[Senate Hearing 118-319]
[From the U.S. Government Publishing Office]
S. Hrg. 118-319
ADDRESSING LONG COVID:
ADVANCING RESEARCH AND
IMPROVING PATIENT CARE
=======================================================================
HEARING
OF THE
COMMITTEE ON HEALTH, EDUCATION,
LABOR, AND PENSIONS
UNITED STATES SENATE
ONE HUNDRED EIGHTEENTH CONGRESS
SECOND SESSION
ON
EXAMINING ADDRESSING LONG COVID, FOCUSING ON ADVANCING
RESEARCH AND IMPROVING PATIENT CARE
__________
JANUARY 18, 2024
__________
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
55-848 PDF WASHINGTON : 2024
BERNIE SANDERS (I), Vermont, Chairman
PATTY MURRAY, Washington BILL CASSIDY, M.D., Louisiana,
ROBERT P. CASEY, JR., Pennsylvania Ranking Member
TAMMY BALDWIN, Wisconsin RAND PAUL, Kentucky
CHRISTOPHER S. MURPHY, Connecticut SUSAN M. COLLINS, Maine
TIM KAINE, Virginia LISA MURKOWSKI, Alaska
MAGGIE HASSAN, New Hampshire MIKE BRAUN, Indiana
TINA SMITH, Minnesota ROGER MARSHALL, M.D., Kansas
BEN RAY LUJAN, New Mexico MITT ROMNEY, Utah
JOHN HICKENLOOPER, Colorado TOMMY TUBERVILLE, Alabama
ED MARKEY, Massachusetts MARKWAYNE MULLIN, Oklahoma
TED BUDD, North Carolina
Warren Gunnels, Majority Staff Director
Bill Dauster, Majority Deputy Staff Director
Amanda Lincoln, Minority Staff Director
Danielle Janowski, Minority Deputy Staff Director
C O N T E N T S
----------
STATEMENTS
THURSDAY, JANUARY 18, 2024
Page
Committee Members
Sanders, Hon. Bernie, Chairman, Committee on Health, Education,
Labor, and Pensions, Opening statement......................... 1
Cassidy, Hon. Bill, Ranking Member, U.S. Senator from the State
of Louisiana, Opening statement................................ 3
Witnesses--Panel I
Vazquez, Angela Meriquez, M.S.W., Long COVID Patient, Los
Angeles, CA.................................................... 4
Prepared statement........................................... 6
Summary statement............................................ 7
Beale, Rachel, M.B.A., Long COVID Patient, Southampton County, VA 9
Prepared statement........................................... 10
Heim, Nicole, Parent of Long COVID Patient, Winchester, VA....... 11
Prepared statement........................................... 13
Summary statement............................................ 19
Witnesses--Panel II
Harkins, Michelle, M.D., Professor of Medicine, University of New
Mexico, Albuquerque, NM........................................ 41
Prepared statement........................................... 43
Summary statement............................................ 46
Al-Aly, Ziyad, M.D., Clinical Epidemiologist, Washington
University in St. Louis, St. Louis, MO......................... 47
Prepared statement........................................... 49
Summary statement............................................ 55
Madlock-Brown, Charisse, Ph.D., Associate Professor of Health
Informatics, University of Iowa, Iowa City, IA................. 56
Prepared statement........................................... 58
Summary statement............................................ 63
Walker, Tiffany, M.D., Assistant Professor, Emory University
School of Medicine, Atlanta, GA................................ 64
Prepared statement........................................... 66
Summary statement............................................ 72
ADDITIONAL MATERIAL
Statements, articles, publications, letters, etc.
Kaine, Hon. Tim:
``After the pandemic ends, long COVID still needs
Congressional attention'', article by Sens. Kaine, Young,
and Inhofe, submitted for the Record....................... 90
Hickenlooper, Hon. John:
Statements from Stakeholders groups, submitted for the Record 93
Yonts, Amy:
Testimony submitted for the Record........................... 184
ADDRESSING LONG COVID:
ADVANCING RESEARCH AND
IMPROVING PATIENT CARE
----------
Thursday, January 18, 2024
U.S. Senate,
Committee on Health, Education, Labor, and Pensions,
Washington, DC.
The Committee met, pursuant to notice, at 10:03 a.m., in
room 430, Dirksen Senate Office Building, Hon. Bernard Sanders,
Chairman of the Committee, presiding.
Present: Senators Sanders [presiding], Murray, Casey,
Baldwin, Kaine, Hassan, Smith, Lujan, Hickenlooper, Markey,
Cassidy, Murkowski, Braun, Marshall, and Romney.
OPENING STATEMENT OF SENATOR SANDERS
The Chair. The Senate Committee on Health, Education,
Labor, and Pensions will come to order. Today, in my view, we
are going to be talking about an issue that has not gotten the
attention that it deserves from the medical community, from the
media, and certainly from Members of Congress, and that is the
crisis of long COVID.
Long COVID, as we all know, is the fact that after people
get COVID, sometimes there are symptoms which simply do not
disappear. And we are going to hear from our panelists in a
moment about that.
What I would like to say to our panelists--and by the way,
we have a full house here. We have an overflow room over there,
and I suspect a lot of folks are watching this on TV and on
livestream. I think there is the sense that something is going
on in America which is serious that we are not addressing.
I just want to say to our panelists and all those who are
dealing with long COVID, we hear what you are experiencing. We
take it seriously. We think we have not, as a Congress, done
anywhere near enough, and we hope to turn that around.
The reality is we are going to hear from our panelists for
a moment, is that long COVID is a very serious illness that can
have devastating consequences for those who contract it in
America today. And it is--the estimate is that some 16 million
people throughout our Country have long COVID.
It affects people of all ages and all backgrounds. And we
are going to hear a little bit of evidence that it
disproportionately impacts people of color and lower income
people. For too many--far too many people who were previously
healthy, and we are going to hear from a former athlete this
morning, who are leading active and productive lives, they have
suddenly found themselves bedridden and grappling with strange,
debilitating systems that they could not conceive of ever
having gotten as a result of long COVID.
The truth of the matter is, and we will hear from our
experts after we hear from the patients, that we still don't
know why. We don't know the cause of the disease. But this is
what we do know.
We know that long COVID can include more than 200 symptoms,
including serious cognitive impairment and severe
cardiovascular and neurological problems that can continue for
weeks, months, or even years after initial infection.
We know that people with long COVID have experienced a wide
variety of chronic symptoms, including extreme fatigue,
insomnia, migraines, brain fog, dizziness, shortness of breath,
loss of smell or taste, and sometimes those diseases can be so
debilitating that it leads literally to suicide.
This case in my own state, where a young man, previously
healthy, committed suicide as a result. So let us be clear, the
symptoms of long COVID are not minor inconveniences. They are
debilitating conditions that affect the ability of people to
work, to care for their families, and to live full lives. And
here is what far too many do not know.
Long COVID, and we are going to hear more about this, this
morning, can affect anybody who has had COVID-19, from those
who experienced mild symptoms to those who are severely ill.
Further, although you may not have long COVID after your
first infection, each reinfection can increase the risk of
developing it. In other words, if you are under the impression
that once you have gotten COVID, you don't need to worry about
it ever again, you are mistaken. This is an escalating danger,
particularly for those who have suffered repeated infections.
It poses a severe threat to public health, and it demands our
immediate and focused attention.
Now let's be clear, the impact of long COVID is not just a
health issue, it is an economic one as well. It is estimated
that as many as 4 million Americans are out of work due to long
COVID. The annual cost of those lost wages alone is around $170
billion a year. So, what should we do about it?
First, we must educate medical professionals on how to
adequately diagnose long COVID, better understand the risks
associated with it, and identify potential therapeutic options.
Far too many patients, and I think we are going to hear a lot
about this morning, with long COVID have struggled to get their
symptoms taken seriously, and far too many medical
professionals have either dismissed or misdiagnosing their
serious health problems.
This crisis is made even worse by the fact that long COVID
patients often require multiple specialists to treat their
complex symptoms. The existing shortage of health care
providers, from primary care to mental health providers, means
that far too many Americans are unable to access affordable,
high quality care when they need it.
That is another issue that some of us hope we can address
in the near future. So let me just conclude by thanking our
panelists, both the patients and the experts who we will be
hearing from in a moment. And let me give the mic over to
Senator Cassidy.
OPENING STATEMENT OF SENATOR CASSIDY
Senator Cassidy. Thank you, Chair Sanders. You know, I am a
doctor, and I worked for a long time with people who had
chronic fatigue syndrome, or other things which are just
difficult to put your finger on, this is my problem.
The frustration they had with real symptoms but without
real test findings was just remarkable. And so, when I hear of
long COVID, you have not my sympathy, my empathy. My
understanding that this is something which can be devastating
for someone. They feel like there is something out of their
control dictating their life.
I thank you for being here. I thank you for sharing your
story. And for the researchers, I thank you for doing that
research. Some of what I say will just be an echo of that which
Senator Sanders says, because the facts are the facts. You
know, most folks with COVID recover, but there is this subset
which does not.
Again, thank you for representing them. And we know that
long COVID sometimes ends. That is the hope there, that there
is not necessarily perpetual long COVID. But for some, it is.
And again, that is the challenge that we have before us. So,
let's get the research better. Let's do what we can so that
those who have it, somehow it does end.
By the way, my own kind of episode of it is that after
having COVID, I could really smell ammonia, and I would walk
into a hospital where they were using it to clean a place, and
whoa, it just powered me. I hope you don't mind me saying this,
but when my dog urinated, I could really smell that urine. It
was just something that was just so acute.
But fortunately, that has kind of waned away and now it's
much less than it used to be, but it still comes back as just a
reminder, and that reminder tells me of that which you who have
these symptoms more severely, just how you might experience
that. So, what are we doing? Well, Congress, I am glad to say,
has put significant funding toward this.
We gave the Department of Health and Human Services $1
billion to study long COVID. And last summer, this Committee
included a policy that would give further direction to HHS's
long COVID research as part of the Pandemic and All Hazards
Preparedness Act, which we call PAHPA, the reauthorization.
Now, we know, we are about to hear, NIH has received
criticism about the effectiveness of their long COVID research
program. The Researching COVID to Enhance Recovery, or the
Recover Initiative, and that is why Congress needs to
reauthorize PAHPA. That gives us the ability to give not just
money but oversight as to how these programs are being
conducted.
Today, we are going to hear from some of our non-Federal
partners working on Recover and other HHS funded projects to
better understand how that work is going, what opportunities
are there, what else can Congress do.
We are also going to hear from patients and from the mother
of a patient, as regards to your long--about your long COVID
experience and allowing that to illuminate the conversations
that we will be having. I thank you for being here.
I thank the Committee for examining--and, Mr. Chairman, I
yield back.
The Chair. Thank you, Senator Cassidy.
[Background noise.]
The Chair. Okay. All right----
[Background noise.]
The Chair. Okay. Let me begin by introducing our first
witness, who is Ms. Angela Vazquez from Los Angeles.
Ms. Vazquez is an individual with long COVID and the Policy
Director for the Children's Partnership, a nonprofit
organization that advocates for children's health equity.
She has advocated for the long COVID patient community
since early in the pandemic.
Ms. Vazquez, thanks very much for being with us.
STATEMENT OF ANGELA MERIQUEZ VAZQUEZ, M.S.W., LONG COVID
PATIENT, LOS ANGELES, CA
Ms. Vazquez. Thank you, Chairman Sanders, Ranking Member
Cassidy, and Members of the Committee for having me here today.
My name is Angela Meriquez Vazquez, and today I am here to
speak as a disabled former athlete, long COVID patient, and
former president of Body Politic, the grassroots, patient led
health justice organization that was at the forefront of long
COVID advocacy.
Before we had to close due to a lack of funding, we
connected and supported over 15,000 long COVID patients
worldwide, the vast majority of whom were from the U.S. Before
getting COVID-19 in Los Angeles in March 2020, I was a healthy
runner for nearly two decades.
What started as a mild illness progressed over weeks with
an increasingly scary set of symptoms, including severe levels
of blood clots, a series of mini strokes, extreme confusion and
numbness in my face, hands, and legs that progressed to an
inability to walk for several days, and new onset allergic
anaphylaxis after every meal.
I had many clinical signs that something was wrong within
weeks, high markers for an autoimmune disease, labs that showed
my blood was severely clotted, markers of an over activated and
exhausted immune system.
All were dismissed by doctors as anxiety, but now are being
verified by the decades long overdue research as clear evidence
of infection related pathology.
I was left to fend for myself from bed that first year
because I did not fit the profile of who is considered high
risk. There wasn't even acknowledgment that infections could
trigger chronic disease, something I knew when I first got sick
since I have a friend who has lived with chronic Lyme for
years.
I was a young person of color, not elderly and white. Now,
even the CDC data shows that Latina and LGBTQ+ communities are
currently experiencing the highest levels of long COVID in the
U.S., and there is strong evidence that people of color are not
prescribed antivirals like Paxlovid at the same rate as white
people.
The medical neglect and discrimination I faced contributed
to my current level of disability and continues to harm
patients like me. With long COVID, I have several chronic
diseases, including myalgic encephalomyelitis, also known as
chronic fatigue syndrome or ME/CFS.
It is a neuroimmune condition whose hallmark symptom is
post exertion symptom exacerbation or post exertion malaise,
which means when I push myself past a dynamic threshold, I will
experience a relapse of my worst symptoms like insomnia, brain
fog, and confusion, sleep apnea, heart palpitations, fevers,
and severe migraines.
I am on 12 different prescription medications, including
weekly IV treatments at the hospital. I have a strict pacing
regimen that allows me to work from home but not do much else.
I don't socialize, I don't enjoy my old hobbies, and I don't
really leave my home, especially now that I am considered high
risk.
I am actually on the mild end of disability and now have
access to a lot of medical support. Patients who have had me
ME/CFS for decades guided me to the right specialists who are
familiar with infection triggered diseases like dysautonomia,
mast cell activation syndrome, and ME/CFS, and how to manage
them.
My employer has been supportive in accommodating my needs,
like frequent breaks and working from home where I can work
while laying down.
Low income and patients of color who are more likely to get
COVID-19, long COVID, and have the least access to health care,
are likely experiencing the greatest levels of disability and
medical neglect, and largely remain unidentified or unsupported
with their new disabilities by the health care system,
employers, and schools.
Having insurance doesn't necessarily guarantee access to
care. Long COVID patients with managed care plans especially
are at the mercy of overwhelmed primary care doctors unfamiliar
with infection triggered sequelae who gatekeep access to
specialists who can diagnose and manage the known pathologies.
I recently had to assist a colleague, a health access
lawyer, navigate her own HMO to get her son a long COVID
dysautonomia diagnosis after 2 years of constant symptoms.
There is also an escalating health access crisis with the
return of Medicaid eligibility redetermination this year.
Having to prove that you are still poor is a time
consuming, stressful, and bureaucratic process that contributes
to millions of otherwise eligible people losing their health
insurance because of application errors or mis-notifications.
Hundreds of thousands of disabled long COVID patients are
now--are new Medicaid recipients who may have moved or--due to
their financial or employment changes, or they may simply be
too ill to understand and fill out the forms as I have been
during relapse.
My insurance keeps me stable enough to work, and I need to
work to keep my insurance, a horrible double bind. We are
living through the largest mass disabling event in modern
history.
Not since the emergence of AIDS has there been such an
imperative for large scale change in health care, public
health, and inequitable structures that bring exceptional risks
of illness, suffering disability and mortality.
COVID-19 is but the most recent driver of a known
phenomenon of post-viral illnesses that cluster around a set of
understudied, complex chronic diseases, and that are compounded
for marginalized communities by social drivers of health.
With enough political will, we can fund a long COVID
moonshot that transforms clinical and community care for all of
us. Thank you.
[The prepared statement of Ms. Vazquez follows.]
prepared statement of angela meriquez vazquez
My name is Angela Meriquez Vazquez and today I am here to speak as
a disabled former athlete, Long COVID patient, and former President of
Body Politic, the grassroots patient-led virtual community health
organization that was at the forefront of Long COVID advocacy. Before
we had to close due to a lack of funding, we connected and supported
over 15,000 Long COVID patients worldwide, the vast majority of whom
were from the U.S.
Before getting COVID19 in Los Angeles in March 2020, I was a runner
for nearly two decades. What started as a mild illness progressed over
weeks with an increasingly scary set of symptoms, including severe
levels of blood clots, a series of mini strokes, brain swelling,
seizures, painful heart palpitations, severe shortness of breath,
extreme confusion, and numbness in my face, hands, and legs that
progressed to an inability to walk for several days, and new onset of
allergic anaphylaxis after every meal. I had many clinical signs that
something was wrong within weeks--high markers for an autoimmune
disease, labs that showed my blood was severely clotted, markers of an
exhausted immune system. All were dismissed by doctors as anxiety, but
now are being verified by overdue and still underfunded research as
clear evidence of Long COVID and infection-related pathology.
I was left to fend for myself from bed that first year, because I
did not fit the profile of who was considered high-risk. There wasn't
even acknowledgement that infections could trigger chronic disease--
something I knew when I first got sick since I have a friend who has
lived with Chronic Lyme for years. I was a young person of color, not
elderly and white. Now, even the CDC's data shows that Latino and
LGBTQ+ communities are currently experiencing the highest levels of
Long COVID in the U.S., and there is strong evidence that people of
color are not prescribed antivirals like Paxlovid at the same rate as
white people. The medical neglect and discrimination I faced
contributed to my current level of disability and continues to harm
patients like me.
With Long COVID, I have several chronic diseases, including myalgic
encephalomyelitis (ME), also known as chronic fatigue syndrome or ME/
CFS. It is a neuroimmune disease whose hallmark symptom is post
exertional symptom exacerbation or post-exertion malaise, which means
when I push myself past a dynamic threshold, I will experience a
relapse of my worst symptoms like insomnia, brain fog and confusion,
sleep apnea, heart palpitations, fevers, and severe migraines. I'm on
12 different prescription medications, including weekly IV treatments
at the hospital. I have a strict pacing regimen that allows me to work
from home, but not do much else. I do not socialize, or enjoy my old
hobbies, and I don't really leave my home, especially now that I am now
considered high-risk. Though we were recently vaccinated, my spouse and
I were reinfected with COVID over Christmas--I am here today despite my
Long COVID and new autoimmune disease flaring, and I am risking
permanent worsening of my MECFS from the exertion.
I am on the mild end of disability and now have access to a lot of
medical support. Patients who have had MECFS for decades guided me to
the right specialists familiar with the historic research on infection
triggered diseases like Postural Orthostatic Tachycardia Syndrome
(POTS), Mast Cell Activation Syndrome (MCAS), and ME/CFS and how to
manage them. Patients of color's access to benefits, and diagnostic and
supportive healthcare, is nonexistent because Long COVID was not even a
diagnosable condition until nearly 2 years into the pandemic, despite
the medical research that has existed, though limited, to guide
clinicians in managing infection-triggered diseases. Low-income,
immigrant, and patients of color who are more likely to get COVID-19,
Long COVID, and have the least access to healthcare, are likely
experiencing the greatest levels of disability and medical neglect and
largely remain unidentified or unsupported with their new disabilities
by the healthcare system, employers, and schools.
Unlike me, at least half to nearly two-thirds of surveyed Long
COVID patients could not work full-time, according to research
conducted by the Patient Led Research Collaborative, a group of
patients with Long COVID that started their peer-reviewed research
through our Body Politic support group. Many patients like me
experience deep fatigue along with neurological and cognitive symptoms
that make it difficult to drive, make decisions, remember instructions,
follow conversations, and plan ahead. The Brookings Institution
estimated that 1.6 million workers are out of the workforce due to Long
COVID, which represents an astounding majority of the estimated 2.2
million people that the labor force is missing from its pre-pandemic
size.
As we speak, the return of Medicaid eligibility redetermination as
a result of the Federal Public Health Emergency unwinding is creating
an escalating health crisis for Long COVID patients. Having to prove
that you are still poor is a time-consuming, stressful, and
bureaucratic process that contributes to millions of otherwise eligible
households losing their health insurance because of application errors
or missed notifications. This process was wisely stopped during the
first 3 years of the crisis in the interest of preserving healthcare
access for vulnerable groups. Hundreds of thousands of disabled Long
COVID patients are likely to be new Medicaid recipients who are
unfamiliar with the process. They may have moved due to their shifting
financial situation and employment and thus may have missed notices
sent by mail. Or, they may be simply too ill, like I have been during
relapses, to understand and complete the process on their own. If they
lose their health insurance, they will inevitably become sicker and
almost certainly become poorer.
We are living through what is likely to be the largest mass
disabling event in modern history. Not since the emergence of the AIDS
pandemic has there been such an imperative for large-scale change in
healthcare, public health, and inequitable structures that bring
exceptional risks of illness, suffering, disability, and mortality.
COVID-19 is but the most recent driver of a known phenomenon of post-
viral illnesses that often cluster around a set of understudied complex
chronic diseases and are compounded for marginalized communities by
social drivers of health. With enough political will, we can fund a
Long COVID moonshot that transforms clinical and community care for all
of us.
______
[summary statement of angela meriquez vazquez]
My name is Angela Meriquez Vazquez and today I am here to speak as
a disabled former athlete, Long COVID patient, and former President of
Body Politic, the grassroots patient-led virtual community health
organization that was at the forefront of Long COVID advocacy. Before
we had to close due to a lack of funding, we connected and supported
over 10,000 Long COVID patients worldwide, the vast majority of whom
were from the U.S.
Before getting COVID19 in Los Angeles in March 2020, I was a runner
for nearly two decades. What started as a mild illness progressed over
weeks with an increasingly scary set of symptoms, including severe
levels of blood clots, and mini strokes, I had many clinical signs that
something was wrong--high markers for an autoimmune disease, labs that
showed my blood was severely clotted, markers of an exhausted immune
system. All were dismissed by doctors as anxiety, but now are being
verified by overdue and still underfunded research as clear evidence of
Long COVID and infection-related pathology.
I was left to fend for myself from bed that first year, because I
did not fit the profile of who was considered high-risk. I was a young
person of color, not elderly and white. Now, even the CDC's data shows
that Latine and LGBTQ+ communities are currently experiencing the
highest levels of Long COVID in the U.S.. The medical neglect and
discrimination I faced contributed to my current level of disability
and continues to harm patients like me.
With Long COVID, I have several chronic diseases, including myalgic
encephalomyelitis (ME), also known as chronic fatigue syndrome or ME/
CFS. It's a neuroimmune disease whose hallmark symptom is post
exertional symptom exacerbation or post-exertion malaise, which means
when I push myself past a dynamic threshold, I will experience a
relapse of my worst symptoms like insomnia, brain fog and confusion,
sleep apnea, heart palpitations, fevers, and severe migraines. I'm on
12 different prescription medications, including weekly IV treatments
at the hospital. I have a strict pacing regimen that allows me to work
from home, but not do much else.
I am on the mild end of disability and now have access to a lot of
medical support. Patients who have had MECFS for decades guided me to
the right specialists familiar with the historic research on infection
triggered diseases like Postural Orthostatic Tachycardia Syndrome
(POTS), Mast Cell Activation Syndrome (MCAS), and ME/CFS and how to
manage them. Low-income, immigrant, and patients of color who are more
likely to get COVID-19, Long COVID, and have the least access to
healthcare, are likely experiencing the greatest levels of disability
and remain unidentified or unsupported with their new disabilities by
the healthcare system, employers, and schools.
We are living through what is likely to be the largest mass
disabling event in modern history. Not since the emergence of the AIDS
pandemic has there been such an imperative for large-scale change in
healthcare, public health, and inequitable structures that bring
exceptional risks of illness, suffering, disability, and mortality.
COVID-19 is but the most recent driver of a known phenomenon of post-
viral illnesses that often cluster around a set of understudied complex
chronic diseases and are compounded for marginalized communities by
social drivers of health. With enough political will, we can fund a
Long COVID moonshot that transforms clinical and community care for all
of us.
______
The Chair. Ms. Vazquez, thank you very much. Our next
witness will be Mrs. Rachel Beale, and she will be recognized
by Senator Kaine of Virginia.
Senator Kaine. Thank you, Mr. Chair. I so appreciate this
hearing. I will actually introduce both Ms. Beale and Ms. Heim,
both from Virginia. The next witness will be Rachel Beale from
Southampton County, Virginia, in the Southeastern part of our
state.
Rachel was previously the Director of Human Relations at
the Paul D. Camp Community College. She is a wife and mother to
three children. Her husband, Steve, is here with her. Last
year, she joined me at a long COVID summit that I hosted in
Richmond, Virginia.
The summit brought together patients and providers to
discuss ways to improve patient centered care. Rachel has been
living with long COVID for almost 3 years, and her story is one
that is very focused upon the tremendous challenges of
maintaining work with long COVID, and also the tremendous
challenges of negotiating the Social Security disability
insurance system with long COVID.
After Ms. Beale testifies, the next witness will be Nicole
Heim from Winchester, Virginia. Nicole is the mother of three
children and is here on behalf of her 16 year old daughter, who
has long COVID.
Nicole will share with us her journey navigating the health
care system and the education system as the parent of a child
with long COVID, one that is so significantly challenging that
it even required the family to move in order to be able to get
the health care that their daughter needs.
With that, Ms. Beale, please, we are glad to have you. We
are open--we are now open for your testimony. Then Ms. Heim,
you can follow.
STATEMENT OF RACHEL BEALE, M.B.A., LONG COVID PATIENT,
SOUTHAMPTON COUNTY, VA
Ms. Beale. Chairman Sanders, Ranking Member Cassidy, and
Members of the Committee, thank you for inviting me here to
testify. It is an honor to be here. My name is Rachel Beale,
and I live in Sedley, a small town in Southeastern Virginia.
I live with my husband, Steven, who is here with me today,
and my daughter and two sons. I tested positive for COVID on
March 17th, 2021. I was sick with COVID for 2 weeks. I had a
high fever and intense body aches. Although I didn't feel well,
I managed my COVID at home.
After the fever went away, I tried to return to my normal
life. I worked as a human resources director at our local
community college. I loved my job but soon realized I was
struggling. Even after my initial COVID infection, I continued
to experience extreme fatigue, chronic pain, and neurological
issues, to name a few.
Before COVID, I was very healthy. I didn't expect to have
problems recovering. When I realized I was struggling, I
visited my primary care doctor. My doctor told me I needed more
time to recover. I was stunned when he took me out of work for
2 weeks.
I was very stressed about missing more work and worried
that I would fall behind, but 2 weeks turned into two more
weeks, and eventually my doctor diagnosed me with long COVID in
May 2021. I was lucky to have a primary care doctor that
believed me and believed my symptoms.
I know not every person with long COVID has that same
experience. My long COVID symptoms persisted beyond May 2021. I
tried to go back to work part time, but I just couldn't do it.
For the first 6 months of my illness, I was on short term
disability.
I tried over and over to work, but I could only manage an
hour before I would start getting headaches and feel sick. Six
months after I was diagnosed with COVID, I was transitioned to
long term disability and at this point I was separated from my
job. As someone who has helped countless employees on short
term disability and has transitioned some to long term
disability, I knew this would happen to me.
I used to have the very same meetings with employees, but
there is nothing that prepares you to hear the words that you
no longer have a job. I loved my position at the college. I
loved my career in human resources. Having to stop working
because of my health has been devastating. I had a very full
life before I got sick.
Long COVID has affected every part of my life now. I wake
up every day feeling tired, nauseous, and dizzy. I immediately
start planning when I can lay down again. There are many days
when I sleep all day, and on my good days I get 2 to 3 hours of
energy. I have had most of the symptoms of long COVID.
The fatigue and chronic pain are the hardest to manage. It
can be debilitating. I also have neurological issues. The
executive functioning part of my brain seems to be affected the
most. Being sick for so long has made my depression and anxiety
worse. I have had low times, and when I don't feel good, I get
depressed.
I was just diagnosed with fibromyalgia, triggered by long
COVID, yet another illness for which there is no cure. In
December 2021, I filed my initial application for Social
Security disability insurance. I have been denied twice. I am
now waiting for hearing date with administrative law judge.
Long COVID is recognized by the Americans with Disabilities
Act. It should be easier for someone with long COVID to be
approved for SSDI. I am very fortunate that I have a supportive
family. My husband has good health insurance. My doctors,
procedures, most of my therapy is covered and I am thankful for
that.
However, the co-pays add up and sometimes we can't pay them
on time. My kids have grown accustomed to me being sick. We
plan things around how I feel and my energy level. If there is
something coming up like a birthday or holiday, I try to get as
much rest as I can before the event.
I know that I will have a crash for the next few days
after, and I won't be able to do much but sleep. Sometimes it
takes several weeks for me to get back to my baseline. For
example, coming to testify today has been a huge effort, and I
know that I will need several days to recover.
We have gotten used to this lifestyle and living within my
physical limitations. When I think about what comes next, I
just don't know. Full recovery seems out of reach for me. I
have been sick for almost 3 years, and it feels like there
hasn't been much progress in long COVID research.
I hope that Congress can help with that to move the
research forward. But for now, I am trying to make peace with
this--with my situation. It makes me sad to think about my
future. This may be as healthy as I get.
[The prepared statement of Ms. Beale follows.]
prepared statement of rachel beale
Chairman Sanders, Ranking Member Cassidy, and Members of the
Committee, thank you for inviting me to testify today. It is an honor
to be here.
My name is Rachel Beale and I live in Sedley, a small town in
Southeastern Virginia. I live with my husband, Steven, who has joined
me here today, my daughter, and two sons.
I tested positive for COVID on March 17, 2021. I was sick with
COVID for 2 weeks. I had a high fever and intense body aches. Although
I didn't feel well, I managed my COVID at home. After my fever went
away, I tried to return to my normal life. I worked as a Human
Resources (HR) Director at our local community college. I loved my job,
but I soon realized I was struggling. Even after my initial COVID
infection, I continued to experience extreme fatigue, chronic pain, and
neurological issues, to name a few. Before COVID I was very healthy, I
didn't expect to have problems recovering.
When I realized I was struggling, I visited my primary care doctor.
My doctor told me I needed more time to recover, I was stunned when he
took me out of work for 2 weeks. I was very stressed about missing more
work and worried that I would fall behind. But 2 weeks turned into two
more weeks, and eventually my doctor diagnosed me with Long COVID in
May 2021. I was lucky to have a primary care doctor that believed me
and believed my symptoms. I know not every person with Long COVID has
the same experience.
My Long COVID symptoms persisted beyond May 2021. I tried to go
back to work part time, but I just couldn't do it. For the first 6
months of my illness I was on short-term disability. I tried over and
over to work, but I could only manage an hour before I would start
getting headaches and feel sick. Six months after I was diagnosed with
COVID, I was transitioned to long-term disability. At this point I was
separated from my job.
As someone who has helped countless employees on short-term
disability and has transitioned some to long-term disability, I knew
this would happen to me. I used to have the very same meetings with
employees. There is nothing that prepares you to hear the words that
you no longer have a job. I loved my position at the college; I loved
my career in HR. Having to stop working because of my health has been
devastating.
I had a very full life before I got sick. Long COVID has affected
every part of my life. I wake up every day feeling tired, nauseous, and
dizzy. I immediately start planning when I can lay down again. There
are many days when I sleep all day. On my good days I get about 2-3
hours of energy.
I have had most of the symptoms of Long COVID. The fatigue and
chronic pain are the hardest to manage. It can be debilitating. I also
have neurological issues, the executive function part of my brain seems
to be affected the most. Being sick for so long has made my depression
and anxiety worse. I've had low times, when I don't feel good I get
depressed. I was just diagnosed with fibromyalgia, triggered by Long
COVID. Yet another illness for which there is no cure.
In December 2021, I filed my initial application for Social
Security Disability Insurance. I have been denied twice. I am now
waiting for a hearing date with an Administrative Law Judge. Long COVID
is recognized by the Americans with Disabilities Act. It should be
easier for someone with Long COVID to be approved for SSDI.
I feel very fortunate to have a supportive family. My husband has
good health insurance. My doctors, procedures, and most of my therapy
has been covered. I'm thankful for that. However, the copays add up.
Sometimes we can't pay for them on time.
My kids have grown accustomed to me being sick. We plan things
around how I feel and my energy level. If there is something coming up,
like a birthday or a holiday, I try to get as much rest as I can before
the event. I know that I will have a crash for the next few days. I
won't be able to do much just sleep. Sometimes it takes several weeks
for me to get back to my baseline. For example, coming to testify today
has been a huge effort and I know that I will need several days to
recover. We've gotten used to this lifestyle and living within my
physical limitations.
When I think about what comes next--I just don't know. Full
recovery seems out of reach for me. I've been sick for almost 3 years.
It feels like there hasn't been much progress in Long COVID research. I
hope that Congress can help with that, to move the research forward.
But for now, I'm just trying to make peace with my situation. It makes
me sad to think about my future. This may be as healthy as I get.
______
The Chair. Ms. Heim.
STATEMENT OF NICOLE HEIM, PARENT OF LONG COVID PATIENT,
WINCHESTER, VA
Ms. Heim. Chairman Sanders, Ranking Member Cassidy, Members
of the Committee, thank you for the invitation to testify today
on this important issue. My name is Nicole Heim and my 16 year
old daughter has long COVID.
In this room alone, I am sure there are countless stories
about the impact of long COVID, but one story that is rarely
shared is that of our children and the devastating physical and
mental long term effects it has.
My daughter is just one example, and I am here to share her
story in the hopes that it may help other families. In
September 2021, my daughter, 14 years old at the time,
contracted COVID. Before COVID, she was a relatively healthy,
typical teenage girl, excelling at school with a robust social
life.
A month following her recovery, I received a panic phone
call from the school nurse saying my child was short of breath,
her pulse was extremely high, and her arms and legs were locked
in place. This is the kind of phone call no parent ever wants
to receive. After seeing she was hypoxic, low blood oxygen, at
the local E.R. they transferred her via ambulance 3 hours away
to a larger hospital where she was admitted and received a long
COVID diagnosis.
Following this diagnosis, we were fortunate to be
introduced to and get into the long COVID clinic at Children's
National Hospital here in Washington, DC.
After a few months of waiting and jumping through prior
authorization hoops with Medicaid, we were able to begin seeing
Dr. Alexandra Yonts, the late lead infectious disease doctor at
Children's who coordinates the team, which includes multiple
specialists.
At the time of our initial visit with them, my daughter was
experiencing a wide range of symptoms, including extreme
fatigue, low blood pressure, increased heart rate, severe joint
pain, daily nausea and vomiting, severe brain fog, depression,
and more.
We learned about and enrolled in the joint Children's
National and NIH Pediatric COVID Outcomes Study, led by Doctor
Roberta DeBiasi. This is the only study of its kind in the
country where 1,000 children are evaluated for 3 years
following enrollment to determine long term effects on children
with COVID infection.
Long COVID stripped away my daughter's life as she knew it.
She was a straight-A honor student, an active member of the
school's marching band, and had an active friend group. Now she
is isolated and struggles to do her schoolwork. Because of the
severity of her symptoms, she is no longer able to physically
participate in the marching band or go to school.
Instead of looking forward to a high school graduation, my
16 year old is working slowly on her GED from home. The mild
depression and anxiety she struggled with prior to COVID has
only been intensified and has led to increased panic attacks
and hospitalization for suicidal ideations.
We so frequently hear about the physical effects of long
COVID. Unfortunately, we rarely discuss the mental health
impact it has. It is especially concerning when considering our
children. Having a chronic illness as an adult is difficult,
but it is more challenging and takes a greater toll, a much
greater toll on a child.
So much of our children's lives revolve around school,
extracurricular activities, sports, and friends, activities
that continue for my daughter's peers but not for her. After 2
years of treatment, my daughter has seen some symptom
improvement. However, we are still experiencing symptoms and
struggling each day to adjust to this new norm.
We are learning more and more every day. In fact, we
recently discovered she has micro-blood clots which will
require her to be on daily blood thinners. We are optimistic
that she will fully recover 1 day, but we remain concerned that
her current treatment regimen may be necessary for the rest of
her life.
Clinics and studies like these done--like those done at
Children's are crucial to understanding this infection and its
unique impact on our children. I feel so grateful for the
treatment my daughter is receiving at Children's, but I know
there are many other parents and children struggling not only
with the long COVID diagnosis, but also to find symptom relief.
In reflecting on our experience, my recommendations to this
Committee are simple. Create medical screening tools to help
identify long COVID. Increase awareness around pediatric long
COVID.
Allow physicians caring for long COVID patients to have
telemedicine appointments in states they are not licensed in,
for both the initial visits and for follow-up. Encourage the
Committee to meet with the hospitals that are running the long
COVID clinics to understand the level of services that they
provide.
I would tell any parent that if their child's existing
conditions worsen or they develop persistent and or new
symptoms after COVID, they should contact their doctor to
discuss long COVID. I look forward to a day when doctors not
only know more about long COVID but can also quickly identify
patients to provide timely treatment.
I hope studies like these at Children's National Hospital
are continually supported to lead new treatment options for
patients like my daughter. I would like to offer myself as a
resource to this Committee and our health care system as we
continue to address long COVID.
Thank you for the opportunity to share our story. I look
forward to our discussion.
[The prepared statement of Ms. Heim follows.]
prepared statement of nicole heim
Chairman Sanders, Ranking Member Cassidy, Members of the Committee
Thank you for the invitation to testify today on this important
issue. My name is Nicole Heim and my 16-year-old daughter has Long
COVID. In this room alone, I am sure there are countless stories about
the impact of a COVID diagnosis. But one story that is rarely shared is
that of our children and the devastating physical and mental long-term
effects of this virus. My daughter is just one example, and I am here
to share her story in the hopes that it may help other families.
In September 2021, my daughter, 14-years-old at the time,
contracted COVID after an exposure in band class. Before COVID, she was
a relatively healthy, typical teenage girl, excelling at school with a
robust social life. She was diagnosed earlier in her adolescence with
POTS, Posterior Orthostatic Tachycardia Syndrome, in which she
experienced an abnormal and elevated heart rate. Her COVID diagnosis
only exacerbated this issue and we saw her heart rate increase after
walking up a flight of stairs from 177bpm before COVID to 208bpm after
COVID. Her COVID symptoms were extensive, and she was very sick, but
thankfully not hospitalized.
A month following her recovery, I received a panicked phone call
from the school nurse saying my child was short of breath, her pulse
was extremely high, and she was unable to move her arms and legs. This
is the kind of phone call no parent is ever prepared to receive. At the
time, we lived in Charles Town, WV, so I rushed her to the local ER
where she was diagnosed with hypoxia with low blood oxygen. She was
transferred via ambulance 3 hours away to Ruby Memorial in Morgantown,
WV, where she received a Long COVID diagnosis.
Following this diagnosis, we were fortunate to be introduced to the
team at Children's National Hospital here in Washington, DC. While
waiting to receive care at Children's pediatric Long COVID clinic, my
daughter's testing and blood work continued. After many months of
waiting and jumping through prior authorization hoops with Medicaid, my
daughter gained access to the wide network of specialty doctors in the
Long COVID clinic led by Dr. Alexandra Yonts, the lead infectious
disease doctor at Children's. She coordinates the clinic and team that
provides my daughter with care. At the time of our initial visit with
Children's, my daughter was experiencing a wide range of symptoms,
including extreme fatigue, low blood pressure, increased heart rate,
rapid weight loss due to daily nausea and vomiting, severe brain fog,
and depression. As patients of the Long COVID clinic, we learned about
and enrolled in the joint Children's National and NIH Pediatric COVID
Outcomes study, led by Dr. Roberta DeBiasi. This is the only study of
its kind in the country, where one thousand children are evaluated for
3 years following enrollment to determine long term effects of a COVID
infection.
Long COVID took my straight ``A'' honors student, talented
flautist, and member of the school's marching band with an active
friend group and stripped her of life as we knew it. Because of the
severity of her symptoms, she is no longer able to physically
participate in the marching band and is now homeschooled full-time.
Instead of looking forward to a high school graduation, my 16-year-old
is working slowly on her GED from home.
The mild depression and anxiety she struggled with prior to COVID
has only been intensified and has led to increased panic attacks and
hospitalization for suicidal ideations. We so frequently hear about the
physical effects of Long COVID. Without a doubt it significantly
impacted my daughter's life. Unfortunately, we rarely discuss the
mental health impact of COVID. It is especially concerning when
considering our children. Having a chronic illness as an adult is
difficult, but it's more challenging and takes a much greater toll as a
child. So much of our children's lives revolve around school,
extracurricular activities, sports, and friends--activities that
continue for my daughter's peers but are no longer a part of her normal
life.
After 2 years with Children's, and through extensive testing and
blood work, physical therapy, supplements, and daily medications, her
GI symptoms, stamina, heart condition, and brain fog are manageable and
under control. Although my daughter has improved, we are still
experiencing new symptoms and struggling each day to adjust to this new
norm, including a recent discovery that she has micro clots which now
requires her to be on daily blood thinners. We are optimistic that she
will fully recover 1 day but remain concerned that her current
treatment regimen may be necessary for the rest of her life. Clinics
and studies like those done at Children's are crucial to understanding
this infection and its unique impact on our children. Unfortunately,
fewer than a dozen pediatric Long COVID clinics exist across the
country to help affected children. Children's National's approach is
unique in that each pediatric patient meets with their whole team of
specialists back-to-back during a single coordinated clinic visit. But
I have heard other clinics focus just on rehab or pulmonology. I would
urge the Committee to meet with the hospitals running Long COVID
clinics to better understand the level of services they provide. With
increased research, I am confident that treatments can be found.
I feel so grateful for the treatment my daughter is receiving at
Children's, but I know there are many other parents and children
struggling, not only with the Long COVID diagnosis but also to find
some symptom relief. In reflecting on our experience, my recommendation
to this Committee and our health care system is simple--do more to
increase awareness around pediatric Long COVID. My daughter had many
medical appointments and interacted with many providers before
receiving a diagnosis. I believe this contributed to the severity of
her symptoms and a delay in appropriate treatment. Like medical
screening tools used for depression and suicidal ideations, there
should also be a screening protocol for providers and patients to help
identify Long COVID. I would tell any parent today that if their
child's existing conditions worsen or they develop persistent and/or
new symptoms after COVID, they should contact their doctor to discuss
Long COVID.
We should also allow physicians caring for Long COVID patients to
have telemedicine appointments in states that they are not licensed in
for both initial visits and for follow-up visits. This is very
important because most states do not have a pediatric Long COIVD
clinic. And even in areas where there is a Long COVID clinic, families
like mine have to travel for several hours to make appointments.
Finally, my daughter's care was partially delayed because of the long
prior authorization requirements of our state's Medicaid program. If
there were less hurdles like these, it would help patients get to
clinics faster.
I look forward to a day when doctors not only know more about Long
COVID but can also quickly identify patients to provide timely
treatment. I hope studies, like those at Children's National Hospital,
are continually supported to lead to new treatment options for patients
like my daughter. Thank you for the opportunity to share our story,
I've done so in the hopes that it can help many other families, and I'd
like to offer myself as a resource to this Committee and our health
care system as we continue to address Long COVID. I look forward to our
discussion today.
Addendum:
I have included attachments to my testimony to further inform the
Committee of all the ways children are being affected by Long COVID.
These graphics are pulled from longcovidkids.org.
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
______
[summary statement of nicole heim]
Chairman Sanders, Ranking Member Cassidy, Members of the Committee.
Thank you for the invitation to testify today on this important
issue. My name is Nicole Heim and my 16-year-old daughter has Long
COVID. I am here to share her story in the hopes that it may help other
families.
In September 2021, my daughter, 14-years-old at the time,
contracted COVID after an exposure in band class. Her COVID symptoms
were extensive, and she was very sick, but thankfully not hospitalized.
A month following her recovery, she was diagnosed with hypoxia with low
blood oxygen and eventually, after extensive testing, Long COVID.
Following a Long COVID diagnosis, we were fortunate to be
introduced to the team at Children's National Hospital here in
Washington, DC. and after many months of waiting and jumping through
prior authorization hoops with Medicaid, my daughter gained access to
multiple specialists in the Long COVID clinic led by Dr. Alexandra
Yonts, the lead infectious disease doctor at Children's. At the time of
our initial visit with Children's, my daughter was experiencing a wide
range of symptoms, including extreme fatigue, low blood pressure,
increased heart rate, rapid weight loss due to daily nausea and
vomiting, severe brain fog, and depression. As patients of Children's
Long COVID clinic, we learned about and enrolled in the NIH Pediatric
COVID Outcomes study also at Children's National Hospital, led by Dr.
Roberta DeBiasi.
Long COVID took my straight ``A'' honors student, talented
flautist, and member of the school's marching band with an active
friend group and stripped her of life as we knew it. Instead of looking
forward to a high school graduation, my 16-year-old is working slowly
on her GED from home. The mild depression and anxiety she struggled
with prior to COVID has only been intensified and has led to increased
panic attacks and hospitalization for suicidal ideations.
After 2 years with Children's, and through extensive testing and
blood work, physical therapy, supplements, and daily medications, her
GI symptoms, stamina, heart condition, and brain fog are manageable and
under control. Although my daughter has improved, we are still
experiencing new symptoms and struggling each day to adjust to this new
norm.
In reflecting on our experience, my recommendation to this
Committee and our health care system is simple--do more to increase
awareness around pediatric Long COVID.
Create medical screening tools similar to those used
for depression and suicidal ideations for providers and
patients to help identify Long COVID.
Allow physicians caring for Long COVID patients to
have telemedicine appointments in states that they are not
licensed in for both initial visits and for follow-up visits.
I look forward to a day when doctors not only know more about Long
COVID but can also quickly identify patients to provide timely
treatment. I hope studies, like those at Children's National Hospital,
are continually supported to lead to new treatment options for patients
like my daughter. Thank you for the opportunity to share our story,
I've done so in the hopes that it can help many other families. I look
forward to our discussion today.
______
The Chair. Well, I think I speak for the whole Committee in
thanking all three of you for being here and for educating us
and the American people about what you, and in your case your
child has experienced.
Let me begin my questioning with Ms. Vazquez. I know you
have experienced obviously not only with yourself, but you have
interacted with many, many hundreds of people with long COVID.
Is one of the frustrations that the medical community or
others do not believe, in fact, what you are experiencing? Is
that one of the problems that you are going through?
Ms. Vazquez. Yes, absolutely. I--daily, it seems like I
hear from patients who have been experiencing long COVID
symptoms that are clearly as a result of their infection with
COVID, being dismissed by doctors as anxiety, as pandemic
stress.
It is, I think, quite alarming that even with the media
attention that it has gotten and then all of the grassroots
advocacy that we have done to educate providers and the
community about long COVID, it is not enough.
There really needs to be, I think, a stronger, louder,
Government campaign around long COVID for public health, and as
well as clinical education to providers, particularly primary
care. I mean, you said yourself that primary care is
overwhelmed.
You--it is really, really difficult to assess a patient in
15 minutes and get them everything they need.
The Chair. Let me jump to, Ms. Beale and Ms. Heim just to
pick up where Ms. Vazquez left off. How has your--how--what
kind of impact--what kind of effect have you had in terms of
reaching out to the medical community? Have you found doctors
understanding of the problem? Have you been able to get the
help you need, Ms. Beale, for your symptoms? Are others in a
similar place?
Ms. Beale. Thank you so much for your question, Senator.
Early on in my long COVID journey, it was difficult to find a
doctor that knew what long COVID was. I even had a doctor tell
me that she didn't believe that long COVID was real.
That is hard when you are sick and you know it is real, and
you have a medical professional telling you that they don't
believe it. It is hard to get anything out of a conversation
like that.
I have become more selective in which physicians I see. I
ask every single one of them, have you heard of long COVID? Are
you treating any other patients with long COVID? I think that
last year more of the providers are more aware of long COVID.
So that has been very helpful.
The Chair. Good. Ms. Heim, you have introduced us to
something I think has less attention than the overall crisis of
long COVID, and that is how it impacts young people.
I guess you have, not by choice, become somewhat of an
expert on COVID in young people. Can you tell us a little bit
about what you have learned as to how many kids are
experiencing long COVID, whether they are getting the kind of
treatment that they need, how it impacts a teenager's life?
Speak into the mic there, please.
Ms. Heim. Just being on social media and connecting with
all these different groups of parents, a lot of times you get
to talk directly with other parents and hear their stories, and
there is a lot of parents that are struggling to get treatment
for their children.
I mean, they are trying all kinds of different medications,
supplements, even hyperbaric chambers. I mean, they are doing
anything to try and help their children feel better. I think
the biggest thing in relation to the question about the doctors
I come across--the doctors I have been around are not
dismissive. They just say, I don't know. I hear that a lot from
doctors.
I don't know, I don't know, I don't know. So, what I do is
because I have got the information from the clinic and the
study and stuff, I tell them what I know. I was at the
gastroenterologist yesterday and I said, did you know COVID
lives in your gut for months after infection?
She said, no, I didn't know that. I said, well, tell
everybody at your office.
[Laughter.]
Ms. Heim. Then she looked at me and she said--yes, well,
she----
[Laughter.]
Ms. Heim. She looked at me and she said, well, how do I do
that test? I don't even know how to order that test to see if
they have COVID in their stool.
I think that is part of the problem, is the doctors need
the information so that they can help the patients because they
just don't know that COVID is doing this to people, I don't
think. They are shocked usually when I tell them the stuff that
I have learned.
The Chair. All right. I am running out of time. My last
question is, what good question did I not ask any of you?
[Laughter.]
The Chair. All right, Ms. Vazquez----
Ms. Vazquez. Yes. I think the--a question that I would have
liked to have answered is why it is important to include
patients in research and education for clinicians and
providers. I think we have been living this. We have been
living with long COVID since the pandemic began. And patients
have been living with infection associated chronic diseases for
generations. We know this stuff backward and forwards, not only
because we live it, but so many of us have had to do our own
research. You know, I am heavily invested in PubMed and Google
Scholar. I can read a paper. I send papers to my providers. We
are experts from a lived experience and because some of us are
getting in there, doing the research ourselves. So that is on
why it is important to include us.
[Applause.]
The Chair. See that? I knew I would ask a brilliant
question, then it was you. Senator Cassidy.
Senator Cassidy. I defer to Senator, Dr. Roger Marshall.
Senator Marshall. Well, thank you, Chairman and Ranking
Member again. And this is personal for me. One of my loved ones
is one of those 16 million people that suffered from long
COVID, incapacitated for some 2 years.
People often ask me, well, what is long COVID? I think that
we have some loose definitions, but it is--I tell people it is
like if you had mono that never goes away. There is a brain
fog. There is aches and pains. And sometimes the pains follow
nerve tracks, the vagus nerve and the femoral nerve.
Maybe it is a venous process and there is micro blood
clots. Like you, we have taken my loved one to dozens of
doctors. I have talked to 40, 50, 60, 80. I have read
everything there is to read about long COVID. Talked to other
Members of the Senate that have had long COVID, what are they
doing.
I share your frustration. I am frustrated that our CDC
seems to be more focused on I guess vaccines than they are
treatment for long COVID. I mean simple questions still have
not been answered. If you take Paxlovid early on, even though
you are young and healthy, does it help decrease the incidence
of long COVID?
I don't think we know the answer to that. Do vaccines
increase or decrease the incidence of long COVID? If you have
already had COVID, does the vaccine increase or decrease your
risk of long COVID? You know, we don't know the answers.
I couldn't be more frustrated that it is vaccines,
vaccines, vaccines, rather than focused on diagnosis and
treatment. I don't need epidemiology anymore. I need diagnosis
and treatment. What blood tests should we be offering? What is
the standard of care when a person has long COVID?
What blood should we be ordering? Now, I am going to give
you some hope though. I think in the past month, I have
finally--talked to a couple physicians that get it. That
understand it. Dr. Bob Redfield from the former CDC is one of
those people that has dedicated his life now to figure out what
is causing long COVID.
I think they are getting closer, but I couldn't be more
disappointed in what is coming out of the CDC right now. That
they are not cooperating adequately enough with private
doctors. Trust me, these doctors--we want to help. We want to
help you, but we don't know--we don't have a cure for mono.
We don't have cures for the flu. I am frustrated. And, Mr.
Chairman, what I am really concerned about is more recent news
coming from across the--from foreign lands that just recently
learned that Dr. Lily Ren, 2 weeks before we knew what COVID
was over here, was sequenced.
That our own NIH--that she had submitted the DNA sequence
for COVID to our own NIH on December 28th, but the NIH deleted
it. That would have given us two more weeks to work toward a
vaccine and curing--and preventing the problem. And then I find
out she was on the Eco Health grant from NIH--our own American
dollars. She was working for the American Government.
She has the sequence, she gives it to us, and we delete it.
Remember, it only took 2 days for Moderna to develop a vaccine.
If we would have had the vaccine earlier--my point is, how many
long COVID would we have prevented if we knew that this was
person to person transmission, which the Chinese certainly did
by then.
If we would have known this is person to person
transmission, that this came from a laboratory, that it was a
superbug, maybe we could have prevented some of these 16
million people. It points out that we don't have a good grasp
of our grants.
We award these grants to people who are doing research, and
we don't have a good grasp of what they are doing. I am even
more concerned recently, again coming out of China, that their
viral gain of function continues. This week, they found--they
have made a COVID virus that attacks the brain more so than
human lung cells and human veins.
That is why we have called for a viral gain of function
moratorium until we can wrap our arms around this horrible
situation. Who here can say the benefits of the virus that
looks like COVID, that attacks the brain more over any other
cells--what are the benefits of that type of research? People
just can't show me what the benefits that are.
I guess my question for you all--and I think it goes to the
mental health of my patients, my family members, the people I
talked to. If we knew where COVID came from and what are we
doing to prevent it? Ms. Heim, is it your daughter or your son,
I am sorry----
Ms. Heim. Daughter----
Senator Marshall. Your daughter. You know, the mental--
her--this is definitely a mental health impact on people as
well. Are you frustrated with the CDC that we don't have better
research out there, diagnosis, treatment? Are you frustrated
that we are not doing more to stop this next round of COVID
from coming?
Ms. Heim. I just want them to do something about it now,
going forward. And to acknowledge that it is real and how it is
affecting their children.
Senator Marshall. I get it. Thank you. Thank you so much,
everybody.
The Chair. Senator Murray.
Senator Murray. Well, thank you very much, Chair Sanders. I
am really glad we are having this really important hearing. I
want to thank all of our witnesses for being here today.
You know, since the COVID-19 pandemic, I have really been
pressing for more NIH funding to help us better understand and
treat long COVID. I continue to fight for strong funding bills
for health research and public health infrastructure, as we are
now negotiating our current funding bills.
Last Congress, I fought very hard to pass my Prevent
Pandemics Act to make sure that we would not be caught so
unprepared for whatever the next pandemic hits. But there is a
lot more that we need to do, as all of you well know. We need
better information. We need better care. We need better
treatment.
We need better public awareness, to help with prevention. I
know for patients dealing with this, long COVID is a serious,
life altering condition, and one we are, as many of you just
said, learning about every single day. I really appreciate all
of you being here and sharing your stories.
You know, throughout the COVID-19 pandemic, we know that
women were likely to be exposed to COVID-19, frontline
essential workers, our daycare workers, our nurses, and many of
them living in underserved communities. Now, I believe in
general that our Country needs to take women's health more
seriously, so I think this question I have for you is extremely
important.
Given the barriers women already face in getting quality
care, what are some of the unique challenges you all may have
seen as women seeking care and treatment for long COVID
complications? Ms. Vazquez, I will start with you.
Ms. Vazquez. Yes, I absolutely believe my gender and my
ethnicity played a role in not being able to get care,
especially at the beginning of the pandemic when they--when
hospitals were absolutely rationing care, even if it wasn't an
official policy, I was told multiple times that unless I was
elderly and in need of a ventilator, that I needed to go home
and save beds for people who were really sick.
This was after getting the labs showing that I was severely
blood clotted. I was told that was a false positive and that I
didn't actually need any care. I was sent home as a psych
patient. And that continues to happen to women, especially
women of color--Black women especially.
I kept going back to the emergency room because I told
myself I am not going to be a statistic. I think,
unfortunately, those statistics are growing.
Senator Murray. Ms. Beale.
Ms. Beale. Thank you for your question, Senator. For me,
early on, I did have a doctor that kept saying that it was just
depression and anxiety. That is why I was achy. That is why I
was tired. It is just depression. It is just anxiety, you know.
Go see a therapist. Let's work on it from that angle. And that
is very discouraging as a woman or any patient that it is all
in my head.
You know, I know it is not all in my head, but this doctor
is trying to make me feel like it is all in my head and it is
very discouraging. You know, there are--there were some
instances where I requested some testing, and it was--there was
a little bit of pushback on that and I think that was coming
into play of the woman--being a woman and I guess kind of
brushing me aside a little bit more.
One of the things I needed was blood work to test my
ferritin levels and the doctor kept testing just the iron but a
separate test, and I found out that I was anemic. But if I
hadn't kept pushing that with him, I wouldn't have come--I
wouldn't have been able to get that conclusion.
Senator Murray. Okay. Ms. Heim.
Ms. Heim. I don't think that is something I can really
speak on for my daughter.
Senator Murray. Okay. Well, let me ask you about access
because lot of patients with COVID, long COVID in my State of
Washington have told me that they have really limited access to
quality treatment and rehab services.
The University of Washington's Post-COVID Rehab and
Recovery Clinic is one of the few that we have in a very large
state. I know you all have lived through the challenge of
navigating our health care system.
What do you want to see done at the Federal level to expand
access to quality care for long COVID patients? Any of you? Ms.
Vazquez.
Ms. Vazquez. Yes. I really feel like we need to broadly
disseminate sort of basic diagnostic and screening tools to,
again, primary care physicians. They are the front line. They
are the first person that folks go to after an infection with
these somewhat nebulous symptoms.
These conditions have existed. We have clinical diagnostic
tools to be able to diagnose and then manage these conditions.
That needs to be disseminated widely. I think there is also a
role to play through HHS, and guidance to state Medicaid
agencies to really hold contracted managed care plans
accountable to identifying and treating long COVID adequately.
Senator Murray. Okay. Very helpful. Either of you want to
comment? I am out of time. I wanted to ask Ms. Heim very
quickly. We know that the education system during COVID, a lot
of kids suffered.
We are still dealing with a lot of the significant impact
of learning throughout that time. Your daughter is now--how are
you educating her with long COVID? Is that a challenge still
for parents?
Ms. Heim. We had transitioned from in-person school to a
homebound program, which most states have. But even that was
too much for her to be able to do with the anxiety, the four
core classes.
They had tutors that would meet with them, but a lot of the
teachers weren't cutting her any slack. They weren't giving her
less work. They weren't sympathetic at all.
Senator Murray. We are dealing with learning loss from
COVID in general, and I think we need to highlight it with long
COVID patients as well, especially young kids. So, thank you.
The Chair. Senator Cassidy.
Senator Cassidy. I will defer to Senator Braun.
Senator Braun. Thank you. When I look at what we do here on
this Committee, I think whatever the particular topic is, we
need to weave it always into maybe a little broader discussion.
When you look at COVID coming along, catching our Country
by surprise the way it did, I think a big part of the
trickiness of navigating through it was what is true and what
isn't. How much transparency is there?
I know in my own business that I ran, that I could only
look back on in terms of what they were doing, we took it
seriously. Just like we took health care seriously 15 years ago
when I was sick and tired of a health care system that was
telling us how lucky we were that our premiums are only going
up 5 to 10 percent a year, along with zero transparency into
the system.
I think COVID, if you want to find a silver lining to it,
shows you how when you really get into a predicament where it
is just laced with uncertainty, novelty, and then you try to
remediate it through a system that you know is not real good at
taking care of the standard operating staff.
No one should go broke in this country because they get
sick or have a bad accident. I think most of us--thank you, and
that should be something we all agree with. Then it gets down
to what are you going to do about it?
I want to highlight something that the Chair of the
Committee and I are doing, and then the question will be around
that as you navigated through your own complications with
COVID. To me, when I wrestled with it 15 years ago, there was
zero transparency. You basically hoped that your insurance plan
was going to take care of it.
You never found out the net result until 3 or 4 months
later, when you opened the envelope up with trepidation to see
how much it was going to cost you. That is no good. We have got
a bill called Healthcare Transparency and Competition, all the
things I have been talking about.
There are bigger things working here in the U.S. Senate.
And thank you, Chairman, for doing that alongside many of us
that are interested in it. Let's start on the left side of
the--down here.
Tell me, once you got into your own predicament fighting
COVID, was it easy dealing with the system itself when you were
trying to see what your alternatives were? Could you actually
quantify that into how much it was going to cost? And tell me
what that was about?
Ms. Vazquez. The costs of living with long COVID are high.
I have an excellent employer based health plan, a PPO, and I
still last year spent $4,000 out of pocket on medically
necessary care.
This was not alternative care or--they were things that
were not covered that were denied by my health plan. And that
is--that was for a variety of reasons. A lot of my medication
needs to be compounded because I am allergic.
Insurance does not cover compound medication easily. I
spent hours, probably a total of 40 hours over a month, just
trying to get one medication covered. So, there is a cost,
there is a financial cost and a time cost.
Senator Braun. Thank you. Ms. Beale.
Ms. Beale. Yes. For me, the same thing with the cost. I
have my co-pays that I pay for every specialist I see, and that
really adds up.
Also, I live in a small town about an hour away from most
of my doctors, so I am having to drive everywhere to these
appointments when my time would be better spent resting,
instead of going everywhere to try to see the doctors. It is
very frustrating for me. You know, with my medical insurance, I
have to see my PCP to ask for referral.
When I wanted to see a neurologist, I had to ask to go see
a neurologist, or cardiologist, hematology. Every time I had to
have a referral. And then you have to wait 6 months to get seen
by the specialists, and all this time is going by, and you know
what the issue is, but you can't get in front of the right
doctor.
That is all--that has been very frustrating. Insurance,
when things aren't covered that you need, it is very
demoralizing because you know you need it and it is out of
your--you know, not in your own personal budget to cover it.
One of the things that I need is massage therapy for my
chronic pain, and I pay out of pocket, but I can't afford to go
every week like I need to. I go maybe once a month. And that is
something that helps people with long COVID. So why can't the
insurance cover it?
Senator Braun. Good question. Ms. Heim.
Ms. Beale. Really frustrating.
Ms. Heim. My experience is very different because my
daughter is on Medicaid. So, what was going on with us was,
well, first off, in order to get into Children's National,
there is a lot of prior authorizations that needed to happen. I
definitely feel for my doctor's office sometimes because of the
hours that they put into getting in--getting us into some of
these specialists.
But part of the reason why we moved states was because we
previously lived in West Virginia, and whenever I needed to see
a specialist, which was a lot, we had to drive over 3 hours to
go to the university to see a specialist.
It was like a full time job getting her to all the
appointments and the testing and all that stuff. So, that was
really hard.
Senator Braun. Well, I think you are all saying the same
thing. We had a kind of broken system that lacks transparency,
competition, and all of that. Again, this health care price
transparency 2.0 addresses all of that. And until we get that,
we are always going to be wrestling with issues like you have
just described. Thank you.
The Chair. Thank you, Senator Braun. Let me take a
Chairman's privilege to pick up on a point that Senator Braun
made. He and I agree with the diagnosis. We have the health
care system, which is broken, which is dysfunctional.
In my view, its main function is to make huge profits for
the insurance companies and the drug companies. Meanwhile, our
life expectancy is far lower than many other countries. We
don't have enough doctors, nurses, mental health practitioners,
pharmacists, you name it.
We need a fundamental overhaul of our health care system
with a Congress that is able to do it. Given the power of the
insurance companies and the drug companies and big money
interests, we will see. Senator Hassan.
Senator Hassan. Thank you, Mr. Chairman, and thank you,
Ranking Member Cassidy, for this hearing.
To the witnesses, thank you for being here today, because
this is really, really important for us to hear and understand.
And before I turn to my questions, I just want to highlight the
long COVID research that is happening in New Hampshire and the
need for consistent investments in this work.
This is more for my colleagues than for the three
witnesses. Patients in New Hampshire have benefited from the
research and care happening at the Dartmouth Hospital Post-
Acute COVID Syndrome Clinic.
The clinic has received some Federal funding through NIH
but additional funding to expand services for patients has been
delayed because of uncertainty around consistent, long term
Federal funding. We have to work in a bipartisan manner to come
to an agreement on long term Government funding, including to
ensure reliable research funding that supports millions of
Americans who are experiencing long COVID.
Now to my questions to the panel. Ms. Beale, I want to
start with you. I want to--this is a follow-up on questions you
have heard and discussions you have had with Senator Murray,
and just now, Senator Braun.
In New Hampshire, our clinic at Dartmouth Health is the
only long COVID clinic in the state. The clinic is in the Upper
Valley region of New Hampshire, and as a result, some patients
may have to drive hours to get there.
You have talked about the impact of long car rides on your
condition, but it can be really hard for any patient,
especially those experiencing symptoms of long COVID, to have
to engage in that kind of travel. That is just one example of
the barriers that patients face to accessing the care they
need.
But I just would like you to elaborate, what has it been
like for you, with the symptoms you have, to have to make long
trips for your care?
Ms. Beale. Thank you for your question, Senator. There have
been many times where I have wanted to cancel appointments
because I am sick.
I don't feel good or I have zero energy and my husband is
at work. He can't take off work to drive me everywhere. You
know, he is our only income. So, yes, there is plenty of times
that I am driving to my appointments, and I am--just I am so
sick.
Then I get into the appointment, and I am in front of the
doctor, and I don't always remember every single thing that I
need to say. I forget the biggest symptom that I need to talk
about, or I forget my questions and all I am thinking about is,
gosh, I don't feel good. I just want to go back home. And it is
hard. It is really hard.
Senator Hassan. Yes. I think it speaks to not only the
challenges of long COVID patients, but just generally whenever
patients with chronic illness have to travel a long time----
Ms. Beale. Right.
Senator Hassan. So that is why rural health care and having
multiple places that can address various health care issues is
so important.
Ms. Vazquez, my office has heard from Granite Staters with
long COVID who are facing difficulties accessing and affording
the health care that they need, just as you have discussed. One
study suggests that patients who experience conditions like
long COVID and chronic fatigue syndrome could face an average
of $9,000 annually in medical bills.
Can you--you talked about your experience and the out-of-
pocket payments you have needed to make. But from a policy
perspective, what can we do to protect patients from these
costs? What are the recommendations? I know you have been
advocating on this front.
Ms. Vazquez. Yes. I think, there absolutely needs to be
Government funding for research, which takes place in clinics
and in long COVID clinics. And additionally, there--we have to
hold health plans and especially managed care plans accountable
for adequately reimbursing for services like care coordination.
If you are working with 10 different specialists----
Senator Hassan. Right.
Ms. Vazquez [continuing]. you are going to need a care
coordinator. And these are services that, again, that health
plans are required by law to provide, and they are not always
doing that.
Senator Hassan. Some of our oversight function could also
come into play here as well.
Ms. Vazquez. Yes.
Senator Hassan. Finally, to Ms. Heim, the small team at New
Hampshire's long COVID clinics serves around 60 new patients
per month and hundreds of existing patients, and the rate of
referrals to the clinic isn't slowing.
About 6 percent of New Hampshire has long COVID. It is
clear that patients need access to more medical providers who
can recognize and treat long COVID. What would you like to see
change in how providers understand and treat children with
symptoms of long COVID? I know that is your particular area of
expertise at this point.
Ms. Heim. I would say just as we do a screening for
depression with teenagers, let's say, why can't we do a write
up that screens for long COVID?
Senator Hassan. Yes.
Ms. Heim. We cannot only have it at the doctor's office but
put it online so people can access it. And then if they realize
that this might be what is affecting them, they can get in
contact with a specialist. Even have it accessible to the
schools.
Senator Hassan. Yes.
Ms. Heim. If they have a child that is coming into the
school counselor's office or missing a lot of school, it might
raise a red flag and they can just put a document in front of
them and that could start the process. And then of course,
telling the doctors what is going on, just giving them
information we already have.
Senator Hassan. Yes.
Ms. Heim. I mean, I know so much just after the past couple
of years, and I tell every doctor I see, but that is not going
to make much of an impact. So why not get it out there to
everybody what we know already.
Senator Hassan. Right. Well, I appreciate that. And it
strikes me that interacting with school nurses and getting
school nurses engaged in this is one way to make sure that the
schools have that information, from the viewpoint of a health
care professional. I appreciate that. Thank you very much, Mr.
Chair.
The Chair. Senator Cassidy.
Senator Cassidy. I am a doctor. You are going to see my
questions kind of reflect the technical aspect of this. By the
way, you are talking about having to leave West Virginia,
beautiful state, to move to be closer.
You are talking about, Ms. Beale, etcetera, same sort of
story. Is telemedicine--are people using telemedicine for this?
Because I am thinking that probably the examination is not
showing very much. It is an interview, and they are asking you
a response. So, is Virginia Medicaid covering telemedicine, or
are your insurance plans covering telemedicine?
Ms. Vazquez. You know, I can, say that, yes, my health plan
is covering telemedicine. However, the specialists--many of the
specialists that I and others have seen are out of network and
sometimes even out of state, which are not necessarily always
covered. Many of the folks who have treated----
Senator Cassidy. Now, are the doctors themselves, herself,
himself, require you to show up in person, or will they do a
telemedicine interview as at least an intake interview?
Ms. Vazquez. It depends. I think for those of us who can
get in that first appointment via telemedicine, it is great.
But so many are in boutique practices.
Senator Cassidy. So--Ms. Beale, your experience?
Ms. Beale. For me, telemedicine, telehealth is available
with my health insurance. However, when I am seeing a
specialist, I want to see them--I need to be in the room with
them. I want them to see me, all of me so that they----
Senator Cassidy. Oh, I get that. Believe me, there is a
therapeutic aspect to that interview, which as a physician, I
am so aware of. Sometimes for follow-up it helps though,
particularly since you have mentioned the drive is so
fatiguing. Ms. Heim, your experience?
Ms. Heim. When we lived in West Virginia, WVU had a
telemedicine office for children.
What would happen was we would go see the specialist in
Morgantown and then for prior visit visits after that, we would
go into an office and see a nurse or a PA, and they would
essentially wheel the doctor in on a screen and we would still
get that visit.
That was powerful. However, as a child, they required us to
be at the hospital to do colonoscopy and pulmonary--all the
testing always had to be done----
Senator Cassidy. Of course.
Ms. Heim [continuing]. at the hospital. So even with that
help of the telemedicine, we still had to travel quite a bit.
Senator Cassidy. Let me ask you----
Ms. Heim. Children's of course, did not--they have not done
the telemedicine because a lot of times the doctors aren't
licensed in different states. So, you have to be in the state
in order to see the doctor. So sometimes we will drive and just
kind of park and then see the doctor on the side of the road,
but that is not very convenient.
Senator Cassidy. Now, you have been involved in Children's.
And as y'all were talking, I was on PubMed listening, looking
at some of the articles and stuff. And the therapies, are they
actually giving you your child therapy at Children's. Put it
this way, is she in clinical trials testing different therapies
as to what might be benefiting her?
Ms. Heim. There is two separate things. There is the long
COVID clinic which has the doctors and the specialists, and
then there is the NIH study that is run through Children's. So,
the study is just gathering information.
Senator Cassidy. It is observational. It is not therapy.
Ms. Heim. Two of my children are in that study because as a
parent, that was the only thing we could do to help the
situation is to give them information. So, we just do the study
to help.
We don't really we get information sometimes, but mostly it
is just them doing testing and questionnaires and stuff. The
actual clinic has offered advice and treatments, and some of
them have helped, yes.
Senator Cassidy. Okay. Now, the treatments, some of them
are like massage. You had mentioned how massage therapy,
etcetera. Are any of them clinical trials? We are going to try
this drug versus placebo to see if this drug is beneficial.
Ms. Heim. I don't know if it is trials necessarily. But
again, they have learned that there is COVID in the stool,
right. So, one of my daughter's symptoms was she was nausea and
vomiting and constipation and pain every day for like 6 months.
She walked around with a puke bag in her hand all the time.
When we found out that it might be in the stool, we did a
clean out through a colonoscopy that was kind of by chance, but
nevertheless, and then we started on a pro and prebiotic that
Children's recommended. And those symptoms almost completely
went away.
Senator Cassidy. Really?
Ms. Heim. Yes.
Senator Cassidy. That is great. And that was not part of a
clinical trial, that was just kind of like----
Ms. Heim. No, but that is what I am saying, I want the
doctors to know what we are learning, because somebody could be
having nausea and vomiting and pain, and all they got to do is
clean out their gut because COVID is still there a year later.
Senator Cassidy. Well, the probiotics helped. I mean,
obviously----
Ms. Heim. Yes.
Senator Cassidy. It has--it is more than cleaning out the
gut. But anyway, that said, Ms. Vazquez, post exertional issues
are a major--I think everybody is describing you get tired, and
you were the runner, so you are going to notice it most.
Has there been--and I have read that there are some
problems with the mitochondrial so this may not be reparable,
but in other cases they are talking about how gradual, physical
therapy, etcetera can actually be a positive thing.
What therapies have been attempted for you as a former
runner to attempt to recover your ability to exert?
Ms. Vazquez. As a former runner, I know what it is like to
push through and overtrain to the point of stress fractures.
And exercise is not good for me, especially when I----
Senator Cassidy. But there is things--there is passive
resistance, for example, where the physical therapist kind of
moves you back and forth, etcetera. I am not prescribing that.
I am just wondering, what is being tried?
Ms. Vazquez. You know, I will say that there is just so
much evidence that post exertional malaise is the downstream
effect of exercise. I think exercise and movement will improve
when we manage the upstream drivers of post exertional malaise.
Senator Cassidy. Okay.
[Applause.]
Senator Cassidy. Okay. Mr. Chairman, I yield. Thank you
all.
The Chair. Senator Kaine.
Senator Kaine. Thank you, Mr. Chair. I really appreciate
the witnesses being here. You know, it is--I think it is an
honor to testify before the U.S. Senate. It can also be a
hassle, but for y'all, it is an additional burden. It is a
burden to come.
As Ms. Beale testified, or as Ms. Vazquez, traveling across
the United States, or Ms. Heim here with family you are going
to suffer a consequence from having been here today, likely
fatigue.
We don't have a lot of witnesses who have to come over the
mountain the way you have had to, to be here, and I really
appreciate it. I have--you know, I have been dealing with my
own long COVID issue for almost 4 years. It is mild, thank
goodness.
I feel like every nerve ending in my body is in an Alka-
Seltzer 24/7, and it is--I can work, I can focus, I can
exercise. It is harder to sleep. After 6 months and it not
going away, I finally decided, I guess maybe it is not going
to. I should see a neurologist.
I have been able to be told this is probably not going to
get worse, and it is probably not going to get better, and both
have proven true.
Two other colleagues, one a former colleague, Senator
Inhofe, and a current colleague, Senator Young, we wrote a
piece about our own experiences together that I would like to
introduce into the record, if I might, Mr. Chair.
The Chair. Without objection.
[The following information can be found on page 90 in
Additional Material.]
Senator Kaine. The reason that we wrote it is, Ms. Vazquez,
you pointed out, and I think subsequent testimony is
underlying, long COVID is disproportionately affecting people
of color. Long COVID is disproportionately affecting women. But
we are three white guys. One got long COVID in his 40's,
Senator Young. One got long COVID in his 60's, Senator Kaine.
One got long COVID in his 80's, Senator Inhofe.
We decided after kind of finding ourselves on the floor of
the Senate bumming around and wonder if anyone else is having
this weird experience here, we found each other and shared our
experiences, and I think the reason that we all started to be
public about it is, we didn't like that you weren't being
believed. U.S. Senators get believed. You know, I----
[Laughter.]
Senator Kaine. By a certain percentage of the population. I
didn't have trouble getting believed by a doctor. I didn't have
trouble getting believed by a doctor. I don't think Senator
Inhofe did. I don't think Senator Young did.
Our physical reports of our own conditions were given
credibility, but so often, with women that is not the case.
With minorities, that is not the case. With young people, it is
not the case. We have seen the similar phenomenon in maternal
mortality when we have had hearings about this.
We decided the three of us to talk about our experiences so
that people would understand they're being believed. And, Mr.
Chair, by doing this hearing today, we can approach some
substantive improvements.
But also, I think doing a hearing like this has a way of
sending a message that people are believed. Ms. Beale, I don't
want you to say more than you comfortably feel like you can,
but can you talk a little bit about this SSDI ordeal and that
you have been--I mean, the ADA says long-COVID is a condition,
a disabling condition that can be one that would either require
reasonable accommodations or lead to an SSDI disability
determination.
But in a situation where you are already low energy, you
are going through an extended process where you have already
been denied twice. Talk a little bit about how frustrating that
might be. And you are a human resources professional who have
helped employees do this, so imagine if you hadn't had that
background, how frustrating this would be.
Ms. Beale. Thank you for your question, Senator. It has
been an ordeal, like you said. It is--the whole process has
been very frustrating. The system is very difficult to
navigate. You know, when I am working on the paperwork, it is
very overwhelming, and I can only work on it but for so long. I
have to--you know, I set like a little timer for about 30
minutes, because if I go over that I start getting headaches.
I am trying to compile all of my medical documentation to
send in. And you know, both times I was denied, SSDI doesn't
give specific reasons why you were denied. I don't know what it
is that they need for me to show that I can't work.
Senator Kaine. Interesting. So, you don't know whether it
is, we don't think you are disabled, or you didn't fill out
this piece of information right, or you left something blank,
or--you really don't know.
Ms. Beale. Right. You know, I don't know if they were able
to get in contact with all the doctors. I don't--you know, I
don't know unless the doctor tells me.
Senator Kaine. Here is a class of folks with long COVID who
really have problems with the SSDI. A lot of people got COVID
before we had tests. You remember how hard it was to get tested
early on? And people who are getting COVID at the front end,
they weren't even getting tested for COVID because there
weren't tests.
Then later, okay, maybe they get a vaccine. And then later
a test will show that they have antibodies in their body, but
that could be because of the vaccine, or it could be because
they have already had COVID, and the medical professionals who
are trying to make a resolution about SSDI are like, well, you
have antibodies, but that doesn't mean you had COVID.
There is a set of problems that make this within the SSDI
framework really tough. Now, we have dealt with situations like
that in other contexts where we have had presumptive
determinations for availability of health care benefits when
firefighters get certain diseases that are because of
conditions that are likely to occur in their profession. We
give them presumptions that can be rebutted if they are not
true.
But it is a difficult proof burden, especially on somebody
who is really suffering continuous symptoms of the kind you
describe. I hope--I am at my time and over it. I want to let my
colleagues go, but I hope that might be something we could
focus some attention on.
The Chair. Good point.
Senator Murkowski.
Senator Murkowski. Thank you, Mr. Chairman. And thank you
for coming here this morning, for sharing your stories speaking
about the different journeys that each of you have had or your
families have had as you have dealt with long COVID.
I want to follow on to what Senator Kaine has been talking
about, which is being believed. And you have gone through an
experience that has impacted you clearly, physically. You have
shared that.
But we are living in a time, in a place when everybody
questions the reality of the facts on the grounds, whether it
is politics, or COVID or, just so many different things. And
that is hard. That is hard on the mental health as well.
I would ask each of you if you can speak to the challenges
that you may have had with regards to access to mental health
care, behavioral health, because I have to assume that as you
have been dealing with the physical effects of this, when you
feel like you are being challenged by others--it is not real.
You will get over it. You are making it more than it really is.
That has to be very stressful. That has to lead to higher
anxiety.
That can lead to depression. So, if I can ask the three of
you to share any thoughts that you may have on mental health
and behavioral health access. We will begin with you, Ms.
Vazquez.
Ms. Vazquez. Yes. Thank you. A large part of my out-of-
pocket expenses have been for therapy, for mental health care.
I was not even in Los Angeles. I was not able to find a mental
health provider who was in that work who would see me regularly
and who didn't require me to drive an hour in traffic.
It was--so that's a big part of my expenses. I will say,
also, I have a history of PTSD and trauma before getting sick.
And honestly, I think having depression in my health record
contributed to the medical gaslighting that I experienced.
I got a lot of, well the mind has really important impacts
on the body. Well, the body has a lot of impact on the mind. I
think there is a social, emotional piece to my depression and
my mood symptoms.
Quite honestly, this is a neuroimmune condition. And brain
inflammation has been shown to be linked to many mental
illnesses and mood disorders. And so, I 100 percent believe
that as I get better care for my long COVID and ME/CFS, my mood
will improve because my brain won't be as inflamed.
Senator Murkowski. Ms. Beale.
Ms. Beale. Thank you. For me, for that access part of your
question, the challenge for me has been getting an appointment
with a neurologist.
I had a neuro-psychological evaluation done, and it took me
9 months just to get that appointment. And in that appointment
you go through the different mental health diagnosis and having
depression that I didn't have before I was sick and trying to
figure out what caused the depression.
Well, in my case, it is the long COVID, you know. It has
had that effect on me. I have insomnia, anxiety. All of that
started when I got COVID and then long COVID. So, that has been
challenging.
Like what you said, what the doctors are saying to you, is
the same for me. You know, you need to walk more. You need to
be in the sun. You need vitamin D, all of those things. You
know, that will make you feel better mentally. And that might
help, yes, but the long COVID is causing the anxiety and
depression.
If I am not treating the long COVID as it needs to be
treated, then the depression and anxiety are going to continue.
Senator Murkowski. Thank you. Ms. Heim, do you have
anything to add?
Ms. Heim. I think one of the things that has been hard for
me with my daughter is that she kind of tells herself, well, I
just need to work harder.
I just need to study more. I just need to do this or this
or that, and things are going to get better. And the fact is,
that is not true. One of the doctors we work with works with
athletes, and they are studying it. And the more we push, the
worse it gets. And that is kind of very counterintuitive.
But with this thing, we have to figure out a way to treat
it without pushing, because what happens is you push harder, it
gets worse, then you feel worse, and it is like this rapid
cycle that just goes.
They have to find a way. When she was doing physical
therapy, they did go very slow on the recommendation of that
pulmonologist that had the information. So again, it is about
them getting the information so we can treat it properly and
not create this cycle of depression and anxiety and push and
then get worse, and you know.
Senator Murkowski. Thank you, thank you, Mr. Chairman.
The Chair. Okay. Thank you, Senator Smith.
Senator Smith [continuing]. why don't you go to Senator
Hickenlooper.
The Chair. Okay.
Senator Hickenlooper. Well, I don't think Senator Smith
would ever defer to me in that--in anything other than allowing
me to speak first because I have to go to a press conference
and then get back here.
But I want to echo the appreciation for all of you to show
up today and show up every day. I have one of--as everyone I
think here probably in this room has known somebody who has
been going through this.
I have an old friend who is an amazing person. She was the
first female producer of Monday night football, which is a
strange claim to fame. And for her to be debilitated, it is
just--I can't get my mind around it. I know that you are all
going through that same psychological evolution with
yourselves, but--with your child. Anyway, thank you. I have got
a couple questions here.
Ms. Vazquez, you mentioned in your testimony that the
tribulations you went through, attempting to obtain a diagnosis
of long COVID. The doctors mistaking, some disbelieving. All of
that, those travails.
Given the nature of long COVID and also the addition to the
symptoms and the biomarkers from patient and patient, I think
you have spoken, but all of you really referred to the
importance of doing more research--of integrating these stories
into research.
The University of Colorado is one of the nine centers that
actually got funding from the Department of Health and Human
Services to do some of this research. And so, Ms. Vazquez I was
going to ask, what is your sense of what that research should
be focusing on? What should be the priorities?
Ms. Vazquez. Well, I think, patients again via lived
experience and diving into the existing research, really needs
to build on the existing research. Long COVID is not a new
thing. ME/CFS is not new.
Dysautonomia is not new. Mass cell activation is not new.
There--and those conditions have historically been very
underfunded compared to the disability that they have
contributed to over generations.
For me, I think the prioritization is grounding the current
long-COVID research in the historical, infection associated
disease research.
Senator Hickenlooper. Ms. Beale.
Ms. Beale. Excuse me. I think the research is extremely
important because long COVID is a new illness, and there is so
much that needs to happen quickly so that there can be a
protocol developed and better treatment for us.
You know, I pray all the time for a cure, but I don't know
if that will happen for us. But at the very least there are
some medicines that do help some patients, and there is some
different therapies that help patients.
But if I had a list of what is going to work, try this,
then I would go down and try every single one. But I don't know
what that list is. You know, some people try different things,
and I don't want to just try different things and make my
problems worse. But I don't--you know, we need to know what we
can do so that we can feel better.
Senator Hickenlooper. Right. Ms. Heim.
Ms. Heim. As I was saying before, share the information we
already have. Get it out there. I mean, we have--the stuff that
we have tried is not expensive, but it has helped, CoQ10 for
the brain fog, probiotics, prebiotics.
I mean, there is stuff that you can--everybody can try,
they just don't know to try it. like she was saying, it gives
us hope to at least have an idea or something we can start--
somewhere we can start. Because if it works, it works, and we
get our lives back or at least they get better.
Senator Hickenlooper. Right. Absolutely. But there is also
an inclination in science, and certainly in health care, to not
present things until you understand, have all the facts and
know what exactly you can recommend and not.
I think we are--what we are seeing is the necessity of
dealing with more uncertainty, being able to navigate with
that. Ms. Vazquez, you also talked about the difficulty of
going on and off health care.
You all kind of alluded to the challenges of the red tape
and the bureaucracy, but there is a strong demand from the
public now to prevent fraud, make sure that we are being
vigilant with every tax dollar that is spent.
What things do you think that we could simplify, and maybe
this is a longer question that you can answer later, but how
can we make this paperwork simpler and yet make sure that we
are still protecting being careful in terms of protecting
against fraud?
Ms. Vazquez. Yes, I will say that the threat and fear of
fraud is probably much smaller in reality. Nobody wants to be
sick. Nobody wants to be disabled in an ableist society. I
would say things we could do is I think presumptive eligibility
would be a huge start for benefits--and both, disability
benefits as well as clinical services and community based
services. Because there is just such a broad population of
folks who are living with this.
Senator Hickenlooper. All right. Great. Well thank you. I
am out of time, but I appreciate it. Sorry--that is--it is a
little bit like jeopardy where you see someone going to the
buzzer. Thank you.
[Laughter.]
The Chair. Thank you, John.
Senator Smith.
Senator Smith. Thank you, Chair Sanders and Ranking Member
Cassidy. And thanks to all of you so much for being here. You
know, health is a very personal thing. And so, to be in this
room with these bright lights and share such personal stories
about your lives is really much appreciated.
I really appreciate Senator Murkowski's line of questioning
around the kind of the interaction between mental health and
physical health, and how one fuels the other and how connected
they are. So, just thank you for your answers to that. I would
like to just take my time to understand a little bit about how
insurance--how it is working with your health insurance
coverage.
There are no FDA approved treatments for long COVID. I am
wondering what your experience has been with your health
insurance and their willingness to cover non-approved drugs.
I mean, I will be honest, I think a lot of times it is hard
for people to get health insurance coverage for stuff that we
have a lot more experience with. And so, would each of you just
be willing to talk a little bit about what that experience has
been.
I am wondering if we might be able to learn something from
that as we think about what we can do to make this work better.
Ms. Vazquez. Yes. Thank you for that question. I feel
like--I will send you a longer story that I think really
highlights this issue. But I will say generally, on my charts
and in billing for my long COVID care, I am diagnosed with a
lot of symptoms, and I am able to get prescriptions or
treatments for those particular symptoms.
That, again, required my specialists to know how to sort of
like bill the care that they are providing me. And again, it
requires a lot of staff time from their office as well to do
prior authorizations, all of that.
I do think there is a lot of--a lot that can be done to
validate from the insurance side treatments that are for long
COVID and not require doctors to sort of do the backend
maneuvering to get something covered, when they know it is
medically necessary.
Senator Smith. This is why I hear from providers all the
time that they have to have like a full time staffs that are
just trying to figure out how to get insurance companies to
cover.
Ms. Vazquez. Absolutely, yes.
Senator Smith. Right, right.
Ms. Beale?
Ms. Beale. For me, I think it would be helpful if the
insurance companies could recognize long COVID as its own
illness, and then maybe some of those treatments and procedures
would be covered more quickly.
I have experienced delays with different things that I have
needed waiting for the insurance to approve it. One example is
I need oxygen at night, and my doctor ordered it in August, but
I didn't get it until, I think, late October.
It was because of my insurance company and the company that
was providing the oxygen. I think having to wait for something
that you need because of whatever conversation that the
insurance company is having with the doctors, all this stuff
that is happening behind the scenes that is taking way too
long.
Senator Smith. Right.
Ms. Beale. It needs to be streamlined.
Senator Smith. Well, and that is got to have a big impact.
You are talking about, for example, suffering from insomnia,
struggling to sleep. And there you have right there something
that could happen that would be useful. Why do you have to
wait?
Ms. Beale. Right, exactly.
Senator Smith. Ms. Heim, I am really interested in your
answer to this question. And I am also wondering, as I
understand it, your daughter was able to get connected into a
long COVID study at Children's National, and I think often our
problems in health care, like you could just sort of multiply
them for people that are living in more rural communities.
It is like--just always worse, it seems. Could you just
maybe talk a bit about your own experience with insurance and
then how it has worked with your daughter? How her care has--I
wonder been improved because she has been able to be part of
this larger hospital study?
Ms. Heim. I would say yes, absolutely. I am very fortunate
that she got the diagnosis so quickly and got referred into
this group. And the study is just separate. It is
informational. It is its own entity.
But the actual long COVID team that they have--my poor
doctor's office, I mean, they had to not only get authorization
for the head of the team, but every single doctor on the team.
So, it was months of back and forth paperwork.
In the meantime, they were trying to do--they thought she
had narcolepsy at one point because her fatigue was so bad. And
just to get the sleep apnea test, all the crap that they have
to go through to just get the test approved, is a nightmare for
the doctor's offices. And again, as this is happening, I am
watching my child suffer.
I am watching her sit down in the middle of a grocery store
and just say, I can't go anymore. And then meanwhile, I am
waiting, I am waiting, I am waiting, I am waiting to find the
answers. So yes, that is very frustrating.
Senator Smith. Chair Sanders, I often feel that our
insurance companies are designed to figure out how to deny care
rather than to provide care, and I think that these stories
illustrate what that means for people that are living with long
COVID.
The Chair. Senator Smith, you are exactly right, and that
is why I intend to bring the major insurance companies here.
These companies make tens of billions of dollars in profit
every single year, and there are very few Americans who don't
have to struggle to get the care that they deserve. So that is
an issue we will deal with in this Committee.
[Laughter.]
The Chair. Senator Markey. I will--before Senator Markey, I
would remind everybody that we have--this has been an
extraordinary panel, but we have four experts who are going to
please tell us what kind of progress we are making in
understanding the disease and treating it. Senator Markey.
Senator Markey. Thank you, Mr. Chairman, very much. Thank
you for this hearing. Thank you, Senator Kaine, for your
continued leadership and partnership on this issue.
COVID is real and it is disabling. And we know that we have
to work on it. The numbers are staggering, actually, from NIH,
staggering. That of people who have had COVID, 22 percent to 38
percent of them are experiencing long COVID.
Can I say that number again? Of people who have had COVID,
it is 22 percent to 38 percent who have long COVID. And that
may be an underestimation, according to NIH. So even as we talk
about 5 percent of adults have had it. Think about the people
who have had it and why people who haven't had it should be
very careful. They should be masking. They should be getting
vaccinated because there is a high probability they will have
long COVID.
That is what NIH is telling us. So, all the warning signs
are there. We thank all of you who are here, for leadership,
for your willingness to be here, and I just hope people
understand, this is not going away. It is still there.
If you get it, there is a very high probability that you
are going to have long COVID. So, just something that I think
has to be made clear over and over again. In 2018, I introduced
a resolution raising awareness of chronic fatigue syndrome.
Like long COVID, this illness can come up after fighting off a
virus. Now we are seeing more and more people navigating both
MECFS and long COVID, and they are fighting for recognition of
both condition.
People don't believe the patients. They think that there is
some phony pretend disease that people have. Well, we know that
is not the case. And that is what our witnesses are making very
clear here today.
Meanwhile, research into these and other infection related
chronic illnesses is sorely overdue and underfunded. And this
has left patients without answers and health care providers
without the training to treat them. It is unacceptable to force
people to fight their chronic illnesses and a health system
that doesn't recognize their illness.
We need to fund research to coordinate and fund research on
conditions triggered by viral infections that will drive us
toward diagnosis and treatments and cures. Research is
medicine's field of dreams from which we harvest the findings
which we need to give help to those who are affected.
Ms. Vazquez, in your testimony, you shared how your
symptoms were dismissed in the early days of the pandemic. And
health providers didn't acknowledge the link between viral
infections and chronic illnesses.
Ms. Vazquez, what would coordinated efforts at the National
Institutes of Health to better understand infection associated
chronic illnesses mean to you and to all of those who have had
similar experiences?
Ms. Vazquez. I think if the NIH really embraced the reality
of infection associated diseases, we could actually do some
incredible science to drive the science forward. I mean, just
historically, we didn't believe multiple sclerosis existed.
Then we got better imaging and saw all the lesions, and now
VA research has shown that Epstein-Barr virus, the virus that
causes mono, is very associated to the point of potentially
causing multiple sclerosis.
If we really embrace sort of the history of infections
triggering disease, we can do some really cool science around
micro clots or viral persistence. The science is happening on
such a small scale, but the U.S. could really be the leader for
a cure for these kinds of conditions.
Senator Markey. Yes. So, we believe you.
Ms. Vazquez. Thank you.
Senator Markey. We know you are not faking it. And we know
that 22 to 38 percent of those people who have had COVID are
not faking it. Otherwise, there wouldn't be so many of them.
So, it is absolutely imperative that we provide the funding for
research. That we have----
[Applause.]
Senator Markey. That we have our top scientists working on
this issue, or else we are going to have people with this
debilitating illness who have to be out there wondering why
they are being stigmatized when there is an underfunding of the
research needed in order to provide hope for those families.
So, thank you all so much for being here again today. Thank
you.
The Chair. Okay. This ends our panel with the patients. I
know I speak for every Member of this Committee in thanking
you. It has not been easy for you literally physically to get
here, and your testimony has been extremely powerful and
helpful in allowing us to go forward. So, we are very grateful
to you being here. Thank you very much.
[Applause.]
The Chair. Now we are going to--now we are going to hear
from our next panel. We just heard an extraordinary panel of
patients, and now we are going to hear a panel of experts,
doctors and experts who are studying the issue and trying to
help us come up with some solutions to this crisis.
We have four very well qualified panelists, Dr. Michelle
Harkins, Dr. Ziyad Al-Aly, Dr. Charisse Madlock-Brown, and Dr.
Tiffany Walker. And we thank all of them very much for being
with us. Our first witness is Dr. Harkins.
She is a Professor of Medicine and Division Chief of
Pulmonary, Critical Care, and Sleep Medicine at the University
of New Mexico. Dr. Harkins, thanks very much for being with us.
STATEMENT OF MICHELLE HARKINS, M.D., PROFESSOR OF MEDICINE,
UNIVERSITY OF NEW MEXICO, ALBUQUERQUE, NM
Dr. Harkins. Thank you. Good morning. Thank you, Chairman
Sanders, Ranking Member Cassidy, and the distinguished Members
of this Committee.
My name is Michelle Harkins, and I am a pulmonary critical
care physician from the University of New Mexico in
Albuquerque. I am honored to appear before you here today to
talk about the impact long COVID is having on patients and to
provide recommendations to this Committee based on my work as a
clinical researcher, a clinician, and an educator.
I am an ICU doc in a busy urban medical center and was in
the trenches with the critically ill COVID-19 patients that
were dying since the beginning of the pandemic. I was our lead
investigator for many COVID clinical trials, including the NIH
funded platform networks.
As the initial phases of the pandemic changed and we began
to learn more about long COVID, and the effects that COVID-19
was having on patients, UNM joined the NIH Recover Initiative
to help understand this new disease, and we will participate in
Recover clinical trials. I want to share a story about a mid-
career primary care doc in rural New Mexico.
After serving her community and treating patients for
years, she herself became infected with COVID-19, and then
months later, she presented with signs of long COVID, including
fatigue, brain fog, and difficulty breathing during even short
periods of exercise.
Two years later, these symptoms so impacted this patient
that she eventually decided to leave her work, unable to
maintain the mental recall needed to do her job in order to
concentrate on her health.
The NIH Recovery Research Initiative is poised to
systematically study risk factors that lead to long COVID and
ultimately lead to treatments that are individualized to
certain patients subsets. Thank you for this Committee and all
the work that you have done to fund this important initiative,
but the research and clinical needs are still ongoing.
In addition to research and clinical care, I have a passion
for sharing emerging new knowledge with my peers and learning
from them about the challenges they face in their own
communities of practice.
When the pandemic began, I worked closely with Project
Echo, leader of the Echo model, an innovative method of
creating virtual communities of practice to help accelerate
peer to peer knowledge in a trusted community.
We set up a virtual Echo network to support the hundreds of
health care providers across my state who were struggling to
treat critically ill COVID-19 patients in their hospitals and
clinics. And when the initial waves of the pandemic slowed, we
then set up a parallel program for primary care providers to
identify and help treat their long COVID patients, which was a
HRSA funded initiative.
Through this program, our team has helped train over 800
providers, mostly in New Mexico, but across the entire United
States, on how to best identify patients and support them with
long COVID.
I believe the Federal Government, and this Committee in
particular, can help support patients with long COVID in
several ways. No. 1, need for continued investment in ongoing
research.
We need to continue the funding for the research of long
COVID, and understanding this very complex disease and its
underlying mechanisms will translate into treatments for
patients. Clinical trials should reflect the demographics of
our population, so improving access for rural participants and
those disproportionately affected by the disease is key.
No. 2, making access to clinical care easier for patients.
We need multidisciplinary clinics with teams of subspecialists
and health care providers together to address the myriad of
symptoms complexes that these patients face.
To make this vision possible, we need to address
reimbursement for providers in a multidisciplinary long COVID
clinic who are seeing the same patient, multiple providers, for
the same illness on the same day.
Asking CMS to provide guidance on the billing codes,
reimbursements for long COVID, and how this code can best be
used in multidisciplinary care is needed. Three, we have to
prevent the recurrence or occurrence of long COVID.
Vaccines do reduce the risk of long COVID, and so reducing
new acquisition and administration costs to give vaccines in
rural clinics and other institutions would improve access to
care. And supporting clinicians across the country to have
access to the most up to date information in trusted
communities of practice.
Creating a national network of regional communities of
practice that meets virtually and can then disseminate and
share information involving new research findings and new
treatment options to patients is key.
This is a tele-mentoring for providers, but in theory, this
model could be used to create regional long COVID clinics where
the experts actually see the patients directly. Expanded
investment in the development of a national network of tele-
mentoring would be a huge difference.
This national network of local providers and regional and
national experts, once created, would then be available to help
respond to the next pandemic or health emergency when it
arises.
Thank you again for the opportunity to testify, and I am
happy to answer your questions.
[The prepared statement of Dr. Harkins follows.]
prepared statement of michelle harkins
Good Morning Chairman Sanders, Ranking Member Cassidy and
distinguished Members of the Committee, my name is Michelle Harkins and
I am a pulmonary and critical physician from the University of New
Mexico in Albuquerque, NM.
I am honored to appear before you today to talk about the impact
Long COVID is having on patients and provide some recommendations based
on my work as a clinical researcher, a clinician, and an educator on
how I believe this Committee and the Federal Government can make a huge
difference on the day to day lives of Americans suffering with Long
COVID.
My background
As an ICU doctor at a busy urban medical center, I was in the
trenches with critically ill patients dying of COVID-19. I very quickly
became part of exciting networks of researchers--public, private, and
everything in between--who came together with the singular goal of
understanding this new disease. I was our lead investigator for many
COVID clinical studies at University of New Mexico, .first to study
therapeutics for the acute disease and then the long-term effects of
COVID-19.
I will share a story of a woman in the middle of career as a
primary care provider in rural New Mexico. After serving her community
and treating patients for years, she herself became infected with
COVID-19 and then months later presented with signs of Long COVID
including brain fog, and difficulty breathing during even short periods
of exercise. She came to see me for these persistent symptoms. All of
her diagnostic tests were essentially normal.
Two years later, she still is active and goes on walks but has to
stop several times to catch her breath. These symptoms so impacted this
patient, that she eventually decided to leave her work, unable to
maintain the mental recall needed to do her job.
I was fortunate to participate in the NIH Adaptive COVID Treatment
Trials (ACTT) and Accelerating COVID-19 Therapeutic Intervention and
Vaccines (ACTIV) trial networks that provided randomized control trial
evidence of medications that worked and those that did not in acute
COVID.
I am currently a Co-Investigator for the adult cohort of the NIH
Recover study and we are now enrolling for the RECOVER VITAL study, a
treatment trial with Paxlovid for Long COVID, and hope to participate
in the other sub studies.
The NIH Recover Research Program is poised to systematically study
risk factors and clinical symptoms that lead to Long COVID and
ultimately to treatments that are individualized to certain clinical
subsets of patients. This network has relied on extreme collaboration
between scientists, clinicians, patients and advocates to inform the
study design and processes that has never before been seen. Thank you
for all this Committee has done to fund this important initiative as
the research and clinical needs are still ongoing.
In addition to research and seeing patients, I also have a passion
for sharing emerging new knowledge with my peers and learning from them
about the challenges they face in their environment. When the pandemic
began, I worked closely with Project ECHO, leader of the ECHO model, an
innovative method of creating virtual communities of practice to help
accelerate peer-to-peer knowledge in a trusted community. We set up a
virtual ECHO network to support the hundreds of health care providers
across the state who were struggling to treat critically ill COVID-19
patients in their hospitals and clinics.
When the initial waves of the pandemic slowed, we then set up a
parallel program for primary care providers struggling to identify and
treat Long COVID patients which was funded by the Health Resources and
Services Administration (HRSA) Telehealth Technology-Enabled Learning
Program (TTELP) initiative. Through this program my team and I have
helped train over 800 local providers across the United States on how
best to identify and support patients with Long COVID.
The problem
The CDC previously estimated that 1 in 5 adults and 1 in 4 children
will experience some form of Long COVID. There are over 1.1 million
deaths due to COVID and now CDC data mark more than 5000 deaths from
Long COVID. These Long COVID death rates varied by race and ethnicity,
from a high of 14.1 cases per million among American Indian/Alaska
Naves, 6.7 cases per million for White, 6.4 cases per million for Black
and 4.7 cases per million for Hispanic to a low of 1.5 cases per
million among Asian. These numbers are likely underestimated for a
variety of reasons; increased mortality from COVID-19 in some racial
and ethnic groups resulting in lower numbers to develop of Long COVID,
lack of access to health care or to providers that could diagnose them,
or patient deaths were attributed to other causes.
Symptoms of long COVID can be wide ranging and difficult to
diagnose. For a primary care practitioner in a small community for
example who doesn't see many cases, it may be difficult for that
provider to differentiate long COVID from symptoms of existing
illnesses a patient may have or would develop.
We are learning every day about the potentially debilitating and
life altering effects of this disease.
Recommendaons
Based on my experience as a clinician, researcher, and educator, I
suggest a few ways in which I believe the Federal Government and this
Committee in particular can help support patients with Long COVID and
the providers and care teams working to help these patients.
A. The need for continued investment in ongoing research
We need to continue funding research in Long COVID. We are learning
more each day about this complex disease and its mechanisms which will
translate into treatment plans for patients to improve their quality of
life and their ability to manage their disease more effectively
To be most effective, we need to ensure that a research network is
able to share data on all levels (public health, community, Federal and
state) among researchers, that transparency of the results of research
is valued. We also need to improve access for all subjects to
participate in research studies on Long COVID no matter where they live
or what other social determinants of health impact them. We must be
sure subjects enrolled reflect all of our population and especially
those that are disproportionately affected by the disease. These
efforts will help us beer understand the parameters of this disease and
the range of ways it is affecting our diverse populations. Long COVID
syndromes and symptoms are varied, and multiple cell types and organ
systems are involved and so answers to therapy are complex and will
take me.
B. Making Access to Clinical Care Easier for Patients
Very few Long COVID clinics exist nationwide. If they do exist,
they are in bigger academic centers in big cities. In New Mexico for
example, we have one Long COVID clinic at UNM run by my Project Echo
co-medical director Dr. Alisha Parada, a general internist.
What we need are multidisciplinary clinics to address the myriad of
symptom complexes that these patients face. For example, we need a
pulmonologist, a cardiologist, a neurologist or psychologist, physical
therapy, occupational and speech therapy and social workers to be in
one location so that the patients can be seen by whomever they need.
Long COVID patients tend to be sicker and use the health care
system more regularly. Multidisciplinary clinics can ultimately help
reduce these costs on the healthcare system.
To make this vision possible, we need to figure out how to
reimburse providers in a multidisciplinary Long COVID clinic for seeing
patients with the same diagnosis on the same day. A Long COVID patient
might come to a multidisciplinary clinic and need to see a neurologist,
a cardiologist, and an internist, all for the same diagnosis of Long
COVID. This Committee should ask CMS to look into ways that it could
provide guidance on the billing codes, reimbursements for Long COVID,
and how this code can be best used for the multidisciplinary care many
Long COVID patients need.
This Committee should also encourage insurers and CMS to support
evaluations for Long COVID. Evaluations for Long COVID are complicated
and can involve a broad group of signs and symptoms. There is no one
blood test for diagnosis. Without insurance coverage and access to
these clinics, many patients will not get the evaluation and assessment
tools they need.
C. Helping to prevent the occurrence of Long COVID in the
future
There is yet another surge in acute COVID-19 infections across the
country. With the end of the public health emergency for COVID-19, it
is harder for patients, especially in rural settings or from
marginalized communities, to get access to vaccines. Reducing cost
barriers will improve the ability to deliver vaccines in rural clinics,
institutions and in all populations.
In many areas, the cost for medical centers to give the vaccine is
more than their reimbursement rate for the visit, making it difficult
for many clinics to provide them.
D. Supporting clinicians across the country to have access to
the most up-to-date best practices in trusted communities of
practice
We can do a much better job with educating the public and providers
regarding COVID and Long COVID. As an example, the ECHO model has been
shown to be a cost-effective, and efficient way to support local
providers to learn new information as a disease is changing and
evolving.
When the pandemic hit, Project ECHO, funded by the Agency for
Healthcare Research and Quality (AHRQ), created a national network of
state and regional virtual communities of practice designed to support
nursing homes to train their state. on infection control and prevention
just as nursing home state. and residents were being hit hard by the
disease. This initiative proved the ability to create a nation-wide
network of regional communities of practice, all sharing evolving best
practices and taking in new information each week and each month about
what clinicians were seeing in their own community as they see
patients. Creating a national network of regional communities of
practice that meet virtually would also help to share and disseminate
evolving research findings and new treatment options.
Once the pandemic is truly over, we need the necessary skills and
network to be ready for the next pandemic or health emergency that
arises.
The HRSA TTELP Initiative provides an early example. Expanded
investment in the development of a national network for telementoring
would make a huge difference This national network of local providers
and regional and national experts, once created, would then be
available to help respond to the next pandemic or health emergency as
it arises. This is telementoring for providers but in theory this model
could be created as regional Long COVID Clinics where the experts
actually consult with the patients.
Thank you again for the opportunity to testify on Long COVID. It is
real. It affects many Americans and we need continued funding for
research in hopes to find treatments for patients, and to educate
providers.
The patient I mentioned at the beginning of my remarks has stepped
away from her career as a primary care physician serving her community
in rural New Mexico. Your investments today can help increase the
chances that we will find treatments for Long COVID and ensure that
these patients such as mine don't lose years of their life to this
disease, but instead can be as active and productive members of society
as possible.
I am happy to answer any questions you may have.
References:
CDC--NCHS--Naonal Center for Health Statistics
Nearly One in Five American Adults Who Have Had COVID-19 Still Have
``Long COVID'' (cdc.gov)
NCHS Data Brief, Number 479, September 2023 (cdc.gov)
______
[summary statement of michelle harkins]
As an ICU doctor at a busy urban medical center, I was in the
trenches with critically ill patients dying of COVID-19. I was our lead
investigator for many COVID clinical studies at University of New
Mexico first to study the disease and then the long-term effects of
COVID-19.
Based on my experience as a clinician, researcher, and educator, my
recommendation points are:
The need for continued investment in ongoing research
We need to continue funding research in Long COVID and have
more representation from rural and underserved or affected
communities in trials. We are learning more each day about this
complex disease and its mechanisms which will translate into
treatment plans for patients to improve their quality of life
and their ability to manage their disease more effectively
Making Access to Clinical Care Easier for Patients
What we need are multidisciplinary clinics to address the
myriad of symptom complexes that these patients face. This
Committee should ask CMS to look into ways that it could
provide guidance on the billing code, reimbursements for Long
COVID, and how this code can be best used for the
muldisciplinary care many Long COVID patients need.
This Committee should also encourage insurers and CMS to
support evaluations for Long COVID.
Helping to prevent the occurrence of Long COVID in the future
With the end of the public health emergency for COVID-19, it
is harder for patients, especially in rural settings or
institutions or disenfranchised communities, to get access to
vaccines. Reducing cost barriers will improve ability to
deliver vaccines in rural clinics and institutions.
Supporting clinicians across the country to have access to
the most up-to-date best practices and trusted communities of
practice via Project ECHO
Creating a national network of regional communities of
practice that meet virtually would also help to share and
disseminate evolving research findings and new treatment
options.
The HRSA Telehealth Technology-Enabled Learning Program
provides an early example. Expanded investment in the
development of a national network for telementoring would make
a huge difference. This national network of local providers and
regional and national experts, once created, would then be
available to help respond to the next pandemic or health
emergency as it arises.
All of these efforts could be done in parallel as we can't do one
without the other.
______
The Chair. Thank you, Dr. Harkins. Our next witness will be
Dr. Ziyad Al-Aly, Assistant Professor of Medicine at the
Washington University School of Medicine. Dr. Al-Aly, thanks
for being with us.
STATEMENT OF ZIYAD AL-ALY, M.D., CLINICAL EPIDEMIOLOGIST,
WASHINGTON UNIVERSITY IN ST. LOUIS, ST. LOUIS, MO
Dr. Al-Aly. Chairman Sanders and Ranking Member, Dr.
Cassidy, and Members of the HELP Committee, thank you for the
opportunity to testify today.
I am a physician scientist at Washington University in
Saint Louis. My team and I produced the first systematic
characterization of long COVID, and so far, the most widely
cited research on long COVID.
We have been at the forefront of long COVID research since
the early days of the pandemic, when patients started telling
us that they are not fully recovering from COVID-19. Now, long
COVID represents the constellation of long term health effects
of COVID-19.
It is a multi-system disorder that can affect nearly every
organ system. It affects the brain. It affects the heart. It
affects the endocrine system. It affects the immune system. It
affects the GI system.
Long COVID affects at least 20 million Americans. It
affects people across the lifespan. We have kids with long
COVID. We will have people who are 100 years old with long
COVID. It affects people across the lifespan and across
demographic groups.
The burden of long COVID, the burden of disease and
disability from long COVID, when you measure it, is on par with
the burden of cancer and heart disease. And even if people
emerge unscathed after having the first infection, they can
still get long COVID after reinfection. And I don't think
enough people really know this fact or know about this.
Recovery rates of long COVID are also low. Between low
rates of recovery from long COVID and the cases are due to
reinfection, we are poised to see continued rise in the burden
of long COVID until we find better ways to prevent it and treat
it.
Now, you should be asking me now how do we prevent long
COVID? Well, the best way to prevent long COVID is to prevent
COVID in the first place. There is actually no long COVID
without COVID.
You know, if you go back to 2019, you go back to 2018, none
of us have heard of long COVID. Have you? You haven't. It
didn't exist. There is no long COVID without COVID. We need a
sustainable, multi-pronged approach to prevent repeated
infections that would be embraced by the public.
This requires accelerating the development of oral
intranasal vaccines that block infections. This is very, very,
very important. Ventilation and air filtration systems are also
very important. They can play a major role in reducing the risk
of transmission of airborne pathogens.
We also need variant proof vaccines. What the virus is
doing is really continuing to mutate on us. You know, every few
months you are going to see a new variant. We need a variant
proof vaccine that lasts for a long time. That is durable. That
has durable--and offers durable immunity.
People are sick and tired of having to have boosters every
few months. We need vaccines that last for 5 years or so they
can get it done and get it over with for 5 years. We must also
understand vaccine side effects.
This must be acknowledged and understood very, very deeply.
This is very, very important. Now you should be asking me also
like how do we treat Long-COVID? You have heard it before.
There are zero, zero approved medication for the treatment of
long COVID. So, these people have nothing to really lean on for
curative treatment. Nothing, zero.
Zero FDA approved medications for the treatment of long
COVID. This must change. We really need to change this. It is
not beyond the might and the prowess of American medicine to
solve this problem. It is absolutely not. We solved much, much
harder problems in the past. We just need to focus on this and
solve it.
We are the best nation on earth, and we can solve this. It
is absolutely not beyond our prowess to address this. Now,
people suffering from long COVID need treatment yesterday. You
know, the ongoing and planned trials for long COVID are too
slow and too small to offer definitive treatments. We have
developed vaccines at record speed, at warp speed.
You know, what we are doing with long COVID, we are doing
trial for long COVID at snail speed. This is what we are doing.
We urgently, urgently need trials, large scale try to test a
broad array of repurposed drugs and development of new drugs to
treat long COVID.
We must also identify and address the barriers that are
preventing the pharmaceutical industry from entering the trials
of long COVID--from doing trials on long COVID.
You could be asking me now, like, is COVID unique in its
ability to produce chronic illness and long COVID? And the
answer is really no. People reported debilitating fatigue,
cognitive decline, and Parkinson's disease after the Spanish
flu, but we just swept under the rug.
You know, other viruses, including polio and Epstein-Barr
virus, can also produce chronic diseases. EBV can cause
multiple sclerosis. Chronic fatigue syndrome, or ME/CFS, is
also linked to a viral illness, a flu like illness.
It is a debilitating disease that affects 4.3 million
people in the U.S. These patients have been marginalized and
ignored for decades. So, what do we learn from all of this?
Well, we learn from all of this acute infections--what I
learned, the lesson No. 1 from this whole pandemic, that acute
infections can lead to chronic disease. That pandemics disable
people.
This is not new. It happened after the Spanish flu, but we
just ignored it. We just swept under the rug. We call all of
this broadly infection associated chronic illnesses. This
include long COVID and includes ME/CFS and other--and other
basket of conditions that are MMA from acute infections.
Had we connected the dots between acute infections and
chronic diseases before the pandemic, we would have been in a
much, much better place to actually address the challenge of
long COVID. We failed to connect those dots before the
pandemic. Let's not do that same mistake again, and be poised
and ready to really address the challenge of long COVID and
also the next pandemic.
Where do we go from here? The research effort of long COVID
must match the urgency and the scale of the problem. This is my
opinion, because really it must. And this going to require a
coordinated approach.
In my opinion, the U.S. should consider the establishment
within NIH of an institute to address infection associated
chronic illnesses. That includes long COVID, ME/CFS have been
ignored for a long time, and other infection associated chronic
illnesses.
You have an historic opportunity to act. The lives of
millions of people here and around the globe, now and in the
future, depend on this. Thank you.
[The prepared statement of Dr. Al-Aly follows.]
prepared statement of ziyad al-aly
Chairman Sanders, Ranking Member Dr. Cassidy, and Members of the
U.S. Senate Committee on Health, Education, Labor, and Pensions.
Thank you for the opportunity to testify today on the importance of
addressing the needs of people with Long COVID.
I am a physician-scientist at Washington University in St. Louis.
My team and I produced the first systematic characterization of Long
COVID and the most widely cited research on Long COVID. We have been at
the forefront of Long COVID research since the early days of the
pandemic when patients started telling us that they are not fully
recovering from COVID-19.
Long COVID represents the constellation of long-term health effects
of COVID-19 \1\, \2\. Long COVID is a multisystem disorder that affects
nearly every organ system including the heart \3\, the brain \4\, \5\,
the endocrine system \6\, \7\, \8\ the immune system \9\ and the
gastrointestinal system \10\.
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\1\ Al-Aly Z, Xie Y, Bowe B. High-dimensional characterization of
post-acute sequelae of COVID-19. Nature. Jun 2021;594(7862):259-264.
doi:10.1038/s41586-021-03553-9
\2\ Davis HE, McCorkell L, Vogel JM, Topol EJ. Long COVID: major
findings, mechanisms and recommendations. Nat Rev Microbiol. Jan 13
2023:1-14. doi:10.1038/s41579-022-00846-2
\3\ XieY,XuE,BoweB,Al-Aly Z. Long-term cardiovascular outcomes of
COVID-19. Nat Med. Mar 2022;28(3):583-590. doi:10.1038/s41591-022-
01689-3
\4\ XuE,XieY,Al-Aly Z. Long-term neurologic outcomes of COVID-19.
Nat Med. Nov 2022;28(11):2406-2415. doi:10.1038/s41591-022-02001-z
\5\ XieY,XuE,Al-Aly Z. Risks of mental health outcomes in people
with COVID-19: cohort study. BMJ. Feb 16 2022;376:e068993. doi:10.1136/
bmj-2021-068993
\6\ XieY,Al-Aly Z. Risks and burdens of incident diabetes in long
COVID: a cohort study. Lancet Diabetes Endocrinol. May 2022;10(5):311-
321. doi:10.1016/S2213-8587(22)00044-4
\7\ XuE,XieY,Al-Aly Z. Risks and burdens of incident dyslipidaemia
in long COVID: a cohort study. Lancet Diabetes Endocrinol. Feb
2023;11(2):120-128. doi:10.1016/S2213-8587(22)00355-2
\8\ BoweB,XieY,XuE,Al-Aly Z. Kidney Outcomes in Long COVID.
Journal of the American Society of Nephrology. 2021:ASN.2021060734.
doi:10.1681/asn.2021060734
\9\ Yin K, Peluso MJ, Luo X, et al. Long COVID manifests with T
cell dysregulation, inflammation and an uncoordinated adaptive immune
response to SARS-CoV-2. Nat Immunol. Jan 11 2024;doi:10.1038/s41590-
023-01724-6
\10\ XuE,XieY,Al-Aly Z. Long-term gastrointestinal outcomes of
COVID-19. Nat Commun. Mar 7 2023;14(1):983. doi:10.1038/s41467-023-
36223-7
Long Covid affects at least 20 million Americans. It affects people
across the lifespan--from children to older adults. It affects people
across race, ethnicity and sex \11\. The burden of disease and
disability in Long Covid is on par with heart disease and cancer \12\,
\13\. Long Covid has wide and deep ramifications on the labor market
and the economy14,15--some estimates suggest that the toll of Long
Covid on the U.S. economy is $3.7 trillion \14\, \15\--on par with the
2008 recession.
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\11\ Xie Y, Bowe B, Al-Aly Z. Burdens of post-acute sequelae of
COVID-19 by severity of acute infection, demographics and health
status. Nat Commun. Nov 12 2021;12(1):6571. doi:10.1038/s41467--021-
26513-3
\12\ Global Burden of Disease Long CC, Wulf Hanson S, Abbafati C,
et al. Estimated Global Proportions of Individuals With Persistent
Fatigue, Cognitive, and Respiratory Symptom Clusters Following
Symptomatic COVID-19 in 2020 and 2021. JAMA. Oct 25 2022;328(16):1604-
1615. doi:10.1001/jama.2022.18931
\13\ Bowe B, Xie Y, Al-Aly Z. Postacute sequelae of COVID-19 at 2
years. Nat Med. Sep 2023;29(9):2347-2357. doi:10.1038/s41591-023-02521-
2
\14\ Cutler DM. The Costs of Long COVID. JAMA Health Forum.
2022;3(5):e221809-e221809. doi:10.1001/jamahealthforum.2022.1809
\15\ Cutler D. The Economic Cost of Long COVID: An Update. https:/
/scholarharvardedu/sites/scholarharvardedu/files/cutler/files/long--
covid--update--7--22pdf.
People can get Long Covid after reinfection16,17. Research from the
U.S. and Canada is clear. Even if people managed to emerge unscathed
after the first infection, they may get Long Covid after reinfection
\16\, \17\. The national RECOVER program found 10 percent of people
with one infection had Long Covid, compared to 20 percent of those with
2 or more infections.
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\16\ Experiences of Canadians with long-term symptoms following
COVID-19.doi:https://www.50.statcan.gc.ca/n1/pub/75-006-x/2023001/
article/00015-eng.htm
\17\ Bowe B, Xie Y, Al-Aly Z. Acute and postacute sequelae
associated with SARS-CoV-2 reinfection. Nat Med. Nov 2022;28(11):2398-
2405. doi:10.1038/s41591-022-02051-3
The risks of getting Long Covid after reinfection are not known to
the general public.
Likely because of viral persistence and other mechanisms, people
can still develop problems related to the infection many months or even
2 years after the initial infection, \18\, \19\.
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\18\ Stein SR, Ramelli SC, Grazioli A, et al. SARS-CoV-2 infection
and persistence in the human body and brain at autopsy. Nature. 2022/
12/01 2022;612(7941):758-763. doi:10.1038/s41586-022-05542-y
\19\ Proal AD, VanElzakker MB, Aleman S, et al. SARS-CoV-2
reservoir in post-acute sequelae of COVID-19 (PASC). Nature Immunology.
2023/10/01 2023;24(10):1616-1627. doi:10.1038/s41590-023--01601-2
Recovery rates for many of the components of Long Covid are low.
Some conditions that develop after COVID (e.g. heart disease, diabetes,
etc.) are chronic conditions that last a lifetime. Some conditions
including fatigue and brain fog seem to improve in a small fraction of
---------------------------------------------------------------------------
people with Long Covid.
Between low rate of recovery and new cases from reinfection and
breakthrough infection, Long Covid will continue to increase until we
find better ways to prevent it and treat it.
The epidemiologic analyses demonstrating the wide-ranging
multisystemic effects of Long Covid are complemented by careful imaging
and autopsy studies showing structural abnormalities, prolonged
inflammation and accelerated aging in human brains of people with even
mild to moderate SARS-CoV-2 infection, \20\, \21\, \22\ and persistence
of the virus in brain and heart tissue of people with severe COVID-
1918. Gut dysbiosis, dysfunctional hypothalamic-pituitary response
(leading to inappropriately low levels of cortisol) and low serotonin
induced dysfunction in vagal signaling have been suggested to play a
role in the development of Long Covid \23\, \24\. Immune dysfunction
and mitochondrial failure (the energy generators that power each cell
in the human body) have also been implicated in the mechanisms of Long
Covid9, \25\.
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\20\ Monje M, Iwasaki A. The neurobiology of long COVID. Neuron.
2022/11/02/ 2022;110(21):3484--3496. doi:https://doi.org/10.1016/
j.neuron.2022.10.006
\21\ Douaud G, Lee S, Alfaro-Almagro F, et al. SARS-CoV-2 is
associated with changes in brain structure in UK Biobank. Nature. 2022/
03/07 2022;doi:10.1038/s41586-022-04569-5
\22\ Fernandez-Castada A, Lu P, Geraghty AC, et al. Mild
respiratory COVID can cause multi-lineage neural cell and myelin
dysregulation. Cell. 2022/07/07/ 2022;185(14):2452-2468.e16.
doi:https://doi.org/10.1016/j.cell.2022.06.008
\23\ Wong AC, Devason AS, Umana IC, et al. Serotonin reduction in
post-acute sequelae of viral infection. Cell. 2023;186(22):4851-
4867.e20. doi:10.1016/j.cell.2023.09.013
\24\ Klein J, Wood J, Jaycox J, et al. Distinguishing features of
Long COVID identified through immune profiling. Nature. 2023/09/25
2023;doi:10.1038/s41586-023-06651-y
\25\ Appelman B, Charlton BT, Goulding RP, et al. Muscle
abnormalities worsen after post-exertional malaise in long COVID. Nat
Commun. Jan 4 2024;15(1):17. doi:10.1038/s41467-023-44432-3
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Prevention of Long Covid
The best way to prevent Long Covid is to prevent COVID in the first
place. This requires a multilayered/multipronged approach. We must
develop sustainable solutions to prevent repeated infections with SARS-
CoV-2 and Long Covid that would be embraced by the public. This
requires acceleration of development of oral or intranasal vaccines
that induce strong mucosal immunity to block infection with the virus
\26\.
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\26\ Topol EJ, Iwasaki A. Operation Nasal Vaccine-Lightning speed
to counter COVID-19. Sci Immunol. Aug 12 2022;7(74):eadd9947.
doi:10.1126/sciimmunol.add9947
Ventilation and air filtration systems can also play a major role
in reducing the risk of infection with airborne pathogens. We did an
amazing job proofing our buildings against earthquakes that happen once
every few decades or few centuries. Why don't we proof our buildings
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against the hazards of airborne pathogens. We can and should do this.
Vaccines partially reduce the risk of Long Covid in adults by 15-70
percent (? mean 40 percent) \27\; they partially reduce the risk of
Long Covid in kids \28\, \29\. The low rates of vaccine uptake in 2023-
2024 winter season suggests that the public's appetite for boosters has
declined dramatically. We need variant-proof vaccines that offer
durable immunity (e.g. vaccine that lasts 5 years). People can then get
their Covid-19 vaccines once every 5 years and be done with it.
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\27\ Catal M, Mercade-Besora N, Kolde R, et al. The effectiveness
of COVID-19 vaccines to prevent long COVID symptoms: staggered cohort
study of data from the UK, Spain, and Estonia. The Lancet Respiratory
Medicine. doi:10.1016/S2213-2600(23)00414-9
\28\ Atchison CJ. Nature Commun. 2023// 2023;14doi:10.1038/s41467-
023-41879-2
\29\ Yousaf AR. Open Forum Infect Dis. 2023// 2023;10doi:10.1093/
ofid/ofad500.2466
Vaccines are safe and effective, but they are not free of side
effects. The benefit of COVID-19 vaccines in reducing risk of severe
COVID-19 illness, death and Long Covid outweighs the small risk \30\,
\31\, \32\. That does not mean vaccine side effects do not exist33. We
must recognize vaccine injury \33\. We must understand how it happens
and how to mitigate it. Understanding vaccine injury will not only help
us produce safer vaccines, but it can also offer insights into the
mechanisms of Long Covid.
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\30\ Thomas SJ, Moreira ED, Kitchin N, et al. Safety and Efficacy
of the BNT162b2 mRNA Covid-19 Vaccine through 6 Months. New England
Journal of Medicine. 2021;385(19):1761-1773. doi:10.1056/NEJMoa2110345
\31\ Polack FP, Thomas SJ, Kitchin N, et al. Safety and Efficacy
of the BNT162b2 mRNA Covid-19 Vaccine. New England Journal of Medicine.
2020;383(27):2603-2615. doi:10.1056/NEJMoa2034577
\32\ Rosenberg ES, Dorabawila V, Easton D, et al. Covid-19 Vaccine
Effectiveness in New York State. New England Journal of Medicine.
2021;386(2):116-127. doi:10.1056/NEJMoa2116063
\33\ Couzin-Frankel J, Vogel G. Vaccines may cause rare, Long
Covid-like symptoms. Science. Jan 28 2022;375(6579):364-366.
doi:10.1126/science.ada0536
Currently available antivirals may reduce the risk of Long Covid
\34\, \35\, \36\, but their effectiveness seems to be weak. Also, we
now are reliant almost exclusively on one antiviral (Paxlovid). Should
the virus become resistant to Paxlovid \37\, \38\, \39\, \40\, it will
become ineffective (we are putting our eggs in one basket). We must
broaden the pipeline of antivirals and develop new ones that are more
effective in preventing Long Covid.
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\34\ Xie Y, Choi T, Al-Aly Z. Molnupiravir and risk of post-acute
sequelae of covid-19: cohort study. BMJ. Apr 25 2023;381:e074572.
doi:10.1136/bmj-2022-074572
\35\ Xie Y, Choi T, Al-Aly Z. Association of Treatment With
Nirmatrelvir and the Risk of Post-COVID-19 Condition. JAMA Intern Med.
Jun 1 2023;183(6):554-564. doi:10.1001/jamainternmed.2023.0743
\36\ Fung KW, Baye F, Baik SH, McDonald CJ. Nirmatrelvir and
Molnupiravir and Post--COVID-19 Condition in Older Patients. JAMA
Internal Medicine. 2023;183(12):1404-1406. doi:10.1001/
jamainternmed.2023.5099
\37\ Service RF. Bad news for Paxlovid? Resistance may be coming.
Science. Jul 8 2022;377(6602):138-139. doi:10.1126/science.add8037
\38\ Iketani S, Mohri H, Culbertson B, et al. Multiple pathways
for SARS-CoV-2 resistance to nirmatrelvir. Nature. 2023/01/01
2023;613(7944):558-564. doi:10.1038/s41586-022-05514-2
\39\ Duan Y, Zhou H, Liu X, et al. Molecular mechanisms of SARS-
CoV-2 resistance to nirmatrelvir. Nature. Sep 11 2023;doi:10.1038/
s41586-023-06609-0
\40\ Iketani S, Mohri H, Culbertson B, et al. Multiple pathways
for SARS-CoV-2 resistance to nirmatrelvir. Nature. Jan
2023;613(7944):558-564. doi:10.1038/s41586-022-05514-2
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Treatment of Long Covid
There are zero FDA approved medications for the treatment of Long
Covid. This must change. People suffering from Long Covid need
treatment yesterday. The ongoing and planned trials for Long Covid are
too slow and too small (i.e. underpowered) to provide definitive
answers.
We developed vaccines at warp speed. We are doing trials for Long
Covid at snail speed.
We urgently need large scale trials to test a broad array of
repurposed drugs and development of novels drugs to treat Long Covid.
This must be an all-hands-on-deck situation. This is not solely a
U.S. Government problem.
We must identify and address the barriers that are preventing the
private sector (pharmaceutical industry) from investing in trials for
Long Covid (for example, build consensus around clinical trial
endpoints that are acceptable to regulators).
Is COVID-19 unique in causing chronic illness (Long Covid)?
No.
SARS-CoV-2 is novel (was novel in 2019/2020) and the scale of the
pandemic is certainly large. But the idea that a virus that produces
acute infections can also cause chronic disease is not new. We just
ignored it for 100 years.
Historical accounts of both the 1889-1892 (Russian flu) and 1918
Spanish flu pandemic show that many people suffered from long-term
health effects including cognitive decline, debilitating fatigue and
Parkinson's disease in the convalescent phase of the infection41-46.
Other viruses including polio lead to chronic disease decades later;
Epstein Barr virus (EBV) is known to lead to multiple sclerosis \41\,
\42\, \43\, \44\, \45\, \46\, \47\.
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\41\ Spinney L. Pandemics disable people--the history lesson that
policymakers ignore. Nature. Feb 2022;602(7897):383-385. doi:10.1038/
d41586-022-00414-x
\42\ Spinney L. Pale Rider: the Spanish flu of 1918 and how it
changed the world.
\43\ Ravenholt RT, Foege W. 1918 INFLUENZA, ENCEPHALITIS
LETHARGICA, PARKINSONISM. The Lancet. 1982/10/16/ 1982;320(8303):860-
864. doi:https://doi.org/10.1016/S0140-6736(82)90820-0
\44\ Stefano GB. Historical Insight into Infections and Disorders
Associated with Neurological and Psychiatric Sequelae Similar to Long
COVID. Med Sci Monit. Feb 26 2021;27:e931447. doi:10.12659/msm.931447
\45\ Honigsbaum M, Krishnan L. Taking pandemic sequelae seriously:
from the Russian influenza to COVID-19 long-haulers. The Lancet. 2020/
10/31/ 2020;396(10260):1389-1391. doi:https://doi.org/10.1016/S0140-
6736(20)32134-6
\46\ Dehner G. Howard Phillips, In a Time of Plague: Memories of
the `Spanish' Flu Epidemic of 1918 in South Africa. Social History of
Medicine. 2019;33(1):343-344. doi:10.1093/shm/hkz093
\47\ Bjornevik K, Cortese M, Healy BC, et al. Longitudinal
analysis reveals high prevalence of Epstein-Barr virus associated with
multiple sclerosis. Science. 2022;375(6578):296-301. doi:doi:10.1126/
science.abj8222
Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is a
chronic debilitating multisystemic illness that is thought to be
initially triggered by a flu-like illness, \48\. ME/CFS affects 4.3
million people in the U.S. (1.3 percent of the U.S. population) \49\.
These patients have been ignored and marginalized for decades.
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\48\ Komaroff AL, Lipkin WI. ME/CFS and Long COVID share similar
symptoms and biological abnormalities: road map to the literature.
Front Med (Lausanne). 2023;10:1187163. doi:10.3389/fmed.2023.1187163
\49\ Vahratian A LJ, Bertolli J, Unger ER. Myalgic
encephalomyelitis/chronic fatigue syndrome in adults: United States,
2021--2022. NCHS Data Brief, no 488. Hyattsville, MD: National Center
for Health Statistics. 2023. . doi:https://dx.doi.org/10.15620/
cdc:134504.
Had we connected these dots (between acute infections and chronic
disease) before the COVID-19 pandemic, we would have been in a much
better place to address the challenge of Long Covid.
What do we learn from this?
If we learn one thing from this pandemic, we must recognize that
``pandemics disable people''--that is acute infections can lead to
chronic disabling disease. We call these Infection-Associated Chronic
Conditions (IACC). These include Long Covid, ME/CFS and many other
acute infections that lead to chronic disease.
Urgent and commensurate (proportional) response is needed
We don't go through an earthquake without dealing with its
aftermath. We cannot live through the biggest pandemic of our lives
without dealing with the aftermath. That aftermath is Long Covid. We
must address the challenge of Long Covid.
The current research effort on Long Covid does not match the scale
and the urgency of the problem. Research effort must be commensurate
with the burden of disease caused by these infections. And it should be
executed with a sense of urgency.
The U.S. should consider the establishment within the National
Institutes of Health of an Institute for Infection-Associated Chronic
Illnesses with a budget of at least $1 billion per year to address the
complexity and multisystemic nature of Long Covid, ME/CFS and other
IACC. Because pandemics will continue to happen (and their frequency
will likely be higher in the 21st century than in the 20th century),
and because pandemics will likely produce in their wake droves of
people with chronic disease and disability, understanding how
infections cause chronic illnesses should also be a cornerstone of
pandemic preparedness and resilience.
An NIH institute for the study of Infection-Associated Chronic
Conditions will help us address the needs of Long Covid, other IACC and
position us to be more optimally prepared for the next pandemic. I urge
the U.S. Congress and the executive branch to work together to
materialize this.
You have an historic opportunity to act. The lives of millions of
Americans now and in the future depend on this.
Disclaimer: My employers had no role in developing this testimony.
The contents of this testimony represent my views; they do not
represent the views of my employers.
______
[summary statement of ziyad al-aly]
Chairman Sanders, Ranking Member Dr. Cassidy, and Members of the
U.S. Senate Committee on Health, Education, Labor, and Pensions:
Thank you for the opportunity to testify today.
I am a physician-scientist at Washington University in St. Louis.
My team and I produced the first systematic characterization of Long
COVID and the most widely cited research on Long COVID. We have been at
the forefront of Long COVID research since the early days of the
pandemic when patients started telling us that they are not fully
recovering from COVID-19.
Long COVID is a multisystem disorder that affects nearly every
organ system including the heart, the brain, the endocrine system and
the gastrointestinal system.
Long COVID affects at least 20 million Americans. It affects people
across the lifespan--from children to older adults. It affects people
across race, ethnicity and sex. The burden of disease and disability in
Long COVID is on par with heart disease and cancer.
People can get Long COVID after reinfection. Research from the U.S.
and Canada is clear. Even if people managed to emerge unscathed after
the first infection, they may get Long COVID after reinfection.
Prevention of Long COVID
We need sustainable solutions to prevent repeated infections and
Long COVID that would be embraced by the public. This requires
acceleration of development of oral or intranasal vaccines, investment
in ventilation and air filtration systems for cleaner indoor air,
development of variant-proof and durable vaccines and broadening the
pipeline of antivirals.
Treatment of Long COVID
There are zero FDA approved medications for the treatment of Long
COVID. The ongoing and planned trials for Long COVID are too slow and
too small to provide definitive answers. We urgently need large scale
trials to test a broad array of repurposed drugs and development of new
drugs to treat Long COVID. We must identify and address the barriers
that are preventing the private sector from investing in trials for
Long COVID.
Is COVID-19 unique in causing chronic illness (Long COVID)?
No. Many acute infections also cause chronic disease. These include
flu, polio, Epstein Barr virus (EBV) and many others. Myalgic
encephalomyelitis/chronic fatigue syndrome (ME/CFS) is a chronic
multisystemic disease that is thought to be initially triggered by a
flu-like illness. Acute infections can lead to chronic disabling
disease. We call these Infection-Associated Chronic Conditions (IACC).
We ignored this idea for more than 100 years.
Urgent and commensurate (proportional) research response is needed
The current research effort on Long COVID does not match the scale
and the urgency of the problem. Research effort must be commensurate
with the burden of disease caused by these infections. And it should be
executed with a sense of urgency.
The U.S. should consider the establishment within the National
Institutes of Health of an Institute for Infection-Associated Chronic
Illnesses with at least $1 billion per year to address the complexity
and multisystemic nature of Long COVID, ME/CFS and other IACC.
I urge the U.S. Congress and the executive branch to work together
to materialize this.
You have an historic opportunity to act. The lives and well-being
of millions of Americans now and in the future depend on this.
______
The Chair. Thank you.
[Applause.]
The Chair. Our third witness--our third witness is Dr.
Charisse Madlock-Brown, Associate Professor of Health
Informatics at the University of Iowa College of Nursing. Dr.
Madlock-Brown, thanks very much for being with us.
STATEMENT OF CHARISSE MADLOCK-BROWN, PH.D., ASSOCIATE PROFESSOR
OF HEALTH INFORMATICS, UNIVERSITY OF IOWA, IOWA CITY, IA
Dr. Madlock-Brown. Chairman Sanders, Ranking Member
Cassidy, and Members of the Committee, thank you for the
opportunity to participate.
Since 2021, I have been the co-lead for the National COVID
Cohort Collaboratives, N3C, their social determinant of health
domain team.
At N3C and through the Recover Program, through their
observational research arm, I have worked with a diverse team
of clinicians, patient representatives, epidemiologists, and
informatics professionals to investigate patterns in EHR data
related to long COVID.
Large scale chronic health record networks have been
essential in advancing our understanding of long COVID, mainly
due to their extensive patient health--their extensive patient
health information and coverage of diverse patient populations.
This diversity is key to studying long COVID's impact across
different groups.
However, using data from these systems presents challenges
like differences in utilization by subgroups and incomplete
health records. These issues are partially addressed through
privacy preserving linkage between health systems and
integrating billing data systems.
These network efforts, such N3C, are crucial in overcoming
observational data limitations, such as the lack of
standardization in these systems. Large networks have been
instrumental in implementing harmonization pipelines and
promoting data standardization at a national level, thus
enhancing the reliability and comparability of research
findings on long COVID.
Identifying patients with long COVID in electronic health
record systems presents a challenge as the condition is
severely underdiagnosed. Analysis of the long COVID code that
came out in October 2021 in the N3C system revealed demographic
disparities in long COVID diagnosis, where patients who were
female, white, non-Hispanic, and living in areas with low
poverty and low unemployment were more likely to receive a
diagnosis, which emphasized the need for greater accessibility
to diagnosis and treatment.
Researchers have--do have several options to identify
patients with long COVID in these systems. For instance, at
our--at N3C, one team developed a machine learning model which
showed high accuracy in classifying patients without a
diagnosis.
The model was trained using data from patients who would
visit a long COVID clinic. At the same time, other
observational studies focus on improving self-reporting of
symptoms like brain fog and fatigue.
Researchers using these electronic health record data
warehouses have been pivotal in helping us understand both
COVID-19 and long COVID, revealing key symptoms and risk
factors. One review by Sudre has identified common symptoms,
while others have really shown the variability in post-COVID
conditions across different populations.
To further characterize long COVID, one N3C team used
computational modeling to classify patients into six distinct
clusters, with an emphasis on indicating cluster's severity of
condition.
Another analyzed data from thousands of patients
categorizing symptom co-occurrence into neurological,
cardiopulmonary, gastrointestinal, and co-morbid condition
clusters, which can help us understand the trends in long COVID
broadly. Infection associated chronic illness is not new.
There is a significant intersection in symptomology between
long COVID and a spectrum of related chronic conditions,
notably myalgic encephalomyelitis, chronic fatigue syndrome, or
ME/CFS.
Studies have shown that 50 percent of long COVID patients
fit ME/CFS criteria. The emergence of long COVID has cast a
spotlight on these conditions, underscoring the urgent need for
more research into their shared characteristics and underlying
mechanisms.
There is a critical need for a moonshot initiative to
tackle long COVID. The scarcity of clinical trials focusing on
long COVID's underlying causes and treatments poses a barrier
to progress.
A call to actions by patients and researchers proposes that
the U.S. Government leads this initiative with a significant
annual investment, like the Cancer Moonshot Program, to inspire
global action against this widespread health challenge.
Key priorities for the moonshot initiative should be
conducting clinical trials for behavioral and experimental
medicine treatments. In tandem with clinical trials, several
activities can support observational research systems like N3C
to enhance our understanding of long COVID and bolster trial
findings.
Activities can include symptoms and phenotypes across the
swath of infection associated chronic conditions, improving
diagnosis and treatment accessibility, and establishing
clinical guidelines for consistent diagnosis.
Additionally, the moonshot should emphasize coordinated
clinical programs for underserved communities, structuring
clinical data for better research, including incorporating
social determinants of health data to better understand biases
in health and disparities in outcomes.
Linking these systems with clinical trials and data sets
like claims and mortality for more comprehensive representation
of patient health. These efforts aim to advance the
understanding and treatment of long COVID, ultimately leading
to better patient outcomes.
[The prepared statement of Dr. Madlock-Brown follows.]
prepared statement of charisse madlock-brown
My Background
Chairman Sanders, Ranking Member Cassidy, and Members of the
Committee, thank you for the opportunity to participant in this
hearing. I am a faculty member in Health Informatics at the University
of Iowa College of Nursing. I was previously an associate professor at
the University of Tennessee Health Science Center. I received my
Master's in Library and Information Science and Ph.D. in Health
Informatics from the University of Iowa. I have a broad background in
health informatics, with a current focus on social determinants of
health, COVID-19, health disparities, obesity trends, and
multimorbidity. I use machine learning and bio-statistics to analyze
large electronic health record (EHR) data warehouses. Since 2021, I
have been the co-lead for the National Cohort Collaborative's (N3C)
Social Determinant of Health (SDoH) domain team directing research on
SDoH and COVID-19 outcomes as well as data engineering efforts to
improve harmonization of individual level SDoH data into Data
warehouses. Additionally, I am the Iowa site PI for the Center for
Linkage and Acquisition of Data (CLAD) for the All of Us program.1 The
``All of Us'' Research Program is a significant initiative aiming to
recruit at least one million participants from across the diverse
spectrum of the United States. CLAD will further the program's efforts
through integrating claims, mortality, and environmental data into
existing EHR and survey data.
The N3C project, \1\ developed in partnership with the National
Center for Advancing Translational Sciences (NCATS), focuses on
identifying cases of COVID-19 in a network of HER systems, including
those that are laboratory-confirmed, suspected, or considered possible.
To facilitate accurate comparisons and analyses, these COVID-19 cases
are demographically matched with control subjects who have tested
negative or equivocal for COVID-19. The matching criteria include age
group, sex, race, and ethnicity. The ratio of COVID-19 cases to control
subjects is maintained at 1:2, ensuring a robust and representative
comparison group for the study. N3C continuously grows its network and
currently comprises 83 distinct healthcare sites representing all
regions in the U.S. and 21.7 million patients. N3C is part of the EHR
arm of the Researching COVID to Enhance Recovery (RECOVER) NIH
initiative. \2\ As a funded N3C RECOVER researcher, I work with a
diverse team of clinicians, patient representatives, epidemiologists,
and informatics professionals to investigate patterns in EHR data
related to long COVID.
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\1\ All of Us Research Program Establishes New Center for Linkage
and Acquisition of Data. All of Us Research Program NIH https://
allofus.nih.gov/news-events/announcements/all--us-research-program-
establishes-new-center-linkage-and-acquisition-data (2023).
\2\ Haendel, M. A. et al. The National COVID Cohort Collaborative
(N3C): Rationale, design, infrastructure, and deployment. J. Am. Med.
Inform. Assoc. JAMIA 28, 427--443 (2021).
These statements are made on my behalf and do not represent N3C or
RECOVER.
Benefits of leveraging EHR data base systems for long COVID research
Large-scale Electronic Health Record (EHR) warehouse networks have
played a pivotal role in rapidly developing insights into long COVID
due to several key factors. First, EHRs contain a breadth of coded
patient health information, including histories of diagnoses,
medication prescriptions, lab results, vital measurements and outcomes.
\3\ Additionally, EHRs cover large and diverse patient populations
across various demographics, geographic locations, and healthcare
settings. This diversity is crucial for studying long COVID in
different groups, enhancing the generalizability of findings. Another
significant advantage of EHRs is the provision of longitudinal data,
allowing researchers to track patients' health over extended periods.
\4\ This aspect is particularly important for long COVID, characterized
by prolonged and evolving symptoms. Inquiries into observational EHR
data warehouses can be launched immediately, provided the data is
available \5\. In contrast, clinical trials take a great deal of time
to launch, enroll, and complete prior to the data becoming available
for analysis. This real-world data aids in understanding patterns of
clinical management surrounding long COVID. \6\ EHRs also contain
critical data on comorbidities, \7\ shedding light on risk factors and
the impact of long COVID on individuals with specific health profiles.
EHRs also enable the identification of subgroups within long COVID
patients, presenting distinct clinical features, which is key for
understanding a disease that may have more than one etiology and
presentation. \8\ The ability to share EHR data bases across
institutions facilitates collaborative research and larger-scale
studies, essential for understanding complex conditions like long
COVID.
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\3\ National Institutes of Health. RECOVER: Researching COVID to
Enhance Recovery. RECOVER: Researching COVID to Enhance Recovery
https://recovercovid.org.
\4\ Bradwell, K. R. et al. Harmonizing units and values of
quantitative data elements in a very large nationally pooled electronic
health record (EHR) dataset. J. Am. Med. Inform. Assoc. 29, 1172--1182
(2022).
\5\ Violn, C. et al. Five-year trajectories of multimorbidity
patterns in an elderly Mediterranean population using Hidden Markov
Models. Sci. Rep. 10, 16879 (2020).
\6\ Jones, R. et al. Risk Predictors and Symptom Features of Long
COVID Within a Broad Primary Care Patient Population Including Both
Tested and Untested Patients. Pragmatic Obs. Res. 12, 93--104 (2021).
\7\ Alshakhs, M., Jackson, B., Ikponmwosa, D., Reynolds, R. &
Madlock-Brown, C. Multimorbidity patterns across race/ethnicity as
stratified by age and obesity. Sci. Rep. 12, 9716 (2022).
\8\ O'Neil, S. T. et al. Finding Long-COVID: Temporal Topic
Modeling of Electronic Health Records from the N3C and RECOVER
Programs. 2023.09.11.23295259 Preprint at https://doi.org/10.1101/
2023.09.11.23295259 (2023).
The continuous updating of EHRs ensures rapid availability of
recent data--crucial for an emerging condition like long COVID where
knowledge is rapidly evolving. Regarding pharmacovigilance, EHR data
can be instrumental in monitoring adverse drug reactions, \9\ which may
be particularly important as new treatments for long COVID emerge.
Last, using existing EHR data is often more cost-effective than new
data collection, \10\ especially relevant for a widespread condition
like long COVID. This cost-effectiveness makes EHRs an invaluable
resource in the ongoing research and understanding of long COVID.
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\9\ Muzaffar, A. F., Abdul-Massih, S., Stevenson, J. M. & Alvarez-
Arango, S. Use of the Electronic Health Record for Monitoring Adverse
Drug Reactions. Curr. Allergy Asthma Rep. 23, 417--426 (2023).
\10\ Mc Cord, K. A. et al. Current use and costs of electronic
health records for clinical trial research: a descriptive study. CMAJ
Open 7, E23--E32 (2019).
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Challenges Associated with Leveraging EHR data bases for research
Numerous challenges are associated with using EHR data for research
given limitations such as the inherently incomplete nature of patient
charts. \11\ Events like visits at external clinics or home COVID tests
likely won't be captured. This type of incompleteness can be partially
mitigated through patient privacy preserving linkage between different
healthcare systems as well as billing data sources, \12\ such as CMS.
Variations in data capture and data mappings between electronic systems
also impact data incompleteness. For example, long COVID diagnosis
coding varied over time and by site, \13\ as did the mapping of this
code to research data warehouses. Implementing data harmonization
pipelines and quality assessments within EHR analytic platforms can
enhance data interoperability and inform data selection and cleaning
prior to analysis.
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\11\ Kim, E. et al. The Evolving Use of Electronic Health Records
(EHR) for Research. Semin. Radiat. Oncol. 29, 354--361 (2019).
\12\ Kiernan, D. et al. Establishing a framework for privacy-
preserving record linkage among electronic health record and
administrative claims data bases within PCORnet, the National Patient-
Centered Clinical Research Network. BMC Res. Notes 15, 337 (2022).
\13\ Pfaff, E. R. et al. Coding long COVID: characterizing a new
disease through an ICD-10 lens. BMC Med. 21, 58 (2023).
Observational health researchers much also keep in mind that
patients who visit large healthcare systems are not representative of
the entire population as healthy patients or patients with less access
to care will be less present in the sample. \14\ This is partially
mitigated by including a diverse range of healthcare sites and linking
CMS data from all patient encounters so that researchers can ensure a
more representative sample that includes patients with milder illness
and fewer healthcare interactions. Patient utilization differences by
sub-groups due to varying levels of healthcare access among different
demographic groups can be partially overcome by ensuring representation
from diverse communities and analyzing utilization patterns to identify
and correct for bias.
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\14\ National Academies of Sciences, E., Division, H. and M.,
Services, B. on H. C. & Disabilities, C. on H. C. U. and A. with.
Factors That Affect Health-Care Utilization. Health-Care Utilization as
a Proxy in Disability Determination (National Academies Press (U.S.),
2018).
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Benefits of large EHR networking efforts
Large EHR networking efforts have helped researcher make progress
on all mitigating factors related to the limitations of observational
data. The lack of standardization in EHR systems, \15\ a significant
barrier in aggregating and comparing data across sources, has been
tackled by large networks implementing harmonization pipelines, and
facilitating data standardization at the national level. A large EHR
network can establish data quality benchmarks by showing institutions
where they might be lacking certain data richness when compared to
other members of the network. This can support investigation and
improvement of local data collection and mapping practices.
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\15\ Sidky, H. et al. Data quality considerations for evaluating
COVID-19 treatments using real world data: learnings from the National
COVID Cohort Collaborative (N3C). BMC Med. Res. Methodol. 23, 46
(2023).
By addressing these various challenges through the strategic use of
large EHR warehouse networks, research into long COVID and similar
complex health conditions (e.g., Myalgic encephalomyelitis/chronic
fatigue syndrome and Postural tachycardia syndrome), can become more
accurate, inclusive, and representative, leading to more effective and
personalized healthcare solutions.
Methods for Identifying long COVID patients
Identifying patients with long COVID in Electronic Health Record
(EHR) systems presents a significant challenge in current medical
research as the condition is underdiagnosed.
Machine Learning Models: Pfaff et al. developed a machine learning
model to identify probable long COVID patients using a training dataset
from 597 patients at long-COVID clinics using N3C. \16\ The XGBoost
model was tested in a cohort of 97,995 COVID-19 patients into three
categories: all COVID-19 patients, hospitalized, and non-hospitalized
patients. Key features for identifying long COVID included healthcare
utilization, patient age, dyspnea, and other diagnosis and medication
information. The models showed high accuracy in pinpointing potential
long-COVID patients.
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\16\ Weiskopf, N. G., Hripcsak, G., Swaminathan, S. & Weng, C.
Defining and measuring completeness of electronic health records for
secondary use. J. Biomed. Inform. 46, 830--836 (2013).
Prospective Observational Cohort Study: Researchers conducted a
nationwide, prospective observational cohort study, involving adults
who completed a symptom survey 6 months after acute COVID-19 symptom
onset or testing positive. \17\ The study identified PASC based on 44
self-reported symptoms, emphasizing symptoms like post exertional
malaise, fatigue, and brain fog. This method provided a symptom-based
definition of PASC.
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\17\ Pfaff, E. R. et al. Who has long-COVID? A big data approach.
2021.10.18.21265168 https://www.medrxiv.org/content/10.1101/
2021.10.18.21265168v1 (2021) doi:10.1101/2021.10.18.21265168.
Analysis of U09.9 ICD-10-CM Code Usage: Researchers used theICD-10-
CM code U09.9, ``Post COVID-19 condition, unspecified,'' in the N3C
system to identify patients with long COVID. It focused on 33,782
patients with a U09.9 diagnosis, examining demographics, social
determinants of health, co-occurring diagnoses, medications, and
procedures within 60 days of diagnosis, particularly noting age group
differences. The study found that long COVID diagnoses (U09.9) were
predominantly among female, White, non-Hispanic individuals from low
poverty and unemployment areas, highlighting disparities in long COVID
diagnosis and suggesting the need for further research and action.
Research using EHR data warehouses to identify symptoms and risk
factors associated with long COVID
Research utilizing EHR data warehouses has significantly
contributed to understanding the symptoms and risk factors of COVID-19
and its prolonged effects, often referred to as Long COVID or post-
acute sequelae of SARS-CoV-2 infection (PASC). Sudre CH et al.'s review
identified symptoms of long COVID common across multiple studies,
including fatigue, exertional dyspnea, musculoskeletal pain, and
``brain fog,'' with additional mental health issues like anxiety,
depression, and PTSD. \18\ This study emphasizes the broad range of
symptoms that can persist or emerge well after the acute phase of the
infection. A comprehensive study across 31 health systems in the United
States, part of N3C, involved 8,325 individuals with PASC. \19\ This
study examined a range of factors, including demographics,
comorbidities, and acute characteristics of COVID-19, to identify risk
factors for PASC. Key findings included the higher prevalence of
diagnosis of PASC in individuals over 50 years old, females, non-
Hispanic Whites, and those with specific comorbidities like depression,
chronic lung disease, and obesity. Zang et al used electronic health
records from two large networks, INSIGHT and OneFlorida+, covering over
27 million patients in NYC and Florida, to investigate post-acute
sequelae of SARS-CoV-2 infection (PASC, or long COVID). \20\ Employing
a high-throughput screening approach, the study identified a range of
diagnoses and medications with higher incidence in patients 30-180 days
post-COVID infection compared to non-infected individuals. Notable
findings include a greater number of PASC cases in NYC than Florida,
with conditions like dementia, hair loss, and pulmonary issues common
in both cohorts. The study highlights the variability in long COVID
risks across different populations. These studies, leveraging the
extensive data available in EHR warehouses, underscore the diverse and
complex nature of COVID-19 and its long-term effects. They highlight
the critical role of comprehensive data analysis in understanding this
evolving health issue, informing potential early intervention
strategies, and guiding future clinical and epidemiological research
for effective management and treatment of PASC.
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\18\ Thaweethai, T. et al. Development of a Definition of
Postacute Sequelae of SARS-CoV-2 Infection. JAMA 329, 1934--1946
(2023).
\19\ Sudre, C. H. et al. Attributes and predictors of long COVID.
Nat. Med. (2021) doi:10.1038/s41591-021-01292-y.
\20\ Hill, E. et al. Risk Factors Associated with Post-Acute
Sequelae of SARS-CoV-2 in an EHR Cohort: A National COVID Cohort
Collaborative (N3C) Analysis as part of the NIH RECOVER program.
2022.08.15.22278603 Preprint at https://doi.org/10.1101/
2022.08.15.22278603 (2022).
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Characterizing and Sub-Phenotyping long COVID using EHR data warehouses
Reese et al. stratified patients with PASC (or long COVID) through
computational modeling of phenotype data from EHRs. \21\ It assesses
phenotypic similarities between patients using semantic similarity,
identifying six distinct PASC patient clusters. Specific abnormalities,
such as pulmonary, neuropsychiatric, and cardiovascular issues,
characterize these clusters. The approach was validated across
different hospital systems. Pfaff et al analyzed data from 33,782
patients diagnosed with U09.9 and identified four major categories of
diagnoses that commonly co-occur with the U09.9 code.12 These
categories include cardiopulmonary, neurological, gastrointestinal, and
comorbid conditions. This method provides insights into the prevalent
health issues associated with long COVID and how they are documented in
healthcare records. It also has evolved into new sub-phenotyping
approaches used in N3C RECOVER queries. These papers show that, despite
the varied nature of the symptomology of long COVID, it is possible to
characterize symptoms in broad categories, which will help future
researchers develop patient profiles for long COVID.
---------------------------------------------------------------------------
\21\ Zang, C. et al. Data-driven analysis to understand long COVID
using electronic health records from the RECOVER initiative. Nat.
Commun. 14, 1948 (2023).
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Long COVID and other Post-viral Syndromes
This section explores the intersection between Post-Acute Sequelae
of SARS-CoV-2 infection (PASC or long COVID) and a spectrum of related
chronic conditions, notably myalgic encephalomyelitis/chronic fatigue
syndrome (ME/CFS). The emergence of long COVID has cast a spotlight on
these conditions, underscoring the urgent need for more research into
their shared characteristics and underlying mechanisms.
Redox Imbalance in COVID-19 and ME/CFS: This review highlights the
similarities between PASC and myalgic encephalomyelitis/chronic fatigue
syndrome (ME/CFS), particularly in terms of redox imbalance, systemic
and neuroinflammation, impaired ATP generation, and hypometabolism.
\22\ These biological abnormalities provide evidence of a shared
biological basis between long COVID-19 and ME/CFS, indicating potential
pathways for new therapeutic approaches.
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\22\ Reese, J. T. et al. Generalisable long COVID subtypes:
findings from the NIH N3C and RECOVER programmes. EBioMedicine 87,
104413 (2023).
Long COVID vs. Long Flu in the Elderly: An observational cohort
study compared long COVID with residual symptoms in elderly influenza
patients (termed ``long Flu''). \23\ The study found that long COVID
patients exhibited a higher incidence of symptoms like dyspnea,
fatigue, palpitations, loss of taste/smell, and neurocognitive symptoms
compared to those with long Flu, suggesting differences in the
symptomatology and severity between post-viral syndromes in elderly
patients.
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\23\ Paul, B. D., Lemle, M. D., Komaroff, A. L. & Snyder, S. H.
Redox imbalance links COVID--19 and myalgic encephalomyelitis/chronic
fatigue syndrome. Proc. Natl. Acad. Sci. U. S. A. 118, e2024358118
(2021).
Long COVID as a Form of infection-associated chronic illness/ME/
CFS: This paper posits that long COVID is essentially the same
condition as ME/CFS, also an infection-associated chronic illness. \24\
It argues that acute COVID-19 triggers ME/CFS, similar to other
infectious agents. The literature review by Komaroff et al. notes
considerable similarities between ME/CFS and Long COVID, particularly
in symptomatology and biological abnormalities. \25\ It emphasizes that
ME/CFS often follows an infectious-like illness and is characterized by
post-exertional malaise, similar to Long COVID. In fact, several
studies estimate that half of long COVID patients fit the criteria for
ME/CFS. \26\
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\24\ Fung, K. W., Baye, F., Baik, S. H., Zheng, Z. & McDonald, C.
J. Prevalence and characteristics of long COVID in elderly patients: An
observational cohort study of over 2 million adults in the U.S.. PLOS
Med. 20, e1004194 (2023).
\25\ Williams, S. P., Michelle A. Long Covid is a new name for an
old syndrome. STAT https://www.statnews.com/2023/09/14/long-covid-me-
cfs-myalgic-encephalomyelitis--chronic-fatigue/ (2023).
\26\ Komaroff, A. L. & Lipkin, W. I. ME/CFS and Long COVID share
similar symptoms and biological abnormalities: road map to the
literature. Front. Med. 10, 1187163 (2023).
Collectively, these papers suggest significant overlaps in the
symptomatology and underlying biological abnormalities between PASC and
other infection-associated chronic conditions, particularly ME/CFS,
indicating a potential common pathophysiological basis.
Future directions
A moonshot initiative is urgently needed in the wake of the
persistent and global challenge of long COVID. \27\ The current
landscape of research into this condition is alarmingly disjointed.
Experts in diverse medical specialties, including pulmonology,
neurology, and cardiology, remain siloed, rarely crossing paths to
share insights. The scarcity of clinical trials aimed at the underlying
causes of long COVID and the need for a robust infrastructure for swift
trial implementation pose a significant barrier to progress. \28\ This
situation is further exacerbated by the inadequate long-term funding,
causing hesitation among scientists and companies in pursuing potential
treatments.
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\27\ Grach, S. L., Seltzer, J., Chon, T. Y. & Ganesh, R. Diagnosis
and Management of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome.
Mayo Clin. Proc. 98, 1544--1551 (2023).
\28\ McCorkell, L. & Peluso, M. J. Long COVID research risks
losing momentum--we need a moonshot. Nature 622, 457--460 (2023).
This call to action urges the U.S. government to spearhead this
moonshot by committing an annual investment of at least $1 billion over
the next 10 years. Such a bold move could galvanize global efforts,
encouraging governments worldwide to rise to this health challenge that
affects every continent. The effectiveness of substantial funding is
evident in cancer research as seen through initiatives like the Cancer
Moonshot. \29\
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\29\ Davis, H. E., McCorkell, L., Vogel, J. M. & Topol, E. J. Long
COVID: major findings, mechanisms and recommendations. Nat. Rev.
Microbiol. 21, 133--146 (2023).
Primary activities for a long COVID moonshot must be clinical
trials so that effective treatments can be tested and developed. There
is a particular need for studies on experimental medicines, as
currently, there are only 12 such studies for long COVID listed in
ClinicalTrials.gov \30\. In tandem with clinical trials, there are
several ways observational research systems like N3C can both enhance
our understanding of long COVID and bolster findings from trials:
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\30\ About the Cancer MoonshotSM--NCI. https://www.cancer.gov/
research/key--initiatives/moonshot-cancer-initiative/about (2022).
1. Identification of Symptom Sub-Phenotypes: Research should
aim to identify common symptom sub-phenotypes across various
post-viral syndromes. This will enhance our understanding of
long COVID and similar conditions, leading to more effective
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treatments and management strategies.
2. Improving Diagnosis and Treatment Accessibility:
Addressing biases in long COVID diagnosis, as highlighted by
research from the N3C RECOVER team, is critical. Efforts must
focus on making diagnoses and treatments more accessible to all
demographics, particularly those currently underdiagnosed.
Furthermore, enhancements of SDoH data within these systems
\31\ can be further leveraged to understand biases in available
data for patients with limited access to care and
identification of health disparities in long COVID diagnoses
and treatment across sociodemographic areas.
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\30\ About the Cancer MoonshotSM--NCI. https://www.cancer.gov/
research/key--initiatives/moonshot-cancer-initiative/about (2022).
3. Clinical Guidelines: Establishing clinical guidelines to
support the accurate diagnosis of long COVID is imperative
\32\. These guidelines will ensure consistency and reliability
in diagnosing this condition across various healthcare
settings.
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\32\ Phuong, J. et al. Advancing Interoperability of Patient-level
Social Determinants of Health Data to Support COVID-19 Research. AMIA
Summits Transl. Sci. Proc. 2022, 396--405 (2022).
4. Coordinated Clinical Programs for Underserved Communities:
Special attention must be given to coordinating clinical
programs that specifically target underserved communities. This
includes people in rural areas, low-income groups, and racial
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minorities who have limited access to healthcare.
5. Structuring of Clinical Note and Flowsheet Data: Ensuring
that more data, such as SDoH data and complete symptom lists,
become structured and easily accessible is vital for
comprehensive research and analysis.
6. Linking Prospective Data with Clinical Trials and Other
Datasets: More prospective data should be linked to clinical
repositories using Privacy-Preserving Record Linkage (PPRL) to
clinical trials data. Additionally, integrating this data with
claims and mortality data will provide a more complete picture
of various treatments' long-term impacts and effectiveness
\33\.
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\33\ Fernandez-de-las-Peas, C., Palacios-Cea, D., Gomez-Mayordomo,
V., Cuadrado, M. L. & Florencio, L. L. Defining Post-COVID Symptoms
(Post-Acute COVID, Long COVID, Persistent Post-COVID): An Integrative
Classification. Int. J. Environ. Res. Public. Health 18, 2621 (2021).
By focusing on these areas, the moonshot initiative can
significantly advance our understanding of long COVID, leading to more
effective treatments and better outcomes for those affected.
______
[summary statement of charisse madlock-brown]
Large-scale Electronic Health Record (EHR) networks have been
essential in advancing our understanding of long COVID, mainly due to
their extensive patient health information and coverage of diverse
patient populations. This diversity is key for studying long COVID's
impact across different groups. However, using EHR data for research
presents challenges like incomplete patient records, with events like
external clinic visits or home COVID tests often missing. This issue is
partially addressed through privacy-preserving linkage between
healthcare systems and integrating billing data sources. EHR networking
efforts, such as the National COVID Cohort Collaborative (N3C), are
crucial in overcoming observational data limitations, such as the lack
of standardization in EHR systems. Large networks have been
instrumental in implementing harmonization pipelines and promoting data
standardization at the national level, thus enhancing the reliability
and comparability of research findings on long COVID.
Identifying patients with long COVID in Electronic Health Record
(EHR) systems presents a significant challenge as the condition is
underdiagnosed. Analysis of the use of the ICD-10-CM long COVID code in
the N3C system revealed demographic disparities in long COVID
diagnoses, emphasizing the need for greater accessibility in diagnosis
and treatment. Pfaff et al. developed a machine learning model showing
high accuracy in classifying COVID-19 patients as having long COVID,
while a nationwide observational cohort study focused on self-reported
symptoms like fatigue and brain fog to define Post-Acute Sequelae of
SARS-CoV-2 infection (PASC).
Research using EHR data warehouses has been pivotal in
understanding COVID-19 and Long COVID (PASC), revealing key symptoms
and risk factors. Studies like Sudre CH et al.'s review have identified
common symptoms, while others, like Zang et al.'s work with INSIGHT and
OneFlorida+, show variability in post-COVID conditions across different
populations. To further characterize long COVID, Reese et al. used
computational modeling to classify patients into six distinct clusters,
and Pfaff et al. analyzed data from thousands of patients, categorizing
symptom co-occurences. These methods are crucial in developing targeted
patient profiles for future research and treatment strategies.
There is a significant intersection in symptomology between Post-
Acute Sequelae of SARS-CoV-2 infection (PASC or long COVID) and a
spectrum of related chronic conditions, notably myalgic
encephalomyelitis/chronic fatigue syndrome (ME/CFS). The emergence of
long COVID has cast a spotlight on these conditions, underscoring the
urgent need for more research into their shared characteristics and
underlying mechanisms.
There is a critical need for a ``moonshot'' initiative to tackle
long COVID. The scarcity of clinical trials focusing on long COVID's
underlying causes and treatments pose a barrier to progress. A call to
action by patients and researchers proposes that the U.S. government
leads this initiative with a significant annual investment, similar to
the successful Cancer Moonshot program, to inspire global action
against this widespread health challenge.
Key priorities for the moonshot initiative include conducting
clinical trials for experimental treatments, identifying symptom sub-
phenotypes, improving diagnosis and treatment accessibility, and
establishing clinical guidelines for consistent diagnosis.
Additionally, it emphasizes coordinated clinical programs for
underserved communities, structuring clinical data for better research,
and linking EHR systems with clinical trials and other datasets. These
efforts aim to advance the understanding and treatment of long COVID,
ultimately leading to better patient outcomes.
______
[Applause.]
The Chair. Dr. Madlock, I want to thank you very much. Our
next witness will be Dr. Tiffany Walker, Assistant Professor at
Emory University School of Medicine. Dr. Walker, thanks very
much for being here.
STATEMENT OF TIFFANY WALKER, M.D., ASSISTANT PROFESSOR, EMORY
UNIVERSITY SCHOOL OF MEDICINE, ATLANTA, GA
Dr. Walker. Thank you so much. Chairman Sanders, Ranking
Member Cassidy, and distinguished Members of the Committee, my
name is Tiffany Walker, and I am Assistant Professor of
Internal Medicine at Emory, staff physician at Grady Memorial
Hospital, a large urban safety net hospital.
I am site PI for Recover a medic cohort and PI multiple
clinical trials in long COVID, as well as the PI for the AHRQ
Atlanta Long COVID Collaborative Center of Excellence. The
views I express today are my own and do not reflect the views
of my employer.
I am honored to provide this testimony today, and I aim to
convey how imperative it is that we continue to invest and
support research to defining the biological drivers of long
COVID and the urgency to identify effective treatments.
We have seen that anywhere from 15 to 38 percent of COVID
survivors develop long COVID. To provide a stark comparison,
this is commensurate to the rate of diabetes in our population.
Long COVID can significantly impact patients' quality of
life and function, and long haulers are more likely to be
unemployed and work reduced hours, which has been addressed
multiple times today, with recent CDC data supporting that over
a quarter of long haulers suffer from significant activity
limitations. Disease duration remains unknown.
However, mounting evidence supports significant overlap
with infection associated chronic illnesses such as ME/CFS and
dysautonomia.
These are debilitating diseases that for many last
lifelong. Economically disadvantaged populations have been
disproportionately affected by long COVID, with African
American and Hispanic Americans experiencing higher rates of
long COVID, and nuanced diabetes, and cardiovascular disease.
Impaired health literacy in economically disadvantaged
populations impacts recognition of symptoms and therefore
access to care. Furthermore, lack of coordination in long COVID
care is amplified in these underserved, minority populations
that have longstanding history of poor access to affordable,
quality health care.
We absolutely see this in our Grady population. However,
long COVID is not limited to this population. Although young,
previously healthy adults have largely been spared from severe
illness in the setting of acute COVID, it is important to
highlight that long COVID can cause illness in anyone, and I
think that we saw this today in our panel.
Previously, healthy patients who had mild acute COVID
infections make up a significant portion of the patients we are
seeing in our long COVID clinics. In fact, CDC data suggests
that adults aged 30 to 60 may be at highest risk, impacting our
working age adults and those of childbearing ages.
Congress investment in the Recovery Initiative well
positions researchers like myself to define the clinical scope
of long-COVID and characterize biological drivers of this
disease. This is critical because a comprehensive understanding
of the organ systems involved can guide clinical care.
It can mitigate the unnecessary spending on extensive
diagnostic workups, which is happening all the time. And
defining these biological drivers helps us identify biomarkers
that we can use to diagnose and monitor long-COVID, which I
know has been addressed already, as well as it helps facilitate
identification of intervenable targets for drug development.
This is very important. We need to know what we are
targeting. However, at this time, NIHLBI anticipates concluding
the cohort in May 2025. This decision does not account for the
ongoing high COVID-19 case rate, protracted nature of long
COVID symptoms, or concerning evidence of potential,
immunodeficiency that warrants long term monitoring in this
population. Now is not the time to de-escalate funding for long
COVID.
Likewise, the Recovery Initiative hosts well-designed
clinical trials. However, current funding is largely siloed
through the Recover mechanism, stifling opportunities for
further innovation.
Despite Recover's best effort, the trials are often
launching sequentially because there are finite resources for
one institution to run all high profile clinical trials for the
entire U.S. population. Trial funding needs to occur at a much
greater scale and should not be limited to one consortium.
Seasoned clinical trialists and long COVID experts
providing care on the ground level should have input. I propose
leveraging real world data to capture patterns of off label
drug use to identify promising candidates that can be rapidly
deployed in adaptive platform clinical trials.
This winner take all trial design expedites drug
development by using real time data to reallocate patients to
drug showing efficacy and retire drug showing futility. This
results in reduced patients on placebo, reduced cost, reduced
timelines.
This model shows significant promise for sustainable
infrastructure that could be rapidly scaled to identify
treatments for future outbreaks of emerging infectious
diseases, bolstering preparedness.
In summary, my recommendations are to expand Recover
Initiative funding to support extension of the observational
cohort. Expand funding for long COVID adaptive platform
repurposed drug trials independent of the Recover mechanism.
Then, in closing, I would like to extend my humble
gratitude to Senator Kaine and colleagues for advocating for
the AHRQ Long COVID Initiative. This is a 5-year effort that
supports essential infrastructure to expand person centered
long COVID care across the U.S., and we feel strongly that this
support will be paramount in improving care, access, and
quality, and will guide policy change in long COVID care
delivery. Thank you so much.
[The prepared statement of Dr. Walker follows.]
prepared statement of tiffany walker
Chairman Sanders, Ranking Member Cassidy, and Distinguished Members
of the Committee:
My name is Tiffany Walker, and I am an assistant professor of
internal medicine at Emory University. The views I express today are my
own views and do not necessarily reflect the views of my employer, the
RECOVER consortium, or AHRQ. I am honored to have the opportunity to
share my testimony with you, and I hope to convey that Long COVID is a
highly prevalent and often disabling disease. It is imperative that we
continue to invest in and support research that defines the
pathobiological drivers of this disease, and there is real urgency to
identify effective treatments.
To review my experience in this field, I co-founded the Long COVID
clinic at Grady Memorial Hospital. I serve as site principal
investigator (PI) for the NHLBI RECOVER Initiative meta cohort and
RECOVER VITAL (Paxlovid) clinical trial, and co-investigator for the
RECOVER SLEEP (Modafinil/Solriamfetol) clinical trial and the NIA
REVERSE-LC (Baricitinib) clinical trial. I lead the Atlanta Long COVID
Collaborative, a consortium of Long COVID providers and subspecialists
in Atlanta and our site serves as a AHRQ Long COVID Center of
Excellence. Additionally, I investigate health disparities and
pathobiological mechanisms driving Long COVID.
Impact on the labor force
The COVID-19 pandemic has resulted in a conservative estimate of 20
million U.S. cases of Long COVID. \1\ In fact, we have seen that 15
percent of those exposed to COVID-19 go on to develop long term
sequelae. \2\ To provide a stark comparison, this is commensurate to
the rate of diabetes mellitus in our population, \3\ a disease that
receives substantial healthcare and research funding support. Long
COVID can lead to significant impairments in quality of life and
function. \4\, \5\, \6\ We know that long haulers are more likely to be
unemployed or work reduced hours, with one estimate reporting nearly
half were unable to work full time due to severity of symptoms and
nearly a quarter were unable to return to work at all. \7\ This is
corroborated by recent CDC data showing that over a quarter of long
haulers suffer from significant activity limitations. This level of
disability also mirrors that seen in diabetes, for which $30 billion of
indirect costs is spent annually on reduced employment due to
disability. \8\ The duration of this disease remains unknown; \9\
however, there is mounting evidence supporting significant overlap
between Long COVID and pre-existing infection-associated chronic
diseases such as myalgic encephalomyelitis/chronic fatigue syndrome
(ME/CFS) and dysautonomia, which are known to be debilitating and can
persist in individuals indefinitely. \10\, \11\
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\1\ Ford ND, Slaughter D, Edwards D, et al. Long COVID and
Significant Activity Limitation Among Adults, by Age--United States,
June 1-13, 2022, to June 7-19, 2023. MMWR Morb Mortal Wkly Rep. Aug 11
2023;72(32):866-870. doi:10.15585/mmwr.mm7232a3
\2\ Perlis RH, Santillana M, Ognyanova K, et al. Prevalence and
Correlates of Long COVID Symptoms Among U.S. Adults. JAMA Netw Open.
Oct 3 2022;5(10):e2238804. doi:10.1001/jamanetworkopen.2022.38804
\3\ CDC. National Diabetes Statistic Report. https://www.cdc.gov/
diabetes/data/statistics--report/index.html. Accessed 1/15/2024
\4\ Huang L, Yao Q, Gu X, et al. 1-year outcomes in hospital
survivors with COVID-19: a longitudinal cohort study. Lancet. Aug 28
2021;398(10302):747-758. doi:10.1016/s0140-6736(21)01755-4
\5\ Seele J, Waterboer T, Hippchen T, et al. Persistent Symptoms
in Adult Patients 1 Year After Coronavirus Disease 2019 (COVID-19): A
Prospective Cohort Study. Clin Infect Dis. Apr 9 2022;74(7):1191-1198.
doi:10.1093/cid/ciab611
\6\ Taquet M, Dercon Q, Luciano S, Geddes JR, Husain M, Harrison
PJ. Incidence, co-occurrence, and evolution of long-COVID features: A
6-month retrospective cohort study of 273,618 survivors of COVID-19.
PLoS Med. Sep 2021;18(9):e1003773. doi:10.1371/journal.pmed.1003773
\7\ Davis HE, Assaf GS, McCorkell L, et al. Characterizing long
COVID in an international cohort: 7 months of symptoms and their
impact. EClinicalMedicine. Aug 2021;38:101019. doi:10.1016/
j.eclinm.2021.101019
\8\ Parker ED, Lin J, Mahoney T, et al. Economic Costs of Diabetes
in the U.S. in 2022. Diabetes Care. Jan 1 2024;47(1):26-43.
doi:10.2337/dci23-0085
\9\ Thaweethai T, Jolley SE, Karlson EW, et al. Development of a
Definition of Postacute Sequelae of SARS-CoV-2 Infection. Jama. May 25
2023;doi:10.1001/jama.2023.8823
\10\ Bonilla H, Quach TC, Tiwari A, et al. Myalgic
Encephalomyelitis/Chronic Fatigue Syndrome is common in post-acute
sequelae of SARS-CoV-2 infection (PASC): Results from a post-COVID-19
multidisciplinary clinic. Front Neurol. 2023;14:1090747. doi:10.3389/
fneur.2023.1090747
\11\ Davis HE, McCorkell L, Vogel JM, Topol EJ. Long COVID: major
findings, mechanisms and recommendations. Nature Reviews Microbiology.
2023/01/13 2023;doi:10.1038/s41579-022-00846-2
Health disparities
Minority populations and those experiencing economic disadvantage
have been disproportionately affected by COVID-19. \12\, \13\, \14\
These racial and ethnic disparities persist in the post-acute phase,
with African and Hispanic Americans experiencing overall higher rates
of Long COVID as well as higher rates of new-onset chronic diseases
following COVID-19 infection, including diabetes mellitus and
cardiovascular disease. \15\, \16\ Impaired health literacy in
economically disadvantaged populations impacts recognition of symptoms
and presentation to care. Furthermore, lack of coordination in Long
COVID care has been identified as a key barrier to optimizing health
outcomes, \17\ leading to increased healthcare costs and delays in care
delivery \18\. These limitations are amplified in underserved, minority
populations that have a longstanding history of poor access to
affordable, quality healthcare. \19\, \20\, \21\, \22\ I have seen this
firsthand in our Grady Long COVID clinic. Even despite our efforts to
minimize unnecessary diagnostic exams and subspecialty referrals, we
have multiple patients who could not be retained in care due to
insufficient funds for office visits and medication prescriptions.
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\12\ Millett GA, Jones AT, Benkeser D, et al. Assessing
differential impacts of COVID-19 on black communities. Ann Epidemiol.
Jul 2020;47:37-44. doi:10.1016/j.annepidem.2020.05.003
\13\ Vasquez Reyes M. The Disproportional Impact of COVID-19 on
African Americans. Health Hum Rights. Dec 2020;22(2):299-307.
\14\ DiMaggio C, Klein M, Berry C, Frangos S. Black/African
American Communities are at highest risk of COVID-19: spatial modeling
of New York City ZIP Code-level testing results. Ann Epidemiol. Nov
2020;51:7-13. doi:10.1016/j.annepidem.2020.08.012
\15\ Khullar D, Zhang Y, Zang C, et al. Racial/Ethnic Disparities
in Post-acute Sequelae of SARS--CoV-2 Infection in New York: an EHR-
Based Cohort Study from the RECOVER Program. J Gen Intern Med. Feb 16
2023:1-10. doi:10.1007/s11606-022-07997-1
\16\ Xie Y, Bowe B, Al-Aly Z. Burdens of post-acute sequelae of
COVID-19 by severity of acute infection, demographics and health
status. Nat Commun. Nov 12 2021;12(1):6571. doi:10.1038/s41467--021-
26513-3
\17\ Robinson, E. Long COVID is a Case Study of Our Fractured
Healthcare System. Content last reviewed March 2023. Agency for
Healthcare Research and Quality, Rockville, MD. https://www.ahrq.gov/
news/blog/ahrqviews/long-covid.html. Accessed 6/1/2023.
\18\ Cutler DM. The Costs of Long COVID. JAMA Health Forum. May 6
2022;3(5):e221809. doi:10.1001/jamahealthforum.2022.1809
\19\ Garcini LM, Pham TT, Ambriz AM, Lill S, Tsevat J. COVID-19
diagnostic testing among underserved Latino communities: Barriers and
facilitators. Health Soc Care Community. Sep 2022;30(5):e1907-e1916.
doi:10.1111/hsc.13621
\20\ Baker DR, Cadet K, Mani S. COVID-19 Testing and Social
Determinants of Health Among Disadvantaged Baltimore Neighborhoods: A
Community Mobile Health Clinic Outreach Model. Popul Health Manag. May
24 2021;doi:10.1089/pop.2021.0066
\21\ . Snowden LR, Graaf G. COVID-19, Social Determinants Past,
Present, and Future, and African Americans' Health. J Racial Ethn
Health Disparities. Feb 2021;8(1):12-20. doi:10.1007/s40615-020--00923-
3
\22\ Maness SB, Merrell L, Thompson EL, Griner SB, Kline N,
Wheldon C. Social Determinants of Health and Health Disparities: COVID-
19 Exposures and Mortality Among African American People in the United
States. Public Health Rep. Jan/Feb 2021;136(1):18-22. doi:10.1177/
0033354920969169
Previously healthy adults
In acute COVID-19, older adults, minorities, and those with
underlying comorbid medical conditions are at highest risk of
developing severe illness, and young previously health adults have
largely been spared. \23\ Although these remain risk factors for
development of Long COVID as well, it is important to highlight that
Long COVID, in contrast, can cause severe illness in anyone.
Concerningly, Long COVID develops even in previously healthy patients
who had mild acute COVID-19 infections, \24\ and these patients make up
a significant portion of patients presenting to Long COVID clinics.
\25\ In fact, some of the most devastating symptoms are those of
dysautonomia, which causes heart racing and dizziness with standing,
which are often seen in younger patients, \26\ and data from the CDC
suggests that those at highest risk for Long COVID may actually be
those aged 30-60 years,1 impacting our working aged adults and those of
child rearing ages.
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\23\ CDC. COVID-19:People with Certain Medical Conditions. https:/
/www.cdc.gov/coronavirus/2019--ncov/need-extra-precautions/people-with-
medical-conditions.html. Accessed 1/16/2024.
\24\ Walker TA, Truong AD, Summers A, et al. Mild antecedent
COVID-19 associated with symptom-specific post-acute sequelae. PLoS
One. 2023;18(7):e0288391. doi:10.1371/journal.pone.0288391
\25\ Vanichkachorn G, Newcomb R, Cowl CT, et al. Post-COVID-19
Syndrome (Long Haul Syndrome): Description of a Multidisciplinary
Clinic at Mayo Clinic and Characteristics of the Initial Patient
Cohort. Mayo Clin Proc. Jul 2021;96(7):1782-1791. doi:10.1016/
j.mayocp.2021.04.024
\26\ Reis Carneiro D, Rocha I, Habek M, et al. Clinical
presentation and management strategies of cardiovascular autonomic
dysfunction following a COVID-19 infection--A systematic review. Eur J
Neurol. May 2023;30(5):1528-1539. doi:10.1111/ene.15714
Limited access to care leads to increased healthcare expenses
Long COVID is a multisystemic and complex disease, which results in
extensive and cost-prohibitive clinical evaluations. Primary care
physicians are unprepared to provide this novel and labor-intensive
clinical care. Patients are often referred to multiple subspecialty
providers without answers. Lack of understanding of Long COVID among
clinicians contributes to increased testing, delays in diagnosis, and
impairment of triage to appropriate services further compounding
healthcare spending burden and barriers to access. Long haulers
continue to experience stigmatization from the community and clinicians
who do not acknowledge it as a real disease despite objective
pathobiological data establishing it as a distinct entity. \27\, \28\
This lack of awareness can lead to feelings of isolation among long
haulers and can have significant impacts on mental health in
conjunction with the psychological stress from new-onset disability.
\29\ High rates of anxiety, depression, and PTSD are observed in this
population and behavioral health services are often limited and
disconnected. \30\, \31\, \32\ Dedicated Long COVID clinics are
equipped to provide this specialty care; however, these clinics remain
rare and numbers continue to dwindle as clinics are shuttering. In the
remaining Long COVID clinics, services are saturated due to high
referral volumes.
---------------------------------------------------------------------------
\27\ List JM, Long TG. Community-Based Primary Care Management of
'Long COVID': A Center of Excellence Model at NYC Health+ Hospitals. Am
J Med. Oct 2021;134(10):1232-1235. doi:10.1016/j.amjmed.2021.05.029
\28\ Pantelic M, Ziauddeen N, Boyes M, O'Hara ME, Hastie C, Alwan
NA. Long Covid stigma: Estimating burden and validating scale in a UK-
based sample. PLoS One. 2022;17(11):e0277317. doi:10.1371/
journal.pone.0277317
\29\ Efstathiou V, Stefanou MI, Demetriou M, et al. Long COVID and
neuropsychiatric manifestations (Review). Exp Ther Med. May
2022;23(5):363. doi:10.3892/etm.2022.11290
\30\ Taquet M, Sillett R, Zhu L, et al. Neurological and
psychiatric risk trajectories after SARS-CoV-2 infection: an analysis
of 2-year retrospective cohort studies including 1 284 437 patients.
Lancet Psychiatry. Oct 2022;9(10):815-827. doi:10.1016/s2215-
0366(22)00260-7
\31\ Han Q, Zheng B, Daines L, Sheikh A. Long-Term Sequelae of
COVID-19: A Systematic Review and Meta-Analysis of One-Year Follow-Up
Studies on Post-COVID Symptoms. Pathogens. Feb 19
2022;11(2)doi:10.3390/pathogens11020269
\32\ Xie Y, Xu E, Al-Aly Z. Risks of mental health outcomes in
people with covid-19: cohort study. Bmj. Feb 16 2022;376:e068993.
doi:10.1136/bmj-2021-068993
AHRQ Long COVID Learning Community: Improving access to care
The AHRQ Long COVID Learning Community is a 5-year initiative
supporting 9 Long COVID Centers of Excellence serving geographically
and demographically diverse populations across the U.S. to provide
coordinated, person-centered care to patients and caregivers affected
by Long COVID. \33\, \34\ The infrastructure provided through these
grants supports increased clinical capacity and expansion of
multidisciplinary services. Through iterative programmatic evaluations,
this consortium seeks to optimize Long COVID clinical management and
guide healthcare policy. At each site, Long COVID teams will engage
with the community to increase community-based referrals and ensure the
needs of the population are met. Long COVID experts have designed
robust peer education series to build capacity for Long COVID care
throughout their region. We are grateful for the funding Congress
provides to support AHRQ in this initiative, and we are grateful to
AHRQ for prioritizing this important work to bridge clear gaps in Long
COVID care quality. There is great value in establishing and supporting
these Long COVID Centers of Excellence during these first 10 years, and
we request continued support of this initiative. In addition to these
centers, given the substantial prevalence of Long COVID, the permanence
of COVID-19 in our environment, and the saturation of Long COVID
clinics, it is imperative to support efforts to ensure primary care
providers are appropriately trained and are competent to provide Long
COVID care, with the ultimate goal of decentralization to ensure
sufficient care access. There are multiple networks of Long COVID
providers independent of the AHRQ Learning Community that are eager to
contribute to this capacity building effort, and we request additional
funding through AHRQ to bolster these activities, including primary
care roadshows, development of adaptable protocols that can be
implemented in community clinic settings, Project ECHO presentations,
Long COVID podcasts and webinars.
---------------------------------------------------------------------------
\33\ AHRQ. Long COVID Grant Awards. https://www.ahrq.gov/
coronavirus/long-covid-grant--awards.html. Accessed 1/16/2024.
\34\ AHRQ. AHRQ Awards $45 million in Grants to Expand Access to
Care for People with Long COVID. https://www.ahrq.gov/news/newsroom/
press-releases/long-covid-grant-awards.html. Accessed 1/16/2024.
RECOVER Initiative: A reason for hope and a reason for concern
Important steps have been taken to advance our understanding of
Long COVID. Notably, Congress's investment in the RECOVER Initiative
meta cohort has resulted in a successful demonstration of team-based
science, with enrollment of over 14,000 patients in a little over 1
year and publications of meaningful data on Long COVID definition and
phenotypes.9 The robust infrastructure and data collection from this
study well-positions investigators to define the clinical scope of Long
COVID and characterize underlying mechanisms driving symptomatology.
Meeting these objectives is critical as comprehensive understanding of
organ system involvement can guide clinical care by mitigating
unnecessary spending on diagnostic work-ups. Defining pathobiological
pathways not only serves to promote credence of disease validity, but
it also identifies biomarkers for Long COVID diagnosis and monitoring
and defines intervenable targets for drug development. However, at this
time, NHLBI anticipates concluding the cohort in May 2025, which is
insufficient time to fully characterize this complex multisystemic
disease and precludes long-term follow-up to monitor disease
trajectory. This decision does not account for the ongoing high COVID-
19 case rate, the protracted nature of Long COVID symptoms, or the
concerning evidence of immune dysregulation observed in this
population, including evidence of fatigability of T-and B-cell lineages
that may indicate impending immunodeficiency that warrants long-term
monitoring. \35\, \36\ Despite the lack of coordinated, robust COVID-19
surveillance, we can estimate from wastewater analysis that new cases
are occurring at very high levels and continuing to rise. \37\ In fact,
this may be the second largest COVID-19 surge to-date with an estimated
2 million cases per day peaking the second week of January 2024. \38\
Now is not the time to deescalate funding for Long COVID.
---------------------------------------------------------------------------
\35\ Peluso MJ, Deitchman AN, Torres L, et al. Long-term SARS-CoV-
2-specific immune and inflammatory responses in individuals recovering
from COVID-19 with and without post-acute symptoms. Cell Rep. Aug 10
2021;36(6):109518. doi:10.1016/j.celrep.2021.109518
\36\ Woodruff MC, Bonham KS, Anam FA, et al. Chronic inflammation,
neutrophil activity, and autoreactivity splits long COVID. Nature
Communications. 2023/07/14 2023;14(1):4201. doi:10.1038/s41467-023-
40012-7
\37\ CDC. National Wastewater Surveillance System (NWSS): COVID-19
Wastewater Data. https://www.cdc.gov/nwss/rv/COVID19-
currentlevels.html. Accessed 1/16/2024.
\38\ Today. The U.S. is starting 2024 in its second-largest COVID
surge ever, experts say. https://www.today.com/health/news/covid-wave-
2024-rcna132529.
A call for expansion of Long COVID clinical trials
Likewise, the RECOVER Initiative provides infrastructure for
platform clinical trials hosted through the Duke Clinical Research
Institute. These well-designed trials target evidence-based Long COVID
manifestations and offer promising drug candidates that have potential
for cure or for chronic symptom management. However, current funding
for clinical trials is largely siloed through the RECOVER mechanism,
stifling opportunities for further innovation. Given the prevalence and
functional impact of this disease, funding for clinical trials needs to
occur at a much greater scale and should not be limited to one
institution or consortium. Despite RECOVER's best effort to roll out
platform trials in parallel instead of in series, trials are launching
sequentially because, despite admirable effort, there are finite
resources for one institution to run all high-profile clinical trials
for the U.S. population. In addition, these trials are designed as
platform trials that allow multiple interventions to be trialed in
tandem; however, many of the trials are only investigating 1-2
interventions at a time. Seasoned clinical trialists and Long COVID
clinicians providing care on the ground level should have input into
the treatments trialed in this patient population.
Innovative and efficient approaches to clinical trials
Several repurposed drugs have been investigated in the management
of acute COVID-19, originating from a top-down approach to rapidly
identify therapeutic options and mitigate severe outcomes. However,
nearly 4 years from the pandemic onset, the same top-down approach has
not been prioritized for Long COVID and as a result, there remain no
effective, FDA-approved treatments. Investigating existing drugs as
therapeutic options repurposed to treat Long COVID can safely expedite
the timeline of identification, development, and time to market. I
collaborate with the CURE Drug Repurposing Collaboratory, a public-
private partnership between Critical Path Institute (C-Path) and the
U.S. Food and Drug Administration (FDA) in partnership with the
National Center for Advancing Translational Sciences (NCATS). We
propose leveraging real-world data prospectively available from Long
COVID patients and clinicians to identify promising repurposed drugs
poised for rapid translation into patient-centered clinical trials.
Real-world data, much like the CURE ID effort supported by the FDA/
NCATS: Cure.ncats.io, can capture patterns of off-label uses of
medications routinely occurring within and outside of the clinic,
providing hypothesis generation that support rapid evaluation of common
drugs in pragmatic clinical trials. \39\
---------------------------------------------------------------------------
\39\ von Delft A, Hall MD, Kwong AD, et al. Accelerating antiviral
drug discovery: lessons from COVID-19. Nat Rev Drug Discov. Jul
2023;22(7):585-603. doi:10.1038/s41573-023-00692-8
Adaptive platform clinical trials
Adaptive platform clinical trials have an innovative design that
allows for drug development expediency. This approach evaluates
multiple drugs simultaneously, often with drugs administered in
combination and with multiple drugs being compared to a single, common
control. Adaptive designs use accruing, using real-time data to
reallocate patients to drugs showing efficacy and retire drugs showing
futility. As research uncovers novel pathophysiologic insights,
treatments can be integrated seamlessly in this design. In contrast,
traditional trials use fixed treatment arms, and data are typically not
analyzed until trial completion, often years after trial initiation.
This may result in a trial design that has insufficient patient
enrollment to estimate the effect of the treatment. Advantages of
adaptive platform design include smaller number of participants,
reduced patients on placebo, reduced costs, reduced timelines, and
better inferences for regulators and researchers. These trials designs
are gaining popularity following successes such as REMAP-CAP, ANTICOV,
and ACTIV6. \40\, \41\, \42\, \43\ Furthermore, many of these trials
can be conducted remotely. Decentralized trials can enroll and complete
all study visits through telemedicine, expanding participant network
beyond institution-based recruitment. Traditional trials are
predominately limited to recruitment of subjects who seek care at large
academic institutions. In decentralized trials, participants throughout
participating states will be able to enroll, promoting recruitment of
marginalized populations with limited healthcare access as well as
those with debilitating Long COVID symptoms which limit travel to study
sites. Additionally, this model allows for a more demographically
diverse study population, promoting inclusion of populations that are
typically underrepresented in institution-based trials, such as rural
and urban populations. This approach facilitates representative
recruitment and ensures the greatest impact for those affected by this
disease.
---------------------------------------------------------------------------
\40\ Angus DC, Derde L, Al-Beidh F, et al. Effect of
Hydrocortisone on Mortality and Organ Support in Patients With Severe
COVID-19: The REMAP-CAP COVID-19 Corticosteroid Domain Randomized
Clinical Trial. Jama. Oct 6 2020;324(13):1317-1329. doi:10.1001/
jama.2020.17022
\41\ ANTICOV. https://anticov.org/ Accessed 7/30/2022
\42\ ACTIV-6: Operationalizing a decentralized, outpatient
randomized platform trial to evaluate efficacy of repurposed medicines
for COVID-19. J Clin Transl Sci. 2023;7(1):e221. doi:10.1017/
cts.2023.644
\43\ McCarthy MW, Naggie S, Boulware DR, et al. Effect of
Fluvoxamine vs Placebo on Time to Sustained Recovery in Outpatients
With Mild to Moderate COVID-19: A Randomized Clinical Trial. Jama. Jan
24 2023;329(4):296-305. doi:10.1001/jama.2022.24100
Barriers to RWD-guided adaptive platform clinical trials
This model demonstrates significant promise to provide sustainable
infrastructure that can be employed not only to identify effective
treatments for Long COVID but also can be rapidly scaled to efficiently
identifying treatments in future outbreaks of existing and emerging
infectious diseases; however, there are key barriers to timely
implementation. As mentioned previously, funding for adaptive clinical
trials in the Long COVID space is limited and primarily siloed to the
RECOVER Initiative. There is concern in scientific and patient
communities that interest in funding Long COVID research may be waning.
In addition, the novelty of these approaches can be challenging for
regulatory bodies who have limited precedence to provide guidance and
approval. I have encountered this difficulty engaging with the FDA on a
sponsor-investigator adaptive repurposed drugs trial. Despite their
many advantages and gain in popularity, regulators remain unsure of how
to interpret data from adaptive trials, impeding drug development and
approval for market. In addition, there is no FDA division specific to
Long COVID and recommendations across Long COVID studies have proven to
be disparate and inconsistent.
Summary of recommendations:
1. Expand RECOVER Initiative funding to support extension of
the observational cohort.
2. Expand funding for Long COVID adaptive platform repurposed
drug trials, independent of the RECOVER mechanism.
3. Request a report from FDA detailing protocols for
expedited Long COVID drug development and strategic planning
for support of adaptive platform clinical trials.
4. Continue funding for AHRQ Long COVID Initiatives and
expand resources for education and capacity building among
primary care providers.
5. Establish a new institute at NIH to address Long COVID,
ME/CFS, and other infection-associated chronic diseases.
______
[summary statement of tiffany walker]
Chairman Sanders, Ranking Member Cassidy, and Members of the
Committee: My name is Tiffany Walker, and I am an assistant professor
of internal medicine. The views I express today are my own and do not
necessarily reflect the views of my employer. I am honored to share my
testimony with you, and I aim to convey how imperative it is that we
continue to invest and support research defining the biological drivers
of Long COVID and the urgency to identify effective treatments.
Impact on Labor Force. We see that 15 percent of COVID-19 infected
people develop Long COVID. \1\ To provide a stark comparison, this is
commensurate to the rate of diabetes in our population. \2\ Long COVID
can significant impact a patient's quality of life and function. \3\
Long haulers are more likely to be unemployed or work reduced hours
with recent CDC data showing that over a quarter of long haulers suffer
from significant activity limitations. Disease duration remains
unknown; \4\, \5\, \6\, however, mounting evidence supports significant
overlap with infection-associated chronic illness such as ME/CFS and
dysautonomia, debilitating diseases that can last lifelong. \7\, \8\,
\9\
---------------------------------------------------------------------------
\1\ Perlis RH, Santillana M, Ognyanova K, et al. Prevalence and
Correlates of Long COVID Symptoms Among U.S. Adults. JAMA Netw Open.
Oct 3 2022;5(10):e2238804. doi:10.1001/jamanetworkopen.2022.38804
\2\ CDC. National Diabetes Statistic Report. https//www.cdc.gov/
diabetes/data/statistics--report/index.html. Accessed 1/15/2024
\3\ Huang L, Yao Q, Gu X, et al. 1-year outcomes in hospital
survivors with COVID-19: a longitudinal cohort study. Lancet. Aug 28
2021;398(10302):747-758. doi:10.1016/s0140-6736(21)01755-4
\4\ Seele J, Waterboer T, Hippchen T, et al. Persistent Symptoms
in Adult Patients 1 Year After Coronavirus Disease 2019 (COVID-19): A
Prospective Cohort Study. Clin Infect Dis. Apr 9 2022;74(7):1191-1198.
doi:10.1093/cid/ciab611
\5\ Taquet M, Dercon Q, Luciano S, Geddes JR, Husain M, Harrison
PJ. Incidence, co-occurrence, and evolution of long-COVID features: A
6-month retrospective cohort study of 273,618 survivors of COVID-19.
PLoS Med. Sep 2021;18(9):e1003773. doi:10.1371/journal.pmed.1003773
\6\ Ford ND, Slaughter D, Edwards D, et al. Long COVID and
Significant Activity Limitation Among Adults, by Age--United States,
June 1-13, 2022, to June 7-19, 2023. MMWR Morb Mortal Wkly Rep. Aug 11
2023;72(32):866-870. doi:10.15585/mmwr.mm7232a3
\7\ Thaweethai T, Jolley SE, Karlson EW, et al. Development of a
Definition of Postacute Sequelae of SARS-CoV-2 Infection. Jama. May 25
2023;doi:10.1001/jama.2023.8823
\8\ Davis HE, McCorkell L, Vogel JM, Topol EJ. Long COVID: major
findings, mechanisms and recommendations. Nature Reviews Microbiology.
2023/01/13 2023;doi:10.1038/s41579-022-00846-2
\9\ Bonilla H, Quach TC, Tiwari A, et al. Myalgic
Encephalomyelitis/Chronic Fatigue Syndrome is common in post-acute
sequelae of SARS-CoV-2 infection (PASC): Results from a post-COVID-19
multidisciplinary clinic. Front Neurol. 2023;14:1090747. doi:10.3389/
fneur.2023.1090747
Health Disparities and Health Adults. Economically disadvantaged
populations have been disproportionately affected by Long COVID, with
African and Hispanic Americans experiencing higher rates of Long COVID
and new-onset diabetes and cardiovascular disease. \10\, \11\ Lack of
coordination in Long COVID care is amplified in underserved, minority
populations that have a long-standing history of poor access to
affordable, quality healthcare. \12\, \13\, \14\, \15\ However, Long
COVID is not limited to this population. Although young previously
health adults have largely been spared from severe illness in acute
COVID-19, \16\, \17\ it is important to highlight that Long COVID can
cause severe illness in anyone. Previously healthy patients who had
mild acute COVID-19 infections make up a significant portion of
patients presenting to Long COVID clinics. \18\, \19\ In fact, CDC data
suggests that adults aged 30-60 years may be at highest risk impacting
our working aged adults and those of child rearing ages.
---------------------------------------------------------------------------
\10\ Khullar D, Zhang Y, Zang C, et al. Racial/Ethnic Disparities
in Post-acute Sequelae of SARS--CoV-2 Infection in New York: an EHR-
Based Cohort Study from the RECOVER Program. J Gen Intern Med. Feb 16
2023:1-10. doi:10.1007/s11606-022-07997-1
\11\ Xie Y, Bowe B, Al-Aly Z. Burdens of post-acute sequelae of
COVID-19 by severity of acute infection, demographics and health
status. Nat Commun. Nov 12 2021;12(1):6571. doi:10.1038/s41467--021-
26513-3
\12\ Garcini LM, Pham TT, Ambriz AM, Lill S, Tsevat J. COVID-19
diagnostic testing among underserved Latino communities: Barriers and
facilitators. Health Soc Care Community. Sep 2022;30(5):e1907-e1916.
doi:10.1111/hsc.13621
\13\ Baker DR, Cadet K, Mani S. COVID-19 Testing and Social
Determinants of Health Among Disadvantaged Baltimore Neighborhoods: A
Community Mobile Health Clinic Outreach Model. Popul Health Manag. May
24 2021;doi:10.1089/pop.2021.0066
\14\ Snowden LR, Graaf G. COVID-19, Social Determinants Past,
Present, and Future, and African Americans' Health. J Racial Ethn
Health Disparities. Feb 2021;8(1):12-20. doi:10.1007/s40615-020--00923-
3
\15\ Maness SB, Merrell L, Thompson EL, Griner SB, Kline N,
Wheldon C. Social Determinants of Health and Health Disparities: COVID-
19 Exposures and Mortality Among African American People in the United
States. Public Health Rep. Jan/Feb 2021;136(1):18-22. doi:10.1177/
0033354920969169
\16\ DiMaggio C, Klein M, Berry C, Frangos S. Black/African
American Communities are at highest risk of COVID-19: spatial modeling
of New York City ZIP Code-level testing results. Ann Epidemiol. Nov
2020;51:7-13. doi:10.1016/j.annepidem.2020.08.012
\17\ CDC. COVID-19:People with Certain Medical Conditions. https//
www.cdc.gov/coronavirus/2019--ncov/need-extra-precautions/people-with-
medical-conditions.html. Accessed 1/16/2024.
\18\ Vanichkachorn G, Newcomb R, Cowl CT, et al. Post-COVID-19
Syndrome (Long Haul Syndrome): Description of a Multidisciplinary
Clinic at Mayo Clinic and Characteristics of the Initial Patient
Cohort. Mayo Clin Proc. Jul 2021;96(7):1782-1791. doi:10.1016/
j.mayocp.2021.04.024
\19\ Walker TA, Truong AD, Summers A, et al. Mild antecedent
COVID-19 associated with symptom-specific post-acute sequelae. PLoS
One. 2023;18(7):e0288391. doi:10.1371/journal.pone.0288391
RECOVER Initiative. Congress's investment in the RECOVER Initiative
well-positions researchers to define the clinical scope of Long COVID
and characterize biological drivers of disease. This is critical as a
comprehensive understanding of organ system involvement can guide
clinical care, mitigating unnecessary spending on extensive diagnostic
work-ups. Defining biological drivers helps us identify biomarkers that
we can use to diagnose and monitor Long COVID, and it facilitates
identification of intervenable targets for drug development. However,
at this time, NHLBI anticipates concluding the cohort in May 2025. This
decision does not account for the ongoing high COVID-19 case rate, the
protracted nature of Long COVID symptoms, or concerning evidence of
potential immunodeficiency that warrants long-term monitoring. \20\,
\21\ Now is not the time to deescalate funding for Long COVID.
---------------------------------------------------------------------------
\20\ Peluso MJ, Deitchman AN, Torres L, et al. Long-term SARS-CoV-
2-specific immune and inflammatory responses in individuals recovering
from COVID-19 with and without post-acute symptoms. Cell Rep. Aug 10
2021;36(6):109518. doi:10.1016/j.celrep.2021.109518
\21\ Woodruff MC, Bonham KS, Anam FA, et al. Chronic inflammation,
neutrophil activity, and autoreactivity splits long COVID. Nature
Communications. 2023/07/14 2023;14(1):4201. doi:10.1038/s41467-023-
40012-7
Clinical Trials. Likewise, the RECOVER Initiative hosts well-
designed trials. However, current funding is largely siloed through the
RECOVER mechanism, stifling opportunities for further innovation.
Despite RECOVER's best effort, trials are launching sequentially
because there are finite resources for one institution to run all high-
profile clinical trials for the U.S. population. Trial funding needs to
occur at a much greater scale and should not be limited to one
consortium. Seasoned trialists and Long COVID experts providing care on
the ground level should have input. I propose leveraging real-world
data to capture patterns of off-label drug use to identify promising
candidates that can be rapidly deployed in adaptive platform clinical
trials. This winner-takes-all trial design expedites drug development
by using real-time data to reallocate patients to drugs showing
efficacy and retire drugs showing futility. This results in reduced
patients on placebo, reduced costs, and reduced timelines. \22\, \23\,
\24\, \25\ This model demonstrates significant promise for sustainable
infrastructure that can be rapidly scaled to efficiently identify
treatments in future outbreaks of emerging infectious diseases.
---------------------------------------------------------------------------
\22\ Angus DC, Derde L, Al-Beidh F, et al. Effect of
Hydrocortisone on Mortality and Organ Support in Patients With Severe
COVID-19: The REMAP-CAP COVID-19 Corticosteroid Domain Randomized
Clinical Trial. Jama. Oct 6 2020;324(13):1317-1329. doi:10.1001/
jama.2020.17022
\23\ ANTICOV. https//anticov.org/ Accessed 7/30/2022
\24\ ACTIV-6: Operationalizing a decentralized, outpatient
randomized platform trial to evaluate efficacy of repurposed medicines
for COVID-19. J Clin Transl Sci.
\25\ McCarthy MW, Naggie S, Boulware DR, et al. Effect of
Fluvoxamine vs Placebo on Time to Sustained Recovery in Outpatients
With Mild to Moderate COVID-19: A Randomized Clinical Trial. Jama. Jan
24 2023;329(4):296-305. doi:10.1001/jama.2022.24100
---------------------------------------------------------------------------
______
[Applause.]
The Chair. Thank you very much, Dr. Walker. October. First,
I am going to offer an apology. I have got an emergency
leadership meeting in a while, and I am going to have to run
out to, and I will give the seat here over to Senator Baldwin.
Let me start off with, which it goes without saying I think
that many of us understand that at a time when we have, a, have
a major disease which has been under discussed,
underappreciated, that while we have put some Federal funding
and some good work has been done, much more needs to be done.
To my point, that is a given. All right. But what I want to
go beyond that and instead ask all of you, starting with Dr.
Harkins, is if I am an individual with long COVID, as people in
this room are and people in another room are, the overflow
room, what--give us some optimism here.
Where do you think we can be going--are we seeing any
breakthroughs in terms of understanding the disease and in
providing, in reasonably short term, some treatments for people
who are hurting very badly right now? Dr. Harkins?
Dr. Harkins. Thank you. Well, I know we all want answers
yesterday because patients are suffering. I think looking
globally and with the studies that are going on currently in
the U.S., we are finding answers.
We are finding trends. We are clustering patients into
different subgroups. However, this is really complex and as my
colleagues have mentioned, it affects every organ system. All
different cells are involved.
Trying to come up with a one size fits all is not going to
work. And so, I think we are learning more about muscle
dysfunction and the post exertional malaise patients, for
example.
Now what we do with that information--there is actual
structural damage that occurs post exercise. So, what we do
with that information now will be critical in what can we do to
address that and improve their symptoms at the time.
Educating providers so that the patients are heard and felt
like they have a partner in this.
The Chair. Thanks. Dr. Al-Aly.
Dr. Al-Aly. We have made a lot of improvement--a lot of
progress in understanding the biology of long COVID.
We understand what happens in the brain, for example, in a
lot of patients with long COVID, low cortisol level, low
serotonin level, fusion of the neurons that actually disrupt
cognition. And neuroinflammation or inflammation in the brain
and some structural abnormalities in the brain have been
documented in people following SARS-CoV-2 infection.
Our understanding--I mean, that is really only to talk
about the brain. There is a lot of issues on the heart and
other aspects. But we have made a lot of--improvement or
progress in understanding the biology of long COVID.
Also, we don't understand quite a bit the epidemiology of
long COVID. We understand that vaccines work--reduce the risk
of long COVID. We understand that to some extent antivirals
also reduce the risk of long COVID.
We also understand that reinfection raises the risk of long
COVID. So, all of that understanding should feed in into some
optimism that we have made some progress. I think the major,
major, sort of a--we note lack of progress in clinical trials.
As I indicated, they are too slow and too small to yield
definitive answers.
Really, for the person who is hurting from long COVID, they
need that treatment yesterday. And we have--you know, while we
made progress in understanding the biology and epidemiology of
long COVID, we definitely need trials and at scale that match
the urgency of the problem.
The Chair. Dr. Madlock-Brown.
Dr. Madlock-Brown. Yes. I would like to just reiterate what
the other witnesses have said that there is a lot that we
understand about the biology. We do know that the clinical
trials have been slow.
There are some instances in which there have been issues
with some of the treatments that are recommended for long
COVID. In the early days, exercise was often recommended, even
for patients that--without testing for post exertional malaise.
There--I think there--right now we are really in a phase
where there are about, I think, 12--there are 12 trials that
are registered in clinicaltrials.gov that are working on
experimental medicines.
I think that we really need investment in this direction to
really identify treatments that are working for patients.
The Chair. Dr. Walker.
Dr. Walker. Yes. To reiterate what many of the last panel
mentioned, we have seen a lot of these patients that have
really not been validated by their primary care providers or
subspecialists.
That is because in our illness script, as physicians, when
we see a normal physical exam, we see a normal diagnostic
workup, we are left with, oh, it seems like everything is okay.
And clearly it is not.
Just to reiterate, understanding the path of biological
mechanisms not only helps us target medications. It helps us
understand the disease, but also provides credence to this
disease. We can now point to something.
This is a real disease. It cannot be refuted. There is
scientific evidence of this. And so, I think that is something
that is really exciting, that gives us hope. But again, it
gives us targets that we can use in drug trials.
The Chair. Okay. I am assuming that--my time is running
out. I am assuming that all of you believe that the Federal
Government has got to play a much more active role with
substantial sums of money for research, development, clinical
trials, etcetera. Is that correct?
Dr. Harkins. Yes.
Dr. Al-Aly. Absolutely, yes.
Dr. Madlock-Brown. Yes.
Dr. Walker. No doubt.
The Chair. Okay. All right. Senator Cassidy.
Senator Cassidy. I will defer to Senator Murkowski.
Senator Murkowski. Thank you, Mr. Chairman. Thank you,
Ranking Member. Thank you all for your testimony here today.
Dr. Harkins, I want to ask a question related to those who are
struggling with long COVID in, rural areas.
As you know, my state is pretty rural. In addition to
extraordinarily rural, we are also home to over half of our
Country's federally recognized tribes. We got about 80 percent
of our communities that are not on a road system, so access to
care is always a challenge. But you had raised that recent CDC
data marks more than 5,000 deaths from long COVID.
While long COVID death rates vary by race and ethnicity,
they were the highest among American Indians and Alaska
Natives. I would ask if you are aware of any research efforts
that have been focused specifically on American Indians, Alaska
Native population?
I appreciate that it may be that the challenge has just
been that access to that care, whether for diagnosis, for any
level of ongoing care, may have challenged it.
But if you can speak to any research efforts that you are
aware of, and then what your recommendations for ensuring that,
in just more of the marginalized populations, specifically in
our rural communities, receive the diagnosis and then the
follow on treatment with regards to long COVID?
Dr. Harkins. Yes. Thank you for your question. In New
Mexico, also very rural state with a large population of Native
American as well, we don't have a very specific trial or focus
just on our American Indian and Native Alaskan population.
I think historically maybe we have not done well with the
research on this population. I think building a better
partnership with our indigenous tribes and other tribal
communities to want to help and share and listen to their input
as to what is needed for clinical trials and other things in
their community.
I think they have to drive miles and miles and miles to
come to a center.
Senator Murkowski. Or they can't drive at all.
Dr. Harkins. Or they can't drive at all, or they don't have
money for gas. Exactly. And there is also the distrust of the
research system.
I think coming to them, going to their communities in a
partnership and maybe talking with them or getting the other
folks to--you know, at least listening, listening and
understanding what is needed and how can we encourage their
participation.
Senator Murkowski. Let me ask about the opportunities
through telehealth. You had highlighted HRSA's telehealth
technology enabled learning program initiative to help train
local providers to identify patients with long COVID, and then,
to work with the coordination. In Alaska, clearly, our
community health centers are a critical component of our health
care system.
They really played a very key role in addressing the COVID
pandemic. Can you share any examples of how Recover grantees
can use technologies in perhaps new or different ways to
advance best practices, but really to allow for increased
access to these clinical services, again, through partnerships.
Because the distances aren't going to get any closer. If
you don't have roads, to your point, the ability to fly is cost
prohibitive. So, we are talking about ongoing access and other
partnerships through perhaps telehealth and others, and our
community health centers.
Dr. Harkins. Sure. You know, through our project Echo
program, we reach many providers and trying to educate them.
But I think also we need to have access for patients to
actually visit with physicians in a multidisciplinary COVID
clinic. That is going to take a lot of the work to do.
But I think having education, broadband technology also is
an issue. Getting that to the patient's homes. But I think
setting up regional centers where potentially the primary care
provider that is in that community can be a partner in the
learning loops and then being able to understand the diagnosis
and then take that to their patient.
I think that telehealth is really going to be the answer
for educating the providers that can then bring the treatments
and recommendations to their patients in their communities that
are very rural, so that the provider is the treater, and the
patients don't have to come to the bigger, academic center.
Senator Murkowski. Thank you, Mr. Chairman.
Senator Hickenlooper. Thank you. Senator Baldwin.
Senator Baldwin. Thank you, Mr. Chairman. I want to thank
this panel of witnesses. I also want to thank the previous
panel of witnesses for coming here, for telling your stories,
and keeping this front and center.
We have to do that. With zero FDA approved medications for
people who are suffering from long COVID--we just know people
are suffering and we have to increase the sense of urgency. I
want to ask a couple of specific questions.
As several of our witnesses today have noticed, it is vital
that we continue to support research into our long COVID, to
better understand, prevent, and treat the disease. Congress has
previously allocated $1.15 billion to fund NIH research on long
COVID through a multi-pronged research network.
However, I know that NIH has received critical feedback
regarding its approach to this research, including the fear
that it may not deliver any meaningful treatments to people
suffering from long COVID.
I want to ask a couple of you to describe any concerns you
might have with the NIH Recover program and highlight the
possible opportunities for oversight and accountability within
this program so that the NIH can better respond to the needs of
patients with long COVID.
I want to add just a little bit to Dr. Harkins, you talked
about one approach to--looking at clusters since this is
multisystem. On the other hand, Dr. Al-Aly, you talked about an
institute for greater number of infection associated chronic
illnesses that have--that are complex and multi-systemic in
nature.
It is kind of like, you are taking it apart, you are
putting more together. I just want to hear a little bit more
about where you would take that. Dr. Harkins and Dr. Al-Aly.
Dr. Harkins. Thank you. I think the Recover Initiative is
really trying to gather data and follow patients and really
understand the disease.
We want to be able to do treatments, and the treatment
trials are taking a while to get going, yes. But the problem is
one treatment isn't going to be available to fix everything,
right. So, all of these patients, we need to find out, well,
what is driving the post exertional malaise? What are the
drivers for the respiratory and the cardiac complications?
Then, how can we devise research treatment plans for both
of those? Because doing one thing and then having everybody
join in, you are not going to see a result, I think. You have
to have it very clarified for your specific patient population
to see a benefit, is my feeling. That is going to take time,
unfortunately. And that is what everyone is frustrated with.
Senator Baldwin. Right.
Dr. Al-Aly. I think the major question that we need to
really solve is that why acute infection. So, we have
trivialized for centuries--for centuries we trivialize acute
infections.
Why acute infection in some cases lead to chronic disease.
I think this pandemic is telling us, it is giving us really
clues that SARS-CoV-2 infection--and most people, they do just
fine. But some people succumb to long COVID.
Then we look back in the history books, it actually
happened after the flu. It actually--you know, look at ME/CFS.
It is also thought to be driven by a viral illness. So, I think
the solution here is to try to really more deeply understand
why acute infections lead to chronic disease.
This requires really a comprehensive approach to really
understand the mechanisms of why viruses actually produce acute
infection, lead to chronic disease, understand the
epidemiology, and also dissect therapeutic pathways.
This really requires an all hands on deck situation and
really a broad, comprehensive approach, interdisciplinary
approach that should be solved, in my view, in the form of a
new institute to tackle this issue. This will not only help you
address the issue of long COVID.
It will also help us solve the puzzle of ME/CFS and all
other infection associated chronic conditions that have been
ignored for decades and help us prepare for the next pandemic.
So, one thing, one certainty in life is that we are going to be
hit with another pandemic.
We just don't know if this is going to be 5 years from now,
10 years from now, or 30 years from now. And it is important
that we learn the lessons from this virus today to really face
the rough waters of future pandemics.
We would be all in failure if we--if our children face a
future pandemic and get hit with another long something--long
virus in 2030 or something, and they don't know how to treat
it.
That would represent our collective failure. And we really,
really need to understand this now, and I think this is
really--the time is now to understand infection associated
chronic diseases.
Senator Baldwin. Thank you. I ran out of time for my
question for Dr. Walker, but maybe I will stick around and see
if we can get another round.
Senator Hickenlooper. Senator Cassidy.
Senator Baldwin. Thank you. Oh my goodness. All right, so
last year, we came together to provide $10 million in new
funding for the Agency for Healthcare Research and Qualities,
patient centered, coordinated care for those living with long
COVID, including new care models.
I was proud to work with colleagues to continue this
funding in our proposed Senate Fiscal Year 2024 bill, and I
certainly want to work with our colleagues in the House to get
this over the finish line.
But Dr. Walker, can you talk about the importance of that
AHRQ funding for long COVID and the gaps that would exist
without it?
Dr. Walker. Yes. Thank you so much for that question and
thank you so much for advocating for that funding. I think it
will be really essential in being able to expand the care that
we provide to long COVID patients.
Just to give a context, it is a multi-systemic, complex
disease and primary care physicians at this stage are
unprepared to manage this novel disease. It is an extensive
workup for these patients and labor intensive.
These patients, as you have already heard, are oftentimes
past back and forth between subspecialists because of this
multi-systemic nature. And I have heard of patients seeing 30
subspecialists before they make it to a long COVID clinic.
Yes, that is absolutely true. And so, these extensive
diagnostic workups that come with this as well is burdensome
for the patient, burdensome for the health care system, and
long COVID clinics are equipped to see these patients. The
problem with that is we are rare. Many of us are closing doors.
The clinics are dwindling. So, having the support is really
important, especially since we receive these referrals and we
become pretty saturated in our clinics to be able to see these
patients. So, this initiative is a 5-year initiative that funds
nine long COVID centers of excellence across the U.S., so it
has a demographically distributed population. And what we are
able to do with it is really expand care.
We are able to hire additional staff, care coordination
staff, so it is really a person centered, coordinated care
model. We are very interested in the patient voice and have
patient advisory committees.
We are engaging with the community and community allies so
we know what the community feels about long COVID, how we can
increase community based referrals, and that we are meeting the
needs of the community.
It also includes a component where we have an iterative
evaluation component, again, with the patient voice, so that we
can continue to improve these care models for long COVID and
then hopefully guide policy.
Then the last thing I will mention is because I mentioned
the primary care physicians and just a lack of understanding of
long COVID, there is a very robust plan in place to provide
peer education through Echo, through primary care roadshows,
through webinars, and multiple education series. So, we are
hoping to eventually decentralize the care of long COVID in the
long run.
Again, if 20 million individuals in the U.S. have long
COVID, they can't be cared for only in these long COVID
centers, yes.
Senator Marshall. Right. Chairman, thank you so much. Let
me--again, if you hear frustration, it is my voice. It is--
because one of my very closest loved one has been incapacitated
for 2 years.
We are one of those families where our loved one has seen
30 doctors. And if you can find--there are not many COVID--long
COVID clinics around. But let me add my frustration with the
NIH.
As Senator Baldwin pointed out, we gave them over $1
billion December 2020. They have been focused on, as I call it,
forming committees and praying about it. But they are focused
on risk factors and causes as opposed to diagnosis and
treatment.
I really--for Senator Sanders' team, I think we should have
NIH come in--and I am not pointing--I am pointing a finger, but
it is their processes. They are not streamlined. I think you
give somebody $1 billion, we could have some studies done on
diagnosis and treatment.
I would suggest that this Committee maybe giving this type
of money more to BARDA which seems to be more streamlined, more
focused on working with the private sector. We keep repeating
the same mistakes. We can't take 2 years just to get geared up.
I hope we come back with NIH. We talked about funding BARDA
somehow, someway. You know, at its core, long COVID is a
vascular disease. It is about immune dysfunction. It is almost
like an autoimmune reaction gone crazy, and the spiked
proteins, the pathogen. We know that.
From the doctors on the cutting edge in the private sector,
they are getting cytokine panels and coagulation workups,
plasminogen activation inhibitors, fibrin monomer dimers. There
is micro-clots going on, too small for us to see on the typical
scans that we would use.
Those are the types of things I wish we were studying to
say, well, here is normal. Here is what is happening in COVID
patients. Those types of things. Dr. Al-Aly, are you doing any
of those types of bloodwork, these cytokine panels, that type
of thing?
Dr. Al-Aly. Not in my lab, but I definitely endorse the
idea that we need to just find out, find treatments as soon as
possible. That is very, very important. The research enterprise
should be oriented to address the problems that people care
about most, which is early treatment. Definitely agree.
Senator Marshall. Right. But if you--it would be great if
in the primary care setting if there was a long COVID panel.
That is what, like a hepatitis panel, we need a long COVID
panel, and then our primary care doctors could identify this
and say, yes, indeed.
Then maybe based upon that, we decide if we are going to
use some off label drugs like Plaquenil, or maybe we are using
acyclovir because we have stirred up the Epstein-Barr virus,
that type of thing as well.
Does anybody in the panel have any experience using off
label drugs to treat this with some success? Plaquenil is what
comes to mind to me. Dr. Walker, you are kind of shaking your
head yes.
Dr. Walker. Yes. I mean, there is some evidence for
medications like low dose naltrexone that have already been
used in the ME/CFS population. There is some observational data
out of Stanford using this medication. It doesn't work for
everybody but is very beneficial for some.
I think that we need to focus not only on curative
treatments, because of course that makes sense, but as you
heard the panel say today, we just need medications that will
cause some relief of symptoms as we are trying to learn more
about this disease and find treatments for it.
Senator Marshall. Okay. Dr. Al-Aly, are you using any
medicines off label with success?
Dr. Al-Aly. [Technical problems]--endorse publicly. But
again, the way we know about what works and what doesn't is to
do trials.
Senator Marshall. Yes.
Dr. Al-Aly. I mean that is really how we know
systematically what works and what doesn't, right. Anecdotally,
there are a lot of things that people say that these things
might work, but I think we need to accelerate trials, so we
actually find out what works and what doesn't.
Senator Marshall. I am all for the longitudinal studies.
And of course those take years as opposed to days. I think that
we could even start with just some retrospective studies in the
machine learning to say, okay, what patients have been given
Plaquenil, what patients have been given acyclovir? The--which
one is it, Neurontin?
Dr. Walker. Low dose naltrexone.
Senator Marshall. Naltrexone as well. Some of those just as
see. And yes, I am all for the longitudinals, but desperate
times call for desperate measures and doctors can't be
persecuted for--you know, I use off label medicines every day,
but it seems like if you use off label medicines in COVID, you
are going to go to COVID hell and be censored. So, it is--I
don't get what the double standard is all about.
Dr. Al-Aly. Senator, we are on the same page. We actually
believe very firmly in the value of observational research to
really inform a lot of our policy discussions. But at the same
time, we also need to really accelerate the conduct of trials
so we actually definitively know what works and what doesn't.
Those are complementary approaches. And we definitely--my
lab, most of my lab really runs on observational research, and
I definitely endorse the idea that observational research can
teach us a lot.
As a matter of fact, it has taught us a lot about COVID and
long COVID in the past 4 years. Most of the--what we know is
from that line of research. So, we are on the same page.
Senator Marshall. Thank you. Mr. Chairman, I yield back.
Thank you.
Senator Hickenlooper. Thank you. First, thank you all for--
--
Senator Cassidy. Well, hang on. I haven't gone yet. Are you
going?
Senator Hickenlooper. I haven't gone yet.
Senator Cassidy. Oh, good.
[Laughter.]
Senator Cassidy. I thought you were going to wrap it up.
Senator Hickenlooper. No. I would never think such a thing.
Wouldn't even consider it, without checking to my--the co-
Chair. Thank you all for coming. I know how busy you are and
how seriously you take this.
You have been--you really brought to light a number of
different facets that haven't really been considered. I want to
ask each of you, and we will start with you, Dr. Al-Aly, do you
think there is potential of directing artificial intelligence--
I mean, we have heard so many different novel cases, sets of
symptoms in different circumstances and all the different
variables that go into the biotics of the gut, and we have all
been hearing about.
Do you think AI is a potential aid for--in diagnosis, being
able to get a faster solution to diagnosis, but then also in
terms of getting to some appropriate medications?
Dr. Al-Aly. Absolutely, yes. AI can teach us a lot about
the biology of long COVID. Why the virus, with its current
structure and evolving structure, can actually lead to chronic
damage.
You know, definitely leveraging technologies like AI to
solve this problem is really important. It can also help us
identify therapeutic pathways and can really also sift through
the trillions of data bits that are available to us in the U.S.
to help us identify patterns and potentially also treatments at
work.
Leveraging--this is an all hands on deck situation.
Leveraging technologies like AI, and actually the might of
people who really do very well and very advanced AI to help us
solve long COVID is going to be very, very important,
definitely.
Senator Hickenlooper. Anybody want to add something to
that?
Dr. Madlock-Brown. Yes. I would just like to add that AI
systems like Open AI that we see right now, those are really
successful because of the fact that we put everything on the
internet all of our business, all the time, all the time.
The problem with EHR systems is we don't have all this data
structured. We don't all have it available in one place. If I
am looking at patients in my system, I don't necessarily know
every single health center they have been to. I don't know when
they picked up their prescriptions.
I don't know all of this information. And so, in order for
observational systems to be able to leverage AI for this,
they--we need a better investment in the data and information
that is available, how it is centralized, how you are able to
track and get a comprehensive picture for patients.
Senator Hickenlooper. Absolutely. Anyone else?
Dr. Harkins. I totally agree. I mean, our systems don't
talk to each other, so we don't have all of the basic
information of what patients have tried, etcetera, so AI has
its limitations in that way. But I think that it could identify
potentially agents that many patients are using and then take
that forward for trials.
Senator Hickenlooper. Right. I think that is the great
possibility. Dr. Walker, do you want to add anything to that?
Dr. Walker. Yes. And this is somewhat adjacent to that
discussion. But similarly, FDA and NCATS already support a
platform that allows capture of repurposed drug data of what
people are using off label and physicians, and we can sort
through this data to find medications that might be helpful, to
be then deployed in randomized clinical trials. And so, not
specifically AI, but a similar use of this existing real world
data.
Senator Hickenlooper. Yes. I think it does come back to
what Dr. Madlock-Brown said in terms of N3C, you know--we got
to get all the data connected, and be able to look at, without
ever revealing a patient's name, but understanding how many
different patients have had these different symptoms, have had
these different conditions, have had micro clots, whatever the
circumstances are, and begin to analyze that more carefully.
Again, I will start with Dr. Al-Aly, do you think--we are
going to get other pandemics. There is no question. For some
reason, Congress doesn't seem willing to fund the basic
preparation for--to be prepared for that next pandemic, which
we are still working on. Well, I do believe we will get there.
But should we also be looking at considering changes in
some of the guidelines we issued for how we--transportation,
how many air changes we have in an elevator or in an airplane,
whether the new air comes in high or comes in low, buildings,
how often the air changes.
Is that--now that we are beginning to understand this type
of pandemic and knowing we will get another, shouldn't we be
considering more carefully how we build things in the future?
Dr. Al-Aly. Yes, yes. So, investment in air filtration and
ventilation, air filtration systems is going to be very, very
important. Updating building codes to actually require that is
going to be very important. Let me give you an example.
We actually earthquake proof buildings for earthquakes that
happen once every 50 years or 100 years. We invest millions of
dollars in making buildings earthquake proof or seismically
proof, right. Why can't we do the same thing to really make
sure that our buildings are proof against natural hazards like
airborne pathogens, right. So, this is very, very important.
One of the lessons that we learned from this pandemic is
that pathogens could be transmitted in the air, like SARS-CoV-2
or airborne pathogens. And one way to protect or to reduce the
chance of transmission and infection is to clean the air in
indoor buildings.
One of the pathways to do that is investment and updating
building codes to require better ventilation and air filtration
systems.
Senator Hickenlooper. I couldn't agree more. And think of
all the auxiliary, the accessory--the health benefits we would
get from those kinds of investments----
Dr. Al-Aly. There are studies demonstrating that actually
kids perform better in schools when they have better air
filtration, better ventilation systems. Like they actually
perform better in schools. That has really been done. And
again, we do the same thing for earthquakes. And in some
instances, earthquakes don't have--.
Senator Hickenlooper. With much less benefit----
Dr. Al-Aly. Absolutely, absolutely.
Senator Hickenlooper. I see all four of you nodding your
head, so I think we can say we have a consensus here in that. I
am out of time, but I will come back. Since I am now sitting in
for the Chair, I get to decide whether we keep you for a few
minutes longer. I promise to put it to use. Senator Cassidy.
Senator Cassidy. You give a man a microphone and all of a
sudden you can't control them.
[Laughter.]
Senator Cassidy. Hey, thank you all. Thank you for what you
are doing and for all of your physician colleagues and
researcher colleagues whom you represent. I really appreciate
that. So, my questions. I have got a bunch of them.
First, I just want to make the point that there has been a
lot of effort here, a lot of discussion about the NIH to do
more to hopefully develop these therapeutics as rapidly as
possible.
I will point out something which is counterproductive, and
which has been shown to be counterproductive, which is the most
frustrating thing, which is the Administration is pushing that
if there are cures with NIH money, that the Federal Government
can march in and dictate whether or not the intellectual
property is taken if they don't like the price.
That has been shown in the past to inhibit investment by
the private sector. And is very populist. It probably does well
on the campaign trail. It is going to be bad for this. And I am
just going to make that point because we have made it before,
but maybe this is the time that it will actually mean something
to people to actually promote development, as opposed to
promote a populist appeal.
Next, Dr. Harkins, a lot of conversation. Dr. Walker
mentioned Project Echo too. You are from the hometown of
Project Echo. How effective has Echo been in terms of
transmitting--what is the uptake among primary care providers
logging on to hear from you, or Dr. Walker, or whomever, as to
how to better manage these patients?
Dr. Harkins. Thank you for the question. You know, we have
over 100 participants in this particular post-COVID primary
care Echo program that we are running. I think----
Senator Cassidy. Now, participants are sites, or
participants are individual physicians?
Dr. Harkins. Individual participants, and the majority are
practitioners.
Senator Cassidy. 100 different doctors.
Dr. Harkins. 800.
Senator Cassidy. 800. I am sorry.
Dr. Harkins. Yes, 800. And so, what we are seeking are case
presentations from these patients, from the providers, but they
were uncomfortable or not knowing how to diagnose long COVID.
Is it long COVID? So, we have done case based presentations----
Senator Cassidy. I get that, but I have limited time.
Dr. Harkins. Okay. So, we have efficacy data where they
feel more comfortable. We are doing polls. They can actually
answer the questions. Now, yes, this meets a long COVID
diagnosis. Yes, this would be the next step to do.
Senator Cassidy. Dr. Walker, you had said you need to
decentralize the management of this. Are you finding these
roadshows and these Echo programs decentralizing the management
yet?
Dr. Walker. These are just being launched now as AHRQ was
just funded. I don't expect that it will be decentralized soon.
And this is a 5-year endeavor, and I expect that we will need
to have that for 5 years, if not longer.
It is a very complex disease. But during these 5 years, it
will be a very intensive capacity building effort amongst
primary care physicians within our regions.
Senator Cassidy. Sounds great. Doctor Al-Aly, let me just
ask you because this begs to be answered. I have been sitting
up here reading my PubMed.
We do know that there is different pathological mechanisms
by which it is theorized COVID would do this. In some cases, it
is immunologic dysregulation, other places, it is gut
dysbiosis, in other cases is thrombi.
But there are specific treatments for each of those. For
example, one of our witnesses said their daughter had been
given a colonoscopy, put on probiotics, which could be
irritable bowel syndrome superimposed, but nonetheless, it
worked.
I guess I am a little bit--and I know there is an answer
for this. I presume the approach is, wait a second, here we
have studies showing that thrombi are probably involved, and
here, to the degree we can separate those two, it seems to be
immunologic dysregulation, and here is something else.
It seems like there could be a therapeutic intervention,
even if not in a clinical trial, aimed on each of those. Is
that being done? If so, what are the successes of this kind of
personalized approach?
Dr. Al-Aly. This is what gives me hope, is that our
understanding of the mechanisms of long COVID has actually
improved over time. And we know that there is gut dysbiosis. We
know that there might have----
Senator Cassidy. Let me stop you though, because again, I
got limited time, and he is going to--he is now the Chairman.
But we have had some of this information for a couple of
years now, and that is time enough for people--like, for
example, the GI doc who ended up giving the patient the
probiotics and making a positive improvement.
To what degree has this information that we have had for 2
years been translated by clinicians into different approaches,
even if it is empiric?
Dr. Al-Aly. Very, very poorly. I think the broader--the
provider community don't really have a very----
Senator Cassidy. Okay, then go--get back to the long COVID
treatment centers, because we funded eight or nine of those.
And so, how are those doing implementing this information?
Dr. Al-Aly. Those are currently treating people
symptomatically, and some of them may be trying sort of may be
trying different treatments according to different mechanisms.
But I think the really the core issue here is that the only
really way, the only solid way we know treatments works is by
doing RCTs or randomized controlled trials.
Senator Cassidy. Oh, I get that totally. On the other hand,
I think--it is maybe you, Dr. Madlock-Brown, who said we could
do have the real world experience. And sometimes a RCT is
stimulated by hey, look at this. In this subset of patients,
this really seem to work, now let's check it. It isn't random
by which you come up with a random----
Dr. Al-Aly. I think a lot of the anecdotal--that anecdotal
evidence, and also the basic and mechanistic evidence, is
informing the development of clinical trial. I think the point,
though, is that the number of trials that are now currently
planned or ongoing is too small and too slow and--to really
yield a definitive answer in the time that we need them to.
Senator Cassidy. Okay. Dr. Harkins, back to you. I have
read--sitting here reading and apparently physiotherapy in some
cases helps people with pulmonary disease because it
strengthens the diaphragmatic muscle, and they can breathe
better.
But we heard in some cases exercise actually exacerbates
the underlying symptomatology. How do you as a pulmonologist
figure that out, or is that empiric too?
Dr. Harkins. Well, you have to have a conversation with
your patient, and you have to really understand what their
limitations are. There are several studies that show that
pulmonary rehab do actually help patients, certain select
patients with long COVID, with better outcomes.
I think it has to be individualized and multidisciplinary.
You have people that help you breathe better. You have people
that can help you do a little bit of activity, whether it is
resistive or etcetera, depending on what you can do at
baseline. You can't just have a one prescription fits all
patients----
Senator Cassidy. Yes. So, how do you differentiate, that is
my question. Now, how do you come up with the person for whom
gentle exercise will gradually strengthen, and gentle exercise
will otherwise further exhaust?
Dr. Harkins. Well, that is the difficult part, but it is
really in trying to get a history from my patient. What can
they physically do day to day. Is the--are they getting better?
Is this improving over time?
Maybe they are a person that could do this pulmonary rehab,
but someone that can't get out of bed because of severe post
exertional malaise because of something that the day before,
that is someone I am not going to send to general pulmonary
rehab.
Senator Cassidy. We are out of time but let me just say one
more thing. Ms. Beale, when she spoke, spoke of wishing to
speak directly to her provider and having that kind of
therapeutic relationship of being able to look someone in the
eyes, not through a zoom screen, but--and I have been there,
too. I just thank you all for being those who provide that face
to face. With that, I yield.
Senator Hickenlooper. Isn't it a spectacular to have
doctors in the U.S. Senate who actually know what they are
doing and put in the time and the effort to make that
observation.
[Applause.]
Senator Hickenlooper. I want to have--I just have one more
question. When I was young and just learning, a friend talked
me into helping him start a community health center in
Connecticut back in 1972.
We just celebrated 50 years ago. And way back then, the
vision of community health centers, and several of you touched
on this, really was interconnectivity. And we have come back to
that again and again and again, the importance of
interconnectivity.
Now, we have got to go well beyond networks of community
health centers, but into the--into larger, all-inclusive
domains. I want to talk a little bit about the research and the
interconnectivity.
Dr. Walker, the University Colorado, like Emory, has--is
one of the nine centers doing this research on long COVID. Were
awarded grant funding. How is it--how do you think it is best
going to pull all that information together between the nine
different, what do you say foci--the focuses, the nine
different campuses?
Dr. Walker. Yes, we actually had our kickoff meeting
yesterday, and it is going on today as well. And so, it was
very interesting to hear the approaches everybody is taking.
I think what was tasked to us in the grant announcement was
a pretty clear delineation of what was needed for long COVID
care, and we all agreed with it. So, our approaches are
actually quite harmonized.
There is a fair amount of unity in how we are going to
approach multidisciplinary care, addressing health disparities,
how we are going to ensure that we are including the patient
voice and community engagement.
I think that these meetings will really be able to
harmonize that. We want to collect similar information for our
programmatic evaluation so that we are able to ensure that we
are improving the quality of care in a way, again, that is
harmonized so that we can lead policy change on health care for
long COVID.
Senator Hickenlooper. Right. Anybody else want to add
anything to that in terms of how we take these efforts around
research that are regional and coalesce them?
Dr. Al-Aly. I think this really needs a quarterback. I
really--you really cannot play a game and play it well without
a quarterback, and this is what we--when we talk about an
institute to sort of--can bind or sort of integrate all of this
together to really help us move the ball forward, this is what
this is about. You know, you can have a lot of things going on,
but unless you have really a coordinated approach, you are
unlikely to move the ball really fast and really forward.
Senator Hickenlooper. Dr. Harkins.
Dr. Madlock-Brown.
Dr. Madlock-Brown. I would just say there needs to be more
sort of I think engagement of the kind of boots on the ground
research that you talked about in your initial testimony of the
people doing a lot of the work being able to direct the
research more.
I think better engagement also with patient advocates, many
of whom are scientifically trained and so they are bringing
both of those knowledge bases.
I am thinking of the patient led research collaborative,
and I think also maybe having--and then also maybe having some
meetings a few times a year where those of us who are working
on the different arms are actually getting together and talk.
This is the first time I am talking to the other three
panelists. I think we need to be more kind of aware of what we
are doing and figuring the direction out together.
Dr. Harkins. I agree. It has to be bi-directional. We have
to learn from our patients, our communities, and also the
providers in a variety of research settings and clinical
settings. But I think, moving forward, having more open
engagement and data transfer, and being very transparent with
the public as well as with the researchers, as to what is going
on and how can we move forward.
Senator Hickenlooper. All right. Well, I think you all
demonstrate that--I mean, we are going to get--we are going to
make progress on this by taking your individual curiosity and
all your coworkers on this and then careful, careful
observation. And then figuring out how to take that and
assimilate it from different groups.
Again, I can't tell you how impressed I am that every one
of you are talking about the importance of talking to patients
and then just getting more and more and more patient based in
terms of determining what the reality is but then also what the
next steps should be. So, we are a little over time, so I am
going to cut it off here. I would stay here. You know, should
take you all out and buy you lunch if they didn't have me going
to another meeting.
But really appreciate, cannot overemphasize how much I
respect your service and your willingness in such a complex,
difficult, challenging circumstance where people's lives are on
the line. You are on that line. You are out on the front line
doing the hard work, so.
We get to speak on behalf of the country, I think to a
certain extent. On behalf of the United States, we thank you.
[Applause.]
Senator Hickenlooper. So that is the end of our hearing
today. Again, can't emphasize how much we appreciate the
participation of our witnesses. Thank you so much for your
taking time and the effort.
Any Senators who wish to ask additional questions, will
have questions for the record. They will be due in 10 business
days, those questions are due February 1st at 5 p.m.
Finally, I will ask unanimous consent to enter into the
record 37 statements from stakeholder groups outlining their
priorities for addressing long COVID. Motion, ah, yes. A claim,
I guess we call that.
[The following information can be found on pages 93-183 in
Additional Material.]
Senator Hickenlooper. Anyway, this Committee stands
adjourned.
ADDITIONAL MATERIAL
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
prepared statement of alexandra yonts
Chairman Sanders, Ranking Member Cassidy, Members of the Committee
Thank you for the opportunity to submit testimony on this important
issue. I serve as the Director of the Children's National Pediatric
Post COVID Program Clinic, which is one of fewer than a dozen such
clinics nationally. Our Clinic operates within a hospital-based setting
at Children's National, a tertiary pediatric care center. Our clinic is
part of multiple outpatient pediatric networks in the metropolitan area
that spans D.C., Maryland, and Virginia, though patients from all over
the country have been referred to and seen in our clinic.
The Post COVID Program Clinic is a referral-based clinic, accepting
referrals from patients, their families, primary care providers, or
specialists who have seen the patient. Once a referral has been
received, one of our case managers calls the patient or family to
perform an intake screening to determine the patient's specific
symptoms and needs and confirm eligibility, a call that takes 25-30
minutes on average. The intake assessment is then reviewed by our Post
COVID Infectious Diseases (ID) team for eligibility criteria and to
determine which specialty providers are needed for each patient. Once
the patient is approved, our team works to schedule the patient into
one of our clinic slots. Our case managers also continue to work with
families to provide any necessary information (e.g., names of specific
providers, CPT codes) for acquiring prior authorization to be seen in
our clinic or to obtain referrals from primary care.
To be eligible for our services, patients must be under 21 years of
age, have had a known or suspected COVID-19 infection, and continue to
experience persistent symptoms beyond 30 days post-acute COVID-19. We
apply the World Health Organization (WHO) consensus definition of
pediatric Post COVID-19 Conditions to make our diagnosis. During peak
referral time in winter 2022, we had a waitlist of more than 5 months
and were strictly observing diagnosis definitions. However, as COVID-19
and Long COVID cases have decreased in the past year, we have evolved
into a broader infection-associated chronic illness clinic and have
therefore increasingly seen patients with less certain COVID-19
diagnoses.
Our multidisciplinary clinic visits last roughly two to two and a
half hours and involve multiple 30-minute ``microappointments'' with
each specialist, including ID, Physical Medicine and Rehabilitation,
Psychology, Hematology, and Gastroenterology. We conduct thorough
assessments, including physical exams, cognitive evaluations,
functional status assessments, and comprehensive laboratory
evaluations. The collaborative visit summary and recommendations are
presented by the ID provider, who is the first and last provider to see
the patient each visit and acts as the primary coordinator for the
patient's team. Notes from the patient visit are sent to the referring
and primary care physician. The patients with ongoing, disruptive
symptoms, or that require referrals to multiple external subspecialists
are recommended for follow-up, either in-person or through
telemedicine, with the Post COVID Program ID team, which is scheduled
for six to 8 weeks later.
It is important to note that during the early years of the clinic's
existence we used telemedicine to conduct multidisciplinary visits or
as a hybrid with a single offsite provider during an onsite visit.
However, the lack of reciprocity or telemedicine waivers among the two
states and D.C. in our region and beyond have restricted our ability to
provide multidisciplinary telemedicine care and longitudinal follow-up
for our patients.
Recommendations for Improving Access to Care:
1. Remove barriers to telemedicine: Allow physicians caring
for Long COVID patients to have waivers for telemedicine visits
across state lines for both initial visits and follow-up
visits. It is prohibitively expensive and time consuming to
obtain a medical license in every state that does not have a
pediatric Long COVID clinic, and it is overly burdensome for
patients and their families to travel several hours or days
just to be seen in clinic.
2. Ease state regulations for Medicaid patients: Address
obstacles faced by patients with Medicaid that are often denied
care at Long COVID clinics.
3. Provide incentives for dedicated Long COVID clinics: Offer
incentives for hospitals and medical care systems to establish
dedicated Long COVID clinics to manage the complexity and time-
intensive nature of care for these patients. For example, a
Long COVID patient may require a 60-minute visit with a
specialist, during which time the specialist would normally be
expected to see four non-Long COVID patients.
4. Educate primary care providers: Develop comprehensive
educational programs for primary care providers across Family
Medicine, Internal Medicine, Pediatrics, and medical trainees
to increase awareness of Long COVID and guide initial
management strategies. This could include screening for PEM and
dysautonomia, helping families with initial management
strategies (e.g. pacing, energy conservation, autonomic
rehabilitation), and coordination of care.
5. Implement care navigators: Introduce Long COVID-specific
care navigators to assist patients in managing the health care
system, coordinating visits, and accessing records.
6. Create a web-based clinical records repository: Develop a
centralized web-based repository for clinical records to
facilitate seamless access across multiple health care systems.
7. Address workforce shortages: Address shortages in
pediatric physical therapists and mental health professionals,
providing training for physical therapists in autonomic
rehabilitation and Long COVID-specific therapies, such as
patients with post-exertional malaise.
Separately, the lack of true treatments for Long COVID, as opposed
to the symptomatic management and rehabilitation strategies currently
employed by clinicians caring for Long COVID patients, is incredibly
frustrating and unacceptable. Accelerated interventional clinical
trials for pharmaceutical therapies for Long COVID are desperately
needed and inclusion of pediatric subjects in these trials at an early
phase should be prioritized and incentivized if possible.
In conclusion, the challenges faced by pediatric Long COVID
patients underscore the critical need for concerted efforts to improve
access to care, enhance awareness, and support health care
professionals addressing the complexities of Long COVID management. I
appreciate the opportunity to contribute to this important discussion
and am available as a resource to the Committee.
______
[Whereupon, at 12:46 p.m., the hearing was adjourned.]
[all]