035 Undated Ppr Int 9Be6A151F9A52052 Covid 19 Lessons Learned To Prepare For The Next Pand - 035 Undated Ppr Int 9Be6A151F9A52052 Covid 19.
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S. Hrg. 116–518 is the printed record of a June 23, 2020 hearing of the Senate Committee on Health, Education, Labor, and Pensions, 'COVID–19: Lessons Learned to Prepare for the Next Pandemic,' published by the U.S. Government Publishing Office in 2022. Chairman Lamar Alexander and Ranking Member Patty Murray gave opening statements. The witnesses were former Senate Majority Leader William Frist, Michigan chief medical executive Joneigh S. Khaldun, Julie L. Gerberding of Merck & Co. and the CSIS Commission on Strengthening America’s Health Security, and former Health and Human Services Secretary Michael O. Leavitt. The additional material includes a testing letter from Senators Schumer and Murray and Frist's December 8, 2005 remarks, 'Pandemic; The Economy’s Silent Killer,' which put the potential hit to the economy from a pandemic at $675 billion.
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S. HRG. 116–518
COVID–19: LESSONS LEARNED TO
PREPARE FOR THE NEXT PANDEMIC
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
(
Available via the World Wide Web: http://www.govinfo.gov
U.S. GOVERNMENT PUBLISHING OFFICE
45–223 PDF WASHINGTON : 2022
For sale by the Superintendent of Documents, U.S. Government Publishing Office
Internet: bookstore.gpo.gov Phone: toll free (866) 512–1800; DC area (202) 512–1800
Fax: (202) 512–2104 Mail: Stop IDCC, Washington, DC 20402–0001
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COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS
LAMAR ALEXANDER, Tennessee, Chairman
MICHAEL B. ENZI, Wyoming PATTY MURRAY, Washington, Ranking
RICHARD BURR, North Carolina Member
RAND PAUL, Kentucky BERNARD SANDERS (I), Vermont
SUSAN M. COLLINS, Maine ROBERT P. CASEY, JR., Pennsylvania
BILL CASSIDY, M.D., Louisiana TAMMY BALDWIN, Wisconsin
PAT ROBERTS, Kansas CHRISTOPHER S. MURPHY, Connecticut
LISA MURKOWSKI, Alaska ELIZABETH WARREN, Massachusetts
TIM SCOTT, South Carolina TIM KAINE, Virginia
MITT ROMNEY, Utah MAGGIE HASSAN, New Hampshire
MIKE BRAUN, Indiana TINA SMITH, Minnesota
KELLY LOEFFLER, Georgia DOUG JONES, Alabama
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
(II)
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C O N T E N T S
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
(III)
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COVID–19: LESSONS LEARNED TO
PREPARE FOR THE NEXT PANDEMIC
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 con-
sulted 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 pub-
lic 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 Com-
mittee 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
(1)
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2
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 infra-
structure, most experts agree the United States is among the coun-
tries 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 dev-
astated the world. This Committee is holding this hearing today be-
cause even with an event as significant as COVID–19, memories
fade and attention moves quickly to the next crisis. While the Na-
tion 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 recommenda-
tions 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 dis-
eases.
No. 3, stock piles, distributions, and surges. Rebuild and main-
tain 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 Fed-
eral agencies during a public health emergency. I have invited com-
ments 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, vac-
cines, research, stockpile surge capacity. Senator Frist is one of our
witnesses today and I am including in the record two of his speech-
es.
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 coordi-
nate the state’s response to COVID–19. Our third witness is Dr.
Julie Gerberding, who served as Director of The Centers for Dis-
ease Control and Prevention under President George W. Bush. She
helped lead preparedness efforts on the response to SARS, West
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Nile Virus, H5N1 Avian Influenza, and the rise of multi-drug re-
sistant 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 fo-
cused 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 inad-
equate. 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 Govern-
ment Accountability Office, and outside experts. The reports con-
tained all sorts of warnings that the United States needed to ad-
dress 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 emerg-
ing 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 fund-
ing 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. Addition-
ally, COVID–19 has exposed some gaps that had not been pre-
viously 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 impeach-
ment 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 for-
ward 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.
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4
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 sub-
stitute 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 say-
ing 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 test-
ing 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 mil-
lion 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 administra-
tion 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 rath-
er 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 se-
riously. 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 ad-
ministration’s irresponsible rule to allow discrimination in health
care.
We have also seen once again how desperately we need a na-
tional 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
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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 eq-
uitably 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 fami-
lies 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 ulti-
mately 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 signifi-
cantly less access to testing than white communities. This is an in-
justice 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 prob-
lems 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 com-
prehensive plan we still haven’t gotten on testing. One that ad-
dresses 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 be-
fore 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 mem-
bers 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 pan-
demic 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
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you. It is my privilege to introduce the first one. Senator Bill Frist,
with whom I served and many of us served. He represented Ten-
nessee 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. Sen-
ate. 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 prepared-
ness. 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 Serv-
ices. In this position she oversees the Population Health Medical
Services, Aging and Adult Services, and Behavioral Health and De-
velopmental Disabilities Administration for the State of Michigan.
Dr. Khaldun has extensive experience in state and local Govern-
ments. 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 Amer-
ican 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 re-
sponse 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 in-
troduce my friend Mike Leavitt. Mike is actually the one who is
most responsible for freeing me from the golden chains of the pri-
vate 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 ex-
traordinary 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
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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 extraor-
dinary 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 Com-
mittee.
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 Com-
mittee for placing a focus now on preparing for the inevitable bio-
logical and infectious diseases that absolutely will come in the fu-
ture. 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 pan-
demic 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 unpre-
pared for what was to inevitably come. In those talks, I proposed
a specific six-point plan called a Manhattan Project of the 21st cen-
tury to prepare the Nation. And during my time in the Senate, we
laid the foundation with the Bioterrorism Act of 2002, Project Bio-
shield 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 ex-
perts, 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 na-
tions 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 inad-
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equate 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-engi-
neered 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 bio-
logically based Manhattan Project to help better defend us against
naturally occurring, like we are seeing now, or accidental or inten-
tional bioterror threats, including infectious disease. Categories of
stockpiling and surge capacity were No. 6. The Federal Govern-
ment should take the lead role serving as overlaying central reposi-
tory 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 vir-
tual 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 con-
clude 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 des-
ignation. This discretionary approach, with exempt from spending
caps, a small number of critical pre-existing health security fund-
ing lines.
Lastly, this whole concept of vulnerable populations of health eq-
uity, any pandemic preparedness response needs to comprehen-
sively 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 immuniza-
tion. 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 invit-
ing 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 plac-
ing 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.
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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 immuniza-
tion and cure, and to manufacture, distribute and administer whatever may be re-
quired 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 Budg-
et 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 Afri-
ca 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 pre-
dicted 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 ig-
nored 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 au-
thorities, 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 in-
frastructure, 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 systema-
tized, 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 coun-
try and in this body remains undone today, thus I outline my recommendations
along the exact same six categories.
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1. Communication
As I said then, ‘‘Number one is communicating with the public.’’ To allay irra-
tional 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 re-
sponse, and loss of life. It’s fixable.
First, we must clarify who is in charge in a pandemic. The current response struc-
ture 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 Di-
rectorate for Global Health Security and Biodefense. The NSC should set out guide-
lines and ensure seamless coordination between and among departments, with reg-
ular and consistent pressure testing.
Second, the CDC should regain its position as the Nation’s apolitical voice of pub-
lic health. The CDC has 20,000 health professionals who dedicate their lives to pro-
tecting 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 inte-
grates 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 delin-
eated emergency channels of communication, authority and action should imme-
diately 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 so-
phisticated. 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 sys-
tem. 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 dis-
bursements, to informing travel restriction decisions as novel viruses emerge, to pro-
viding states and localities real-time information to guide their public safety deci-
sions in an outbreak.
While not necessarily intuitive, a huge part of effective infectious disease surveil-
lance 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 abil-
ity of developing nations to detect, track and contain a novel virus will be inex-
tricably 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 assist-
ance, but in our COVID–19 emergency packages, only one-tenth of 1 percent of
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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. (In-
deed, New Zealand had just announced the eradication of COVID–19 when two in-
fected 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 dif-
ferent committee and subcommittee structures across both chambers) should be rec-
tified by the establishment of separate bipartisan special committees or formal
working groups that provide a coordinating, overarching vision for the regular com-
mittees 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 deci-
sions 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 liveli-
hoods. 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, treat-
ments, and vaccines for a pandemic . . . ’’ It will take partnerships.
What was true in 2005 is still true today: we have a dangerously inadequate vac-
cine 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 sus-
tained and are not at risk of disappearing with each Appropriations cycle. We can-
not 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 un-
known 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 test-
ing components are about to be magnified when every nation in the world is simul-
taneously seeking the vaccine and the components needed to package and admin-
ister 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.
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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) Accel-
erator 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. en-
gagement 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 Pre-
paredness 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, acci-
dental, 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 counter-
measures. 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 mes-
sage 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 confu-
sion 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 re-
sponders 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 sys-
tems 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-struc-
tured 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 Govern-
ment 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 ex-
isting 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 Stock-
pile. 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 vol-
unteer corps to step in and help handle the surge. It means allocating adequate
surge facilities—vaccination sites, treatment centers, laboratories, and morgues. I
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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 ac-
ceptance.
The recommendations within each of these six categories are by no means exhaus-
tive, and I know my colleagues on this panel will have much to add. A few addi-
tional areas I want to touch on are: (1) Public health funding; (2) Vulnerable popu-
lations and health equity; (3) Virtual care, and (4) Establishing a Coronavirus Com-
mission.
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 pub-
lic health investment—approximately a $10 billion deficit. It is time we look at pub-
lic 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 out-
breaks 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 protec-
tion 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—> Con-
gress) 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 ap-
proach to combat funding shortfalls.
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While I recognize that the HELP Committee does not appropriate these funds, ro-
bust 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 spe-
cific economic, or social or health status. With COVID–19, we continue to see a dis-
proportionate 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 condi-
tions. 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 popu-
lations 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 commu-
nities of color and other marginalized groups to inform and shape pan-
demic response decisions.
We are living through a singular time in our Nation’s history, and our prepared-
ness policies should seek to end the barriers to health and well-being for commu-
nities of color, with the goal of health equity.
Virtual Care
Necessity is the mother of all invention, and the explosion of telehealth and vir-
tual 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 Fed-
eral and state levels have in an overwhelmingly positive way unleashed private sec-
tor 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 loca-
tion: 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 pro-
viders: 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 reim-
bursed by Medicare.
3. Allow federally Qualified Health Centers and Rural Health Clin-
ics 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 re-
ceive appropriate reimbursement for their services.
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While the Administration has done a good job, there is a risk that broad tele-
health 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 tele-
phone (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 tele-
health and virtual care during COVID should be made permanent, parity in pay-
ment is one that should be revisited following the crisis. Undoubtedly it was a need-
ed 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 recog-
nized that our country faced a new threat that required a new approach to our na-
tional 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 dev-
astation 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 pub-
lic health.
• We must make sure what is said at the Federal level coordinates and in-
tegrates 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 lo-
calities. That’s why we need a real-time domestic and international
threat detection system.
3. & 4. Antiviral Agents and Vaccines
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• We have a dangerously inadequate vaccine manufacturing base in this
country. We must establish public-private partnerships that are sus-
tained 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 dis-
eases. 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 sur-
veillance system, our Nation could fortify our stockpile at early signs of
a threat, and also accurately track outbreaks to ensure supplies are dis-
tributed to those in greatest need. Stockpile resources should be stored
regionally, with a transparent and operationally capable plan for dis-
tribution to local municipalities.
• Being prepared also means training first responders, and ensuring a civil-
ian 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 crit-
ical health protection funding lines at the CDC, NIH, FDA, and ASPR from spend-
ing 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 Mur-
ray, 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 in-
fected 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 nec-
essary 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 per-
cent. But let me be clear, this is not the time for victory laps.
COVID–19 is still very present in Michigan and across the coun-
try. We simply cannot let our guard down on COVID–19. More
than ever, leaders must be laser focused on protecting our commu-
nities and addressing the inadequacies in our public health infra-
structure. 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 rep-
resent 31 percent of COVID–19 cases and 40 percent of deaths.
This is not unique to Michigan.
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Racial and ethnic minorities are disproportionately being in-
spected 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 perpet-
uate 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 medi-
cine physician and public health leader, I rely on swift, scientif-
ically 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 ca-
pacity to do more. I am grateful for the support of our Federal part-
ners, 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 pre-
vented state and local Governments from competing with each
other and avoid one of the most outrageous realities of this pan-
demic, 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 physi-
cians 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 his-
tory, 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 out-
break of Eastern equine encephalitis, a mosquito borne illness that
infected and killed a record number of people and animals. Simul-
taneously, I had to pull together a team within weeks to respond
to a mysterious vaping related illness without any additional fund-
ing 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 infra-
structure. 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
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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 emer-
gency. 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 test-
ing 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 de-
cline in cases and deaths over the past several weeks. Our hospital systems, particu-
larly 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
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 in-
fected, meaning most people are not immune to the disease. There is no FDA-ap-
proved 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.
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 Afri-
can 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.
The racial disparities in the effects of COVID–19 are not unique to Michigan. Afri-
can Americans, Hispanics, and other racial and ethnic minorities across the country
1 https://covidactnow.org/?s=53768.
2 MI Safe Start Plan. May 7, 2020.
3 Executive Order 2020–55.
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19
are disproportionately being infected by and dying from COVID–19. 4 This is no sur-
prise. Health disparities and inequities have plagued this country since its incep-
tion. To be clear, these disparities cannot be explained by genetics. Instead, the dis-
parities exist because of institutional and structural racism that has deprived com-
munities 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, fund-
ing, 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.
These policies have caused communities of color to be more likely to live in pov-
erty, 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 condi-
tions that are often undiagnosed or poorly treated, putting them at higher risk of
being severely affected and dying from COVID–19.
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 insur-
ance, 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 on-
going challenges with access to care. These partnerships will also be critical to over-
coming the mistrust of the healthcare system that often exists in communities of
color, fueled by historical inequities in treatment. 6
We also have to ensure access to adequate housing. Housing policy is health pol-
icy. In the short term that means safe places where people who have COVID–19
can self-isolate and longer term making sure people have access to affordable,
healthy housing in safe neighborhoods.
Finally, we must address implicit and explicit bias in our healthcare system. Re-
search 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 asso-
ciated 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 ex-
plicitly 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 diver-
sity in their classes.
4 Garg S, Kim L, Whitaker M, et al. Hospitalization Rates and Characteristics of Patients Hos-
pitalized 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.
5 US Bureau of Labor Statistics, Report 1082, Labor force characteristics by race and eth-
nicity, 2018. October 2019. https://www.bls.gov/opub/reports/race-and-ethnicity/2018/
home.htm.
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/.
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 Acad-
emies Press (US); 2003. Available from: https://www.ncbi.nlm.nih.gov/books/NBK220358/.
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Consistent and Accurate Messaging
I have the utmost respect for my colleagues at the U.S. Centers for Disease Con-
trol 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 mes-
saging 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 clini-
cians 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 cri-
sis. This has not been the case since the beginning of this outbreak, with incon-
sistent 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 mes-
saging 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 coun-
try, 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 inconsist-
encies in the testing platform.
By the end of February, Michigan’s public health laboratory was the only labora-
tory 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 sup-
plies to run a few hundred tests a day for a few days. Weeks of delays and restric-
tions 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 cur-
rently operating. With this expanded capacity, Michigan has broadened testing cri-
teria 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 con-
sistently answered our calls and Michigan is now regularly receiving testing sup-
plies. 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
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today, Michigan is unable to meet its testing goal of 30,000 tests per day. Labora-
tories still struggle with a fragmented and inconsistent supply of test kits and lab-
oratory 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 ex-
pressed 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 de-
partments 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
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 sig-
nificant impact on our ability to adequately fund and respond to public health
threats.
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 local health depart-
ments 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 invest-
ment 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
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.
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.
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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 pro-
grams.
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 injus-
tice of racial inequality in our society. But it is not too late to save the lives of hun-
dreds 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 in-
frastructure is strong. We must remain vigilant, hopeful, and committed to pro-
tecting 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 pro-
vide 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 op-
portunity 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 every-
thing to do with institutional and structural racism that has consistently left com-
munities 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, accu-
rate, 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 prac-
ticing 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.
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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 pro-
tect 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 ef-
forts 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 cri-
sis. We also know that shelter in place and quarantine can be suc-
cessful in slowing down transmission, but that comes at a tremen-
dous 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 im-
portant 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 vulner-
able 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 suc-
cessful in a single dose and we need a vaccine that we can reason-
ably 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 effi-
cacy. We need a vaccine that produces effective immunity, neutral-
izing the virus, preventing infection even among vulnerable, older
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or immunosuppressed people, and we need a vaccine that is dura-
ble so that protection lasts beyond a few weeks or months. And fi-
nally, of course, ideally, we would like to have a vaccine that is ro-
bust 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 communica-
tion 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 immuniza-
tion.
While I am cautiously optimistic about the prospects for a vac-
cine, we are a long way from being able to promise the delivery
date or the characteristics of what I suspect will be several vac-
cines 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 pre-
sented 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 pre-
paredness, 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 al-
lows 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 pre-
paredness 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 Com-
mittee, thank you for the opportunity to appear today. Reviewing the lessons
learned from COVID–19 and other past pandemics and preparing for the next pan-
demic 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 capa-
bilities 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
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vulnerabilities in our system that need to be addressed for the future. We must in-
crease 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 stra-
tegic 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 stake-
holders. 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 guar-
antees. 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 exceed-
ingly 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 or-
ders 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 col-
laborators are working at risk. In other words, we are making considerable invest-
ments 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 oppor-
tunity 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 dem-
onstrate more transmission.
I believe we need to find the right evidence-based balance between sufficient so-
cial distancing, including masks and avoidance of crowds, with prudent steps to re-
sume business activities and more normal activities of daily life. This is imperative.
We also need to address escalating levels of misinformation related to the pan-
demic and the public and individual health impact of future vaccines. We are con-
tinuously 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 vac-
cines, 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 pre-
venting 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.);
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5. Test to understand patterns of transmission risk and improve policy deci-
sions (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 ad-
dress vulnerabilities;
2. Examining how to best strengthen the Strategic National Stockpile per-
formance to be the most effective and efficient during a pandemic (e.g., con-
sider expansion of personal productive equipment, ventilators, and other
durable medical equipment);
3. Augmenting supplies of antibiotics, intravenous fluids, and other medi-
cines to sustain critical care;
4. Formalizing augmented health care workforce contingency plans (creden-
tials across states, retirees, volunteers, Department of Defense) and updat-
ing 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 fol-
low 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 com-
plexity 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 chal-
lenges for COVID–19 will be significantly greater and will require unprecedented
partnerships amongst manufacturers, supply chain and logistics professionals, gov-
ernments, 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 col-
laborators 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 manufac-
turing process at each manufacturing facility for licensure. Accounting for
these complexities requires more standardization and rightsizing specifi-
cally 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 require-
ments can act as barriers to the free flow of raw materials and other compo-
nent 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
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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 out-
break 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 polit-
ical 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 contin-
uous 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 cen-
tral 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 peo-
ple 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 invest-
ments 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, sup-
port 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 de-
layed 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 sig-
nificantly 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 in-
vestment 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 Inno-
vations, or CEPI, an international alliance that finances and coordinates the devel-
opment 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.
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[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 en-
sure 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 compla-
cency. 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 infec-
tious 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 aug-
menting 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 ad-
dress vulnerabilities.
• Examining how to best strengthen the Strategic National Stockpile per-
formance to be the most effective and efficient during a pandemic.
• Augmenting supplies of antibiotics, intravenous fluids, and other medi-
cines to sustain critical care.
• Formalizing augmented health care workforce contingency plans (creden-
tials across states, retirees, volunteers, Department of Defense) and up-
dating 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 fol-
low through on lessons learned.
The CHAIRMAN. Thank you, Dr. Gerberding.
Welcome, Governor Leavitt.
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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 brief-
ing 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 indi-
cated earlier Mr. Chairman, Congress was alerted and appro-
priated $7.4 billion. Several Members of this Committee will re-
member that well.
Over the next three years, we undertook an aggressive effort to
heighten our Nation’s readiness for a pandemic. We sought to de-
velop 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 Prepared-
ness 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 ter-
ritory. 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 for-
get, 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, every-
one 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 com-
munity that fails to plan thinking that somehow the Federal Gov-
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ernment will ride to its rescue will be tragically mistaken, not be-
cause the Federal Government lacks the will, not because it lacks
the wallet, but because the Federal response plan is based on fo-
cusing primarily on localized disasters.
Gratefully, the H5N1 Avian Influenza did not become a pan-
demic 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 be-
ginning. 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 invest-
ment 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 Na-
tion. 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 sup-
port 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 terri-
tories. 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 over-
reaction, and anything you say sounds alarmist. But after a pandemic starts, any-
thing 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–
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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 prepared-
ness 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 subse-
quent 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 for-
eign policy and a combat-ready military. In the subsequent five years alone, Con-
gress 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). Collec-
tively, 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 tan-
gible 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 in-
volved 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 indi-
viduals who suffer injuries as a direct result of a countermeasure admin-
istered 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 re-
sponsibility 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
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a significant supporter of this state-based infrastructure. Second, the Federal Gov-
ernment provides leadership, support, and coordination to the states and local agen-
cies 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 limita-
tions, the Federal Government is highly dependent on states to meet emergency re-
sponse 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 Fed-
eral 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 po-
tential 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 lead-
ership 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. Be-
cause 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 Govern-
ment 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 res-
cue. 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 pan-
demic, 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 per-
sonal 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 emer-
gency 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;
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• 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. home-
land is attacked or devastated by a natural disaster, it must also prepare to develop
and deploy life-saving countermeasures and vaccines. This understanding led Presi-
dent 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 mar-
ket 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 emer-
gency 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 De-
velopment 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 even-
tually sold and used to produce seasonal vaccines or as contract manufacturing fa-
cilities. They may eventually be made available for COVID–19 vaccine manufac-
turing.
HHS has announced contracts with manufacturers to buildup domestic manufac-
turing 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 sus-
tain domestic vaccine manufacturing capacity, including:
• Support the research, development, and domestic manufacturing of sea-
sonal influenza vaccines. Domestic seasonal influenza vaccine platform
technologies and manufacturing facilities are the foundation of domestic
pandemic vaccine capacity. Increased domestic seasonal flu vaccine infra-
structure investments can be leveraged to produce pandemic vaccines
with similar scientific and platform technology profiles. The Federal Gov-
ernment can further support the U.S. domestic seasonal flu vaccine mar-
ket through tax incentives, reimbursement strategies, research, develop-
ment, 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
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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:
¯ Funding the warm base maintenance required to keep domestic vaccine
manufacturing facilities, their personnel, and their technology up-to-date
and pandemic-ready;
¯ Entering into cost and risk-sharing agreements with commercial and aca-
demic partners to co-manage domestic vaccine manufacturing facilities;
¯ 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 addi-
tional compensation for operating losses from forgoing manufacturing of
their traditional business lines.
• Leveraging Federal Contracting Authorities in New Ways. While the Fed-
eral Government must ensure domestic vaccine manufacturing capacity,
it cannot do it without the cooperation and innovation of the private sec-
tor. 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 counter-
measure with demonstrated safety and efficacy for delivery on a par-
ticular schedule. Producing a nationwide supply of domestically manufac-
tured 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 capabili-
ties. 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 au-
thorities exist under DOD programs with similar interests.
• Recruiting Federal Employees with Vaccine Manufacturing and Procure-
ment Experience. Every day of my tenure as Secretary of Health and
Human Services, I was impressed by the knowledge, expertise, and com-
mitment 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 manu-
facturing and procurement. A further area of required expertise is famili-
arity 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-gov-
ernment 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. Govern-
ment.’’ 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
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-counter-
measure-response-to-infectious-diseases-enabling-sustainable-capabilities.
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.
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than partnering with the Federal Government. The U.S. Government
needs to be a consistent, efficient, and transparent contracting partner.
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 estab-
lished 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 test-
ing. 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 re-
porting by more than 25 percent. 3
Some of this confusion comes from conflicting reporting requirements for labora-
tories and states, while a critical element is the lack of interoperable software ca-
pacity 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 ca-
pacity to collect and aggregate test results submitted by state and local public
health agencies but coordinated and maintained by the CDC. HHS should give guid-
ance 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 biosurveil-
lance system that is necessary to detect, identify, and model emerging infectious dis-
eases.
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 popu-
lations 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 invest-
ments 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 capac-
ity as necessary, Congress wouldn’t need to come up with such large emergency sup-
plemental 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 emer-
gency.
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-Re-
port-CTP.pdf.
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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 busi-
ness was develop a continuity of operations contingency plan for a pandemic or eco-
nomic 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 miti-
gate 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 Gov-
ernors and Mayors must make. After the pandemic, these officials should be encour-
aged to preserve these risk frameworks so they can build on them in future emer-
gencies. 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 to-
gether’’ 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 coordi-
nation in some cases. But a pandemic imposes a unique strain on our system of re-
sponse since the emergency is happening on such a wide scale all at once and re-
quires 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 Govern-
ment 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;
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• 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 Capac-
ity 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 pan-
demic, 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
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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 try-
ing to produce several hundred million doses by early 2021. Ideally,
what sort of manufacturing capacity should the Federal Govern-
ment 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 dimin-
ished, 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 proc-
ess 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 man-
ufacturing plants or pay for the private sector to build manufac-
turing 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 man-
ufacturing that has been built in these partnerships is that was
primarily targeting influenza, and influenza vaccine is a dual-pur-
pose 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 var-
ious 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 in-
novate. 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——
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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 de-
velop specific recommendations for how we address them. So some
of the things that we have done is making sure that testing is ac-
cessible 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 test-
ing, 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 mak-
ing 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 vac-
cine?
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
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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 responsi-
bility for administering the smallpox vaccination program for First
Responders, it was the National Academy of Medicine that mon-
itored 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 as-
sume 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 fund-
ing 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 invest-
ment 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 in-
fectious disease outbreak would look different than what we cur-
rently have?
Dr. FRIST. Well, I think all or many of the panelists have
empathized this importance of the sustained funding and the pub-
lic 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 need-
ed to build an ongoing strong public health system. If you look back
at the Great Recession, frontline state and local health depart-
ments have lost more than 56,000 positions due to funding cuts.
These are the people we need whether for contact tracing or epide-
miology. 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 recogni-
tion. Senator Frist, Secretary Leavitt, Dr. Gerberding, Dr.
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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 in-
novative 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 be-
fore 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 pri-
vate sector partners. Just seeing it from the outside looking in,
there has been a tradition of recognizing the importance of the pri-
vate sector when I was there. We had desks in the Emergency Op-
eration Center for a number of private-sector entities that we rec-
ognized 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 defi-
ciency was most evident in testing and the inability for CDC to
reach out to the private sector. Thank goodness PAHPA reauthor-
ization 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 co-
ordination 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
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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 dif-
ficult to program over and surge in front of that vaccine for
coronavirus. Can both of you give us what you think this Com-
mittee 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 appropria-
tion, supporting it when there is not a crisis is the first thing that
has to happen because it is keeping facilities warm and keeping ac-
cess 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 ap-
propriation 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 an-
nual 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 par-
ticular 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 nib-
ble, 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 man-
ufacturing.
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.
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Senator CASEY. Mr. Chairman, thank you very much. And thank
you for noting that, and I am grateful for the testimony of our wit-
nesses and the wisdom and experience they bring to bear on these
issues for this hearing. I wanted to start with Dr. Khaldun regard-
ing 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 hard-
est hit cities in the country, just like all major cities, like Philadel-
phia 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 lit-
tle 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 pro-
tect 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 dis-
parities in COVID–19 as they contribute to other health dispari-
ties.
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 pov-
erty 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 coordina-
tion and the convening power of the Federal Government?
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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 Fed-
eral colleagues at the CDC who since January has been really sup-
portive 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 bet-
ter 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 avail-
able, 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 get-
ting 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 for-
eign manufacturing of drugs, diagnostics, and medical supplies. For
example, about 80 percent of the basic components used in medi-
cines, the active pharmaceutical ingredients, are coming from
China and India for our U.S. market. The exact dependence re-
mains unknown since there is no API registry. Well, what hap-
pened 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 re-
porting requirements on the sources of APIs as well as redundancy
plants and tended to deal with shortages, but are there specific in-
centives that the Senate should consider specifically to encourage
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domestic manufacturing, including perhaps tax incentives or great-
er investment in FDA’s emerging technology program?
Dr. FRIST. Thank you, Senator Collins. I think this whole coordi-
nation 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 stock-
pile.
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 be-
tween the public-private partnerships and the private sector mov-
ing 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 re-
affirmed my belief that a baseline test for all residents and staff,
not just those that are symptomatic, is necessary to prevent out-
breaks. 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 im-
portant 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.
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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 meas-
urement 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. With-
out 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 Oc-
cupational Safety and Health Administration has failed to move
forward with mandatory and meaningful rules for employers. In re-
sponse 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 frank-
ly to do its job and to issue an emergency temporary standard that
establishes a legal obligation of all workplaces to implement infec-
tious 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 cor-
related with that, why is a focus on worker safety particularly im-
portant for communities of color and others who have been dis-
proportionately 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 estab-
lished robust protections for our workers so that is incredibly im-
portant. 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
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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 chal-
lenge with the money that they have been given and before signifi-
cant more dollars are given, would like to see some sort of rec-
ommendations 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 re-
form 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 sci-
entists 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 mod-
ernization is a word that really needs to be the framework for con-
sidering 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 pre-
paredness, again involving some of the very same people, we re-
hearsed everything except one thing, we didn’t rehearse testing be-
cause 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 dif-
ferent 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
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been a plan I have seen to actually go beyond mitigation into ac-
tual suppression. And so we have communities that have moved be-
yond 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 Con-
gress 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 sci-
entists 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 con-
flicting 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 situa-
tion 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 pro-
vide situational awareness.
Senator CASSIDY. Thank you.
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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 re-
form 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 depart-
ment that has a house on fire and a house next door that is in dan-
ger 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 pre-
vent 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 for-
ward. Dr. Gerberding, you referenced how important it was for us
to join the international vaccine effort, CEPI. The Coalition for Epi-
demic 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 pan-
demic but we should join CEPI right now, correct? There is no rea-
son 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 bio-
pharmaceutical entities that are working on vaccines. So they have
already reviewed and invested, but they also are positioned unique-
ly right now on a global basis to help adjudicate the allocation and
the planning for how we are going to solve this global problem be-
cause 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
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other partners, to provide the credibility and the scientific over-
sight 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 hap-
pened 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 ca-
pacity 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, Sen-
ator 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 pro-
vides 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 Pro-
gram and we were allowed into secret cities in Russia at that par-
ticular time. Obviously, we are not now. But there was one that I
visited called Obokensk. It is about 60 miles north of Moscow and
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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 pre-
paredness or no treatment, but the big one was hoof and mouth
disease and these scientists were trying to weaponize these patho-
gens 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 doc-
tor 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 Agri-
culture 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 Da-
kota. 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 oth-
ers.
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 con-
tinue facilitating coordination between public health and agri-
culture sectors and improving our surveillance in these areas be-
fore 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 hu-
mans. 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 re-
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lationship and this focused understanding, this important under-
standing 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 think-
ing, 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 al-
most 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 peo-
ple are dying every single day. In Massachusetts, we learned first-
hand just what happens when the Federal Government isn’t pre-
pared 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 con-
struction 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 Flor-
ida and Texas and Arizona where cases are now rising are going
to pay the price.
Dr. Khaldun, Michigan has also experienced some of these sup-
ply chain problems. Since March, the Federal Government has im-
plemented 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 work-
ing aggressively to try to make sure we have enough PPE for now
and the potential second wave that we will probably see in Michi-
gan 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.
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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 infec-
tions, 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 trac-
ing, more than 500 of them are already deployed. We have addi-
tional 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 Re-
publicans 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 al-
ready 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 commu-
nities that are at risk for the coronavirus infection?
Dr. KHALDUN. I think if we don’t aggressively address those so-
cial determinants of health, so adequate housing, making sure peo-
ple have access to health care, no out-of-pocket costs for testing, ab-
solutely. 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 se-
cure 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 Sen-
ator 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.
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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 manufac-
turing, 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 at-
tention to that. But the one that I want to speak to and have ques-
tions 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 bol-
stering 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.
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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 pub-
lic health infrastructure underfunded at the state and local level.
A lot of them don’t even have epidemiologist to the local commu-
nities 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 ap-
plicants 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 re-
quired. It will require some local execution. Let me be deliberate
about that. Clearly, we will need to have national funding to sup-
port 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.
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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 sick-
est 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 wit-
nesses, 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 com-
ments of all my colleagues that we got a current challenge, we have
to plan for the future one. Just the magnitude of the current chal-
lenge, 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 experi-
ence 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 trac-
ing, isolation, treatment should be a template that we should pre-
pare 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 ab-
sent 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 med-
ical intervention has side effects and this has side effects.
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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 so-
cial logic damage that is becoming more evident.
Senator KAINE. You have anticipated my next question, Sec-
retary Leavitt. The side effects on the economy. I was having this
conversation with Chairman Rich in the Foreign Relations Com-
mittee 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 mis-
sion because of an adequate supplies and mixed messaging. Over
the weekend, the President said he had instructed his administra-
tion 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 Sen-
ator 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 Addi-
tional Material.]
Senator KAINE. Pointing out that $14 billion that has been pro-
vided by Congress for testing has yet to be obligated by the Admin-
istration. 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 Administra-
tion issued national guidance about how many tests we should do.
The website of the CDC, instructions to colleges doesn’t even men-
tion 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
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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 sit-
ting 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 pan-
demic 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 pop-
ulation 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 chal-
lenges 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 cer-
tainly 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 fo-
cused 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 con-
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tact 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 strat-
egy 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 resi-
dents 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 im-
prove health and wellness in communities of color and work toward
eliminating these health disparities during the pandemic and be-
yond?
Dr. KHALDUN. We really have to focus upstream and talk about
those social determinants of health. So housing policy is health pol-
icy. We have to make sure communities of color who are dispropor-
tionately 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 treat-
ment or a vaccine. And to make sure there is equitable distribution
across this communities to make sure that we are addressing dis-
parities. I also talked about implicit and explicit highest in our
health care system. Again, many people, it has been well docu-
mented 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 liv-
ing through right now. And I especially am concerned about how
COVID–19 is exacerbating existing health disparities and the sys-
temic racism that is literally deadly for black and Hispanic and na-
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tive 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 complica-
tions 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 re-
turns for a fourth time and she is so sick that an emergency cesar-
ean 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 profes-
sionals students.
I think that our health professional schools should all work to ex-
pand 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 hem-
orrhage bundles and just the top quality care for OB care really im-
plemented 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 im-
portant. That is some of the work we have done here in Michigan.
Again, with our coronavirus racial disparities task force, we are
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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 pub-
lic 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 Govern-
ments right now in order to help make sure that this response hap-
pens. 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 ab-
solutely have been underfunded for her decades, especially our
local health departments. They often don’t have even one epi-
demiologist. 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 Govern-
ments. 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 like-
wise 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 stock-
pile, 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
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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 glob-
al 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 atten-
tion 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 pub-
lic funding that will guarantee a market over that 10, 15 year pe-
riod 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 deter-
mined 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 sec-
onds 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
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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 gen-
erally 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 causa-
tion. I am just saying there is correlation here that Medicaid budg-
ets 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 dol-
lars. 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 Rank-
ing 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 Pro-
tect Public Health Act.
This bipartisan bill would direct the NIH to conduct a longitu-
dinal study of patients that includes diversity among gender, race,
ethnicity, geography, and age, and many other things. We are look-
ing at both the short-term and long-term impacts along with inter-
ventions.
This would be reported publicly on a regular basis so that all re-
searchers 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 com-
prehensive 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. Obvi-
ously, 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 abso-
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lutely 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 com-
prehensive 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 coordina-
tion 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 Medi-
care 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 pa-
tient.
They do a history and physical, they take the vital signs, they
may do blood work right there, and then can speak with the physi-
cian. 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 out-
come and people’s ability to receive care?
Dr. KHALDUN. Telehealth has been incredibly important to main-
taining our health care system during this response, and I actually
hope that we don’t go backward, that we continue to use the les-
sons 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
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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 experi-
ence in Michigan, would you characterize the Federal Govern-
ment’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. Chair-
man, thank you for this hearing. I really do appreciate all of our
witnesses for taking the time to join us today and share your ex-
pertise. 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 cri-
sis.
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 out-
line 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 Addi-
tional 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, im-
mediate 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 com-
ments. 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.
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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 at-
tention of Congress on difficult issues was on other matters. The
same thing happened in the states where hospitals and states al-
lowed their stockpiles to be diminished because other matters de-
manded more budgetary considerations. So I would ask my col-
leagues, 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 ac-
celerate 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 some-
one 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 noto-
riously poor record of short memories when it comes to doing every-
thing 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 mat-
ters.
A couple of other comments before I ask our witnesses for their
concluding remarks, one was I appreciate Dr. Gerberding’s com-
ment about asking the National Academy of Medicine to become in-
volved in transparency for the vaccines. I think that is a very good
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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 bil-
lion 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 av-
erage 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 pur-
pose of hiring contact tracers if they chose to use it.
Senator Blunt, who is the Chairman of the Appropriations Com-
mittee 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 ev-
erywhere so we got to think globally. We need to test more. Con-
tinue 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 de-
velop 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
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disparities, we have to talk about housing. Everyone should have
access to affordable and healthy housing. We have to invest in com-
munities of color, so education and jobs, access to healthcare we
have to focus on, so funding for the health care safety net, our fed-
erally qualified health centers who provide this care in these com-
munities. 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 epidemiolo-
gist or no epidemiologist, and we are always building these re-
sponses 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 influ-
enza, and we need to exercise health care surge under that sce-
nario. 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 influ-
enza 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 im-
portant 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 mod-
ernization.
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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 fi-
nally, again the echo, annual appropriation on emergency manage-
ment 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 opin-
ion, 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 rec-
ommendations 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 com-
ments 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 partici-
pated, 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 allo-
cated for COVID–19 testing and contact tracing, including for providing testing to
the uninsured. Congress provided more than $25 billion to increase testing and con-
tact tracing capacity 1 and $2 billion to provide free COVID–19 testing for the unin-
sured 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
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.
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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 vic-
tory, leave lifesaving work undone, and leave resources our communities desperately
need sitting untouched.
Regarding funding for ramping up testing and contact tracing capacity, the Ad-
ministration 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 gov-
ernments 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 coun-
try 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—includ-
ing $12 billion for expansion of the contact tracing workforce. 5
Dr. Scott Gottlieb, who served as Commissioner of the Food and Drug Administra-
tion 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.
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 in-
formation on race or ethnicity, preventing public health officials from knowing
where to target interventions in communities of color. 7 Even with these low report-
ing 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.
Regarding funding to provide free testing for the uninsured, to date, media re-
ports 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 avail-
ability 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 pan-
demic, in which reluctance to seek care because of cost endangers the health of oth-
ers. 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
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-Lead-
ers-Letter-on.
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/.
7 https://www.politico.com/news/2020/06/14/missing-data-veils-coronavirus-damage-to-mi-
nority-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-mi-
nority-communities-316198.
11 https://www.norc.org/PDFs/WHI%20Healthcare%20Costs%20Coverage%20and%20Policy/
WHI%20Healthcare%20Costs%20Coverage%20and%20Policy%20Issue%20Brief.pdf.
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health care system, leaving increasing numbers of Americans uninsured. Even be-
fore 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 num-
ber of uninsured children increased. 12
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 admin-
istration 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 bene-
fits, like prescription drugs.
This funding is also important to addressing health disparities. As of 2018, non-
elderly 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 out-
comes experienced by communities of color with respect to COVID–19. 15
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
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 mat-
ter.
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 Administra-
tion must initiate a high-level, broad-based, comprehensive and scientific review of
the COVID–19 response through either a Federal commission or a qualified, non-
partisan entity such as the National Academies of Science, Engineering, and Medi-
cine. This process should also be forward-looking and make cross-cutting rec-
ommendations 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.
12 https://khn.org/news/number-of-americans-without-insurance-rises-in-2018/.
13 https://www.kff.org/coronavirus-covid-19/issue-brief/eligibility-for-aca-health-coverage-fol-
lowing-job-loss/.
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-minori-
ties.html.
16 https://www.aha.org/guidesreports/2020-05-05-hospitals-and-health-systems-face-unprece-
dented-financial-pressures-due#:-:text=Discussion,of%20%2450.7%20billion%20%20month.
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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 inter-
national 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 short-
comings in our ability to respond to a public health emergency. Some of these were
the results of ‘‘real-time’’ decisionmaking, while others exposed systemic break-
downs, chronic underfunding, and a lack of resources that were years—if not dec-
ades—in the making. These cut across multiple agencies and span levels of govern-
ment 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 bio-
medical 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 practi-
tioners. ASM’s mission is to promote and advance the microbial sciences.
ASM advances the microbial sciences through conferences, publications, certifi-
cations and educational opportunities. It enhances laboratory capacity around the
globe through training and resources. It provides a network for scientists in aca-
demia, industry and clinical settings. Additionally, ASM promotes a deeper under-
standing 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
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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 re-
view 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 rec-
ommendations 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 de-
partment 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 work-
places to mitigate shortages;
• Protect the most vulnerable in our communities by reducing patient access bar-
riers 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 short-
comings 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 com-
prehensive, well-planned approach will be critical to a long-term strategy to head
off future pandemics. A comprehensive approach includes medical research and de-
velopment, social, behavioral and economic considerations, corporate partners to en-
sure product and service delivery, small businesses, universities and research insti-
tutions, as well as healthcare professions.
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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 ten-
ure 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 obliga-
tions, 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 pro-
fessions, 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 phi-
losophy 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 re-
sponsibilities.
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 ac-
complished 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
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that though individually each might be devastating, they are susceptible of either
purposeful or accidental combination, in which case they could be devastating al-
most 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 some-
times 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 mil-
lion 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 ad-
vances of biological science were capable of permanently suppressing infectious dis-
ease 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, fortu-
itous, and unavoidable changes. Human population increase, concentration, and
spread, intensification of animal husbandry, and greater wealth in developing coun-
tries bring animals both wild and domestic into closer contact with ever-larger num-
bers of people. War, economic catastrophe, and natural disasters subdue active
measures of public health. The unprecedented use of antibiotics builds unprece-
dented resistance. Travel, trade, and climate change bring into contact disparate
types and strains of disease. And as a consequence of all this, microbes evolve, mu-
tate, and find new lives in new hosts.
The annual toll of infectious diseases worldwide—including four million from res-
piratory infections, three million from HIV/AIDS, and two million from waterborne
diseases such as cholera—is a continuing and intolerable holocaust that, while spar-
ing 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 thresh-
old 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, opportu-
nities 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 coun-
try 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 Sep-
tember 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 com-
mon to hemorrhagic fevers. Nor is influenza nearly as infectious as, for example,
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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 dur-
ing 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 terror-
ists 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 epi-
demic 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 wis-
dom, 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 immuniza-
tion 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 unex-
plored territory. Economic and environmental changes in Asia have forced wilder-
ness-deprived waterfowl to alight to feed amid farm animals in newly dense popu-
lations 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 underpre-
pared 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 im-
posed 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 hos-
pital beds; and a now heavily urbanized and suburbanized American population de-
pendent 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 thresh-
olds 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 rear-
ranged, 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 infec-
tiousness of smallpox with the almost absolute fatality of Ebola fever. It is possible
simply and inexpensively to synthesize virulent pathogens from scratch, or to engi-
neer 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 investiga-
tion to anticipate even a small proportion of them. Never have we had to fight such
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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? In-
deed it is. Al-Qaida has declared that, ‘‘We have the right to kill four million Ameri-
cans—two million of them children . . . [and] it is our right to fight them with chem-
ical 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 bio-
logical 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 ine-
luctable 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 re-
sources 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 occur-
ring 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 inad-
equacy 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 an-
nouncement 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 ap-
proaching 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 ma-
terial 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 univer-
sities, 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 sur-
prising 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;
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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 nec-
essary 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 bu-
reaucratic organization charts and the repetition of a hundred million Latinate
words in a hundred million meetings that substitute for action, but action itself, un-
adorned 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 manufac-
ture, 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 re-
sources 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 in-
formation 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 na-
ture 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 ambi-
tious, 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 De-
cember, 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 under-
standing of mortality, second to none, is present in the people—who are not super-
ficial, 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 Amer-
ican 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 Amer-
ican people are intact, and I believe that the sinews of our allies and their great
civilizations are intact as well.
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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 cer-
titude 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 any-
thing about it.
The persistent inaction is especially gratuitous in light of the fact that the mag-
nitude 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 illu-
sory and impractical, and for those who protest that devotion solely to practical mat-
ters 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 na-
tional level, in a loose confederation with unavoidable duplications but with, none-
theless, 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 criti-
cism 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 accom-
panied 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 great-
er 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 imme-
diate destiny not only of America but of the world, for pandemics know neither bor-
ders, 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.
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It is my pre-eminent obligation as a public servant and my sacred duty as a phy-
sician to ask you to support the essence of my proposal. In respect of human mor-
tality, 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 accumu-
lated 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 peo-
ple. 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 capac-
ity to respond—that the ensuing death toll could be devastating.
In recent weeks, the growing death toll of the avian flu and the mounting drum-
beat 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 preserva-
tion 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.
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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 trans-
mission.
For the final element to fall into place, it will require little more than the shuf-
fling of a few genes between the animal and human forms of a virus (—a phe-
nomenon 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 immu-
nity 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, Malay-
sia, Russia, Kazakhstan, Mongolia, Turkey, Romania, and Croatia—infecting 135
humans, and killing 69 (in five countries—Cambodia, China, Indonesia, Thailand,
Vietnam). 1
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 ti-
gers.
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-as-
sortment 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.
1 From 2003 to present. Deaths have occurred in Cambodia, China, Vietnam, Thailand, and
Indonesia.
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‘‘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 dra-
matic 20th century advances in science and medicine. We have far more sophisti-
cated tools for surveillance, the ability to design vaccines, and better treatment op-
tions 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 disrup-
tion; and last that a million people living today with preexisting compromised im-
mune 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 pro-
found 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
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 dra-
matic 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 suf-
fered more than $1 billion in economic losses. 3
The second economic wave is caused by the DIRECT impact of the disease. It rep-
resents the hit the economy takes from hospitalizations, deaths, lost productivity,
and a consequent slowdown in the flow of goods and services. In SARS, these DI-
RECT economic losses—from the medical treatment costs and lost productivity—ac-
counted for only 1–2 percent of the $30–50 billion in total damages. 4
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 ad-
dressed when forecasting the economic impact of a pandemic.
CDC Study
‘‘What current economic studies have looked at the impact of a modern avian pan-
demic on the US economy?’’
2 Economic Risks Associated with an Influenza Epidemic, Bio-Era.
3 Economic Risks Associated with an Influenza Epidemic, Bio-Era.
4 Economic Risks Associated with an Influenza Epidemic, Bio-Era.
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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 pan-
demic 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 per-
cent case fatality rate, and for a mild scenario they assumed a 0.1 percent case fa-
tality 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 pro-
ductivity, 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, res-
taurants, 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 reduc-
tion in GDP.
This is a $675 billion hit (in 2006 dollars) to the U.S. economy.
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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 imme-
diately 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 op-
tion—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 ne-
glecting 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 bil-
lion to build it. By developing rapid testing technology, by training more epidemiolo-
gists, by enhancing our global partnerships, and by helping developing nations com-
pensate 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 trans-
mission 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 distribu-
tion. 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 manu-
facturing today.
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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 stock-
piled, 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 sea-
sonal 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, stream-
line regulations, and offer balanced, sensible liability protection for man-
ufacturers to make these life-saving emergency medicines.
• Together these will lay the groundwork for a quicker ‘‘bug-to-drug’’ time-
frame.
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 tech-
nology, 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-per-
son’’ 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 commu-
nication 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 fa-
cilities—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 vac-
cinations—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, vac-
cines, 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 pub-
lic policy—grounded in communication and information—renders us the ability to
ease the indirect effects.
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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.]
Æ
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