[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




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        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\.
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    \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\.
---------------------------------------------------------------------------
    \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\.
---------------------------------------------------------------------------
    \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
---------------------------------------------------------------------------
                        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\.
---------------------------------------------------------------------------
    \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 
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    \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
---------------------------------------------------------------------------
                        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\.
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    \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).
---------------------------------------------------------------------------
   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.
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    \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).
---------------------------------------------------------------------------
                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.
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    \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).
---------------------------------------------------------------------------
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).
---------------------------------------------------------------------------
               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.
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    \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\
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    \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\
---------------------------------------------------------------------------
    \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:
---------------------------------------------------------------------------
    \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 
---------------------------------------------------------------------------
        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.
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    \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 
---------------------------------------------------------------------------
        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\.
---------------------------------------------------------------------------
    \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\
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    \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 
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                                 ______
                                 
    [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.]


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