled, and 22 million more on order--enough to treat 11
million people--clearly far less than we need.
How do we grow our manufacturing base?
We can immediately begin by increasing the annual
market for the seasonal flu vaccine. The most we've ever sold
in a year is 83 million doses, but by recommending that a
larger percentage of the population receive the annual vaccine,
we can increase the demand for vaccines and incentivize
manufacturers to enter the market.
We should target tax credits to increase
manufacturing capacity, streamline regulations, and offer
balanced, sensible liability protection for manufacturers to
make these life-saving emergency medicines.
Together these will lay the groundwork for a quicker
``bug-to-drug'' timeframe.
5. Research and Development
5th is research and development.
Vaccines and antivirals our best tools for the present. But
research is our best hope for the future. We must harness the best
minds in academia, and in the public and private sectors. We need to
bring them together to form a ``Manhattan Project for the 21st
Century'' which can help us better defend against naturally occurring,
accidental, and intentional threats--including infectious diseases.
One example is targeted research for a cell-based flu vaccine. By
investing in cell-based manufacturing technology, rather than relying
on antiquated egg-based technology, the window for bug to drug can be
cut from a year to less than 6 months. With tens of thousands of people
dying every week, every moment counts. (When tens of thousands of
people are dying every week, every moment will count . . . ?)
6. Stockpiling & Surge Capacity
6th, we need to stockpile and prepare for surge capacity.
If identification and vaccine manufacture represents the ``bug-to-
drug'' portion of the equation, stockpiling of medicine and surge
capacity represents the ``drug-to-person'' side--that is, to respond
with medical treatment.
Our current health infrastructure simply and unequivocally lacks
the capacity to respond effectively to a severe pandemic. We don't have
the number of hospital beds, ventilators, health care personnel,
morticians, vaccines, antivirals, or communication networks we need.
All would be overwhelmed.
Being prepared means training first responders, and ensuring a
civilian volunteer corps to step in and help handle the surge. It means
allocating adequate surge facilities--vaccinationsites, treatment
centers, laboratories, and morgues. Has your community done so?
Our goal should be building a stockpile of antiviral agents for 75
million people, and putting in place a specific plan to deliver them.
As soon as an effective vaccine is available, we must begin
stockpiling, with the objective of having 300 million vaccinations--
enough for every American.
Conclusion
We know that a pandemic influenza is no longer a question of if,
when.
While there is no way to predict when an avian pandemic will occur,
what we CAN predict, what we DO know, is the cost of being under-
prepared.
The study I report on today sends a strong message.
A $675 billion potential hit to our economy--almost half of which
is brought on by factors which CAN be eliminated by planning--gives us
every reason to act now with a prescription, and immediately implement
the course of action. Now is the time to act.
The six-point prescription is simple--communication, surveillance,
antivirals, vaccines, research, stockpile/surge capacity. We have the
intellect, the ingenuity, the tools, the knowledge to minimize the
blow.
Science and technology afford us the power to allay the direct
effects. Sound public policy--grounded in communication and
information--renders us the ability to ease the indirect effects.
My duty as an elected official, and as a doctor, is to ensure that
we begin filling that prescription today. Our economy, our Country, our
lives depend on it.
______
[Whereupon, at 12:39 p.m., the hearing was adjourned.]
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