[Senate Hearing 117-198]
[From the U.S. Government Publishing Office]
S. Hrg. 117-198
THE PATH FORWARD:
BUILDING ON LESSONS LEARNED
FROM THE COVID 19 PANDEMIC
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HEARING
OF THE
COMMITTEE ON HEALTH, EDUCATION,
LABOR, AND PENSIONS
UNITED STATES SENATE
ONE HUNDRED SEVENTEENTH CONGRESS
FIRST SESSION
ON
EXAMINING BUILDING ON LESSONS LEARNED FROM THE COVID-19 PANDEMIC,
FOCUSING ON THE PATH FORWARD
__________
JULY 27, 2021
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Printed for the use of the Committee on Health, Education, Labor, and
Pensions
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]
Available via the World Wide Web: http://www.govinfo.gov
__________
U.S. GOVERNMENT PUBLISHING OFFICE
46-778 PDF WASHINGTON : 2023
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COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS
PATTY MURRAY, Washington, Chair
BERNIE SANDERS (I), Vermont RICHARD BURR, North Carolina,
ROBERT P. CASEY, JR., Pennsylvania Ranking Member
TAMMY BALDWIN, Wisconsin RAND PAUL, M.D., Kentucky
CHRISTOPHER S. MURPHY, Connecticut SUSAN M. COLLINS, Maine
TIM KAINE, Virginia BILL CASSIDY, M.D., Louisiana
MAGGIE HASSAN, New Hampshire LISA MURKOWSKI, Alaska
TINA SMITH, Minnesota MIKE BRAUN, Indiana
JACKY ROSEN, Nevada ROGER MARSHALL, M.D., Kansas
BEN RAY LUJAN, New Mexico TIM SCOTT, South Carolina
JOHN HICKENLOOPER, Colorado MITT ROMNEY, Utah
TOMMY TUBERVILLE, Alabama
JERRY MORAN, Kansas
Evan T. Schatz, Staff Director
David P. Cleary, Republican Staff Director
John Righter, Deputy Staff Director
C O N T E N T S
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STATEMENTS
TUESDAY, JULY 27, 2021
Page
Committee Members
Murray, Hon. Patty, Chair, Committee on Health, Education, Labor,
and Pensions, Opening statement................................ 1
Burr, Hon. Richard, Ranking Member, a U.S. Senator from the State
of North Carolina, Opening statement........................... 3
Witnesses
Becker, Les, Deputy Secretary of Innovation, Washington State
Department of Health, Olympia, WA.............................. 7
Prepared statement........................................... 8
Summary statement............................................ 16
Arthur, Phyllis, Vice President, Infectious Diseases and
Diagnostics Policy, Biotechnology Innovation Organization,
Washington, DC................................................. 17
Prepared statement........................................... 18
Janz, David, M.D., Director, Medical Critical Care Services,
University Medical Center New Orleans, New Orleans, LA......... 27
Prepared statement........................................... 29
Summary statement............................................ 34
Cicero, Anita, Deputy Director, Center for Health Security, Johns
Hopkins Bloomberg School of Public Health, Baltimore, MD....... 35
Prepared statement........................................... 37
Summary statement............................................ 40
ADDITIONAL MATERIAL
Statements, articles, publications, letters, etc.
S. 1543 STANDUP Act.......................................... 67
STANDUP ACT section-by-section............................... 75
The Suicide Prevention Lifeline Improvement Act redline to
current law................................................ 77
S.2425....................................................... 79
QUESTIONS AND ANSWERS
Response by Les Becker to questions of:
Senator Braun................................................ 89
Response by Phyllis Arthur to questions of:
Senator Braun................................................ 92
Response by Anita Cicero to questions of:
Senator Rosen................................................ 92
Response by David Janz, M.D., to questions of:
Senator Rosen................................................ 93
Senator Braun................................................ 94
THE PATH FORWARD:
BUILDING ON LESSONS LEARNED
FROM THE COVID-19 PANDEMIC
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Tuesday, July 27, 2021
U.S. Senate,
Committee on Health, Education, Labor, and Pensions,
Washington, DC.
The Committee met, pursuant to notice, at 10 a.m., in room
430, Dirksen Senate Office Building, Hon. Patty Murray, Chair
of the Committee, presiding.
Present: Senators Murray, Casey, Baldwin, Murphy, Kaine,
Smith, Rosen, Lujan, Hickenlooper, Burr, Cassidy, Braun,
Marshall, Scott, Romney, and Tuberville.
OPENING STATEMENT OF SENATOR MURRAY
The Chair. Good morning. The Senate Health, Education,
Labor, and Pensions Committee will please come to order. Today,
we are holding a hearing on lessons learned from the COVID-19
pandemic and how we make sure we are never in this situation
again. Ranking Member Burr and I will each have an opening
statement, then we will introduce our witnesses. And after they
give their testimony, Senators will each have 5 minutes for a
round of questions. While we are unable to have the hearing
fully open to the public or media for in-person attendance,
live video is available on our Committee website at
help.senate.gov. And if anyone is in need of accommodations,
including closed captioning, please reach out to the Committee
or the Office of Congressional Accessibility Services.
Before I begin my opening remarks, I do just want to
personally comment on our loss in the Senate of former Senator
Mike Enzi. He sat in this seat. I had the opportunity to work
with him many times, especially on workforce issues. He chaired
the Budget Committee. He was always--believed in his
philosophy, which is everyone is right, but he was
accommodating, he was a listener, and I know I speak on behalf
of all my Democratic colleagues, and I am sure my Republican
colleagues as well, that our thoughts and prayers are with his
family today.
Earlier this year, Patti Hayes, who is the Director of
Public Health for Seattle and King County, reflected on the
pandemic and noted one of the big things that the entire
country realized, that if you allow your public health
infrastructure to be dismantled, then when you have an
emergency of this sort, it is not ready to handle it. And she
is right. I have been pushing for greater investments in public
health for years because even before this pandemic, the
diminished state of our public health infrastructure was
incredibly alarming. Since 2010, spending for state public
health departments has dropped by 16 percent and spending for
local health departments by 18 percent. In 2019, less than half
of our state spent even $40 per person on public health, with
only a few states spending over $100 per person.
Even though our health care spending was over $11,000 per
person nationwide, local and state health departments have lost
nearly a quarter of their workforce since 2008. In other words,
before the pandemic struck, public health departments across
the country were woefully understaffed and underfunded, and our
Nation was unprepared. How are we supposed to test for diseases
like COVID-19 and sequence four new variants without modernized
data systems and adequate lab capacity? How are health
departments supposed to do contract tracing when a single case
can have over 70 contacts? But a city like Detroit, with
670,000 people, has only 200 workers in its public health
department. How are we supposed to track disparities when we
don't have a consistent, standardized way of reporting the data
we get?
When Federal data doesn't often accurately identify some
communities like Pacific Islanders, beyond inequities, how are
we supposed to track cases at all when data is coming into
health departments by fax, thousands of printed pages at a
time? Last July, in my home State of Washington, we brought in
members of the National Guard just to help manually enter data
from tests that weren't reported electronically. And then
beyond the challenge of getting all that crucial data, how are
we supposed to make good use of that data to fight public
health threats when only 28 percent of local health departments
have an epidemiologist or statistician?
How are our communities supposed to get clear, science
based guidance on public health issues, coordinate vaccination
efforts to reach our most distant and vulnerable communities,
or fight a deluge of misinformation about safe, effective
vaccines when only half of all people in this country are
served by a comprehensive public health system? We have to end
the cycle of crisis and complacency in public health that led
us here.
As a public health leader in Kansas put it, we don't say to
the fire department, oh, I am sorry, there were no fires last
year, so we are going to take 30 percent of your budget away.
And we shouldn't be doing that to public health either. We need
to dramatically rebuild our public health infrastructure and we
need to build it to last. We need to invest in modern
technology in our health departments and hospitals. We need to
invest in addressing inequities and making sure our data
includes everyone, our vaccines reach everyone, and our health
departments are building trust in communities of color, which
we know are often hit the hardest when disaster strikes. And to
do all this, we also desperately need more people like Patti
Hayes. However, as Hayes retired from the health department
this May, she is not alone.
A survey taken before the pandemic showed nearly half of
public health workers were considering retiring in the next 5
years. That is why it is so critical we take steps to build our
public health workforce, including steps to help address the
reality that outside of big cities, more than a fifth of local
public health workers earn less than $35,000 a year. In her
comments earlier this year, Ms. Hayes went on to say, and I
quote, ``I am hoping that the wisdom will prevail to really
invest in the core public health infrastructure so that we are
faster, better coordinated, and ready for the next thing.'' I
am hoping for that, too, and I am pushing as hard as I can to
make it happen, which is why I introduced the Public Health
Infrastructure Saves Lives Act so we can finally end the cycle
of crisis and complacency in public health funding. It is why I
have been pushing so hard for Congress to invest in public
health in our COVID response bills. And that is why I have been
pushing for bipartisan work to reflect lessons learned from
this pandemic.
Of course, while the value of strong public health
infrastructure may be the most important lesson we have to
learn from this pandemic, there are many others we should be
addressing as well, like the need to address supply chain
disruptions, improve our stockpile of critical medical
supplies, improve health equity, fight misinformation, prevent
hospitals from being overwhelmed, and support and expand our
health care and public health workforce. Additionally, Congress
should enact an independent, comprehensive assessment of our
Nation's COVID-19 response to make sure we have a full
accounting of this chapter in our history and never repeat it.
I know that is a goal that we all share, and I look forward
to hearing from our all of our witnesses today. Thank you all
so much for being here today. We look forward to your
testimony. We look forward to learning what we can learn from
this pandemic. And we will work with colleagues on both sides
of the aisle to act on those lessons. With that, I will turn it
over to Ranking Member Burr.
OPENING STATEMENT OF SENATOR BURR
Senator Burr. Thank you, Madam Chair. Welcome to our
witnesses today. I would also like to take a minute at the
beginning to talk about our former colleague, Mike Enzi.
Michael is a good friend. He is a great Senator. Mike was
Chairman of this Committee and Ted Kennedy was the Ranking
Member at the time, and I think Ted Kennedy taught Mike a
really important thing, it is called the 80-20 rule, that this
Committee can find 80 percent that we can agree on, and we can
agree that 20 percent of it we will never find a solution to.
Mike and I work together on many bills, especially with our
good friend Tom Coburn, when Tom was alive. We worked on Ryan
White program that helped provide affordable treatment to
America's HIV and AIDS patients. He was a leader on protecting
Americans from discrimination based upon their genetics in the
GINA Act. He was a leader and a partner in pandemic
preparedness.
He was a thought leader with biology--with biologics
legislation that created biosimilars--a biosimilar pathway at
the FDA, which has allowed more drugs to be available that cure
cancer, breast cancer, lymphoma, Crohn's disease, and many
other things on the horizon. Most importantly, Mike was a good
friend. He was a loving husband, and he was a devoted
grandfather. Not only will we miss him, but his family misses
him today. I urge my colleagues to keep he and Diane in your
prayers.
Madam Chair, I thank you for holding this hearing today.
Even before the first case was identified in America, this
Committee had been extremely dedicated in a bipartisan manner
to understanding the impact of the COVID pandemic. Just last
week, we heard from our Federal response team about the ongoing
outbreak and what our next round of challenges may be. I am
particularly looking forward to today's hearing because we are
focused on this question, where do we go from here? I have
worked on preparedness issues for as long a time and can see
pretty clearly where some of our Country's vulnerabilities lie.
My first priority is no secret. The CDC is desperately in
need of reform. Primary reform CDC needs is to its culture. It
is critical that CDC engage with the private sector, with
academia, and integrate new technologies to keep the American
people safe from 21st century public health threats. The
culture change is always the most difficult, but it is
possible. I know it because I have accomplished it. I went
through it in 1997 with the FDA. The culture reform over 20
years ago and other laws along the way gave the agencies the
tools it needed to quickly respond and fight COVID.
The FDA was a shining success, vaccines, treatments, and
tests approved in record time while maintaining the gold
standard of safety and efficacy over the last year. The
Committee's learned that the CDC, one, did not have the
surveillance tools in place to track the spread of the virus in
near real time. Two, and had not hired the experts to meet its
bio-surveillance mission despite congressional authority to do
so. Three, experienced massive and systematic failures in
deploying tests to public health labs, which delayed our
testing in critical early days of the response and cost lives.
Four, poorly communicated with Americans and was too often two
steps behind the science.
Last, its leadership is reluctant to meet with innovators
raising their hands to say I want to help. While I am critical
of the CDC, it is because I believe that we have a
responsibility to protect the public health, and I want to help
the CDC do it better. As a result of COVID-19, the agency has
new resources and new tools to be the world's premier public
health agency once again.
We need to make sure they know what their mission is and
focus the CDC on the right priorities. Business as usual has to
be over. I am looking forward to hearing from our witnesses
today on this extremely important task. We all witnessed the
breaks in our medical supply chain during COVID-19. Our just in
time inventory system that supported our health care providers
were overwhelmed in the early days of the response. I have no
doubt that every Member of this Committee received the same
heartbreaking calls I did from their hospitals, brave, tired
frontline workers asking for help that we could provide to get
mask, gowns, and other medical supplies.
I have mentioned in previous hearings the need to closely
examine the effects of the pandemic that we did not anticipate,
and our supply chain is the best example. Who would have
expected companies like Heinz in my state to make masks or for
Merck to offer their durum manufacturing facility to another
drug company to make their vaccine? The efforts of the private
sector to meet the demands was truly unprecedented.
As the Federal Government, our ability to affect the supply
chain for medical supplies, however, is limited. The Federal
Government is just 4 percent of the purchases of PPE. The other
96 percent belongs to the private sector, who have far greater
capabilities to increase our preparedness if leveraged
appropriately. Our reforms need to focus on sustainable
policies that endure after the attention of this response
fades. When we designed the stockpile, it was a bioterror event
in mind.
The stockpile should serve as a bridge for acute time,
limited events, not as the primary source for surge level
medical needs. It houses our countermeasures for Ebola,
anthrax, and smallpox. But we never maintain the level of PPE
and ancillary medical supplies that we have purchased for COVID
in the long term. And that was never the goal of the stockpile.
As the author of BARDA and a big fan of Project Bioshield, I
remember how we had to fight for every bit of funding for these
programs during peacetime. Remember that Bob? We cannot put our
simple supply chain needs in the same position.
We need to keep the private sector nimble and creative at
meeting demands and to retain the market incentives, not
Government commands. With COVID-19, we had no choice but to
innovate. There were no shelf-ready tests, treatments, or
vaccines. There was no humming manufacturing line capable of
making vaccines to combat this novel virus. Even with our
investments over the years in BARDA, the ASPR, and the
stockpile, we need lead-time.
A clear gap in our readiness capability is the work on the
front end for countermeasures. Early stage discovery like what
occurred through NIH and BARDA's RADx initiative, and NIH's
newly announced AVID Program, will help build our library of
medical platforms and technologies that we can pull off the
shelf when the next novel pathogen arrives on our doorstep. But
these programs need partners. And the engagement of academia
alongside the private sector can produce the innovative
products we need to be ahead of the curve. Once we develop the
countermeasures, we also need to manufacture them at scale,
which will depend on private sector partners to once again rise
to the challenge.
The FDA is a key partner in this enterprise and was
prepared with the tools needed to truly rise to the challenge
facing COVID. FDA has reviewed and authorized almost 400 tests,
11 therapeutics, and 3 vaccines for emergency use that have
changed the trajectory of COVID-19 pandemic. Two of the
vaccines depend on a brand new platform. In fact, many of the
countermeasures used to tackle COVID-19 use platform based
technologies. Most of these countermeasures were developed for
COVID-19 in less than 1 year, a process that usually takes more
than three times that amount of time. The agency's actions
helped speed deployment of needed medicines, send signals to
innovators that FDA can be more nimble, more approachable and
more efficient in its ability to bring new hope to all
America's patients, not just in response to COVID. But it
doesn't stop once these products are authorized.
We need to get them in the hands of doctors and nurses to
help patients just as urgently today to address the delta
variant as we did previously in this response. Senator Murray
and I know our priorities are big undertakings. The lessons we
have learned from this pandemic and the solutions at hand will
likely be different for each state, locality, and community.
The HELP Committee has a long bipartisan history of putting in
the work to bring together the right answers to solve problems
facing Americans.
Our goal is to provide a targeted legislative response this
fall to the biggest gaps in our preparedness architecture. To
our witnesses today, your part--you are a very important part
of that process. Your testimony can help us understand where
you all witnessed the biggest gaps in our preparedness and
response framework, and how best to address these gaps so that
we can leave our framework better prepared than in fact we
found it. With that, I thank the Chair and I yield back.
The Chair. Thank you, Senator Burr. Again, welcome to all
of our witnesses. We will now introduce them. Our first witness
is Mr. Les Becker. He is the Deputy Secretary of Innovation at
Washington State Department of Health. His work leading the
Department's first ever Office of Innovation and Technology
includes overseeing data, informatics, and health technology.
Before joining us in Washington State, Mr. Becker worked on
public health in Harris County, Texas, leading the county's
nationally acclaimed Public Health Innovation Lab. Mr. Becker,
thank you for being here with us today. Next, I would like to
introduce Ms. Phyllis Arthur, Vice President of Infectious
Diseases and Diagnostics Policy at the Biotechnology Innovation
Organization, or BIO for short. Ms. Arthur first joined BIO
back in July 2009 as Director of Health Care Regulatory
Affairs.
In her role at the organization, she works with member
companies in the areas of vaccines, molecular diagnostics, and
biodefense. Prior to joining BIO, she worked for Merck in their
vaccine division. Ms. Arthur, thank you for joining us. I look
forward to your testimony. Dr. Janz is our next witness. He
will be introduced by Senator Cassidy.
Senator Cassidy. I think this is the fourth person I have
had the privilege to introduce to whom I lectured on diarrhea
and hepatitis. So it is--I was famous for that lecture--
lectures. But anyway, I had the privilege of representing Dr.
David Janz, who is the Director of Medical Critical Care
Services at University Medical Center in New Orleans. And Dr.
Janz has seen firsthand what works and does not work in the
COVID-19 pandemic response.
On the front line, he helped direct the response--remember,
New Orleans was terribly one of the first places that was hit
right after Mardi Gras, where presumably it was introduced. And
so as New York was higher in profile, we were also having our
troubles. And Dr. Janz on the front line helped direct the
response at the medical center and across Louisiana, hosting
regular conference calls, updating colleagues on best
practices. He continues to help coordinate Louisiana's
statewide critical care response as a member of the Louisiana
Department of Health Critical Care Task Force.
With Dr. Janz, the Critical Care Task Force has developed
easy to use patient care tools and operational solutions for
hospitals across Louisiana. These have later been rolled out
nationally, helping hospitals across the country fight the
pandemic. Before the pandemic, Dr. Janz started with a medical
degree from LSU School of Medicine and Internal Medicine
Residency Critical Care Fellowship and Master of Science and
Clinical Investigations at Vanderbilt.
As we, elected officials, weigh the economic, social, and
physical health impacts of proposed policies, it is valuable to
hear from medical experts. I look forward to Dr. Janz's
testimony. And with that, I yield.
The Chair. Thank you, Dr. Janz. Welcome to you. Our final
witness today is Anita Cicero. She is the Deputy Director of
the Center for Health Security at the Johns Hopkins Bloomberg
School of Public Health. As Deputy Director, Ms. Cicero has
expanded the Center's efforts in epidemic preparedness, global
biological risk issues, and international biosecurity.
She also currently chairs multiple World Health
Organization working groups on research and has 30 years of
experience as a health lawyer. Ms. Cicero, thank you for
joining us today. I am pleased to have you as well. With that,
we will begin our witness testimony. And Mr. Becker, we will
begin with you.
STATEMENT OF LES BECKER, DEPUTY SECRETARY OF INNOVATION,
WASHINGTON STATE DEPARTMENT OF HEALTH, OLYMPIA, WA
Mr. Becker. Good morning, Chair Murray, Ranking Member
Burr, and Members of the Committee. Thank you for your
leadership and inviting me to testify today to share lessons
learned from COVID-19. Let me start by acknowledging that this
pandemic is far from over. When my boss, Dr. Shah, Washington
State Secretary of Health testified to this Committee in March,
he noted 500,000 Americans have lost their lives. I would be
remiss not to acknowledge the tragic loss of another 100,000
since then.
I want to thank Dr. Janz and all the other health care and
public health professionals on the front lines across our
Nation that are helping to keep our communities safe as we
respond to this pandemic. While we still have a long way to go,
I believe there are lessons that we have learned that can shape
a public health system built for the 21st century to protect
the safety of all Americans. My name is Less Becker, and I was
recently hired from the private sector as the new Deputy
Secretary of Innovation and Technology for Washington State
Department of Health.
Previously, I worked at Harris County Public Health for 11
years with Dr. Shah, and we innovated, and we increased data
systems and we use technology to make our work better, building
one of the best local health departments in the country. I come
at public health and innovation and technology from a slightly
different perspective of some of my colleagues. My background
is grounded in technology, business management, project
management, and finance. I don't believe that people recognize
how decrepit and desperate our current public health data
systems are, and that it will take a lot of work, time and
resources to modernize them.
I believe to build and maintain strong public health
infrastructure, we need to apply innovative practices that
ensure efficient use of resources, achieve desired outcomes,
and foster a continuous improvement environment that bridges
the Federal Government, State Government, and local public
health divide. Today, I want to touch on three main points, the
criticality interoperable data systems, the value of public
private-partnerships, and the need to invest in well-
coordinated local, state and Federal data systems through
regional innovation hubs.
First, we need policies that incentivize interoperability
to connect public health data systems with a broad range of
partner systems, including health care. For example, in
Washington, WA Health was developed quickly as a public-private
partnership with public health, our health care system, and
Microsoft to provide actionable data for preparedness and
response during the pandemic. WA Health provided decision-
makers with real time input from Washington's hospital system
for staffing, emergency department availability, PPE, and other
items needed during the response.
When the need arose, WA Health was expanded to collect data
from approximately 1,800 providers to feed the state's vaccine
data locator system, and that included data on wheelchair
accessibility and language translation options onsite. Second,
we need to incentivize private partners to stay the course post
pandemic. Through this pandemic, we have seen the amazing
accomplishments industry and public health can achieve when we
all come together.
In Washington, one example of this is the Vaccine Action
Command and Coordination Center, or VACS, which brought
together health care organizations including Kaiser Permanente
and countless private business partners such as Amazon, Costco,
Microsoft, and Starbucks to figure out how to distribute
vaccines equitably and efficiently across Washington State.
Finally, we did an investment and well-coordinated local,
state, and Federal data systems through regional innovation
hubs. Right now we are funding siloed programmatic data systems
that are not suited to handle the needs of today or tomorrow.
Moving forward, we need a strong and empowered team of
Federal, state, and local public health agencies to come
together at one table, shaping the 21st century data systems of
tomorrow. Let me close by saying, if nothing changes, we will
get more of the same, systems without the robust capabilities
and capacity to respond to the next emergency. And we are at a
crossroads. Either we can act now and invest in public health,
or we can react later. I hope COVID-19 will move us to action.
Federal legislation like Chair Murray's Public Health
Infrastructure Saves Lives Act could help make that hope a
reality. On behalf of the State of Washington, Asato, and my
colleagues across the Nation, I appreciate the opportunity to
testify today. Thank you.
[The prepared statement of Mr. Becker follows:]
prepared statement of les becker
Let me start by expressing my sincere gratitude to Committee Chair
Patty Murray, Ranking Member Richard Burr, and distinguished Members of
the Committee, for the opportunity to appear before the Senate
Committee on Health, Education, Labor, and Pensions to discuss lessons
learned from the COVID-19 pandemic to innovate public health.
The COVID-19 pandemic is the most significant public health
emergency in the last century. More than 600,000 Americans have lost
their lives to COVID-19, \1\ which is approximately the same population
as Baltimore. \2\ To quote Chair Murray, ``[w]e have to make sure we
learn from this history and take action so we never repeat it. This
crisis has cost too much, has taken too many lives, for us to do
anything less.'' \3\ And to quote Ranking Member Burr, ``[t]he window
to update our public health and medical preparedness policies is now.''
In America, we can do anything if we do it together.
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\1\ Source: https://covid.cdc.gov/covid-data-tracker/#datatracker-
home (Accessed July 21, 2021).
\2\ Source: https://www.census.gov/data/tables/time-series/demo/
popest/2010's-total-cities-and-towns.html (Accessed July 21, 2021).
\3\ https://www.help.senate.gov/hearings/the-path-forward-a-
Federal-perspective-on-the-covid-19-response (Accessed July 21, 2021).
Speaking on behalf of my colleagues in public health at the state
and local level, thank you for the time and energy being devoted by
this Committee to craft bipartisan policies to strengthen our public
health infrastructure and invest in preparedness now to prevent and
better prepare for future public health threats. As you know, to date,
the state of Washington has had one of the Nation's most successful
responses to COVID-19 under the leadership of Governor Jay Inslee, and
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I am proud to be a part of this response.
As the new Deputy Secretary of Innovation & Technology for the
Washington state Department of Health (DOH), I was recently hired from
the private sector by Dr. Umair A. Shah, Washington's Secretary of
Health, to join DOH in this immensely important time in our state's
history and in this new and exciting role for our agency and the people
of the Washington. This is a newly created role for a newly created
office that sits at the highest level of DOH executive leadership,
recognizing the importance of innovation and use of technology in our
public health mission. In this role, I am responsible for building and
supporting innovation work across the agency (and beyond) including
overseeing our existing data/informatics and health technology services
areas while building the Innovation First culture of tomorrow.
Prior to my private sector role, I previously worked at Harris
County Public Health (HCPH) in public service leadership serving the
Nation's third largest county in Texas. At HCPH, I worked with Dr. Shah
in his previous role as executive director of HCPH to advance an array
of innovation, data systems, and technology work building one of the
best local public health departments in the Nation. Our work included
creating the nationally acclaimed Public Health Innovation (PHI) Lab,
which focused on developing novel public health interventions into
sustainable projects that improved the health of the community. We
implemented an award-winning data warehouse used to deliver timely data
for key public health decision across many domains. In my role there, I
also led key areas of advancement including the Medicaid 1115
transformation waiver implementation, public health accreditation and
the agency's strategic plan development. I am excited to bring my
experience to DOH and work with Secretary Shah in championing his
vision of applying the cornerstone values of equity, innovation, and
engagement to Washington and its public health systems.
We all know that everyone, everywhere, in all communities, should
be able to rely on a strong public health system that is able to
support them when emergencies strike, and even beyond those
emergencies--in their everyday lives. Indeed, Federal legislation like
Chair Murray's Public Health Infrastructure Saves Lives Act \4\ could
help make this a reality. Public health activities and services must be
delivered efficiently and effectively, making the best use of
innovation, technology, science, expertise, and reliance on a qualified
and dedicated public health workforce that is truly valued and
supported. While there have been so many uncertainties with the COVID-
19 pandemic, one thing is certain: this pandemic would have played out
very differently if the capacity of the public health system across
this Nation was better able to support the needs of communities
everywhere, and if this capacity was adequately built and in place in
advance of this crisis.
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\4\ https://www.help.senate.gov/ranking/newsroom/press/murray-
introduces-legislation-to-build-and-maintain-core-public-health-
infrastructure-needed-to-save-lives-fight-threats-like-covid-19.
I come at the notion of public health innovation and technology
from a different perspective than some of my colleagues because my
background is grounded in project management, technology, and finance.
While my experience may be different than others in the field of public
health, I believe this expertise is critical to build the structures to
transform our Nation's aging public health ecosystem. I have worked to
develop plans to guide and prioritize work to align with strategically
set goals and include strong performance measures to innovate our
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public health systems.
The chronic underfunding of public health infrastructure is well
documented, as well as examples of outdated technology that have
hamstrung local, state, and Federal public health responses to the
COVID-19 pandemic. \5\ And yet, we have heard many stories about how
Americans came together, rose to the challenge, and persevered. In my
own journey, I transitioned from the field of public health during the
pandemic last year, but stayed connected to what was happening in the
field and then rejoined to apply my expertise in the process of
rebuilding what is necessary to advance our work. I want to highlight
some of the progress we have made to improve public health systems in
Washington state that exemplify structures and principles we can learn
from and share some additional concepts I recommend the Committee
consider as it looks ahead.
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\5\ https://www.help.senate.gov/hearings/examining-our-covid-19-
response-an-update-from-the-frontlines (Accessed July 21, 2021).
Examples of Success--the Washington Experience
WA HEALTH (Washington's Healthcare and Emergency Logistics Tracking
Hub)
WA HEALTH was developed as a public-private partnership with our
health care system and Microsoft to provide actionable data for public
health and medical preparedness. \6\ WA HEALTH data categories were
aligned with U.S. Department of Health and Human Services (HHS)
hospital reporting requirements. \7\ WA HEALTH is a testament to what
we can accomplish through public-private partnerships and innovation.
DOH had to overcome several hurdles to operationalize WA HEALTH.
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\6\ https://www.doh.wa.gov/ForPublicHealthandHealthcareProviders/
WAHealth.
\7\ https://www.hhs.gov/sites/default/files/covid-19-faqs-
hospitals-hospital-laboratory-acute-care-facility-data-reporting.pdf.
The first hurdle was the lack of digital bridges between public
health and health system electronic health records (EHRs). EHRs are
generally not built to send data to public health systems
automatically. Likewise, few public health departments participate in
the U.S. Centers for Disease Control and Prevention (CDC) program to
develop digital bridges due to lack of funding and capacity within
health \8\ departments. \9\ In 2009, the Federal Government invested
$27 billion to encourage the health system to adopt EHRs, but a similar
investment was not made in public health and public health department
needs were not considered when these systems were developed. \10\
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\8\ Centers for Disease Control and Prevention. 2020. Bridging
Public Health and Health Care. Available at: https://www.cdc.gov/
surveillance/projects/bridging-public-health-and-health-care-better-
exchange-better-data.html (Accessed July 22, 2021).
\9\ Miri, A., and D. P. O'Neill. 2020. Accelerating Data
Infrastructure for COVID-19 Surveillance and Management. Health Affairs
Blog. https://dponeill.com/2020/04/14/Accelerating-Data-Infrastructure-
For-COVID-19-Surveillance-And-Management.html.
\10\ Gold, M., & McLaughlin, C. (2016). Assessing HITECH
Implementation and Lessons: 5 Years Later. The Milbank quarterly,
94(3), 654-687. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5020152/.
To maintain WA HEALTH, hospital staff must run reports and send
this data to the state public health data system. This is a labor-
intensive solution and once the emergency goes away, it is feared that
the hospital participation and associated data will likely go away as
well. WA HEALTH has demonstrated the benefit of digital bridges between
public health and health systems that we must build upon in a
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sustainable and automated way.
Going forward, it is critical that we operationalize rapidly
configurable systems with the capacity to capture data quickly and
share case data across states in a standardized way. To address the
lack of digital bridges between public health and health system EHRs,
Federal funding for electronic case reporting (eCR) could (1) initiate
broad-scale, secure reporting from EHRs in clinical care organizations
to public health agencies across all jurisdictions; (2) support
interoperable and intelligent real-time reporting from multiple
sources; and, (3) eliminate paper-based reporting.
The second hurdle was the fact that data systems amongst entities
such as hospitals, laboratories, and public health data systems, are
not always interoperable. These data systems do not consistently rely
on the same data standards (e.g. FHIR or HL7), so they cannot connect.
During the COVID-19 response, DOH worked closely with hospitals to
develop necessary mechanisms for exchange. Going forward, public health
must ensure vendors are held responsible for standardization for
transport protocols. Transfer protocols need to be built in to
contracts, which need to be standardized through granting agency
requirements. In today's world, interoperability is a bare necessity of
a minimum viable product.
To address interoperability of data systems amongst hospitals,
laboratories, and public health data systems, Federal funding for areas
such as syndromic surveillance and beyond should be ready to do the
following: (1) expand the number of hospitals participating; (2)
enhance reporting to other health system entry points such as urgent
care centers; and, (3) add predictive analytics and artificial
intelligence to uncover changes in the occurrence of illness and
injuries.
The third hurdle was having outdated public health case management
data systems. These public health data systems were not set up to
rapidly add new diseases or data variables. Many of the data systems
used by public health labs or in epidemiology were created decades
ago--some as old as forty years ago. Often these technologies have not
matured and are certainly not as mature as hospitals or private labs.
For example, the data surveillance system used by Washington and other
public health jurisdictions faced challenges in capacity to upgrade
this critical system rapidly. In addition, when data systems are
hardware bound, they are not scalable to an emergency on the scale of
the COVID-19 pandemic. With the additional data variables required for
Federal reporting of COVID-19, there was a lot of work that had to go
on behind the scenes because the data systems did not align with the
mission and myriad needs.
Going forward, we need sustained investment for entities to work
across siloes, especially in bringing the private sector to the table
to help maturate these critical public health data systems. Public
health data systems must be ``cloud-based'' to allow for rapid
scalability to respond to a host of issues including the most ominous
one before us, namely a global pandemic in real-time. Funding must be
systematic and sustained, while also being smart and strategic. We
truly must have public health data systems that are scrappy and
scalable; that are built for the 21st century.
In our state, WA HEALTH informatics and visibility were used to
allocate critical medical supplies and support health care capacity. It
provided decision-makers with real-time input from Washington's
hospitals for staffing, emergency department availability, room
availability, personal protective equipment (PPE), and other needed
items for preparedness and response. When the need arose, WA HEALTH was
expanded to collect data from 1,800 vaccine providers to help with our
vaccine efforts. The example of WA HEALTH shows that public health has
the capability to develop modernized data systems and actionable
dashboards when the structures for success are aligned.
2. VACCS Center (Vaccine Action Command and Coordination System Center)
The VACCS Center is a unique public-private partnership launched in
early 2021 to support efficient and equitable access to COVID-19
vaccinations across Washington. \11\ VACCS is scheduled to demobilize
on July 30, 2021. This effort built on a history of strong public-
private partnership in the state of Washington through efforts like
Challenge Seattle, a coalition of regional employers that worked
closely with Governor Inslee to address regional challenges throughout
the COVID-19 pandemic.
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\11\ Building Public-Private Partnerships to Support Efficient and
Equitable COVID-19 Vaccine Distribution, Access, and Uptake. Margolis
Center for Health Policy. April 2021. https://healthpolicy.duke.edu/
publications/building-public-private-partnerships-support-efficient-
and-equitable-covid-19-vaccine (Accessed July 21, 2021).
The VACCS Center was created by Secretary Shah as part of DOH's
pandemic response, during the critical time of vaccine dissemination.
Led by VACCS Center Director Dan Laster, who arrived to DOH with an
array of private sector experience, the VACCS Center brought together
key stakeholders within state government all the way up to the
Governor's Office and extended beyond to critical partners such as
health care organizations, including Kaiser Permanente and countless
Washington large-scale private business partners, including Amazon,
Costco, Microsoft, and Starbucks, as well as those representing
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community pharmacies, clinics, and others.
The VACCS Center had five complementary workstreams co-led by
representatives from the public and private sectors: technology and
data, communications, business processes, supply and logistics
deployment, and situational awareness. Since launch, the partnership
was incredibly successful, creating multiple integrated solutions to
address early challenges, including an enhanced vaccine locator tool,
an expanded 211 Call Center, and a Vaccine Playbook for Public-Private
Partnerships. An example of synergy included having partners from
Starbucks visit the state-led mass vaccinationsites set up in early
2021, to review and enhance process flow and the consumer experience
with respect to vaccine delivery at these sites.
The VACCS Center acted as an intermediary between the public and
private sectors ensuring private sector solutions are relevant to the
needs of the public sector. The VACCS Center's structure worked to
surface problem statements and needs, and then worked across
participating organizations to identify opportunities to leverage
resources and expertise. The VACCS Center served as a ``translator''
between sectors and matched the public sector's needs with the private
sector's capabilities. This coordination structure was critical for the
facilitation of meaningful and pragmatic partnerships. Not only was the
VACCS Center's work recognized nationally, but it held true to its
mission of ensuring that private sector solutions could be applied to
public sector challenges in the area of vaccine delivery.
The VACCS Center is an excellent example of the need for engagement
through public-private partnerships. The public sector is often not
nimble enough to assess effectively private sector resources and match
relevant offerings with state needs; however, during a public health
emergency many barriers are removed in order to get to the work at
hand. I hope the Committee considers ways to support states and regions
to establish and sustain coordination structures to help convene public
and private sector interested parties, develop solutions, and direct
resources where they can have the most impact. We must have Federal
policies that permit flexibility in structure and incentives in place
to allow state public health systems to sustain public-private
partnerships once the emergency that brings the entities together
passes.
3. Washington's Notifiable Disease Surveillance System
There are two ways to stop the spread of a pathogen like a flu
virus, HIV, or COVID-19. \12\ Hard science examines the chemistry, the
biology, and the response to the immune system of the pathogen.
Epidemiology looks at the circumstances surrounding a disease or
outbreak. The state of Washington, like other states across the
country, has worked to increase visibility and improve data system
collection of demographic data for COVID-19 and other notifiable
conditions, so we can better understand the circumstances surrounding a
disease and respond accordingly.
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\12\ Richtel, M. (2020). An elegant defense: the extraordinary new
science of the immune system: a tale in four lives. William Morrow.
When there is insufficient data, the problem remains invisible, and
the initial lack of demographic data around morbidity and mortality
from COVID-19 allowed some people to turn a blind eye to inequities.
Standing up data systems that could handle demographic data for COVID-
19 was critical to reveal the disparate toll COVID-19 was particularly
taking on Washington's African-American, Native Hawaiian, Asian-
American, Pacific Islander, and Hispanic communities, amongst
other1A\13\ groups. \14\ HHS COVID-19 demographic data guidance
provided minimum standards to states.
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\13\ Arias, E., Tejada-Vera, B., Ahmad, F., & Kochanek, K. D.
(2021). Provisional Life Expectancy Estimates for 2020.
\14\ https://www.doh.wa.gov/Portals/1/Documents/1600/coronavirus/
data-tables/COVID-19MorbidityMortalityRaceEthnicityLanguageWAState.pdf.
In Washington, we complied with both HHS guidance and Washington
State Board of Health (WSBOH) notifiable condition regulations for
health care providers, hospitals, and laboratories, including
demographic data reporting requirements for patient race and ethnicity.
\15\ During the COVID-19 pandemic, we had hoped to adopt more expansive
categories for race and ethnicity to understand better the populations
impacted by COVID-19, but ran into technical challenges with data
collection and interoperability. Gaps in data collection, analysis, and
dissemination, including in key areas such as data aggregation, can
mask ``at-risk'' populations that may be disproportionately affected by
a public health threat.
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\15\ https://sboh.wa.gov/News/Articles/ID/2856/Board-Adopts-
Fourth-Emergency-Rule-to-Extend-COVID-19-Reporting-Requirements.
In the midst of the pandemic, DOH had to enhance data systems to
accept the demographic data established by HHS guidance and often had
to manually go back in to add demographic data because providers did
not submit the information initially or data systems were not
interoperable. Since then, DOH has found ways to address these
technical challenges. Additionally, DOH and WSBOH came together to
engage community partners and WSBOH adopted new notifiable condition
regulations which include 71 reporting categories for race and
ethnicity that were community-informed and incorporated standards
established by the U.S. Office of Management and Budget and HHS Office
of Minority Health. \16\
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\16\ https://sboh.wa.gov/Rulemaking/CurrentRulesandActivity/
NotifiableConditions.
Through ongoing community engagement processes, additional
demographic variables were identified that must be prioritized in
future policy making, including but not limited to Tribal affiliation,
disability status, and housing status. Getting these data categories
correct requires meaningful engagement with a variety of communities,
which takes time, resources, and trust. We must continue to develop
frameworks for more equitable engagement and collaboration in order to
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promote health and achieve health equity for all of our communities.
We know when dealing with health, a person's environment, physical,
social, and emotional needs, all contribute to their immediate and
future resiliency. Understanding these social determinant variables are
crucial to decision-making. Data reporting for variables that reflect
the social determinants of health is less mature and certainly not
inter-connected as it should be. Moving forward, we absolutely need to
be specific with the standards for housing, food insecurity, and other
social determinant variables to get meaningful and usable data. Data
governance will be critical. In addition, data related to social
determinants is often being collected downstream in other disparate
data systems. Data is being siloed, and we need to create public health
data systems that reduce duplication of efforts or match the data to
improve outcomes.
In 2021, the Washington State legislature passed House Bill 1272
that includes requirements for hospitals to submit patient discharge
information to DOH that identify the patient's race, ethnicity, gender
identity, sexual orientation, preferred language, any disability, and
zip code of primary residence. \17\ Both the public and decision-makers
demand informatics and information about community health and well-
being. I believe we must develop data systems that provide the same
level of protection from a variety of threats whether infectious
disease in nature such as a pandemic, or chronic disease related, or
environmental in nature, regardless of where you live, who you are, or
what your income is, because of our experience expanding reporting
requirements and our ability to implement structures for public-private
partnership and community engagement.
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\17\ https://app.leg.wa.gov/
billsummary?BillNumber=1272&Year=2021&Initiative=false.
The issue of standardizing demographic data reporting practices is
a challenge across the U.S. \18\ Currently, demographic categories and
definitions differ between states. To understand the population's
health, we need data systems that reflect the public we serve. To
identify these demographic categories, state and local public health
must be at the table because ultimately, we know our communities best.
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\18\ Blauer, B. (2021) Data disarray damages COVID-19 response,
expert says. The Hub. https://hub.jhu.edu/2021/06/17/beth-blauer-data-
disarray-in-covid-reporting/.
Federal funding to support a national notifiable disease
surveillance system would improve: (1) data security across the
infrastructure; (2) automated electronic receipt of data (existing and
new data sources); (3) integrated, real-time analytics of data from
multiple sources (clinical, lab, epidemiologic); and, (4) seamless,
efficient communication and sharing of robust data to and from health
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care providers to public health agencies and onto CDC.
To date, Washington's DOH has received approximately $120 million
in Federal COVID-19 funds for data systems to support critical efforts
such as disease surveillance and reporting, testing, case investigation
and contact tracing, and vaccine distribution. Through 14 response
missions and 38 data system projects, we have invested in a public
health ``cloud'' environment, engaged countless vendor partners in
development and modernization of essential infrastructure and systems,
brought in new tools and resources, and ultimately identified over a
hundred staff members to be trained to support these new capabilities.
Essential costs include new equipment, cloud hosting, software
licensing and maintenance. Without systematic and sustained funding, we
will not be able to keep the forward progress made to innovate public
health.
Looking Ahead--A Long Journey
The stories above reflect some of the successes we have had in
Washington while simultaneously protecting the public from the COVID-19
pandemic in one of the Nation's most successful responses. They reflect
DOH's cornerstone values of equity, innovation, engagement in practice.
While these efforts are noteworthy, we know even after we are through
this crisis, our work is far from over. We require investments,
strategies and structures in place at every level of government to
strengthen our public health systems to use sequencing technology
efficiently and effectively, modernize data systems to track the spread
of diseases and monitor the success of key initiatives such as
vaccination efforts, standing up of testing and contact tracing to stop
disease outbreaks, build partnerships in hard to reach communities, and
build trust as communicators to fight misinformation.
Looking ahead, we must think about ways to innovate data
management, systems changes, and operational strategies to create a
modern 21st century governmental public health system that we can all
be proud of and rely on during times of emergency and beyond.
1. Data Management
Significant work is needed to innovate public health data
management, including governance and consensus-based standards. Prior
to COVID-19, most people saw the systems that collected data and
governance of that data as singular, but as we moved in to COVID-19 and
cloud-based analytics, data and systems are increasingly being
separated. When data is housed outside of the original data system, we
need optimal governance to protect people's privacy and the security of
this data while leveraging these insights to protect our communities.
With these shifts, all levels of public health will require an equally
strong and supported workforce that can help navigate and lead on these
critical issues.
Meanwhile, numerous organizations are developing public health data
standards and technical roadmaps, including the Office of the National
Coordinator for Health Information (ONC) and the Healthcare Information
and Management Systems Society (HIMSS). They are working on the
technical side of data systems. I believe we will need an equal focus
on how to operationalize these standards. There are significantly
different maturity levels for data systems across our federated public
health ecosystem. As I follow the work of these technical groups on
data standards, I believe we will need a substantial investment in
resources to operationalize these standards and move forward from a
long-term sustainability standpoint. I believe that most state,
territory, local and Tribal public health entities may struggle with
the organizational systems change needed to implement these vital
frameworks and standards. We must consider new mechanisms for funding,
incubating, and maturing all levels of the system.
2. Systems Change
Federal funding in public health data systems and infrastructure
needs to move away from programmatic siloed funding to enterprise-wide
systems and shareable systems. We need to set aside pre-conceived
expectations for how funds flow into these programs to build a 21st
century governmental public health system that is connected, resilient,
adaptable, and sustainable--a `pandemic-ready' system that can help us
solve problems before they happen and reduce the harm caused by the
problems that do happen.
Currently most Federal funding channels provide for specific
programs (e.g. immunization or STD prevention). The Public Health
Emergency Preparedness cooperative agreement funding is used to create
infrastructure to respond to emergencies, including capacity and
supply. When we go into a public health emergency response, there is
not always alignment between this programmatic funding and the
emergency response needs. During an emergency, one must work with each
program to realign personnel and IT systems, so it is hard to pivot.
Programmatically siloed funding for data infrastructure and data
systems creates barriers for innovation and barriers for emergency
response.
In addition to a shift toward investment in enterprise-wide systems
and shareable systems, I believe we should consider funding and support
that brings multiple states together to form regional innovation hubs.
There is regional variance in both capacity and capabilities across
America, as well as gaps in systems and workforce. The most efficient
path to address this complexity is through regional innovation hubs.
Placing the responsibility and decision-making at the regional
level can best shepherd this modernization for the immediate and future
needs of the impacted communities. These regional centers could bring
together Federal, state, local, and Tribal governmental agencies in
partnership with community stakeholders, academia, and private sector
partners to innovate the way public health is delivered to their
communities. These regional hubs should have the ability to direct and
redirect resources while being held accountable for maturing the
systems and demonstrating outcomes.
One of the primary tenants of this type of approach would be having
a Federal presence in the regional innovation hub that can communicate,
bridge, and coordinate the myriad Federal agencies and programs that
fund and support public health. The decentralization of the decision-
making will align public health at all levels to be nimble, cost
effective, and outcome oriented.
The reality is that there are regional differences in all aspects
of community, health, resources, challenges, opportunities, and types
of emergencies we face. Our Federal system provides ample opportunity
for taking risks in our work with respect to innovation. Regional
innovation hubs could provide a ``laboratory'' structure to implement
public health data infrastructure strategically for the 21st century.
Thanks to robust visualization tools, we have all been able to see the
geographic uniqueness of this pandemic. After witnessing the pain and
suffering COVID-19 has caused, we have an opportunity to acknowledge
that uniqueness with a Federal approach that recognizes, embraces, and
supports those unique regional public health needs.
Operational Strategies
Data modernization is not just about the technologies, it requires
operational strategies to implement successfully. More funding alone
will not bring public health data systems in to the 21st century.
State, territorial, local, and Tribal public health agencies will need
increased organizational operational capacity, modernized enterprise IT
architecture, and a culture of innovation to build the Innovation First
culture of tomorrow. I hope the examples and concepts shared throughout
my testimony capture these operational strategies.
We will only be able to build a 21st century governmental public
health system if we have the workforce to do it. During the COVID-19
pandemic, as many public health entities across the Nation, DOH had to
expand its own workforce rapidly. This translated into the hiring of
over 500 staff members and the contracting of over 500 additional
personnel, including for work in laboratory settings, case
investigation and contact tracing, surveillance and informatics,
outbreak response, public affairs/communications, diagnostic testing,
and incident management command and control for dealing with the
logistics of testing, contact tracing, PPE distribution and
vaccinations. This ``just in time'' building of capacity in the midst
of a crisis is no rational way of preparing our Nation for future
emergencies.
Technology's potential can only be realized if public health
agencies are equipped to harness it. We must have systematic and
sustained funding to increase salary caps to recruit and retain optimal
staff and create new jobs in the public and private sector across
jurisdictions, new curricula, professional development, post-graduate
fellowships, and on-the-job training. Funding would help the public
health system achieve full capacity to understand and securely
integrate health data to: (1) provide more complete, accurate, and
timely population-level monitoring; (2) ensure optimal health security
through robust public health surveillance to prevent death and disease;
(3) move data to action by driving policy and practice to accelerate
health improvement; (4) reduce provider reporting burden; and, (5)
bolster and maintain cybersecurity. The growth and retention of the
public health workforce should contain a specific focus on diversity--
racial, ethnic and beyond--to address issues of trust, confidence, and
representation of the diversity of the residents served by the public
health agency in both rural and urban areas. The very health, well-
being, and resiliency of that workforce must also be maintained and
supported.
Congress should explore alternative funding models to ensure
predictable and sustained funding over the next decade. These funding
models could potentially be outside of discretionary appropriations and
provided through a ``public health infrastructure fund'' approach,
which is a critical component of Chair Murray's Public Health
Infrastructure Saves Lives Act. Rather than constraining states by
defining what types of occupations and how many individuals should be
employed, workforce dollars should be flexibly administered to states
either via block grants or an alternative mechanism for use in hiring
the public health professionals and experts needed to meet both the
current and future workforce needs of the jurisdiction. Ensuring key
flexibility is critical to enabling public health agencies to recruit
and retain staff.
Conclusion: The Future Is Achievable
Moving forward, I am excited by what innovation and technology can
bring to the issues at hand within public health and beyond. I
recommend the following for further policy consideration by the U.S.
Senate Committee on Health, Education, Labor, and Pensions, to improve
our Nation's public health system:
1. Coordinate policies, consensus-based standards, decision-
making, and invest in enterprise-level IT and data
infrastructure that supports cloud-based platforms, shared
cross disease systems and real-time data automation. This
includes closer integration of state and Federal partners
including the CDC to develop interoperable systems that allow
for efficient data exchange and the development of more timely,
efficient and effective automated reporting systems to report
results to state (and local) health agencies.
2. Create a system-wide environment of structured innovation
that modernizes public health systems and enables new public-
private partnerships with healthcare providers, private sector,
and other entities to create new tools that serve communities,
patients, and consumers.
3. Create regional innovation hubs for systems modernization
that allow for states to achieve economies of scale, small
enough to develop data standards to collect data that is
meaningful to communities, engage and leverage private sector
expertise located in the region and enable a unified Federal
voice that can be nimble within a localized structure that
actually operationalize state and local public health systems/
data modernization efforts that are accountable.
In closing, COVID-19 is the challenge of our lifetime, but it is
also a watershed event to improve the health and well-being of all
individuals through more robust, smart, and sustained investment in our
public health system. There are critical investments that need to be
made and innovative policies that should be considered to meaningfully
modernize our public health system. On behalf of our state and my
colleagues at ASTHO and across the public health system in this Nation
(and beyond), we stand ready to work with you to begin the process of
innovatively investing in public health. It is what our Nation needs
and what our Nation requires to move forward successfully.
Thank you for holding this hearing to discuss lessons learned from
the COVID-19 pandemic as this Committee develops legislation to define
the vision and capabilities for a 21st century governmental public
health system that promotes health, prevents disease, and protects all
communities across the country.
______
[summary statement of les becker]
The U.S. public health system has worked around the clock to
respond to the COVID-19 pandemic since the first identified U.S. case
was confirmed in our State of Washington in January 2020. As you know,
to date, the State of Washington has had one of the Nation's most
successful responses to COVID-19 under the leadership of Governor Jay
Inslee, and I am proud to be a part of this response. I want to
highlight some of the progress we made to improve public health systems
in the State of Washington and discuss ways to innovate data
management, systems changes, and operational strategies to create a
21st century governmental public health system to better prepare the
U.S. for future public health emergencies.
Public health has the capability to develop modern data systems and
actionable dashboards when the structures for success are aligned. One
example is WA HEALTH which was developed as a public-private
partnership with our health care system and Microsoft to provide
actionable data for public health and medical preparedness. It provides
decision-makers with real time input from Washington's hospital system
for staffing, ER availability, room availability, PPE, and other needed
items for preparedness and response. More recently, WA HEALTH was
expanded to collect data from 1,800 vaccine providers to feed into the
state's Vaccine Locator tool and included data on wheelchair
accessibility and language interpreters onsite. Another example is
standing up data systems that could handle demographic data for COVID-
19 which was critical to reveal the disparate toll COVID-19 was
particularly taking on Black, native Hawaiian and Pacific Islander,
Asian-American, and Hispanic communities, amongst other groups.
Washington recently adopted new notifiable condition regulations which
include 71 reporting categories for race and ethnicity that were
community-informed. We need data systems that reflect the public we
serve.
Public health emergencies strike and funding spikes; however, the
funding is temporary and targeted and does not address the sustained,
longitudinal needs of our public health system, including a 21st
century public health workforce and modernizing public health data
systems. Everyone, everywhere, in all communities, should be able to
rely on a strong public health system that is able to support them when
emergencies strike. Indeed, Federal legislation like Chair Murray's
Public Health Infrastructure Saves Lives Act \1\ could help make this
hope a reality.
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\1\ https://www.help.senate.gov/ranking/newsroom/press/murray-
introduces-legislation-to-build-and-maintain-core-public-health-
infrastructure-needed-to-save-lives-fight-threats-like-covid-19-.
______
The Chair. Thank you very much.
Ms. Arthur.
STATEMENT OF PHYLLIS ARTHUR, VICE PRESIDENT, INFECTIOUS
DISEASES AND DIAGNOSTICS POLICY, BIOTECHNOLOGY INNOVATION
ORGANIZATION, WASHINGTON, DC
Ms. Arthur. Good morning, Chair Murray, Ranking Member
Burr, and Members of the Committee. My name is Phyllis Arthur.
I am the Vice President of Infectious Diseases and Emerging
Science Policy at the Biotechnology Innovation Organization, or
BIO. Thank you for the opportunity to share our thoughts
regarding lessons learned from the COVID-19 pandemic.
Since January 2020, our industry has initiated over 950
unique therapeutics and vaccines against COVID-19,
demonstrating our commitment to the critical research,
development, and manufacturing of medicines that help save
lives in a public health emergency. COVID-19 will not be our
last public health emergency. We face numerous bio threats from
natural and bioterror threats. Strong support for medical
countermeasures R&D is critical to protecting our National
Security.
Today, I will share BIO's thoughts on how to strengthen our
national preparedness through coordinated leadership, expanded
partnership with industry, and better public health
infrastructure. We applaud the success of the Government
partnerships in developing and distributing vaccines and
therapeutics. BIO believes a stronger PHEMCE led by the ASPR
could accomplish similar success in the future given the health
emergency expertise within ASPR. An interagency PHEMCE should
prioritize products, move products swiftly through agencies for
development, and procure MCMs through the SNS. Appropriate
funding levels must be provided for early stage development
through large clinical trials, manufacturing scale up, and
procurement.
Second, maintaining a permanent framework for MCM clinical
trials such as ACTIV to rapidly evaluate products for emergency
situations is the best way to rapidly respond. Third, our
Government must work with industry on communicating clear
product priorities and requirements, as well as strategies for
maintaining excess capacity for emergencies through multiple
partnerships. Any payment for this capacity should be viewed as
a cost effective insurance policy for national preparedness.
BIO agrees with the strategic focus of the American Jobs
Act that proposes investment in the U.S. supply chain and
domestic production. Congress should also consider several
bills offered by the Ways and Means Committee that seek to
incentivize investment in domestic manufacturing. Fourth, the
Government must expand partnerships across a host of threats.
PAHPAIA included authorities allowing strategic investments for
novel platforms and manufacturing advancements. Congress should
authorize BARDA funding for platforms to provide the most shots
on goal for potential threats.
Establishing partnerships with platform companies to work
on a predetermined set of infectious diseases will shorten the
development timelines for the next pandemic. Congress should
also work with the FDA to clarify the regulatory mechanisms by
which platforms can be authorized or approved when deployed
against subsequent pathogens. There must also be continued
investments in novel antiviral mechanisms. BIO is encouraged by
the launch of the antivirals program for pandemics and UNC's
READDI Program, which could stimulate early stage development.
These programs then must be supported by BARDA funding for
later stage development and manufacturing support.
These initiatives must be in addition to the ongoing
programs to develop, produce, and stockpile MCMs for specific
CBRN and biological threats, preparing for all possible
scenarios. This includes support of therapeutics that treat
severe consequences like acute respiratory distress syndrome
and antibiotic resistant infections. COVID-19 infections
reinforce the urgent need for antimicrobial products as both
major public health and a National Security threat.
We therefore encourage the inclusion of PASTEUR and DISARM
as part of the legislative effort. Last, we must invest in
public health infrastructure by expanding CDC surveillance
capabilities for viral testing and genomic sequencing, and also
the HHS systems that capture utilization and demographic data
for MCMs during an emergency, while sustaining the
infrastructure improvements made this past year for delivery of
therapeutics and adult vaccines.
This will ensure that communities can get vaccines and
treatments not only during a pandemic but also on a routine
basis. BIO and our members are committed to working with
Congress on these issues. And we thank you again for the
opportunity to testify today.
[The prepared statement of Ms. Arthur follows:]
prepared statement of phyllis arthur
Good morning Chair Murray, Ranking Member Burr and Members of the
Committee. My name is Phyllis Arthur and I am the Vice President of
Infectious Diseases and Emerging Science Policy at the Biotechnology
Innovation Organization, or BIO. Thank you for the opportunity to share
our thoughts on the topic of the lessons learned from the COVID-19
pandemic.
BIO is the world's largest trade association representing
biotechnology companies, academic institutions, state biotechnology
centers and related organizations in the United States and over 30
nations. Our mission is to advance biotechnology innovation by
promoting sound public policy and fostering collaboration, both locally
and globally. Our members range from entrepreneurial companies
developing their first product to Fortune 500 multinational companies.
BIO and our members appreciate that the Committee is proactively
working to collect lessons learned from the COVID-19 pandemic and put
forward legislation to prepare for future pandemics. As companies
investing in novel therapeutics, vaccines, diagnostics, and platform
technologies to help save lives from all types of biological threats,
our members are committed to continuing to strengthen the public-
private partnerships enabling this critical research, development, and
production, and we welcome the opportunity to provide comments on how
to bolster our pandemic preparedness. To this effect, the global
biopharmaceutical industry has initiated over 900 unique therapeutics
and vaccines against COVID-19 since January 2020.
Our national biodefense enterprise supports medical countermeasure
(MCM) development for a host of known and unknown threats: chemical,
biological, radiological, and nuclear (CBRN), pandemic influenza,
emerging infectious diseases, and antimicrobial resistance (AMR).
Pandemic preparedness relies on the Nation's ability to develop,
procure, and deliver the necessary medicines and diagnostics to combat
biological threats. The U.S. needs to maintain a robust stockpile of
MCMs for each of these risks. We know that periodic threats, such as a
100-year pandemic like COVID-19, will occur but each individual threat
has such a rare occurrence rate that commercial markets for such
countermeasures do not exist. That is why the U.S. Government, through
the Biomedical Advanced Research and Development Authority (BARDA), the
Project BioShield Special Reserve Fund (SRF), and the Strategic
National Stockpile (SNS), must invest in and procure the necessary MCMs
to be ready for the next pandemic and other biological threats.
The Department of Health and Human Services (HHS) and the
Department of Defense (DOD) work in partnership with the private sector
on the development of vaccines, therapeutics, diagnostics, and
platforms to protect the American people against these threats. As
BARDA's portfolio has grown to include 61 approved products, funding
levels for HHS Assistant Secretary for Preparedness and Response (ASPR)
and BARDA initiatives have remained largely stagnant over the past
decade. Recent iterations of the Public Health Emergency Medical
Countermeasures Enterprise (PHEMCE) Multi-Year Budget have shown
increased projections of necessary funding for BARDA advanced research
and development (ARD), pandemic influenza, Project BioShield, and the
SNS, and BIO would expect further increases projected in the next
iteration of the Multi-Year Budget.
Leadership
Role of the ASPR and the PHEMCE
Current statute clearly places authority for pandemic preparedness
and response with the ASPR. The ASPR has the most appropriate expertise
and statutory responsibilities for coordinating a public health
emergency response, given their relationship across the healthcare
supply chain, the pharmaceutical industry and public health
preparedness leaders. This was the intent of the original Pandemic and
All-Hazards Preparedness Act (PAHPA), which was further codified in
PAHPA's subsequent bipartisan reauthorizations passed during the Obama
& Trump Administrations. The ASPR should be empowered to lead the
coordination of government preparedness initiatives, public health
emergency and pandemic responses. Since the ASPR is intended to be the
leader of the PHEMCE, in partnership with the DOD, other relevant
agencies should work in collaboration and coordination with the ASPR.
The ASPR currently lacks the authority to clearly direct the
actions of the PHEMCE. While we certainly applaud the success of both
Operation Warp Speed and the current White House COVID-19 Taskforce in
developing and distributing COVID-19 vaccines and therapeutics, BIO
believes a stronger PHEMCE could have accomplished similar goals
without the delays of building new organizational structures. The roles
within the PHEMCE should be clearly defined, with a clear, centralized
power structure, in advance of a public health emergency. Legislation
ought to clarify the responsibilities and authorities of the many
actors for pandemic preparedness and response and determine the chain
of command so that directives come from a single top-down source or
inter-agency group. Confusion regarding leadership undermined the
government's ability to clearly communicate with industry during its
COVID-19 response, and a proper pre-planned organizational structure
and procedures could help prevent these issues from occurring in the
future.
Leadership and Management of the Strategic National Stockpile
Another specific area of concern is leadership of the SNS. As we
learned during the COVID-19 pandemic, the SNS is vital for many
healthcare products from personal protective equipment (PPE) to generic
essential medicines to complex biologicals and vaccines. BIO strongly
believes that the SNS must remain under the ASPR's jurisdiction with
funding levels that account for the breadth of products in the
Stockpile and the complexity of managing the myriad roles the SNS must
play. For many MCMs, such as smallpox vaccines, anthrax antitoxins, and
pandemic influenza products, the Federal government is the primary
customer through procurements by the SNS and the SRF. The ASPR is best
equipped to manage all of the products included in the Stockpile,
especially MCMs, given the role of the office in setting requirements,
coordinating responses to many types of health emergencies, leading
BARDA investments in product development, and planning lifecycle
management and stockpile operations. For MCMs, future stockpiling
strategies must be applicable to each specific product being procured,
based upon characteristics such as the market size, use, timelines for
manufacturing, and the speed of pathogen spread for the different
medical countermeasures.
With respect to state and hospital-based stockpiles, BIO believes
that they may be suitable for some products such as PPE, antibiotics,
or threats endemic to the region, but they are not replacements for the
national stockpile for specific MCMs for national security threats,
like anthrax. Investment in state and hospital stockpiles does provide
value to the preparedness of the Nation, though money spent on any
potentially new state stockpiles should not come at the expense of the
investment in, or replenishment and maintenance of, classic or non-
commercial MCMs within the Federal SNS.
Communications With Stakeholders
The ASPR and PHEMCE leadership need to strengthen communications
systems surrounding pandemic preparedness. Clarity on the distribution
plan of an MCM is important for Federal, state, and local response to
public health emergencies, and industry often has a role to play in
communicating around and facilitating product distribution. Federal,
state, and local government public health responses are intimately
interconnected. There must be the infrastructure and resources to allow
seamless communication and coordination between all parties for the
fastest possible response. The ASPR and the Centers for Disease Control
and Prevention (CDC) must be unencumbered in their ability to ensure
coordination and communication between Federal, state, local, and
industry partners when time matters most.
Threat Assessment and Awareness
Congress must take steps to ensure its awareness of the threat
assessments that drive PHEMCE's MCM requirements and decisions.
Currently, this information is not regularly shared with Members of
Congress, even though statute requires an annual submission of a
threat-based review to Congress. To our knowledge, the threat-based
review report required by the most recent PAHPA reauthorization has
never been submitted to the appropriate congressional committees. BIO
believes that a better understanding of these threat assessments would
help Congress better understand the role played by the PHEMCE and the
changes in the threat matrix on a year-to-year basis. Regular
visibility into the threat assessment process would assist Congress in
evaluating appropriate levels of funding to ensure the PHEMCE fulfills
its statutory requirements. Congress would also be better able to
perform its oversight role with an improved understanding of all
biological threats, whether naturally occurring, deliberate, or
accidental.
Commitment to Public Private Partnerships
Private sector partners must be treated as true partners rather
than vendors. This means understanding the business needs of partners
so that the private sector can be sustained and therefore all products
can be available over time. These relationships should not be only
transactional.
Clear Communication on Product Requirements
Industry partners need clarity around product requirements, plans
for product replenishment, and when the U.S. Government thinks that a
requirement or threat is fulfilled or completed. When there are changes
in prioritization, those changes must be communicated with industry
partners in a timely manner. The ASPR should use the Multi-Year Budget
process to communicate the short-and long-term strategy and priorities
of the U.S. Government for the development and procurement of MCMs.
Staffing for BARDA Contracting
Another key aspect of the public-private partnership is the length
and complexity of contracting timelines. Legislation should facilitate
ASPR/BARDA to quickly bring in contracting staff from other Federal
agencies or other implement other solutions for expedited contract
reviews. This was recommended by the Bipartisan Commission on
Biodefense and implemented by the last Administration. Contracting
authority should principally remain with BARDA.
The billions of dollars recently appropriated to ASPR and BARDA for
COVID-19 response necessitates an increase in BARDA support staff.
Limited contracting staff is a bottleneck to rapidly issuing contracts
and other agreements to accelerate development of drugs, vaccines, and
diagnostics that can save lives during a public health emergency.
Additional contracting staff can enable not only a standard review
process but an expedited process that is badly needed.
Under usual circumstances, contract timelines at BARDA have been
lengthy. At best, new contracts have taken about 60 days for very small
awards (under $750,000) for BARDA's Division of Research Innovation and
Ventures (DRIVe) program. For larger awards under routine BARDA
programs, contract decisions can take 6-9 months.
This is a bureaucratic issue but also fundamentally a staffing
issue. Over the last several years (before COVID-19), companies
interfacing with BARDA have experienced a severe shortage of
experienced contracting staff within the agency. Several companies have
reported up to four contracting manager changes in under a year.
Increasing Domestic Biopharmaceutical Manufacturing
The public-private partnerships for MCM research & development,
manufacturing, and stockpiling are critical to the health security of
the U.S. Neither the U.S. Government nor industry would be successful
in this effort alone, and the investments made by the U.S. Government
are important to sustaining and bolstering our national preparedness.
The health security provided by a robust domestic market for medical
products, along with the economic impact of high paying jobs, is of the
utmost value to the United States. Fair and competitive markets are
important for maintaining the rigor and vitality of the industry, and
Executive Order 14005 (Ensuring the Future Is Made in All of America by
All of America's Workers) includes many provisions to improve upon the
economic ecosystem.
There is a need to incentivize future investment in U.S.
manufacturing capabilities, to ensure that the United States is the
best place in the world to locate global biomanufacturing facilities.
BIO recommends that Congress consider providing targeted incentives to
grow and maintain the U.S. domestic biopharma manufacturing sector.
Legislation should require clarity from the U.S. Government related to
the requirements for MCMs, so Congress has needed visibility and
private sector partners can accurately assess the government's needs.
One model to consider strengthening is the Centers for Innovation
in Advanced Development and Manufacturing (CIADM) program, which was
created in 2012. This program, which had seen inadequate government
investment over many years, has unfortunately resulted in the sale and
exit from the program of one of the three facilities due to the
unsustainability of the model as actually funded and supported.
The American Jobs Act proposes investment in both the U.S. supply
chain and domestic production, and currently the House Ways and Means
Committee has several bills, including the ``Start-Ups for Cures Act,''
the ``More Cures Act,'' the ``Infectious Disease Therapies Research &
Innovation Act,'' and the ``IP Repatriation Act'' that seek to
incentivize onshoring and continued investment in domestic medical
manufacturing. Passage of these bills would help ensure that the U.S.
has a robust medical supply chain and the necessary domestic
manufacturing capacity needed to combat the next pandemic.
Investments also should be made in workforce development and
training. Onshoring and growing the domestic manufacturing industry is
more than just a health security priority, it is also a jobs and
economic priority. One of the United States' major national strengths
has been the high-quality workforce that manufactures our medicines and
supply chain inputs through a diverse network of job training and
occupational expertise respected around the world.
We believe the United States should create a national industry/
academic preparation clearinghouse focused on new curricula and
programs that incentivize an adequate supply of management, sales,
marketing, and regulatory personnel experienced in manufacturing for
the biotechnology industry.
The US must also invest more significantly in science and Science,
Technology, Engineering, and Math (STEM) education at all levels but
especially at the college and graduate level. The rapid evolution of
life science knowledge is a driving force in the biopharmaceutical
industry and should be viewed as a core national security and domestic
policy priority. These efforts should be complemented with a sound
foundation of immigration policies that attract and retain the best
technologists, scientists, and innovators from around the world.
BIO supports increasing U.S.-based manufacturing of critically
needed medicines, but not a broad mandate requiring MCMs, essential
medicines, and related active pharmaceutical ingredients (API) to be
made in the United States. There are numerous challenges to relying
solely on U.S. manufacturing, including lack of access to certain raw
materials, gaps in specialized workforce needs, and governmental
regulations that would make it extremely challenging to produce in the
United States without significant regulatory changes and cost
considerations. This is especially important for those MCMs targeted to
specific biological threats with limited demand. These medicines are
generally made in one facility and shifting them to a U.S. production
site may cause undue cost, delays, and manufacturing inefficiencies.
Also, any changes would take significant time for companies to
implement, as supply chains, including the facilities for manufacturing
API, often are established years in advance of a product's launch, from
the base of global regulatory filings/approvals, and are designed with
global access and resiliency in mind.
Any policies to incentivize U.S. medical supply manufacturing must
be targeted and recognize the complex nature and inherent global
aspects of the biopharmaceutical supply chain. The medical supply chain
is incredibly delicate and complex. The many products in supply chain
are unique and have their own market intricacies, and so BIO would
caution against any one-size-fits-all or product-blind policy for
managing the supply chain. At the same time, there is, of course, a
need for redundancy built into the supply chain. When determining where
redundancy is required, it is important to keep in mind production
capability and the complexity of certain products.
Investment across the whole supply chain, along with an incentive
structure that rewards market entry as well as rewards those who choose
to stay in the MCM market, is needed to create a domestic supply chain
that is sustainable and secure.
Private companies have solutions related to supply chain and
manufacturing challenges, but the U.S. Government must be a
transparent, communicative, and cooperative partner. The U.S.
Government must work with industry to find strategies for maintaining
some level of excess capacity for emergencies, a sustainable
infrastructure that can surge during a public health crisis. To reserve
manufacturer capacity to use when needed, the government would need to
pay for that reserved capacity and ensure it is not double-booked for
other clients. To ensure adequate capacity is achieved, the U.S.
Government should pursue multiple partnerships, build excess
manufacturing capacity into the system, and pay for capacity on top of
existing demand--not supplant existing demand. These manufacturing
partnerships should be viewed as a cost-effective insurance policy for
national preparedness. Additionally, public-private partnerships to
stockpile ancillary materiel such as glass vials and syringes that will
be needed for fill-finish capabilities for a variety of products should
also be utilized.
Strategies That Support MCM Development
Platform Technologies for Vaccines and Therapeutics
COVID-19 will not be the last emerging infectious disease that the
U.S. will need to respond to. Support for capacity and capability
building for MCMs and our public health system is critical to
protecting our national health security from emerging infectious
disease threats. Investments must be made now in new technologies to
ensure our national health security through preparedness and quick
resolution of an outbreak when any emerging pathogen arises. The 2019
Pandemic and All-Hazards Preparedness and Advancing Innovation Act
(PAHPAIA) included clear authorities for ASPR and BARDA related to
strategic innovation in countermeasures for emerging infectious
diseases, especially through support of novel platform technologies and
manufacturing advancements. The PHEMCE Multi-Year Budget has long
highlighted the need for dedicated emerging infectious disease funding,
but neither Congress nor multiple Administrations have called for
annual investments to better address this critical need. Funding during
a crisis is often too late, as development of drugs, vaccines,
diagnostics, and platform technologies takes time. Even with
accelerated timelines during the COVID-19 pandemic, biotechnology
innovations took the better part of a year to bring to FDA
authorization. As COVID-19 demonstrated, that delay risks lives and
causes trillions of dollars in losses to our economy--considerably more
than any upfront investments in these MCMs and rapid response
capabilities.
Establishing flexible partnerships with industry, particularly
those with established vaccine, therapeutic, and diagnostic platforms,
to then work on developing MCMs for a pre-determined set of emerging
infectious diseases and families of viruses that have pandemic or even
regional outbreak potential, will shorten the development timelines for
the next outbreak or pandemic. When an outbreak of a novel pathogen
occurs, companies can then pivot to applying that platform to the novel
pathogen.
Congress should specifically authorize funding within BARDA to
allow for investments in numerous platforms (such as mRNA, protein
subunit vaccines, monoclonal antibodies) so that the U.S. has the most
``shots on goal'' to be able to respond quickly and effectively to any
potential threat. BARDA should, in collaboration with the National
Institutes of Health (NIH) and the DOD, create a prioritized list of
emerging infectious diseases and viral families with outbreak
potential, including vector-borne diseases. This list should be
incorporated into the MCM advanced research and development and
procurement programs at HHS and DOD, including the SNS, to ensure the
U.S. can meet a surge in demand when outbreaks occur.
Additionally, Congress should work with FDA to clarify the
regulatory mechanisms by which platforms can be authorized or approved
in a timely manner for the next pathogen. Platforms that are tested and
proven for a certain pathogen hold the promise of potentially
shortening timelines for other pathogens, but FDA's thinking about how
they are viewing regulatory considerations for the base platform in
addition to review and approval for specific products could help spur
further innovation in novel technologies.
Investment in Novel Antivirals and Therapeutics
Investments in novel mechanisms for developing antivirals as well
as treatments for the secondary consequences of infections can make
future public health emergency responses more efficient and potentially
faster. Almost 20 percent of the therapeutics tested against SARS-CoV-2
were repurposed from other fields and served as a model for not only
quickly understanding the virus but also for directing the development
of novel clinical products designed specifically to counter the unique
nature of the virus.
BIO is encouraged by important programs like the Antivirals Program
for Pandemics and the University of North Carolina Rapidly Emerging
Antiviral Drug Development Initiative (READDI). These programs will
help invest in new antiviral technologies through partnerships between
government, academic, and industry scientific leaders. These programs
must be accompanied by funding at BARDA for later stage development and
manufacturing support for the most promising technologies, especially
those that could be applied to both commercial and pandemic pathogens.
While there is a need for more R&D in versatile products that can
address an array of threats, such as antivirals, the government must
continue to stockpile and invest in MCMs for specific CBRN and biologic
threats so that the Nation is prepared for all possible predictable
scenarios. Novel therapeutics for the treatment of the severe
consequences of a serious infection should be supported and developed
as well. Many of these products developed during the COVID-19 pandemic
may be effective for treating the same or similar consequences of other
respiratory illnesses, like a bad influenza season. BARDA and the SNS
must balance their investment between specific countermeasures and
versatile ones to fully prepare for any future threat.
Additionally, investments in novel and more accessible delivery
systems for MCMs can improve the emergency response of the Nation and
provide better outcomes for patients. Less invasive MCMs and easier
delivery mechanisms improve access for Americans, especially in
underserved or rural communities where, for example, access to infusion
centers may be difficult to reach.
Pandemic Influenza Strategy
Pandemic influenza remains as likely a threat as it has ever been,
and investments through BARDA, NIH, and the CDC are critical to
preparing the Nation and the world for a pandemic influenza event. The
development and manufacturing of influenza vaccines, therapeutics, and
diagnostics by industry is dependent on Federal funding to support the
scale and scope of U.S. Government requirements. There is no commercial
market for pandemic influenza vaccines. Continued investment is
necessary to maintain a robust R&D pipeline and sustain the
capabilities the U.S. has developed.
The September 2019 ``Executive Order on Modernizing Influenza
Vaccines in the United States to Promote National Security and Public
Health'' acknowledges that the current domestic enterprise for
manufacturing influenza vaccines has critical shortcomings. Further
funding for BARDA's pandemic influenza activities will support work on
the development of more effective, longer lasting vaccines, as well as
novel antivirals and therapeutics and rapid diagnostics. These
additional funds are critical to meeting the needs and objectives
expressed in the Executive Order with respect to preventing the spread
of influenza viruses and protecting the United States from future
pandemics.
Antimicrobial Resistance (AMR) as a National Security Threat
Antimicrobial resistance (AMR) represents a major public health and
national security threat. The CDC estimates almost 3 million Americans
suffer from AMR-relevant infections annually, with over 48,000 deaths
resulting from those infections. As the COVID-19 pandemic continues, a
sizable minority of patients are suffering from secondary infections,
with the CDC identifying resistant secondary infection outbreaks in
COVID-19 units. This reinforces the urgent need for access to effective
antimicrobial products as a part of our pandemic preparedness and
response.
A key component of addressing AMR is to address the market
challenges that have caused a deterioration of the antimicrobial
medicines pipeline. The Government Accountability Office (GAO)'s 2019
``Antibiotic Resistance Report'' concluded that pull incentives as well
as reimbursement reform are needed to ensure the Nation has the AMR
medicines it needs. While BARDA's CARB-X program makes investments to
help support R&D, HHS has indicated it does not have the authority to
implement the policies to reform these market challenges. However,
Congress has put forward two pieces of legislation, the Developing an
Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM)
Act of 2021, which address reimbursement barriers to patient access, as
well as The Pioneering Antimicrobial Subscriptions to End Upsurging
Resistance (PASTEUR) Act, which creates a sustainable return on
successful R&D investments into AMR. BIO believes both policies are key
steps to address the market challenges of AMR and should be included in
any pandemic preparedness package.
MCM Marketplace and SNS Investments
For many MCMs, the SNS is the only market. Industry partners have
invested in these technologies in part due to the guarantee that there
is a sustained government market. In order for the SNS to be properly
prepared for the next pandemic, it must be fully funded. For the last
10 years, funding of the SNS has been flat while new FDA approved MCMs
have been added to the Stockpile. Though the President's fiscal year 22
budget and the draft budget in the House do propose an increase in
funding, it still lags behind the amount recommended by the
professional judgment in the PHEMCE Multi-Year Budget. Because of this
deficit in funding, many products have not been replenished as they
should have been. This is particularly true for MCMs against biological
threats like smallpox and anthrax. Adequate, sustainable funding for
the SNS keeps the MCM manufacturers in the countermeasure space, allows
for companies to properly plan for long-term development, and propels
competition and innovation.
Additionally, ASPR and BARDA play a critical role in managing the
lifecycle of an MCM as the entities responsible for late-stage
countermeasure development and procurement. When funded effectively,
they facilitate the transition of every medical countermeasures from
BioShield to sustainable procurement by the SNS, which is vital for the
continued health of the MCM marketplace.
MCM Priority Review Voucher (PRV)
BIO is supportive of the Medical Countermeasure PRV program created
by the 21st Century Cures Act and sees the program as an important
incentive for the research and development of medical countermeasures.
However, the current five-year sunset of the program will likely offset
any incentive that the program offers. The program should be extended
through the removal of the sunset.
Clinical Trials for Pandemic Response
During the COVID-19 pandemic, the NIH established the Accelerating
COVID-19 Therapeutic Interventions and Vaccines (ACTIV) program, which
is managed by the Foundation for the National Institutes of Health
(FNIH) and includes BARDA, the CDC, FDA, DOD, the Department of
Veterans Affairs (VA), ``The Operation'' (formerly known as Operation
Warp Speed), the European Medicines Agency (EMA), and representatives
from academia, philanthropic organizations, and numerous
biopharmaceutical companies.
This public-private partnership seeks to develop a coordinated
research strategy for prioritizing and speeding development of the most
promising treatments and vaccines. The problem that it sought to
address was that there were numerous products in development, all
competing for patients to participate in clinical studies. ACTIV worked
to coordinate and streamline processes to make the best use of
biomedical research resources and testing of preclinical and clinical
compounds. It also worked to prioritize the most promising candidates
and move them into clinical trials in a way that was safe and
efficient.
This coordination across agencies and with industry led to many of
the successful products, especially the therapeutics, being used today
to combat the pandemic. The fast-tracking framework gave needed
guidance to industry, led to the development and use of master
protocols, and also expedited the trials process while maintain the
highest standards of safety and oversight.
Setting up and maintaining a permanent structure for a clinical
trial framework to rapidly evaluate products for emergency situations
is the best way to rapidly respond to emerging health threats. NIH, FDA
and BARDA should lead, and coordinate with international partners
(e.g., the Coalition for Epidemic Preparedness Innovations (CEPI), the
Foundation for Innovative New Diagnostics (FIND), European Health
Emergency Preparedness and Response Authority (HERA)), in the
identification of priority pathogens and the creation of a global
research agenda to accelerate the development of therapeutics,
vaccines, and diagnostics against emerging infectious diseases. There
is no reason to disassemble or abandon this successful program, only to
have to rebuild it again sometime in the future. An ACTIV-like program
as a long-term part of the pandemic preparedness infrastructure will
ensure the fastest, safest, and best-planned pathways to vaccines,
treatments and diagnostics in the future.
Also, diversity in clinical trials was an important aspect of the
COVID-19 response and must be prioritized going forward. Prioritizing
diversity in trials not only leads to better data generation and more
effective outcomes, but it also strengthens the public confidence in
the products across the many groups represented in the trials.
Strengthen and Clarify the Emergency Use Authorization (EUA) Process
The EUA process functioned largely as designed during the COVID-19
pandemic. Since going through the process in a pandemic setting, it may
be of value to set up an emergency response framework to more rapidly
get decisions made by FDA, NIH, CDC, and/or the Advisory Committee on
Immunization Practices (ACIP). Expedient communication with industry
and stakeholders is paramount to an effective EUA process. Making the
process standardized and providing as much transparency to the public
as possible will ensure a successful response in the future and help to
combat vaccine hesitancy by helping to ensure the American people
understand the safety, effectiveness, and quality of any vaccines and
therapeutics that receive EUA. This should be coordinated with
promotional outreach efforts for EUA products that could help with the
uptake or use of vaccines and therapeutics to directly combat
misinformation.
However, the EUA process proved to be more complex and challenging
in terms of providing requirements and authorization to a number of
manufacturing facilities--even with a significant, frequent, and
sometimes embedded presence from the FDA as well as Operation Warp
Speed representatives from HHS and DOD.
Health Defense Operations (HDO) Budget Designation
Congress should authorize an HDO budget designation for a narrow
set of programs, projects, and activities critical to our Nation's
health security. The HDO designation would exempt certain programs from
statutory (and deemed) budget caps to ensure Congress is able to
appropriate sufficient sums to protect our national health security. In
order to understand the true need of agencies, Congress should require
agencies to provide a bypass professional judgment budget that is not
constrained by spending caps.
Public Health Infrastructure
U.S. Surveillance Systems
As our Nation's public health agency, CDC is the lead for viral
surveillance. CDC's efforts help to provide early warnings of emerging
infectious diseases and emergent variant strains of infectious
diseases. More funding is needed to support and expand CDC's viral
testing, genomic sequencing, and surveillance capabilities so that we
continue to have an accurate picture of disease epidemiology and
circulating viral strains to properly direct public health response.
This is pivotal to track the evolution of SARS-CoV-2 but also emerging
infections, both viral and bacterial.
We must remain vigilant against other infectious diseases during
the COVID-19 pandemic by increasing surveillance of seasonal and
pandemic influenza and other novel viruses and bacteria.
To improve our understanding of emerging infectious diseases in the
U.S., Congress should improve CDC surveillance by expanding the
National Center for Emerging and Zoonotic Infectious Diseases (NCEZID)
Division of Vector-Borne Diseases' ArboNet system to enhance active
data collection and analysis of vector-borne diseases, within our
borders or from returning travelers into the U.S. and enhance
collection of information on geographic and behavioral risk factors. In
addition, Congress should ensure adequate funds are authorized for the
CDC for the collection, sequencing, and analysis of viruses with
outbreak or pandemic potential and improve overall data collection by
directing the CDC to request that States and territories include
serious vector-borne diseases, as ``reportable'' diseases.
Data Generation
Over the course of the COVID-19 pandemic, ASPR worked closely with
hospitals, public health departments, and other organizations to
distribute therapeutics. However, the data systems used to track the
distribution, availability, and use of COVID-19 medicines were not
robust enough to help industry truly understand where, how, and in
which populations federally purchased doses of vaccines and
therapeutics were being utilized.
HHS should invest in more robust systems that capture complex and
important data on the location, utilization, and patient demographics
for all MCMs.
Immunization Information Systems
Our national public health infrastructure is not only vital in
``normal'' times, it is the backbone of our pandemic response and
recovery system. Investing in this infrastructure by increasing support
for state, local, and territorial health departments and state data
systems, like immunization registries, can help track immunization
uptake, ensure individuals receive all of their necessary doses, and
help restore our routine immunization rates. Taking action here will
also enhance our ability to respond better to outbreaks of vaccine-
preventable diseases as well responses to future pandemics.
One way that Congress can support public health is by strengthening
the functionality and interoperability of state immunization
information systems (IIS) by including H.R. 550, the ``Immunization
Infrastructure Modernization Act.'' Immunization information systems
are computerized, multi-faceted systems that operate in 62
jurisdictions, and have the ability to maintain immunization records
across the lifespan. They can be used by providers to order vaccines
and maintain an accounting of inventory, project what a patient needs
based on what they have received previously (preventing both over-and
under-vaccination), remind patients when they are due to receive a
recommended vaccine, and, at a population level, track coverage and
identify areas where there are low immunization rates so public health
programs can develop targeted immunization efforts in response. IIS are
managed at the state level, creating a patchwork of these systems'
functionality across the country. Having immunization data systems that
are able to efficiently and effectively manage vaccine ordering,
inventory, and patient records, and securely exchange information
across providers, health systems, and public health agencies in real-
time is essential to COVID-19 vaccine efforts, as well as routine
vaccination efforts.
Strengthen the Adult Immunization Program
The COVID pandemic and mass vaccination efforts has driven
substantial immunization infrastructure investments at the state and
local level that includes systems, provider recruitment and developing
relationships and partnerships with community-based organizations that
supports the diverse needs of adult populations. Adult immunization
infrastructure improvements and investments in the CDC Immunization
Program made during the pandemic must be sustained for routine
vaccination beyond COVID-19. It is vital for public health and pandemic
preparedness that adult immunization infrastructure remains a priority
over the long-term if we are going to have a life course approach to
immunization. This infrastructure is also critical to replicating the
success of high childhood immunization rates for the adult population.
It is important that communities can get vaccines to where people are,
whether it's through a community provider, pharmacy, health care
center, senior center, or through a mobile van that can go to remote
areas or provide vaccine services to disabled and homebound
individuals. This capability is essential not only during a pandemic,
but also for routine immunizations, such as annual flu vaccine
campaigns. Having a reliable immunization network for adults will also
ensure that this form of preventive health is available those who
otherwise would not be able to afford it.
Conclusion
Thank you for considering BIO's recommendations on pandemic
preparedness. BIO, along with the rest of the country, learned a lot
from the experience of COVID-19, and we hope that our insights shared
here can help prepare us better for the next pandemic. BIO and our
member companies are committed to working with the HELP Committee as it
drafts legislation on these issues and would be happy to serve a
resource. Thank you again for the opportunity to provide testimony for
today's hearing.
______
The Chair. Thank you.
Dr. Janz.
STATEMENT OF DAVID JANZ, M.D., DIRECTOR, MEDICAL CRITICAL CARE
SERVICES, UNIVERSITY MEDICAL CENTER NEW ORLEANS, NEW ORLEANS,
LA
Dr. Janz. Chair Murray, Ranking Member Burr, and the
distinguished Senators of the Committee, I am grateful to have
the opportunity to testify today and discuss important lessons
that have been learned during the COVID-19 pandemic, and how
might these lessons inform future pandemics and other crises in
health care. These lessons learned from my experience at
University Medical Center in New Orleans as the Director of
Medical Care Services, as a health care worker who has treated
hundreds of critically ill adults with COVID-19.
University Medical Center in New Orleans cares for a
diverse and underserved patient population, including uninsured
patients in low income communities. The first lesson I would
like to discuss is that learning in real time from forward
positions in a pandemic prepares locations which will soon
experience a similar strain in their health care system. In
March 2020, New Orleans had a rate of rise of COVID positive
patients similar to the Lombardy region of Italy, which was
already experiencing marked strain in their ability to deliver
health care.
An early description from this region, not just of what
illness coronavirus causes, but how large numbers of patients
with this disease impact the health care system was critical to
our preparation. These operational reports early in the
pandemic made it clear that early in the fight against this
disease, success would be driven by public health measures and
a hospital's ability to manage what is called hospital strain.
Hospital strain is defined as an excess of demand on the
resources or abilities of a hospital and is a problem that has
existed in health care for decades. For example, what systems
are in place to respond when emergency department is full of
patients and there is a large number of patients in the waiting
room? How does a hospital manage mass casualty incidents, or
how do we care for critically ill adults when intensive care
units are full? Hospital strain occurs much earlier than the
nightmare scenarios of running out of ventilators.
Even more worrisome, hospital strain is associated with
worse patient outcomes. At University Medical Center in New
Orleans, we responded to the soon to come strain by scaling
critical care services for COVID-19, adding personnel such as
nurses and physicians, giving them evidence based patient care
tools that allowed them to provide high value critical care to
a large number of patients. Strain will continue to affect
hospitals in various ways in the future, and successful
responses to strain may avoid poor patient outcomes. The
ability for us and others to share these operational successes
with other hospitals via seminars conducted by the Louisiana
Department of Health and the Department of Health and Human
Services was vital to smaller, more resource limited hospitals
to aid them during times of current and future strain.
The past year and a half has also been characterized by an
unprecedented repair and discovery of effective vaccines and
treatments for COVID-19 due to an integration of clinical
research into health care systems. Another key response to
future pandemics will be high quality clinical research
conducted efficiently alongside clinical care to develop new
preventive and treatment strategies for future pandemics.
The final lesson learned I like to discuss today is the
lesson that worries me most today in my home city of New
Orleans and home State of Louisiana. That is specifically
caring for the caregiver is a vital component to crisis
response. We have asked a lot of health care providers caring
for COVID-19 patients over the past year and a half, a first,
second, and now third, and now fourth wave. We have strained
the human beings providing this care to a critical point. 43
percent of nurses around the Nation are considering leaving the
health care profession this year. The past and current COVID-19
surges and future health care crises will likely be
characterized by running out of health care workers rather than
running out of ventilators.
Beyond COVID-19, how do we improve care for underserved
patient populations, increase access to care, make inroads in
decrease cardiovascular disease and diabetes when--and improve
many other aspects of health care when health care is asked
repeatedly instead to focus on COVID-19 surges? Over one-third
of health care workers are experiencing anxiety or depression.
As many as one in four are experiencing symptoms of post-
traumatic stress disorder. And symptoms of burnout experience
over half of critical care physicians. This is the state of the
workforce asked to return to the COVID-19 front lines for a
second, third, and now fourth wave.
We will continue to confront this current wave that we are
experiencing, which is our duty, knowing that our physical and
mental health is the cost that we will continually pay. But we
are still focused on saving the patients in front of us who
unfortunately may pay a higher price. However, in this time,
when almost all of this suffering may be prevented by a
vaccine, we ask, why is this suffering unnecessary and when
will it end?
In conclusion, learning from the front lines, health care
systems responding effectively to strain, rapid dissemination
of medical evidence, understanding that good clinical research
results in better clinical care, and taking better care of the
caregivers are just a few of many approaches to future crises
in health care.
Let's continue to develop the national resolve to end this
current crisis by embracing the gift medical science has
repeatedly provided to humanity for hundreds of years, that
gift being vaccinations.
[The prepared statement of Dr. Janz follows:]
prepared statement of david janz
Chair Murray, Ranking Member Burr, and distinguished Senators of
the Committee. I am grateful to have the opportunity to testify before
this Committee and discuss my opinion as to what important lessons have
been learned during the COVID-19 pandemic and how might these lessons
inform our response to future pandemics and other crises in healthcare.
I offer my testimony as only one member of the healthcare community, a
community which certainly has a wealth of lessons from this pandemic we
can all learn from, and we should continue to elicit these lessons from
all of my colleagues beyond my testimony today. These lessons learned I
present to the Committee are from my experience at University Medical
Center New Orleans as an Intensive Care Unit physician, the Director of
Medical Critical Care Services, and as a healthcare worker who has
treated hundreds of critically ill adults with COVID-19. University
Medical Center New Orleans is a public-private partnership with the
State of Louisiana carrying on the legacy of Charity Hospital in the
city of New Orleans and aims to provide the best possible care for a
diverse and underserved patient population, including the uninsured and
low-income populations.
Learning in real-time from ``forward positions'' during a pandemic
prepares locations which will soon experience similar strain in their
healthcare system.
Pandemic preparation in early 2020 had been well underway prior to
the first positive test in the New Orleans area on March 9, 2020.
Existing guidelines \1\ for care and hospital organization were being
incorporated into pandemic planning; however, at the time there was
relatively little known about how the COVID-19 pandemic could strain
the healthcare system. When large numbers of patients seek healthcare
for an illness that has the potential to cause severe disease, where
would we see the healthcare system strain under that new weight?
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\1\ Hick JL, Einav S, Hanfling D, et al. Surge Capacity Principles
Care of the Critically Ill and Injured During Pandemics and Disasters:
CHEST Consensus Statement. Chest. 2014;146(4):e1S-e16S. doi:10.1378/
chest.14-0733.
In March 2020, New Orleans had a rate of rise of positive SARS-CoV-
2 tests \2\ similar to New York City and the Lombardy Region of Italy.
\3\ The Lombardy Region was already experiencing marked strain in their
ability to deliver healthcare due to this rapid influx of patients with
COVID-19. This was, perhaps, not just a forward position in the fight
against COVID-19 with early experience with this disease, but also one
of the first regions to report how the pandemic was straining their
healthcare infrastructure. Importantly, this experience was relayed to
the world in not just the news media but also rapidly in the scientific
literature. While New Orleans was experiencing our first positive cases
and seeing an exponential rise, on March 13, 2020, physicians from the
Lombardy Region reported their experience in the Journal of the
American Medical Association about how patient surges were affecting
hospital operations. It was an early description not just of what
illness SARS-CoV-2 causes, but how large numbers of patients with this
disease impact a healthcare system. Among groups of healthcare
personnel in New Orleans planning a response to a potential surge of
patients, their report on forecasting ICU demand was both shocking and
critical to our own preparatory work.
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\2\ Zeller M, Gangavarapu K, Anderson C, et al. Emergence of an
early SARS-CoV2 epidemic in the United States. Medrxiv. Published
online 2021:2021.02.05.21251235. doi:10.1101/2021.02.05.21251235.
\3\ Grasselli G, Pesenti A, Cecconi M. Critical Care Utilization
for the COVID-19 Outbreak in Lombardy, Italy. Jama. 2020;323(16):1545-
1546. doi:10.1001/jama.2020.4031.
Nothing captured our attention more than the forecast modeling
included in the publication suggesting that if an exponential growth
model predicting possible ICU demand was accurate, as many as 14,542
ICU admissions would occur in the Lombardy Region in the next 7 days.
From our perspective as healthcare personnel in New Orleans planning
how to respond to a surge in COVID-19 patients, we were alarmed that a
similar exponential rise in positive cases had begun in New Orleans and
there is not a healthcare system in the world that can manage the
influx of thousands of critically ill adults over such a short period
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of time.
The Lombardy region went on to experience marked strain in their
healthcare system during March 2020; however thankfully not to the
degree that their exponential forecast modeling predicted. \4\ Of
critical importance to our preparations at University Medical Center
New Orleans and other hospitals in the region was being able to learn,
in almost real-time, not just information from the lay press media but
also actionable information on operations in healthcare systems
currently experiencing strain and their response to that strain.
Furthermore, if operational impact occurred, potential mitigation
strategies, countermeasures, and predictive modeling could be used to
estimate the potential scope of the problem.
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\4\ Grasselli G, Greco M, Zanella A, et al. Risk Factors
Associated With Mortality Among Patients With COVID-19 in Intensive
Care Units in Lombardy, Italy. Jama Intern Med. 2020;180(10).
doi:10.1001/jamainternmed.2020.3539.
Planning for future COVID-19 surges and for any new crisis that
will impact the healthcare system worldwide should involve organized,
intentional information gathering from locations currently experiencing
the crisis. Information collected should be beyond what is reported in
the lay media and include specific operational information of local
healthcare systems, the degree of strain in each operational unit,
identification of common problems, and elucidation of solutions. This
information should be available to other hospital systems in real-time
and disseminated not only in medical journals but also in an open-
access, nationally centralized method, so that healthcare systems
planning their response to an emerging problem can get information from
a single location on the experiences of systems currently responding to
the crisis. Our ability to learn from the experiences in Italy and New
York City was vital in planning how our system of hospitals in New
Orleans would respond to this crisis. It was clear that in the early
fight against the pandemic, successful public health measures would be
key in preventing complete collapse of the healthcare system and
success on the level ofindividual hospital systems would be determined
by their ability to manage a commonproblem in healthcare: hospital
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strain.
Managing hospital strain is vital in a healthcare system's response
to COVID-19 and any future healthcare crisis.
Hospital capacity strain, defined as ``excessive demand on the
strength, resources, or abilities of a hospital and any resource the
hospital uses to provide care (e.g. beds, nurses, physicians,
equipment)'', is a problem that has existed in healthcare for decades.
\5\ Prior to the COVID-19 pandemic, hospitals would experience strain
on a smaller scale. For example, what systems are in place to respond
when an emergency department is full with a large number of patients in
a waiting room, how does a hospital manages mass casualty incidents, or
how do we care for critically ill adults when the ICU is full and these
patients have to remain in the emergency department? Hospital strain
occurs much earlier than the nightmare scenarios of running out of
ventilators or other vital resources and having to invoke crisis
standards of care. However, prior to and during the COVID-19 pandemic,
\6\ hospital strain has been repeatedly associated with increased risk
of poor patient outcomes. A recent study in the Annals of Internal
Medicine estimates that influxes of COVID-19 patients causing excessive
demand on hospital resources may have contributed to as many as 1 in 4
deaths related to COVID-19 in the United States. \7\
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\5\ Eriksson CO, Stoner RC, Eden KB, Newgard CD, Guise J-M. The
Association Between Hospital Capacity Strain and Inpatient Outcomes in
Highly Developed Countries: A Systematic Review. J Gen Intern Med.
2017;32(6):686-696. doi:10.1007/s11606-016-3936-3.
\6\ Bravata DM, Perkins AJ, Myers LJ, et al. Association of
Intensive Care Unit Patient Load and Demand With Mortality Rates in US
Department of Veterans Affairs Hospitals During the COVID-19 Pandemic.
Jama Netw Open. 2021;4(1):e2034266. doi:10.1001/
jamanetworkopen.2020.34266.
\7\ Kadri SS, Sun J, Lawandi A, et al. Association Between
Caseload Surge and COVID-19 Survival in 558 U.S. Hospitals, March to
August 2020. Ann Intern Med. Published online 2021. doi:10.7326/m21-
1213.
As previously stated, it was clear early in the COVID-19 pandemic
that hospital strain would be a vital problem for healthcare systems to
manage in order to save as many lives as possible. Our response in
March 2020 to decrease the impact of this strain on our hospital system
and specifically our intensive care units was to ``scale'' critical
care services. Scaling critical care services via the development of
what is referred to as surge capacity has been performed for decades
around the world in times of acute, brief periods of need. Guidelines
on how to respond to ICU strain by creating ICU surge capacity have
been published prior to the COVID-19 pandemic. These guidelines were
used by many hospital systems during the COVID-19 pandemic, including
ours, and provided a framework on how to create additional care teams,
how to re-organize staff to accommodate more patients, recommendations
on communications and triage, and other operational guidance. These
guidelines are purposefully broad in recommendations so that they are
applicable to any disaster or pandemic and, therefore, additional
response was needed on the hospital level to address the strain unique
to COVID-19: an illness that causes a large influx of critically ill
adults with a high severity of illness and continues to strain the
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system over the course of months and now, over a year.
At University Medical Center New Orleans, we scaled critical care
for COVID-19 in the following ways. First, we focused on increasing the
uniformity of critical care provided by improving the application of
evidence-based critical care practices to all ICU patients. Too many
different ways of caring for a large number of critically ill adults
would quickly extinguish the bandwidth of an ICU. Given the concern
early in the pandemic of hospitals running out of ventilators or ICU
beds, we used the medical evidence that has existed for decades in
critical care medicine that tells us what practices to use to prevent a
patient needing a ventilator, if a ventilator is needed using evidence-
based practices to help the patient improve and be liberated from the
ventilator as soon as possible, and uniformly applying practices known
to help patients survive and no longer need an ICU bed.
Second, we scaled critical care capacity by adding more nurses,
therapists, and physicians to ICUs, as recommended in guidelines, by a
partnership between the LCMC Network of hospitals and the Louisiana
State University and Tulane Schools of Medicine who provided additional
physician support. Experienced nurses and other staff were brought in
from other areas of the hospital. I cannot emphasize enough the
importance of our existing and newly added ICU healthcare workers in
responding to this crisis and their bravery for running toward the
problem and not away. They work incredibly hard with a sense of purpose
and duty, selflessly asking only how they can help their colleagues and
our patients. Patients are alive today because of these heroes and
institutional partnerships. These additional personnel needed quick,
simple instruction on four decades of previous medical evidence of best
critical care practices and how to apply this evidence to a large
number of COVID-19 ICU patients. We created a number of local protocols
and guidelines that were simple enough to hand to a new ICU provider
and they could then easily apply best practices to their patients.
Finally, we added processes to make this uniform, evidence-based
care reliable with observers ensuring a checklist of good ICU practices
was occurring with each and every patient and notifying providers when
items needed to be performed. With this approach, intensive care units
at University Medical Center New Orleans have achieved COVID-19
survival rates as good or better than survival rates reported in the
medical literature, despite high rates of medical comorbidities that
portend a worsened prognosis with COVID-19. \8\, \9\
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\8\ Janz DR, Mackey S, Patel N, et al. Critically Ill Adults With
Coronavirus Disease 2019 in New Orleans and Care With an Evidence-Based
Protocol. Chest. 2021;159(1):196-204. doi:10.1016/j.chest.2020.08.2114.
\9\ Rosenthal N, Cao Z, Gundrum J, Sianis J, Safo S. Risk Factors
Associated With In-Hospital Mortality in a US National Sample of
Patients With COVID-19. Jama Netw Open. 2020;3(12):e2029058.
doi:10.1001/jamanetworkopen.2020.29058.
Responding to hospital strain by scaling critical care services and
creating surge capacity is applicable to future COVID-19 waves and any
new emerging threat that has the potential to strain the healthcare
system. The implementation of simple, easy to use patient care tools
that increase uniformity and reliability are key when healthcare
systems are stressed and may avoid the associated increase in poor
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patient outcomes historically associated with hospital strain.
Dissemination of early experiences and knowledge improves patient
care outside of individual hospitals.
After several hospital systems in Southeast Louisiana began to
experience an influx of COVID-19 patients in March 2020 and had
developed their operational responses to the subsequent strain, Dr.
Alex Billioux at the time was the Assistant Secretary for the Louisiana
Department of Health's Office of Public Health. Dr. Billioux recognized
the extensive organizational work occurring in hospital systems in New
Orleans and Baton Rouge and decided to create a task force of intensive
care unit physicians and nurses that would collect the COVID-19 patient
care resources developed so far in these hospitals and disseminate
those current best practices to hospitals around the state. This
Louisiana Department of Health COVID-19 Critical Care Task Force
conducted numerous online seminars in the Spring of 2020 where we
educated hospitals around Louisiana on the most current, evidence-based
practices in caring for COVID-19 patients in the ICU, shared our own
operational challenges and solutions, and helped other hospitals solve
other challenges they were experiencing. The feedback from hospitals
around the state was positive: these hospitals were commonly too busy,
too overwhelmed, too understaffed to have time to develop these easy to
use patient care tools or come up with operational solutions and these
seminars immediately solved many of those problems. The Office of the
Assistant Secretary of Health and Human Services (Preparedness and
Response), learned of our early experience with COVID-19 in Louisiana
and our dissemination of this experience with the Louisiana Department
of Health. The Office of HHS ASPR then added our materials developed in
Louisiana to the nationwide HHS ASPR COVID-19 Clinical Rounds and had
representatives from our Louisiana Task Force conduct live seminars via
these clinical rounds.
I personally witnessed two significant impacts during these state-
and nation-wide educational seminars. First, many hospitals
experiencing strain from a pandemic do not have the time or expertise
to develop patient care and operational tools that are evidence-based,
easy to use, and reliable. Published pandemic response guidelines from
national organizations are available to all hospitals during these
crises, but often hospitals need more specific help and problem solving
that is not covered in general guideline statements. Hospitals
responded with gratitude when we were able to share what we created
with them and allowed them to spend more time in patient care at the
bedside. Second, non-evidence-based practices were being disseminated
frequently at the time via the internet, social media platforms, and
other non-peer reviewed sources. \10\ This created a great deal of
confusion amongst healthcare providers early in the pandemic as to how
to treat a patient with COVID-19. These state- and nation-wide
educational seminars helped clarify questions from healthcare providers
on which practices were supported by medical evidence and recommended
by national guidelines.
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\10\ Rice TW, Janz DR. In Defense of Evidence-Based Medicine for
the Treatment of COVID-19 ARDS. Ann Am Thorac Soc. 2020;0(ja).
doi:10.1513/annalsats.202004-325ip.
Future responses to healthcare crises and pandemics need to
incorporate on a national level not only the generation of guidelines
by medical societies and health organizations, but also frequent, open-
access educational offerings and interactive seminars where providers
on the front line can share knowledge and help others solve their own
operational challenges. Strained hospitals, especially critical access
hospitals and hospitals in resource-limited settings, do not have the
time or resources to develop their own approach to every aspect of a
pandemic. Larger hospital systems can share their experiences via a
national educational platform to lighten the workload of the more
resource-limited hospitals and collectively decrease strain on the
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entire healthcare system.
A Learning Healthcare System is vital in the response to the
current and future pandemics.
Early information gathering and creation of surge capacity were
only the first steps in the response to the COVID-19 pandemic. The
approaches described above are only a way to save lives while new
preventative and treatment tools are created through scientific
discovery. Even during a pandemic, ``The randomized, double-blind,
placebo-controlled trial with systematic and comprehensive collection
of safety, biomarkers, short-and long-term survival outcomes, remains
the most effective and ethical science to save lives.'' \11\ Within
weeks of COVID-19 spreading around the world, not only were healthcare
systems focused on treating patients but of equal importance these
systems were focusing on learning from these patients in order to save
lives in the future. Randomized, controlled trials were designed and
instituted in parallel with the provision of patient care, giving the
world high-quality answers to questions about almost any proposed
treatment for COVID-19. This allowed the medical community to focus on
what was discovered to be high-value care for COVID-19 and avoid
interventions that were found to be of no benefit.
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\11\ Singer M, Kalil A. Do not just sit there, do something but do
no harm: the worrying aspects of COVID-19 experimental interventions.
Intens Care Med. Published online 2021:1-3. doi:10.1007/s00134-021-
06460-9.
The first treatment to show robust evidence of benefit in
critically ill patients with COVID-19, a steroid medication named
dexamethasone, was published online in the New England Journal of
Medicine on July 17, 2020 in a randomized trial of over 2,000 patients.
\12\ In the span of only approximately 7 months, a novel viral pathogen
had been discovered, a pandemic had ensued causing high rates of
critical illness, and a randomized trial of over 2,000 patients was
able to be conducted and shared with the world a treatment that saves
lives. Five months later on December 10, 2020, approximately 1 year
since the first reports of patients infected with the novel SARS-CoV-2
pathogen, the results of a randomized trial of the BNT162b2 vaccine in
over 43,000 patients was published. \13\ The rapidity of these
discoveries is unprecedented in the history of Medicine, is a result of
the integration of clinical research into patient care via a learning
healthcare system approach and is clearly lifesaving.
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\12\ The RECOVERY Collaborative Group. Dexamethasone in
Hospitalized Patients with Covid-19--Preliminary Report. New Engl J
Med. Published online 2020. doi:10.1056/nejmoa2021436.
\13\ Polack FP, Thomas SJ, Kitchin N, et al. Safety and Efficacy
of the BNT162b2 mRNA Covid-19 Vaccine. New Engl J Med.
2020;383(27):2603-2615. doi:10.1056/nejmoa2034577.
A learning healthcare system aims to provide high-quality
healthcare to patients while also integrating in parallel clinical
research infrastructure to learn from patients during their care as to
how to improve medical care in the future. \14\ This integration of
patient care and discovery allows the medical community to ``learn from
what we do and do what we learn.'' Lives will be saved in future
pandemics as hospital systems continue to integrate clinical research
infrastructure into the care of patients.
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\14\ Lindsell CJ, Gatto CL, Dear ML, et al. Learning From What We
Do, and Doing What We Learn: A Learning Health Care System in Action.
Acad Med. 2021;Publish Ahead of Print. doi:10.1097/
acm.0000000000004021.
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Caring for the caregiver is a vital component in crisis response.
We have asked a lot of healthcare providers caring for COVID-19
patients over the past year and a half. At the beginning of the
pandemic, ICU nurses, physicians, advance practice providers,
respiratory therapists, pharmacists, environmental services staff, and
many others ran toward the problem, not away from it. This was in the
setting of many unknowns at the time about caring for COVID-19
patients, including how much of a risk this type of work would be to
the health of the caregiver, how long this pandemic would last, when
was more help coming, when would we see family again or have a day off,
and how do we care for both critically ill patients and our loved ones
at home. Healthcare workers responded to this overwhelming amount of
work with a sense of purpose, meaning, and duty. People needed help, it
is the nature of the healthcare worker to help them. There is not an
option to run away from this problem, that is not who we are.
Since the beginning of this pandemic, it is easy to see what we
have asked of the healthcare system and the people who perform the work
of caring for COVID-19 patients. In Louisiana, that has been asking
healthcare providers to help rescue all of us from an initial COVID-19
surge in March 2020, followed by again by a second surge in July 2020,
a third in December 2020, and now the beginning of our fourth COVID-19
surge in Louisiana in July 2021. The human beings performing these jobs
are being strained with every additional COVID-19 patient admitted and
every additional COVID-19 surge that occurs.
There is developing evidence that we have strained the human beings
providing care to patients with COVID-19 to a critical point. Even a
brief review of healthcare news over the past year immediately reveals
countless stories of nurses, healthcare's most precious resource and
who have shouldered the heaviest load in the COVID-19 response, are
leaving the profession at high rates. A recent report by Vivian Health
revealed 43 percent of nurses are considering leaving the healthcare
profession in 2021 and 72 percent report hospital morale has worsened
over the past year. In my specialty of Critical Care Medicine, 48
percent of ICU nurses are considering leaving healthcare. The past and
current COVID-19 surges and future healthcare crises will likely be
characterized by running out of healthcare workers rather than running
out of ventilators and stretching existing healthcare workers to an
even greater degree. Expending healthcare resources on recurring COVID-
19 surges and losing valuable healthcare workers from the profession
will almost certainly impact all the other important goals we hope to
accomplish in improving the health of the nation. How do we improve
care for underserved patient populations, increase access to care, make
in-roads on decreasing cardiovascular disease and diabetes, improve
outcomes for patients with cancer, and improve many other aspects of
healthcare delivery when healthcare is asked repeatedly to instead
focus on COVID-19 surges? How do we accomplish all these goals when so
many healthcare workers leave the profession?
Studies of healthcare workers caring for COVID-19 patients have
shown that the risk for the development of mental health problems may
be as high as other disasters such as the September 11th attacks or
Hurricane Katrina. \15\ Recent research focusing on the psychological
impact of COVID-19 on healthcare workers suggests that over one third
of healthcare workers are experiencing anxiety or depression, \16\ as
many as one in four have symptoms of post-traumatic stress disorder,
\17\ and symptoms of burnout are experienced by over half of critical
care physicians. \18\ This is the state of the workforce asked to
return to the COVID-19 front lines for a second, third, and now fourth
wave. We will continue to confront current and future waves, which is
our duty, knowing that our physical and mental health is the cost we
will continually pay. Our eyes are forward, focused on saving the
patients in front of us who unfortunately may pay a higher price.
However, in this time when almost all this suffering may be prevented
by a vaccine, we ask why is this suffering necessary and when will it
end?
---------------------------------------------------------------------------
\15\ Wright HM, Griffin BJ, Shoji K, et al. Pandemic-related
mental health risk among front line personnel. J Psychiatr Res.
2021;137:673-680. doi:10.1016/j.jpsychires.2020.10.045.
\16\ Sun P, Wang M, Song T, et al. The Psychological Impact of
COVID-19 Pandemic on Health Care Workers: A Systematic Review and Meta-
Analysis. Front Psychol. 2021;12:626547. doi:10.3389/fpsyg.2021.626547.
\17\ d'Ettorre G, Ceccarelli G, Santinelli L, et al. Post-
Traumatic Stress Symptoms in Healthcare Workers Dealing with the COVID-
19 Pandemic: A Systematic Review. Int J Environ Res Pu. 2021;18(2):601.
doi:10.3390/ijerph18020601.
\18\ Azoulay E, Waele JD, et al. Symptoms of burnout in intensive
care unit specialists facing the COVID-19 outbreak. Ann Intensive Care.
2020;10(1):110. doi:10.1186/s13613-020-00722-3.
Conclusion
I present these lessons learned as one member of the healthcare
community, eager to also learn lessons from my colleagues around the
world. Experiences during this pandemic have been diverse and we need
to learn from everyone's successes and failures by ongoing discussions
as we are having today. Learning from the frontlines, healthcare
systems responding effectively to strain, rapid dissemination of
medical evidence and operational strategies, understanding that good
clinical research results in better clinical care especially when these
are integrated, and taking better care of the caregivers are just a few
of many approaches to future crises in healthcare. Let us continue to
develop the national resolve to end the current crisis by embracing the
gift Medical Science has repeatedly provided to humanity for hundreds
of years: vaccinations.
______
[summary statement of david janz]
Lessons Learned During the COVID-19 Pandemic and How These Lessons
Apply to Future Crises in Healthcare
1. Learning in real-time from ``forward positions'' during a
pandemic prepares locations which will soon experience similar strain
in their healthcare system.
Summary: Healthcare systems first to experience a crisis can
inform those about to experience a crisis.
How this applied to COVID-19: Many healthcare institutions
benefited from not just the early descriptions of the disease
caused by SARS-CoV-2, but also from learning what operational
challenges locations experienced early in the pandemic.
How this applies to future crises: organized dissemination of
operational information from forward positions in a pandemic
can prepare the locations at highest risk of spread.
2. Managing hospital strain is vital in a healthcare system's
response to COVID-19 and future healthcare crises.
Summary: Excessive demand on hospital resources, referred to as
strain, has occurred for decades in healthcare, occurs much
earlier than running out of a resource, and is associated with
worse patient outcomes.
How this applied to COVID-19: Healthcare systems response to
COVID-19 has largely been a story of how successful a system is
in dealing with strain on a large scale.
How this applies to future crises: Adding healthcare personnel
and effective, evidence-based patient care tools will mitigate
strain in COVID-19 surges and beyond.
3. Dissemination of early experiences and knowledge improves
patient care outside of individual hospitals.
Summary: Operational experiences of hospitals have historically
existed in silos.
How this applied to COVID-19: The ability to disseminate
solutions from our hospital system to hospitals around the
country improved care of COVID-19 patients.
How this applies to future crises: Future crises should be
responded to by breaking down silos around healthcare
institutions so others can learn from their experiences.
4. A Learning Healthcare System is vital in crisis response.
Summary: A Learning Healthcare System emphasizes and integrates
both patient care and discovery of new treatments.
How this applied to COVID-19: The rapidity of discoveries of
treatments and vaccines to prevent COVID-19 is lifesaving,
unprecedented, and a result of clinical research.
How this applies to future crises: Lives will be saved in
future pandemics if we continue to integrate clinical research
into healthcare systems.
5. Caring for the caregiver is a vital component in crisis
response.
Summary: The ability for a system to respond to a healthcare
crisis is largely dependent on the physical and mental health
of the healthcare worker.
How this applied to COVID-19: The COVID-19 pandemic has
resulted in healthcare workers experiencing increasing rates of
physical and mental health problems.
How this applies to future crises: Our ability to respond to
future crises or improve the health of the Nation will be
limited by healthcare workers leaving the profession due to the
ongoing COVID-19 pandemic.
______
The Chair. Thank you.
Ms. Cicero.
STATEMENT OF ANITA CICERO, DEPUTY DIRECTOR, CENTER FOR HEALTH
SECURITY, JOHNS HOPKINS BLOOMBERG SCHOOL OF PUBLIC HEALTH,
BALTIMORE, MD
Ms. Cicero. Chair Murray, Ranking Member Burr, and Members
of the Committee, thank you so much for the opportunity to
speak with you today. I am the Deputy Director of the Johns
Hopkins Center for Health Security. The opinions expressed are
my own and don't necessarily reflect the views of Johns Hopkins
University. For over 20 years, the mission of our Hopkins
Center for Health Security has been to protect people's health
from epidemics and disasters, and to ensure that communities
are resilient to major challenges.
Last year, our center launched the Capitol Hill Steering
Committee on Pandemic Preparedness and Health Security, and I
would like to acknowledge the excellent leadership from
Senators Baldwin, Burr, and Casey, three of the six Senate co-
chairs of the steering committee. For as long as I can
remember, this HELP Committee has crafted and supported
comprehensive bipartisan policies. Thank you for continuing
that tradition today. The profound effects of the COVID-19
pandemic should galvanize this Committee and Congress broadly
to do everything in your power to prevent this or worse from
happening again, and to better--be better prepared if it does.
Our goal should be a pandemic free future. When we take a step
back and look at the big picture, and identify the lessons
learned from the COVID-19 pandemic, what jumps out is the need
to fundamentally shift from a largely reactive posture to a
more proactive posture across the board.
In my remarks this morning, I will focus on three points
where we need to shift to a more proactive stance. First, we
support the $30 billion investment over the next 4 years to
improve pandemic preparedness as called for in the American
Jobs Plan. This would bolster our public health capabilities
and biomedical preparedness to better protect Americans. Second
is the need for a dedicated Disease X medical countermeasure
program at BARDA. BARDA has a proven track record of partnering
with private industry and developing vaccines, therapeutics,
and diagnostics against a defined list of biological threat
agents. However, there is no sustained funding or program, or
strategy dedicated to accelerating the development of medical
countermeasures for previously unidentified infectious disease
threats.
While it is not possible to identify which specific virus
will cause the next pandemic, we do know that certain viral
families possess the kinds of attributes such as high
lethality, high transmissibility, and asymptomatic spread that
are likely to lead to large scale outbreaks. Because we know
that viral families with these attributes can produce our next
pandemic pathogen, BARDA could was sufficient and sustained
resources work in partnership with companies to advance the
development of innovative technologies and specific vaccine
platforms that are best suited against these viral families.
That way, when the next viral pathogen emerges, we would have
the ability to adapt the technologies and platforms quickly,
and quickly develop effective vaccines and drugs before the
outbreak has a chance to spread.
A dedicated Disease X medical countermeasure initiative
should be created in BARDA in coordination with NIH, DOD, and
other Federal stakeholders. My final example is the need for
innovation in next generation masks and respirators for medical
workers, essential workers, and the public. Advances in this
area are long overdue. Despite the importance and daily utility
of masks, health care workers have been using basically the
same surgical masks, procedure masks, and respirators that--for
decades.
By incentivizing innovation, we can develop medical masks
and respirators that are reusable, better fitting, and more
comfortable for long stretches. The public should also have
better quality masks. While it is great that you can buy a mask
almost anywhere these days made of cloth, there is very little
quality control. The Government could establish standards
around breathability, wearability, and effectiveness of masks
to ensure more reliable protection. Currently, also, most masks
and respirators are either made overseas or their materials are
sourced from overseas. BARDA could provide financial support to
domestic companies to scale up production, and the SNS could
purchase enough to meet future needs based on a range of severe
scenarios.
In conclusion, there are many more common sense, attainable
things that we can do today with your vision and leadership and
support to save American lives and our Nation's jobs and
economy tomorrow. Thank you for inviting me to contribute and I
look forward to answering any questions you may have.
[The prepared statement of Ms. Cicero follows:]
prepared statement of anita cicero
Chair Murray, Ranking Member Burr and distinguished Members of the
Committee, thank you for the opportunity to speak with you today about
the COVID-19 pandemic.
I am the Deputy Director of the Johns Hopkins Center for Health
Security and a Senior Scientist in the Department of Environmental
Health and Engineering at the Johns Hopkins Bloomberg School of Public
Health. The opinions expressed herein are my own and do not necessarily
reflect the views of the Johns Hopkins University.
For over 20 years, the mission of our Center for Health Security
has been to protect people's health from epidemics and disasters and
ensure that communities are resilient to major challenges. We have 30
faculty at the Center with expertise in fields including infectious
disease, epidemiology, medicine, law, the social sciences, and
immunology.
During the past year and a half, I have co-led our Center's policy
work in response to the pandemic and our efforts to understand what the
Nation should do to be better prepared for even more catastrophic
pandemics in the future. Last year our Center launched the Capitol Hill
Steering Committee on Pandemic Preparedness and Health Security, a
bipartisan, bicameral educational initiative to provide congressional
staffers and other stakeholders with information and analysis on
current and future national health security priorities. I would like to
acknowledge the excellent leadership of HELP Committee Members,
Senators Baldwin, Burr and Casey--three of the four Senate co-chairs of
the steering committee--along with Senator Cindy Hyde-Smith of
Mississippi and Senators Ben Cardin and Chris Van Hollen of Maryland.
I also would like to express my appreciation for this Committee's
long-standing leadership and bipartisan work to improve our Nation's
pandemic preparedness and biodefense. For as long as I can remember,
the HELP Committee has crafted and supported comprehensive, bipartisan
policies. Thank you for continuing that tradition.
Covid-19 has done great damage to our country in terms of sickness,
loss-of-life, terrible economic consequence, and job loss. And we are
not in the clear yet.
The profound effects of this pandemic should galvanize Members of
Congress to do everything in their power to prevent this, or worse,
from happening again and to be better prepared if it does. We should
aim for creating a pandemic-free future. Investing $30 billion over the
next 4 years to improve pandemic preparedness, as called for in the
American Jobs Plan, would get us on a more solid footing by bolstering
our public health capabilities, innovation, and biomedical preparedness
to better protect Americans.
When we take a step back and look at the big picture to identify
important lessons learned from the COVID-19 pandemic, what jumps out is
the need to fundamentally shift from being largely reactive to being
more proactive across the board.
Before the next large scale outbreak occurs, we need to be more
proactive in improving our situational awareness through better data
collection, diagnostics, surveillance and genomic sequencing; more
proactive in bringing our antiquated public health infrastructure into
the 21st century; more proactive in using cutting-edge technologies to
quickly develop medical countermeasures; more proactive in having a
reliable supply chain and stockpile in place; more proactive in our
ability to provide excellent care for patients in our health system,
even during large surges; and more proactive in earning the trust of
diverse communities before a pandemic so that there is greater support
for outbreak response measures. We have learned the hard way that
trying to play catch up and accomplish these things in the midst of a
pandemic is like swimming against a strong rip tide.
Our Johns Hopkins Center for Health Security has submitted
recommendations to Senator Murray and Senator Burr for improving the
Nation's public health and medical preparedness response programs.
In my remarks today I will focus on two of the important areas
where we need to shift to a more proactive stance if we want to be
better prepared for a future pandemic--one that could be more
catastrophic than COVID-19. The first area is advancing biomedical
preparedness and the second is improving our public health
infrastructure.
I want to stress that the examples I will give of innovations in
each of these areas are not futuristic, out-of-reach goals. They are
achievable and realistic improvements that, with the support of
Congress, can enormously advance our Nation's preparedness for future
pandemics.
1. Advancing Innovation in our Biomedical Preparedness
Three ambitious but achievable goals for advancing innovation in
our biomedical preparedness are: (1) establish a dedicated ``Disease
X'' medical countermeasure program; (2) incentivize innovation in masks
and respirators for health care workers and the public; and (3)
prioritize development and review of at-home diagnostic technologies.
We have seen firsthand during this pandemic how powerful and
lifesaving it is to have rapid and safe vaccines and therapeutics, as
well as reliable diagnostics against novel infectious disease threats.
The Biomedical Advanced Research and Development Authority (BARDA)
within the Office of the Assistant Secretary for Preparedness and
Response (ASPR) at the Department of Health & Human Services (HHS) has
a proven track record of partnering with private industry and
developing medical countermeasures against a defined list of biological
threat agents.
However, there is no sustained funding, program, or strategy
dedicated to accelerating the development of medical countermeasures
for previously unidentified infectious disease threats. The U.S. should
set an ambitious goal of rapidly developing medical countermeasures for
novel or unknown viral threats in just a few months. Innovative
technologies, outside-the-box thinking, sustainable partnerships, and
game-changing science can be harnessed to meet this goal.
Disease X
The next deadly virus, or ``Disease X,'' could be right around the
corner. The U.S. will need to move even faster to develop and deploy
medical countermeasures to save lives and safeguard the economy.
Accordingly, a new dedicated Disease X Medical Countermeasures
Initiative should be created to accelerate this process at BARDA, in
coordination with DOD and other Federal stakeholders. BARDA needs
sufficient and sustained Federal funding dedicated to developing
medical countermeasures against future viral threats that are unknown
and therefore not on the ``material threat determination'' list.
It is not possible to identify which specific virus will cause the
next pandemic, but we do know that certain viral families possess the
kinds of attributes--such as high lethality, high transmissibility, and
asymptomatic spread--that are likely to lead to large scale outbreaks.
Because we know that viral families with these attributes can produce
our next pandemic pathogen, BARDA could, with sufficient, sustained
resources, advance the development of the technologies and vaccine
platforms that are best suited to use against these viral families, and
support innovations that enable rapid, large-scale response. That way,
when the next viral pandemic pathogen emerges, we would have the
ability to quickly adapt those technologies and platforms to develop
effective vaccines and other medical countermeasures before the
outbreak picks up speed.
Next Generation Masks and Respirators
Just as we need to commit to developing medical countermeasures in
weeks, not months or years, we should likewise increase our
expectations for effective masks for medical workers, essential
workers, and the public. Innovations in this area are long overdue.
Medical masks and respirators for health care workers are essential
pieces of personal protection equipment (PPE), especially during
outbreaks of contagious respiratory pathogens. However, despite their
importance and daily utility, health care workers have been using
basically the same surgical masks, procedure masks, and respirators for
decades. Through incentivizing innovation, we can develop masks and
respirators that are reusable, better fitting, and more comfortable for
long stretches.
The public should also have better-quality masks that are certified
to meet breathability, wearability, and effectiveness standards
established by government. It's great that anyone can buy a cloth mask
almost anywhere these days, but there is little quality control for
public use masks. BARDA launched a Mask Innovation Challenge, and they
should continue to foster technical advances in this area. Using new
information gleaned from this challenge, BARDA could create target
product profiles for new and better-quality medical respirators and
public use masks.
As with other types of PPE and medical supplies, we must ensure the
stability of a reliable supply chain for a range of respiratory
devices. Currently, most masks and respirators are either made
overseas, or their materials are sourced from overseas. Once devices
meet new target product profiles established, BARDA should provide
financial support if needed to domestic companies to scale up
production, and the SNS should purchase enough to meet anticipated
future needs based on modeling of various severe scenarios.
Although it is uncomfortable to imagine, a future viral pathogen
could be even deadlier and spread more easily than SARS-CoV-2. On the
most basic level, health care workers, other essential workers, and the
public must have an abundant supply of masks that can protect them from
infection while countermeasures are being prepared.
At-Home Diagnostics
Another area ripe for innovation are at-home diagnostics for viral
threats. Limitations around access to reliable diagnostic testing have
dominated much of the response to COVID-19. As outbreaks emerged in
countries around the world, the US was unable to quickly deploy
reliable testing tools. Looking ahead, a world in which individuals and
families have access to reliable home testing for infectious disease
threats is in reach if we set that as our goal. We can change the
paradigm if there is enough will and commitment to do so. People
already can take home HIV tests, and BARDA is currently funding
advanced development of at-home diagnostics for influenza. Imagine if
you could conveniently and cheaply test yourself and your family for
things like strep throat, flu or a new dangerous virus. Currently, we
mostly fly in the dark without knowing what kinds of viruses are
infecting us or circulating in our communities.
Congressional funding, and the development and review of at-home
diagnostic technologies by BARDA, FDA, and CMS should be prioritized.
BARDA could increase the development of direct-to-consumer home tests
for infectious diseases. FDA could help to streamline regulatory
pathways for such devices. And CMS and private insurers should provide
payment and reimbursement schedules for these devices to facilitate
uptake. There are now some at-home COVID tests on the market, but it
took us more than a year into the crisis to get there, and their
pricing puts them out of reach for many people.
At-home diagnostics for infectious diseases, coupled to information
technology, could have a transformative benefit for current and future
pandemic response. Not only could it decrease the unnecessary use of
antibiotics, but it could also greatly improve our early warning
surveillance for infectious disease threats.
For these and other achievable advances in our Nation's biomedical
preparedness, it is critical to have strong Federal leadership that is
motivated and empowered to maintain the momentum and contribute to the
success of our pandemic response efforts. In this regard, it is
important to have a strong, operational, well-functioning office of the
Assistant Secretary for Preparedness and Response which has the hiring
and budgeting authorities it needs to respond quickly and proactively
during serious health emergencies that the Nation could face.
2. Advancing Innovation in our Public Health Infrastructure
In addition to innovation in biomedical preparedness, we must
support innovation in our public health capabilities at the state and
local levels; they are our first line of defense against dangerous
outbreaks. We also need to fully support the creation and annual
funding of a National Center for Epidemic Forecasting and Outbreak
Analytics.
State and Local Public Health Capacity
Because we have never sufficiently prioritized public health in the
past, its infrastructure is woefully inadequate now. Some of our state
and local public health agencies are still reliant on 1950's
technologies--using pencil, paper, and fax machines to manage data--
while the hospitals down the street from them are fully in the 21st
century. There is a technological disconnect between public health and
health systems that greatly hinders our ability to collect, share, and
appropriately respond to actionable data during a public health crisis.
A strong public health infrastructure is not something that can be
ramped up after a large-scale outbreak has already gained steam. We
have certainly seen this across the board during the COVID-19 pandemic
from spotty and irregular collection and reporting of COVID-19 case
data to the too little/too late attempt to hire contact tracers to
trace infections once there was already rampant community spread of the
virus.
Although Congress has appropriated $1 billion for data
modernization across the CARES Act and the American Rescue Plan, it
will take years for our country's public health data infrastructure to
be brought up to speed. In the meantime, we are now in a position where
we are facing a new wave of Covid-19 without the data we need to make
crucial decisions. We do not conduct surveillance in a way that gives
us real time data about who is getting sick from which variant. Many
states are moving to weekday-only or even weekly reporting of cases.
Data on mild breakthrough cases of fully vaccinated people is not being
collected. There is no central tracking of outbreaks in schools. These
kinds of gaps make it difficult to understand how the virus is
circulating in our communities.
What does a more proactive strategy for public health
infrastructure look like? Given sufficient resources, people, and
modern IT systems, public health agencies at the local and state levels
could be seamlessly connected to health care providers and labs and
collect more accurate, standardized, real-time data. We need to leave
the disjointed, local reporting systems behind and develop uniform
systems for reporting on testing, positive cases, hospitalizations, and
deaths.
National Center for Epidemic Forecasting and Outbreak Analytics
There is $500 million in the American Rescue Plan for the National
Center for Epidemic Forecasting and Outbreak Analytics, as well as data
modernization. To establish this as a permanent capability, the
epidemic forecasting center should be included in annual appropriations
to support its ongoing mission.
I thank Congress for the investments it has already made in our
data infrastructure and encourage a continued commitment to supporting
our Nation's public health institutions with the authorities and
funding they need to ensure we have a proper infrastructure in place
for the next pandemic.
Again, I hope that my testimony has shown that there are
commonsense, attainable things we can do today, with your vision,
leadership, and support, to save American lives and our Nation's jobs
and economy tomorrow.
Thank you for inviting me to contribute to the hearing and for your
important work on pandemic preparedness. I look forward to answering
any questions you may have.
______
[summary statement of anita cicero]
Chair Murray, Ranking Member Burr and distinguished Members of the
Committee, thank you for the opportunity to speak with you. I am the
Deputy Director of the Johns Hopkins Center for Health Security and a
Senior Scientist in the Department of Environmental Health and
Engineering at the Johns Hopkins Bloomberg School of Public Health. The
opinions expressed are my own and do not necessarily reflect the views
of the Johns Hopkins University.
The profound effects of the COVID-19 pandemic should galvanize
Congress to do everything in its power to prevent this from happening
again and to be better prepared if it does. Investing $30 billion over
the next 4 years to improve pandemic preparedness, as called for in the
American Jobs Plan, would bolster our public health capabilities,
innovation, and biomedical preparedness to better protect Americans.
When we take a step back and look at the big picture of lessons
learned from the COVID-19 pandemic, what jumps out is the need to
fundamentally shift from being largely reactive to being more proactive
across the board. I will focus on two of the important areas where we
need to shift to a more proactive stance if we want to be better
prepared for a future pandemic that could be even more catastrophic
than COVID-19. The first area is advancing biomedical preparedness and
the second is improving our public health infrastructure.
1. Advancing Innovation in our Biomedical Preparedness
Three ambitious but achievable goals for advancing our biomedical
preparedness are: (i) Establish a dedicated ``Disease X'' medical
countermeasure program in BARDA to leverage platform technologies and
rapidly develop medical countermeasures against those viral families
that have the attributes likely to lead to future pandemics. (ii)
Innovate and set quality standards for next generation masks and
respirators for health care workers and the public; ensure the
stability of a reliable supply chain for a range of respiratory
devices; and stockpile sufficient quantities. (iii) Prioritize
development, facilitate regulatory review, and find workable
reimbursement and payment mechanisms for at-home infectious disease
diagnostics to increase surveillance and accessibility. For these and
other achievable advances in our Nation's biomedical preparedness, it
is critical to have strong and operational ASPR.
2. Advancing Innovation in our Public Health Infrastructure
In addition to innovation in biomedical preparedness, we must
support innovation in our public health capabilities at the state and
local levels. We must bridge the technological disconnect between
public health and health systems that greatly hinders our ability to
collect, share, and appropriately respond to actionable data during a
public health crisis. What does a more proactive strategy for public
health infrastructure look like? Given sufficient resources, people,
and modern IT systems, public health agencies could be seamlessly
connected to health care providers and labs and collect more accurate,
standardized, real-time data on testing, positive cases,
hospitalizations, and deaths. We also need to fully support the
creation and annual funding of the National Center for Epidemic
Forecasting and Outbreak Analytics.
These recommendations are attainable with your vision, leadership,
and support, to save American lives and our Nation's jobs and economy
tomorrow. Thank you.
______
The Chair. Thank you. And again, thank you to all of our
witnesses for being here today and for your testimony. We will
now begin around a 5-minute questions for our witnesses. I
again ask our colleagues, keep track of the clock and please
stay within those 5 minutes. Mr. Becker, let me start with you.
You do have significant experience building innovative data and
laboratory infrastructure for state and local health
departments.
As we have all seen over this past year and a half,
complete and accurate data on cases, hospitalizations, and
deaths allows us to reduce community spread and it saves lives.
I want to ask you, what was the biggest initial barrier to
effectively sharing COVID-19 data between public health
systems, medical systems, and Federal agencies?
Mr. Becker. Thank you for the question, Senator. I would
say interoperability is the biggest challenge, but it is only
the biggest by an nth degree. So interoperability with our
hospital systems create a lot of workload and stress on the
public health system, which is already underfunded and
understaffed. And one of the issues that we have from a public
health standpoint is that our systems don't talk the same
language. So we are talking at each other, but not to each
other and that creates confusion and especially in the
pandemic.
That is the top one. But I would say just underneath that
is just the scalability of the systems that exist today. These
systems were built 20, 30, even some of them 40 years ago, and
they are slow and they don't adapt to today's world. One of the
issues that we had, for instance, in Washington State was the
electronic lab reporting system, which was designed many, many
years ago, could only handle about 350,000 cases per year in
the State of Washington. And that is about what we asked of it.
In the pandemic, we were asking it to do that in less than
a month, and it created slow systems that couldn't respond, a
frustrated workforce, and that just leads to error and the
ability--the lack of ability to respond to the immediate needs
of the system. So I think those were two. I took liberties with
your question but thank you.
The Chair. That was great. Thank you so much. You know, the
flood response to this pandemic caused new health inequities
and exacerbated existing ones. And without improved data on
race and ethnicity, it is difficult to know the extent of the
impact and to adjust our response accordingly. How can we
improve data collection and sharing so we can have a better
understanding of the impact of the pandemic on communities of
color?
Mr. Becker. Thank you for the great question. And that is a
true issue that we are going to have to deal with at all levels
of state, local, and Federal Government. And we need standards
for one on the collection of that data, so it is normalized
across all those systems. And it sounds very simple when you
talk about just collecting additional race, ethnicity, and
demographic data, but it is actually quite complicated. It is
complicated by the systems that don't allow for those quick
changes.
But it is complicated by the way the questions need to be
asked and the workforce that needs to be trained to ask them
and the regional variations that happen across this country
with racial and ethnic diversity. For instance, in Washington
State, we have tribal Governments and there is 29 of those. And
we need to get those affiliations right so we can report back
to those tribal partners. And that is a lot of work for them
right now to classify themselves once that data is in our
system.
The Chair. Okay, thank you. Ms. Cicero, we have to address
all the facets of our public health infrastructure while
working to improve our response workforce, data, medical
countermeasures to state and local capacity. We can't solve
just one of these challenges, ignore all the others, and expect
our system to work better the next time around. What is your
top recommendation for Federal action that will allow us to
comprehensively and systematically address the failures we have
seen over the course of this pandemic?
Ms. Cicero. Thank you for that question, Senator. Once
again, I believe it is very important to invest sufficiently in
our future for long standing, sustained support for our public
health infrastructure, for biomedical preparedness, for our
hospitals, frontline workers. And we can do that through the
$30 billion investment, or at least that is a good start,
through the American Jobs Plan. And that money would be well
spent so that we don't just react to this crisis and move on in
that crisis complacency cycle but invest in the future in a
sustained way.
The Chair. Thank you. I will retain the balance of my time.
We have a number of Senators and a vote at 11:30 a.m. So,
Senator Burr, I will turn it over to you.
Senator Burr. Thank you, Madam Chair. Mr. Becker, what if I
told you that technology was available today that through
video, an algorithm could determine the pulse rate, the
oxygenation level, the respiration rate of individuals in the
video and could predict a potential outbreak of COVID in any
given geographical area 3 days before somebody presented
themselves to the emergency room for a test. Would that be a
plus for the surveillance network?
Mr. Becker. Thank you, Senator. It would be an absolute
plus. I mean that--real time data analytics and the ability to
predict things and catch them before they spread in the
community are a fantastic thing, but the challenge is
operationalizing that within the current system.
Senator Burr. The challenge is incorporating that in a
layered surveillance system and a culture that looks and says,
no, we just need a bigger computer that processes 10 day old
data faster. That is the challenge that we are in right now, is
that we are not taking advantage of technology in all aspects.
And we have seen it in development. We have seen it in
manufacturing, but we haven't seen it in the early stages. Ms.
Cicero.
Ms. Cicero. Yes. Thank you, Senator Burr. I wanted to add
to that I agree with your point. And we have the ability now,
if we invest and commit to it, to develop at home diagnostics
for infectious diseases. People can already get HIV testing
from home. I know that HHS is working on supporting companies
that are developing at home influenza testing, and that should
be the future. That wouldn't it be great if we could test our
families for strep or for flu or for the new unknown virus and
better diagnose those viruses so that we can have early warning
and reduce use of antibiotics and also better protect
Americans.
Senator Burr. Great point. Ms. Arthur, you said solutions
like READDI at the University of North Carolina, Chapel Hill
have established--have been established to fill the gaps in the
early stage discovery development so that we can better be
prepared when the next pandemic comes. How can early stage
discovery of treatments targeting virus families better prepare
us for future pandemics, and what tools do we need to succeed
in that type of work?
Ms. Arthur. Thank you, Senator. I think this is an example
of how we invest in early stage development in peacetime. It is
very similar to what Anita was saying, that we should be
working on leveraging novel technologies, both platform
technologies for viral families as well as new antiviral
mechanisms for viral families. We can do a lot of different
work across these families, the coronaviruses, the
flaviviruses, and have a base of knowledge and understanding of
how those different technologies actually could respond if we
see a novel virus in that family.
I think we learned that with SARS and MERS, with the SARS-
CoV-2 outbreak, and doing a deeper analysis and a deeper set of
testing of these kinds of new mechanisms could actually allow
us to spring forward even faster with new products if we see a
disease x that we don't know. It has to have that funding on
the back that pulls those products through from early stage
development through the more expensive later stage clinical
trials and the manufacturing scale up. But that partnership
between the agencies could do that.
Senator Burr. Let me just remind you, the shelf life of
Congress funding programs is about 18 to 36 months. And then we
sort of forget about it unless there is a crisis that
materializes. So it is a challenge. Ms. Cicero, let me ask you
a question, but before I do, let me just--you talk about the
expanded jurisdiction authority of BARDA. BARDA does have the
authority today to invest and develop massively in technology
platforms. So even though it is not there in an increased
threat list, we did add antibiotics to their portfolio.
From the standpoint of the technology platforms, it has
expanded their capabilities significantly. Now, Hopkins gave
the CDC a good run for their money with COVID tracking. Not
only did it become a useful tool for the American people to be
able to track the virus in their communities, Federal officials
were also using it as a resource, and it was quoted frequently.
How can the Federal Government better partner with the
private sector and academia to advance virus surveillance
capabilities?
Ms. Cicero. Thank you for that question, Senator, and I
agree with your stated goal early on that for CDC it should be
the premier CDC in the world. It has been for years, and that
needs to be our goal going forward into the future. We need to
provide CDC with a sufficient resources and purpose to be able
to expand, to be able to work more seamlessly with the private
sector, with academia, and to invest in the kinds of systems
that they need for better surveillance, to work more seamlessly
with state and local public health agencies, and to be able to
really have that real time data that is more actionable so that
it informs the response.
Senator Burr. Madam Chair, just one last question. Dr.
Janz, how was Dr. Cassidy as lecturer?
[Laughter.]
Dr. Janz. Best diarrhea there is.
Senator Burr. Very good answer. Thank you.
[Laughter.]
The Chair. Thanks.
Senator Casey.
Senator Casey. Chair Murray, thank you for calling this
hearing. I want to thank you and Ranking Member Burr, and I
want to get to our witnesses, we are honored you are here, and
get to my questions. I did want to join so many of our
colleagues in paying tribute to Mike Enzi, former Senator from
Wyoming. Probably the best way to describe Mike Enzi is he was
a paragon of decency in a town where that is often in short
supply. Just such a good person.
It is always interesting what you remember when you hear
about the passing of someone that you knew or someone that you
had some familiarity with. And I got to know Mike on this
Committee. But before I was on this Committee, I think it was
my first year. I remember standing on the Senate floor, just
one of those interactions you remember at a moment like this
where our former Senate Majority Leader, Harry Reid, was
standing next to me toward the back of the chamber and he made
reference, and he pointed across the room and said, he said,
Bob, that is Mike Enzi. He is a good man. That is all he said.
And then as Harry Reid often does, he didn't say much more. But
I didn't know Mike at that point in time and then got to know
him a few years later on this Committee. And we are going to
miss him in so many ways. And we are just so saddened that soon
after leaving this chamber that he, in this legislative body,
that he was taken from us.
We are thinking of him, remembering him with respect and
fondness, but also, of course, thinking of his family and
praying for them. So we are all going to be paying tribute to
him in the next number of days. I wanted to thank the witnesses
for sharing their remarkable expertise with the Committee on
Pandemic Preparedness legislation, all kinds of legislation.
I appreciate the opportunity to have worked with Chair
Murray in the past on these issues. And Ranking Member Burr, he
was working on these issues before, just a number of years
before I got to the Senate, also with Ted Kennedy, I guess,
Richard, at that time, as he made reference to, Senator Enzi,
Senator Kennedy working together. But I appreciate both the
Chair and the Ranking Member and the work they have done,
especially on previous authorizations of the so-called Pandemic
All Hazards Preparedness Act. We are still grappling, of
course, with the COVID-19 pandemic. And we also need to look
ahead to the next public health emergency and get prepared for
that. So I will start with me Ms. Arthur. I want to thank you
for your testimony today and the expertise you bring. The
many--and also the many times you have shared that expertise
with members of our staff. I wanted to ask you to expand on
what you had in your written testimony on page 13.
Just for reference, you made reference to state
immunization information systems, and you describe them this
way on page 13, ``computerized multifaceted systems that
operate in 62 jurisdictions and have the ability to maintain
immunization records across the lifespan that can be used--can
also be used for providing for providers, I should say, to
order vaccines and maintain an accounting of inventory and it
goes on from there. But I guess the basic question with regard
to these information systems is what are some of the challenges
they currently face?
Ms. Arthur. Thank you, Senator, for that question. These
systems are very, very important to the core public health
infrastructure of each state, and they face many different
challenges. Data capture, the way that they are built. Some of
them are older. Each state has their own. Some of them do not
yet include or had to quickly add space for adult immunization
because of the pandemic. I think what is most important, very
much like Mr. Becker said, is the interoperability of systems.
Interoperability with the electronic health record,
interoperability between states. Many people might live in one
state and work in another. It is really important that we think
of these immunizations information systems as one of the core
foundations of our vaccination infrastructure.
Senator Casey. How about, are there resources available
from the Federal Government to support both as you make
reference to functionality and interoperability?
Ms. Arthur. Absolutely there are. The CDC actually has
immunization cooperative agreements with the 50 states,
territories, HHS, etc. But the funding here has been stagnant
for many years. And each state then apportion some, or maybe a
very small amount of their state budget to these systems. They
really do need an overhaul and a clear modernization. And
certainly there are several legislative bills moving that
actually seek to help the states modernize their immunization
information systems. We strongly support those among the
vaccine companies at BIO. And thank you for your support of
that as well.
Senator Casey. Thank you.
The Chair. Thank you.
Senator Cassidy.
Senator Cassidy. Thank you. Let me just follow-up right
there, Ms. Arthur. You allude to it in your testimony and going
back to what Chair--Ranking Member Burr said earlier. Congress
gave $1 billion to CDC to upgrade information systems. And I
was specifically asking last year for more money for
immunization information systems and was told that billion was
going out to states in order to upgrade. That is where it was
targeted because I was frustrated with CDC's inability to give
real time data.
Now, Mr.--so it seems as if we are advocating for dollars
of which a billion has already been appropriated and we are
told that is where it went. But Mr. Becker, in your testimony,
you indicate that in Washington State there has been inadequate
money to upgrade the immunization information system. I say
that because it seems like there is a disconnect here. We gave
$1 billion.
I was specifically told it is going to go to upgrade state
information systems. And I am hearing from a very innovative
state that you have inadequate resources to upgrade. So let me
ask, did you receive money from that $1 billion that we gave
CDC last year?
Mr. Becker. Thank you, Senator. I will have to go back and
find out how much Washington State actually received from the
CDC. But I can tell you that whatever we received was not
adequate to meet the needs of what we have faced today.
Senator Cassidy. Now, it could be that the state used it
for something else. Let's just be fair to CDC. Unless they came
down with a specific instruction to spend it on immunization
information systems. But it does seem, let me just ask, in your
testimony, you do mention that you had a hard time keeping
track, but this is exactly what information--immunization
information systems are supposed to do. Why was Washington
State's not adequate to do so?
Mr. Becker. Thank you, Senator. Is this the scalability,
interoperability that I mentioned in the very first part?
Senator Cassidy. But in the interoperability, you mentioned
by EHRs, but the way if a child is given a measles, mumps,
rubella vaccine, the provider actually enters that. So, and we
have had other states come in here and testify that their IIS
was able to, is currently accepting adult immunizations on
COVID. Now, I guess I am just exploring, I am not trying to
accuse. I am just trying to understand why this is not the
case. Why isn't it the case in Washington?
Mr. Becker. I think it is this disparate system. So you
have very big hospital systems that can invest the
infrastructure to send those things seamlessly. You have
private providers----
Senator Cassidy. What I am not sure about though, if a
pediatrician has any measles, mumps, rubella in that big
hospital system, clearly the mechanism occurs. I won't belabor,
but it does seem--I am just not, I am just not getting a clear
picture into what the problem is. We get $1 billion the CDC.
Somehow it is not happening. And yet the system works for
childhood immunization, but it is not working for adult. I
won't belabor. Dr. Janz, I think one thing is clear. You
mentioned in your testimony the need to have uniform standards
of care. Fecal material is hitting the fan. And we don't have
enough ICU beds--I probably used that line in my diarrhea
lecture.
We don't have enough ICU beds, but then we learned that we
are putting too many people on ventilators and putting on
ventilators at too early a stage actually was associated with
negative outcomes. How do we--I have to think that there is
probably uneven uptake of that information in ICUs across the
Nation. I don't know that I am just assuming. How do we
establish that uniform communication of care when--how we
manage a ventilator patient, to ventilate or not, really is
critical in terms of both ICU utilization, but also the
patient's survival?
Dr. Janz. Yes. Thank you, Senator. It was vital for us to
be able to spread evidence based medicine, how to prevent
patients----
Senator Cassidy. How did you do it?
Dr. Janz. Via the Louisiana Department of Health and the
Department of Health and Human Services. When we have conducted
seminars with hospitals around the state in the Nation where
they asked us, how do you solve these specific operational
problems? We gave them answers.
Senator Cassidy. Were you also able to give them like a
checklist, similar----
Dr. Janz. Yes, we shared with them all of the materials we
developed on our own hospital. We stepped outside of the silo
of an individual hospital system and shared all that.
Senator Cassidy. Sorry to interrupt but I am almost out of
time. And you want went nationally. Who sponsored your national
outreach?
Dr. Janz. ASPR with the Department of Health and Human
Services.
Senator Cassidy. Well hats off to ASPR for pulling that
together.
Dr. Janz. Absolutely.
Senator Cassidy. Did you--were you able to demonstrably see
that how patients were being managed kind of stayed in lockstep
with best practices across the nation?
Dr. Janz. Yes, it did catch up over time into what----
Senator Cassidy. Over time, how long over time? A month, a
week?
Dr. Janz. Oh, in the scale of weeks. It was very quick.
Hospital, the feedback I got from hospitals----
Senator Cassidy. One more thing. We were short--I got a
call from an anesthesiologist in San Francisco when things were
really bad in New Orleans. He goes, we shut down elective, but
COVID hadn't hit us yet. We should be shipping all our machines
to you and then you ship them back when it hits us because we
understood there is going to be an uneven kind of
implementation. It never happened. Instead, we are scrounging
to build new ventilators when they were sitting idle in many
parts of our Nation. I just say that because I do think part of
what we are doing here would be to source existing resources
where they are needed from one part of the Nation to another,
as opposed to attempting to build from scratch a lot of
machines that are very sophisticated, but then we don't need
them when it is all done. So anyway, with that, I thank you all
for your service and your testimony.
The Chair. Thank you.
Senator Smith.
Senator Smith. Thank you, Ranking Member Murray--I mean,
Chair Murray and Ranking Member Burr. I really appreciate this
bipartisan hearing. I am struck--here we are today. We are at a
pivotal point in the COVID-19 pandemic. There has been a 400
percent increase in new COVID cases over the past month. So
what we do right now is going to determine what happens next
with COVID-19. So today we are talking about lessons learned,
but I feel driven to remind us that we need to learn these
lessons like today and then apply them today so that we can
avoid and mitigate what looks to me like being another very
concerning surge. So that is in my mind as I think about where
we are.
Mr. Becker, I was really struck by how you described our
public data systems as decrepit. I think you are right. So many
of us during this pandemic have talked about the need of
following the science and the data, yet our data systems are so
inadequate to the task that we have. But I want to pull in on
the issue that Senator Murray raised about the issues of how
the COVID-19 pandemic has really laid bare the deep inequities
and disparities in our health care system as we see that
communities of color are so much more likely to get sick and
even to die.
I think that this disparity is caused in large part by the
social determinants of health, right. By our access to housing,
food security, employment, education, transportation. Some
people say that these upstream, so-called upstream impacts are
responsible for up to 80 percent of a patient's outcome, likely
outcome.
I want to ask you about this, could you tell us what steps
you think we should be taking as we think about data to help
improve--how can the Federal Government work better with state
and local entities on data collection related to these social
determinants of health?
Mr. Becker. Thank you, Senator. If I described our public
health system as decrepit and old, I would describe that as
social determinants of health system as infantile. It hasn't
developed. It is in its infancy. And there are no standards
across the country about how the last mile of those systems
around housing and food insecurities collect data and then
report it back up to the health care system or the public
health system.
There needs to be an adequate investment in that technology
now to create the technology of the future. And I certainly
believe in honor of our Seattle Kraken, our new NHL team, that
we don't need to skate to where the puck is as we work today,
we need to skate to where the puck is going. And social
determinants of health is where it is going from an infancy
standpoint. We have a huge opportunity in front of us for that.
Senator Smith. A huge opportunity. And I can only imagine
the challenges around interoperability between data systems
that tackle social determinants of health issues like housing
and employment and integrating that with the public health
system. But the opportunity to actually have an impact on
population health here is really, really huge.
Dr. Janz, I am very interested in the work that you have
been doing, and I am wondering if you could tell us a little
bit about how health equity issues factored into the work that
you did, that you are doing around scaling up critical care
capacity in the hospital.
Dr. Janz. Thank you, Senator, for that question. As I
mentioned earlier, University Medical Center in New Orleans
cares for a vulnerable patient population in a low income
community where over 80 percent of the patients that we serve
are patients of color. We aim to improve their care. And it is
difficult to do when we have to deal with COVID surge after
surge after surge.
When I leave here today, I will go back to New Orleans.
Instead of working on improving care for these patients,
improving cardiovascular care, decreasing rates of diabetes,
improving access to care, things like that, instead, we will
deal with how do we manage this next COVID surge. And that is
predominately the majority of what we will spend their time
dealing with. That means this unlevel playing field will remain
unlevelled. Every time we have to spend time and resources
dealing with the next COVID surge is time we have lost.
Senator Smith. Right. Well let me--in fact, it strikes me
that as we grapple with this next surge of COVID, we are going
to be exacerbating health disparities as sort of people,
communities of color, black and brown people fall further and
further behind because of lack of access to basic care for
chronic diseases that are caused by the social determinants of
health that Dr. Becker and I were talking about.
I am out of time, but I just want to pause and acknowledge
the powerful statements that you made about the impact of
stress and your concerns about the mental health of health care
providers. I think that this is a deeply concerning issue and
something that we can't look away from. We need to see, and we
need to address. So I am grateful for you bringing that up
also.
The Chair. Thank you.
Senator Marshall.
Senator Marshall. Thank you, Madam Chair, and welcome to
our witnesses as well. I want to talk about innovation for a
second. And Ms. Arthur, that means I am looking at you.
Certainly the lessons to be learned. I have always believed
that innovation could do more to drive the cost of health care
down than any legislation we can write. That innovation could
impact this current pandemic and future pandemics more than any
legislation we can write here if we would just get out of your
way and let your people do their job.
I think a good analogy here is FMD, foot mouth disease. And
we are starting to build vaccine banks. Much like the COVID
virus, there are different variants of FMD, and that is one of
the challenges. Is there any talk in your world of any type of
vaccine banks being built?
Ms. Arthur. Not exactly. But I think that the companies
want to work with the Government to again exploit these
opportunities to work on viral families. Many companies
actually do that. They are constantly looking at the genetic
sequence data for both existing pathogens of pandemic potential
as well as novel pathogens when they show up in these various
global databanks.
Companies are constantly exploring whether or not the
products they have, be they vaccine technology or diagnostic
technology or treatment technology, could work in some way
against that pathogen. So I think that companies rely on the
big public data banks, but they are constantly pressure testing
their products in that case.
Senator Marshall. Would you agree with me, if you were
going to try to set up these vaccine banks, knowing the origin
of COVID would be very helpful. So, for instance, if it was
from a bat cave and you had a collection of the eight most
similar viruses, that those might be clues to help you develop
future vaccines.
Ms. Arthur. I think it is very important to always
understand the zoonotic nature of every virus, whether you know
what animal it comes from, how it, animal to human
transmission. All very important in understanding the
epidemiology of a disease.
Senator Marshall. Is there much talk in your world about
viral gain of function and how that would impact vaccine
development?
Ms. Arthur. We don't talk about that very much within the
industry.
Senator Marshall. Okay, I am going to turn to Dr. Janz just
for a second. Dr. Janz, the doctors, nurses, respiratory
therapist were the heroes of this pandemic. Extra shifts,
working days at a time, major burnout going on. We put our
lives on the line. And I say we, I spent time in an ICU
treating COVID patients in an ER and certainly understand the
stress that is going on there. You know, as we stand here
today, and I talked to my docs back home, the biggest concern
treating COVID patients isn't therapeutics and what type of
respiratory therapy to give, it is a nursing shortage. Would
you agree that is certainly a huge limiting factor for your
docs, and just not in big hospitals, but small hospitals and
across the Nation?
Dr. Janz. Oh, I couldn't agree more, Senator. If we ever
ran out of ventilators in our hospital, we would have run out
of nurses 30 ventilators ago. The nursing shortage--nurses are
perhaps the most vital responders to this pandemic. They have
shouldered the greatest workload in responding to taking care
of patients with COVID-19. And among their most precious,
precious resource, we have too few of them. And we are not
supporting them enough.
Senator Marshall. I just want to bring to the attention of
the Committee that I spoke to a hospital yesterday who is
trying to bring in some nurses from the Philippines, and they
have worked with this agency for quite some time, but they are
running into passport issues and State Department issues and
they de-prioritize nurses down to forgive me the nomenclature,
may be a level four. We need the State Department to go back to
work to the office to get through these.
I hope that you all would join me in letters urging our
State Department to help get some of these nurses from other
countries in here as well. Last thing I want to talk about when
it comes to doctors is I am getting lots of phone calls from
doctors and they are referring--they would tell me, well we
appreciate the word of thanks from Congress, but why are you
trying to cut our pay? Thanks to the budget neutrality clause
in the Medicare physician fee schedule, we are going to say
thanks to all these doctors by cutting their pay up to 10
percent.
I just think that is the wrong message to send to be
sending to the health care heroes who have saved our lives. I
am not sure if your association, your medical associations is
looking into that issue or not, but certainly a lot of concern
from docs back home about their pay getting cut.
Dr. Janz. I think all health care professionals right now
need help, especially our nursing colleagues who again, are
shouldering the heaviest load in responding to this pandemic.
And we need to think of ways to help bolster them, not things
that we can take away from them or else otherwise we are not
going to get out of this any time soon.
Senator Marshall. Thank you, Dr. Janz. Thank you, Madam
Chair. I yield back.
The Chair. Senator Lujan.
Senator Lujan. Thank you, Chair Murray and Ranking Member
for this important hearing. Before us today, we have a
distinguished panel of experts whose thoughtful approaches
about how to better prepare for the next pandemic. However, as
Dr. Janz notes in his testimony, non-evidence based practices
were being disseminated frequently at the time via the
Internet, social media platforms, and other non-peer reviewed
sources. Going down the panel, yes or no, does COVID
misinformation spread online undermine public health efforts?
Dr. Becker--Mr. Becker?
Mr. Becker. I would say any information that is
misinformation hurts public health.
Ms. Arthur. Absolutely.
Senator Lujan. Dr. Janz.
Ms. Cicero. Yes. Yes, it does.
Senator Lujan. Mr. Becker, you also state that we must
operationalize systems that capture uniform data quickly and
shared across state lines rapidly. In your testimony, you state
that eliminating paper based reporting is the best way to
achieve that goal. How can we better equip and prepare rural
providers who at times do not have access to the broadband
needed to move away from paper based reporting?
Mr. Becker. Yes, I think, Senator, you are hitting on a
fundamental problem that I am really hitting at with the
regional concept. Each region faces different infrastructural
problems, community problems, and we need solutions that
address that from the beginning of the process to the end of
the process at CDC. And that is going to be different in each
community, whether it is a broadband connection, whether it is
the lack of resources from a workforce. And we need everyone at
the table from the local, state and Federal level to help solve
those problems and direct funding that can directly impact
those problems.
Senator Lujan. It is just a reminder of why the
infrastructure package must have the goal of 100 percent
connectivity across the country, and it would allow us to have
better health outcomes as well based on your advice there, Mr.
Becker. I appreciate that. Mr. Becker, Ms. Cicero in sustained
investment--is sustained investment in public health
infrastructure the best way to ensure that we are receiving the
best on the ground data?
Mr. Becker. Certainly sustained support has to be there for
the long term. We can do a lot with the money that has been
given, but it will only triage the problem. The sustained
funding will get us to that next mile.
Senator Lujan. Ms. Cicero.
Ms. Cicero. Yes, thank you, Senator. We do need that
bolstering of capability around data. Right now, we don't
know--we don't have a central way of tracking outbreaks in
schools. We don't have real time data to let us know if when
someone is infected, which variant they are infected with. We
are beginning to do this. It takes a while with the funds that
are appropriated to be usefully used. It takes a while to scale
up those systems, but that will be very important to do going
forward.
Senator Lujan. Appreciate that. And I echo the concerns
raised by Chair Murray about better data collection by race and
ethnicity. Dr. Becker, you mentioned challenges faced by tribes
in collecting data. How can these challenges be overcome?
Mr. Becker. Thank you, Senator. Yes, in the State of
Washington we have 29 tribal Government affiliations, and that
is not represented in the data systems as we collect them. And
right now what happens is our epicenters and our tribal
partners go in and correct that data and accurately reflect it.
But that is a labor intensive processes and we need to design a
system that allows us to collect it right up front.
Senator Lujan. My understanding is IHS is still not
releasing the data they have state by state. That has also
created challenges and us being able to understand where
progress is made and where it is not and how we can refocus our
efforts. I very much appreciate your attention and response in
that area, Mr. Becker. Dr. Janz, New Mexico faces a significant
health care workforce shortage. As a result, caring for the
mental health of our providers is especially important. How can
we better support the mental health needs of our health care
workforce?
Dr. Janz. I think we first need to engage with these
frontline staff to understand what their exact needs are. I
think every individual is going to have different needs,
especially when they have been dealing with the stress of
taking care of a high volume of COVID-19 patients. And thinking
that one solution for every hospital in the country is going to
meet all those needs is probably an inadequate response. We
need to engage the stakeholders here, which are those frontline
workers, and figure out what are their needs and how can we
best develop systems to fill those needs.
For example, if one particular hospital, the nurses in that
hospital and the physicians have a greater need for mental
health resources, those resources should be made readily
available. They should not be difficult for them to seek out
and obtain those resources. If a different hospital has a
different need, for example, among their workforce, then the
system should be nimble enough to respond to that need.
But there needs to be response everywhere, because in this
time of COVID, what happens in someone else's hospital affects
my hospital, affects the hospital next to it and around the
country. And so if one hospital is suffering, all of them will
continue to suffer.
Senator Lujan. Appreciate that. And Chair, I do have a line
of questioning around Project Echo. I will submit them into the
record. As well, just very much appreciate the panelists for
being here today. And with that, I yield back.
The Chair. Thank you.
Senator Tuberville.
Senator Tuberville. Thank you, Madam Chair. Thank you for
being here today. And this is for the whole group, just a short
answer would be great. We spent trillions of dollars, the
Federal Government has on COVID relief legislation. I am a firm
believer that just throwing money sometimes is not the proper
answer. What we need is people and a plan. Aside from spending
more money, what would you do differently, Mr. Becker, on our
next go around for whatever we have coming our way?
Mr. Becker. Thank you, Senator. And I completely agree that
just throwing money at the problem is not going to solve it.
What I suggest is actually having the partners sit down at the
table and help design systems that are localized to their
community. And that is why I talk about having the local
partners there, the state partners there, but also our Federal
partners there not just as funders that send off a contract and
say get it done, but to help us knock down those roadblocks and
barriers that come up as you implement a plan, because the plan
is never going to be what you wrote on paper when you begin
with. But we don't have that Federal partnership on the other
side to help knock down those roadblocks.
Senator Tuberville. Thank you.
Mr. Arthur.
Ms. Arthur. Thank you, Senator. I would actually make sure
that all the data we are getting as we are learning about the
disease is very quickly disseminated to both the academic and
industry sector. I think that was a place where there was some
delays and particularly small and medium sized companies didn't
necessarily have access quickly to the natural history data,
all the different science, the outcomes which could have
allowed them to move even faster in their development of
products.
Senator Tuberville. Thank you.
Dr. Janz.
Dr. Janz. I would echo the statements by my colleagues in
this panel. There isn't a day that we don't use data generated
by public health experts to plan what we are going to do in the
hospital that day, the next week, the next month, and over the
next few months. Public health infrastructure and data obtained
in real time from these experts has been vital in our response
to the current pandemic and any future pandemic.
Senator Tuberville. Thank you.
Ms. Cicero. Senator, I agree wholeheartedly with the
comments that are made by my fellow panelists. So I will pick a
different issue. And that is, again, I think we need to be much
more proactive in getting ready. But we are not going to be
able to scale up contact tracers, have lots of different
therapeutics, etcetera, in the midst of a surge during a
pandemic.
We have to prepare in the future to do that. I think for
medical countermeasures in particular, we need a strong PHEMSE,
as Ms. Arthur said, we also need a very strong ASPR that is
able to be nimble and flexible and have the authorities that it
needs to work quickly and deploy resources effectively in the
middle of a crisis.
Senator Tuberville. Thank you. This is another question for
the whole group. We will start with you again, Mr. Becker. We
spent $41 billion on COVID research, $41 billion. And kids are
getting ready to head back to school. Are any of you all aware
of any studies that we have focused on for the effectiveness of
masks for kids under 12 years old? That is getting ready to be
a huge topic. Mr. Becker?
Mr. Becker. Thank you, Senator. That is outside my lane of
expertise.
Senator Tuberville. Okay.
Ms. Arthur. Me as well. I don't know of any----
Senator Tuberville. Dr. Janz.
Dr. Janz. It is also outside my line of expertise.
Ms. Cicero. Senator, thank you for that question.
Senator Tuberville. Found somebody that knew something
about it. Good.
Ms. Cicero. I think that opening schools and how safe our
kids are in schools in the fall is on everyone's mind right
now. And I am not aware of a study that focuses on the
effectiveness of masks for children under 12. But again, this
is an area where we shouldn't--we need to develop better masks
that are reliable, that fit different kinds of faces, that are
wearable all day, that kids can communicate through.
I do think that it is very reasonable in states and
localities where cases are surging, and hospitalizations are
beginning to fill up to maybe reimpose some mask mandates in
those areas. And certainly for our kids in school, for now, it
would be important that they wear those masks indoors.
Senator Tuberville. I hope that what we have just gone
through for the last year and a half, that if we start to wear
these masks again, God forbid, heaven help us, that we would
come up with a mask that everybody understands it actually
works to some degree. Because you see people wearing masks that
obviously they don't work. They are just wearing something put
over their face. I heard very early from doctor friends of mine
that said, listen, nothing but N95 really helped. Everything
else is kind of shut the door. Is that your thoughts?
Ms. Cicero. Thank you, Senator. Not completely. They--I
believe that wearing the cloth masks that we have had available
has helped to reduce transmission, especially indoors when we
know the risk of COVID transmission is much higher. And we--but
we can do better. And I think that we haven't innovated in this
area, and we haven't really tried hard.
I know that BARDA has recently had a massive innovation
challenge. That is a good thing. I think we can do a lot more
in this area to get better masks for the general public and
also to be able to generate them quickly. I think when people
buy masks in the CVS, they should know, first of all, they are
available and second, they are certified. And so they are
effective at reducing the risk of infection.
Senator Tuberville. That is a good idea, certification.
Thank you, Madam Chair.
The Chair. Thank you.
Senator Murphy.
Senator Murphy. Thank you very much, Madam Chair. Thank you
for convening this hearing. I would have hoped for a little bit
more robust answer from the panel with respect to the efficacy
of masks. I mean, we have enormous amounts of pretty well
reliable data telling us that this is an incredibly effective
means of controlling the virus. We have to look no further than
the story of influenza in 2020 to know what a difference it
makes, even if you are not all wearing N95 masks. We
essentially eliminated the flu over the course of the past
year. Why? Because the flu is much less contagious than COVID-
19.
I share my--the hopes of Senator Tuberville, that we can
get to a point where we are not required to wear masks in any
setting. But I think it is important to tell the American
public that they work. I wanted to turn to you, Ms. Arthur, to
talk to us for a second about the issue of intellectual
property protections.
The United States has some of the strongest IP protections
for medicine in the world. We should be proud of that because
we save a lot of people's lives through the innovations that we
create in the United States. But our IP protections were really
never envisioned for a setting like this. They were never
envisioned to provide protection in the case of a pandemic with
a massive built in Government marketplace buying technology or
medicines that every single American is going to need or
desire.
The risk here is pretty obvious that the amount of profits
that could be made by private industry in this case is
potentially limitless. And the question is whether, especially
as we enter a world in which we may be needing annual booster
shots, essentially get potentially paid for by the US
taxpayers, guaranteeing a marketplace for decades for the small
number of companies that have produced the vaccine, whether we
need to sort of step back and have a conversation about perhaps
modifying the level of IP protection specific for these
technologies.
Obviously, we have had this conversation internationally
through the WTO. But make the case as to--I assume BIO is
probably very protective of IP protections. So make the case as
to why from a taxpayer standpoint, we shouldn't be worried
about the amount of money that can be made in the out years
when it comes to vaccines and boosters.
Ms. Arthur. Thank you, Senator, for that question. I will
say yes, indeed, at BIO we are very protective of the
intellectual property our companies work hard to arrive at. I
think that actually you should think of these products as an
investment, not just in COVID, but all the other things that
these technologies will be able to do that will save lives both
in the short term and the long term. And that intellectual
property is the base of that ability for companies to continue
to do the R&D they should do for, commercial and of course
future pandemic indications.
From many of our companies, particularly small and medium
sized companies, this intellectual property that they have
garnered for this technology they have worked on is the
foundation of the valuation of that company. I think it is
extremely important to understand that moving or loosening the
intellectual property protections we have in the U.S. could
have a number of negative effects. It could certainly limit
companies' willingness to respond to the next pandemic. I think
that is extremely important to understand.
But in addition, it could actually devalue some of those
companies for some of the other uses they have for that
technology as investors worry about them losing the
intellectual property rights. And then I think last, it could--
it really does devalue the great--the great exercise--the great
abilities of the U.S. Government and the U.S. as a leader in
biotechnology. I do think, however, that in the future,
remember that the commercial value of these products will
actually lead to more competition, not less.
There are companies behind the three that have vaccines on
the market now who are going to have better innovations. Maybe
it is lower dosing, maybe it is less dosing, maybe higher
efficacy, better safety. This actually will spur more companies
to work on great vaccines and therapeutics for COVID.
Senator Murphy. I don't know that--I appreciate the answer
and I want to give you the chance to make the case, but I am
not sure I agree. I think that given the exceptional nature of
this moment and what it will hopefully be the exceptional
historical nature of this pandemic, it is not a danger to the
overall bottom line of any individual company or the industry
writ large to create some special set of rules for these
technologies, given the fact that we are spending trillions of
dollars in a way that we don't for any other comparable disease
or virus on an annual basis. So I look forward to continuing
this conversation. And I appreciate the chance to talk about
this. Thank you, Madam Chair.
Ms. Arthur. Thank you, Senator.
The Chair. Thank you.
Senator Scott.
Senator Scott. Thank you, Madam Chair. At a risk of
continuing the conversation with Senator Murphy. I am prepared
to ask the question. I am unwilling to ask the question, so I
am going to do it anyway, Ms. Arthur. I believe that had it not
been for our ability to partner with the private sector, we
might not be sitting here today. I believe that if we were
unable or unwilling to recognize that perhaps the greatest
economic engine, the greatest engine of innovation our Nation
has seen and health care doesn't come from the Government, it
comes from the private sector. But if, in fact, we had not had
Warp Speed partnering with the private sector, we would not be
having a conversation in person in this Nation and maybe in the
world, and that the death toll would be multiple times higher
than it is today. Am I in the realm of possible?
Ms. Arthur. I firmly agree. I think what was really strong
about Operation Warp Speed was the collaboration and the skills
that were deployed by industry with the help and advice of
Government, but really, the U.S. Government relied on what our
decades of experience with experienced and small and medium
manufacturers to really deploy the best of science for a really
important goal. And doing it in--I still marveling because I
have been in the vaccine business 25 years. I am still
marveling that we made these extremely important, efficacious
and safe vaccines in a year and deployed them in 6 months. It
is incredible what we have done.
Senator Scott. I remember sometime in April, May 2020, when
I think it was NBC that said that the theory that we were going
to have a vaccine within a year would take more than a miracle.
It was nearly impossible to have any appreciation or
expectation that somehow, some way, with all the great minds in
the world working together, we could do what we have done. And
so I do think we should have a longer conversation about the
power of partnership and the synergy of public private-
partnerships in many areas of Government. I think we could
easily miss the point of why we are having this hearing and why
we are able to have this hearing.
However, I have questions about virtual health and
telehealth, and I will get to those prepared questions. So
thank you for that. When I think about the pandemic, I don't
find many silver linings at all. The death toll is devastating.
The number of folks who have recovered but not fully is just
mind boggling. But I do see, however, as the possibility of a
silver lining is that perhaps the telehealth conversation
accelerated forward five or six or 7 years. But in that silver
lining, I think about in rural America or rural South Carolina,
where one out of four people don't have the ability to connect
because they have a flip phone, no phone or not a smartphone,
15 percent of Americans find themselves in the same category as
one out of near--almost one out of four rural Americans.
The telehealth platform is so important that we probably
need to spend more time investigating audio only in that
telehealth delivery system with integrity in the system to make
sure that we are talking to the patient if you can't see the
patient. I think this platform needs greater investigation, and
frankly, more resources. Thoughts on that? Let's start with
you, Mr. Becker.
Mr. Becker. Thank you, Senator. Yes, absolutely. I think
telehealth has advanced because of the pandemic and there is
infrastructural problems to getting it to the last mile in
rural areas. When we were at public health in Harris County, we
put the mobile telehealth on mobile vans and drove them out to
communities of need that didn't have access. And we found
community centers with extra space to set up the private room
so patients can come into the community centers they were
already visiting and have access to those services while they
were there. So there are solutions, Senator. But I think,
again, coming back to your previous--we need to work with our
local partners, but also our private partners to figure out how
to get that technology and those services out.
Senator Scott. Thank you. My last 30 seconds here. Dr.
Janz, my mother has worked in the hospital for the last 47
years. And I think about all of our emergency responders who
are willing to stick around and do their jobs in the face of
losing their lives. And I know that the importance of PPE and
obtaining the drugs that were necessary--did your hospital
encounter any problems or challenges with PPE or drugs?
Dr. Janz. Thank you, Senator. And thank you to your mother
for her service over all those years. We obtained and
maintained adequate supplies of PPE and medicines during the
pandemic. It did require lots of work and effort, asking lots
of other hospital systems around the state and country to help
us out with those items. But we were able to maintain those
items. And by just the generosity of our community. In spring
of 2020, community members were dropping off N95 masks in the
lobby of our hospital for us to use on the scale of hundreds to
thousands of them a day. It took a village, but it worked.
Senator Scott. I will say, as my time has run out, Madam
Chair, that the excellence that we have seen in America's
health care system is a marvel of the world. And I think bills
like my Made in America Act that would provide more reasons to
bring your PPE home and your generic drugs being made here in
America is a necessary component of what I consider resiliency.
Our Nation needs to be more resilient when it comes to
challenges. And one of the ways for us to get there is for us
to work in a bipartisan fashion together to bring home some of
those really important resources to our Nation. Thank you for
the extra minute.
The Chair. Thank you.
Senator Baldwin.
Senator Baldwin. Thank you, Chair Murray. I have long
prioritized the need to prepare for a pandemic influenza and
have worked with Members of this Committee and back in my House
days on the Energy and Commerce Committee on that mission. And
we have made progress. But I think we can build on this
progress as we plan for unknown disease threats. I will soon be
introducing the Disease X Act to do exactly that. Specifically
the Disease X Act would provide BARDA with the additional
resources needed to stand up a medical countermeasures program
aimed at developing responses to unknown viral threats or
disease x.
Ms. Cicero, you noted in your testimony that there are
certain viral families that are more likely than others to lead
to a large scale outbreak. What do we know about these viral
families that are cause for concern? And why is it critical
that we make an investment sooner rather than later in a
disease x model?
Ms. Cicero. Thank you for that question, Senator. When we
look at the characteristics of pandemic pathogens that are most
likely to result in a large scale outbreak, first of all, we
look at the viral families that have been known to infect
humans in the past, and then those that have the kinds of
characteristics like high transmissibility, high lethality, and
also asymptomatic spread.
When you pair that with the fact that you don't have
existing countermeasures already in the stockpile and ready to
go, that is a terrible brew for the kinds of viruses that will
cause a problem. And the handful of viral families that we
would recommend is important to start with are things like the
paramyxovirus family, which has deadly viruses in it, like
Hendra and Nipah.
Surely the coronavirus family, which is SARS-1, SARS-CoV-2,
as we have seen, and also MERS, the orthomyxoviridae families,
which avian flu is a member of that, as well as the poxvirus
family. So it is those types of families that we know could
produce a member that could become a pandemic. The reason why
we need to invest now and not wait for the pandemic pathogen du
jour to present itself is because it takes a long time to
develop the kinds of platforms and technologies that will work
well and could be quickly adapted into effective and safe
vaccines and therapeutics and even diagnostics.
I think it is a wonderful success story that Operation Warp
Speed has produced in less than a year three different vaccines
that Americans are able to use. But we must remember that
coronavirus research started after SARS-1 in 2003. And then
there was MERS, which is also part of the coronavirus family.
That research also. So if you look back, it is almost,
research since--15 years of research and over $12 billion that
were invested to allow us to be able to generate these vaccines
quickly. So we need to prepare in advance.
Senator Baldwin. Thank you. Like many of you, I view this
pandemic as an opportunity to reset and make us better prepared
going forward. But I want to caution that we have planned
before. It has been widely reported that the Obama
administration left behind a pandemic playbook intended to
inform the work of the incoming Administration. When I was
serving on the Energy and Commerce Committee in the House, I
remember working with George W. Bush administration for the
pandemic influenza implementation plan.
When I look at how little of that guidance in these two
documents was put to use by the previous Administration, it
makes me wonder how we can reset, provide guidance moving
forward, and expect that won't be gathering dust in a
department somewhere around Homeland Security or HHS.
I don't know, it's not fair to ask you this, but Ms.
Cicero, how can we best equip our public health preparedness
infrastructure to really build on what already exists and use
it, and then chart out a path to responding to future
pandemics?
Ms. Cicero. Yes. Thank you for that question, Senator. And
it is true that these playbooks have existed in the past. We
don't think just because they weren't deployed and used and
followed strictly during this pandemic that playbooks aren't
useful. It is very useful. Coordination across different
agencies and sectors is so difficult that kind of coordinating
playbook of who is doing what, who is responsible for what is
very, very important. At the same time, we can't just live by
the playbook. We have seen that we have had a lot of curveballs
thrown at us during this pandemic and we have to have some
flexibility and nimbleness baked into the system so that we are
able to pivot as necessary.
Our Center for Health Security at Hopkins over the years
has done a number of tabletop pandemic exercises to test
capabilities, and we would never have done something so
dastardly as having a delta variant in the middle of kind of
the recovery from COVID. I mean, it would just be unheard of--
but that has happened to us. And so a playbook can't give us
everything, but it is fundamental to be the basis of the
planning.
We have seen too, even if we had followed the Obama
playbook, I believe that we--our public health infrastructure
is still woefully under-resourced and not quite in the 21st
century. So we have to get those capabilities so that they can
be deployed according to national plans that makes sense.
Senator Baldwin. Yes. But the fact is, we didn't use the
playbook, so----
Ms. Cicero. I don't think so.
Senator Baldwin. Alright. Thank you.
The Chair. Thank you.
Senator Braun.
Senator Braun. Thank you, Madam Chair. In observing this
journey from the beginning, I would like to reflect what
Senator Scott said. I think it is amazing how the private
sector--I remember early on CDC, FDA kind of maybe arguing
about who was going to control the dynamic. Thank goodness it
went the way it did and a modern miracle that we got the
vaccines done that quickly. I am more concerned about this. We
got the delta variant. When you look at vaccinations, it has
got to be 80, 85 percent of the world, technically.
I was in the logistics business before I got here. It seems
like mission impossible, and I think we need to keep pushing to
do the best we can. Begs the question, though, that this is so
disproportionately affected, 1 percent or under of our
population. And I would like you to each take maybe a minute or
less, I would like to hear all four opinions, doesn't it make
more sense to put resources into where you really go after the
therapeutics to focus just--because of the numbers, where you
got to focus on maybe 1 percent to have something that looks
like it is already eluding vaccinations.
I think you have got to do both. But I have not heard
enough conversation about putting disproportionate resources
into therapies that when you do get critically ill, and
especially focused on the data we have got on who does get
critically ill, shouldn't we be pivoting to putting more effort
and resources on therapy while doing vaccines? Start with Mr.
Becker.
Mr. Becker. Thank you, Senator. I think we are going to
have to do both. And I think you have to leverage and triage
what the immediate need is of the virus at the time. And that
is going to require pivoting at multiple points, probably the
way this virus has handled itself.
Ms. Arthur. Thoroughly agree. It is extremely important,
Senator, that we have therapies not just that can potentially
treat early stage disease, which I think we are now, but the
new therapies that we see coming that could treat the more
serious consequences and get you out of the hospital faster
will save lives and save money as well.
Dr. Janz. I completely agree that a combination approach is
going to be vital. The ad coming out added and the therapy
front, though, is remember all of the therapies developed to
date to treat patients with COVID, especially critically ill
adults with COVID, none of them are curative. They may save
some lives, but many patients will still die, even with these
new therapies that have been developed. So I don't think that
only a therapeutic approach here is an answer. The preventive
approach is still vital.
Ms. Cicero. Thank you, Senator. I agree with Dr. Janz. I
agree that we need to do both, but we also should remember what
vaccines are intended to do. When we talk about vaccine
effectiveness, it doesn't mean effectiveness against any
infection at all of the virus. Instead, it is effectiveness
against clinically apparent disease.
We have seen, while cases are still rising, that as
compared to last year, hospitalizations, deaths are about half
of what they were before. And that really is due in large part
to vaccination. But certainly we support the development of
therapeutics as well because they have an important role to
play.
Senator Braun. Then I will be more specific. Do you think
that we can outmaneuver this devious virus through vaccinations
only? And I know you have just said you would like a combined
approach. And do you think conferred immunity from infection is
an ally in the effort as well? Mr. Becker.
Mr. Becker. Thank you, Senator. I would just say that is
probably outside my lane of expertise so I will pass to my
colleagues.
Ms. Arthur. I think that it is extremely important to
actually focus on the vaccination campaign because I think it
is the longest term way to protect us. The vaccines are showing
that they work against the variance. And I think innovation
will actually allow us to keep up majestically.
Senator Braun. Logistically we can actually pull that off
across the world?
Ms. Arthur. I think we can. I think the industry, GAVI, the
countries that are working hard to get--do just what we did in
the U.S., get these vaccines as close to----
Senator Braun. My comment would be that logistically it
looks like we are not even though I wish we could. Even when
you look at the most kind of agile country in the world
ourselves, with the difficulties we are running into, and this
has nothing to do with the anti-vaccine because we are lucky we
got a vaccine. It is just the mechanics of pulling it off.
Ms. Arthur. I agree, Senator. It is definitely complicated,
but you have seen a lot of innovation in the way we are doing.
And for treatments, I think what is hard is, is that some of
the treatments have a very complex way of being given. So we
could probably have the same logistics issue there. If we had a
simple pill we could give, I agree with you that might help us
save lives. But I think vaccination has an infrastructure
globally where once we get the vaccines there, they can be
deployed.
Dr. Janz. I would point us toward all the pandemics and
diseases of the past. Fortunately, they have been eradicated by
vaccines around the world. This has been done before. This can
be done again. We need to root cause analyze why it hasn't
happened yet. Figure out what those reasons are, why we haven't
had as much vaccine uptake, and then address those causes and
attack this from that angle.
Senator Braun. Seems to be most of the other ones have not
been that transmissible and they haven't looked like they turn
into variants that quickly.
The Chair. Senator Braun, we have a vote called and we have
got a few more Senators here. I am going to ask you if we can
please wrap quickly.
Senator Braun. Thank you.
The Chair. Thank you.
Senator Rosen.
Senator Rosen. Thank you, Chair Murray. And thank you,
everyone, for being here and testifying. As Dr. Janz just said,
no therapy is curative yet. I do hope that we get there, but it
will take time. And so I want to talk about booster shots. We
continue to work toward fully vaccinating our Country. We have
to plan ahead, and we have to ensure a robust and effective
system for any booster shots that might be needed in the
future, particularly for some of our vulnerable populations.
So, Dr. Janz, some early research is showing promise for immune
compromised patient patients such as organ transplant
recipients. We have increased--they need to have increased
antibodies to fight COVID after a third dose possibly of the
vaccine. More reporting has just recently come out about this.
So has the research determined what is sufficient antibody
level would be to provide protection? And is there currently a
standard testing protocol for health care providers to test
their patients, especially the most vulnerable, to see what
those levels are, and if, in fact, they might need the booster?
Dr. Janz. I am aware of the recent research that was
published that in patients specifically solid organ transplant
patients, where they--when they received a third vaccination
dose, that they had almost a 50 percent increase in their
antibody response. What level is protective is outside of my
area of expertise.
My specific environment that I work in University Medical
Center in New Orleans, which serves an underserved patient
population, and patients that are immunocompromised, we need
the answer to these questions to know how to take care of these
patients better. And we look toward the experts in giving us
those answers.
Senator Rosen. Yes, I think it is really important for us
to be able to have the scientists tell us what those levels are
so we can determine the next case, and if we need a booster,
when we need it.
Ms. Arthur. Senator, I will say that there is a lot of
really great research going on as we analyze the small number
or the small number of breakthrough cases to existing vaccines
that will help us establish what that correlate is. They will
test people, have a breakthrough, and see where their
antibodies are. That data taken together allows us to see what
the number is we should watch for that tells us what protection
will be long term.
Senator Rosen. Yes, that will be helpful all around the
world, I think. And do you have any information, anybody on the
panel for the latest research on a possibly a universal
booster, so regardless of what vaccination you may have
received, you can just go ahead and get a booster?
Ms. Arthur. There are several studies going on. There are
studies going on with what we call heterozygous boosting where
they are looking at if you got J&J, you get boosted with Pfizer
or Moderna and other products that are right behind that are
also in those studies like Novavax's product.
We will certainly see whether we can boost across the
various platforms. I think, in addition, companies are looking
at what we call the cross protection across new variants. And a
lot of this data we are seeing on whether or not you work
against delta or lambda is part of that assessment of how these
products work long term. And then some companies are looking at
actually adding more virulent strains to their existing
product. You may have what we call like a pan-corona vaccine in
the future.
Senator Rosen. Right. No, that is right. Thank goodness the
scientists are working so fast with the modern computing. It is
going to hopefully save the world. And speaking of computing
and everyone going around the world, we have supply chain
issues sometimes. So our domestic supply chain, I would like to
talk about that and the role of non-profits. I recently
introduced Expanding Access to Affordable Prescription Drugs
and Medical Devices Act, because we have to do more to shore up
our domestic supply chain.
Hopefully this is going to reduce drug costs and drug
shortages and buildup our domestic manufacturing capacity
through support of nonprofit drug and medical device
organizations. So Ms. Cicero, could you talk about the impact
that increased domestic supply of affordable critical drugs and
devices would have in our ability to strategically plan while
still going on in this pandemic, or God forbid, any future
pandemics.
Ms. Cicero. Thank you, Senator Rosen. And I do not have the
adequate background to talk in detail about the supply chain
issues for low cost drugs versus other kinds of drugs. But I
can reiterate your concern, and I agree that one of the major
lessons that we have learned from this pandemic is that we did
not have a resilient enough supply chain. We need to do more to
bring manufacturing into the United States. We need to know
where our supplies are coming from.
We need to make that more reliable so that it will be able
to surge in the middle of--if some kind of public health
emergency and have the supplies we need rather than losing
control of that and not being able to get lifesaving drugs to
people. And also PPE and other medical supplies that we need in
the middle of a pandemic.
Senator Rosen. Thank you. I appreciate all of your answers
and being here today.
The Chair. Senator Hassan.
Senator Hassan. Well, thank you, Madam Chair and Ranking
Member Burr. Thanks to all of our panel for being here today. I
want to start with a question to you, Ms. Cicero. You are very
familiar with the challenges we faced during this pandemic,
including the inability to manufacture and distribute essential
medical supplies and personal protective equipment to health
care workers. I recently introduced bipartisan legislation with
Senator Cassidy to help address these challenges.
You have spoken generally about the importance of being
prepared. But specifically, our bill would improve transparency
into the strategic national stockpile, authorize transfers of
expiring products, assist states in establishing and
maintaining their own stockpiles, and incentivize domestic
manufacturing.
Can you speak generally or if there are specific issues we
haven't addressed yet to the importance of investing in our
preparedness infrastructure, including the strategic national
stockpile?
Ms. Cicero. Thank you for that question, Senator. And as
Senator Burr referenced earlier, our strategic national
stockpile really was created with a bioterrorism mindset. And
it is time to break out of that, not to leave that behind, have
that to be included, but go beyond that. And I think that is
partially what resulted in the lack of transparency now in
understanding what is in the stockpile. People seem to know
little bits and pieces, but a lot of it is classified. And so
we should do what we can to increase the transparency.
Also I think it is appropriate to have a deep assessment of
the stockpile. Do we have what we need? How do we get what we
need? I agree with you that having stockpiles in states or
other locations to add on, not replace, our strategic national
stockpile would be a good thing.
I also think we should be thinking creatively about how to
make sure all our products in the stockpile don't sit on the
shelf and expire and then be thrown away. We could recycle or
we can give PPE and masks, etcetera, to hospital systems to
make sure they are being used and then replenish the stockpile
as we go rather than holding on to it all. So, thank you for
introducing that legislation. I think that would be an
improvement.
Senator Hassan. Thank you very much. Mr. Becker, the
clinical lab at Dartmouth Hitchcock Medical Center in New
Hampshire has been conducting COVID-19 test sequencing in
partnership with public health officials. Sequencing COVID-19
test samples helps us stay ahead of potential outbreaks, which
is especially important given the emergence of several
variants, including the delta variant that we are dealing with
right now.
The size of the sequencing data files can make data
exchange between hospital systems and public health officials
more difficult, which limits the ability of states to identify
emerging variants in real time. What specific steps can we take
now to ensure that labs and public health departments are able
to quickly and efficiently exchange data in support of their
efforts to track the delta variant?
Mr. Becker. Thank you, Senator. I think having the CDC set
standards and a secure system to allow that to happen like they
do in other disease sets would be an initial first step that we
should take.
Senator Hassan. Thank you. And then a question for you, Ms.
Arthur. Over the past year, companies have struggled to source
active pharmaceutical ingredients and Americans have struggled
to access essential medications. And this is really kind of a
follow-up on Senator Rosen's line just now. The Federal
Government has made significant investments through BARDA and
the National Institutes of Health to support development of new
medical countermeasures over the past year, including vaccines
and therapeutics.
However, our limited domestic manufacturing of essential
medications, including generics, leaves us vulnerable to
potential shortages of critical drugs during future public
health emergencies. What specific steps should we be taking to
increase domestic manufacturing of essential medications? And
how do we incentivize competition within this space in order to
improve supply chain resiliency?
Ms. Arthur. Thank you, Senator, for the question. So I
think that it is important to understand the reasons why
different types of companies are no longer manufacturing in the
United States. So in the biologics space that--the companies we
work with, there is actually lots of investment in footprints
of manufacturing here in the U.S., although there certainly
could be more, and there is many legislative actions to do
that.
For essential medicines, I think we need to look at what
are the different laws around the environmental impact, how do
they source the chemicals that they need in the U.S., and some
of--fixing some of these things could indeed encourage
companies to return some of their manufacturing for essential
generic medicines to the United States.
Senator Hassan. Thank you very much. And thank you, Madam
Chair and Ranking Member Burr.
The Chair. Thank you. Senator Burr, do you have a final
comment?
Senator Burr. Just ending comments, Madam Chair. All of you
highlighted BARDA, ASPR, a number of other things. 20 years
ago, they didn't exist. These are new entities and thank
goodness we have shown a little bit of vision at updating them
every 5 years to reflect what we have learned. Ms. Cicero, the
challenge with SNS is the Federal Government purchases 4
percent of PPE. The private sector purchases 96 percent of all
PPE. The Federal Government probably won't buy every time China
dumps.
We are going to rely on domestic manufacturing, and we are
going to incentivize. We don't have the control of making the
private sector buy the 96 percent. And if the N95 mask is being
dumped by China, 3M, Honeywell, all those manufacturers are
out. The only option is a payment for warming those facilities
that will only be outstripped by Congress's memory and they
will not fund it forever. So something that is sustainable is
got to be what we are shooting for.
Mr. Becker, your state received $154 million in 2020 and
2021 for vaccine preparedness, which can be used to upgrade
your data systems. That has nothing to do with the $1 billion
that Senator Cassidy alluded to. So I would love for you to go
back and look at that and see if, in fact, the state shared all
of that with our public health entities. There has been a lot
of criticism toward previous Administrations playbooks that
weren't used. Let me just make two statements. One, Congress
deserves as much criticism as any Administration out there,
period. End of sentence.
It doesn't have to be that way going forward. But we do.
Second, I remember vividly in Ebola when that Administration
didn't use the playbook that was written, we wrote it in
statute. The ASPR, Dr. Laurie was relegated over to run the
hospital, domestic hospital structure, not to be in charge of
this global outbreak and the coordination of treatment. That
was all taken out of her hands. Every Administration has
recreated the wheel and Congress 20 years ago had a vision of
what we needed, and we put it in place.
The last Administration followed most of it that was in
statute, so they deserve a little bit of credit for having
accomplished something that none of us thought they could do.
Senator Lujan talked about broadband and the need to stretch it
out. I have been having that conversation up here for 20 years.
I have no firm belief today that if we appropriate X amount of
money that last mile, Mr. Becker, is going to get covered and
that community health center is going to be covered. But I will
tell you this, if we stop focusing on putting cable in the
ground and we start funding the technology that is available
today, Starlink, the sister company to SpaceX, started by Elon
Musk, can deliver broadband delivery anywhere in the United
States today.
High speed, $50 a month average, and we don't have to put a
thing in the ground. So this belief that America has to sit
with or without, we can turn on the without tomorrow. It just
takes Federal Government coordinating with the technologies
that are out there. And Amazon is going to have a competing
satellite network up in 2 years. So we are going to have two
people delivering satellite direct broadcast competition. Last
thing I want to say is, if there is a takeaway, if there is a
headline today or tomorrow on what this hearing is about, I
would suggest to it is this, if you are not vaccinated, get
vaccinated.
We can work out all of the challenges that each one of you
have expressed to us because we are that good. But what we
can't do is we can't overcome bad decisions by people that sit
at home and say, even though this benefits my children, even
though this benefits my parents, this happened too fast, so I
am scared of it. Boy, that is a cop out. If Americans would get
vaccinated at the same rate they started when vaccines became
available, yes, we would be talking about breakthrough
infections--breakthrough infections, are 0.004 percent of the
individuals who have been vaccinated. Infections for the
population of the United States is a little over 10 percent.
Breakthroughs are just a speed bump in a parking lot
compared. What does it tell us? It tells us every American owes
it to everybody to get vaccinated. So my hope is that we are
well on the way to doing that. Thank you, Madam Chair.
The Chair. Thank you, Senator Burr. Especially want to echo
that last comment. That will end our hearing today. I really
want to thank all of our colleagues and I especially want to
thank our witnesses today, Mr. Becker, Ms. Arthur, Dr. Janz,
Ms. Cicero. We learned a lot. Very thoughtful discussion and I
appreciate all of your contributions.
For any Senators who wish to ask additional questions,
questions for the record will be due in 10 business days,
August 10th at 5 p.m.. The hearing record will also remain open
until then for Members who wish to submit additional material
for the record. This Committee will next meet Tuesday, August
3rd, for an executive session. Committee stands adjourned.
Thank you.
ADDITIONAL MATERIAL
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
QUESTIONS AND ANSWERS
Responses by Les Becker to questions of Senator Braun
senator braun
Question 1. As we look toward future disease outbreaks, even
localized ones, how important is it that hospitals be able to quickly
trace contacts so we can learn how a disease is spread?
Answer 1. Case investigation and contact tracing (CICT) is the gold
standard approach recommended by the Centers for Disease Control and
Prevention (CDC) for investigation, mitigation, and containment of
cases and outbreaks. CICT is typically conducted by the local public
health disease detective staff who initially interview a case, or
cases, to gather critical information to further educate the individual
and inform broader public health action at workplaces, congregate
settings, and the community-at-large.
While the notion is enticing to have CICT closer to patient/
provider interactions, three core issues could be detrimental to
community health. Those issues are (1) a duplicative workforce, (2)
complications with integration of data systems, and (3) coordination
and resource connections.
Duplicative workforce: While a hospital may hire staff to perform
CICT, it would require a robust and flexible workforce coupled with an
epidemiology workforce to ensure proper investigation considerations,
data integrity, and reporting. This workforce would only cover
potential cases that intersect with that particular hospital system and
not necessarily all the provider clinics throughout the state that
interact with potential cases. Therefore, one would still need to
maintain a similar workforce at the local public health department to
ensure statewide coverage. With two workforces providing similar
functions, this would lead to larger coordination issues and would
complicate the autonomies of local health departments prescribed by
state statues in ``home rule'' states--especially in healthcare systems
that span county lines.
Integration of data systems: With an additional workforce would
also come the burden on hospitals to work with public health on
universal data systems. Hospitals would need to ensure their systems
can cater to the ongoing local needs but also mesh with local and state
public health systems. This work is already conducted at the state
level to ensure continuity between all county health departments.
Adding an additional layer of hospitals to the mix will further
complicate technology upgrades to these data systems. Additionally, as
outbreaks and emerging diseases occur, they require rapid modification
and maintenance to existing systems critical to rapid, coordinated
response.
Coordination and resource connections: This workforce would need to
be continually trained and aware of public health actions and resources
available at the local level that is consistent with local public
health. There are pre-existing and ever-evolving partnerships
maintained at the local health department level to ensure current and
future response lessons are learned across all settings. Partnerships
and coordination are key to the day-to-day public health work. Care
coordination and connection are other aspects conducted by public
health. Adding another workforce that would need to maintain similar
relationships and knowledge could create scenarios of inconsistent
knowledge and messaging between local health departments and hospitals
that could confuse a situation.
Current state and moving into the future: There is always room for
improvement for better coordination between hospitals and public
health. There is tremendous public health value in improving
partnerships with healthcare providers. Providers are the trusted
messengers and often the first responder to a potential case in an
emerging situation. While notifications to public health through
electronic lab reporting are instantaneous, the information a patient
with potential disease receives while waiting for a test result can
impact the trajectory of an outbreak. Providers can let a patient know
what to expect from public health and what to do while waiting for a
test result. Public health and healthcare also need to continually and
rapidly identify communications and tools to be used for patient-
provider interactions for emergent situations. This includes some
education on the patient's role in protecting their loved ones and
their community.
Question 2. At the onset of the COVID-19 pandemic, the Trump
administration took swift action to expand health care accessibility
across the country to meet Americans' health care needs. Through the
temporary expansion of virtual medicine, our country has had the
opportunity to innovate as well as collect and analyze data around the
value and utilization of virtual medicine.
Qustion 2(a). A survey by the Harris Poll recently found that ``87
per cent of Americans receiving telehealth services during the pandemic
were satisfied with the services they received''. Yet, 82 percent of
participants in this study ``agreed that telehealth appointments were a
great option during the pandemic but doctors' visits are best in
person.'' While increased virtual medicine flexibilities has been one
silver lining of the pandemic, there are many factors--such as the real
value of health care services via video or phone and the potential for
fraud and abuse and duplicative services--that Congress must consider
before taking legislative action.
These are some of the immense considerations that Congress is
grappling with.
Question 2(i). What are the most salient lessons learned in the
virtual medicine space over the pandemic, and how do you recommend
Congress respond?
Answer 2(i).
1. Invest heavily in broadband access. U.S. Department of Health
and Human Service's recent announcement that Health Resources and
Service Administration invested $19 million will support expansion of
telehealth nationwide and improve access in rural and other underserved
communities; \1\ however, Congress must increase investment in
broadband across America. Broadband policy is critical to making
telemedicine a success. One of the largest equity issues we still face
as a Nation is lack of access to services due to lack of access to
reliable high-speed internet. Coverage and policy changes do not help
if patients cannot use the service due to structural limitations.
Consumers of telehealth need high speed and unbiased access, which will
allow smaller firm innovation to drive effective competition. Consumers
of health care via telemedicine should not be penalized with speed
reduction, data caps, or prioritized services based on which company
can afford to purchase prioritization of their services.
---------------------------------------------------------------------------
\1\ https://www.hhs.gov/about/news/2021/08/18/biden-harris-
administration-invests-over-19-million-expand-telehealth-nationwide-
improve-health-rural.html.
2. Payment methods and policies must support health care
practitioners. Working in a remote environment, the treating
practitioner does not have direct access to ancillary health care
providers (e.g. nurses, medical assistants or scribe support). This
raises general productivity issues for practitioners as they must
accomplish all support work for the visit, and in some cases American
with Disability Act compliance issues if those staff serve as an
accommodation. Some doctors anecdotally shared that productivity was
lessened by telehealth in systems that did not have adequate support
---------------------------------------------------------------------------
for the peripheral aspects of medicine.
3. Bring back the home office tax deduction. Many practitioners are
operating from home for telemedicine purposes and this additional
fiscal incentive could help maintain adoption.
4. Congress and U.S. Department of Health and Human Services must
lift CMS restrictions on telemedicine/telehealth treatments, and make
sure these coverage standards are identical in Tri-Care and Medicaid
where possible. Variation in coverage standards reduces adoption by
patients and practitioners and could lead to exploitation by private
insurance.
5. The Office of Management and Budget (OMB) may want to more
broadly consider how we assess the value and savings of telemedicine in
proposed legislation. The savings, while not always direct to the
encounter, are quantified for the patient in other ways such as travel,
quicker access and potential referral/intervention, the prevention of
critical escalation due to the frequency of basic care, reduced
potential for transfer injuries, and savings to those supporting the
patient.
6. Congress must consider policies to review use of artificial
intelligence to reduce the potential for large scale unintended
consequences and disparate outcomes. As larger data sets are gathered,
due to the increase in telemedicine and expanded use in Electronic
Medical Records, the application of artificial intelligence is growing.
With this progression we are seeing documented results nationally
showing significant unintentional bias against marginalized
populations. Federal agencies must be given funding to evaluate and
approve use of artificial intelligence tools in health care settings to
reduce the potential for large scale unintended consequences and
disparate outcomes.
7. Authority for the practitioner, housed in state law or policy,
to reject the visit as not appropriate for telemedicine. In Washington
State, the Washington Medical Commission has adopted a policy that
explicitly stated this discretion for doctors and physician assistants.
\2\ To a large degree health system operators also adhered to that
standard.
---------------------------------------------------------------------------
\2\ https://wmc.wa.gov/sites/default/files/public/documents/
TelemedicineAndContinuityOfCarePOL2018-01.pdf.
8. Respect and encourage license portability through new and
existing compacts between the states. Medical doctors (allopathic and
osteopathic) have what is arguably the most successful compact with 35
member states and seven more under consideration in state legislatures.
This compact was heavily utilized throughout the pandemic and is
---------------------------------------------------------------------------
considered an essential portability tool.
Question 2(ii). Does the data available support the permanent
extension of certain virtual medicine services, or do we need more
before we discuss permanency of pandemic virtual medicine
flexibilities?
Answer 2(ii).
1. With obvious exceptions, health systems in Washington activated
near total telehealth systems for the majority of patients during the
early days of the pandemic. The overwhelming results show telemedicine
can work for most patients, but it is not perfect. It was clear that
practitioners need certain support. Those specific supports are
discussed above.
2. Harris polling data. Based on health care provider complaints we
have received thus far in the pandemic, some patients are simply not
comfortable with telemedicine visits and will never opt for them. This
is acceptable and should be allowable going forward. With that in mind,
it is possible the Harris poll cited is accurate in both statistics.
Polling answers are likely not mutually exclusive depending on the
question asked and demographic polled. Similarly, our demographic data
indicates there will be a subset of practitioners, independent of
specialty area or age, that simply will not participate in telemedicine
as a modality unless forced. This avoidance should also be allowable
going forward.
3. Notably, we did not see increased allegations of fraud regarding
telemedicine since the onset of the pandemic.
4. Reduced costs through telemedicine are frequently only
experienced by the patient's side of the equation but not the
practitioner or the system. Patients, and to some degree the system,
benefit from earlier intervention at a basic level which reduces costs.
Chronic disease management and monitoring is a classic example of this.
On the practitioner side however, the savings are not significant
enough to warrant a deviation from payment parity. Direct to Consumer
telemedicine companies may benefit from reduced overhead, but they
offer limited services to patients and are more beneficial to contract
with larger systems to offer those limited services as an extension.
The practitioner did not go to 75 percent of their medical school, the
system is not paying for 75 percent of practitioner service, and the
brick and mortar system and IT infrastructure did not cost 75 percent
less to build.
Where is the reduced overhead? By paying practitioners less, there
is less incentive to try a new modality and that will prevent
appropriate telemedicine expansion.
5. Overall, the permanent extension of certain pandemic
flexibilities is likely warranted. Many groups such as Center for
Telehealth and e-Health Law (CTeL) and regional health systems have
gathered data showing increased adoption by patients and practitioners.
What that data supports comes down to how OMB scores the bills that
establish the changes. As discussed previously, it is not always about
direct savings, but downstream savings as well, which are sometimes not
considered or more difficult to quantify. A reasonable approach may be
to have Centers for Medicare and Medicaid Services (CMS) expand their
trial and assessment of extension of virtual medicine services so
relevant data may be gathered where little currently exists in those
use cases where it is needed.
6. Care should be taken to harmonize making pandemic flexibilities
permanent. There needs to be suitable messaging and clear understanding
of what is possible by CMS or others. For example, when CMS lifted
geographic restrictions on treatment of beneficiaries via telemedicine.
There was significant confusion that this change only applied to
reimbursement as opposed to legality of practice, which is retained by
the states.
7. The most difficult part of this conversation is appropriate
treatment vs. appropriate modality. This usually comes down to audio
only and asynchronous or message interaction. However, certain
modalities simply are not conducive to effective assessment, diagnosis,
and treatment for specific conditions and use by certain professions.
Again, CMS determination of effectiveness and coverage could assist in
clarifying the landscape on a Federal level and many others would
likely follow suit. Mandating reflective standards in Tri-Care and
others could further that goal.
______
Responses by Phyllis Arthur to questions of Senator Braun
senator braun
Under the direction of the Trump Administration, HHS established
Operation Warp Speed, a public-private partnership that accelerated
vaccine, therapeutic, and testing development, all while maintaining
proper safety and efficiency standards. As devastating as the COVID
pandemic has been, a positive outcome has certainly been greater
efficiency in medical countermeasure innovation.
Question 1. In your testimony, you discussed the importance of
public-private partnerships in facilitating efficient medical
countermeasure research and development--what are the most important
lessons that BIO has extracted from the pandemic in the therapeutics
space?
Answer 1. Senator Braun, thank you for the thoughtful question. I
want to agree with your assessment that Operation Warp Speed (OWS) was
highly successful in its goal of partnering with industry to rapidly
develop and distribute medical countermeasures during the pandemic.
Much of that success is due to companies in the countermeasure space,
large and small, stepping up and dedicating resources to combating the
pandemic. It is also a credit to the design of OWS which combined the
industry leadership and expertise in Dr. Slaoui's role along side
General Perna and HHS's know-how and capabilities. OWS was effective at
quickly identifying potential successful countermeasures, contracting
with the companies, accelerating their trials, and scaling up
production of the final product.
From the perspective of industry, the initial pathways for products
were clear. OWS had the needed resources to ``take multiple shots on
goal'' and support many different products and types of products in
both the vaccine and therapeutics space. With OWS the NIH established
the Accelerating COVID-19 Therapeutic Interventions and Vaccines
(ACTIV) program, which coordinated research strategy for prioritizing
and speeding development of the most promising treatments and vaccines.
The Administration through OWS identified there were numerous products
in development, all competing for patients to participate in clinical
studies. ACTIV worked to coordinate and streamline processes to make
the best use of biomedical research resources and testing of
preclinical and clinical compounds. It also worked to prioritize the
most promising candidates and move them into clinical trials in a way
that was safe and efficient. This system was successful in streamlining
the development process, and the well-funded OWS was able to contract
with companies and purchase products as they were finishing
development.
Ultimately, OWS became a supercharged version of what many had
envisioned the ASPR role to be. It was a clear leader in planning the
response that drove product development and procured products from
their private sector partners. OWS showed that given the resources and
authority, the Public Health Emergency Medical Countermeasures
Enterprise (PHEMCE) and industry can rally to respond to any health
security threat.
As OWS went along, eventually a decision was made to focus on
vaccines. Therapeutic funding and opportunities began to disappear, and
that culminated in the COVID therapeutic BAA being pulled from BARDA.
BIO has expressed its disappointment in that decision, and with a
sizable portion of the population still unvaccinated and variants on
the rise, the need for therapeutics is more important than ever.
Additionally, we are now able to look at COVID with a more long-term
view and see the need for a second generation of COVID products, but as
of now there are limited pathways for the companies working in this
space to partner with the Government. I would urge Congress to continue
to invest in COVID therapeutics. Those investments will pay dividends
not only by saving lives from COVID but may also better prepare us for
the next pandemic.
______
Response by Anita Cicero to questions of Senator Rosen
senator rosen
As we have seen, this pandemic has had a significant impact on most
aspects of our medical and public health systems. As we work to
strengthen our critical safety-nets and better prepare for the future,
we must not overlook the importance of safeguarding our Nation's blood
supply. There have been shortages throughout the country. Just last
month, an urgent call for donations went out to residents in the Las
Vegas area to help with blood donation shortages so cancer patients
could receive the treatment they needed.
Question 1. It's not just the volume of blood donations, but also
the supplies needed and the staff who are essential both for collecting
the blood donations but also managing the supply at our blood banks.
Ms. Cicero what are your recommendations for how to include
consideration of safeguarding our blood supply as we look at improving
other critical public health infrastructure and our medical domestic
supply chain? Dr. Janz, please comment if you have anything to add as
well.
Answer 1. Thank you for that question, Senator Rosen. We are
experiencing a blood and platelet shortage in the United States. I
agree that our country needs to be able to sustain the infrastructure
necessary to maintain a sufficient supply of blood donations and other
essential medical services even during pandemics and other public
health emergencies. It is important to understand that hospital
preparedness and pandemic preparedness extend well beyond the hospital
walls, into communities with other vital healthcare related facilities
and services, such as blood banks. In order to minimize the disruption
of services during shocks to the healthcare system, blood banks need to
ensure that they have appropriate emergency staffing plans in place.
Employees of blood banks, including nurses and phlebotomists, must be
appropriately supported and supplied with personal protective
equipment, training, and infection control practices that ensure their
safety and their willingness to continue working even during times of a
surge in cases. Blood banks should also join and play an active part in
regional healthcare coalitions. Healthcare coalitions facilitate
information sharing among participating organizations, promote
situational awareness, provide a way to share resources among members,
and serve as a link with regional authorities. During `peace times',
healthcare coalitions also support pandemic exercises and drills, so
that members such as blood banks can pressure test their procedures and
pandemic plans, including plans for successfully handling the complex
logistics of managing the blood supply during infectious disease
outbreaks. As we continue to digest lessons learned during the COVID-19
pandemic, it will be important to assess the role and performance of
healthcare coalitions in the response. If the assessment determines
that healthcare coalitions did not play a beneficial or proactive role
during the COVID response, measures should be taken to address any
limitations or challenges that inhibit their performance. Apart from
healthcare coalitions, public health authorities should take into
account the critical role that regional blood banks play and ensure
that public health strategies and communications (including those
related to `stay at home' recommendations) do not inadvertently
discourage donations or the provision of other daily health needs.
______
Responses by David Janz to questions of Senator Rosen, and Senator
Braun
senator rosen
Throughout the pandemic, we have seen the important role mobile
clinics have played in delivering lifesaving health care and COVID-19
vaccines to our most vulnerable patients, particularly those in rural
communities. I was incredibly grateful to FEMA for sending two mobile
trailers on vaccination routes across rural Nevada, where volunteer
nurses and doctors were successfully able to deliver over 7,600 COVID-
19 shots into arms. Allowing providers the flexibility to meet patients
where they are is especially vital in our rural communities. That's why
I've introduced bipartisan legislation with Senator Collins to expand
access to mobile health clinics and ensure that our small and rural
communities are not left behind.
Question 1. Dr. Janz, how can we use lessons learned from the
COVID-19 pandemic and utilize mobile clinics on a more permanent basis
going forward, to ensure patients receive regular, routine care, rather
than on an emergency basis?''
Answer 1. I thank Senator Rosen for this important question and I
agree that increased access to preventative healthcare is vital to
improve the health of the Nation. I believe each community will have
unique needs and challenges and recommend engaging community leaders to
learn what these may be and which type of healthcare outreach will
address these issues.
Question 2. As we have seen, this pandemic has had a significant
impact on most aspects of our medical and public health systems. As we
work to strengthen our critical safety-nets and better prepare for the
future, we must not overlook the importance of safeguarding our
Nation's blood supply. There have been shortages throughout the
country. Just last month, an urgent call for donations went out to
residents in the Las Vegas area to help with blood donation shortages
so cancer patients could receive the treatment they needed.
It's not just the volume of blood donations, but also the supplies
needed and the staff who are essential both for collecting the blood
donations but also managing the supply at our blood banks. Ms. Cicero
what are your recommendations for how to include consideration of
safeguarding our blood supply as we look at improving other critical
public health infrastructure and our medical domestic supply chain? Dr.
Janz, please comment if you have anything to add as well.
Answer 2. I thank Senator Rosen for this excellent question on a
vital and limited resource. I think it is important for the Nation to
take an accounting of all the potentially lifesaving but limited
resources in healthcare and learn how we can bolster these resources as
a response to current and future crises. The blood supply is certainly
one of these resources. However, as discussed in my original testimony,
the shortage of healthcare providers, including nurses, respiratory
therapists, and physicians looms as a larger threat to our
preparedness. An ample blood supply without a nurse to infuse the blood
in a timely manner would not benefit our patients.
senator braun
Question 1. COVID increased attention on the safety for patients
and staff in hospitals while also intensifying demands on health
leaders to act more efficiently and decisively. Can technology--
including faster and more accurate data collection--be the bridge
between these two priorities?
Answer 1. I would like to thank Senator Braun for this important
question. The backbone of a Learning Healthcare System, discussed in my
original testimony, includes collecting data and disseminating these
data in real-time. These data can be important to a variety of
stakeholders: patients, healthcare providers, healthcare systems, and
leadership in these systems. Historically, data would be collected,
analyzed, and disseminated over the course of years, which resulted in
very slow advances in healthcare delivery. A Learning Healthcare System
aims to integrate clinical research infrastructure with the
infrastructure of the hospital system to collect high-quality data and
not only disseminate these data in real-time, but also have the backing
of hospital leadership to make changes in patient care and hospital
function. This can occur on the scale of weeks rather than years.
Hospital leadership should look toward this model of integration of
clinical research infrastructure into the daily function of the
hospital to improve every aspect of healthcare delivery.
______
[Whereupon, at 12 p.m., the hearing was adjourned.]
[ALL]