[Senate Hearing 116-492]
[From the U.S. Government Publishing Office]
S. Hrg. 116-492
SHARK TANK: NEW TESTS
FOR COVID 19
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HEARING
OF THE
COMMITTEE ON HEALTH, EDUCATION,
LABOR, AND PENSIONS
UNITED STATES SENATE
ONE HUNDRED SIXTEENTH CONGRESS
SECOND SESSION
ON
EXAMINING NEW TESTS FOR COVID-19
__________
MAY 7, 2020
__________
Printed for the use of the Committee on Health, Education, Labor, and
Pensions
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]
Available via the World Wide Web: http://www.govinfo.gov
__________
U.S. GOVERNMENT PUBLISHING OFFICE
45-218 PDF WASHINGTON : 2021
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COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS
LAMAR ALEXANDER, Tennessee, Chairman
MICHAEL B. ENZI, Wyoming PATTY MURRAY, Washington
RICHARD BURR, North Carolina BERNARD SANDERS (I), Vermont
RAND Paul, Kentucky ROBERT P. CASEY, JR., Pennsylvania
SUSAN M. COLLINS, Maine TAMMY BALDWIN, Wisconsin
BILL CASSIDY, M.D., Louisiana CHRISTOPHER S. MURPHY, Connecticut
PAT ROBERTS, Kansas ELIZABETH WARREN, Massachusetts
LISA MURKOWSKI, Alaska TIM KAINE, Virginia
TIM SCOTT, South Carolina MARGARET WOOD HASSAN, New Hampshire
MITT ROMNEY, Utah TINA SMITH, Minnesota
MIKE BRAUN, Indiana DOUG JONES, Alabama
KELLY LOEFFLER, Georgia JACKY ROSEN, Nevada
David P. Cleary, Republican Staff Director
Lindsey Ward Seidman, Republican Deputy Staff Director
Evan Schatz, Minority Staff Director
John Righter, Minority Deputy Staff Director
C O N T E N T S
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STATEMENTS
THURSDAY, MAY 7, 2020
Page
Committee Members
Alexander, Hon. Lamar, Chairman, Committee on Health, Education,
Labor, and Pensions, Opening statement......................... 1
Murray, Hon. Patty, Ranking Member, a U.S. Senator from the State
of Washington, Opening statement............................... 5
Witnesses
Collins, Francis, M.D., Ph.D., Director, National Institutes of
Health, Bethesda, MD........................................... 8
Prepared statement........................................... 12
Disbrow, Gary, Ph.D., Acting Director, Biomedical Advanced
Research and Development Authority, Office of the Assistant
Secretary for Preparedness and Response, United States
Department of Health and Human Services, Washington, DC........ 14
Prepared statement........................................... 16
ADDITIONAL MATERIAL
Statements, articles, publications, letters, etc.
COVID-19 has shuttered scientific labs. It could put a
generation of researchers at risk.......................... 52
SHARK TANK: NEW TESTS
FOR COVID-19
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Thursday, May 7, 2020
U.S. Senate,
Committee on Health, Education, Labor, and Pensions,
Washington, DC.
The Committee met, pursuant to notice, at 10 a.m., in room
SD-106, Dirksen Senate Office Building, Hon. Lamar Alexander,
Chairman of the Committee, presiding.
Present: Senators Alexander [presiding], Enzi, Collins,
Cassidy, Roberts, Murkowski, Scott, Romney, Braun, Murray,
Casey, Baldwin, Murphy, Warren, Kaine, Hassan, Jones, and
Rosen.
OPENING STATEMENT OF SENATOR ALEXANDER
The Chairman. The hearing of the Health, Education, Labor,
and Pensions Committee will please come to order. As we begin
our hearing, I would like to explain a few of the changes that
we have made to address the health and safety recommendations
made by the Attending Physician and the Sergeant at Arms after
they consulted with the Department of Health and Human Services
and the Center for Disease Control and Prevention.
First, as you can see if you are watching, seating has been
spaced so that we are 6 feet apart. Second, we have made it
possible for Senators and witnesses to participate via
videoconference if they choose to do so and several have.
Third, to maintain social distancing we have very limited
seating so we don't have room for members of the public to
attend.
However, this hearing is available to watch live online and
the recording will be available on the Committee's website,
which is www.help.senate.gov. It is important to be clear that
the hearing will be shown from gavel-to-gavel in its entirety,
unedited by anyone from the moment we start until the very end
when we stop.
Fourth, due to the limited seating, representatives from
the press are working as a pool to relay their observations to
their colleagues, and Senators and staff present have been
reminded about the safety guidelines put in place by the
Attending Physician. We all wore our masks. I am not going to
wear mine during the hearing since we are 6 feet apart but
Senators may do whatever they choose to do. I would like to
thank the Senate Rules Committee, the Sergeant at Arms, the
press gallery, the Architect of the Capitol, the Capitol
Police, and our non-partisan Committee staff, Chung Shek and
Evan Griffis, for all of their hard work to help keep all of us
safe as we conduct these important hearings.
In April, the owners of a senior living facility gave a
COVID-19 diagnostics test to 2,500 employees and residents,
that is 26 communities in Tennessee and Kentucky. According to
the owner Gary Keckley, there were ``very few who tested
positive of the 2,500.'' Those who tested positive were all
without symptoms and they were all put in quarantine. This is
what Mr. Keckley told the Tennessean newspaper, ``Because of
the fear, we decided the only way to make sure residents didn't
have the virus was to test them. There is no substitute for
testing everybody,'' Mr. Keckley said.
All roads back to work and back to school lead through
testing. Our country will soon be doing 2 million diagnostic
tests for COVID-19 a week, an impressive number. But to contain
the disease and give Americans confidence that it is safe to go
back to work or go back to school, we will need tens of
millions of tests, many more than our current technologies can
produce. Testing is necessary first to identify the small
number of us who have the disease or have been exposed to it so
those Americans can be quarantined, so we don't have to
quarantine the whole country. And testing is important secondly
because it will help Americans who are traumatized by the daily
reports of the virus, it will help us gain confidence that will
be necessary to go back to work and back to school.
This hearing is about how we will find those new
technologies that are needed to rapidly produce tens of
millions of tests in one of the most ambitious scientific
enterprises in recent memory headed by one of our country's
most distinguished scientists. Looking ahead, I want to mention
two important oversight activities for this Committee.
Number one, next Tuesday our hearing will examine how we
are dealing with this pandemic, COVID-19. Our witnesses will be
Dr. Anthony Fauci, Director of the National Institute of
Allergy and Infectious Disease at the National Institutes of
Health, Dr. Robert Redfield, Director of the Center for Disease
Control and Prevention, Dr. Brett Giroir, Assistant Secretary
for Health at the U.S. Department of Health and Human Services,
and Dr. Stephen Hahn, Commissioner of the Food and Drug
Administration.
The second oversight activity I would like to mention is
that during the next few months, our Committee will examine
what our country needs to do to prepare for the next pandemic,
which will surely come. I believe that Congress should put in
place the structures and the funding to be ready for that next
pandemic during this year while the current crisis is still on
our mind. Over the last 20 years, the last three presidents and
several Congresses, including after 9/11, bird flu, Katrina,
SARS, and Ebola, have passed seven major laws that created the
national stockpile and assistant secretary for preparedness,
provided incentives for development and manufacturing for
diagnostics, treatments and vaccines, strengthen the Centers
for Disease Control, and for the last time five years, thanks
to the leadership of Senator Blunt and Senator Murray as well
as others, have provided record funding for the National
Institutes of Health.
We will talk about the importance of preparing for the next
pandemic at our hearing next Tuesday as well. As a result of
all of that effort by three Presidents and several Congresses
over the last 20 years, the New York Times reported on March
the 1st on its front page the following, ``Most experts agree,
the United States is among the countries best prepared to
prevent or manage such an epidemic,'' but I think we would all
agree that we would like to have been even better prepared for
COVID-19. And it is everybody's responsibility to make sure
that we are even better prepared for the next infectious
disease.
I want to place in the record a remarkable speech by former
Senate Majority Leader Bill Frist delivered in 2005 who saw
very clearly then the problems we still have to deal with
today. On April 13, the American Mind published Senator Frist's
essay, ``A Storm for Which We Were Unprepared,'' which I would
also include in the record. The end of this crisis will be
determined by three things, tests, treatments, and vaccines.
There is promising news that we are likely to hear today from
our witnesses that treatments and therapies will be available
this summer.
The Administration's warp speed pursuit of a vaccine has a
goal of 100 million doses by the fall and 300 million doses by
January, a target that is much more ambitious than ever has
been achieved before. And the private sector is demonstrating a
capacity to turn out quickly tens of millions of serology
tests. These are the tests that determine whether you have had
the disease and have antibodies that might create some
immunity, at least for a time, although that has not been
proven yet.
The FDA this week is taking aggressive steps to make sure
serology tests are accurate. After a bumpy start caused mainly
by a faulty test developed by CDC, the United States is now
conducting over 1 million diagnostic tests weekly. By mid-June,
there will be 2 to 2.5 million available weekly according to
Dr. Deborah Birx, Coordinator of the Coronavirus Task Force.
And as of yesterday, according to President Trump and John
Hopkins University, the United States has conducted over 7
million diagnostic tests. On May 1, The Wall Street Journal
described the testing situation this way, ``The Food and Drug
Administration has now approved 70 coronavirus tests, about
four times more than it approved for the H1N1 flu virus in
2009.
More tests per capita have been performed in New York City
than in Singapore, South Korea, and Australia. Hospitals and
labs have performed about 1.6 million tests in the past week,
according to the COVID Tracking Project. Governor Andrew Cuomo
last week said tests would be available at some 5,000
pharmacies across New York State. Abbott Lab says it has
shipped 1 million tests for its 18,000 portable machines in the
field that can return results in 5 minutes and is manufacturing
50,000 kits a day. U.S. hospitals have more than 5,000 Cepheid
fast testing machines, which require no special training.
Some 93 percent of the U.S. population lives within 10
miles of a test site, according to the Wall Street Journal.
``As testing has expanded,'' the Journal said, the choke point
now is a shortage of no swabs and chemical reagents to process
specimens, but those shortages are easing thanks to FDA
flexibility and the resourcefullness of private industry. The
FDA is allowing polyester swabs so that swab manufacturers can
prioritize coronavirus tests.'' That is the end of the Wall
Street Journal summary. The Coronavirus Task Force reports that
states have submitted their goals for testing for May and the
administration is working to help supply media and swabs that
states are not able to obtain on the commercial market so that
states can meet those goals.
All that is very impressive but not nearly enough to test
every nursing home, every prison, everyone in an operating
room, and some entire classes and campuses and factories, teams
at sports events. And to give those tests more than once, we
will need millions more tests than we are producing today. This
demand will only grow as the country goes back to work and some
100,000 public schools and more than 5,000 colleges plan to
reopen this August. There are two ways to increase our testing
capacity. Of course the first is to squeeze every possible test
out of our current technologies, and the second which is to
focus our--our focus today is on the need for new testing
technology.
Throughout March and April, Senator Blunt, the chairman of
the Senate Appropriations Subcommittee on Health, and I had
many conversations with experts across the Government and the
private sector. We couldn't find anyone who believed that
current technology could produce the tens of millions of test
necessary to put this virus behind us. So we worked to include
in the most recent coronavirus legislation $1.5 billion for
what we called a competitive Shark Tank. This is described, the
name was described after the reality television show that pits
entrepreneurs in a competition to see who can succeed.
This Shark Tank at the National Institutes of Health would
utilize the capacities of Government itself, in coordination
with the private sector, to pull out all the stops and fast-
track new technologies designed to produce tens of millions of
tests by August, or at least millions more tests by August, and
even millions more than that by the flu season. We allocated
another $1 billion to BARDA, the Biomedical Advanced Research
and Development Authority, to work with the National Institutes
of Health to accelerate production of those tests.
Talking with scientists across the country, there are many
ideas, some utilize CRISPR, the gene editing technology. At
least one allows you to use your cell phone to photograph your
test swab result and send it to your doctor. Several may
incorporate wearable technology. There is a lot of talk about
antigen tests. The NIH, only five days after the funding was
signed into law, announced the official start of its Shark Tank
program to boost the most promising testing technologies. There
were 400 requests for applications in the first 24 hours as of
May the 5th, and I am sure Dr. Collins will update us on this,
there were 850 expressions of interest and 50 applications have
been submitted in review.
Many of these early stage concepts won't work or they won't
be able to be scaled up quickly enough, but that is okay.
Thomas Edison said that he tried 10,000 times, made 10,000
mistakes, before he produced the first incandescent light bulb.
We hope we don't have that many failures, but all we need are
two or three successes, or even one from this Shark Tank. The
first place to find these technologies is at the National
Institutes of Health. Dr. Francis Collins who leads the NIH,
who once led the effort to map the human genome, is here today
to talk about the $1.5 billion Shark Tank program.
The second place is BARDA, a Division of the Department of
Health. It has been working across Government and the private
sector to invest in multiple innovative ideas to achieve
accurate, fast, and easy testing capabilities to help build new
capacity. Dr. Gary Disbrow, the Acting Director of BARDA is
here to talk especially about BARDA's role in scaling up
whatever new innovative test Dr. Collins finds. BARDA has
another $1 billion for that purpose, bringing it to $2.5
billion the total effort for this acceleration of diagnostic
tests. Nearly 80 years ago, in 1942, President Franklin D.
Roosevelt invited Senator Kenneth D. McKellar of Tennessee, the
chairman of the Senate Appropriations Committee, down to the
White House for a private talk.
``Senator McKellar', President Roosevelt said, `I would
like for you to hide $2 billion in the Appropriations bill to
create a project to win the war.'' Senator McKellar said, ``Mr.
President, that should be no problem, I just have one question,
where in Tennessee will the project be built?'' Well, that was
Oak Ridge, Tennessee. That $2 billion funded the Manhattan
Project that in record time produced two nuclear devices that
won World War II. That effort assembled perhaps the greatest
number of distinguished scientists working on one project in
history.
Dr. Collins' Shark Tank is at least a mini Manhattan
Project. It doesn't have to be in Tennessee but Tennesseans at
the Oak Ridge National Laboratory will be helping it succeed
with their supercomputers and their other assets. $2.5 billion
does not go as far today as $2 billion did in 1942 but it is
still a lot of money. And it is likely that at this moment,
more scientists are working to create solutions to COVID-19
than on any other project in the world.
Their success in delivering new technologies to create
simple diagnostic tests with quick results, and then safe and
effective treatments and vaccines, is the only way this will
end. There is no safe path forward to combat the novel
coronavirus without adequate testing. Let us hope that out of
Dr. Collins' Shark Tank will emerge at least one mighty great
white shark that will help us combat this disease.
Senator Murray.
OPENING STATEMENT OF SENATOR MURRAY
Senator Murray. Well, thank you very much, Chairman
Alexander. Good to be here today with you. And I also want to
thank our Committee staff who helped us set up this technology
to make this hearing possible. And of course, thank you to our
witnesses for being here today as well. Our Committee's last
hearing on COVID-19 was March 3rd, and during that hearing I
expressed my intense frustration at the administration's lack
of preparedness, its failure to ramp up testing, the White
House's constant contradictions of public health experts
guidance and more. Now we are more than 60 days later.
I wish I could say I had better things to say about the
administration's response but I do not. The only difference is
that now over 800 people in my home state have died, nationwide
now more than 73,000 are dead, and tens of millions are
unemployed. Meanwhile, the President is still denying the
severity of this crisis, he is still insisting it is not his
problem, and he is increasingly attempting to control and
silence those who want the truth to be told. The President is
afraid of the truth because here it is, he failed and continues
to fail to protect lives and our economy and our way of life.
And that brings me to our witnesses today.
I appreciate you being here and I expect you to tell the
truth today. I will want to know your honest assessment of
where we stand on testing capacity and whether we are preparing
appropriately to have a safe, effective vaccine as soon as
possible. I will want to understand how you are planning to
prioritize public health over political influence and corporate
profits, and I will want your commitment that you will protect
workers at HHS who will speak out when they see that public
health is not being put first.
Dr. Disbrow, you are here instead of Dr. Rick Bright who
filed a complaint earlier this week detailing a shocking
culture of corruption that prioritized cronyism over public
health, including at an agency critical to vaccine development
and distribution. You can expect a question from me on that and
I expect the truth from you. And while I appreciate the
interest in this ``Shark Tank'' initiative to develop new
tests, we have to remember that the fight against this virus is
reality--it is not reality television. It has to be led by
scientists and it has to prioritize public health, not profits,
not politics.
While innovation plays an important role in the development
of vaccines and treatments and tests, there is no silver
bullet. In fact, we have already innovated faster high
throughput tests, at home collection tests, and point-of-care
tests, and critically there is much more in the pipeline. The
problem is not lack of innovation, it is lack of national
leadership and a plan from this White House. You can innovate
the fastest car in the world. It still won't get you to where
you are going without a good driver and good directions. And
when it comes to testing, this administration has had no map
and no one at the wheel.
There is a reason they say failing to plan is planning to
fail and it absolutely applies here because the fastest, most
innovative test is not much use if we don't know how many tests
we need, if we don't have a supply chain with capacity to
manufacture all the tests and supplies that we need, and if we
don't have the workforce and lab capacity to actually use those
tests and supplies.
Even if we had enough tests and supplies and labs and
workers, they can't have the necessary impact if they aren't
distributed widely across the country, if they don't reach
essential workers, and underserved communities, and tribes,
people with disabilities, homebound seniors, communities of
color, and high risk populations if test don't become available
to asymptomatic people or if we don't enforce current law that
requires free testing for everyone. And even addressing these
issues won't be enough without plans to use testing results as
effectively as possible to fight coronavirus like rapidly
recruiting training and sustaining the workforce we need for
public health efforts like contact tracing, and quarantine, and
isolation, and using data to surveil and track this disease
within our communities while protecting privacy.
Now, I was pleased the administration finally told
Washington State last week it would be sending all states a
significant number of supplies to help expand testing capacity.
However, even if they finally deliver the supplies we have been
asking for months, that is still not a plan, it is a piece of
the puzzle. As long as the administration refuses to look at
this full picture and develop a detailed, national plan to
rapidly ramp up testing, we are not going to make the progress
we need to get people safely back to school, back to work, and
to some sense of normal life on a national scale because our
experts won't have the visibility into transmission they need
to ensure public health drives our efforts to reopen.
That is exactly why I fought to secure language in the
latest COVID-19 package that Congress passed that requires the
administration to submit a strategic testing plan no later than
May 24th. I am going to be watching closely to make sure their
plan addresses all of the questions we desperately need
answered. And I am going to be pushing for more resources to
build and sustain the testing efforts that we need, support
contact tracing and other public health efforts, and to plan
for vaccine production and distribution so that as soon as we
have an effective vaccine, we can scale it up quickly and make
it available and free for everyone.
While the $25 billion we passed for testing recently was a
good start, it is going to take a lot more to get this job
done. Yes, it will take innovation, but it will also take some
semblance of leadership from the President because no matter
how innovative our tests are, we cannot reopen our country
safely until they are fast, free, and everywhere.
No matter how hard frontline workers and Governors and
families work to do their part, we still need the Federal
Government and its President to step up and finally do its
part. Thank you, Mr. Chairman. It is great to be with you this
morning.
The Chairman. Let me make sure my microphone is on. I am
pleased to welcome our two witnesses. I want to give them a
full introduction, and after they give us their statements, we
will proceed back and forth from the parties in seniority. So
technologically that is the way it is recommended that we do
it.
We are very fortunate to have these two witnesses today on
the subject of how do we create new technologies for diagnostic
testing so that we can have millions more tests to help us go
back to work and back to school and to contain the disease. Our
first witness is Dr. Francis Collins. I have asked him to take
up to 10 minutes for his opening remarks. He is the director of
the National Institutes of Health and we are fortunate to have
him in this position at this time. He oversees the work of the
largest public funder of biomedical research in the world. He
is a physician geneticist by training.
Prior to becoming the NIH Director 11 years ago in 2009, he
served as Director of the agency's National Human Genome
Research Institute from 1993 to 2008, during which he led the
International Human Genome Project. He is an elected member of
the National Academy of Medicine and the National Academy of
Sciences, was awarded the Presidential Medal of Freedom in
2007, and received the National Medal of Science in 2009.
We are looking for a distinguished scientist to head this
accelerated program. I think we are lucky to have one. He is a
graduate of the University of Virginia, received a Ph.D. from
Yale, his M.D. from the University of North Carolina School of
Medicine, and he plays the guitar very well. Next we will hear
from Dr. Gary Disbrow. He is broadly experienced as well. I
have asked him to summarize his written testimony in 5 minutes.
He serves as Acting Director of BARDA, the Biomedical Advanced
Research and Development Authority. He is responsible for
making sure BARDA is focused on the innovation, advanced
research development, and procurement of medical
countermeasures, such as diagnostic test subject today,
critical to preventing and combating COVID-19 and other health
threats we may face.
Dr. Disbrow has been at BARDA for more than 10 years. He
joined in 2007. He began working on the smallpox vaccine
program. Since then, he served as Deputy Assistant for
Preparedness and Response, and Director of Medical
Countermeasures at the U.S. Department of Health and Human
Services. In 2014 and 2015, he was named Ebola Incident
Coordinator for BARDA and played a key role in efforts that led
to the first licensed Ebola vaccine.
Prior to joining BARDA, Dr. Disbrow was Assistant Professor
of Oncology and Pathology at Georgetown University Medical
Center where he focused on vaccines and therapeutics. He
received his undergraduate from the University of Rochester and
a Ph.D. from Georgetown. Welcome again to our witnesses. We
will begin with you, Dr. Collins. Welcome.
STATEMENT OF FRANCIS COLLINS, M.D., PH.D., DIRECTOR, NATIONAL,
INSTITUTES OF HEALTH, BETHESDA, MD
Dr. Collins. Well, thank you very much. Good morning,
Chairman Alexander, Ranking Member Murray, and distinguished
Members of this Committee both here in the room and joining
virtually at this unusual time. I am glad to be here with my
colleague Gary Disbrow from BARDA who has also just been
introduced.
I want to thank you Senators for your sustained commitment
to the National Institutes of Health, which has enabled us to
be at the forefront of action in this time of a national public
health crisis. I am grateful to have this opportunity to
address how we at the NIH and our scientists across the country
are harnessing innovation to diagnose, treat, and prevent the
novel coronavirus. Can you hear me alright?
The Chairman. You are muffled either because of your mask
or because of the microphone. I am not sure which it is.
Dr. Collins. Well, we are going to do an experiment here. I
don't know if this is randomized but it is at least a
comparison test----
The Chairman. You are still pretty--you are still pretty
muffled. We did get advice from the Attending Physician of the
Senate that it was appropriate for us not to wear our masks if
we chose to when we were six feet apart and arranged this way.
Dr. Collins. Well, I see I am at a safe six-foot distance
from everybody and I do want you to be able to hear the
testimony so I will follow that direction. NIH has taken an
all-hands-on-deck approach to bringing the best and the most
innovative science to diagnosis, to treatment, and to
prevention.
If I could have the slide up that I would like to be
showing, that would be great, thank you. When the genetic
sequence of SARS-COVID-2, the virus that causes COVID-19, was
first released on January 10----
The Chairman. Dr. Collins, let me ask you to wait just a
minute and let technicians try to work on your microphone.
Dr. Collins. Yes, we are having a little bit of a staticky
thing, I think.
The Chairman. You are our principal witness so we want to
hear what you have to say.
Dr. Collins. I am staticky enough without help. Maybe the
other microphone was actually better. Now that I have the mask
off, can we try that again?
The Chairman. Sure. We will take just a moment for a
technical adjustment and see if that makes a difference. Yes,
sir. You like my mask? Well, it didn't work for other things. I
thought it might work for this.
[Laughter.]
Dr. Collins. How is this one?
The Chairman. That is a lot better----
Dr. Collins. Sounding better? No staticky thing? Okay.
Thank you for your patience. Well, when the genetic sequence of
SARS-COVID-2, the virus that causes COVID-19 was first released
just on January 10th of this year, NIH worked quickly to
identify possible therapeutic agents and to begin developing a
fast-track vaccine. Within a month, the National Institute of
Allergy and Infectious Diseases, NIAID, had launched a clinical
trial on the Gilead drug remdesivir at sites across the Nation,
as well as internationally, and that trial reported, as you
heard, preliminary results just last week showing that patients
that received remdesivir had a 31 percent faster time to
recovery than those who received a placebo.
While this is not a home run, it does represent a landmark,
the first rigorous demonstration of efficacy of a treatment for
COVID-19. And on March 16th, just 63 days after receiving the
viral genome sequence, NIAID completed all pre-clinical
evaluation of a vaccine candidate and the first human patient
was dosed in a phase 1 trial. That trial, I am happy to tell
you, is going really well and I am excited to see how the
timetable for full phase 3 testing of this vaccine and several
other candidates has been advancing.
As more information has poured in from scientists and
patients all over the world, we have been sifting and sorting,
looking for the best ideas, funding everything from basic
biology to clinical trials, while closely watching private
sector efforts and seeking ways to collaborate. And it has been
apparent that the biomedical research world has fully charged
up to tackle the COVID-19 challenge. And that expression of
American creativity also applied to the development of new and
more powerful and accessible approaches to diagnostic testing,
and that is the main topic of our hearing and I will come to
that shortly.
But first if you will permit me, I wanted to share just a
bit more about progress on therapeutics and vaccines for COVID-
19. On April 17th, NIH announced the start of an unprecedented
partnership that now includes 18 pharmaceutical companies,
multiple academic experts, the FDA, the CDC, BARDA, the
European Medicines Agency, the Department of Veterans Affairs,
and the Department of Defense. This partnership, which I am
happy to co-chair with Paul Stoffels of Johnson & Johnson is
called ACTIV, Accelerating COVID-19 Therapeutic Interventions
and Vaccines.
You may be able to see on the slide the incredible
selection of organizations across all sectors that have come
together to speed up progress. To conduct its work, ACTIV has
developed an executive committee made up of senior leaders from
industry, NIH, and FDA, and four working groups, each working
group is co-chaired by a senior scientist from industry and one
from NIH. As just one example, that clinical therapeutics
working group has been conducting a rigorous scientific review
of approximately 170 therapeutic candidates already proposed,
seeking to prioritize those that are of the greatest urgency to
get into clinical trials. We can't do 170 clinical trials.
We want to be sure we used the resources for those that
have the greatest promise. Another active working group is hard
at work to make sure that the maximum clinical trials capacity
is assembled and used for this purpose in order to test those
highest priority candidates and standardized the evaluation
methods to speed FDA review. We have never done it like this
before to have this kind of coordinated approach across sectors
to identify the highest priority candidates and figure out how
to get them into trials efficiently and quickly.
I have to say a word about our industry partners here.
Within two weeks, they embraced this partnership. They made
unprecedented commitments. They agreed to abide by a
prioritization of candidates no matter who owns the drugs, and
even indicated their willingness to contribute their own
clinical trial capacity irrespective of whether the drug being
tested was one of their own. That is a partnership in the
truest sense of the word, but there is more. The most recent
endeavor of our COVID-19 effort spurred in part by you the
Congress and representing the main topic for today's hearing is
our diagnostic innovation initiative and I want to turn to
that.
First, the National Cancer Institute is using their
expertise in virology immunology and lab medicine, and
supported by funding from this Congress, to evaluate and
improve serology testing. Serology testing is based on the idea
that we can look through your immune system's playbook to see
whether your body has produced antibodies that respond to this
virus. Such a serology test has the potential to tell generally
how widespread a disease has been but it is critical that such
a test be validated to make sure it is sufficiently sensitive
and specific. You don't want a test out there that is giving
wrong information. The tests are getting better and better.
At the moment we still do not know for sure, however,
whether someone with a prior infection with SARS-COVID-2 and
who is antibody positive is completely resistant to
reinfection, and if so, how long such immunity will last. The
answer to those questions are being intensively studied. Once
that information is in hand, we will be in a better position to
advise people about the meaning of a positive antibody test.
Second and most directly relevant for this hearing, NIH
launched a COVID-19 initiative called Rapid Acceleration of
Diagnostics or RADx just last week. As you heard from the
Chairman, most current testing for the virus depends on
detection of the viral RNA genome using the polymerase chain
reaction or PCR.
A PCR test takes a small code of DNA or RNA, amplifies it
millions of times over so that it can be detected, but that
amplification process is time-consuming, requires a thermal
cycling machine available only in laboratory settings in
general, and needs personnel who know how to run the test and
how to troubleshoot problems. This program, RADx, supported by
the funding from the Congress, seeks to expand the range of
diagnostic technologies to include a whole bunch of novel
approaches that can rapidly expand access to testing.
RADx is engaging scientists across the country from the
basement to the boardroom in an effort to improve current tests
and advance completely new technologies. As America moves back
into public spaces but seeks to avoid increased infections with
COVID-19, tests have to be more accessible ideally to people at
the point of care to make it easier for everyone to get tested.
We need tests that don't require hours or days to determine
results. The new types of tests need to be sensitive enough to
flag asymptomatic individuals who may have just become infected
and don't even know it yet. They must be reliable and have a
user-friendly design. They must utilize various types of
samples including saliva. And ideally, they should be able to
integrate with mobile devices to process and show results and
transmit data seamlessly.
Above all, they need to be accessible to everyone. So, how
should we inspire this outpouring of new technologies? How can
we unleash the legendary American ingenuity at this time of
great public urgency? How will we provide the resources to
accelerate development, scale up, and deployment of new and
powerful testing platforms? Our approach, which Senators
Alexander and Blunt recently compared to a Shark Tank, is
diagrammed on this slide. You can see a bunch of light bulbs.
Your comment from Thomas Edison seems relevant here. Light
bulbs that maybe have promise or maybe they need some work.
Well, this is what is going to be happening with this RADx
initiative. It occurs in three phases.
First of all, there is a call for innovative technologies
that went out last week on April 28. Phase 0, though, requires
a review to be done of what the responses were to that call to
be sure that they fit this model. Phase 0 is then a rapid
evaluation of the technology over the course of only about a
week by clinical technical business, regulatory, and
manufacturing experts. Expert review boards covering
scientific, clinical, regulatory, and business domains are
going to rapidly evaluate these proposals, looking for the gems
that provide real promise for COVID-19. Those promising early
stage technologies will initially move into phase 1 where we
will make a modest award of funds while simultaneously
supporting that inventor or company with technical and clinical
experts to address any scientific or business weaknesses
identified in the review.
Already well developed technologies can actually go
directly to phase 2. We don't want to hold anybody back and it
is possible that some of these arrivals in the Shark Tank are
already big enough fish that they are ready to move on and we
will support that as well, providing scale up for tests for
validation. We have to know it works, meeting regulatory
requirements, supporting manufacture and distribution, working
closely with our colleagues at BARDA.
In that regard, we are interested in reproaches that can
substantially increase throughput and accessibility of
laboratory based tests even though the ultimate goal of RADx is
to develop and deploy point-of-care tests. So to tell you the
update, as you heard, the RADx solicitation was just announced
last week. This is day eight since that came out. We are
allowing submissions of proposals on a rolling basis. I got to
say I am delighted and somewhat astounded that as of noon
yesterday, there were 1,087 applications initiated, 79 of those
already complete. They had to provide a lot of details.
In 27 years at NIH, I have honestly never seen anything
move this quickly. The expert review team already in place has
identified 20 of these completed applications that are ready to
move into that first phase of intense scrutiny and the game is
on and it is going to be a wild ride. Before I close though, I
want to tell you about the third part of our initiative, a
major focus on implementation of strategies to enable testing
of rural, underserved, and under-resourced populations, among
the hardest hit by the coronavirus, and often those for which
testing has been less available.
This effort which we are calling RADx-UP, as in
underrepresented populations, will include the development of a
centers program that will allow demonstration projects to be
put in place across the country in places where COVID-19 has
hit hardest and where testing has thus far been accessible. It
will also include a program focused on the ethical, legal, and
social issues associated with COVID-19 diagnostic testing and
ways to try to avoid the inequities associated with unequal
access.
To conclude, the goal of RADx is to help make millions more
accurate and easy to use tests per week available to all
Americans by the end of summer and even more in time for the
flu season. I must tell you Senators that this is a stretch
goal that goes well beyond what most experts think will be
possible. I have encountered some stunned expressions when
describing these goals and this timetable to knowledgeable
individuals.
The scientific and logistical challenges are truly
daunting, but I remain optimistic because of the track record
of American ingenuity and the outpouring that has already
happened of great ideas coming into this Shark Tank. So at NIH,
we believe that putting the best minds in the world together is
the only way to meet the challenge and to bring this virus
under control. So I thank you for this opportunity to testify
and to lead this initiative, and I look forward to your
questions.
[The prepared statement of Dr. Collins follows:]
prepared statement of francis collins
Good morning, Chairman Alexander, Ranking Member Murray and
distinguished Members of this Committee. It is an honor to appear
before you today. I want to thank you for your sustained commitment to
the National Institutes of Health (NIH) which has enabled us to be at
the forefront of action in this time of a national public health
crisis. I am grateful to have this opportunity to address how we at the
NIH and our funded scientists across the country are harnessing
innovation to prevent, diagnose, and treat the novel coronavirus
currently plaguing our Nation.
When the genetic sequence of SARS-CoV-2, the virus that causes
COVID-19 was first released on January 10, 2020, NIH worked quickly to
identify possible therapeutic agents and to begin developing a fast-
track vaccine. Just one month later, the National Institute of Allergy
and Infectious Diseases (NIAID) launched a clinical trial on the Gilead
drug remdesivir at sites across the Nation, which reported preliminary
results just last week, showing that patients who received remdesivir
had a 31 percent faster time to recovery than those who received
placebo. This is a landmark--the first rigorous demonstration of
efficacy of a treatment for COVID-19.
On March 16th, just 63 days after receiving the viral genome
sequence, NIAID completed all pre-clinical evaluation of a vaccine
candidate and the first human patient was dosed in a Phase I trial.
As more information has poured in from scientists and patients all
over the world, we have been sifting and sorting, looking for the best
ideas, and funding everything from basic biology to clinical trials--
while closely watching private sector efforts and seeking ways to
collaborate. It soon became apparent that the biomedical research world
is fully charged up to tackle the COVID-19 challenge, but what was
needed was coordination of that vast community.
On April 17th, NIH announced the start of an unprecedented
partnership with 16 biopharmaceutical companies, academic experts, and
government partners that now include the Centers for Disease Control
and Prevention (CDC), the Biomedical Advanced Research Development
Authority (BARDA), the Food and Drug Administration (FDA), the
Department of Veterans Affairs (VA), and the Department of Defense
(DoD). The partnership is called ACTIV--Accelerating COVID-19
Therapeutic Interventions and Vaccines. That initiative has moved
quickly to accelerate progress by conducting a scientific review of the
approximately 170 therapeutic compounds and more than 50 vaccine
candidates already identified. Another ACTIV Working Group is hard at
work to ensure the maximum clinical trials capacity is assembled, in
order to test the highest priority candidates and standardize the
evaluation methods to help FDA review.
I must say a word about our industry partners here. Within two
weeks, they embraced this partnership and made an unprecedented
commitment. They agreed to abide by a prioritization of therapeutic
candidates, no matter who owns them, and indicated their willingness to
contribute their clinical trial capacity irrespective of their
potential for profit. It is a partnership in the truest sense of the
word.
But there's more. The most recent endeavor of our COVID-19 effort
is an initiative called Rapid Acceleration of Diagnostics, or RADx,
which NIH launched just last week.
Most current testing for the virus depends on detection of the
viral RNA, using a polymerase chain reaction or PCR. A PCR test takes a
small code of DNA or RNA and amplifies it millions of times over so
that it can be detected. This amplification process is time consuming,
requires a thermal cycling machine available only in laboratory
settings, and needs personnel who know how to run the test and
troubleshoot problems.
RADx seeks to expand the range of diagnostic technologies to
include novel approaches that can rapidly expand access to testing.
RADx is engaging every scientist from the basement to the boardroom in
an effort to improve current tests and advance completely new
technologies. As America moves back into public spaces but seeks to
avoid increased infections with COVID-19, tests must be accessible,
ideally to people at the point of care to make it easier for everyone
to get tested. We need tests that do not require hours or days to
determine results. The new types of tests need to be sensitive enough
to flag asymptomatic individuals who have just become infected but may
not know it. They must be reliable and have a user-friendly design,
must utilize various types of samples (nasal swabs, saliva, blood,
exhaled breath, etc.), and ideally should be able to integrate with
mobile devices to process and show results and transmit data
seamlessly. Above all, tests need to be accessible to everyone who
needs them.
Such tests sound like science fiction but are scientifically
possible. One category we will pursue actively is called viral antigen
testing. Antigen testing detects a part of the protein capsule of the
virus itself and not its genetic code. This doesn't require PCR, and
allows for immediate detection if the virus is present in the body.
With time and effort, antigen tests can be modified to be done at home
which would allow for easier and more frequent testing. They have
traditionally been more difficult to develop to a sufficient level of
accuracy, but that is where RADx comes in.
The RADx solicitation for applications was just announced last
week, and proposals may be submitted on a rolling basis. The RADx
technology assessment and potential scale up process will occur in
three phases. Phase 0 is a rapid evaluation of the technology by
clinical, technical, business, regulatory, and manufacturing experts.
Expert review boards covering scientific, clinical, regulatory and
business domains will rapidly evaluate technology proposals to find
gems with promise for COVID-19.
Promising early stage technologies will initially move to Phase I,
where NIH will make a modest award of funds while simultaneously
supporting that inventor or company with technical and clinical experts
to address any scientific or business weaknesses identified in the
review. Already well-developed technologies may go directly to Phase
II, where support will be provided for scale-up of tests for
validation, meeting regulatory requirements, and support manufacture
and distribution. We are also interested in approaches that can
substantially increase throughput and accessibility of laboratory-based
tests. While the ultimate goal of RADx is to develop and deploy of
point-of-care tests, lab-based approaches can also be supported as
intermediate solutions.
The goal is to help make millions of accurate and easy-to-use tests
per week available to all Americans by the end of summer 2020, and even
more in time for the flu season. To be completely honest, this is an
ambitious goal. The scientific and logistical challenges are truly
daunting. But I remain optimistic because of the track record of
American ingenuity. At NIH, we believe that putting the best minds in
the world together is the only way to meet the challenge and bring this
virus under control.
Thank you again for this opportunity to testify. I look forward to
your questions.
______
The Chairman. Thank you, Dr. Collins.
Dr. Disbrow, welcome.
STATEMENT OF GARY DISBROW, PH.D., ACTING DIRECTOR, BIOMEDICAL
ADVANCED RESEARCH AND DEVELOPMENT AUTHORITY, OFFICE OF THE
ASSISTANT SECRETARY FOR PREPAREDNESS AND RESPONSE, UNITED
STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES, WASHINGTON, DC
Dr. Disbrow. Thank you. Good morning, Chairman Alexander,
Ranking Member Murray, and distinguished Members of the
Committee. Thank you for the opportunity to testify today. I am
Dr. Gary Disbrow, Deputy Assistant Secretary and Acting
Director of the Biomedical Advanced Research and Development
Authority, or BARDA, within the Office of the Assistant
Secretary for Preparedness and Response at the Department of
Health and Human Services.
The Chairman. Could you put the slides back up for him,
please?
Dr. Disbrow. Today, I want to highlight how BARDA is
supporting efforts to develop vaccines, treatments, and
diagnostics and response to the COVID-19 pandemic. HHS
Secretary Alex Azar declared a public health emergency on
January 31st, 2020. At nearly the same time, as per BARDA,
established an interagency call with industry highlighting our
high-level strategy for the development of vaccines,
therapeutics, and diagnostics to address COVID-19, attracting
over 1,500 participants.
That same day, BARDA opened a medical countermeasure or MCM
portal to accept market research missions from stakeholders,
receiving over 2,700 submissions to date. We are working with
our interagency partners to quickly prioritize and review all
submissions. Prior to receiving supplemental funds, BARDA
modified our two solicitations to allow submissions of COVID-19
products. We have received 210 submissions under our Broad
Agency Announcement, or BAA, and 310 to our Easy BAA, which is
a streamlined solicitation with a cap of $750,000 in funding.
This is what we do, we engage innovative stakeholders,
establish partnerships, develop medical countermeasures, and
bring them forward to the American people to save lives. Under
the response structure, task forces were established to bring
together experts from across the U.S. Government to address key
challenges and find solutions. One task force is the Medical
Countermeasure Task Force as shown on this first slide. The MCM
task force includes representation from across the USG and
working groups were established to address vaccines,
therapeutics, and diagnostics.
BARDA is a key leader in the MCM task force working groups.
The goals of the task force are to prioritize and align MCM
development and share information across the USG in a
transparent manner. BARDA has a track record of success in
delivering effective countermeasures in response to public
health emergencies. Past examples include H1N1, Ebola, and
Zika. BARDA has unique authorities, allowing my organization to
leverage and rapidly expand partnerships to push candidates
forward to the review, testing, and approval phase. To date,
BARDA has leveraged the $3.5 billion provided under the CARES
Act COVID-19 supplemental and made investments in multiple
vaccine candidates, multiple therapeutic candidates, and
important for today's discussion, COVID-19 diagnostic programs.
The second slide shows diagnostic candidates supported by
BARDA, CDC, and the Department of Defense. Starting at the top
with molecular lab-based or near patient, then molecular point
of care, and the last two rows highlight investments in
antibody and antigen based tests. On the next slide, it is
showing the BARDA specific products with emergency use
authorization. To support the need for expanded diagnostic
capacity, BARDA has made investments in molecular tests for
commercial labs, near patient and point of care test to
identify individuals who are infected. The slide shows lab-
based and near patient molecular diagnostics on the left and
point of care on the right.
The green stars indicate diagnostics that have been granted
emergency use authorization or EUA by the Food and Drug
Administration, FDA. BARDA has recently only shifted our focus
to antigen and serological tests. BARDA is supporting a total
of 19 diagnostic products and 8 have been granted EUA by the
FDA. BARDA's efforts have helped ensure the availability of
diagnostic testing in the U.S., with 2.7 million diagnostic
tests shipped in the last seven weeks, and we expect our BARDA
funded partners to continue to increase production in the
coming weeks.
BARDA is proud to collaborate with NIH on two new efforts.
First, we are integrated with the efforts established by Dr.
Collins under the accelerated COVID-19 therapeutic
interventions of vaccines or the ACTIV partnership. Second, we
are collaborating with the rapid acceleration of diagnostics,
or the RADx program, run by the National Institute of
Biomedical Imaging and Bioengineering. BARDA will provide
subject matter expertise as applications are reviewed,
potential candidates are identified, and as teams are assembled
to shepherd development.
NIH's initiative and BARDA's efforts are complementary, and
together, we will make the RADx program a success. BARDA has
over 300 industry partners, 13 years of product development
experience, and 54 FDA approvals. BARDA's long-standing
expertise in accelerating advanced research and development of
candidate diagnostics, therapeutics, and vaccines is a
testament to our dedicated and experienced team.
This Committee and Congress at large have been very
supportive of the BARDA mission, and today more than ever we
need your continued support and flexibility to ensure our staff
can stay focused on the task at hand. Again, thank you for
passing the recent supplemental appropriations that will aid in
our overall response efforts.
We could not do our job without your partnership and
support. I look forward to discussing how we can continue to
work together on this important issue. Thank you.
[The prepared statement of Mr. Disbrow follows:]
prepared statement of gary disbrow
Chairman Alexander, Ranking Member Murray, and distinguished
Members of the Committee, thank you for the opportunity to testify
today on our efforts to develop appropriate and effective medical
countermeasures to prevent infection and test and treat those with or
suspected of having COVID-19. I am Dr. Gary Disbrow, Deputy Assistant
Secretary and Acting Director of the Biomedical Advanced Research and
Development Authority (BARDA) within the Office of the Assistant
Secretary for Preparedness and Response at the Department of Health and
Human Services (HHS or Department). Today, I will provide a brief
overview of the current response structure and then provide detail on
BARDA's role in developing countermeasures and diagnostics to aid in
the overall response.
As you all know, the Federal Government has been monitoring the
spread and threat of the severe acute respiratory syndrome coronavirus,
SARS-CoV2, the virus that causes COVID-19--since last December when
cases began emerging in the city of Wuhan, Hunan province in China.
COVID-19 is a new disease, caused by a novel (or new) coronavirus that
has not previously been seen in humans. Immediately after the virus was
detected, various HHS agencies to include the Centers for Disease
Control and Prevention (CDC), the Assistant Secretary for Preparedness
and Response (ASPR), the National Institute of Allergy and Infectious
Diseases (NIAID) along with several other components of the National
Institutes of Health, and the Food and Drug Administration (FDA) began
coordinating and leveraging tools and resources to respond to COVID-19.
Specifically, these agencies began implementing efforts to prevent and
slow the spread of the disease, assisting repatriated Americans,
protecting the supply of food, drugs, and devices, and developing
diagnostics, therapeutics, and vaccines.
ASPR's Role in Response
ASPR's mission is to save lives and protect Americans from 21st
century health security threats. During past response operations, ASPR
has led, on behalf of HHS, Emergency Support Function #8: Public Health
and Medical Services, under the National Response Framework. This means
ASPR serves as the primary coordinator for public health information
and deployment of assets to support the health components of a
response.
For the current COVID-19 pandemic response, ASPR is participating
in 14 Task Forces comprised of subject matter experts that are
operating under the Federal response structure. ASPR has subject matter
experts leading and/or serving on a number of the task force groups,
including the Supply Chain Task Force, the Medical Countermeasures Task
Force, the Healthcare Resilience Task Force, Laboratory Diagnostics
Task Force, and the Data and Analysis Task Force to name a few. The
purpose and goal of the various Task Forces is to explore policy
issues, identify gaps in capabilities, and identify solutions to aid in
the response. The Task Force structure supports streamlined
communication across the Federal Government and expedites
implementation of identified solutions as and when needed.
The Biomedical Advanced Research and Development Authority's Role in
Medical Countermeasure Development
Outside of the current FEMA response structure, ASPR's BARDA
continues to support the innovation, advanced research, development,
manufacturing capacity improvements, and acquisition of medical
countermeasures (MCM) (e.g., vaccines, medicines, diagnostics, and
other necessary medical supplies). Since late January, BARDA has been
collaborating with counterparts across the government, under the
Medical Countermeasure Task Force, to continue to identify potential
candidates and accelerate their advanced development.
Even before initial COVID supplemental funds were made available on
March 6, 2020, BARDA initiated investments utilizing annual funding to
quickly evaluate existing partnerships to determine those that had
promising candidates and immediately made investments in vaccines,
therapeutics, and diagnostics. Supporting this strategy, ASPR hosted an
interagency call with industry on January 30, 2020, to inform external
stakeholders of the high level strategy to pursue development of
vaccines, therapeutics, and diagnostics. Over 1,500 attendees
participated in the call. Shortly after the industry call, BARDA
established the MCM Portal for Coronavirus, or Portal. This Portal
which is accessible by NIH, CDC, FDA, the Department of Defense (DoD),
and BARDA, ensures U.S. Government partners are able to stay current
with the rapidly evolving landscape of promising, emerging
technologies. Information and proposals from industry are submitted to
the portal and then reviewed and prioritized by BARDA and interagency
colleagues. After the initial review ``CoronaWatch'' meetings are
scheduled. CoronaWatch is a unique tool that BARDA utilizes to ensure
that those technologies that are ranked as highly relevant by
interagency partners can be further evaluated and considered for
funding across the U.S. Government. During the CoronaWatch meeting,
BARDA and interagency experts discuss the specific proposal with the
submitter, review data and other supporting information, and provide
technical input for future submission for potential funding. As of May
1, 2020, over 2,590 applications have been submitted via the Portal and
over 250 CoronaWatch meetings have been held with companies that were
ranked at the highest priority level for the interagency, 99 of these
for diagnostics.
In addition, BARDA continues to encourage applications to its two
primary funding solicitations. To date, there has been 128 submissions
under BARDA's Broad Agency Announcement (BAA) and 275 submissions under
our Easy BAA (EZ BAA). The EZ BAA was established in 2018 to advance
early stage innovative approaches to health security, with the ability
to make awards in as few as 12 days.
Leveraging the funds provided in the first COVID-19 supplemental,
the Coronavirus Preparedness and Response Supplemental Appropriations
Act, 2020 (Public Law 116-123), awards have already been made to
promising candidates to date. Specifically, BARDA has made investments
in three vaccine candidates, 8 therapeutic programs and 19 diagnostic
programs. BARDA's COVID-19 portfolio is rapidly expanding, with daily
awards and updates. For the most up-to-date information, please visit
https://www.medicalcountermeasures.gov/app/barda/coronavirus/
COVID19.aspx.
BARDA has a track record of success in delivering effective
countermeasures in response to public health emergencies. Past
successes include the 2009 H1N1 influenza pandemic, Ebola outbreaks in
2014-2016 in West Africa and in 2018 the Democratic Republic of the
Congo, as well as Zika in 2015. For these past response operations as
well as the current response to COVID-19, Congress has provided
emergency supplemental funding to support medical countermeasure
development. For the current COVID-19 response, BARDA reviewed
investments with Regeneron, Janssen, Sanofi Pasteur, and Genentech, all
of which have previously shown success in the successful development of
both prophylactic and therapeutic medical countermeasures for emerging
infectious diseases. BARDA's leveraging of these existing partnerships
and established platforms may help shave months off the development
timelines for medical countermeasures and has been made possible
because of flexible authorities and prior investment into these
platforms.
Beyond medical countermeasure development, BARDA is also supporting
efforts to strengthen domestic manufacturing capacity. Several years
ago, BARDA established the Centers for Innovation in Advanced
Development and Manufacturing (CIADMs). While these CIADMs provided
such benefits as training opportunities for current and future industry
and government scientists who engage in advanced development and
manufacturing of medical countermeasures, there is great potential that
they will aid the response to COVID-19 by supporting manufacturing as
products are identified. Specifically, Janssen, a Johnson & Johnson
company, has identified a lead candidate using their AdVac system. They
have signed a partnering agreement with the BARDA CIADM at Emergent
BioSolutions to help manufacture their vaccine.
The focus of today's Hearing is diagnostics. To support the
anticipated need for expanded diagnostic capacity, BARDA initially
invested in molecular tests to identify individuals who were infected
with COVID-19. These tests specifically look for the virus RNA in
respiratory samples. In March, BARDA invested in adding SARS-CoV-2
assays to systems that are routinely used in the commercial and
clinical diagnostic space to rapidly expand high throughput capacity
(Hologic, Luminex, DiaSoran, Cepheid). BARDA also invested in near
patient/hospital based molecular diagnostics (Qiagen, GeneMark,
Cepheid, Vela, Luminex). Finally, BARDA has supported hand-held and
point of care molecular diagnostics (Mesa BioTech, Cue, Cepheid). The
latter, point-of-care diagnostics are ``sample-to-answer'' systems that
do not require the separate extraction reagents required by other
systems that have been in short supply. BARDA's efforts have helped
ensure the availability of diagnostic testing in the Unites States. In
the last 6 weeks, 2 million diagnostic tests have been shipped by
BARDA-funded test developers for use domestically and we expect our
partners to continue to increase production and scale. As the pandemic
has progressed, the need to develop antigen or antibody/serological
tests is now the emphasis. These types of tests will allow for
identification of individuals who were infected and now have antibodies
against the virus. BARDA's investments include antibody/serological
based tests (DiaSoren, InBios, Nanomix, Hememics) and antigen tests
(OraSure, Nanomix, Hememics). BARDA has and will continue to work
closely with interagency partners (FDA, CDC, NIH/NIAID, DoD) and with
the Laboratory Diagnostics Task Force to help address existing and
emerging technical and operational challenges related to COVID-19
diagnostics. BARDA is also currently supporting the Serology Project
Team established by HHS to address the research, technical, and
operational issues and gaps for utilization of antibody tests.
BARDA is proud to partner with the new NIH effort, Rapid
Acceleration of Diagnostics (RADx). BARDA will provide subject matter
expertise to review applications, evaluate potential candidates, and
support development teams as they are assembled. NIH's initiative and
BARDA's efforts are complimentary and will ensure RADx is as successful
as possible to expedite development of new countermeasures. As products
are developed, BARDA stands ready to aid in the manufacturing as
needed, through established partnerships.
Conclusion
Since its inception, BARDA has entered over 300 industry
partnerships, attained 13 years of clinical product development
experience, and helped partners achieve 54 FDA approvals. BARDA's long
standing expertise of accelerating the advanced research and
development of candidate diagnostics, therapeutics, and vaccines
through to FDA approvals, clearances, licensures and Emergency Use
Authorizations, is unmatched across the government and underscores the
overall capabilities that we have brought to bear on COVID-19.
Thank you for passing the recent supplemental appropriations that
will aid our overall response efforts. We could not do our job without
your partnership and support.
Thank you for your time and I look forward to discussing how we can
continue to work together on this important issue.
______
The Chairman. Thank you, Dr. Disbrow. We will now go to 5
minute round of questions. We will go and seniority order
including those Senators who are participating by video. And I
will begin. Dr. Collins, you said that you would define the
millions, tens of millions of tests that we need, diagnostic
tests--first thing you are going to do is squeeze every test
out of existing technology, but am I correct that existing
technology won't produce that number of tests so we need a new
technology?
Dr. Collins. I think it is both and, not either, or. I do
think existing technologies have the potential for further
scaling up and we are very interested in seeing that happen.
And BARDA is also very much in that space and we will work
closely together on that, but most of the existing technologies
are done in central laboratories.
They are not what you would call point of care and we want
to see that feature very heavily emphasized in what we do with
the new technologies so that they could be more accessible,
give a more rapid turnaround as far as a result of the tests,
and be generally distributed to places that currently don't
have much access.
It is definitely the case--anything we can do that is going
to increase the number of tests available by a factor of 5 or
maybe even 10 is very worth what we would want to put into it.
But we also believe that it is not just a matter of taking what
we have and making it higher throughput, we need new
technologies that have these more appropriate features.
The Chairman. I want to have a question for Dr. Disbrow,
but let me ask you one first. Just before I came in here, I got
off the phone with the chancellor of the University of
Tennessee at Knoxville. They have invited their students to
come back in August. Talked to the President of University of
Middle Tennessee State University, South of Nashville.
They have done the same. What can you tell university
presidents and principles? We have 5,000 colleges. We have
100,000 public schools. They would like to go back to school in
August. What can you tell them about the availability of
testing in August, including the possibility there may be some
of these new tests that would expand the supply dramatically?
Dr. Collins. Well that would very much be our goal and you
have made the point, I think repeatedly, how critical that is
going to be in terms of getting us back into school and not
having what would be another second or third wave of
coronavirus at that very vulnerable moment when the flu season
is starting up as well. What you want to have at that point is
the ability in a community to know whether the virus is
circulating. So that means being able to do surveillance,
finding out whether the virus is around.
If so, then immediately identifying those who are infected
and getting them quarantined. And obviously schools and
colleges are a critical place to watch over. So having a great
expansion in the number of point-of-care tests at that point so
that university presidents or chancellors have a chance of
knowing what are the risks of bringing people back. That is
what we want to contribute to. That is what this project is all
about.
The Chairman. Let me ask you and then Dr. Disbrow, if you
will save him some time. Let's talk about scaling up. I am not
a scientist and I am not going to pretend to be one but I have
so much respect for our scientific community in the United
States. I cannot imagine that out of the thousand applications
that you have, or expressions of interest that you have
received, that there won't come a few new ideas that will
permit us the kind of quick, simple, inexpensive, easy to
administer tests that will be widely available, and we are
talking about tens of millions of tests.
But the question is, how do you manufacture all those? And
when you select the survivors of your Shark Tank or your RADx
experiment, are you taking into account whether you can scale
them up? And then let me ask Dr. Disbrow within my minute and
20 seconds, what will BARDA do working with you to scale up
what you discover is a new technology for producing tens of
millions of tests?
Dr. Collins. Great question. Very quickly, the review group
that is going to be looking at these more than a thousand
applications is well populated with people who are experts in
business and commercialization and scale up. We are not going
to invest in something that looks like it doesn't have that
potential.
But then once you have decided it is going to have that
potential, you got to get the resources together. These may
come from small businesses. Most of the applications are. How
do you find a large business partner? How do you provide the
resources? BARDA is in a great spot there to assist with that
scale up.
The Chairman. Dr. Disbrow.
Dr. Disbrow. Right. Thank you. So, as Dr. Collins
mentioned, we envision this as a seamless transition. So BARDA
does have experience, our 300 industry partners that we have,
partnering with industry, bringing together engineers. So that
as those products are moving through the funnel that you saw,
it is a seamless transition and we assist with funding that we
would have available to help scale up the manufacturing.
The Chairman. You will be involved in helping to identify
promising technologies based upon their scalability----
Dr. Disbrow. Correct.
The Chairman. Then you will be coordinating with outside
groups to see that the scaling is done so that we can----
Dr. Disbrow. To help partner them, correct.
The Chairman. That is right.
Senator Murray.
Senator Murray. Well, thank you very much, Mr. Chairman,
and thank you again to our witnesses. You know, two months
after the President claimed everyone who wants a test, gets a
tests, we now have well over a million COVID-19 cases. As I
said, there is more than 73,000 deaths and no plan to bridge
the huge gaps in testing across the country. Instead take
states are left to respond with limited Federal support and
blind spots on how the disease has spread and fighting with
each other for critical supplies.
To address those failures, Congress required the
administration to submit a national strategic plan to increase
testing by May 24th. On Tuesday, approximately 260,000 tests
were performed in the United States. Experts have said we need
anywhere from 500,000 tests per day right now to 5 million a
day or even more going forward.
To reach those targets, states need more than vague musings
from the White House. They actually need numbers and timelines
and clear expectations of how the Federal Government intends to
get us there.
Dr. Collins, I want to ask you just yes or no, in order for
that plan to ensure America's Governors and public health
leaders have enough testing to begin safely reopening, should
that National strategic plan on testing include specific
numeric targets testing capacity, supply chain capacity, and
projections of shortages?
Dr. Collins. Senator, I am sorry. It is not my sweet spot
because of course this is the job of the Coronavirus Task Force
and the CDC. Certainly, I know states are looking for those
kinds of specific guidelines, and I totally understand that.
Senator Murray. Well, should a plan detail how to best
allocate different tests for use in different settings? For
example, at a hospital versus a workplace?
Dr. Collins. There is certainly scientific reasons why
those kinds of decisions ought to be nuanced based on the
circumstances. They can be quite different from one environment
to the next. So I would hope yes, any plan would have that kind
of specific recommendation about particular environments where
testing is going to be offered.
Senator Murray. Okay. Thank you, doctor. Dr. Disbrow, thank
you for testifying here so soon in your tenure in this role.
This week, your predecessor, Dr. Bright, filed a complaint with
the Office of the Special Counsel, detailing actually an
alarming degree of corruption and incompetence among political
leadership across HHS and the Trump administration. We learned
from Dr. Bright yet again that the White House has largely
ignored warnings about COVID-19, failed to take steps to
adequately secure supplies of PPE, and otherwise prepare a
response.
The White House failed to secure supplies for testing, they
pushed untested and unproven drugs against the advice of
experts, and political leaders put career public health
officials in terrible positions where they had to decide
between doing what they have been told versus doing what is
right with people's lives on the line. Dr. Collins and Dr.
Disbrow, I expect you to cooperate fully with any investigation
into Dr. Bright's complaint and I am going to continue to look
into these allegations.
There are so many workers across the Federal Government
that are trying to do the right thing to help us get increased
testing and generate a plan to develop and distribute a
vaccine, putting science ahead of politics and refusing to put
the public health at risk.
To those of you who are doing that who are watching, thank
you. Dr. Disbrow and Dr. Collins, can you commit to me today,
without reservation, that you will always prioritize the public
health and never give in to pressure to do political favors and
that you will speak out against corruption and incompetence and
misconduct when you see it?
Dr. Collins. Yes.
Dr. Disbrow. Yes.
Senator Murray. Thank you. And I appreciate that. And do
you both commit to doing everything in your power to protect
HHS employees from political interference and doing their jobs,
and especially to protect those who speak out to make sure
public health efforts are guided by science and not personal
profit or politics?
Dr. Collins. Yes.
Dr. Disbrow. Yes.
Senator Murray. Do either of you have any reason to doubt
that Dr. Bright faced the political pressure that he described
in this complaint?
Dr. Collins. It is Dr. Collins. I have to say I just don't
have any personal primary information so I am only going by the
things that I have read. It is not a circumstance that I can
form my own opinion because I don't have the facts as a sort of
personal experience.
Dr. Disbrow. Right. This is Gary Disbrow. So, now that this
is a personnel matter being handled by the Office of Special
Counsel, I can't really comment.
Senator Murray. Okay. Well, do you both commit to being
transparent with Congress and the public regarding any
partnerships your agencies engage in throughout this COVID-19
response, including regarding what guardrails are in place to
make sure Government resources are devoted to the products most
promising to public health and not those that will drive
profits for politically connected companies?
Dr. Collins. Yes.
Dr. Disbrow. Yes.
Senator Murray. Did I hear yes from both of you?
Dr. Disbrow. Yes, you did.
Senator Murray. Alright. Thank you. I just have a few
seconds left and I hope to ask a few more questions in the next
round if that is possible, Mr. Chairman.
The Chairman. Sure. Thanks, Senator Murray. Good to see you
even if at a distance.
Senator Enzi.
Senator Enzi. Thank you, Mr. Chairman, and thank you,
Senator Murray, for this hearing. I want to thank the witnesses
for all of the information that they provided. It is very
helpful.
This is a critical thing for our Nation and I hope this
doesn't turn into a hearing about Trump. I noticed that the
vaping one that was surprisingly turned into that but getting
to my questions, the administration has announced a number of
public, private partnerships are geared to bring the Federal
agencies and private industry together to develop medical
countermeasures.
The NIH is at the helm of most of these efforts. How is the
agency's role different in the RADx and ACTIV partnership and
Operation Warp Speed? Dr. Collins.
Dr. Collins. Yes, we are very much a fan of partnerships to
get science to happen. When I had the privilege of leading the
Human Genome Project, I learned how much can be gained by
bringing groups together that have different skills and talents
and not worrying too much about who is going to get the credit,
just get the job done. More recently, I have had the privilege
of leading several of these public-private partnerships focused
on trying to develop the next generation of therapeutics for
diabetes, for Alzheimer's disease, for rheumatoid arthritis and
lupus, for Parkinson's disease, for cancer, and those have
turned out to be enormously productive by bringing the best and
brightest scientists around the same table to design the work,
hold themselves accountable, and make sure all the data is
accessible to everybody.
When the COVID-19 crisis came along. It was clear that we
might benefit from that same kind of model. And by talking to
my colleagues in all sectors, we did decide that this was worth
a try. On April the 3d, which is just 34 days ago, convened
senior leadership of pharmaceutical companies, of FDA, CDC,
BARDA, and the NIH, and the European Medical Medicines Agency,
came up with a series of things that we thought could be done
better as a partnership than either of the sectors or either
the companies or institutions could do on their own. And that
is what ACTIV has become.
I must say, it has been astounding to see the way in which
people have rolled up their sleeves and plunged in to this
effort to advance therapeutics and vaccines for COVID-19. Some
of those previous partnerships I mentioned took a couple years
to sort of work out the details and finally get everybody
sitting down at the same table. This took two weeks. And on
April 17th, we announced the launch of this enterprise, and it
has been 24/7 for these working groups that are trying to knock
down the barriers that might otherwise get in the way.
The RADx effort is not the same kind of partnership. I
might call it more of a bottom-up kind of partnership in the
sense that the talent and the innovation and the creative ideas
about new testing platforms is largely coming from small
businesses. And so they become our partners because they are
feeding these ideas into the Shark Tank.
Of those 1,087 that I told you that we have already
received as far as responses to the solicitation, two-thirds of
those are from small businesses. There is also a wonderful
input from academics and a few middle sized businesses as well.
That is just the kind of thing you would like to see for this
kind of a partnership which is going to be intensely
competitive.
Yes, I guess in my time at NIH, 27 years now, I learned
over and over again, if you want to get something done, find
all of the potential contributors who have skills, talents,
energy, motivation, and resources, and let's do it together,
and that is certainly what we have to do at a time like this
with this global pandemic all around us.
Senator Enzi. Thank you. I now have a question of--it is
kind of a who is in charge question. We are having to scramble
to catch up and that means conducting the early stage of
research at the same time that we are trying to move products
through the advanced development stages.
Public health emergency MC mission statement identifies the
National Institute of Health taking the lead role in the early
research and BARDA as taking the lead role in advanced
development and manufacturing. Do NIH or BARDA have primary
authority for advanced manufacturing support or scale up?
Dr. Collins. I think this is what we are talking about at
this hearing, the handoff that we are making sure happens in
this space. We are really good at getting those early ideas
started, figuring out how technologically they can be advanced.
But when they get to the point of being ready for a real
commercialization scale up, BARDA steps in with all their
skills. Gary, you may want to say more about how that works.
Dr. Disbrow. Yes. I appreciate that, Francis. So this is
not the first partnership between NIH and BARDA. We have
partnered over the past decade or more with the National
Institutes of Allergy and Infectious Diseases transitioning
vaccines and therapeutics for some of the greatest threats that
our Nation faces such as chemical, biological, radiological,
and nuclear threats, and pandemic influenza.
I think this is, just a building of that natural
partnership that occurs. We work hand in hand. You saw on Dr.
Collins's slide that BARDA is integrated into the ACTIV
partnership. You saw on the slide that I presented that it is
in a whole of Government where everybody is integrated and
working across Government, sharing information, and helping to
develop those medical countermeasures.
Senator Enzi. Thank you. The clock on my screen is behind
my picture so I suspect that I have used my time and I thank
you.
The Chairman. Thank you, Senator Enzi. your timing is very
good. Senator Casey, who has done a lot of work in this area
over the years with Senator Burr especially.
Senator Casey.
Senator Casey. Can you hear me?
The Chairman. We can hear you.
Senator Casey. Mr. Chairman, thanks very much. And I want
to thank our witnesses, both the Dr. Collins and Dr. Disbrow. I
want to start with the reality that so many communities are
facing now that the case numbers and the deaths are
overwhelming. As we all know the national numbers, those
numbers translate in Pennsylvania to something on the order of
more than 51,000 cases.
The death number in our state went up recently. We are now
over 3,100 deaths. So we are thinking of those families that
are suffering in so many ways. I want to start by commending
the frontline workers in this crisis. The frontline healthcare
workers as well as so many others, and I won't try to list all
of the occupations, all of the work that is being done on those
front lines.
Second, I want to commend those who are, throughout our
country, the tens and tens of millions, who are doing their
part by staying home and by social distancing and wearing masks
and doing all the things that the experts tell us we should do
to stop the spread of the virus. We are grateful for that. I
think the administration's response so far has been inadequate
and that might be an understatement. It is nowhere near the
dedication of those frontline workers nor is it compliant or
adhering to standards like people are at home.
I wanted to start with that in terms of just the what I
think our failures that we have to recognize and try to
mitigate in the short term, but make a pledge never to have
such failures in the future. I think there are at least three,
the testing failure, the failure to deliver adequate supplies
of personal protective equipment, and then third the failure to
effectively communicate over time. Sometimes the administration
has been guided by science and expertise, and then that
expertise is undermined by way the administration has
communicated.
Finally, let me just say before I get to my questions, the
Senate, as it has in the first four pieces of legislation, four
being the Response Act, the Families CARES Act, the CARES Act,
and then the--we have been focused on both stopping the spread
of the virus, dealing with the public health challenge, but
then second also helping those who are adversely impacted by
the terrible economic consequences that flows in the wake of
the virus.
I would say that is also concern or should focus our work
on oversight. And I know the Chairman will be getting to that
but we have to do a lot more oversight of the response so far.
Dr. Disbrow, I want to pose a question to you about the next
generation of PPE. You know BARDA's mission and part of BARDA's
mission is to make sure that when we have a pandemic, the
agency, or BARDA itself, limits the harm of such a pandemic and
PPE is obviously part of that.
You have heard, and you have read, and I am sure you are
well aware of the limitations that the PPE has meant for so
many workers. Sometimes out-of-date PPE, sometimes personal
protective equipment that is causing harm to those workers. We
have to get to the next generation of personal protective
equipment and I would hope that you would work with us on
preparing not just for the next couple of months but preparing
for the next 50 years. And I hope we can have your commitment
on that, both you personally as well as BARDA. Do we have that
commitment from you?
Dr. Disbrow. Yes, you do.
Senator Casey. Thank you very much. And Dr. Collins, in my
remaining minute, let me just get to a question about evidence-
informed policymaking. We have heard so much from public health
experts and from scientists about how to stop the spread of the
virus and how to deal with this pandemic. I would ask you, Dr.
Collins, do you agree that science and peer-reviewed evidence
should be what we implement by way of policy in our response to
the pandemic?
Dr. Collins. Well, I have built my whole career on science
and evidence and rigorous ways to derive that. In the hopes
that, that would in fact be the way in which we as a society
make decisions. So I certainly agree that ought to be the way
in which we move ourselves forward in a fashion that we can be
confident is based on real facts.
Senator Casey. I hope you will continue to advocate for
decisions that we make in the Senate based upon science and
based upon the best possible expertise, not based upon
arbitrary deadlines of politics or philosophy. So I thank you
for that. We are grateful. Mr. Chairman, I might have some
follow-up questions in the next round. Thank you.
The Chairman. Well, we will see Senator Casey, whether
there will be a next round. We are going to try to end by 12:45
p.m. because the witnesses have to go on and we have votes at
noon, I think.
Well, we have a vote at 1:30 p.m. So we will see if there
is time for next round. Thank you. We will--Senator Roberts has
an important engagement and has asked to go next and others
have been kind enough to allow him to do that.
Senator Roberts.
Senator Roberts. Mr. Chairman, thank you very much. I
apologize to my colleagues for going out of order. At 12 p.m.,
I am to speak on the floor of the Senate and it is in regard to
the fact that the Eisenhower Memorial dedication has been
delayed obviously because of circumstances. And this is on
behalf of the Eisenhower Commission of which I am very
privileged to be in the chair.
For that reason, I am going to proceed and I will try to
make my remarks very succinct. Thank you to the witnesses for
being here this morning and your tireless work. I want to talk
about--I am sorry. I want to talk about--well, Okay. I hope you
heard my--the reason that I am stepping forward here out of the
recognition of the situation. I want to talk about a situation
that is unique, that we are going through right now, and that
is the packing plant situation, the meatpacking plant
situation.
Testing rates in Kansas have largely logged or lagged
behind other states during this crisis, but that really changed
here in the past couple of weeks. We have 23 percent of the
cattle market. We have five packing plants in Kansas, Liberal
Kansas, Garden City, Dodge City where I am from, and then also
Emporia.
We have had quite a break out among the workers of the
meatpacking plants. We are working with Governor Kelly of
Kansas. We made an early decision and the Governor concurred
that we would try to keep these plants open. We don't need not
only a problem with our meat supply, but it was backing up the
entire food chain. Others on the Committee can speak to that.
The same situation is happening at the pork industry and in
the poultry industry. At any rate, the CEOs of the packing
companies were very eager, and we are very pleased when the
President initiated the Defense Production Act over three of
them. I could have just gone up there and whispered in your
ear----
[Laughter.]
Senator Roberts. It might have worked out. But at any rate,
the CEOs at the packing houses have really stepped forward. The
President initiated the Defense Production Act. He declared the
meatpacking plants a national asset. Not only the guards to
meat or pork, which is in a more serious situation, and
poultry, but the backing up of our entire food chain.
Our consumers are discovering, finally, that their food
doesn't come from grocery stores, it comes from farmers and
ranchers and growers. So the CEOs have really stepped up. They
wanted to invest in this kind of a situation before but now
they are absolutely forced to but it is a willing kind of
situation.
The problem is our workers. And just this morning they
showed up at the plant, not numbers that we had hoped for, but
we at least kept the meatpacking plant open. And what is
happening is that they are not catching the virus at the
meatpacking plant. It is afterwards. And so we have CDC, we
have OSHA, and we have NIOSH. That is a fancy acronym for a
team of people going out to inform the workers that the plant
is safe and that they should practice social distancing, lack
of congregation, etcetera, etcetera when they leave the plant
and then at home. That has not been the case, at least up to
date. So I think we are in a situation where if there is any
need, that I can see, for an immediate test, right now they are
having their temperature taken and when they go in and then
when they come out.
My question to you is on a rapid test, this is the kind of
situation that demands an answer now if in fact we had any kind
of a situation where you could have an immediate test. By the
way, that they are--in most making most meatpacking plants
there are at least 15, 16 different languages that are spoken,
and so to educate the workers and to alleviate their fears is a
tall job as well. So you can see the need for the test.
Now I have gone on over time and I haven't left you any
time to respond. But can we at least get something done on the
rapid testing on something like this that is happening right
today?
Dr. Collins. If I could take 10 seconds I would say, this
is a very good example of why we need exactly, what this RADx
program is trying to put forward which are rapid point-of-care
tests that are readily accessible in any kind of place where
there has been an outbreak because that is the only way you are
going to identify who the people are who are infected and
quickly get them quarantined so they don't spread it to others.
We know that people who have no symptoms sometimes and no
fever can be carrying the virus. We need to have a test to
identify that. That is what we are trying to do with RADx.
The Chairman. Thank you, Senator Roberts.
Senator Roberts. Appreciate it. Thank you, Mr. Chairman.
The Chairman. Senator Baldwin.
Senator Baldwin. Thank you, Mr. Chairman, and Ranking
Member, and to our witnesses. Dr. Collins, I think you are
quite aware of how supportive I am of Federal investments in
medical research and it is encouraging to hear about the work
of the NIH during this really difficult time. You noticed--you
noted in your testimony that above all, tests need to be
accessible to everyone who needs them.
I agree and it is why I introduced the Medical Supply
Transparency and Delivery Act with my colleague Senator Murphy,
who you will likely hear from shortly, which requires the
administration to develop a national testing plan and it
unlocks the full authority of the Defense Production Act to
increase the production of supplies needed for testing.
Dr. Collins, the goal of RADx is to develop and deploy
tests for COVID-19. Each of the tests is likely to have
supplies that will be needed in order to actually utilize and
get specimens for these tests. We also need to know whether we
will need personal protective equipment or swabs or reagents to
actually conduct these tests. Can you describe sort of with
your crystal ball looking forward to what might be produced by
RADx, what sort of associated supplies will be needed to use
these tests?
Dr. Collins. Senator, that is a great question. Every one
of these various nominated platforms for technological advances
is going to have a different set of requirements as far as
those kinds of supply questions. And here again, we will be
looking at that closely as we try to evaluate which of these
ought to get the strong support in the Shark Tank to move
forward quickly.
Many of them will require swabs in order to acquire the
sample. We do, by the way, think that swabs that sample the
front of the nose are maybe just about as good as the ones that
have to go all the way in the back and most people would be
glad to hear that. We also think that saliva may very well turn
out to be an attractive alternative which might then not
require a swab at all if you had a way of collecting just a
saliva sample. But all those things have to be thought about
and certainly we would not want to make a major investment in a
particular diagnostic technology without having a very clear
sense of what that supply chain need was going to be if this
was going to be distributed and implemented all over the
country.
Here again, as we are working closely with BARDA, is going
to be critical because this is a sweet spot for them in terms
of keeping track of all of the details of how you make sure you
don't end up with a success story that you can't actually
implement because you forgot about some part of the supply
chain.
Senator Baldwin. Right. I thank you for that answer because
what I am seeing with the available already testing platforms
is that each has a different swab, a different reagent. They
are sort of closed loop in many instances. And if that is going
to be the case in the future, we need to anticipate that as we
try to ramp up and make sure that we are supplying the reagents
and the swabs and the specimen collection for each of the
various tests that will be out there.
The second complication I see frequently is the--if I look
at Wisconsin, for example, there is so many different entities
that are trying to seek these tests for enhancing their testing
capacity. Certainly the state. Some hospitals and systems,
employers who want to test employees before they reopen for
business when that time comes, K through 12 private and public
schools, higher education, etcetera. There is no streamlined
logistics right now.
Again, I return to this idea of having the full authority
of the Defense Production Act involved with you at NIH and
BARDA in order to make--to create a streamline system for
testing. Would it help you to know at your stage at NIH what
sort of facilities and institutions will need testing and when
so that you can identify the gaps and actually be looking at
tests that are likely to be able to fill those gaps?
Dr. Collins. Yes, of course we want to have a full sense of
the needs that are out there from multiple institutions and
particularly in places that are vulnerable. And we are aware
that this is not evenly distributed. I mentioned these
demonstration projects that we are going to try to put in place
for places that don't have ready access to testing for
underrepresented groups. And that is just one example of what
you are referring to. So we do need to have our finger on that
pulse.
The Chairman. Okay. Thank you very much, Senator Baldwin.
Senator Collins.
Senator Collins. Thank you, Mr. Chairman. Mr. Chairman, let
me start by saluting you for your extraordinary leadership in
putting together this initiative that is going to make such a
difference for the health of our country. Dr. Disbrow, last
year I introduced a bill called the MEDS Act after I reviewed
alarming data that indicated how dependent our country's
pharmaceutical market was on overseas suppliers of active
pharmaceutical ingredients APIs.
I discovered that 72 percent of the facilities producing
APIs were located overseas, 13 percent of the facilities where
located in China. And sure enough in the midst of this
pandemic, India took steps to restrict the export of 26 APIs to
our American market.
Clearly we should not be so dependent on foreign nations
for essential ingredients for our medications and that is going
to be really important as we develop treatments for the
coronavirus. As RADx leads to the development of promising new
diagnostics, how will you ensure that we have the capacity to
manufacture and scale up these innovations right here in the
United States?
Dr. Disbrow. Thank you. So the global pandemic has
highlighted the vulnerabilities in the supply chains for many
products. PPEs were one of the first things that we saw and now
it is also raw materials for manufacturing active
pharmaceutical ingredients. So for the active pharmaceutical
ingredients and raw materials for drugs, we are currently
looking at advanced manufacturing technologies.
We are evaluating multiple programs. Those are ongoing
right now so I can't discuss that but it is to bring that into
the U.S., use a much smaller footprint than you would for a
typical or traditional manufacturing facility to try and bring
that back. But again for these raw materials for the
diagnostics is to partner them with U.S. companies that have
the experience and know how to scale up diagnostics.
They have the engineers and work with them to acquire all
those raw materials that they would need now so that we can
scale that up. That is what we are doing for vaccines. Vaccine
manufacturing is a very long process so we need to acquire
those raw materials now so that our vaccine manufacturers can
manufacture on scale.
Senator Collins. Well, part of the MEDS Act, which I
authored, was included in the Cures Act, but I really think we
do need to do more work in this area and I appreciate the fact
that you are very aware of the problem and are working on it.
Dr. Collins, let me turn to you next. So you were just
talking about swabs and how they are an essential part of
diagnostic tests. I am proud of the fact that one of the two
leading manufacturers of swabs is Puritan Medical Products,
which is located in rural Guilford, Maine. And just last week,
with support from the Defense Production Act and private
investments, Puritan has teamed up with Cianbro, a large
construction company, and Bath Iron Works, better known for
building Naval destroyers, to open a new facility in record
time that will double the production of swabs. So that
obviously is very good news.
In addition, we have a laboratory, that is Abbott Labs, in
Southern Maine that has helped produce the point of care rapid
test. My question to you is what more could we be doing to tap
in to the authority under the Defense Production Act so that
when you do get a winner, we can be assured of a rapid scale up
in manufacturing of the new test?
Dr. Collins. Would any of us imagined four or five months
ago we would have talked about swabs at a Senate hearing? It is
like this is coming in such an interesting and unexpected way
and yet it has absolutely been critical to the availability of
testing. But certainly, again, this comes back to needing to
think ahead.
With any one of these new kinds of technologies that we are
trying to encourage through the Shark Tank, what are all of the
things that you are going to be short of and you should have
plan for, and how can you take advantage of what BARDA has in
terms of experience and resources to make sure that happens,
deal with the supply chain and make sure that is not going to
get cutoff by something international, and if necessary, come
up with ways as you have done in Maine to double or triple the
production.
Just what you need to do. We have to be thinking of
everything in advance and not get caught by surprise. We
won't--we will not make that mistake again.
Senator Collins. Thank you.
The Chairman. Thank you, Senator Collins.
Senator Murphy.
Senator Murphy. I thank you very much, Mr. Chairman. Thank
you for being here today. A comment and then a couple of
questions. We are just so grateful for all the work that you
are doing and your efforts to inform us as to some of these
innovative partnerships. But of course, you are only as good as
the direction that you are given by the President of the United
States and what you have effectively told us today is that this
new effort to try to find widely available point-of-care test
was launched eight days ago, largely at the urging of members
of the Senate.
If we had a President who truly prioritized testing, this
effort would have been launched the minute that we heard about
the prospect for coronavirus coming to the United States. And
instead literally in the middle of the epidemic, when some of
our states have actually gotten through the worst of it, we are
now launching this initiative. It shouldn't be lost on us how
far behind we are on testing.
Frankly, it is not an accident. It is not an accident. The
President told us early on that de didn't want to bring folks
to the United States from a cruise ship because it would drive
up our numbers not because of any public health risk. And then
just yesterday he said this, by doing all this testing we make
ourselves look bad.
That is the President's belief that the testing makes us
look bad. And if you don't think that perception is important
to this President, you haven't been paying attention for the
last three years. And so we are playing catch-up and so the
question is how we do that most effectively. And so Dr.
Collins, let me ask you a question not so much about the new
diagnostic project but ACTIV, which is the project to try to
develop a vaccine and treatment.
I appreciate the fact that you have reached out to our
European partners to be a part of this effort, but there are
ready is an international effort designed to try to develop a
vaccine, CEPI. In fact, it has been working on pandemic
vaccines for three years and on Monday of this week, or maybe
it was last week, the partners, our European partners all got
together to try to rally the world to put more money not into
ACTIV but into CEPI. And so my question is this, we should be
running our own efforts to try to develop a vaccine, but why
not also join CEPI?
Why not also make sure that we have a seat at the table
when it comes to the biggest international effort to develop a
vaccine? And maybe just my question is this because it is not
necessarily your policy decision as to whether to join. We
could do both, right. We could be developing our--leading our
own efforts to develop a vaccine and also be a member of this
international group, which by the way, all of our allies are
part of, the Europeans are part of it, the Saudis are a part
of, the Japanese, the Indians, the Australians, the Canadians,
everybody is working on a vaccine together.
We are not part of that effort, which is just really hard
to understand. We could do both, right?
Dr. Collins. I actually was present at the founding of CEPI
at the World Economic Forum in Davos and that has been a
wonderful contribution to try and prepare for pandemics, which
we are now in the middle of. And while we were not present in a
direct way at this recent fundraising effort to try to put
together additional support for vaccine development in Europe,
we are certainly connected in multiple other indirect ways.
For instance, the companies that are part of ACTIV, many of
them have strong European connection, some of them are in fact
European companies, and CEPI is in a position also to
contribute to the development of some of the vaccines that we
are actually talking about getting into this master protocol
this summer.
It is, I think--you are exactly right. This is a global
crisis. We should approach it globally wherever the resources
are and not get too wound up about what obstacles are in the
way. I am a scientist. I want to see this project succeed.
Senator Murphy. Mr. Disbrow one quick question. You
referred to the allegations that Dr. Bright made as a personnel
matter, but it is not a personnel matter. He didn't get fired
for showing up late. He alleges he got fired because he was
trying to talk to his superiors about a culture of corruption
in which industry players and non-scientific input had
influence over the decisions that BARDA was making.
That is not a personnel matter. That is a public policy
matter. And so would you agree that getting to the bottom of
the allegations that he makes is important for you as the
temporary or acting head of this agency? And do you have any
opinion as to whether outside industry groups have too much
sway inside this operation?
Dr. Disbrow. I do think it is important and I am sure there
will be an investigation. I stand by--I have been at BARDA for
13 years. All proposals that come in have to go through a
scientific review. The review is based on science, technical
merit, the feasibility of the actual program, and the ability
of the company to potentially do the work.
We review those. They are done by interagency partners
through the technical evaluation process. They are then
reviewed and then we make awards. And so I am still confident
in the way that we make our investment decisions that they are
based on science and based on the best technology that we can
bring forward.
Senator Murphy. Thank you. Thank you, Mr. Chairman.
The Chairman. Thank you, Senator Murphy.
Senator Cassidy.
Senator Cassidy. Dr. Collins. All three questions will be
for you. Thank you both for your good work. I appreciate it. I
was intrigued it wasn't in your testimony, but I would like to
hear your kind of further thoughts about the RADx underserved
population program. In Louisiana we have been hard hit. We have
many populations underserved, and we--I am actually kind of
working with my group, with people back home as to how we
address this. So how do we apply for it? How do we get it? What
resources, and you can reply to that as a QFR too.
[Laughter.]
Dr. Collins. Well very quickly, this is a program, again,
because the funding for RADx just came along fairly recently,
that is still in the formative spaces, but we will be in
soliciting applications for centers that could be placed in
locations where underrepresented groups have been particularly
hard hit and have not had access to testing in the way that you
would ideally want to see. And that will be coordinated
together along with an ethical, legal, and social implications
program, and a coordinating center. So watch this space, it
will be coming.
Senator Cassidy. Who do I call, you can call me?
Dr. Collins. You can call me.
Senator Cassidy. Sounds great. Second, next question. You
spoke about having to look at the ability of antibodies to
provide protection and the duration, etcetera. But if it is
like flu, quite likely those antibodies will be completely
protected in some, and mitigate the symptoms in others, and in
a few it may just not have any effect whatsoever. And indeed,
we may not know the duration of the benefit until three years
from now.
I guess my question was all that. There is going to be
uncertainty as we roll out this information. Are you suggesting
that we wait for absolute certainty before we begin to make
policy decisions based upon how useful anybody testing is both
in terms of looking at the spread of disease, but more
importantly I think as to its protection against reinfection?
Dr. Collins. It is a fundamentally important question and
you as a physician have thought deeply about this as I have. We
do know that coronavirus, the COVID-19, is one the immune
system recognizes and eradicates the virus. We do know that
people recover from it, and after a while, you can't recover
the virus anymore. That is good. That tells you the immune
system knows what to do with this. It is not like HIV.
At the same time, we do know that this virus can mutate. We
have already been able to observe that. It is an RNA virus.
Fortunately, it doesn't mutate the way influenza does so we
don't think it will have this sort of very rapid seasonal
change that we have to deal with influenza, which means last
year's vaccine is maybe not the one you want this year.
We really don't know the answer though to a lot of your
questions and they are fundamentally important. Can you get re-
infected with this? There have been a few cases of that. They
are not incredibly convincing. If you do develop immunity, how
long does it last? We do not have a good reason to----
Senator Cassidy. Can I ask you though, there is evidence
both from rhesus monkeys that this antibody is protective and
there is also from SARS-1, if you will--somebody writes about
immunity being for 18 years. So it does seem as if the
scientific evidence is pointing in that direction.
Dr. Collins. It is pointing in that direction. You are
absolutely right and we are counting on that to be the answer
here, but until we know--we will need to know.
Senator Cassidy. Now, let me ask you though, what is
defined as knowing? Because knowing may not be for one or two
years and yet we have to make policy decisions hopefully before
then.
Dr. Collins. Indeed and I think at the present time to be
able to evaluate the meaning of a positive antibody test one
should be quite cautious. I think it is going to help a lot to
see if there is anybody who has such an antibody test that
turns out to get infected again in the next six months or so
because the virus is going to be around. We will start to get
an early warning sign there, but we won't know whether it is
three years or five years or ten years for quite a long time.
Senator Cassidy. You are suggesting that not only should we
test but we should be tracking who is positive so that we can
follow them longitudinally to see whether or not they develop
once more.
Dr. Collins. With their appropriate consent, of course, and
this is where the All of Us program that you and I have talked
about which has enrolled now 300,000 Americans who are pre-
consented for exactly this kind of follow-up is going to be
very useful to track and see what happens.
Senator Cassidy. Let me ask you as well, and to the
Chairman, I would like to enter an article for the record,
``COVID-19 has Shuttered Scientific Labs, Putting a Generation
of Researchers At Risk.''
The Chairman. So ordered.
[The information referred to can be found on page 52]
Senator Cassidy. This is an issue that my universities back
home have told me that they just had research projects shut
down. The article, which I speak about specially raised
genetically modified rats we have had to be euthanized because
of the inability to access the lab, for example. And the
expense of extending programs in want in just one of my
university is $20 million for all the grad students who need to
complete now.
I understand that NIH is a relaxed budgetary and spending
guidelines and allowed no-cost extensions to grants and
contracts but I'm also told that probably won't be enough. So
I'm just asking you what is NIH's planning for all these
scientists.
Dr. Collins. Well, I am deeply concerned about that. This
is a heartache seeing the rest of the scientific enterprise
pretty much put on hold. My own research laboratory has
researchers who are at home trying to write papers and read
literature, but they are not at the bench doing experiments
they would be doing on diabetes or aging right now if we had
the chance.
If you add up what this is going to cost just in terms of
the lost productivity, the need to keep people employed, the
estimates are something like $10 billions of NIH-funded
research is going to disappear because of the way in which this
virus has affected everybody, requiring this kind of distancing
and sending people home. And universities, of course, are very
much hoping that this is something that could somehow be
ultimately compensated. I worry particularly about trainees who
have lost time who are really quite concerned about what this
does to their professional career.
We have to do everything we can to reassure them that we
are going to get through this and that they will look back on
this someday and say, well, that was a pretty bad time but we
all managed to figure out a way to cope with it. But you put
your finger on something that wakes me up at night a lot, what
have we done to the rest of the research enterprise because of
COVID-19.
Senator Cassidy. I am not sure you though you gave me a
plan. You sympathize with the issue, but didn't give a plan,
but I am over my time. I yield back.
The Chairman. Thank you, Senator Cassidy.
Senator Warren.
Senator Warren. Thank you, Mr. Chairman. Three months ago,
America saw its first case of coronavirus, and President
Trump's response has been a complete disgrace. Instead of using
this time to drastically ramp up our testing supplier, make an
actual plan to test as many people as possible, he has dawdled,
he has peddled conspiracy theories, and he has bragged on
television that U.S. cases would soon be close to zero. Today,
over 70,000 people are dead, 1.2 million people are infected,
and 30 million people have lost their jobs.
Meanwhile America is still racing to get its testing
numbers up. I showed a detailed plan for how to do it. I am
pleased that some pieces like funding to boost testing capacity
and better reporting of demographic information are already
logged, but there is more we need to do to correct for the
President's failures, including using the power of the Federal
Government to publicly manufacture testing supplies.
Dr. Disbrow, you are the Acting Director of BARDA which was
set up 14 years ago to make sure that the Government has life-
saving drugs on hand in a crisis even if it isn't profitable
for drug companies to make those drugs on their own. Does that
mean that the Federal Government is running drug factories all
over the country with Federal employees inside and on the
production line?
Dr. Disbrow. Thank you for the question. What we do at
BARDA is we partner with companies and we form these public-
private partnerships to help develop life-saving medical
countermeasures vaccines, therapeutics, and diagnostics. We
provide funding. The companies also in most cases provide
funding.
There is a cost shared in some instances for the
development of that, but we are providing the funds, and in
particular for COVID-19, the Government will take the risk for
developing those vaccines, therapeutics, and diagnostics
because we need to expedite the development of those. No,
Federal employees are not inside the factories, but we do work
as a true partnership with our industry partners to bring those
medical countermeasures forward.
Senator Warren. Thank you, Dr. Disbrow. In other words,
BARDA identify a public health threat, helps take a drug or
other countermeasures from concept to reality, and then
contracts with private companies to make it happen. So in other
words, it uses the power of the Federal Government to ensure
that the market uses what we need and when we need.
BARDA has already invested, I should point out, in dozens
of companies including Moderna and Hello Check, both based in
Massachusetts making therapeutics and vaccines and diagnostic
tests to fight COVID-19. Our scientists are racing around the
clock and they are going to get it done. But coming up with
these life-saving innovations isn't the only challenge we face
in this area.
Dr. Collins, let's say that science delivers all the tests
we need and eventually a vaccine, what other basic medical
supplies do we need to be able to actually produce and
administer these tests and treatments?
Dr. Collins. Well again, I think we have to think about
exactly what those supplies would need to be and whether that
involves some kind of swab to collect the sample to do the test
or some sort of material, some sort of solution that you have
to transmit to the laboratory.
All of those parts of the supply chain have to be thought
about if we are going to make this as successful as it needs to
be. Likewise with vaccines, people are worried about, do we
have enough medical glass to be able to put all of these doses
of the vaccines in vials so that they can be administered and
that is a serious issue to think about. Right now, even as we
are anticipating if all goes well, that such vaccines may be
available in millions of doses as soon as this fall, again all
of that requires thinking forward.
Senator Warren. Alright, so thanks very much. I appreciate
that, Dr. Collins. In other words to put it bluntly, even if we
come up with vaccines or better tests, if we don't have the
right supplies, if we don't have enough cotton swabs, if we
don't have enough reagents, if we don't have enough glass, then
it is not going to do us any good because we won't be able to
get the job done. So let me ask this, Dr. Disbrow, is BARDA's
job to supply the Nation with cotton swabs and reagents?
Dr. Disbrow. BARDA will do whatever is necessary to get the
job done to protect our Nation. So, your question about
vaccine. So BARDA is focusing on ancillary supplies. So making
the bulk vaccine, which is the liquid, is only one staep . You
need a vial to put the vaccine in, you need a stopper to, close
the vile, and you also need needles and syringes. So we are
responsible for making sure that all of those ancillary
supplies to develop and administer that vaccine are taken care
of.
Senator Warren. Well, so in other words, we can't just wait
for the cotton swabs and the--to roll off the assembly line
from the cotton swab factory. We have really got to be planning
this out as Dr. Collins was saying.
Dr. Disbrow. Correct.
Senator Warren. I think that means that Congress should
pass Senator Murphy and Senator Baldwin's bill to force the
President to use every bit of his authority under the Defense
Production Act and get private companies making what we need.
And we can do more.
Last week, I announced the COVID-19 Emergency Manufacturing
Act. My bill establishes an Office of Manufacturing for Public
Health. It is modeled after BARDA. This office would publicly
manufacture or enter into contracts for manufacturing
everything the country needs to fight COVID-19, swabs,
reagents, masks, face shields, intubation drugs, other COVID-19
products, and manufacture them at scale.
Congress should include it in the next coronavirus relief
package so that we can save lives that are still being put at
risk by the President. Thank you very much.
The Chairman. Thank you, Senator Warren.
Senator Murkowski.
Senator Murkowski. Mr. Chairman, thank you. Gentlemen,
thank you for your leadership. Greatly appreciate it. So this
hearing is Shark Tank, a reality TV show. Alaska knows a little
bit about reality TV shows and I have got a stress test for you
today. And that stress test is Cordova, Alaska, a small fishing
community, population about 2,000. In the winter, it doubles
during the summer when the fisheries come on. It is a strong
fishing community, 7th in volume of landings in Alaska, 16th
nationwide, overall about $50 million in revenue plus so it is
significant for us.
I mentioned that it is a small community. So that means it
has a small hospital facility. We have got a license for 23
beds, 12 of those are long-term and are occupied. So we
basically have 6 available beds for the community there. The
fisheries begin, the big salmon season, the copper rivers are
coming on, and that season begins May 14th. So we are moving
onto it very, very quickly. We have got five processors that
work in town. They bring in on average about 450 seasonal
workers. Total workforce there is about 550. Yesterday, we had
the first positive COVID test that we have seen in Cordova and
it was a worker who had flown in to begin the fisheries season.
I want to share with you what the community of Cordova in
collaboration with the processors has done to make sure that we
keep this virus out. All out of state workers are gathered in
Seattle. They are put up in a hotel room. There are security
guards at the doors. They are tested and then they wait until
the tests come back. If they are cleared, then they are put on
an airplane, either a charter or Alaska Airlines, flown direct
into Cordova, they are met at the airport, they are put in a
special bus, they go directly to the processing facility where
they are again administered a second test.
It was on that second test that this individual tested
positive and they got the results just yesterday. The
individual was asymptomatic. So we have got a situation here
where you have got a community that is completely cutoff from
the rest of the world. You only get in by airplane. There have
been no ferries since the entire winter and you have got a
situation where we now have three Abbott ID analyzers. We are
waiting on a Cepheid test. All the other tests are completed by
swab and those swabs are then flown to Anchorage, an hour's
flight away and we have about 1,300 tests that are available in
the community now.
I talked to the Mayor. I am texting back and forth with the
Mayor last night speaking with our chief medical officer, Dr.
Zinc last evening. What do you need? We have got this, we have
got the Shark Tank going on. What does Alaska need? We need to
have at point testing. We have to recognize that when you have
these rural distances. It just doesn't work otherwise. It has
to be easy to run.
Dr. Collins, you have mentioned the RADx-UP demonstration,
and that sounds very intriguing and I will probably be calling
you along with Senator Cassidy here, but you have indicated
that it is intended for those areas that are hard hit. We don't
want Cordova to be hard hit because if Cordova is hard hit,
that fishery doesn't move forward. And it is not just Cordova's
fishery that doesn't move forward, it is the Bristol Bay
fishery that will be coming up in another month that is going
through these same protocols here to try to determine if it's
even possible to open up the fisheries. This is our economy.
I appreciate what you are saying about testing for those
that are hard hit. This is your stress test in the Shark Tank.
What are you going to give me?
Dr. Collins. That is a great story and a wonderful way to
point out just how critical this is.
Senator Murkowski. It is for real though and it is in real
time.
Dr. Collins. Shark Tank aims to give you, by the end of the
summer, it is not going to help you this month, a kind of point
of care testing that you really would love to have where you
have an immediate answer within an hour. And you can actually
not just test people when they come in but maybe test
everybody, every week to be sure that there is not something
brewing there because you always worry about a negative test
from somebody who actually has the virus but not enough of it
yet to pop up on the tests. Maybe that is what happened with
the individual you talked about a negative test and then it
went positive.
You would want to be able to do this continually. And of
course, as you say, you want to be able to do this in a way
that doesn't require shipping the sample off to a central
laboratory and waiting for the results to come back, if it
does. You want something that is going to work right there.
That is affordable. That is highly accurate.
It is a little bit of a knock on the Abbott test because it
does have false negatives where you have somebody who probably
is already infected but the test doesn't quite pick it up yet.
We want to drive that number up to 100 percent. So that is what
Shark Tank aims to do for you. Meantime, this whole business of
RADx-UP, the idea of providing a special attention to places
where testing has not been available, I think you make a very
good point.
It doesn't mean they have to already be hard hit. It means
they are vulnerable to becoming hard hit if the testing isn't
accessible to them in a very special circumstance and you have
just taught me about one of them. Thank you.
Senator Murkowski. I look forward to speaking with you more
about it. Thank you.
The Chairman. Thank you, Senator Murkowski.
Senator Kaine.
Senator Kaine. Thank you, Mr. Chairman for the hearing and
to our witnesses. The last time that we were here as a
Committee was March 3 and 9 deaths had occurred in the United
States of coronavirus when we were last together. And today the
number is 74,665 in the days we have been apart. It has been an
average of about 1,126 deaths a day. Personally, I am a well-
off U.S. Senator.
I know four people who have died of coronavirus since we
were last together. Jeanette Galliano, my brother Steve's
mother-in-law, Dolson Anderson, a friend of 25 years in
Richmond who was married to one of my agency heads when I was
state Governor, Gerald Glenn a bishop and an Act of Faith
leader in the Richmond community who was active and appointed
by both Democratic and Republican Governors to juvenile justice
positions, Louis Shaver who is my wife's best friend's mother
who died in a nursing home here in Fairfax County couple weeks
ago. My next-door neighbor Dean DeForest died, next door
neighbor of 28 years in the last two weeks, not of coronavirus
but of a long battle with lung cancer, but because of
coronavirus, couldn't have visitors like he normally would,
couldn't grieve with the family together like a family normally
would.
Then Lorna Brie and I didn't know Lorna, but I have gotten
to know her family. Lorna is from Charlottesville and was
working in emergency medicine at Columbia Presbyterian Hospital
and was trying to save as many people as she could. And she got
coronavirus and went home, and then when she was well, she came
back to the hospital and found it overwhelming, went back to be
with her family in Charlottesville, and died 10 days ago by
suicide.
I don't know who it was that said this brutal thing about a
million deaths are a statistic and one death is a tragedy. The
numbers are large, but we can't forget that each one is a
tragedy. March 3d, we had nine deaths in this country. On March
3d, South Korea had 28 deaths on March 3d. The total death toll
in South Korea today from coronavirus is 256. 19--I am sorry,
28 on March 3d and 256 today.
My question to you is why? South Korea is a messy,
vigorous, robust democracy like us. It is not an authoritarian
nation. South Korea is filled with super packed metropolitan
areas, but also rural areas. So in that sense, it is like us. I
am assuming, and this is a hearing about testing, I am assuming
it has something to do with testing, but that is the only
question I have, why on March 3 to today has the South Korean
death toll gone from 28 to 256 and the U.S. death toll has gone
from 9 to 74,665.
Dr. Collins. Senator, it is very sobering. I am glad you
started talking about specific individuals because sometimes we
get into these conversations about coronavirus as if it was an
academic question or it is about statistics or it is about some
fancy technology, which I confess I spend a lot of my time on
that too, but this is really about people, real people who have
lost their lives, have been terribly sick, whose families now
have found the chance to grieve but not be able to grieve in
the usual way.
My wife said to me a couple days ago, she said, you seem so
burdened about this particular set of intense priorities and
projects, you have done this before and you seem to just sort
of sail along, what is going on? Said, when I was in charge of
trying to lead the Human Genome Project it was incredibly
competitive. It was comparably exciting. It had this historic
nature to it.
But this time it is about people living or dying. It is
different, and we have to think about that at every step in a
conversation like this. South Korea did some amazing things. It
is certainly helpful for them that they are a smaller country
than we are with a whole lot less population to try to manage.
They did figure out how to do the distancing thing and the
testing thing and with great speed and rapidity.
South Korea, which I have visited, is an amazing
technologically advanced country. If you haven't been there, it
is like pretty breathtaking when you see what they have been
able to do. And so they jumped in on this in a very effective
way. A big, sprawling country is a whole other kind of
challenge and obviously a challenge that we now grieve to see
what has happened with those more than 75,000 deaths and we are
not through this.
We are nowhere near through this and everything we have to
do right now is to try to look at that experience and say we
have got to put everything we have got into keeping this
terrible tragedy from getting any worse. And that means testing
and that means therapeutics and that means vaccines. And I will
tell you, for me personally, that is what I am doing 24/7 and I
will continue as long as there is anybody still at risk.
Senator Kaine. Thank you, Dr. Collins. Thank you, Mr.
Chairman.
The Chairman. Thank you, Senator Kaine.
Senator Scott.
Senator Scott. Thank you, Mr. Chairman. Thank you to the
panel for being here with us today. And I know that we have
made significant progress over the last several weeks. And I am
excited to see that I am also excited about the future
prospects of your Shark Tank activities and efforts. So thank
you for your willingness to spend 24/7, 7 days a week on trying
to find ways to insulate America's health. Coming from the
State like South Carolina we have around 6, 936 confirmed
cases.
We assume that there is probably over 50,000 infected in
South Carolina, but we haven't had the availability of testing,
because as you already know, South Carolina is a state that is
considered to be on the low side of the number of cases and
therefore the testing resources are going in other directions.
As you think about our future, we really want to make sure that
as we serve America's needs, that those rural communities, and
South Carolina is a fairly rural state, that we do indeed have
more access to testing.
That is why I am encouraged by your, I think it is your
RADx prospects. I would love to hear you talk a little bit more
about the RADx prospects because in McCormick County, or
Calhoun County, or in Newberry, or Greenville County, a larger
county, the testing needs are very important in rural America
and rural South Carolina. So would love to have you illuminate
that a little bit more for us. The second question that I have
is about the vulnerable populations in certainly rural America,
and rural South Carolina is a part of that.
Are some minority groups like African Americans and
Hispanics, in Alaska Native Americans as well, Native Alaskans,
are all a part of the same type of grouping as it relates to
the underlying health conditions that may make you more
predisposed, having a significantly harder road through the
coronavirus. Love to have you talk about the importance of
having folks in control groups of minorities in our country
participate there as well.
Dr. Collins. Great questions, Senator. And yes, it sounds
like South Carolina and Alaska are both in the same situation
here of not being able to have access to tests that you need
right now to try to keep people in your state healthy. That is
one of the main reasons that we are proposing this so-called
RADx-UP program to try to put in places like that where there
are vulnerable populations, some of which are getting sick at
an alarming rate. The access to testing particularly needs to
be focused on there.
I am particularly concerned when I look in across the
country at the statistics about what is happening with African
Americans where clearly the burden of COVID-19 in terms of the
most serious illness and the deaths are falling
disproportionately on the shoulders of black individuals.
Look at Georgia where something like 80 percent of the
individuals with serious illness and hospitals are African
American and Georgia is only 30 percent African American. So
that tells you right there, there is something going on. And a
lot of that is the disproportion in terms of access to testing,
making it much more difficult for many of those societies to be
able to practice physical distancing just because of social
circumstances and maybe can't really afford to stay at home and
stay out of the public circulation because you have an hourly
job and if you don't show up, you are not going to get paid.
We recognize that this is one of those moments where health
disparities, which in this country have been a problem for
decades, a bright light is being shown upon them and we should
not miss the chance to react to that and come forward with
solutions. And that is what in this area of trying to be sure
that testing is accessible, maybe we can do something that
hasn't quite been done this way before.
We imagine something like 10 or 20 of these demonstration
projects located in places that are in particular need of
access to these resources now populated by scientists who are
dedicated to that goal with a very strong community outreach to
try to be sure the community embraces what it is, that this can
represent, and recognizes this may also be a way in which when
vaccines come along, we make sure the vaccines are also
distributed in a fashion that is not otherwise affected by
going to the obvious places where there happened to be more
resources.
We want to work through the federally qualified health
centers for testing and for vaccine delivery, so I am right
there with you. And I think South Carolina is a great example
of a place that we could really benefit from working with.
Senator Scott. One comment, and I am sure I will be out of
time but I will ask the question as the time ticks away and
maybe the Chairman will allow you to answer that question.
One of the things that I found to be quite interesting is
when you take a look at the prevalence of the coronavirus in
nursing homes, look at the fact that the death rates are
significantly higher there, you couple that with the fact that
as I talked to the nursing home community, about 60 to 70
percent of their certified nursing assistants are African
Americans, about 80 percent are female. You have a very
vulnerable population serving another vulnerable population. If
there is ever a case for more testing in nursing homes, not
only for the residents but for the workers, this is a classic
example.
Final question, perhaps to both the panelists, would be
around the CRISPR and gene editing technologies to advance more
testing and new types of testing. Any closing comments with my
last 38 seconds?
The Chairman. The--if you can make your answers succinct,
that would be appreciated. We have other Senators waiting.
Senator Scott. I apologize.
Dr. Collins. Well that is a question I loved but I will try
to be quick. Yes, CRISPR which is this amazing new technology
that allows you to find a very specific DNA or RNA sequence of
letters in a complicated mixture is a really powerful way to
find the presence of a little bit of a virus somewhere in a
biological sample.
A number of the new protocols that are coming into the
Shark Tank are based upon that and those are some of the ones I
am most excited about because it is a totally different
approach. It looks like it could be very point-of-care and very
readily done but without requiring special technology.
Dr. Disbrow. I agree with that completely. I mean, it is a
new technology that could look at a very low level of the virus
in a sample and I think that is the true advantage of that and
we look forward to pushing those forward.
Senator Scott. Thank you, Mr. Chairman, for your
indulgence.
The Chairman. Thank you, Senator Scott.
Senator Hassan.
Senator Hassan. Here we go. Thank you, Mr. Chairman, and
thank you Ranking Member Murray for holding this hearing and
allowing for remote participation. Thank you as well to the
witnesses for being here today and for your ongoing work and
that of your entire teams in responding to this pandemic. We do
know how hard people are working.
I will just start by saying that yesterday in the small
State of New Hampshire, a little under 1.4 million people, we
lost 19 people all of whom were in long-term care facilities.
Death rate is now about 8 per 100,000 from the coronavirus.
The need for testing has never been more clear and I think
what is hanging over this entire hearing is that question, the
question Senator Kaine so eloquently asked, but it is the
question that we have all been really referencing is what would
our trajectory look like right now if we had more testing where
and when we needed it, accurate testing that could be done
rapidly and why have some countries been able to do that
testing and we haven't? So we need to discuss the near-term
testing issues today to be sure and the other issues that the
Chairman has talked about are also important too.
But I would like to just formally request that we also hold
a hearing on COVID-19 vaccines as well because as it has
already been discussed, we need to plan for the entire
production and distribution of vaccines if we are fortunate
enough to meet these intense and rapid goals or getting a
vaccine up and operating. In my state, there is a manufacturer
of hypodermic needles who says they have not been receiving the
kind of purchase orders from the Federal Government that will
allow them to have the kind of volume of hypodermic needles on
hand when we are hoping this vaccine might be ready.
I hope very much that we will have a hearing just on
vaccines and the manufacturing supply chain that we need to
have up and ready because this administration has been slow to
respond to the needs for testing and for personal protective
equipment, and we need to learn from those mistakes and avoid
this situation in the future.
Dr. Collins, a couple of questions for you because
relatively few people can access testing and I would like it if
we would start talking about the rate of testing we are doing
per population in this country not just the wrong numbers. On
advising those with potential COVID-19 symptoms who cannot
access a test as to behave as though they have the virus has
been an important part of our containment efforts. However, as
states reopen and people are asked to return to work, it will
become harder to comply with this advice. Meanwhile reports
suggest some COVID-19 diagnostic tests are returning inaccurate
results 15 to 30 percent of the time.
These quality issues may hinder containment of COVID-19 as
individuals either correctly believe they aren't infected or
incorrectly believe that they were infected and therefore they
have developed immunity.
Dr. Collins, the goal of the Shark Tank initiative is to
accelerate development and increase testing capacity. However,
a reliable testing infrastructure depends as much on quality as
it does on quantity. What steps will NIH take to ensure that
any companies receiving funding or support through the Shark
Tank initiative are producing high-quality products?
Dr. Collins. That is a critical question, Senator, and it
is a critical step in the Shark Tank phase 1 too. The approach
that we are taking, which is that along that, fairly early in
that pathway, the technology has to be validated. That is, it
has to be tested against a variety of gold standard samples of
varying degrees of the presence of the virus to see whether it
is sensitive enough to be able to detect the virus when it is
there and specific enough so that it doesn't give a false
positive on a sample that has no virus in it.
That is absolutely essential. Anything that fails at that
point will basically fall out of the Tank and will not be taken
forward unless there can be a technical solution to dealing
with that performance issue. Once of course this does pass that
gate and gets successfully moved forward into commercialization
and scale up, the FDA will be in the strongest position then
and they will look at this carefully to see whether it passes
their muster. You may know in this current crisis, FDA has been
authorizing tests with what is called EUA, emergency use
authorization.
But in the longer term, they are going to be very
determined to make sure that these tests pass all of the
appropriate validation steps so you can count on that coming in
there as well. So it is really critical question. We will make
sure not to have this missed as an opportunity. It has got to
not just be out there, but it has got to be accurate.
Senator Hassan. Very quickly, and I know I am over time Mr.
Chairman, what--how will you ensure, Dr. Collins, that in order
to receive Federal funding these new diagnostic tests will
represent a significant enough improvement over existing
products that justify Federal investment?
Dr. Collins. That again will be something that BARDA will
also be engaged in. We will not want to put taxpayers money
into something that doesn't represent a significant advance
over what is already there. I don't think we will have to worry
though that there is going to already be enough testing that
you don't want to think about bringing on board one of these
new point-of-care platforms. If it is highly accurate and if it
is quick and giving a response, it seems highly likely we will
want to invest in it.
Senator Hassan. Thank you very much. Thank you, Mr.
Chairman.
The Chairman. Thank you, Senator Hassan.
Senator Romney.
Senator Romney. Thank you, Mr. Chairman. I appreciate very
much you holding this hearing. The first question is for Dr.
Disbrow. It is a pretty quick question, which relates to
probabilities. Those of us who have been in the business world
have dealt with probabilities. People at NASA, I am sure do.
Doctors certainly have to. What is the probability that we will
have a generally available vaccine for the American public by
the end of the year? What is your personal sense of what the
probability is? 50/50, 90 percent, 20 percent? What is the
likelihood?
Dr. Disbrow. I am not a betting person but if we don't set
lofty goals, we will never achieve those goals. And so we are
working very hard across the Federal Government to make sure
that we were doing everything we can to expedite the
development----
Senator Romney. I know that. I know we all have lofty
goals. I am not asking for goals. I am asking for the
probability. What is the probability, 50/50, 90/10, 60/40? What
is your sense of what the likelihood is that we will actually
have a vaccine available for the general public let's say by
the begining of the year for the population of our country. I
know what our goal is, of course. Our goal is a 100 percent.
But what is your sense of the probability. You have been in
this vaccine world for a long time?
Dr. Disbrow. Yes.
Senator Romney. What should we be thinking about?
Dr. Disbrow. That is why I don't like to set either
timelines----
Senator Romney. Never mind. Never mind. You won't answer
the question, we will move on. Second question, Dr. Collins,
which is the Abbott machine. It is already providing
information I guess almost on a real-time basis. What is wrong
with sort of making a lot more of those and using that as a
machine that could be available at most businesses retailers
and so forth? Is it just an inadequate? Is it the false
negatives that gives? But it strikes me that we already have a
technology that works. Am I wrong on that?
Dr. Collins. No, it is a great machine, Senator. This is
the Abbott ID now approach. It does provide you point of care
and it does it very quickly in the space of 15 minutes. It does
require having this special machine. And of course, there is a
limited number of those machines out there. I think it is
18,000 or something like that. And to be able to really meet
the need, that would have to go up substantially, and the
machines are not exactly inexpensive--I think the other concern
has been that it does have about a 15 percent false negative
rate.
If you are in a circumstance where you really, really don't
want to miss a diagnosis of somebody who is already carrying
the virus, you would like to have something that has a higher
sensitivity than that, and I know they are working on how to
make that happen. But, so it is great. It is certainly one of
the most exciting things we have got right now, but we think we
could even do better.
Senator Romney. Yes, I am--your judgment is a lot better
and more experienced than mine in this regard, but it does seem
to me that given the fact we have a test that works, it can
perhaps be made more sensitive. If we were to devote a lot of
resources to making a lot of these machines, perhaps having
some other people around the world or around the country at
least making these machines on accelerated basis, while we
could fulfill the need that we are talking about with
technology that already exists because the probability of
finding a new technology--I hope we can find that but it
strikes me that this kind of machine has some potential.
Finally, the last question for you, Dr. Collins. You know,
I have been sort of puzzled by the conflicting data that I see
and I am sure you see the same thing. The reports that came out
of Massachusetts as to the number of people there that were
asymptomatic, the people that the course of the testing, and
New York that suggested over 20 percent of the people there had
already had COVID-19, the prisoners tests as well in five
states in the South which is our recall 93 percent of the
people who had tested positive never had any symptoms, and then
the experience of Sweden, which said we are really not going to
test everybody and we are going to let the economy keep going.
Do we really need to have a kind of testing we are talking
about or does this information suggests that given so many
people that are asymptomatic--this was in a hearing yesterday
with the Homeland Security Committee, the suggestion was
between 50 and 90 percent of the people that get COVID-19 have
no symptoms. If that is the case, should we let this run its
course through the population and not try and test every
person? I am saying that a bit as a strong man, but I am
interested in your perspective.
Dr. Collins. I appreciate your putting it forward as a
strong man because while it is true that lots of people seem to
get this virus without any symptoms at all and the estimates
are that maybe 60 percent of new cases are transmitted by such
people, it is still the case that 74,000 people have died from
this disease. And so the people who are out there infected who
may not themselves be suffering are passing this on and
becoming a vector to others who were vulnerable with chronic
illnesses or in the older age group. And sometimes young people
too.
Let's not say that they are immune. There are certainly
plenty of sad circumstances of young people who really you
would not have thought would be hard hit by this, who have
gotten very sick or even died. So I think it is extremely
unusual to have a virus like this that is so capable of
infecting people without symptoms, but having them then spread
it on.
We just haven't encountered something like that before but
it doesn't mean that it is not a terribly dangerous virus for
those people who aren't so lucky and who get very sick and end
up in the ICU and perhaps lose their lives. The only way we are
really going to put a stop to that is to know who the people
are who are infected even if they have no symptoms, get them
quarantined, follow their contacts. It is just good, solid shoe
leather public health and we have learned it over the decades
and it applies here too.
Senator Romney. Thank you, Dr. Collins, Mr. Chairman.
The Chairman. Thank you, Senator Romney.
Senator Jones.
Senator Jones. Thank you, Mr. Chairman, and thank you for
having this hearing, you and Ranking Member Murray. It is very,
very important. I have been monitoring this and decided to come
down. But I have been listening to a number of things and I
want to first follow-up a minute on what Senator Collins said
and alluded to with regard to foreign dependence on vendors for
healthcare equipment. She was talking more in terms of
prescription drugs, but obviously we have seen a lot of
problems with regard to PPE, other healthcare manufacturing.
I have been working on a bill that we hope to file next
week that will give tax incentives and other things to try to
get those manufacturing, healthcare manufacturing into this
country so that in any future endeavors and as we replenish the
national stockpile we can do so with American-made goods. And I
would encourage my colleagues on the Committee to take a look
at that and perhaps join me on that. I also listened carefully
to Senator Murkowski and Senator Scott's questions regarding
the rural areas of the country and how important that is in
their particular states.
Senator Scott in particular stole my questions, Dr.
Collins, but I appreciated your answers very, very much. And so
I would like to follow-up just a little bit on that because
with all candor, we talked about rural areas, but we also
talked about vulnerable populations yet we--and I think your
word is that this pandemic has shown a spotlight on the health
disparities in this country.
It is a phrase I have been using as well in my home state
and I don't think--it is not lost on me that ironically we are
having this discussion this week when just within the last 24,
48 hours, the administration has issued briefs in the U.S.
Supreme Court attempting to dismantle a health care program
that has given good health care and insurance to millions of
Americans in this country not only through the exchanges but
also through Medicaid expansion in any number of states.
Unfortunately, my State Alabama is one of 14 states that
did not expand Medicaid, and so as part of those vulnerable
populations in Alabama and those rural areas, I have got some
326,000 Alabamians that are without healthcare and without
healthcare insurance and access to good healthcare and I find
that just appalling when we have the opportunities. And so as
we go forward, number one, I am hoping that we, the Congress,
in its next package will consider ways to incentivize states to
expand Medicaid the way we did under the ACA.
I am obviously hoping that the ACA remains viable and
intact, but I would like for you to comment just a little bit.
We have spoken a lot on the your RADx and I really appreciate
that, but I would also like to figure out what we can do now
that we have shown this spotlight to make these vulnerable
populations less vulnerable not just to this pandemic, but to
all of the pre-existing conditions that we see in these
populations, and I would appreciate you may be commenting on
that and how specifically we are going to get some of these
testing and the distributions into those areas. Thank you, Dr.
Collins. Thank you all so very much.
Dr. Collins. I appreciate the question. This is a matter of
great passion I think for virtually all of the institute
directors at NIH and we have an entire institute, the National
Institute of Minority Health and Health Disparities, which is
focused on this issue. And increasingly, the research that we
are doing is going beyond trying to identify what the factors
are that are responsible for health disparities. We learned
pretty much about those into what we could actually do about it
in terms of interventions and demonstration projects.
That is what we are thinking of in this space by having
these demonstration projects where you introduce the access to
testing, introduce therefore connection to vaccines, you can
actually change the dynamic instead of just studying it. We
have studied health disparities a lot. It is time to take some
actions.
We think as the largest supporter biomedical research in
the world, we have a chance to do those things and really learn
what works and then try to see if that can be extrapolated to
the whole country.
Senator Jones. Would you agree that if something like this
happens in the future, that one of the things we also focus on
and use a spotlight to try to make sure that people with pre-
existing conditions, we reduce the number of the vulnerable
population, we reduce the number of folks with the pre-existing
conditions by doing all we can to get good, affordable access
to healthcare throughout this country?
Dr. Collins. That is what we need as long, with all the
other things you need to do to reduce the incidence of obesity
and diabetes and cardiovascular disease, all of these things
which at the present time take a heavy toll on people from
certain subgroups and we ought to be doing everything we can to
prevent that.
Senator Jones. Great. Well, thank you, Dr. Collins. Thank
you, Mr. Chairman. I appreciate it.
The Chairman. Thank you, Senator Jones.
Senator Braun.
Senator Braun. Thank you, Mr. Chairman. Patience pays off.
I may be the last one. I am not sure. Testing, you hear it so
often, to me it repeats what we all agree with. I would like to
find out as you said South Korea kind of was the standard to
maybe try to aspire to. If there is a test that they used that
was part of their protocol, is that--was that a significant
part of it or was it their hygiene, their sheltering, and all
the other things that all of us are doing anyway? Because if
there is a test that anybody else used wouldn't we want to have
access to it?
Dr. Collins. I don't recall the details of their particular
technology, but I don't think it was anything out of the
ordinary. It was based upon using this PCR reaction to be able
to identify the presence of the viral RNA genome and certainly
the kind of test that we are doing lots of those in this
country as well. I think it was more the speed with which they
were able to set this up their access to be able to test people
very quickly who had any symptoms and their very strong
enforcement of such things as physical distancing, doing this
in a country where people were also quite amenable to those
recommendations. Maybe not quite as much in the sort of
American zone of not necessarily where Government has to tell
you----
Senator Braun. Which tests and which company would be
closest to what they use there that we have here?
Dr. Collins. I think the kinds of ones you see now in
companies like LabCorp and Quest would be the sort of thing
that you have where it's a fairly high throughput but it is
done in a central laboratory.
Senator Braun. What is the timeframe, and talking to a
pharmaceutical company one of the few headquartered in Indiana,
the CEO said that about 40 companies across the country, that
it has been at a breakneck pace to get there, especially for
the one that is quick for a country our size that is going to
have reliable results. We hear so often and we heard it today,
that we dawdled and that we didn't get there.
I would really like your opinion, and from what I heard
from the people that are actually doing it, they have been
working at this in an entrepreneurial at a feverish pace and
they didn't even have the genome to work with until what maybe
four months ago or so. What is your comment on that?
Dr. Collins. I think there has been an incredible amount of
energy put into trying to do this testing. I just gave you a
small example. At NIH up here in Bethesda, I have 25,000
employees. I want to be sure that they are safe. We didn't have
access to easy testing for our own employees and we wanted to
be sure if they were coming to work, that they weren't going to
be infecting other people.
I asked our laboratory in the clinical center, which is a
research hospital, to set up a lab test. And they were able to
do that but the most tests we can do in a given day is in the
hundreds, it is not in the tens of thousands. It is not simple
to do this.
Senator Braun. It is not that we dawdled. It is the fact
that we have got a country that is scaled much larger than say
South Korea and then it is going to take a point to get the
equipment in place to do it. Is that fair?
Dr. Collins. I think that is part of it and part of it is
bringing on board with some of these new technologies, which is
what RADx is all about to try to do this at a scale----
Senator Braun. That is going to take time in and of itself.
Dr. Collins. But we haven't had the need to do this kind of
scale of testing. I mean the kind of testing we do now even for
something like HIV or for hepatitis C, which is a lot of tests,
it pales by comparison to what we need now for this. So we
didn't have in the laboratory community the kind of capacity to
take on this number of tests and all of a sudden there it was.
Senator Braun. Very good. And answers one question for me.
Last question would be, and we have touched on it a little bit
here, Senator Romney, Senator Jones talked about it, that idea
of the broad methodology where we took an approach say similar
to Sweden where you let herd immunity be the approach. Yes, I
know.
Could we have built an iron dome around the most vulnerable
in some fashion with better protocol to where it would have
been different from a one size fits all blanket approach that
might have had difficulties to unfurl in this country just due
to the nature of who we are as well? Could we have protected
the most vulnerable if we had focused the available resources
to where we could have contemplated a different approach since
it seems to pass over so many people in a way where, they are
asymptomatic. I am just throwing that out there as a question.
Dr. Collins. Yes, it would have to have been an iron dome
that was pretty impenetrable because imagine that if just one
case got in there and then again with the easy spread from
people who don't have symptoms pretty soon you have a nursing
home situation in your iron dome. And in a certain way in this
country we have been doing a version of the iron dome which is
particularly with vulnerable people having them stay at home,
keeping physical distance, making sure that other people around
them are doing the same. It has been I would say a fairly
successful enterprise when you see the flattening of the
curves.
That has happened in many places. That didn't just happen
because we got lucky. That happened because people went to
considerable difficulties, and it did terrible damage to our
economy, to try to save lives by this kind of sequestering of
people so that they couldn't get fatal illnesses. But obviously
what we really need to get back to where we all want to be is a
circumstance where you don't have to do that anymore. That is
why the vaccine is so prominent in our minds, and until we had
the vaccine, the idea for the testing to identify people and
get them quarantined if they are actually already incubating
this virus.
It has got to be that mix, the diagnostics, the
therapeutics, and vaccines. Don't let anybody tell you, what if
we just did one of those it will be alright. We have to do all
three.
Senator Braun. Thank you.
The Chairman. Thank you, Senator Braun.
Senator Rosen.
Senator Rosen. Can everyone hear me Okay?
The Chairman. Yes, we can hear you.
Senator Rosen. Thank you. I guess I think I get the luxury
of being the last question. I hope it is a good one. I really
appreciate Chairman that you set up this hearing and I
appreciate the scientific research that the doctors are doing
in their teams. I know how important it is. I know you have
been working around the clock in Nevada. Of course, the
seriousness of the pandemic is very real. We have had strict
lockdown order, social distancing. We are beginning to flatten
our curve. Our hospitals aren't overwhelmed and we seem to be
doing alright there.
But of course everyone has talked about how we reopen our
economy in a way that is thoughtful, that is science-based, how
we need diagnostic testing capacity, antibody all of that. I
spoke about this yesterday, but Senator Rubio and I have
introduced legislation to start a longitudinal study for COVID
with NIH and CDC. It is going to be reporting to us every three
months and six months and further as we go down so we can point
to scientists and us as policymakers with data into some better
directions as we collect that.
Dr. Collins, have you seen any studies yet on your end or
are you doing any that will track those individuals, so we
talked about the have the positive antibody test, see how long
they stay in their system, and what that means? That is my
first question there and then I have I will just give them all
so you can answer them.
The Shark Tank program doesn't include the antibody test,
only acute testing. Are we going to add the antibody test to
that? And then, I am very concerned about unintended
consequences when you talk about the Shark Tank. In this
instance, we need researchers to collaborate all around the
world.
The competitive nature of Shark Tank is going to spur
people on. What are their unintended consequences of putting
people in silos where collaboration that we so desperately need
right now are not happening to get the best results? So those
are my three questions for you.
Dr. Collins. Those are great questions. In terms of the
need to track people and to see what happens, and particularly
as was brought up earlier, is the presence of antibody actually
something you can say makes you immune? I think maybe our best
chance at this is this program that Congress has funded and it
is part of 21st Century Cures Act.
I have to specifically give a shout out to this Committee
about that and the Chairman. And that is this program called
All of Us, which is tracking, when we get there, a million
people over time. We are already up to over 300,000 that have
signed up and those individuals answer lots of questions, their
electronic health records are available for researchers to look
at after they have been anonymized, they give blood samples
over the course of time so you can track and see, oh, it didn't
have the antibody, then, oh, now it does have the antibody,
what happened there? We should be able to utilize that for this
and many other purposes to try to get some of those answers and
I totally agree we need those.
Your second question about antibody testing, our sense was
that the commercial community has done a pretty good job of
getting anybody tests out there. Our scientists at the National
Cancer Institute were asked by FDA to do the validation and
they have been able to do so and a bunch of those, which was
just published a couple of days ago, actually are really good
in terms of their sensitivity and specificity, so there seemed
to be less of a need to make a big investment in the antibody
testing area.
But I would say if we have a new technology that would give
a twofer where you could get both a virus test and the antibody
test at the same time for a really good price, that might be
something we would be pretty interested in. And finally, in
terms of the unintended consequences of Shark Tank resulting in
silos, we are going to do our darnest not to let that happen.
Our kind of a Shark Tank actually kind of discourages that
kind of siloing because the advisers who are going to be
helping each of these platform developers that have new
technology to succeed, they are very well connected. They come
from the business community. They are going to be constantly
looking for ways that the technology developer ought to meet
this particular company that has the ability to do the scale up
and we will not let those sort of opportunities go by. We will
watch for that closely.
Obviously there will be competition and the successful
companies are going to want to be on top and that is what
American capitalism success, which is what we need in this
space too, but not in the point where it becomes destructive
and people don't share information that we could all learn
from.
Senator Rosen. Thank you very much for your time and your
work. And I will yield my last few seconds back.
The Chairman. Thank you, Senator Rosen. I am going to call
on Senator Murray just a moment for her closing remarks and
then I am going to wrap up the hearing. We told our witnesses
they could leave by 12:45 p.m. So if Senators could ask any
other questions they have for the record and we will have an
opportunity on Tuesday because we have a hearing Tuesday on
back to school and back to work which includes Dr. Fauci from
NIH, Dr. Redfield, the head of CDC, the head of FDA, Dr. Hahn,
and Admiral Giroir, who is in charge of testing.
The questions will be relevant to them. For those who might
be watching, I want to assure you we are following the rules
that the Attending Physician told us. We are socially distant.
We have worn our masks and he said we could take them off while
we were asking questions and we will put them back on as we
leave.
I thank the Senators who have joined by video and I hope we
have had an audience because this has been a very interesting
time. Now, let me call on Senator Murray and after that we will
conclude the hearing.
Senator Murray. Mr. Chairman, thank you so much for doing
the hearing. I do have a number of other questions. I
especially wanted to ask Dr. Collins about the racial and
ethnic disparities and how he is going to ensure testing and
diagnostics and the agency's partnerships are going to be
deployed to communities in need and several others. I will
submit those for the record, but Dr. Collins, I hope that you
and I can talk about that in the future. And thank you to both
of our witnesses today.
Mr. Chairman, I want to thank you. I do really want to
thank our witnesses for coming in today circumstances, but I
also really want to thank all the Senate employees, especially
those who were required to come to the campus today. We really
owe it to all of you and your families and your communities to
take adequate safety precautions and I am pushing hard to make
sure that happens. I also want to really thank everybody who
helped set up the technology to make this hearing possible.
You know, our country has really grappled with a world of
change since our last hearing on coronavirus and my gratitude
goes out to our healthcare and public healthcare heroes to our
essential workers, to our families across the country who have
made sacrifices, both big and small to help slow the spread of
this. And my heart goes out to everyone who is struggling with
this awful disease themselves, the illness or loss of a loved
one, or they are very real mental health effects of isolation
and loneliness and stress and trauma.
But one thing has not changed since our last hearing, even
though it has been over two months since President Trump said
anyone who wants a test can get one, it still is not true. And
that is not going to change if the President continues to deny
the severity of this crisis to insist it is not his problem and
to silence those who wanted the truth to be told.
While President Trump has yet to show the leadership or
type of detailed national plan I think he should, I am not
going to stop pushing on this because our families and our
communities and our country cannot afford to keep waiting to
finally get our response to this crisis on the right track. So
thank you very much for having this hearing, Mr. Chairman, and
I look forward to our next one as well.
The Chairman. Thank you, Senator Murray, and thanks for
your cooperation and that of your staff and all the employees
always in arranging for this hearing and the one on Tuesday.
Just a few comments as we wrap up. According to Johns Hopkins,
as well as President Trump, the United States has conducted 7
million diagnostic tests. That is more per capita than South
Korea, for example, and that is a very impressive total.
This hearing is about needing millions of more tests, but
that is because of the uniqueness of the situation not because
we don't conduct a lot of tests today. For example, my State of
Tennessee, the Governor has been pretty aggressive on testing.
For example, he is testing everybody in the state prisons.
He has drive-through testing on the weekends in many parts of
our state. I began my testimony or my statement today with the
nursing home in Franklin, Tennessee that has tested all 2,500
of its residents and staff. So we have been able to find that
number of tests for those kinds of activities yet it is not
enough for me to assure the president of the University of
Tennessee, with whom I talked, that she will be able to have
enough tests to assure students and faculty it is safe to come
back.
On the other hand, I talked to a professor at University of
California at Berkeley and he has converted his own laboratory
into a laboratory that he believes can test everybody on the
Berkeley campus within a week if they wish to be so tested. So
while this is a hearing about needing tens of millions more
tests, already having 7 million test, no country in the world
has tested that many people for coronavirus.
I want to emphasize also the effort. I know that Senator
Blunt, I, many others, we understand that in your RADx Shark
Tank program there will be failures. In fact, if there are not
failures, you are probably not doing your job because failure
can mean it doesn't work or it doesn't work well enough to be
scaled up fast enough to help the schools and to be ready for
this education season and the flu season as it comes on.
We understand that and we support the idea that there may
be failures. On the other hand, going to Senator Rosen's
comment, the closest thing to this I remember is when I was the
Education Secretary and David Kearns was the Deputy under H.W.
Bush, we sent out a solicitation for ideas for new American
schools.
There was a lot of money available. We were deluged with
good ideas, only a few could win, but we gave a citation to so
many others and we may have gotten more bang for our buck out
of the ones that didn't win than the ones who did because it
unleashed so much enterprise and opportunity. And as you said,
maybe that will produce the test or the platform that can be
used for the next virus or maybe it will introduce a really
bright scientist to a manufacturing company that is looking for
such a person.
I can see all sorts of dividends coming from this
enterprise other than the one or two or three or four new
technologies that will allow us to produce tens of millions of
diagnostic tests so we can number one, identify all those with
the disease--and they are not many of us. I don't know number.
Maybe it is 3. Maybe it is 5. Maybe it is 7 percent. We really
don't know. But those of us who are sick, those of us who are
exposed, that will permit us to track and quarantine that
percentage of us and then the rest of us can go back to work
and back to school.
Right now, we have been quarantining the whole country
because we are unable to identify just those who are sick or
those who were exposed. We--that works, but it causes a
terrible price to pay on our economy. I would like to also
mention that tests are free. I mean Congress and the
administration have made sure that if you take a COVID-19 test,
it is free. You are--either your insurance company or the
Government is going to pay for it. And that is also true with
the antibody test.
First test is whether you have it and the antibody test is
whether you have had it. And on those tests, at least in the
conversations Senator Blunt and I had with a large number
people, sounds like the private sector is well on their way
with the serology are antibodies tests that we are not likely
to have any problem with shortages of those over the next six
months. Although the FDA has a job to do in making sure that we
know which ones are accurate and which ones are not. So let me
complete conclude the hearing with the appropriate words or I
will be in trouble.
The hearing record will remain open for 10 days. I want to
especially thank Dr. Collins and Dr. Disbrow for being here
today. We are counting on you to do something that doesn't
always happen in Government, which is unleashing the private
sector, taking advantage of the best of it, and then letting
our agencies collaborate and work together and not be sunk into
their individual silos.
We need for Dr. Collins to find the new technology with the
help of Dr. Disbrow who will say, well that may be a great
idea, but I can't scale it up, and then we need for Dr. Disbrow
to work with all the manufacturing people that he knows to make
sure we can produce tens of millions of them so that we can go
back to work and back to schools. Members may submit additional
information for the record within the next 10 days if they
would like.
The Chairman. As I have mentioned, we will meet again at 10
a.m. on Tuesday, May 12 for our hearing on COVID-19, safely
getting back to work and back to school. Thank you for joining
us today. The Committee will stand adjourned.
ADDITIONAL MATERIAL
Covid-19 has shuttered scientific labs. It could put a generation of
researchers at risk
By Justin Chen May 4, 2020
Reprints https://www.parsintl.com/publication/stat/.
Scientists are skilled at tackling unexpected problems that
threaten the integrity of their experiments--it comes with the
territory. But the coronavirus pandemic poses a new--and entirely
unprecedented--challenge.
The global health emergency has shut down scientific research labs
across the country in a crisis that has left some scientists scrambling
to save their work--and has left others grieving the loss of
experiments they had dedicated months or even years to carrying out.
Many are grappling with an overwhelming sense of uncertainty about how
they'll continue their work.
The situation has hit early career researchers particularly hard.
Their funding--and their futures--depend on quickly gathering data to
publish in prestigious journals. Without additional financial support
and an extension of tenure clocks, some scientists who have just
started their own labs fear the delays to their studies may be too
disruptive to overcome.
``Early career scientists will be very vulnerable,'' said
Cullen Taniguchi, assistant professor at University of Texas MD
Anderson Cancer Center. Taniguchi said it will be crucial to
properly support researchers when labs reopen--or, he warned,
``we may lose a whole generation of researchers because of
this.''
Related: Patients, drug makers grapple with how to continue cancer
trials during the coronavirus https://www.statnews.com/2020/04/29/
patients-drug-companies-grapple-cancer-trials-coronavirus/.
Despite these struggles, many researchers say that shutting down
the labs was necessary to stem the spread of the virus. And some labs
are still up and running, though not all are doing so at full capacity.
But for scientists whose work has been deferred, the closures have
fueled a devastating ripple effect of consequences, both big and small.
Even when laboratories are reopened, it may take months to a year
for research to resume as normal.
``I have [new hires] in the lab that haven't even met each
other physically,'' said Alice Soragni, a cancer researcher and
assistant professor who runs a lab at the University of
California, Los Angeles. ``There is a lot of training that
needs to have happened that hasn't happened,'' she added.
STAT spoke to scientists across the country to better understand
the wide-ranging impacts of lab shutdowns.
In Portland, Ore., a scientist races to save her research--and then
grieves its loss
Scientists have transitioned from long hours in the laboratory to
working from home--but the abrupt halt to their research projects has
left a lingering sense of disorientation for researchers like Kathleen
Beeson, a sixth-year graduate student at Oregon Health and Science
University.
Like many of her colleagues, Beeson was caught off guard by her
lab's closure.
``We were given a week's notice,'' she said. ``Immediately, I
and others were in a race to finish experiments, collect any
data that we could, and get the lab prepared for a minimum of
six weeks of shutdown.''
Beeson had been completing a final experiment for a publication she
needs to earn her Ph.D. and move onto a postdoc research position at
Harvard Medical School.
The shutdown has upended Beeson's research, which involves
measuring electrical activity in the brains of genetically engineered
mice. Her work aims to describe how proteins at the junction of nerve
cells help transmit chemical signals--an important step in
understanding neurological dysfunctions such as epilepsy.
While other scientists were able to freeze cells or preserve tissue
samples in formaldehyde, Beeson's research relied on analyzing freshly
dissected brain tissue. Because she could no longer come into the lab,
she had to sacrifice most of her mouse colony, which she had
painstakingly raised from one male and one female to approximately 200
animals.
``In the end, I found myself euthanizing mice by the masses in
the university basement,'' she said. ``It was the punctuation
on a sad and disorienting week.''
Beeson said it will likely take her months to raise enough animals
for experiments again. In the meantime, she has been working on her
Ph.D. dissertation and a second publication from home--although not at
the pace that she had hoped for.
``I applaud anyone making any progress, on anything, during
this time,'' she said. ``Sometimes my progress is processing my
grief.''
In Los Angeles, an early career researcher confronts `exquisite
challenges'
Disruptions to research and long startup times pose an especially
daunting challenge to early career scientists who have just a few years
to establish themselves as experts in their fields and obtain critical
funding for their laboratories.
With experiments on hold, some early career scientists can't
collect the kind of preliminary data that is crucial for them to
compete with more established researchers who have a decade or more of
experimental findings to build on.
``[All researchers] are impacted but I think there are
exquisite challenges for early career investigators like
myself,'' said UCLA's Soragni.
To protect early career scientists, the NIH has extended the
timeframe for which researchers can be considered ``early stage
investigators''--a status that helps government institutes and centers
prioritize funding for scientists running new laboratories. The agency
has also relaxed some of the eligibility requirements for maintaining
grants and added additional flexibility for spending funds.
Despite these welcome efforts, early-career researchers--especially
those lacking data needed to apply for new grants--remain in a
precarious position. Soragni and others said they hoped the NIH would
take the impact of Covid-19 into account and temporarily adjust its
criteria for reviewing applications. However, the agency has
recommended that scientists without enough preliminary data submit
their applications at a later date.
For Soragni, the most difficult challenge has been the uncertainty.
``You are kind of left not knowing what you should do. . . . Should you
be ramping up completely? But what if you are switched down again?''
ALICE SORAGNI, UCLA CANCER RESEARCHER
``We really don't know if we are going to have a second wave of
infections and what will be the consequences,'' she said. ``You
are kind of left not knowing what you should do. . . . Should
you be ramping up completely? But what if you are switched down
again? Should you be hiring? Will the economy bounce back? What
is going to happen to your grants?''
``We are just at a more vulnerable stage of our career,''
Soragni said. ``I believe we may lose some laboratories to
this, so that will be very painful to witness.''
In Atlanta, a postdoc grapples with saying goodbye to a mentor
The shutdowns have taken a toll not only research, but also on the
close professional relationships at the heart of scientific
collaboration.
COURTESY STEPHANIE CAMPOS
For Stephanie Campos, Covid-19 meant that she would not complete
her research or be able to say goodbye to her mentor, Walter
Wilczynski, in person. Campos had come to Georgia State University for
a postdoctoral fellowship with Wilczynski, a pioneer in the field of
behavioral neuroscience and the first director of the university's
Neuroscience Institute. But after 37 years of research, the lab was
scheduled to close this summer after Wilczynski's cancer, once in
remission, returned.
Campos and her colleagues were wrapping up their research--a study
of the brain activity in lizards aimed at unraveling the neural
underpinnings of social behaviors--when the pandemic hit. The lab
shuttered earlier than expected.
Related: Covid-19 Drugs and Vaccines Tracker https://
w.w.w.statnews.com/2020/04/27/drugs-vaccines-tracker/.
With the laboratory closed, Campos has been limited to writing
manuscripts from home and analyzing old videos of lizard behavior. She
can't see Wilczynski--who is immunocompromised--again in person before
she moves to a new role as a visiting assistant professor at Swarthmore
College.
``[This experience] has really affected me emotionally in the
way that I knew I was going to be his last student,'' Campos
said. ``And so I had really wanted to get as much as I could.''
With Georgia easing restrictions on social distancing, there is a
possibility that Campos could return to the lab late in the summer, but
she is still unsure if returning to work would be socially responsible.
Instead, she is planning on mailing the bulk of her delayed research
project--which involves 68 lizard brains preserved in vials of
paraformaldehyde--to Pennsylvania, where she will begin work in August.
Campos credits Wilczynski, who was at times too fatigued to read
papers, for guiding her through the gauntlet of an academic job search
and giving her the confidence to continue in academia.
``His kindness during this time is what I'll remember the
most,'' Campos said. ``For me it is all about the personal
connection, how well your mentors make you feel. Those are the
things that I will take away.''
In Boston and Baltimore, lab leaders plan for a new rhythm
Waiting for their labs to reopen, principal investigators are
steeling themselves for the months of effort that will be needed to
reestablish the rhythms of a productive laboratory.
There's a mountain of work to muddle through before experiments can
get off the ground again.
``We will have to first retest [our equipment] to make sure it
is working, regrow our [bacterial] cultures, which takes a
while, before we can even consider doing an experiment,'' said
Eric Rubin, an immunology and infectious diseases researcher
and professor at the Harvard T.H. Chan School of Public Health.
Rubin also the editor-in-chief the New England Journal of
Medicine.
Regrowing bacteria in Rubin's laboratory is not a job for the
impatient. The focus of his studies, Mycobacterium tuberculosis, causes
tuberculosis and kills more people worldwide than any other infectious
pathogen. M. tuberculosis also grows approximately 50 times more slowly
than other microorganisms. Experiments that would take a day with other
commonly studied bacteria typically take weeks in the Rubin lab.
Related: Infect volunteers with Covid-19 in the name of research? A
proposal lays bare a minefield of issues https://w.w.w.statnews.com/
2020/05/01/infect-volunteers-with-COVID-19-in-the-name-of-research-a-
proposal-lays-bare-a-minefield-of-issues/.
When laboratories closed, Rubin's team was in the midst of testing
a batch of promising drug compounds for the ability to kill the
bacteria. To resume the study, researchers will have to thaw out stocks
of frozen bacteria and coax them to replicate in liquid broth.
``We normally always have things growing so that we can grab
them and do our next experiment,'' said Rubin. ``[But now] it
will likely take four months before we will have enough cells
to do experiments at full tilt again.''
Restarting research may take even longer--up to a year--for those
working with laboratory animals, such as Subhash Kulkarni, a scientist
and assistant professor at Johns Hopkins University School of Medicine.
In 2017, Kulkarni showed that, contrary to established dogma, nerve
cells lining the intestines continue to grow and divide in adult
animals. To understand how this discovery could lead to new treatments
for digestive disorders, Kulkarni had begun analyzing how neurons
behaved over the lifespan of a mouse. This project required raising
genetically engineered mice at staggered times to have enough of each
age group at the start of the study.
With his lab closed, the entire effort will have to be repeated
once Kulkarni is allowed to work again. That timeline is daunting.
``Think of this as the time when the planets are in perfect
alignment,'' Kulkarni said. ``Once that time is lost, making
the next time requires [new] breedings, which can take anywhere
from six to 12 months.''
______
[Whereupon, at 12:54 p.m., the hearing was adjourned.]
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