[Senate Hearing 116-557]
[From the U.S. Government Publishing Office]


                                                       S. Hrg. 116-557

                                COVID-19

=======================================================================

                                HEARING

                               BEFORE THE

                              COMMITTEE ON
               HOMELAND SECURITY AND GOVERNMENTAL AFFAIRS
                          UNITED STATES SENATE

                     ONE HUNDRED SIXTEENTH CONGRESS


                             SECOND SESSION

                               ----------                              

ROUNDTABLE: ARE WE PREPARED? PROTECTING THE U.S. FROM GLOBAL PANDEMICS, 
                           FEBRUARY 12, 2020

 THE FEDERAL INTERAGENCY RESPONSE TO THE CORONAVIRUS AND PREPARING FOR 
                 FUTURE GLOBAL PANDEMICS, MARCH 5, 2020

 REMOTE ROUNDTABLE COVID-19: HOW NEW INFORMATION SHOULD DRIVE POLICY, 
                              MAY 6, 2020

   EVALUATING THE FEDERAL GOVERNMENT'S PROCUREMENT AND DISTRIBUTION 
                 STRATEGIES IN RESPONSE TO THE COVID-19
                         PANDEMIC, JUNE 9, 2020

THE ROLE OF THE STRATEGIC NATIONAL STOCKPILE IN PANDEMIC RESPONSE, JUNE 
                                24, 2020

  CBP OVERSIGHT: EXAMINING THE EVOLVING CHALLENGES FACING THE AGENCY, 
                             JUNE 25, 2020

            OVERSIGHT OF COVID-19 FINANCIAL RELIEF PACKAGES,
                             JULY 28, 2020

 EARLY OUTPATIENT TREATMENT: AN ESSENTIAL PART OF A COVID-19 SOLUTION, 
                           NOVEMBER 19, 2020

 EARLY OUTPATIENT TREATMENT: AN ESSENTIAL PART OF A COVID-19 SOLUTION, 
                       PART II, DECEMBER 8, 2020

                               ----------                              

          Available via the World Wide Web: http://govinfo.gov

                       Printed for the use of the
        Committee on Homeland Security and Governmental Affairs

[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]







                           COVID-19 VOLUME 2



                                                        S. Hrg. 116-557

                                COVID	19

=======================================================================

                                HEARING
				
			       BEFORE THE

			      COMMITTEE ON
	       HOMELAND SECURITY AND GOVERNMENTAL AFFAIRS
			  UNITED STATES SENATE

		     ONE HUNDRED SIXTEENTH CONGRESS
				
		           SECOND SESSION

                               __________

ROUNDTABLE: ARE WE PREPARED? PROTECTING THE U.S. FROM GLOBAL PANDEMICS, 
                           FEBRUARY 12, 2020

 THE FEDERAL INTERAGENCY RESPONSE TO THE CORONAVIRUS AND PREPARING FOR 
                 FUTURE GLOBAL PANDEMICS, MARCH 5, 2020

 REMOTE ROUNDTABLE COVID-19: HOW NEW INFORMATION SHOULD DRIVE POLICY, 
                              MAY 6, 2020

   EVALUATING THE FEDERAL GOVERNMENT'S PROCUREMENT AND DISTRIBUTION 
                 STRATEGIES IN RESPONSE TO THE COVID-19
                         PANDEMIC, JUNE 9, 2020

THE ROLE OF THE STRATEGIC NATIONAL STOCKPILE IN PANDEMIC RESPONSE, JUNE 
                                24, 2020

  CBP OVERSIGHT: EXAMINING THE EVOLVING CHALLENGES FACING THE AGENCY, 
                             JUNE 25, 2020

            OVERSIGHT OF COVID-19 FINANCIAL RELIEF PACKAGES,
                             JULY 28, 2020

 EARLY OUTPATIENT TREATMENT: AN ESSENTIAL PART OF A COVID-19 SOLUTION, 
                           NOVEMBER 19, 2020

 EARLY OUTPATIENT TREATMENT: AN ESSENTIAL PART OF A COVID-19 SOLUTION, 
                       PART II, DECEMBER 8, 2020

                               __________

          Available via the World Wide Web: http://govinfo.gov

                       Printed for the use of the
        Committee on Homeland Security and Governmental Affairs
        
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]

                               __________

                    U.S. GOVERNMENT PUBLISHING OFFICE                    
44-391 PDF                 WASHINGTON : 2022                     
          
-----------------------------------------------------------------------------------   

        COMMITTEE ON HOMELAND SECURITY AND GOVERNMENTAL AFFAIRS

                    RON JOHNSON, Wisconsin, Chairman
ROB PORTMAN, Ohio                    GARY C. PETERS, Michigan
RAND PAUL, Kentucky                  THOMAS R. CARPER, Delaware
JAMES LANKFORD, Oklahoma             MAGGIE HASSAN, New Hampshire
MITT ROMNEY, Utah                    KAMALA D. HARRIS, California
RICK SCOTT, Florida                  KYRSTEN SINEMA, Arizona
MICHAEL B. ENZI, Wyoming             JACKY ROSEN, Nevada
JOSH HAWLEY, Missouri

                Gabrielle D'Adamo Singer, Staff Director
            Joshua McLeod, Senior Professional Staff Member
               Charles Carroll, Professional Staff Member
             Barrett F. Percival, Professional Staff Member
               Charles Carroll, Professional Staff Member
                 Caroline K. Bender, Research Assistant
             Jessica J. McTigue, State Department Detailee
               David M. Weinberg, Minority Staff Director
               Zachary I. Schram, Minority Chief Counsel
         Alexa E. Noruk, Minority Director of Homeland Security
             Megan L. Petry, Minority Investigative Counsel
   Christopher J. Mulkins, Minority Senior Professional Staff Member
        Samuel Rodarte, Jr., Minority Professional Staff Member
                     Laura W. Kilbride, Chief Clerk
                     Thomas J. Spino, Hearing Clerk
                           
                           
                           C O N T E N T S

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Opening statements:
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    Senator Rosen 

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    Senator Hawley 

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    Senator Sinema 

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    Senator Romney 

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    Senator Lankford 

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    Senator Portman 

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    Senator Enzi.................................................  1174
    Senator Paul.................................................  1976
Prepared statements:
    Senator Johnson 

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    Senator Peters 

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    Senator Hassan...............................................  2008

                      Wednesday, February 12, 2020
                               WITNESSES

Hon. Scott Gottlieb, MD, Former Commissioner (2017-2019), of the 
  Food and Drug Administration, U.S. Department of Health and 
  Human Services.................................................     3
Julie L. Gerberding, MD, Former Director (2002-2009) of the 
  Centers for Disease Control and Prevention, U.S. Department of 
  Health and Human Services......................................     5
Luciana Borio, MD, Former Director for Medical and Biodefense 
  Preparedness (2017-2019) at the National Security Council......     7
Nikki Clowers, Managing Director, Health Care Team, U.S. 
  Government Accountability Office...............................     9
Asha M. George, DrPH, Executive Director, Bipartisan Commission 
  on Biodefense..................................................    10

                     Alphabetical List of Witnesses

Borio, Luciana MD:
    Testimony....................................................     7
    Prepared statement...........................................    48
Clowers, Nikki:
    Testimony....................................................     9
George, Asha M. DrPH:
    Testimony....................................................    10
    Prepared statement...........................................    52
Gerberding, Julie L. MD:
    Testimony....................................................     5
Gottlieb, Hon. Scott MD:
    Testimony....................................................     3
    Prepared statement...........................................    42

                                APPENDIX

Chart submitted by Julie Gerberding..............................    57
CSIS Report......................................................    58
Bipartisan Commission on Biodefense Reports......................   129

                        Thursday, March 5, 2020
                               WITNESSES

Hon. Ken Cuccinelli II, Senior Official Performing the Duties of 
  the Deputy Secretary, U.S. Department of Homeland Security.....   323
Hon. Robert Kadlec, M.D., Assistant Secretary for Preparedness 
  and Response, U.S. Department of Health and Human Services.....   325

                     Alphabetical List of Witnesses

Cuccinelli, Hon. Ken II:
    Testimony....................................................   323
    Prepared statement...........................................   364
Kadlec, Hon. Robert M.D.:
    Testimony....................................................   325
    Prepared statement...........................................   370

                                APPENDIX

HLC statement for the record.....................................   395

                         Wednesday, May 6, 2020
                               WITNESSES

Pierre Kory, MD, MPA, Critical Care Service Chief, Associate 
  Professor of Medicine, University of Wisconsin School of 
  Medicine and Public Health.....................................   402
David L. Katz, MD, MPH, President, True Health Initiative........   407
Tom Inglesby, MD, Director, Center for Health Security, Johns 
  Hopkins Bloomberg School of Public Health......................   411
Avik Roy, President, Foundation for Research on Equal Opportunity   412
John P.A. Ioannidis, MD, C.F. Rehnborg Professor in Disease 
  Prevention School of Medicine, Stanford University.............   414
Scott W. Atlas, MD, David and Joan Traitel Senior Fellow, Hoover 
  Institution, Stanford University...............................   417

                     Alphabetical List of Witnesses

Atlas, Scott W.:
    Testimony....................................................   417
    Prepared statement...........................................   479
Inglesby, Tom MD:
    Testimony....................................................   411
    Prepared statement...........................................   466
Ioannidis, John P.A.:
    Testimony....................................................   414
    Prepared statement...........................................   476
Katz, David L.:
    Testimony....................................................   407
    Prepared statement...........................................   458
Kory, Pierre:
    Testimony....................................................   402
    Prepared statement...........................................   453
Roy, Avik:
    Testimony....................................................   412
    Prepared statement...........................................   471

                                APPENDIX

Causes of Death chart............................................   483
Influenza in U.S. chart..........................................   484
States Compared Chart............................................   485
Countries compared chart.........................................   486
COVID Age Risk Calculator........................................   487
LinkedIn Article.................................................   488
MedRxiv Article..................................................   492
Roger Stein Statement............................................   494
Medium Article...................................................   558
WSJ Article......................................................   587

                         Tuesday, June 9, 2020
                               WITNESSES

Admiral Brett P. Giroir, M.D., Assistant Secretary for Health, 
  U.S. Department of Health and Human Services...................   595
Hon. Peter T. Gaynor, Administrator, Federal Emergency Management 
  Agency, U.S. Department of Homeland Security...................   597
Rear Admiral John Polowczyk, Vice Director for Logistics, Joint 
  Chiefs of Staff, U.S. Department of Defense....................   599

                     Alphabetical List of Witnesses

Gaynor, Hon. Peter T.:
    Testimony....................................................   597
    Joint prepared statement.....................................   645
Giroir, Admiral Brett P.:
    Testimony....................................................   595
    Prepared statement...........................................   634
Polowczyk, Rear Admiral John:
    Testimony....................................................   599
    Joint prepared statement.....................................   645

                                APPENDIX

Harris Letters...................................................   661
FEMA Hurricane Plan..............................................   678
Responses to post-hearing questions for the Record:
    Admiral Giroir...............................................   737
    Mr. Gaynor and Rear Admiral Polowczyk........................   751

                        Wednesday, June 24, 2020
                               WITNESSES

Julie Gerberding, M.D., Former Director, Centers for Disease 
  Control and Prevention, U.S. Department of Health and Human 
  Services.......................................................   786
Daniel M. Gerstein, Ph.D., Senior Policy Researcher, RAND 
  Corporation....................................................   788
Andrew Phelps, Director, Oregon Office of Emergency Management, 
  on behalf of the National Emergency Management Association.....   790
Gregory Burel, Former Director, Strategic National Stockpile, 
  U.S. Department of Health and Human Services...................   792

                     Alphabetical List of Witnesses

Burel, Gregory:
    Testimony....................................................   792
    Prepared statement...........................................   849
Gerberding, Julie, M.D.:
    Testimony....................................................   786
    Prepared statement...........................................   820
Gerstein, Daniel M., Ph.D.:
    Testimony....................................................   788
    Prepared statement...........................................   824
Phelps, Andrew:
    Testimony....................................................   790
    Prepared statement...........................................   842

                                APPENDIX

Portman Letter to DOD............................................   856
CSIS Report......................................................    58
Responses to post-hearing questions for the Record:
    Ms. Gerberding...............................................   859
    Mr. Gerstein.................................................   870
    Mr. Phelps...................................................   877
    Mr. Burel....................................................   884

                        Thursday, June 25, 2020
                               WITNESSES

Mark A. Morgan, Chief Operating Officer and Senior Official 
  Performing the Duties of the Commissioner, U.S. Customs and 
  Border Protection, U.S. Department of Homeland Security
    Testimony....................................................   896
    Prepared statement...........................................   928

                                APPENDIX

SW Border Apprehensions Chart....................................   940
Southwest Border Apprehensions/Asylum Claims Chart...............   941
SW Border Apprehensions Chart....................................   942
Statements submitted by Senator Harris...........................   943
Statements submitted for the Record:
    Church World Service.........................................   953
    Human Rights First...........................................   954
    Kids In Need of Defense......................................   960
    United States Conference of Catholic Bishops.................   963
Responses to post-hearing questions for the Record:
    Mr. Morgan...................................................   971

                         Tuesday, July 28, 2020
                               WITNESSES

Maya MacGuineas, President, Committee for a Responsible Federal 
  Budget.........................................................  1035
Veronique de Rugy, Ph.D., Senior Research Fellow, Mercatus 
  Center, George Mason University................................  1037
Danielle Brian, Executive Director, Project on Government 
  Oversight......................................................  1038
Hon. Neil Barofsky, Partner, Jenner & Block, LLP, and Former 
  Special Inspector General (2008-11) Troubled Asset Relief 
  Program........................................................  1040
Hon. Phil Gramm, Former U.S. Senator from the State of Texas, and 
  Visiting Scholar, American Enterprise Institute................  1042

                     Alphabetical List of Witnesses

Barofsky, Hon. Neil:
    Testimony....................................................  1040
    Prepared statement...........................................  1105
Brian, Danielle:
    Testimony....................................................  1038
    Prepared statement...........................................  1088
de Rugy, Veronique, Ph.D.:
    Testimony....................................................  1037
    Prepared statement...........................................  1083
Gramm, Hon. Phil:
    Testimony....................................................  1042
    Prepared statement...........................................  1127
MacGuineas, Maya:
    Testimony....................................................  1035
    Prepared statement...........................................  1073

                                APPENDIX

Danielle Brian attachment to testimony...........................  1130
Responses to post-hearing questions for the Record:
    Mr. Barofsky.................................................  1137

                      Thursday, November 19, 2020
                               WITNESSES

Peter A. McCullough, M.D., M.P.H., Vice Chief of Internal 
  Medicine, Baylor University Medical Center.....................  1152
Harvey A. Risch, M.D., Ph.D., Professor of Epidemiology, Yale 
  School of Public Health........................................  1154
George Fareed, M.D., Medical Director and Family Medicine 
  Specialist, Pioneers Medical Center............................  1157
Ashish K. Jha, M.D., M.P.H., Dean, School of Public Health, Brown 
  University.....................................................  1159

                     Alphabetical List of Witnesses

Fareed, George M.D.:
    Testimony....................................................  1157
    Prepared statement...........................................  1201
Jha, Ashish K., M.D., M.P.H.:
    Testimony....................................................  1159
    Prepared statement...........................................  1203
McCullough, Peter A., M.D., M.P.H.:
    Testimony....................................................  1152
    Prepared statement...........................................  1195
Risch, Harvey A., M.D., Ph.D.:
    Testimony....................................................  1154
    Prepared statement...........................................  1197

                                APPENDIX

Hatfill statement................................................  1226
Zelenko statement................................................  1259
COVID studies....................................................  1269
McCullough attachments...........................................  1580
Risch attachment.................................................  1599
Fareed's attachments.............................................  1900
Responses to post-hearing questions for the Record:
    Dr. McCullough...............................................  1901
    Dr. Risch....................................................  1944
    Dr. Fareed...................................................  1946
    Dr. Jha......................................................  1948

                       Tuesday, December 8, 2020
                               WITNESSES

Ramin Oskoui, M.D., Vice President of Medical Staff, Sibley 
  Memorial Hospital, and Chief Executive Officer, Foxhall 
  Cardiology.....................................................  1962
Jean-Jacques Rajter, M.D., Pulmonologist, Broward Health Medical 
  Center.........................................................  1964
Pierre Kory, M.D., Associate Professor of Medicine, St. Lukes 
  Aurora Medical Center..........................................  1966
Armand Balboni, M.D., Ph.D., Chief Executive Officer, Appili 
  Therapeutics, Inc..............................................  1969
Jane M. Orient, M.D., Executive Director, Association of American 
  Physicians and Surgeons........................................  1971
Jayanta Bhattacharya, M.D., Ph.D., Professor of Medicine, 
  Stanford Institute for Economic Policy Research................  1974

                     Alphabetical List of Witnesses

Balboni, Armand, M.D., Ph.D.:
    Testimony....................................................  1969
    Prepared statement...........................................  2039
Bhattacharya, Jayanta, M.D., Ph.D.:
    Testimony....................................................  1974
    Prepared statement...........................................  2043
Kory, Pierre, M.D.:
    Testimony....................................................  1966
    Prepared statement...........................................  2023
Orient, Jane M., M.D.:
    Testimony....................................................  1971
    Prepared statement...........................................  2041
Oskoui, Ramin, M.D.:
    Testimony....................................................  1962
    Prepared statement...........................................  2009
Rajter, Jean-Jacques M.D.:
    Testimony....................................................  1964
    Prepared statement...........................................  2017

                                APPENDIX

Four Pillars of Pandemic chart...................................  2047
Three stages of COVID chart......................................  2048
Statements submitted by Senator Peters...........................  2049
Kory attachments.................................................  2089
Oskoui attachments...............................................  2136
Rajter attachment................................................  2160

 
                         OVERSIGHT OF COVID-19.
                       FINANCIAL RELIEF PACKAGES

                              ----------                              


                         TUESDAY, JULY 28, 2020

                                     U.S. Senate,  
                           Committee on Homeland Security  
                                  and Governmental Affairs,
                                                    Washington, DC.
    The Committee met by videoconference, pursuant to notice, 
at 10:02 a.m., Hon. Ron Johnson, Chairman of the Committee, 
presiding.
    Present: Senators Johnson, Romney, Scott, Hawley, Peters, 
Carper, Hassan, Harris, Sinema, and Rosen.

             OPENING STATEMENT OF CHAIRMAN JOHNSON

    Chairman Johnson. Good morning. This hearing will come to 
order.
    I want to thank all of our witnesses. They have put a lot 
of time and effort into their testimony. I have read it. We 
have a star-studded cast. We have the Honorable former Senator 
Phil Gramm. We have Danielle Brian from the Project on 
Government Oversight (POGO). We have Maya MacGuineas from the 
Committee for a Responsible Federal Budget; Veronique de Rugy 
from the Mercatus Center; and then we also have the Honorable 
Neil Barofsky, who is the former Special Inspector General for 
the Troubled Asset Relief Program (SIGTARP). We are really 
looking forward to the testimony and your answering of our 
questions. But, again, I really want to thank you for taking 
the time, getting your computer ready, and your very thoughtful 
written testimony, which all of it will be included in the 
record.
    And speaking of inclusion in the record, I ask consent that 
my written statement be included.\1\ I am not hearing an 
objection, so that will happen.
---------------------------------------------------------------------------
    \1\ The prepared statement of Senator Johnson appears in the 
Appendix on page 1069.
---------------------------------------------------------------------------
    In reading through the testimony, I can certainly see that 
there is a fair amount of agreement. I really do think that 
certainly most Members of Congress by our vote at the end of 
March agreed that Congress had to act quickly; we had to act 
massively; but we knew that what we were going to pass was 
going to be far from perfect, and it was far from perfect. 
Again, I am not being overly critical. I am just saying that we 
really do need to analyze what we have done, what went well, 
what did not work so well, and what we should do fixing things 
in the future.
    A couple of examples. On Paycheck Protection Program (PPP), 
there is no doubt it helped millions of businesses survive, but 
it was really designed for an 8-week time period, a short 
crunch. There is also absolutely no doubt that a lot of 
businesses--and I do not know how many billions; nobody knows 
how many billions was provided businesses and organizations 
that truly did not need it.
    Now, there is a simple fix, by the way, moving forward in 
terms of forgiveness of those loans. To the extent that--
because PPP was not meant to guarantee people's income or grow 
income, so a simple profit test, taxable income test, to the 
extent you have taxable income, I would suggest you should pay 
that portion of the PPP loan back. If you are a nonprofit, to 
the extent that your net assets increases would be a nonprofit 
indicator that you could pay that extent of your PPP loan back 
as well.
    The $600 flat payment, again, we were really trying in the 
Coronavirus Aid, Relief, and Economic Security (CARES) Act to 
make people as whole as possible. It is nobody's fault, 
coronavirus disease 2019 (COVID-19), so we are really trying to 
be very inclusive in our financial relief to businesses, 
organizations, and individuals. Because States could not handle 
anything more complex than a flat payment, people came up with 
$600. I was certainly one of the Senators that voted against 
that, realizing it would create a huge disincentive for people 
to reengage in our economy and help us recover economically.
    The Wall Street Journal reported a study that said that 68 
percent of workers that are on unemployment actually make more 
on unemployment than they make working. That is a huge 
disincentive.
    The Congressional Budget Office (CBO) has conducted a 
study, and they said five out of six workers make more on 
unemployment than they make actually working. Even Larry 
Summers, who was an economic adviser to both President Clinton 
and President Obama, talked about the harmful effect of 
unemployment benefits as it relates to reducing unemployment. 
He said, and I quote: ``The second way government assistance 
programs contribute to long-term unemployment is by providing 
an incentive and the means not to work. Each unemployed person 
has a reservation wage, the minimum wage he or she insists upon 
before getting or accepting a job. Unemployment insurance and 
other social assistance programs increase the reservation wage, 
causing an unemployed person to remain unemployed longer.''
    I thought that was pretty good advice from Larry Summers, 
and the fact of the matter is that at the end of May, there 
were 5.4 million jobs open even though we had close to 20 
million Americans unemployed at that point in time. I certainly 
hope Congress, if they decide to do anything, will fix that 
huge disincentive for people to reengage in the workforce.
    One thing I think all of our witnesses agree on--and I 
certainly agree on this--is we need robust oversight over the 
$2.9 trillion to $3.6 trillion that we have already allocated. 
Senator Cruz, Senator Scott, and I sent a letter to States. 
Initially, only seven States responded saying that they spent 
or obligated about 31 percent of what we had provided relief 
for them. I think two more States have responded. I have not 
got the figures on that yet.
    But, during the crafting of the CARES Act, myself and 
Senator Peters worked with Inspector General (IG) Horowitz and 
tried to come up with an oversight function, an auditing 
function modeled--and certainly we are looking at the Special 
Inspector General for TARP and hoping that that would be the 
oversight function of the CARES Act. The power that be that 
negotiated this set it up not keeping it simple, not just 
having one oversight function. They ended up with three. Our 
proposal ended up being the Pandemic Response Accountability 
Committee (PRAC). It is not fully up and operational. Then we 
also have the Inspector General for Pandemic Recovery and then 
the Congressional Oversight Commission (COC). Because we have 
three of these things, none of them are fully operating, and we 
will hear witness testimony as it relates to that.
    Now, one area that the witnesses do not agree on is exactly 
how much we have already authorized. We are looking at the 
figure of about 2.9, but a couple of witnesses say it is more 
like about 3.6. They can explain that discrepancy. But what all 
the witnesses agree on from what I can tell by testimony is 
that we have at least $1 trillion of what we have already 
authorized that has not been spent or even obligated.
    My closing point is to put that into context. The $2.9 to 
$3.6 trillion represents about 13.5 to 16.8 percent of our 
economy. If we authorize another $1 trillion, that will be 
about 18.1 to 21.5 percent of our economy. If we were to 
actually agree with what Nancy Pelosi wants to do and spend 
another $3 trillion or more, that would be 27.5 to 30.8 percent 
of our economy. That is how massive our financial relief has 
already been, and I need to put that into context. I need to 
relate that to something.
    Current employment stands at 142.2 million. Prior to COVID 
it was 158.8. We have reduced employment by 16.6 million 
individuals, which is about 10.5 percent. At the lowest level, 
we have already authorized 13.5 percent; at the highest level, 
Nancy Pelosi would want us to authorize close to 31 percent of 
gross domestic product (GDP). A number of very respected 
economists from Goldman Sachs, the International Monetary Fund 
(IMF), CBO, Federal Governors are projecting somewhere between 
a 4.6 and 8 percent shrinkage in our GDP. Again, just to put 
that all into context.
    From my standpoint, before we should authorize even another 
dime, we need to conduct that oversight, and we really do need 
to consider the macroeconomics of how much we are authorizing, 
how much we are willing to spend, when we take a look at really 
what harm has been done to our economy because of COVID.
    With that, I will turn it over to Ranking Member Peters.

             OPENING STATEMENT OF SENATOR PETERS\1\

    Senator Peters. Thank you, Mr. Chairman, and thank you to 
our witnesses for being here today. We appreciate you coming 
and offering your testimony.
---------------------------------------------------------------------------
    \1\ The prepared statement of Senator Peters appear in the Appendix 
on page 1071.
---------------------------------------------------------------------------
    The United States clearly has not faced a public health 
crisis as severe and widespread as the coronavirus pandemic in 
any of our lifetimes. More than 148,000 Americans have now lost 
their lives, and across the country the virus is continuing to 
spread at an incredibly alarming rate; 65,000 new cases are 
identified each and every day.
    This virus has devastated the health and the economic well-
being of individuals, of families, of businesses all across our 
country. Tens of thousands of small businesses have been forced 
to lay off their workers and to close their doors.
    Minority-owned businesses in particular have 
disproportionately suffered. Families are struggling to pay 
their rent and mortgages and are now facing a financial cliff 
as emergency unemployment insurance (UI) is expiring. The 
jobless claims are also starting to rise again.
    Our country is clearly still struggling. The House passed 
legislation to address these problems more than 2 months ago, 
and now the Senate needs to act quickly.
    In March, Congress worked quickly to pass a bipartisan 
CARES Act to help fight this pandemic and bolster the economy. 
Unfortunately, the administration has failed to carry out 
several CARES Act programs as Congress has intended. The PPP 
provided millions of dollars to large companies, and even to 
some foreign companies with the easiest bank access. These 
funds did not go to the small companies that needed it the 
most.
    Stimulus payments meant to help families make ends meet 
were also plagued with errors. In fact, last month I released a 
report confirming that the administration sent more than $1 
billion in improper CARES payments to more than 1 million 
deceased Americans. I have worked with Senator Carper to 
advance his bipartisan bill to prevent these errors in the 
future, and we are going to continue to press to have this 
legislation signed into law.
    Now, I recognize there are challenges to distributing $2 
trillion in stimulus funds, and that is why Chairman Johnson 
and I worked closely to ensure that the CARES Act had strong 
oversight and transparency measures. These measures included 
the creation of the Pandemic Response Accountability Committee, 
a group of independent watchdogs charged with overseeing our 
government's coronavirus response. But, unfortunately, the 
administration has refused--they have refused to comply with 
these and other oversight measures as required by law.
    The administration has refused to disclose detailed 
information on the Paycheck Protection Program loan recipients.
    The administration has refused to collect or report 
detailed information on more than $1 trillion in financial 
assistance provided in the CARES Act, despite clear 
requirements by Congress that we put in the law.
    The administration's refusal to make accurate data 
available to the public undermines the ability of Congress, of 
independent watchdogs, and the American taxpayers to know how 
these funds are being spent, where they are going, to families, 
small businesses, and others who so desperately need them.
    Now, while I appreciate the expertise of today's witnesses, 
I am frustrated that the Committee is not able to hear directly 
from the administration, those officials who are actually in 
charge of these relief programs and are responsible, quite 
frankly, for blocking effective oversight right now. I hope the 
Chairman will ask the administration to answer to this 
Committee, but in the meantime, Congress must reinforce 
oversight provisions and hold this administration accountable.
    We can do that by continuing to provide desperately needed 
resources to working families and small businesses, hospitals, 
schools, and to State and local governments. We cannot leave 
Americans to fend for themselves in the midst of a dangerous 
and ongoing pandemic.
    With that, Mr. Chairman, thank you for holding this 
hearing. To our witnesses, we appreciate your testimony, and I 
look forward to it.
    Chairman Johnson. Thank you, Senator Peters.
    Our first witness will be Maya MacGuineas. Ms. MacGuineas 
is the president of the Committee for a Responsible Federal 
Budget. She currently serves on the advisory board of the Penn-
Wharton Budget Model and is a co-chair of the National Budget 
Roundtable. In addition, she is a member of the Economic 
Strategy Group at the Aspen Institute. Ms. MacGuineas.

  TESTIMONY OF MAYA MACGUINEAS,\1\ PRESIDENT, COMMITTEE FOR A 
                   RESPONSIBLE FEDERAL BUDGET

    Ms. MacGuineas. Good morning, Chairman Johnson, Ranking 
Member Peters, and Members of the Committee. Thank you for 
inviting me today and thank you for holding this hearing.
---------------------------------------------------------------------------
    \1\ The prepared statement of Ms. MacGuineas appears in the 
Appendix on page 1073.
---------------------------------------------------------------------------
    Let me start by saying that the initial COVID packages have 
been both necessary and successful. We needed to get a lot of 
money out the door fast to prevent economic collapse, and 
lawmakers acted quickly and impressively in a bipartisan 
manner. Things would have been unimaginably worse had you not 
acted.
    Now that we have had time to better assess the situation, 
we can act more deliberately, so let me touch on what we have 
done and what we should consider as we think about future 
economic packages.
    Through legislative actions to date, policymakers have 
authorized, we say, $3.6 trillion in fiscal support, which will 
have a net deficit effect of $2.4 trillion; and $2.1 trillion 
of that has been committed or disbursed so far. The support 
comes in a variety of forms, including tax breaks, direct 
payments, loans, and grants, and it is also partnered with very 
significant Federal Reserve activities of $2.2 trillion thus 
far, with support for as much as $5.8 trillion.
    The Committee for a Responsible Federal Budget is tracking 
all this through our new tool, COVID Money Tracker, and I 
encourage lawmakers, staff, and citizens to explore this tool 
because transparency is critical, particularly so when spending 
this much taxpayer money.
    The money has, for the most part, met the timely criteria 
and the three T's of timely, temporary, and targeted. But there 
is also $1.5 trillion in legislative support that has not yet 
been spent for a few main reasons. Some of that money spends 
out over time, like payroll tax delays and some of the 
unemployment insurance. There is a lack of demand for some of 
the programs like there is still $130 billion left for the PPP 
loans. Some of the money has not been allocated.
    While there is still money in the pipeline, we are also 
facing some potentially very damaging cliffs in, for instance, 
unemployment insurance and State and local government 
financing. The fact that some funds have not been released does 
not address those problems. Macroeconomic conditions also make 
it clear we are nowhere near to close to being out of the woods 
with the unemployment rate at over 11 percent in June, still 
higher than during the peak of the Great Recession.
    As policymakers consider another round of COVID relief, 
further packages should be designed both from the top down, to 
get a sense of the right size, and from the bottom up, targeted 
to the needs of people, industries, and the economy.
    Over the next 6 months, there will be a projected $750 
billion output gap. The amount needed to fill that gap, or 
whatever objective you may choose, will depend on the fiscal 
multipliers of the specific policies, which, along with your 
timeframe, should be used to guide the decisions about the size 
of a package.
    Now, looking from the bottom up, it is also critically 
important here you may want to think about things like public 
health, societal and economic needs, such as avoiding economic 
cliffs, helping schools and businesses adapt to the current 
crisis, filling in State and local budget gaps, and making sure 
that we have what we need to mitigate, contain, and reduce the 
risks associated with COVID-19. Also, you want to consider the 
direct costs, the presumed effectiveness of any policy, the 
associated risks, and opportunity costs of the choices made. It 
is not easy to come up with any perfect package.
    As we also think about the longer-term recovery issues, we 
will want to think about some of the shifts in permanent 
changes in the economy. Online learning, telehealth, supply 
chain dependencies, and building a more resilient economy all 
come to mind.
    Finally, all the needed borrowing will obviously have a 
profound consequence on the national debt, and the short-run 
borrowing is exactly what we need to be doing. In the longer 
run, the debt accumulation will have to be dealt with. 
Unfortunately, we entered this crisis already facing trillion-
dollar deficits during a period of strong economic growth, 
which was reckless. Now, the long-term fiscal outlook is even 
worse, and while the focus now must be on, first, fighting the 
pandemic and stabilizing the economy, the other challenge down 
the road of addressing the debt must not be ignored when the 
time is right.
    Thank you so much for what you have done so far. Thank you 
for holding this hearing to think about really the important 
issues of both oversight and the analysis of what we have done 
and what we should do in the future, and I look forward to the 
discussion.
    Chairman Johnson. Thank you, Maya.
    Our next witness is Dr. Veronique de Rugy. Dr. de Rugy is a 
senior research fellow at the Mercatus Center at George Mason 
University. Previously, she has served as a resident fellow at 
the American Enterprise Institute, a policy analyst at the Cato 
Institute, and a research fellow at the Atlas Economic Research 
Foundation. Dr. de Rugy.

   TESTIMONY OF VERONIQUE de RUGY, PH.D.,\1\ SENIOR RESEARCH 
        FELLOW, MERCATUS CENTER, GEORGE MASON UNIVERSITY

    Ms. de Rugy. Thank you for having me. Mr. Chairman, Ranking 
Member, and Members of the Committee, thank you for having me 
today.
---------------------------------------------------------------------------
    \1\ The prepared statement of Dr. de Rugy appears in the Appendix 
on page 1083.
---------------------------------------------------------------------------
    As Congress prepares to pass another fiscal relief package, 
it must be realistic about the real impact of Federal policies 
put in place to assist Americans through the pandemic.
    I will make three points, to be brief.
    One, the extension of Federal unemployment insurance comes 
with a high price tag and disincentive to work.
    Two, the Payroll Protection Program suffers design flaws 
sometimes counterproductive to its goal.
    Three, the overall relief packages added significantly to a 
burdensome public debt.
    Let us start. First, unemployment insurance extension. 
Extending benefits made sense in the beginning of this crisis 
to prevent severe deprivations. It more than achieved that 
goal. One study found that two-thirds of the recipients made 
more from unemployment than from working, and data showed the 
disposable income increased by 5.4 percent between February and 
May. While some cheer these results, it is not all good news. 
The negative impact of programs are well documented. Many 
studies of the much slower extension of UI benefits during the 
Great Recession find that it created incentives for workers to 
delay looking for jobs until the benefit expired. The result 
was reduced output and unemployment. The more generous the 
benefit, the bigger the negative impact and the bigger its 
impact on our national debt.
    Congress cannot ignore these realities when deciding if and 
how to renew the benefit and the bonus extension, I mean, 
because we need to be clear. We talk of either the bonus is--
that the bonus is all there is, but there is actually State 
benefits.
    Second, the Paycheck Protection Program, 99.9 percent of 
firms are small, and 81 percent of these have no employees. 
Thanks to your loophole, large hotel and restaurant chains 
became eligible.
    Two, helping the many diverse firms in different 
industries, locations, and markets requires that eligibility 
and use of funds be as flexible as possible. Also, it must be 
done with the national debt and future generations in mind. 
This balancing act is difficult, and, unfortunately, it was 
lost in the design of PPP.
    First, it was an implementation nightmare. It left many 
smaller businesses standing in line unable to get loans, but 
this outcome was predictable. Normally the Small Business 
Administration (SBA) makes about 60,000 loans totaling $30 
billion annually. Under the CARES Act, the SBA had to process 
more than ten times its annual load in just a few weeks, with 
very little guidance from Congress and many changes along the 
way.
    Second, the PPP also followed a one-size-fits-all model 
that excluded thousands of businesses such as commercial 
cleaners, home repair companies, and hair salons, all of which 
were hit hard by the pandemic.
    Third, the employee retention requirement, while it made 
sense, imposed a high cost, because it made it harder for some 
firms to survive while imposing large costs on taxpayers. Also, 
under the PPP, many larger firms got cheap loans regardless of 
their needs. The result was such a rush to get loans that 
accountability and oversight became impossible.
    Finally, data show that funds generally flow to areas where 
the pandemic effect was less severe. Firms seemed to use the 
funds to buildup savings, so Congress must keep these facts too 
in mind when designing a new relief package, because these 
trends in the way we design the programs actually we see them 
repeated over and over and over again, I mean, I want to say 
almost no matter what type of relief package you see.
    The conclusion is obvious. One trillion dollars was spent 
without much oversight. A lot of money remains to be spent, and 
while the relief funds helped many Americans, they also created 
disincentives to work while burdening future generations with 
an unprecedented amount of debt.
    In a review of the academic paper published since the Great 
Recession, Jack Salmon and I found that increases in national 
debt adversely affect economic growth. Congress must pause 
before undertaking even more spending and debt to critically 
assess the already undertaken measures.
    Thank you.
    Chairman Johnson. Thank you, Dr. de Rugy.
    Our next witness is Danielle Brian. Ms. Brian is the 
executive director of the Project on Government Oversight. 
Additionally, she is a member of the Open the Government 
Steering Committee and serves on the board of Taxpayers for 
Common Sense. Ms. Brian.

TESTIMONY OF DANIELLE BRIAN,\1\ EXECUTIVE DIRECTOR, PROJECT ON 
                      GOVERNMENT OVERSIGHT

    Ms. Brian. Chairman Johnson, Ranking Member Peters, and 
Members of the Committee, thank you for holding this important 
hearing.
---------------------------------------------------------------------------
    \1\ The prepared statement of Ms. Brian appears in the Appendix on 
page 1088.
---------------------------------------------------------------------------
    We agree that Congress did the right thing in responding to 
the crisis, but consequence of flaws in COVID relief spending 
goes beyond the squandering of taxpayer funds to the 
devastating impact on the lives and livelihoods of Americans. 
We must determine where pandemic profiteers have siphoned off 
funds, who has been left behind, and evaluate what needs to be 
fixed before it is too late. Transparency and oversight are 
crucial to this evaluation. It is only because of the hard-
fought but still inadequate disclosure of the Paycheck 
Protection Program that we know institutions with billion-
dollar endowments were given loans intended for struggling 
businesses. Even though Congress gave clear direction to 
prioritize traditionally underserved businesses, especially 
veteran-, minority-, and women-owned and rural businesses, the 
SBA failed to give this guidance to lenders. We have found 
companies owned by private equity firms being approved for a 
total of over $1 billion worth of loans and found millions in 
loans even going to Chinese State-owned companies. As Congress 
evaluates next steps, it is even more important to be concerned 
about what we do not know yet.
    In response to the lack of transparency around the relief 
programs, POGO is launching a comprehensive COVID relief 
spending tracker. We count $2.9 trillion appropriated. What 
Maya was referring to, their number was higher because they are 
including the tax cuts, but those, of course, are not 
appropriated. We have been able to track about where half of 
those have gone. However, we still cannot track whether 
agencies have distributed $1.3 trillion let alone who got them.
    But it is important that we put the relative magnitude of 
the relief programs into context and focus on the biggest 
ticket items at highest risk for fraud. For example, the 
unemployment insurance program is only about 10 percent of what 
Congress appropriated, and there is less than half the cost of 
the PPP program. But before we can declare any program 
successful or not, economists and other analysts need data that 
is not being collected, even though it is required under the 
CARES Act. This lack of transparency is a self-inflicted wound 
that Congress and the administration can and must address 
immediately.
    Each of the three COVID oversight offices that the Chairman 
referred to that Congress created face fixable challenges, but 
today I would like to focus on those facing the Pandemic 
Response Accountability Committee.
    This body of Inspectors General from across government 
faces two obstacles preventing it from obtaining the data it 
needs to detect and deter waste, fraud, and abuse across 
agencies and programs. In April, the Office of Management and 
Budget (OMB) was wrong when they told agencies the existing 
USASpending.gov infrastructure is sufficient to collect data 
Congress required about how the funds were used. For example, 
that platform does not even include any information on jobs. 
Agencies have been implementing these relief programs for 
months, but are not collecting the required data about how the 
programs are working.
    To correct this, Congress should direct OMB to rescind its 
flawed guidance and require agencies collect the data that PRAC 
needs. In May, the Treasury's General Counsel (GC) compounded 
this problem, exempting more than $1 trillion from these 
reporting requirements, including the PPP and the $500 billion 
to Treasury. Congress should clarify its intent to apply 
recipient reporting requirements to all COVID relief programs 
and should resist proposals to streamline wholesale forgiveness 
of loans as that invites wholesale fraud. I agree with you, 
Chairman. These loans should not automatically become grants, 
given what we have seen.
    Finally, Congress prohibited CARES Act aid being spent on 
company dividends, executive compensation, and stock buybacks, 
and required employee retention. Congress should repeal the 
provision that exempts Federal Reserve securities transactions 
from these conditions and should codify and enhance reporting 
requirements for them. It makes no sense these conditions apply 
only to small businesses but not large corporations. By setting 
up proper oversight and accountability, you are not only 
serving your constituents in need; you can create a model for 
future crises.
    I would like to make something clear, though. I do not want 
my testimony to be misconstrued to suggest that failures in 
implementation of these relief programs means they are not 
helping or should end. We are still in the middle of a 
pandemic, and the crisis that prompted Congress to create these 
relief funds has not abated. All of us at this hearing have the 
luxury of being able to continue to be paid for doing our jobs 
remotely, but not everyone else in this country has that 
luxury. We just have to address these lessons learned so the 
money gets to those who have been hardest hit by the pandemic. 
As always, POGO stands ready to assist you, and I am happy to 
answer your questions.
    Chairman Johnson. Thank you, Ms. Brian.
    Our next witness is Neil Barofsky. Mr. Barofsky is a 
partner at Jenner & Block. He is the former Special Inspector 
General for the Troubled Asset Relief Program of the U.S. 
Department of Treasury. Previously, he was a Federal prosecutor 
in the U.S. Attorney's Office for the Southern District of New 
York. Mr. Barofsky.

TESTIMONY OF THE HONORABLE NEIL BAROFSKY,\1\ PARTNER, JENNER & 
  BLOCK, LLP, AND FORMER SPECIAL INSPECTOR GENERAL (2008-11) 
                 TROUBLED ASSET RELIEF PROGRAM

    Mr. Barofsky. Thank you, Mr. Chairman, thank you, Ranking 
Member Peters, for inviting me to this Committee today and 
having the opportunity to address you on these oh so important 
topics to the national interest.
---------------------------------------------------------------------------
    \1\ The prepared statement of Mr. Barofsky appears in the Appendix 
on page 1105.
---------------------------------------------------------------------------
    I plan to share with you today three lessons that we 
learned at SIGTARP from the last crisis that I fear are not 
being fully learned and addressed in this one. First is the 
importance of transparency. The government's initial response 
to the last crisis was often clouded in secrecy. For example, 
hostility to transparency led to the tooth-and-nail fight to 
keep us from disclosing to taxpayers how the TARP banks used 
TARP funds. Even though we were told at every turn that the sky 
would fall and the economy would crumble if we gathered and 
disclosed such information, those warnings proved empty. There 
were only benefits when we gathered and disclosed that 
information and published those reports, such as greater 
insight into what was working and what was not, and as a result 
of our work, attempts to corrupt the process withered in the 
sunlight that we provided.
    Second, we learned that when running government programs, 
private companies will not carry out government's policy goals 
unless they are incentivized to do so. Treasury back then 
invested hundreds of billions of dollars in banks in the hopes 
that they would in turn use that money to restore lending to 
Main Street and to help struggling homeowners. But it provided 
no incentives that they do so. We warned that this was 
misguided, that banks are for-profit institutions that act 
based on economic incentives, not amorphous governmental goals. 
We were ignored and, as we later proved, the banks did not do 
as Treasury had asked.
    The third lesson is that the effectiveness of watchdogs 
depends on the degree to which you in Congress support them. 
When Federal agencies blocked SIGTARP from obtaining 
information or otherwise tried to undermine our independence, 
they were met by fierce and bipartisan support from the 
Committee Chairs, Ranking Members, and others from both parties 
who came to our defense. When a series of our recommendations 
regarding the proposed Treasury program with hundreds of 
billions of taxpayer dollars at stake were ignored, Senators 
joined hands across the aisle to cosponsor a bill to adopt 
those recommendations that was passed without a single 
dissenting vote. I believe that we were successful as an 
agency, but so much of that success was a result of the 
bipartisan congressional support we received.
    I worry that each of these three lessons have not been 
fully learned. As to transparency, with PPP in particular, 
Treasury has certainly not. It initially refused to provide any 
information regarding borrowers and, after pushback, then only 
details for those who received the most. But even these 
disclosures were riddled with errors and left unidentified the 
precise amount that they borrowed and also, more importantly, 
left out the identities of more than 4 million other 
borrowers--a gross failure in transparency.
    PPP is already a program that is highly vulnerable to 
fraud, and the refusal to disclose information throws a dark 
cloak, giving cover to fraudsters who are able to hide in its 
shadows. Similarly, lack of transparency makes it difficult to 
fully evaluate the success of the program, particularly with 
respect to the participation of women-and minority-owned 
businesses.
    As to the second lesson, Treasury again failed to include 
the necessary incentives to get lenders to advance loans to the 
underbanked and underserved women-and minority-owned 
businesses. Instead, the program's design tilts in the opposite 
direction.
    Finally, Congress needs to give the same strong bipartisan 
support to the current crop of watchdogs that it gave to me and 
SIGTARP. It feels like IGs recently have been under fire, with 
the President asserting in his CARES Act signing statement the 
right to interfere with the new Special Inspector General's 
obligation to immediately report to Congress any effort by the 
administration to obstruct its work, taking away what was for 
me and SIGTARP an incredibly important tool.
    Similarly, IGs recently have been fired or demoted 
seemingly for just doing their jobs. Congress should respond by 
enacting legislation that protects IG independence, including 
the Securing Inspector General Independence Act of 2020, a 
bipartisan bill cosponsored by Ranking Member Peters and other 
Members of this Committee, along with rules that IGs can only 
be fired for cause.
    Congress must also forcefully respond when the 
administration fails to cooperate or starts firing its 
watchdogs. The President's signing statement and his firing of 
IGs will embolden those in the administration who want to 
thwart oversight. Indeed, it was shortly after the President's 
de facto removal of former Acting Inspector General Glenn Fine 
from serving as the chief watchdog of PRAC, as has been 
discussed, that Treasury refused to acknowledge PRAC's 
jurisdiction over large portions of the CARES Act. As my co-
panelist just mentioned, while it is important that Congress 
help Treasury, force Treasury to back down, PRAC still may be 
unable to meet its reporting requirements due to actions of the 
administration. Both parties of Congress must continue to step 
up and protect the watchdogs, and I applaud the Chairman and 
Ranking Member for scheduling this hearing and taking it as an 
important step forward.
    Thank you again for the opportunity to testify today, and I 
look forward to answering any questions you may have.
    Chairman Johnson. Thank you, Mr. Barofsky. Thank you for 
your service as the SIGTARP in the past crisis.
    Our final witness is the Honorable former Senator Phil 
Gramm. He is a former U.S. Congressman and Senator from the 
State of Texas. Following his time in Congress, Mr. Gramm was 
Chairman of Union Bank of Switzerland (UBS) Investment Bank. He 
currently serves as a senior adviser to U.S. Policy Metrics and 
a visiting scholar for the American Enterprise Institute. He 
received his Ph.D. in economics from the University of Georgia, 
was a professor of economics at Texas A&M between 1967 and 
1978. Senator Gramm.

 TESTIMONY OF THE HONORABLE PHIL GRAMM,\1\ FORMER U.S. SENATOR 
    FROM THE STATE OF TEXAS, AND VISITING SCHOLAR, AMERICAN 
                      ENTERPRISE INSTITUTE

    Senator Gramm. Mr. Chairman, there has been a lot said and 
much of it very good, much of it I agree with. Let me try to 
talk about things that have not been said.
---------------------------------------------------------------------------
    \1\ The prepared statement of Senator Gramm appears in the Appendix 
on page 1127.
---------------------------------------------------------------------------
    First of all, how much money is $2.9 trillion? I spent much 
of my 25 years in Washington trying to understand what $1 
billion was. Nobody understands what $1 trillion is. But $2.9 
trillion is more than all the wages and all the salaries or all 
the workers in America in the last 4 months of 2019. It is 
enough money to give everyone who has been unemployed during 
the pandemic--and I wrote down the numbers here--$131,818.
    Now, it is so much money that, despite every effort to get 
it out the door, sending checks to dead people, making loans at 
rates unprecedented in the history of mankind, you have been 
unable to spend at least $1.2 trillion that has not been 
appropriated and much of it has not been authorized or 
committed. So that money could be reprogrammed, and I strongly 
recommend that you look at reprogramming it before borrowing 
more money to spend.
    Let me talk about that borrowing. The deficit was already 
large. We are now talking about the range of the government 
borrowing about 20 percent of GDP to fund what has already been 
spent. The Federal debt for the first time is going over 100 
percent of GDP. Should you worry about that? At low interest 
rates, record low interest rates, it is probably manageable. It 
is a burden but it is manageable. But I am not talking about 
claiming there is a wolf at the door. I am just talking about 
what would happen if things went back to normal. What would 
happen if interest rates returned to their historic norm prior 
to the financial crisis in the post-war period?
    What would happen is by the time all this money that has 
already been spent had spent out at the end of 2021, under 
those circumstances the servicing costs of this debt would be 
about $1 trillion a year. It would rival Social Security 
spending. It would create a financial hemorrhage.
    Now, the borrowing of the 20 percent of GDP so far has not 
been a problem because the private sector is not borrowing a 
whole lot of money, at least from the private financial system. 
The Federal Reserve Bank (FRB) has bought 55 cents out of every 
dollar of debt the government has issued. But you are now 
talking about a situation where you have huge financial demand 
that could affect interest rates, certainly will affect them in 
the future.
    Finally, let me say you have to take account of the fact 
that we have spent a tremendous amount of money. If we spend 
another huge amount of money, we are committing soon to have to 
make excruciatingly painful choices about defense spending, 
nondefense discretionary spending. We already faced an 
entitlement crisis. That is going to be sped up, and it is 
going to be made far more difficult. I think, look, if you are 
going to be honest with yourself, you have to recognize that if 
you are going to vote for another $1 trillion, $2 trillion, or 
$3 trillion of spending here, you are voting for a tax 
increase--not now, but soon and permanently.
    I think we need some tough decisionmaking here. It is 
always difficult in an election year with all of the pressure, 
with all the screams. But let me say there is no logic to 
paying people more not to work than to work. The fact that 
every day in the paper it reads as if it is somehow an outrage 
that we are going to pay people ordinary unemployment insurance 
rather than a premium with 70 percent of them getting more for 
not working than they ever got for working, the fact that we 
are just saying to people, ``You can take a year off and not 
pay your mortgage,'' well, look, the mortgage company, the 
bank, and the mortgage holder, they have a great incentive to 
work this out. No mortgage company wants to hold a house that 
is empty. But when you encourage people not to pay your 
mortgage, you put them in a financial hole that someday they 
are going to have to deal with.
    So much of what has been done has been harmful, and we need 
to stop doing those things, in my opinion.
    Chairman Johnson. Thanks, Senator Gramm. Let me start the 
questioning with a question for you.
    You mentioned that the Federal Reserve has been buying up 
about 55 percent of the debt that we are issuing. At some point 
in time, this party is going to be over. What does trigger 
those higher interest rates? I have always said when the United 
States fails to become--or fails to be the world's reserve 
currency and creditors start looking at the United States and 
say, ``You are a credit risk. I will loan you money, but not at 
these low rates,'' can you just describe that process and 
potentially how dangerous it is that we apparently do not have 
outside buyers for 100 percent of the debt that we are 
floating?
    Senator Gramm. Let me say that the Federal Reserve Bank 
during World War II bought 12 percent of all the government 
debt issued, which was unprecedented. The Fed obviously in 1951 
in the accords broke away from the Treasury and said they were 
not going to do it anymore because of inflation. We are buying 
debt through the Fed at rates unprecedented. The Fed is 
borrowing the money from commercial banks by paying interest on 
the excess reserves. Banks have more money loaned to the Fed 
than they have commercial credit outstanding, than they have 
demand deposits outstanding. We have never had a circumstance 
similar to this.
    Now, how long can it go on? Nobody knows the answer to 
these things because it has never really happened before. But 
it seems to me that it creates a potential instability that we 
ought to be concerned about.
    Now, how long can the low interest rates last? What has 
caused these low interest rates? One, the huge amount of 
foreign capital coming into the United States; two, massive 
thrift rates in the developing world where you have countries 
that have generated what to them are high levels of income but 
yet they have a lot of political uncertainty, so that capital 
comes to the United States.
    At some point that process is going to normalize, and when 
it does, interest rates are going to go back up. If you are 
betting you can borrow all this money and that rates are going 
to stay at historic lows, that is probably a risk you should 
not be taking.
    I believe that rates will go up, and at that point we will 
have to make some very difficult decisions. Or you will have to 
make them.
    Chairman Johnson. Right. I have always felt that economic 
growth is the No. 1 component of any solution. We have to grow 
economically in order to pay for debt or whatever. You made an 
interesting point. In order to grow economically--or two 
interesting points--we need workers. If workers are 
incentivized to stay out of the workforce, that is going to 
harm economic growth.
    Senator Gramm. Right.
    Chairman Johnson. Second, in order to have economic growth, 
private sector businesses are going to have to borrow money. If 
banks right now are loaning all the money to the Federal 
Reserve, that is going to certainly reduce the amount of money 
available to loan to the private sector. Can you speak to that 
a little bit?
    Senator Gramm. Yes, look, we have totally changed the 
nature of American banking. Banks are bigger lenders to the Fed 
than they are to American business. They hold more assets than 
the Fed, and they have outstanding demand deposits. There is 
obviously a debate going on politically about whether to turn 
post offices into banks, whether to have the Fed given 
permanent lending authority in the private sector. There is a 
tremendous change going on in American banking that alarms me 
basically because I do not see the system that we are evolving 
toward working anywhere in the world. When something does not 
work anywhere else in the world, it suggests to me it will not 
work here.
    But, look, let me tell you something else I think we need 
to be concerned about. We are now at a point where the national 
debt is bigger than GDP. If you figure we grew at 3 percent a 
year, which now would be a very good growth rate, if the cost 
of servicing the debt were 3 percent, all of the economic 
growth of the country would go to service the debt. None of the 
growth would go to the people that generated the growth.
    Clearly, when we get out of this thing, we have to grow 
this economy. The only way out of this hole is economic growth. 
That is how we paid for the Civil War, that and running big 
surpluses and burning money and prices fell dramatically 
through the end of the 19th Century as a result; or in World 
War II where basically we had very rapid growth, and we had 
significant inflation. We have done it twice, but we did it by 
doing things that the political system that now exists would 
have almost no possibility of doing.
    Chairman Johnson. Thanks, Senator Gramm.
    Mr. Barofsky, as the former SIGTARP, you obviously know 
what worked and what did not work there, and we really did try 
and model or certainly learn from your experience there as we 
created the oversight function. There was only one SIGTARP, 
right, in the last economic crisis? We did not have three 
different bodies trying to provide oversight?
    Mr. Barofsky. We did have as a sister agency the 
Congressional Oversight Panel, which was headed by now-Senator 
Warren. That was sort of our sister agency in looking over the 
TARP program.
    Chairman Johnson. OK. So you did have two. I was actually 
surprised. In the end TARP only allocated $475 billion. I had 
always heard $700 billion, and in my briefing it was 475. Do 
you think having multiple oversight agencies, having three of 
them--did two work? Is three better? Do we need three because 
this is just so massive we need more oversight capability?
    Mr. Barofsky. I think it is, but I do agree, Senator, that 
this is indeed bigger in size and scope and in the number of 
recipients for sure. But I think here, you have the two that 
are focused on the Treasury program, which parallels what we 
had in the last crisis. Then you have the PRAC, which is 
similar to something that was called the ``RAC Board,'' which 
was passed in connection with the Obama stimulus, that had 
broader, more comprehensive oversight over more programs.
    I see it as being somewhat similar, the difference being 
PRAC does have, I think, overlapping jurisdiction with the 
other two oversight bodies. But given how hobbled those 
oversight--the other two, the Special Inspector General for 
Pandemic Recovery (SIGPR) and the COC, have been, it is 
probably not a problem of too much oversight at this point. If 
anything, it is probably the opposite of not enough.
    Chairman Johnson. OK. I have been on the record saying, we 
need to do the oversight and we need to probably repurpose, 
redirect what we have not spent before we authorize more. But 
if we are going to do something, I agree with you and the other 
witnesses that we need to codify the fixes for, what went wrong 
in terms of the implementation of the current oversight.
    With that, Senator Peters.
    Senator Peters. Thank you, Mr. Chairman. Again, thank you 
to the witnesses here today for your testimony.
    Ms. Brian, a recent POGO report found companies supported 
by the Chinese Government obtained millions of dollars in SBA 
loans that were intended for our struggling small businesses. 
In fact, one of those companies was featured in the White House 
report as to why we should be imposing tariffs on Chinese 
imports, and yet this company received taxpayer money.
    My question to you is: Could the administration have 
prevented companies supported by adversaries like the Chinese 
Government from receiving taxpayer-funded loans?
    Ms. Brian. Thank you, Senator, for that question. It is 
such an important one. The way that happened was because of 
lobbying by the investment lobbying association. The American 
Investment Council lobbied Congress, so it included in the 
CARES Act provisions that waived the SBA's affiliation rule in 
order to enable companies backed by venture capital and other 
types of financing to obtain these small business loans.
    So that is what opened up access to loans for companies 
that the SBA normally would not have given loans to, including 
those that are foreign entities. But I think that is such a 
great example of the systemic problem, which is what we are 
basically seeing is powerful special interests that are 
corrupting this process, and in order to combat that, we have 
to remember that those who need the help the most are not those 
who have these armies of lobbyists that are getting their 
provisions in these laws.
    Senator Peters. What steps should the administration take 
or should we take to prevent this from happening again?
    Ms. Brian. The first thing that should happen is that we 
should not be having these ceilings. For example, Secretary 
Mnuchin said that any loan that is under $2 million will not be 
audited. That is inviting fraud for any loan that is under $2 
million, and we are already seeing a number of recipients that 
have multiple loans that are just below that threshold. One of 
the most important things is to have everyone who has received 
this money have some concern that they may be audited. I 
understand all the loans cannot be, but there needs to at least 
be an assumption that randomly they can be audited.
    Senator Peters. Yes. Audit is a pretty standard operating 
procedure (SOP) for American business, and certainly we need to 
be focused on that. I agree.
    Mr. Barofsky, I have serious concerns that PPP funds were 
misallocated in a way that left many particularly small 
minority-owned businesses without the assistance that they 
needed to stay afloat. Could you comment about how we need to 
make sure that strong transparency and accountability measures 
are absolutely essential and what more we need to do?
    Mr. Barofsky. I think that, there is a problem in even 
understanding what happened in the PPP program, and that is 
where transparency becomes so important. The disclosure of 
every single recipient and the amount that they borrowed is so 
key to that. As Ms. Brian just said, they were able to find out 
some really important information because of those limited 
public disclosures. When you release all that information to 
the public, you unleash a citizen army of nonprofits and 
journalists and concerned citizens who can provide the 
oversight that, frankly, it is just too much material for the 
existing oversight bodies alone to do, even in ideal 
circumstances. We are not in ideal circumstances. That has a 
real help to the IGs, the Department of Justice (DOJ), of 
finding ineligible borrowers and focusing resources that are 
scarce. I think that is one thing we can do.
    I think the second is the Congressional Oversight 
Commission, it needs a Chair. It is 4 months, and it still does 
not have a Chair. But I think Congress should consider 
assigning jurisdiction over the PPP to it as well. It currently 
does not have jurisdiction over that. It is more limited to 
some of the Treasury programs and the Federal Reserve, which 
have not really got off the ground. And having that extra set 
of eyes can be really helpful. Above all, learning the lessons 
that we have gotten. Law firms with millions of dollars of 
profits per partner should not have gotten PPP funds. Rich 
sports franchises should not have gotten PPP funds. We need to 
learn the lessons from the limited transparency that we have 
received and use that to better do the program, and that will 
enable better oversight and a more efficient use of resources. 
But I have to agree with Ms. Brian. The fact that there are 
problems with the program does not mean that it should not be 
continued, and particularly in many ways, not to continue it 
means that all that money that went to these businesses that 
kept them alive for a couple of months--as noted earlier, it is 
8 weeks of support, really. If you pull the rug out from under 
them now and do not give them another round of support, that 
money will have all gone in the garbage, and those businesses 
will fail, and we will be right back to square one.
    Senator Peters. I am glad you highlighted just the limited 
amount of information that we have, although that has raised a 
whole host of questions and concerns. Unfortunately, a lot of 
the data continues to remain incomplete when it comes to PPP. 
It is filled with all sorts of errors as well.
    My follow-up question to you, Mr. Barofsky, is: Do you 
believe that the problem is due to the inability to actually 
produce accurate data? Or do you think it is a lack of 
commitment and direction from the administration?
    Mr. Barofsky. I think it is clearly a lack of dedication of 
resources. We put a man on--I do not know if that came through. 
I think it is a lack of dedication of resources. We put a man 
on the Moon. We can put out data that is sight-checked and 
accurate. This is an effort that should have started on day 
one. As soon as they started making these loans, they should 
have been preparing for the public disclosure.
    Now, look, Netflix is able to keep track of all of its 
millions and millions of accounts and put out information. 
Businesses do this every day. The government is more than 
capable. The Internal Revenue Service (IRS) handles massive 
amounts of data and gets it right.
    So this is just a lack of planning, a lack of commitment, 
and if they cannot do it right, then they need to go get a 
vendor who can. But there is no--look, I think that, what we 
learned from the last crisis is that whenever the government 
puts up objections to being more transparent, it is usually 
because they are hiding information that they do not want to be 
made public, either because it is inconvenient politically or 
shows incompetence or undermines goals. But excuses like, ``We 
cannot put out data,'' or, ``This discloses private 
information,'' those should be recognized for what they are: 
excuses to cover something up. This information has to be 
disclosed.
    Senator Peters. Absolutely. Ms. Brian, the Chairman and I 
actually included language in the CARES Act to require PPP loan 
participants to support the actual number of jobs that are 
supported or were created. The administration has refused to 
collect this information, so why is this so important? And 
should the administration start doing something immediately? 
Could you talk to us about that?
    Ms. Brian. Yes, absolutely. In terms of the broader what 
should the administration be doing, they should be releasing 
the information, as Mr. Barofsky is saying. It has simply been 
giving excuses. For example, the data that we got on the PPP 
program was very hard fought. The whole community both of 
Inspectors General and civil society and journalists have been 
suing essentially to get this information, even though previous 
laws, the Digital Accountability and Transparency Act (DATA), 
the Federal Funding Accountability and Transparency Act 
(FFATA), and Freedom of Information Act (FOIA), have all 
required that all of this data about loans be available--for 
decades it has been available. It is a totally fallacious 
argument that it is private information or proprietary.
    As I mentioned in my oral statement, I think immediately 
the administration does not need Congress to just rescind the 
OMB guidance that is essentially telling the agencies not to 
collect the recipient data. I mean, that is the foundational 
problem. The data that we are looking at that is sort of coming 
up piecemeal on jobs is deeply flawed data. All that is is the 
data when people applied for loans, and they gave an 
application and said, ``I will use this toward this many 
employees.'' It is not what they actually did. Yesterday the 
U.S. Attorney in Miami just announced that they hired someone 
who bought a Lamborghini with his PPP loan. He promised to keep 
a number of employees on his payroll, so that is the kind of 
data that we are looking at rather than buying the Lamborghini. 
We need the real data being collected, and the administration 
at the moment is refusing to do that.
    Senator Peters. Thank you very much. I appreciate it.
    Chairman Johnson. Thank you, Senator Peters.
    I just have to take this opportunity. I completely support 
100 percent disclosure. The application said it was going to be 
disclosed. It should be disclosed.
    I also want to point out that from my standpoint, we should 
limit forgiveness. PPP is not meant to guarantee or increase 
profitability to the extent that a business has profits, pre-
tax profit, they ought to pay that portion of the loan back. I 
know there is an effort--I think people are trying to insert in 
the next package automatic loan forgiveness for any loan under 
$150,000. I think that also would be disastrous. I hope, one of 
the results of this Committee hearing will make sure that that 
does not happen, that we get full disclosure.
    With that, Senator Romney.
    [No response.]
    Chairman Johnson. Is Senator Romney there?
    [No response.]
    Why do we not we go to Senator Hassan if she is available?
    [No response.]
    Senator Carper? I will just go down the list.
    Senator Peters. Senator Hassan is there.
    Chairman Johnson. Senator Hassan.
    I do not see Senator Hassan. We will go to Senator Carper 
because--oh, here is Senator Romney. Senator Romney, are you 
ready to go?
    [No response.]
    Senator Peters. Senator Hassan is there, Mr. Chairman. Her 
microphone is not on or we are not hearing her, is the only 
problem. I see her visually. She is trying to talk.
    Chairman Johnson. It is unfortunate because this has 
generally worked very well up until this point. I see Senator 
Romney there, too. Senator Romney, can you hear us?
    [No response.]
    I am going to go with Senator Carper then.

              OPENING STATEMENT OF SENATOR CARPER

    Senator Carper. Senator Carper is willing to go forward.
    Chairman Johnson. OK. Go ahead, and we will try and get the 
other folks working. Go ahead, Senator Carper.
    Senator Carper. I want to thank Senator Romney and Senator 
Hassan for yielding their time to me. I now have 21 minutes. It 
should be almost enough.
    To our guests, welcome abroad. Maya, always great to see 
you. Neil, welcome. Danielle. Phil. Phil Gramm and I served 
together in the House for at least 10 years, and 10 of the most 
informative years of my life. Phil, great to see you again, and 
thank you all. This is a great hearing. I am so happy that we 
could have it and am grateful to everyone for participating.
    When I was new in the Senate, among the Senators I did not 
now well was Ted Kennedy. I arranged to have coffee at all the 
Senators I did not know well from my days as Governor or in the 
House. One of the last people I finally got to have a cup of 
coffee with--actually, lunch with him was Ted Kennedy. I asked 
him at lunch, I said, ``Why is it always Republican Senators 
wanting you to be the lead sponsor on their big bills? Why is 
that?'' And he said--I will never forget what he said. He said, 
``I am always willing to compromise on principle, but never on 
programs.'' That is what he said: ``I am always willing to 
compromise''--``never willing to compromise on principle, 
always willing to compromise on programs.''
    I am going to ask our witnesses, just to start off, we will 
start with Maya, where do you think we should be in agreement 
on principle? What are the major two of three principles that 
we ought to be in agreement on before we figure out the 
particulars? Maya, would you just get at a couple of those 
principles, please?
    Ms. MacGuineas. Sure. Thank you so much, Senator Carper, 
and the world of Zoom is getting old for all of us, isn't it? I 
hope that my WiFi is working well enough.
    I think the principles--there are a number of principles in 
terms of navigating this, and I think the first one I would 
start with is that the first thing that we can do, the first 
and most important thing we can do both for the pandemic and 
the economy is focus on getting control of this virus. A 
productive investment dollar in fighting the pandemic or 
figuring out how to make it less damaging to all of us is the 
best thing we can do for the economy.
    The second thing in terms of principles is stick with the 
three T's of timely, temporary, and targeted. As I mentioned, I 
thought we did an excellent job of focusing on timely and 
getting the dollars out the door fast. I was so impressed with 
the witnesses who focused it on oversight, much of their advice 
that they gave, and I really agree with it. I think more 
oversight, more accountability, and using that to better target 
future measures is critically important. So that would be my 
second principle, which is stick with those three T's.
    Senator Carper. OK.
    Ms. MacGuineas. And the third is that a number of people 
brought up the fiscal challenges. We cannot ignore those once 
we get through these first two issues.
    Senator Carper. All right. Thank you so much.
    Ms. MacGuineas. Thank you.
    Senator Carper. Let us see. Danielle.
    Ms. Brian. Hi. Thank you, Senator Carper. I would agree 
with Maya. The first principle is we are still in a pandemic, 
and so it is a secondary--we are not going to be able to get to 
fixing the economy until we have actually dealt with the fact 
that many people are home because they cannot go to work, 
either they have child care problems or they have family people 
who they are afraid of getting sick.
    But the second thing that I think is essential is making 
sure that the money is actually going to those people in 
communities that are hit by the pandemic rather than the 
outrages that--I could spend my entire time talking to you 
about the outrages of, the Cleveland Clinic got a grant, and 
they had so much in reserves, they got $1 billion in interest 
last year on their reserves. These are the kinds of money that 
the government should be clawing back so it can go to those who 
really need it.
    Senator Carper. Thanks. Neil, principles?
    Mr. Barofsky. Principles. We need to help people. I think 
that sometimes it gets lost in all of these numbers, but I 
think that is the last crisis. I think that where we failed in 
the TARP program was we took the eye off of the millions of 
people who were being thrown out of their homes left and right. 
And as the Chairman noted, we left hundreds of billions of 
dollars on the table that could have been used to help those 
people. And when you help people, you help not just them. You 
help their neighbors, you help their communities, you help tax 
bases. You help the overall economy. One of the reasons our 
economy was so sluggish, I think, in the recovery last time, 
was because in the heat of the crisis we did not do enough to 
help people. And so I think to me just keeping our eye that we 
are on a pandemic, that people are suffering through no fault 
of their own, is such an important principle.
    I guess the second one I will say is, remembering that you 
have these watchdogs and supporting them and backing them up. 
Senator, we so appreciated your support at SIGTARP because, 
look, Republican administrations sometimes are not good on 
oversight, and neither are necessarily the ones on the 
Democrats. The fact that Democratic Senators supported us when 
we got into the occasional tussle with the Obama Administration 
is why we had effective oversight. Thank you, and I think 
oversight should always be bipartisan, and it is always in the 
interest of the American people to get to the bottom of issues 
and get the money out. I think those are two of the most 
important ones.
    Senator Carper. One of my Republican friends likes to say, 
``Bipartisan solutions are lasting solutions.''
    ``Bipartisan oversight is effective oversight.'' I would 
add that.
    OK, Dr. de Rugy, same question. Principles?
    Ms. de Rugy. Yes. Senator Carper, you probably do not 
remember me, but I remember you extremely well because the 
first time ever I testified before Congress, I was testifying 
before you on SBA issues with Senator Cotton. Of course, it was 
such a landmark in my life, I remember you really well. You 
were great. Much better than mine. [Laughter.]
    I agree with what Maya said. I also agree with Neil. I am 
in agreement with so far a lot of what has been said. I think 
it is a mistake often--we should focus on individuals rather 
than companies. We should focus on easy, flexible, universal 
type of measures during an emergency like this. Oversight is 
extremely important. But I think also--and the national debt 
obviously, I think, is an extreme concern, even though there is 
really actually a role for increasing the deficit during 
catastrophic times like today. I will say I wish we were more 
realistic about the ability of Congress to actually follow 
these principles. I think if we have learned anything from 
oversight, it is that we--you hold oversight hearings, I mean, 
how many every year? I do not know, but many. Many lessons 
should be learned. The testimony from what we should have 
learned from TARP is very clear, and it is not the first time I 
hear things like this.
    Senator Carper. Dr. de Rugy?
    Ms. de Rugy. Yes?
    Senator Carper. I do not mean to be rude, but if we are 
going to let Phil Gramm have any time here----
    Ms. de Rugy. Sure. But we need to be realistic.
    Senator Carper. Thank you for all of that.
    My friend?.
    Senator Gramm. Go ahead. The Chairman is not going to cut 
me off. [Laughter.]
    Listen, there are only two guys on that Committee that I 
served with, and you are one of them.
    Senator Carper. Oh, there you go.
    Senator Gramm. I enjoyed working with you on the Banking 
Committee.
    Senator Carper. It was good.
    Senator Gramm. Look, let me--principles. If I thought that 
spending more money on research related to the virus would get 
us out of this mess quicker, there are very little limits to 
what I would spend. But I would have to say in all honesty that 
we have already committed more money than has ever been 
committed to medical research on any project in the history of 
mankind, and it is going to pay off big for us. So it is not 
that dealing with the virus is not the be-all and end-all. My 
guess is that we have dealt with it and any money spent now 
would probably be wasted.
    I think it is important to note that there are $100 billion 
in PPP that we are offering to give people, and nobody is 
taking it. I think it is important to note that the thrift rate 
is at the highest level in the post-war era. People are saving 
more money than they have in the entire post-war period. I 
think it is very important to note that bank accounts are at 
massively inflated levels.
    So the point I am making is it is always tempting, it 
always makes you feel good and righteous--and it should--that 
we want to help people. But the truth is we have spent a 
massive amount of money, and the bill is yet to really come 
due. People will take whatever you give them. The PPP thing, 
very difficult to understand. But it will not be there forever, 
I can assure you.
    I would be very careful. I guess I believe that we would be 
blessed if we did not see another bill pass here and we simply 
went back and reprogrammed some of the $1.2 trillion. I am not 
sure we need to spend all of that either. In any case, those 
are the principles I think that are important.
    Senator Carper. Good. Thank you.
    May I say, Mr. Chairman, this is a great hearing, and I 
look forward to following up with each of our witnesses, my 
staff and I, and in pursuit of what you said, there is lots of 
work to do here, and we need to do it right away. Thank you all 
so much. Thanks for your appearance and your time.
    Chairman Johnson. And Senator Gramm has not seen me cutoff 
witnesses in the past, but I did not cut him off that time.
    Senator Romney, are you available? There you go. I see you. 
Senator Romney?
    Senator Carper. There is a reason why I called on Phil 
last. [Laughter.]
    Chairman Johnson. Oh, I know. You know the system.
    Senator Romney. I see you.
    [No response.]
    Senator Romney.
    [No response.]
    I will have to go to Senator Hassan.

              OPENING STATEMENT OF SENATOR HASSAN

    Senator Hassan. OK. Let us see. Is this working now?
    Chairman Johnson. Yes, we can hear you.
    Senator Hassan. Can you hear me? All right. Excellent.
    Thank you, Chairman Johnson and Ranking Member Peters, and 
to all of our witnesses for being part of this hearing today. 
As Ranking Member of the Subcommittee on Federal Spending 
Oversight and Emergency Management (FSO), I take the Federal 
response to the coronavirus very seriously, and I believe it 
should be executed in an effective and fiscally responsible 
way. I am sorry, who have we got on?
    [Technical difficulties with Senator Romney.]
    As I was saying, as Ranking Member of the Subcommittee on 
Federal Spending Oversight and Emergency Management, I take the 
Federal response to the coronavirus very seriously, and I 
believe it should be executed in an efficient, effective, and 
fiscally responsible way. And to do true oversight of the 
Federal response, we need to ask questions of government 
witnesses. Their absence at today's hearing is not only 
noticeable, but it is disappointing.
    In addition, as I speak to community leaders, small 
business owners, and school officials in New Hampshire, it is 
clear that the bipartisan CARES Act was a vital lifeline that 
helped families keep food on the table and allowed some 
businesses to stay afloat.
    It is also clear as I talk to people in my State as well as 
look at unemployment statistics and other economic data across 
the country that additional financial relief is necessary to 
ensure the economic stability and health of our constituents. I 
will note, just to echo something that I think Ms. Brian said, 
this is a unique economic crisis because it is, of course, 
based in a public health one. And until we get to a point where 
the Centers for Disease Control and Prevention (CDC) and 
Occupational Safety and Health Administration (OSHA) are giving 
employers clear guidance about how to reopen their businesses 
safely, it will be hard to enable all the workers who want to 
get back to work to get back to work. So failing to provide 
additional financial relief will exacerbate the economic 
effects of the coronavirus and prevent the United States from 
moving past this deadly disease.
    So to Ms. Brian, the outrageous attempts by this 
administration to undermine the independence and integrity of 
the Inspectors General are well documented, and I appreciate 
the work of the Project on Government Oversight's annual 
advocacy to the Inspector General community. What can Congress 
do to support the Inspectors General against attacks on their 
independence to ensure that they are able to continue their 
work of rooting out waste, fraud, and abuse?
    Ms. Brian. Thank you, Senator Hassan. As Mr. Barofsky 
noted, really what our IGs need is for-cause protections. 
Currently, we have a situation, as you are referencing, where 
the President has been removing IGs ostensibly for doing their 
jobs well, and what that is doing is not only removing good 
people from doing good jobs, but it is creating an environment 
for the existing IGs to really be fearful that, if they do 
their jobs well, they will be fired for it. We believe strongly 
IGs need the for-cause protections that do exist for other 
Executive Branch offices.
    Senator Hassan. Thank you for that.
    The Project on Government Oversight expressed support for 
my draft legislation to authorize and fund oversight.gov and to 
provide Inspectors General with testimonial subpoena authority. 
Both of these bills aim to strengthen the oversight 
capabilities of the Inspector General community.
    Ms. Brian, how would these tools assist Inspectors General 
in doing their jobs more thoroughly and more transparently as 
they conduct oversight of the Federal coronavirus relief 
efforts?
    Ms. Brian. Thank you very much for your work on this, 
Senator, and this is a request that Inspectors General have had 
for many years. Their ability to get testimonial evidence has 
been hampered for years, and it is a very important element in 
their ability to fight waste, fraud, and abuse.
    You have also been supportive of giving the Special 
Inspector General emergency hiring authorities, and that is a 
very important element that is missing right now. That is 
something that Neil had as SIGTARP that, unfortunately, the 
current Special Inspector General does not have, and that is 
the main thing that is stopping that office from moving 
forward.
    And in terms of appropriations for oversight.gov, right now 
really what I hope they can use it toward is creating a portal 
for the recipient reporting that is currently not being 
collected by the agencies, but hopefully the Congress will tell 
OMB that they must be collecting, because that is what the 
CARES Act requires, so that the IGs can get that data and start 
getting to work on it.
    Senator Hassan. Thank you for that response, and I do now 
want to turn to Mr. Barofsky to follow up a little bit on this.
    Mr. Barofsky, the CARES Act established the Special 
Inspector General for Pandemic Recovery, modeled on your 
position as the Special Inspector General for the Troubled 
Asset Relief Program following the 2008 financial crisis. The 
Special Inspector General position is key to ensuring that 
Federal funds are spent as intended and delivered to those most 
in need.
    Reflecting back on your time as the SIGTARP, what do you 
wish you had known then to help your office better achieve its 
oversight goals and prevent waste, fraud, and abuse? And, 
relatedly, what advice do you have for the Special Inspector 
General for Pandemic Recovery?
    Mr. Barofsky. I think that perhaps the thing that I had not 
known was sort of the willingness in Washington of people to 
not tell the truth to each other, and I think maybe in my early 
days I was a little naive, I think, going in. It was a job 
that, unfortunately, taught me a little bit of cynicism, and so 
I think that was probably--if I could go back and give myself 
advice, it might be just that, that and when transparency is 
being pushed back against, that usually is a very good sign of 
when you need to keep digging, because it is a really 
significant flash point.
    I think that, and I just want to really reiterate what Ms. 
Brian said about hiring authorities. That we got a bill passed 
in Congress to give it to us. Our budget was twice that of what 
the Special Inspector General has. I think bringing these two 
offices into full [inaudible] will be very helpful.
    Senator Hassan. I thank you for that. I do think that the 
need to be direct and factual with each other is critically 
important.
    I wanted to highlight that there is a bill, one that I have 
cosponsored, and it is quite a mouthful, but it is called the 
``Special Inspector General for Pandemic Recovery Expedited 
Hiring Authority Act,'' which would allow the Special Inspector 
General to set up his office quickly and ensure that he has the 
resources to conduct this vital oversight.
    You had expedited hiring authority. Anything else you want 
this Committee to know about how that expedited authority 
really helped you and why you think it is necessary for us to 
really be able to do effective oversight of how the coronavirus 
relief funds are spent?
    Mr. Barofsky. It would have been impossible for us to be 
effective without it. There is no other way to say it. You are 
a new Special Inspector General. You are trying to hire people. 
You cannot go through the normal hiring process and wait months 
and months to go through competition and to do that. You need 
to be able to hire annuitants, people who have retired. You 
cannot go through that process while hundreds of billions of 
dollars are going out the door. We originally got some 
dispensation from the administration, from the Office of 
Personnel Management (OPM), but then you lose your 
independence. They started pulling authority from us, and it 
became a battle. And until Congress stepped in--also a 
mouthful. It is called the ``Special Inspector General of the 
Troubled Asset Relief Program Act of 2009.'' I have a copy of 
it hanging on my office wall because it was the reason why we 
were able to function as an oversight body. We would not have 
been able to do so without it.
    Senator Hassan. Thank you very much.
    Mr. Chairman, I just think it speaks to the need for our 
Inspectors General as a general matter but also in this 
particular one to really have some teeth behind their 
authorities. Thank you very much.
    Chairman Johnson. First of all, I agree. Again, I am not 
looking to pass anything quick, but if we pass something, let 
us all work together to make sure that we make these 
corrections so we actually get oversight on this thing, which 
we are not getting right now.
    Senator Hassan. Thank you.
    Chairman Johnson. Senator Rosen.

               OPENING STATEMENT OF SENATOR ROSEN

    Senator Rosen. Can you hear me OK?
    Chairman Johnson. Loud and clear. Thanks.
    Senator Rosen. Perfect. Thank you, Mr. Chairman, Ranking 
Member Peters, all the witnesses for being here today. I really 
appreciate you.
    I would like to talk a little bit about State and local 
funding. Ms. MacGuineas, in your testimony you wrote about 
Federal funding for State and local governments, and I am going 
to quote you here: ``While bailouts should not be given to 
paper over previously mismanaged State finances, this crisis is 
an unprecedented situation that requires Federal action to 
ensure that State and local budget cuts do not harm the overall 
economic recovery.''
    Before this crisis, Nevada had not mismanaged its State's 
finances. The State had an unemployment rate under 3 percent 
and a rainy-day fund that has since been used to pay 
unemployment benefits and other unanticipated expenses. 
Nevertheless, the legislature just had to meet in special 
session to close a $1.2 billion budget shortfall that resulted 
from the impact of this pandemic on tourism, hospitality, and 
gaming industries, and the hundreds of small businesses and 
workers that depend on those industries. So particularly during 
a global pandemic, cuts to State funding hurt.
    Ms. MacGuineas, can you expand more on the ripple effects 
of State and local budget cuts on our economic recovery? And 
maybe after that, Ms. Brian, can you discuss the importance of 
ensuring we do not leave our State and local governments behind 
in the next recovery package, please?
    Ms. MacGuineas. Sure. Thank you for the question. I think 
as you just illustrated, the States are all facing different 
situations. Some are kind of the model for exactly how they 
should have managed their finances, some are the model for how 
they should not have, and many fall in between. But all of them 
are facing the hardships that are caused by two huge things: a 
global virus and basically needing to shut down our entire 
economy to fight it.
    So all States are facing challenges that come from no fault 
of their own, and much like many parts of the bill, the really 
difficult thing is to craft something that creates the exact 
right incentives but is also widespread. And so it is going to 
be imperfect, but there is clearly a need for more money to get 
into State and local governments because they for the most part 
do not have the capacity to borrow, they have been hurt in 
terms of a massive drop-off in revenue, and their expenses are 
higher.
    Now, I think it is OK to say we do not want to incentivize 
bad behavior for those that have not handled the rainy-day 
funds right or have poor unemployment insurance systems. Can we 
tie a lot of this money to future reforms? That could be a 
smart incentive. It would not affect the States that have 
managed things correctly. But this is not the moment to cutoff 
funding completely, or that will exacerbate the rest of the 
problems throughout the economy.
    Senator Rosen. Thank you. And like I said, Ms. Brian, can 
you discuss the importance as well of ensuring that we do not 
leave our State and local governments behind?
    Ms. Brian. Thank you, Senator Rosen. I have to say that of 
those programs, that is not where we are seeing real concerns 
about fraud, and so I think it is so important as we are 
looking at what are the parts to really be worried. The money 
going to States and local governments is not where we have been 
seeing the problems. I think one thing that is useful to 
highlight is, despite the fact that the administration has 
directed the agencies not to collect recipient reporting data, 
the Treasury Inspector General is actually standing up a portal 
for the States and local governments to report how they are 
spending their money, which I think is really fabulous leaning-
forward work on the part of that office. We will actually be 
able to get some of the data to be able to demonstrate how they 
are using the money.
    Senator Rosen. Thank you. I can tell you that I spoke with, 
I believe, every mayor of every town in Nevada, all of our 
county commissioners up and down the State, and they have 
expressed to me they want me to let everyone know that they 
have done the right thing. They have balanced budgets. They 
have taken care of their communities and their citizens. They 
did the right thing this time to protect the ones that they 
love, and they just want to get through this crisis and come 
out the other side, so I appreciate what you have to say.
    I would like to move now to a little bit about oversight of 
PPP. Of course, in March we saw overwhelming bipartisan 
support. We passed the CARES Act, including the PPP to help 
small businesses survive, retain their employees. We have 
estimated to save somewhere between 1.5 and 3.5 million jobs.
    The program was so important in Nevada. We are actually 
predicted to be one of the hardest-hit States and the greater 
Las Vegas area projected to be one of the hardest-hit 
metropolitan areas in the country. And so we, of course, had 
the highest unemployment rate in the country, and I helped 
introduce legislation with Senator Cardin to extend the PPP 
through August 8.
    But, of course, it was not perfect, and we realized that 
the very businesses we intended to help, including small 
businesses in rural and underserved markets, minority-owned 
businesses were having trouble accessing the funds. The SBA 
Inspector General found that the SBA did not provide guidance 
to lenders on how to prioritize borrowers in underserved and 
rural markets, including, like I said, we have lots of rural 
communities in Nevada, of course, minority-and women-owned and 
veteran-owned businesses, and these are contrary to the 
requirements by Federal law.
    We need to ensure that fiscal relief to small businesses 
and workers during this crisis is timely, targeted, and I would 
like to the other ``T'' which for me is ``thoughtful,'' because 
this is small businesses. This is everything to these families, 
often in my State multigenerational small businesses. They are 
the heart of our communities.
    And so the focus of my question is to Mr. Barofsky since 
you have conducted a large part of oversight in the past. Can 
you please share with us what indicators or signs Members of 
Congress and our staffs should be looking for, watching, 
monitoring to ensure that Federal spending is getting to where 
it is targeted? And what do you think is the best course to 
correct it when we see that there have been unintended 
consequences?
    Mr. Barofsky. Thank you for that really important question. 
Look, one of the problems, we talk a lot about transparency, 
and part of transparency is disclosing the information that the 
government has to the public. So part of the answer to the 
question is we have to disclose to the public all the 
information about all the PPP recipients so we can really get 
to the bottom of what this program has been doing with respect 
to minority-and women-owned businesses, because we have a lot 
of anecdotal evidence that it did not work, but data is better.
    But, second, we need to gather information, and in addition 
to not providing guidance, the SBA IG report notes that the SBA 
and Treasury did not collect demographic information. Right? 
And without that information, it is extraordinarily difficult--
or it would be far easier to assess the success of the program. 
So that is one of those red flags.
    So what can we do? I think in legislation we should require 
the SBA to collect that information for new borrowers and, 
perhaps as part of the forgiveness process, collect that 
information for borrowers who already got the money. There is 
still another chance to reach out and get this vital 
information. I think that getting that transparency then gives 
an opportunity to act. Among other things, it can address the 
incentives and design of the PPP program, which really was 
tilted against borrowers who did not have established banking 
business relationships with the banks. And those incentives 
need to be addressed and the program designed in order to help 
make sure that that money gets to the people who are intended 
to receive it.
    Senator Rosen. I could not agree with you more. The data 
tells a story, and it can tell us where we have been and inform 
us where we need to go and to do good legislation. I appreciate 
that.
    My time is up. Thank you, Mr. Chairman.
    Chairman Johnson. Thank you, Senator Rosen. Senator Scott.

               OPENING STATEMENT OF SENATOR SCOTT

    Senator Scott. Thank you, Chairman Johnson. First of all, I 
want to thank everybody for being here today. I just finished a 
year and a half ago 8 years as Governor, and we had sunshine 
laws, and we basically gave people whatever information they 
wanted. And then we also had a very successful Inspector 
General program, and so I think that helped try to do, a good 
job of trying to prevent fraud in State government, and I think 
our Inspector Generals did an unbelievable job. I have been up 
here for 19 months, and our Inspector Generals have been really 
helpful to me to get information about how agencies are 
spending money and to have some oversight.
    I would like to go back and talk about the State bailout 
stuff. In my years as Governor, I had four hurricanes. The 
Federal Government has a program under Federal Emergency 
Management Agency (FEMA) that would cover some of my costs, but 
one thing that they did not cover all my costs for that, and 
they for sure did not cover a dime of problems I might have if 
I lost revenues. At the State level we lost revenues--we are a 
tourism State--and I think at the local level we would lose 
revenues for some areas months on end and years on end. Right 
now, the hurricane we had in 2018, Michael, has impacted the 
Panama City area for now more than 2 years or almost 2 years of 
impacted revenues. The Federal Government was not a partner. 
They did not help pay for any of that.
    In the CARES Act, we allocated over $500 billion in many 
tourist States and gave them access to another $500 billion in 
loans. With Chairman Johnson and Senator Ted Cruz, we asked our 
States: How have you spent the money? Shocking to me, more than 
40 States said--they have not given us any information. And so 
now what we have is we have a proposal on the table that is 
going to give States access to more information--or more money 
with no accountability. They can use it to pay off a pension 
plan. They can use it to have programs that most of us would 
never want to fund at the Federal level. And they are going to 
be able to do whatever they want with it.
    What I am concerned about is there is no accountability in 
this. I think all of us want to help our States, help our local 
governments, but we have no earthly idea of, how they have 
spent the money we have already given them, and it is not an 
insignificant amount of money. We have given them over $500 
billion, and we covered 100 percent--not a portion like you do 
with a hurricane, but 100 percent of the cost of the virus, 
given them 100 percent of the money for testing, I mean 
unbelievable things that we have done that we never do for any 
other disaster.
    My concern is how can we even look at giving the States 
more money when we have no idea how any of this money has been 
allocated yet. I know that the Treasury Department has an 
Inspector General program that is working on it, but I have 
been asking for that, and we still do not have any information 
in that regard.
    I would like to get you-all's feedback of, how can we--and, 
by the way, the way FEMA works with hurricanes is you spend the 
money, that you pay a portion of it, and then you ask for 
reimbursement as it fits within the program. We are talking 
about just giving people blank checks, which makes no sense to 
me.
    I would like to get you-all's feedback on how is that good 
government and how could we ever--why would we ever want to do 
that with Federal revenues?
    Senator Gramm. Why don't I start since I did not get to 
participate in the discussion before. First of all, if you look 
at creditworthiness in terms of financial conditions, there 
probably are not three States in the Union that are not better 
credit risks than the United States of America.
    Now, the United States can borrow money because we have 
sovereign authority and we can print money, and debts are 
payable in legal tender and we can print legal tender. But this 
idea that the Federal Government is this endless pot of money 
that can bail out everybody's problems is a concept that is 
difficult for me to understand or to accept. The plain truth is 
the United States is in worse shape financially than probably 
all but three or four States in the whole Union.
    Second, money is fungible. This idea that, oh, well, we 
will tell them you cannot solve your pension problem with 
Federal money, with this money we are giving you, is a fraud. 
You remember when every State wanted to do lotteries and people 
were against them, and so they did it so the money would go to 
education. Every State except Georgia--Zell Miller, the 
Governor of Georgia, set up a fund independent of the 
government and extraordinarily based on merit has a scholarship 
fund that government has nothing to do with. But other than 
that, 49 States set up lotteries to help education, and if you 
go back and look, where is education today based on where they 
started exactly what it was, where it was? They spent the money 
on other things. And inevitably that will happen here.
    Again, I think Senators and Members of the House have to 
consider, are you ready, not now but soon and permanently, to 
raise taxes to pay for these things? If you are not, maybe you 
should not do it.
    Ms. de Rugy. If I can weigh in--so who is going?
    Senator Gramm. Go ahead.
    Ms. de Rugy. OK. I agree, but I also think it is important, 
Senators, regarding the data that you talked about, about 
asking States to send you data about what they have done with 
the money, I think we also very likely reveal, if you look at 
those who have actually shared this data, that a lot of this 
money has not been spent. And we can learn a lot from what has 
happened during the Great Recession. Actually, at Mercatus we 
did a lot of work and tried to follow the stimulus money and 
other shovel-ready projects. In particular, if you remember 
this, the whole idea of this Keynesian cycle where if you shove 
money into the economy, it gets spent. But one of the things 
that you see with individuals and with States is when there is 
a great loss of net wealth, what happens is that people use 
this money to save, to show they are saving, and they do not 
really use it.
    I think it is just--again, we have to be very realistic. I 
agree that there are a lot of arguments actually against giving 
more money to the States because of accountability. But I would 
add on top of that that even if you were in favor of giving it, 
you have to be absolutely realistic that whatever constraints 
that you put, actually, why aren't we learning from the lessons 
of the past? Why do we keep doing over and over again the same 
thing pretending it is going to have different effects?
    Ms. Brian. If I could also add, in fact, Senator Scott, the 
States and municipalities are the only recipients of funds that 
have been asked to report in how they have used the funds. They 
were asked to report it this month. The Treasury IG has said 
that they will be able to have the information up by September, 
but I suspect if you call them, you can find out about what is 
happening in Florida directly.
    Senator Scott. We have asked, and only, I think, eight 
States and one territory would even give us information. I 
mean, Chairman Johnson and Senator Cruz and I all asked, and 
they are not giving it to us. I am a business guy. I cannot 
imagine--I cannot imagine, giving people money with no 
accountability, you would never do that, and that is exactly 
what we are talking about doing, is just giving people money, 
and whatever they do with it--you do with it whatever you want.
    Ms. Brian. My guess is they are watching this hearing, and 
your staff will be getting information this afternoon from 
their office, because all the States apparently have reported 
it by the end of this month, which is now.
    Chairman Johnson. Thank you, Senator Scott. I guess I am 
not holding my breath to get that information, but let us hope 
that is true.
    I think we have Senator Hawley next.

              OPENING STATEMENT OF SENATOR HAWLEY

    Senator Hawley. Thank you, Mr. Chairman.
    Mr. Barofsky, can I just come back to you and ask you about 
Federal Reserve lending programs. We have discussed and you 
have pointed out that those programs are quite well 
capitalized. I know you mentioned this in your written 
testimony that, by your estimation, of the $454 billion that 
was provided to the Treasury through the Exchange Stabilization 
Fund (ESF) to support Federal Reserve lending activities, how 
much of that has actually been committed to lending and been 
spent?
    Mr. Barofsky. So $195 billion has been committed to support 
the Federal Reserve programs with commitments of the Federal 
Reserve of up to $1.95 trillion, so about a 10:1 leverage. A 
very small amount of that has actually been spent; I think less 
than a percent.
    Senator Hawley. And you talked about the announcement 
effect that has helped, in your view, calm markets and restore 
liquidity, but I am wondering what else might explain here the 
limited uptake for these programs. Is there a design flaw here? 
I mean, what is your view?
    Mr. Barofsky. I think it is a combination, right? So with 
the Federal Reserve, it is culture, and its approach is going 
to be to serve as a backstop. They call themselves the ``lender 
of last resort.'' And so these are programs that are designed 
to kick in when there are major dislocations in the markets 
that they are trying to address. When the Treasury Department 
put its equity investment in, when the Secretary of the 
Treasury did so, it did so under the presumption that Congress 
intended that there be no losses to the $454 billion. In other 
words, the intent was not to subsidize riskier loans, but 
consistent with the idea of a backstop.
    So what happens, for example, using the corporate debt 
markets, when the announcement effect hits and the corporate 
debt markets stabilize--and right now the private markets are 
functioning--there is not going to be a need or uptake for 
those facilities from the Federal Reserve. That is sort of 
where it will be unless, of course, there is more dislocation 
in those markets. Then they will turn to the Federal Reserve, 
which will go from right now offering less favorable terms than 
the private market to more favorable terms as that market locks 
up.
    And so you are seeing that at each one of those programs, 
and if Congress wants to get that money deployed and pushed out 
on the streets, it is going to have to do so through 
legislation and sort of disrupt this presumption that the 
Treasury Department and the Federal Reserve have on how these 
programs should be operated.
    Senator Hawley. That is interesting. Let me ask you about a 
lending facility for which I have heard there is much demand, 
but there does not appear to be much going out the door--the 
Main State Lending Facility. In your view, why has the Federal 
Reserve made eligibility requirements for its loan facilities 
there so difficult, so onerous?
    Mr. Barofsky. I think for similar reasons. I think that 
with the mandate coming from the Treasury Department that they 
are not to suffer any losses and this idea that the private 
debt market or companies that are in good shape--right? Because 
that is the eligibility standard, and that is how you end up 
with no losses, is that you lend to companies that are 
otherwise in good shape but might be having liquidity issues 
because of the crisis. Right now the private debt markets is 
offering more generous terms than the Federal Reserve, and so 
there is that limited uptake. If the Federal Reserve offers 
more generous terms and increases eligibility, that is going to 
result in the potential for losses, and it also in the Federal 
Reserve's mind will be competing with what it views as 
otherwise functioning private markets.
    I think that sort of explains the cultural approach of why 
this is so limited and why, again, if you want to get that 
program up and putting more money in the economy, you need to 
do so with clear direction.
    Senator Hawley. Let me just ask you to elaborate on that 
point a little bit. Given your experience with TARP programs, 
why do you think--I mean, should we be directing economic 
relief through the Federal Reserve in the way that we have 
tried to do, we did with TARP--the Congress did with TARP, and 
that we tried to do with CARES? What is really the efficacy of 
that approach?
    Mr. Barofsky. I really think it is a question of what you 
want to accomplish. So just for example, the Municipal Lending 
Facility is one of those facilities to help provide loans to 
State and local governments, and it has had one loan. One loan 
to one State so far.
    Senator Hawley. Right.
    Mr. Barofsky. Notwithstanding, a huge amount of dry powder 
to effectuate that. It may just be that if you want to support 
and help those municipalities, you take that money and you turn 
it into grant programs. I know Senator Scott would not like 
that, but if you want to close those budget caps and if you 
want to get the schools funded, it is more realistic to go in a 
grant than a loan because of all the legal restrictions on 
taking on debt from municipalities and some of the issues that 
Senator Gramm alluded to in his testimony. So that might just 
be the better course.
    Or, if you want to use the Federal Reserve to do it, you 
are going to have to make those program terms more attractive. 
You are going to have to lower the interest rate. You are going 
to have to remove the penalty effect that is not there. You are 
going to have to extend out the term. But, again, doing so, 
that will put the Federal Reserve in competition with the 
private markets. And so you have to be willing to do that as a 
form of relief, but it might make more sense just to give the 
money, frankly, rather than to subsidize it through the Federal 
Reserve.
    Senator Hawley. It looks like given what the Fed has done 
so far, given who has benefited from it, one could be forgiven 
for thinking that it is the largest corporations that are best 
positioned to take that from the Fed's programs, and smaller 
businesses, Main Street businesses, just are not very well 
positioned to take advantage. I mean, so you get the corporate 
behemoths who have gotten quite a lot of money, and then you 
get those businesses, frankly, that are most at risk that end 
up not being able to take advantage. Am I off base there?
    Mr. Barofsky. I think that very little money has gone out, 
but I think that you are totally right that is where the 
benefits are being felt. The big corporations, when you look at 
what has happened with the debt markets--and, look, there are 
good things about that and bad things about it. It is good that 
we are not having a whole bunch of businesses go under because 
of the impact that would have on unemployment and the economy. 
But, there are negative effects as well. You are supporting and 
propping up zombie institutions that the normal measures of 
capitalism would kick to the curb. And you are delaying that 
for a period of time by having these programs and announcing 
them. But, again, I think overall you want to keep people 
employed, and that is one of the sort of necessary evils of a 
program like that.
    But you are entirely right. The Fed is not well equipped to 
serve Main Street. It has made an attempt with this program, 
but given its role and view as a backstop in avoiding of 
losses, it is going to require some substantive change for it 
to actually end up in money coming into the economy, unless, of 
course, we see another dislocation of the private debt markets, 
banks are no longer willing to lend because of more stresses in 
the economy, and then I think you would see this Main Street 
program kick in and you would see more uptake. I think that is 
the plan right now from the Federal Reserve and will stay 
unless directed otherwise.
    Senator Hawley. Very good. Thank you, Mr. Chairman.
    Chairman Johnson. Senator Sinema.

              OPENING STATEMENT OF SENATOR SINEMA

    Senator Sinema. Yes, thank you, Mr. Chairman.
    My first question is for Mr. Barofsky. Tracking how 
coronavirus emergency funds have been distributed by Federal 
agencies and how States have spent or allocated those dollars 
has been difficult if not impossible at times. SIGTARP reports 
have previously emphasized the importance of accountability in 
facilitating the speed by which Federal emergency assistance 
reaches where it is needed and the purpose it was meant for.
    So money spent on testing and contact tracing without 
investments in turn-around times for test results negates the 
effectiveness of those public health dollars. State 
stabilization dollars meant for small localities that do not 
get released by State governments also blunt the effectiveness 
of emergency stabilization funding.
    Do you believe that accountability and oversight should 
extend to examining the speed by which Federal emergency 
assistance reaches its intended targets and then how 
intermediaries such as State Governors allocate these 
resources? And if so, how should Congress improve its oversight 
to ensure these aspects of coronavirus aid get greater emphasis
    Mr. Barofsky. I am sorry to repeat myself. It all comes 
down to transparency. But, yes, absolutely, there should be 
accountability for the speed with which money is distributed 
because so often assistance delayed is assistance denied. Going 
back to the last crisis, it did very little good for a 
homeowner who lost their home in the foreclosure crisis that 
eventually some money came online to help other homeowners. For 
hospitals, it is not going to do them a lot of good--right?--if 
they have already had to lay off or fire emergency workers 
because the money from the hospital program was too late to get 
to them or, even worse, if they have been shut down because the 
money was not there.
    So it is incredibly important to measure and hold 
accountable the speed with which funds are distributed, and I 
think it is--and part of that, of course, is getting the data 
and disclosing it. The government needs to acquire that data. 
They need to publicize that data. It needs to enable its 
oversight bodies like PRAC to be able to obtain and publish 
that data so you in Congress can measure it and then take steps 
to ensure accountability.
    Senator Sinema. Thank you. I have a follow-up question for 
Ms. Brian and Ms. MacGuineas. Back in May, I joined Senator 
Lankford in sending a letter to Government Accountability 
Office (GAO) asking for policy recommendations on how to 
improve Federal preparations in response to challenges such as 
the coronavirus pandemic. The CARES Act included important 
provisions for GAO monitoring of pandemic aid, but it is also 
important that we develop policy recommendations for how to 
improve Federal programs so they are more prepared to protect 
our families and our economy.
    Based on your examination of the ongoing Federal response 
to COVID-19, what are some policy changes regarding financial 
relief and stabilization that Congress should consider to 
improve Federal programs and make them more efficient?
    Ms. Brian. Thank you, Senator Sinema. I think that is 
exactly the way we need to be looking at this. This is not the 
last crisis we are going to have. It is also not the first. We 
have had some lessons learned. One of them was actually setting 
up these three different oversight bodies. There is a good 
reason and we did have the three oversight bodies in the past 
in the last recovery, and the reason is they have three 
different kinds of jurisdictions. What the commission is doing 
is looking at the overall economic impact, as Mr. Barofsky 
pointed out, but their jurisdiction right now is a little too 
limited. So to really look at the economic impact, they need to 
be able to look at, for example, the PPP loan program or some 
of the airline programs that they are currently not able to do.
    The Special Inspector General needs to have the same 
authorities Neil had back when he was doing this work, and the 
PRAC really needs to have access to the data that the 
administration is still essentially withholding from them. It 
struck me, the question about whether States are reporting in. 
Part of the delay is the fact that the administration told all 
the agencies not to collect the data on how this money is being 
spent. So if we could learn from this, make sure that the 
Congress' intent, as it was very clear in the CARES Act, is 
that the data needs to be released immediately, we need to be 
seeing it now--we are way past the last quarter--to know how to 
tweak the programs to make sure those who are hurt are helped 
first.
    Ms. MacGuineas. I will jump in as well. Thank you, Senator, 
for the great question. I really have to agree with everybody 
who has been emphasizing the importance of oversight through 
all of this, and those of you who have been taking a leadership 
role in pushing that, thank you.
    I am going to go a little bit broader since we covered that 
so well, but in addition, the real importance of making sure 
that transparency and oversight are available in a timely 
manner, I think we have learned a lot of lessons, many of which 
we have also learned in previous crises, but we are continuing 
to learn again. One is that we need to update our unemployment 
insurance systems in the States. It is a real problem that we 
have faced throughout this crisis, how they are not able to 
talk to each other and are not modernized. I think modernizing 
a number of systems throughout government is something that we 
see the critical imperative to do.
    Timely really matters at a moment like this, and the 
ability to not be able to get dollars into people's pockets 
basically immediately should not be out of our reach going 
forward given our digital innovations, what we should be able 
to do there.
    I also think thinking about things about the timing of when 
you want to help people who are unemployed, when you want to 
encourage people to get back to work and become attached to the 
workforce, and even longer term when you want to find ways to 
help people if their industries have been massively disrupted, 
the innovations to help them in the entrepreneurial kind of 
approach to start new businesses, start new jobs, those are 
things we will be looking at going forward.
    Finally, something you have taken a lead on, as well as 
others on this Committee, is also not forgetting the fiscal 
issues, because it is so important that we borrow now and not 
be overly constrained and cutoff the recovery prematurely. That 
will be really dangerous. But it is also very important that we 
take the measures to think about how we will deal with this 
massive amount of debt that we are raking up down the road. And 
so some of the work that you and Senator Romney and others have 
done on the Time to Rescue United States Trusts Act (TRUST) Act 
is the kind of thing that gives us the leeway to borrow now 
with programs to help deal with that in the future.
    Senator Sinema. Thank you.
    Thank you, Mr. Chairman. I yield back.
    Chairman Johnson. Thanks, Senator Sinema.
    Senator Peters, do you have any closing questions? Is 
Senator Peters even here? He may be voting.
    I have just got a couple quick questions, and then we will 
close out the hearing. Senator Gramm, you mentioned that there 
is more than $100 billion of PPP that we extended the 
application time, but those dollars are not going out the door 
very quickly. Do you have any explanation for that? Or does 
anyone else on the panel have that?
    Senator Gramm. No, but I think it shows the fact that you 
have $100 billion we are offering to give away and nobody is 
taking it. The fact that the Fed has the ability to lend 
massive amounts of money and people are not borrowing it really 
says something about the liquidity needs of the American 
economy right now.
    Now, I want to be clear. I think Neil did a fantastic job 
on TARP, and I think it was one of the most successful bailout 
programs in American history. But where I would differ from 
Neil is he says if you want the money out there, you need to 
push it out there. The point is if it is emergency lending, why 
do you need to push it? And, look, I am not saying that 
Treasury has done anything like a perfect job, but I want the 
Secretary of the Treasury, since this is partly my money, to 
try to not lose it. And I think, again, the fact that money is 
available in the private sector at conditions that are deemed 
to be more favorable than from the Fed tells you something that 
we should be hearing, and that is, there is not today, thank 
God, a liquidity problem in the American economy. There is not 
a lot of evidence of lack of purchasing power. All of these 
things call into question this we have to spend another $1 
trillion or $3 trillion when we have $1.2 trillion sitting 
there that could be reprogrammed by an agreement by a small 
number of leaders of both Houses and the President.
    I think that what we are seeing all over the economy is 
evidence that the recovery has started. We are not going to go 
back into a lockdown. That has been looked at very carefully 
here in Texas because we had a spike. But we are not going 
back, and it is not really happening anywhere in the country. 
The economy is moving forward. In our case in Texas, cases are 
beginning to turn down, thank God. We do have improving 
treatment. We are going to get a vaccine, and probably several.
    So our focus ought to be on the recovery. We are not trying 
to get people to hunker down now. We want businesses to go out 
and make investments. We want people to be hired to go back to 
work. I think that ought to be the focus. Again, we have lights 
flashing all in this money program we have set out. People are 
not taking it.
    And another reason people are not taking these loans, all 
the conditions that Congress has set. You cannot oppose the 
unionization movement in the companies. You cannot use funds to 
pay dividends. You cannot buy back stock. And companies need 
equity. They do not need debt.
    Again, I think each of these arguments is an argument at 
least of equal weight to look at whether we really need another 
bill or not. That is the point I want to make.
    Chairman Johnson. OK. I think you made it well. I 
appreciate that.
    Mr. Barofsky, I think you used the words ``clawing back.'' 
I would use ``limit loan forgiveness.'' First of all, do you 
have an explanation--I know Senator Hawley was asking you about 
the other lack of uptake in some of these other programs. What 
about PPP? Do you have an explanation on that?
    Mr. Barofsky. Yes, I mean, I have some good guesses--let us 
put it that way--based on what we are seeing in the market and 
what we are seeing with our clients. I think there is a supply 
problem. Banks are pulling back on making these loans, 
particularly for the underbanks, companies that do not have 
established business banking relationships with the financial 
institution. These are some of sort of the rural and women-
owned and minority-owned businesses. They are still having 
trouble getting into the program as banks would not lend them 
to before and now, as they are sort of dealing with the process 
of forgiveness applications, do not want to dedicate certain 
bandwidth. I think that is part of it.
    The second part of it, the ones that could get into the 
program got into the program--right?--and there is right now 
not an opportunity to get more funds even though those funds 
have been basically been burned through and used.
    And the third part is that, some companies were sort of 
scared away from the program by some of the politicization of 
it, and, we know of companies that gave back money or did not 
take the money, and that is because they did not necessarily 
need the money to survive, but they have basically chosen to 
give back the money and then lay off a bunch of people where 
they would have kept those people employed if they had kept the 
money.
    I think it is a combination of those things. I think that 
if you give companies a chance for another 8 weeks, that you 
will see uptake, give them a chance to continue. Look, I think 
a lot of this comes down to that question. Senator Gramm is 
right. Things are not as bad as they could or would be, given 
this pandemic, because of the CARES Act. But it is a lot 
cheaper to prevent a massive crisis than it is to clean one up. 
And continuing to support these businesses will make sure that 
they stay alive and do not fail. So it is not, as Yelp recently 
said, 60 to 70 percent of all the restaurants that have 
temporarily closed are never coming back. It is going to cost a 
lot more, ultimately to our economy for all those restaurants 
to start over than it is if we can keep them alive for a little 
bit longer by keeping these programs going.
    Chairman Johnson. It all depends on how much you actually 
spend whether it actually costs less, and that is what is on 
the table. Was I correct, did you use the term ``clawing 
back''?
    Mr. Barofsky. I am sorry.
    Chairman Johnson. Or was it another witness who talked 
about clawing back some of these funds?
    Ms. Brian. I think that was me, Chairman.
    Chairman Johnson. OK. Let me talk to you a little bit about 
that. I have certainly proposed limiting loan forgiveness 
because I do not think PPP was meant to guarantee profitability 
or increase profitability. So to me, a pretty simple fix is if 
you have taxable income, to that extent you should pay that 
loan back. Or as a nonprofit, if you increase your net assets, 
to the extent you have increased net assets, you should pay 
that loan back.
    Now, doing that retroactively, which would be clawing back, 
I mean, I would do it, but I do not think anybody else would. 
But at least prospectively, do you agree that is--because we 
are right now talking about whether we are going to have a 
revenue test. You can have a reduction of revenue and still be 
pretty profitable. Would you agree with me that profitability 
or an increase in net assets is the proper test in terms of 
loan forgiveness?
    Ms. Brian. Chairman, I am actually not an economist, so 
that is not going to be my strength. But I can tell you we are 
seeing so many businesses that clearly should not--I mean, 
right now they are being floated $30 billion going to defense 
contractors, even though Lockheed had profits of 18 percent 
over last year. I absolutely agree that profits needs to be 
part of the equation, and I commend you for really looking at 
that. I mean, that is where a lot of the money is going. Those 
are those big-ticket items I was talking about that really need 
the attention and are not getting.
    Ms. MacGuineas. Chairman Johnson.
    Chairman Johnson. Maya.
    Ms. MacGuineas. I was hoping I could jump in on that 
because I do agree with that as well. I think it is actually 
good news that there is $150 billion or that there is money 
left in PPP, because it may be that we do not need all of that. 
I really agree with the frustration that I think so many people 
have of the people who took the loans who should not have and 
the stories of abuse and the lack of targeting. But that should 
not take away from the importance, the huge importance it 
played in keeping people attached to their jobs. And the 
numbers that I have seen, most small businesses--I think it is 
84 percent of small businesses have voiced concern that they 
will not have the money to continue, they do not feel stable 
going forward, and they are worried about having the resources 
to keep people employed.
    I think it is worth thinking about how to extend that, but 
I completely agree with you that there should be a test because 
the grants-versus-loans question should become more stringent, 
and we should find a way now that we have the time to target 
keeping the dollars that should have gone to places, turning 
them back into loans, they should not be grants. I agree with 
that.
    Ms. de Rugy. If I can jump in just very quickly, Mr. 
Chairman.
    Chairman Johnson. Sure.
    Ms. de Rugy. The thing that always gets to me is the bill 
was designed for these companies to actually be able to get 
that money, and then there is inevitably the finger-pointing 
afterwards and shaming the companies for actually using--and I 
am not talking those who were not eligible and used loans, but 
if we point fingers at these companies that actually the bill 
is designed like this. It is no surprise--I mean, I wrote 
before when it was implemented that these type of things would 
happen. It always happens.
    The other thing that I think is important to keep in mind 
is that no economy can actually survive and companies will not 
be able to survive if the economy stays locked down for very 
long. So as we can hear, in the comfort of our home, writing an 
economic paper kind of designed like it is some technocratic 
plan that actually looks great on paper, in the real world--I 
mean, you do not keep an economy on ice or half on ice with 
measures like this. It helps at the beginning, but I think 
ultimately we have to be extremely realistic about what we are 
facing and the best thing to do, I think, is to be very 
skeptical about the ability of government to make it all OK.
    Chairman Johnson. First of all, let me agree with you. The 
design absolutely was to push money out as quickly as possible, 
for PPP to keep employees connected to their employer, and so 
we are encouraging people to take out those loans. And we set 
such a very low sort of certification standard just, in other 
words, if you check the box saying because of economic 
uncertainty I am taking out this loan, it would be a travesty 
to hold people accountable like they committed fraud by 
checking that box. I would not agree with that. The problem 
with PPP is there was no backside control that, again, laid out 
that fact. Listen, if you are wildly profitable, you have to 
pay that thing back. Of course, we have also elongated the 
number of weeks that people can pay employees, which means they 
did not keep employees on for the 8 weeks, they need 24 weeks. 
Again, the whole point of that is oversight.
    And so in closing out this hearing, if there are any 
Committee Members still out there--there probably are not--at 
least their staffs, and for the record, let me say I think the 
recommendations from this panel of witnesses were pretty in 
agreement in terms of the requirement for oversight. There are 
specific recommendations that I think staff ought to get 
together today--and I would certainly offer this to Senator 
Peters and anybody else on the other side, let us accumulate 
these suggestions. I am opposed to passing something right now. 
I think we have authorized enough. We should reprogram it. But 
if we are going to pass something, this Committee ought to 
insist on fixing the oversight function so it can operate 
properly and so we can have the information we are going to 
need moving forward.
    Again, I just want to thank all the witnesses. I thought 
your testimony was excellent. I appreciate your thoughtful 
answers to the questions. I think we have laid out a game plan 
here. I hope the Senate will pay attention, I hope Congress 
will pay attention, if they insist on passing something, that 
we at least fix the oversight function and hopefully fix PPP 
prospectively moving forward so we are not using limited 
dollars and using a shotgun approach and providing it to people 
who do not need it, because that was the main problem with PPP.
    Again, thank you all for your testimony. The record will 
remain open for 15 days until August 12th at 5 p.m. for the 
submission of statements and questions for the record.
    This hearing is adjourned.
    [Whereupon, at 12:08 p.m., the Committee was adjourned.]

                            A P P E N D I X

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[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]


  EARLY OUTPATIENT TREATMENT: AN ESSENTIAL PART OF A COVID-19 SOLUTION

                              ----------                              


                      THURSDAY, NOVEMBER 19, 2020

                                     U.S. Senate,  
                           Committee on Homeland Security  
                                  and Governmental Affairs,
                                                    Washington, DC.
    The Committee met, pursuant to notice, at 9:02 a.m., via 
Webex and in room SD-342, Dirksen Senate Office Building, Hon. 
Ron Johnson, Chairman of the Committee, presiding.
    Present: Senators Johnson, Portman, Lankford, Romney, 
Scott, Enzi, Hawley, Peters, Carper, Hassan, Sinema, and Rosen.

            OPENING STATEMENT OF CHAIRMAN JOHNSON\1\

    Chairman Johnson. Good morning. This hearing will come to 
order.
---------------------------------------------------------------------------
    \1\ The prepared statement of Senator Johnson appears in the 
Appendix on page 1191.
---------------------------------------------------------------------------
    I want to first thank all of our witnesses for taking the 
time to write your testimony; those of you appearing in person, 
traveling here to D.C. to give it orally; and also answer our 
questions.
    The title of this hearing now is, I guess, ``Examining the 
U.S. Approach to Early Coronavirus Disease 2019 (COVID-19) 
Treatments.'' I thought it was--I had originally set out a 
title of ``Early Treatments for COVID: An Essential Component 
of a COVID Solution.''
    It was inevitable that the coronavirus pandemic would be 
politicized, and it is a tragedy that it was. From the start, I 
knew it was impossible to have a perfect response. We were 
facing a new virus that caused an entirely new disease. No one 
wanted to underreact, and as a result, I feared the tendency 
would be to overreact and create unrealistic expectations 
regarding our ability to stop a highly contagious pathogen.
    The challenges facing us were daunting. Our national 
strategic stockpile had been reduced during the H1N1 pandemic 
and had not been replenished. It took time to develop a 
reliable test and even more time to scale up production to meet 
the demand. The fact that a large percentage of people that 
become infected exhibit no symptoms made the coronavirus even 
more difficult to detect and contain.
    I have tried not to criticize elected officials that had 
the responsibility to make very tough decisions with limited 
and highly imperfect information. Others have not been so 
reluctant. Perhaps my background in manufacturing taught me to 
be more understanding of those forced to face and deal with 
very difficult situations.
    The Members of this Committee have had a front-row seat to 
government's response, at both the Federal and State level. We 
participated in dozens of conference calls and multiple 
hearings with agency officials who have worked 24/7 to respond 
to an unprecedented event. It is always easy to criticize, but 
I for one have been sympathetic with the challenges they faced 
and highly appreciative of their efforts.
    As we are all aware, the coronavirus is not going away. 
Even though it appears an effective vaccine may have been 
developed and might be available in record time, people will 
continue to become infected and sick for months to come. We 
still need to develop effective therapies, particularly in the 
very early stages of the disease.
    It is on this point that I have been and will continue to 
be highly critical of our collective dereliction in not 
robustly exploring therapies designed to stop viral replication 
and halt the progression of the disease. We are all aware that 
Tamiflu is only effective when prescribed early enough to stop 
the flu virus from replicating and before the patient becomes 
too sick. Why haven't Federal agencies and the medical 
community applied the same logic and approach to the 
coronavirus?
    This question has baffled me since March, and there 
probably is not a single explanation. We do know the 
coronavirus was politicized and used as an effective weapon in 
the Presidential election. We also know some of the suggested 
therapies included off-the-shelf supplements and off-label uses 
of widely prescribed drugs. The cost of these therapies is well 
under $50 versus a brand-new drug, remdesivir, that costs over 
$3,000 and can only be used in-hospital and, therefore, does 
not prevent hospitalization in the first place. Could Big 
Pharma have played a role in discouraging less costly 
alternatives? I think the answer seems pretty obvious, even 
though their methods will no doubt remain obscure.
    This hearing is not about promoting any one particular 
therapy over others, although, as a quick aside, by reading the 
testimony and watching the Tweets, it may be unavoidable. But I 
have to say the absence of any serious National Institute of 
Health (NIH) study or consideration of hydroxychloroquine 
(HCQ)--either by itself or in combination with other drugs and 
supplements--is worth discussing. This is a drug that has been 
safely and effectively used to prevent malaria and treat lupus 
and rheumatoid arthritis for decades.
    Yet doctors who have had the courage to follow the 
Hippocratic oath and use their off-label prescription rights to 
treat patients using hydroxychloroquine have been scorned, and 
State medical boards have threatened to withdraw their 
licenses. The same has happened to pharmacists filling 
prescriptions for the drug in some States. Will those using 
ivermectin and other off-the-shelf drugs being used off-label 
to treat COVID patients suffer the same fate?
    Since the onset of this pandemic, I have publicly advocated 
for allowing doctors to be doctors--to practice medicine, 
explore different therapies, and share their knowledge within 
the medical community and with the public. I believe 
international, Federal, and State medical agencies and 
institutions have let us down. I fear too many have been 
closed-minded bureaucrats, potentially driven by conflicting 
interests and agendas. Tragically, media and social media have 
failed to ask the right questions and censored what they do not 
understand.
    My public advocacy has connected me to doctors who care and 
who are trying to compassionately help their patients in spite 
of the bureaucratic roadblocks they have encountered. Over the 
last month, I have been included in an email group comprising 
over 250 practicing physicians from all over the world sharing 
their knowledge and experience. Three members of that group are 
here today.
    To me, it is obvious that we should robustly explore every 
possible treatment to combat this pandemic at every stage of 
the disease. Why has there been such resistance to low-cost, 
off-the-shelf therapies that might stop the progression of 
COVID-19 and help keep people out of hospitals and intensive 
care units (ICUs)?
    I hope today's hearing can answer that question and provide 
direction on how to correct this glaring blunder that has cost 
far too many lives.
    I just want to make a couple other points. A personal story 
to make a point. My first child, my daughter, Carey, was born 
with a very serious congenital heart defect called 
``transposition of the great arteries.'' Her aorta and 
pulmonary artery were reversed. The first day of life, a 
wonderful man, Dr. John Thomas, came in in the middle of the 
night, 1 in the morning, and performed a balloon septostomy. 
They catherized her heart, shoved an uninflated balloon through 
a hole in the chamber of her heart, blew the balloon open, 
pulled it back and ripped a larger hole so that her blood could 
oxygenate until she was old enough to have a surgery, which 
occurred 8 months later, with another incredibly skilled 
surgeon. Dr. John Foker rebaffled the upper chamber of her 
heart. Now, at the time some people were using Dacron to do 
that baffle. This surgeon had developed a technique of using 
pericardial tissue so it would grow with the heart.
    Now, my daughter is 37 years old today, a mother of two 
children, and a nurse practitioner in a newborn intensive care 
unit (NICU) previously.
    We had a wonderful result because I had access to doctors 
and to treatments produced by previous doctors that practiced 
medicine. I do not think there was a random controlled trial on 
the balloon septostomy or that Schumacher rebaffling technique. 
These were skilled physicians practicing medicine.
    What I have found over the last 8 or 9 months in dealing 
with this issue is we have fewer practicing doctors and more 
doctors that follow protocols, which is entirely appropriate. I 
completely agree with practicing protocols, using random 
controlled trials. But there are moments in medicine, moments 
in our history where you have to allow doctors to practice 
medicine, to develop these therapies, and that has been the 
history, quite honestly, of the development of medicine.
    My final point is to talk about the bill I championed 
through Congress: Right to Try. Now, the current situation, for 
example, of hydroxychloroquine is not a prime example of Right 
to Try because hydroxychloroquine is a fully approved drug. 
What Right to Try says is if a drug has gone through the first 
two stages of the Food and Drug Administration (FDA) approval--
so it has been proven safe--but it has not gone through the 
final efficacy approval, a patient and a doctor still have the 
right to try that if there are no other available treatments. 
Isn't that the position we are in in the early treatment of 
COVID? There are no other treatments. Yet doctors who have had 
the courage to practice medicine and try things like ivermectin 
or hydroxychloroquine have been scorned and worse. It makes no 
sense to me whatsoever.
    I am glad there is a vaccine, but that vaccine will not be 
widely available for months. More people will get sick. More 
people will die. I for one am for allowing doctors to practice 
medicine to treat patients compassionately as early as possible 
so they do not progress into the hospital and the intensive 
care unit. Senator Peters.

             OPENING STATEMENT OF SENATOR PETERS\1\

    Senator Peters. Thank you, Mr. Chairman, and to our 
witnesses for being here today. We look forward to hearing your 
testimony.
---------------------------------------------------------------------------
    \1\ The prepared statement of Senator Peters appear in the Appendix 
on page 1193.
---------------------------------------------------------------------------
    We now have lost more than 250,000 Americans to 
coronavirus.
    The United States is now the first country in the world to 
reach more than 170,000 confirmed COVID cases in a single day. 
Those numbers, unfortunately, are continuing to rise.
    In my home State of Michigan, positivity rates rose to 
almost 12 percent, and we have lost 439 Michiganders to this 
pandemic in just the last week.
    In order to successfully tackle this pandemic, our response 
must be driven by recommendations from public health officials 
that are rooted in science and transparency.
    It will take an all-hands-on-deck approach to ensure that 
Americans receive the most accurate information on how to 
protect themselves. Unfortunately, misinformation and 
disinformation continue to run rampant.
    That is why I introduced legislation to create a COVID-19 
disinformation and misinformation task force that would work to 
slow the spread of unfounded information and in the process 
save American lives.
    As Members of Congress, we also have a responsibility to 
ensure the information we present to the public is accurate and 
rooted in science.
    Americans must be able to rely on and trust the independent 
FDA and Centers for Disease Control and Prevention (CDC). 
Political interference and misinformation undermine the hard 
work that dedicated scientists and experts are carrying out at 
these critical agencies.
    We must also be careful of giving Americans a false sense 
of security by promoting untested and unproven outpatient 
remedies. We all want answers that will keep our families 
healthy and safe, but I am concerned many of the treatments 
that will be discussed today have been presented as panaceas 
for the coronavirus.
    It would be irresponsible to give Americans false hopes 
that these types of treatments will be enough to keep them safe 
in lieu of other measures that are scientifically shown to slow 
the spread of coronavirus.
    Our Nation's top scientists must be able to do their work 
without meddling to ensure that both treatments and vaccines 
for COVID are safe and are effective and are trusted by the 
American people.
    Unfortunately, this administration has continued to exert 
pressure on our government's top public health agencies to 
water down health guidance and even promote unproven 
treatments, further putting Americans at risk.
    These actions have also diminished the public's confidence 
in eventual coronavirus vaccines and treatments.
    From the very start of the pandemic, the President and 
others in the administration have consistently undermined and 
questioned public health experts at the Food and Drug 
Administration and the Centers for Disease Control and 
Prevention.
    They have pushed unproven treatments instead of leading by 
example and practicing simple measures that we know prevent the 
spread of this virus, like wearing a mask and social 
distancing.
    We have made significant progress in the development of 
COVID-19 treatments, but those developments must be free from 
politics and must be driven by solid data.
    Recent promising news from both Pfizer and Moderna 
indicates that their vaccines could be highly effective.
    However, we are still waiting for further review of this 
data, and even an authorized or approved vaccine will likely 
not be widely available for many more months.
    We must continue to use masks, social distancing, contact 
tracing, and other measures for the foreseeable future to 
protect our friends and neighbors, to stop the spread, and 
ultimately to save lives.
    Thank you, Mr. Chairman.
    Chairman Johnson. Thank you, Senator Peters.
    It is the tradition of this Committee to swear in 
witnesses, so if you will all stand and raise your right hand? 
Do you solemnly swear that the testimony you will give before 
this Committee will be the truth, the whole truth, and nothing 
but the truth, so help you, God?
    Dr. McCullough. I do.
    Dr. Risch. I do.
    Dr. Fareed. I do.
    Dr. Jha. I do.
    Chairman Johnson. Please be seated.
    Our first witness is Dr. Peter McCullough. Dr. McCullough 
is the current vice chair of internal medicine at Baylor 
University Medical Center and a professor of medicine at Texas 
A&M College of Medicine. Dr. McCullough received his Doctor of 
Medicine (M.D.) from the University of Texas Southwestern 
Medical School and his Master of Public Health (M.P.H.) from 
the University of Michigan. Dr. McCullough is board-certified 
by the American Board of Internal Medicine in the areas of 
internal medicine and cardiovascular disease. He specializes in 
the treatment of patients with complicated internal medical 
problems that have affected major organs, including the heart 
and kidneys. Dr. McCullough.

 TESTIMONY OF PETER A. McCULLOUGH, M.D., M.P.H.,\1\ VICE CHIEF 
     OF INTERNAL MEDICINE, BAYLOR UNIVERSITY MEDICAL CENTER

    Dr. McCullough. Thank you, Chairman Johnson, Ranking Member 
Peters, and Members of the Committee for allowing me to talk to 
you today about the critical need for early ambulatory 
treatment for COVID-19 as an emergency measure in the middle of 
this national crisis.
---------------------------------------------------------------------------
    \1\ The prepared statement of Dr. McCullough appears in the 
Appendix on page 1195.
---------------------------------------------------------------------------
    As we sit here today, we have the greatest mass of infected 
Americans that we have ever had since the start of the 
pandemic, and Americans are pouring into hospitals untreated. 
The hospital census is already at capacity.
    A national calamity of unimaginable mortality is right 
around the corner. In a matter of weeks to months, Americans 
are going to be horrified with what they see on the news with 
respect to a hospital overrun, mortality skyrocketing for both 
COVID and non-COVID complications and conditions, and patients 
further infecting other Americans as this pandemic spirals out 
of control.
    My viewpoint and my views expressed here are those of my 
own and not necessarily my institution's. My viewpoint is this 
pandemic should have always been viewed as having four pillars.
    If we can bring up the figure, the first pillar is 
contagion control. We have had probably the vast majority of 
government efforts solely focused on contagion control. The 
entire media representation of what the government has been 
doing has been on contagion control. As we sit here today, it 
is obvious contagion control has not solved the problem.
    The second pillar is early ambulatory treatment. This virus 
infects individuals, and they sit at home for 2 weeks. We have 
a 2-week opportunity to treat this problem, and we hear nothing 
about it. We hear nothing about early ambulatory treatment. 
There are no updates. There is no viewpoint to Americans of 
what is going on outside of the United States where early 
ambulatory treatment is a standard of care in countries that 
are doing much better than the United States. It is grossly 
overlooked.
    The third pillar is the hospitals, and I have already told 
you they are overrun. We are doing all the best technologies we 
possibly can in the hospital, but the hospital is an inadequate 
safety net. The current hospital mortality rate is about 5 to 7 
percent. When patients get in the ICU, it is 25 percent. 
Virtually all the COVID deaths that occur occur in the 
hospital. It is obviously not an adequate safety net for 
Americans.
    The fourth pillar is vaccination. Vaccination should bring 
out the close to the pandemic. But this hearing is about early 
ambulatory treatment, if we can bring up the next figure.
    We have learned a lot about the virus. There have been over 
75,000 peer-reviewed publications in PubMed since the onset of 
the pandemic. Information is flowing in at about 500 papers a 
day, so any expert who claims that a review of data and studies 
is contemporary, they are quickly out of date. I can tell you, 
with this pandemic and this virus, what we have learned is that 
there is an early viral replication phase, followed by a 
destructive immune activation called ``cytokine storm,'' and 
then blood clotting--thrombosis. What doctors have done is they 
have innovated, and they have identified both in a hospital and 
outside of the hospital, aided by clinical trials and 
observational studies, an approach that involves combination 
antivirals followed by corticosteroids and antithrombotic 
agents. Doctors in the outpatient communities faced with 
thousands of patients calling and begging for help have 
innovated. Dr. Zelenko is one in New York, in the middle of the 
calamity in New York, who was an early innovator. I summarized 
these and published them in the American Journal of Medicine, 
the synthesis of the principles of randomized trials and 
observational studies, and this algorithm has been updated 
multiple times and provides a framework for new drugs and 
agents to be incorporated in an early ambulatory treatment 
approach.
    I have reviewed every report from real-world data from 
American doctors who have innovated and faced this problem, and 
I can tell you that they are achieving rates of hospitalization 
and death less than 3 percent for high-risk Americans, over 50 
with multiple conditions. Most doctors can achieve less than 1 
percent. With no treatment in the United States right now, an 
individual over 50 with medical problems faces a 7-percent rate 
of hospitalization and death. Someone in their 80s, that 
skyrockets to 40 percent.
    I can tell you as a doctor I have always treated high-risk 
patients with the best tools available, and I looked at all the 
evidence. When it was obvious that acquired immunodeficiency 
syndrome (AIDS) drugs did not work, I did not use them. But 
hydroxychloroquine, ivermectin, if I had favipiravir, I would 
combine it with other drugs, and then steroids. That should be 
noncontroversial. Doctors should be using corticosteroids in 
patients and outpatients. They are supported by both inpatient 
and outpatient studies, as well as blood thinners. What doctor 
would not help a patient who is at risk for a catastrophic 
stroke that occurs as a complication of this condition?
    I can tell you right now I am not asking for permission to 
do this, but I am asking for your help. I am asking for the 
government to organize all government agencies that are related 
to this to assist doctors rapidly with their innovation and 
their compassionate care of patients with COVID-19 at home, 
because we can prevent hospitalization and death, and right now 
it is the only option on the table.
    Thank you.
    Chairman Johnson. Thank you, Dr. McCullough.
    Our next witness is Dr. Harvey Risch. Dr. Risch is a 
professor of epidemiology in the Department of Epidemiology and 
Public Health at the Yale School of Public Health and the Yale 
School of Medicine. Dr. Risch received his M.D. from the 
University of California, San Diego, and his Doctor of 
Philosophy (Ph.D.) in biomathematics from the University of 
Chicago. He is the author of more than 325 original research 
publications and is a member of the Connecticut Academy of 
Sciences and Engineering. This year, Dr. Risch researched the 
efficacy of seven outpatient medications for the treatment of 
high-risk COVID-19 patients in 42 hospitals across Brazil. Dr. 
Risch.

  TESTIMONY OF HARVEY A. RISCH, M.D., PH.D.,\1\ PROFESSOR OF 
           EPIDEMIOLOGY, YALE SCHOOL OF PUBLIC HEALTH

    Dr. Risch. Senators and colleagues, thank you very much for 
convening this hearing. We all understand the endemic disease 
that we are facing and that we have to face it head-on and not 
hide from it hoping that it will go away. I am going to give 
you my perspective on this.
---------------------------------------------------------------------------
    \1\ The prepared statement of Dr. Risch appears in the Appendix on 
page 1197.
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    In May of this year, I observed that results of studies of 
a drug suggested to treat COVID, hydroxychloroquine, were being 
misrepresented by what I thought at the time was sloppy 
reporting. We have heard from Dr. McCullough how COVID disease 
progresses in phases, from viral replication, to florid 
pneumonia to multi-organ attack. Viral replication is an 
outpatient condition, but the pneumonia that fills the lungs 
with immune system debris and is life-threatening is 
hospitalizable. We have also heard how each phase, each 
pathologic aspect of the disease, has to have its own specific 
treatments, how those treatments are derived from the biologic 
mechanisms of the disease. Thus, I was frankly astounded that 
the studies of hospital treatments were being represented as 
applying to outpatients, in violation of what I had learned 
about how to treat patients in medical school.
    We are now finally coming to address why over the last 6 
months our government research institutions have invested 
billions of dollars in expensive patent medications and vaccine 
development but almost nothing in early outpatient treatments, 
the first line of response to this pandemic. It is not that we 
have lacked candidate medications to study; we have had a 
number of promising agents. I think that the early on 
conflation of hospital with outpatient disease served to imply 
that treatment of outpatient disease had been studied and found 
ineffective. This illogical premise motivated me to look at 
what actually the evidence for outpatient disease and treatment 
were.
    I want to reiterate that we are considering the evidence 
for early treatment of high-risk outpatients to prevent 
hospitalization and mortality. That is it. I am not talking 
about inpatient disease. That is a totally different 
consideration. I am talking only about outpatient disease. This 
treatment starting in the first 5 days or so after the onset of 
symptoms. Treatment of older patients or patients with chronic 
conditions like diabetes or obesity, heart diseases, lung 
diseases, kidney diseases, immune system diseases, survivors of 
cancer, and so on, these are the people who are most likely to 
die from COVID, and they are the people most in need of 
protection.
    In doing my research, I sought to obtain reports of every 
study of every medication pertaining to early treatment of 
high-risk outpatients. I monitor the literature daily, which is 
a task. What I have found is actually remarkable. What I have 
observed is that while there have been positive reports about a 
number of drugs, every study of the outpatient use of one 
particular drug, hydroxychloroquine, with or without 
accompanying agents, has shown substantial benefit in reducing 
risks of hospitalization and mortality.
    Now, these studies break down into two major types. The 
first is double-blinded, randomized controlled trials that 
various government and scientific personalities say provide the 
strongest, supposedly the only trustworthy form of evidence. 
The second is nonrandomized but still controlled trials. There 
is some truth in that assertion about the nature of the quality 
of the evidence. But there is also much falsehood.
    We know, for example, that the great majority of drugs used 
to treat heart diseases were established before randomized 
controlled trials with nonrandomized trials. Cholesterol-
lowering drugs were in widespread use before randomized trials 
were ever done. Azithromycin, which is the most common 
antibiotic used in children, was not established by randomized 
controlled trials. The great majority of drugs that are in use 
today were not established when they went into widespread use 
with randomized trials. Many of them had randomized trials 
later, but the establishment and use of drugs is not always 
done on the basis of randomized trials but on the study--with 
other kinds of studies. Thus, the idea that only randomized 
trials provide trustworthy evidence is a simplistic notion that 
sounds good in theory--and perhaps Dr. Jha later may tell you 
that it is what many doctors believe--but this idea does not 
stand up to the body of medical studies and data that addresses 
it. In fact, we have large amounts of empirical data looking at 
the difference between nonrandomized and randomized trials.
    Dr. Tom Frieden, who was previously the Director of the 
Centers for Disease Control, in 2017 wrote an extensive essay 
in the New England Journal of Medicine showing that 
nonrandomized trials and randomized trials provide equivalent 
compelling evidence, equivalent evidence for the efficacy of 
treatments. Would you please enter the Frieden article into the 
record?\1\
---------------------------------------------------------------------------
    \1\ All articles referenced by Dr. Risch appear in the Appendix on 
page 1599.
---------------------------------------------------------------------------
    Underlying this was a gigantic meta analysis of meta 
analyses, what I call a ``mega analysis,'' done by the Cochrane 
Library Consortium, which is a British organization formed to 
organize evidence-based medical research. The Cochrane 
investigators examined what involved tens of thousands of study 
comparisons--this is a gigantic amount of data--between 
randomized trials and their corresponding nonrandomized 
counterparts. When they compared these two kinds of studies, 
they found that they arrived at virtually identical 
conclusions. Please enter the Anglemyer study also into the 
record.
    This evidence is why well-performed nonrandomized trials 
are every bit as much of a gold standard today as the 
randomized trials you have heard of. This is empirical data, 
not opinions. This is empirical data.
    What did I find when I investigated hydroxychloroquine in 
early use among outpatients? The first thing is that this drug 
is extremely safe, exceedingly safe. We know this from common 
sense. This is a medication that has been used for 65 years by 
hundreds of millions of people in tens of billions of doses 
worldwide, prescribed without routine electrocardiogram (EKG) 
screening. It is given to adults, to children, pregnant women 
and nursing mothers. Such a drug must be safe, and it must be 
safe when used in the initial viral replication phase of this 
illness which is, in fact, in outpatients initially similar to 
a cold or flu. And so could you please put the Oxford, the Lane 
paper and its supplement into the--the evidence into the 
record.
    This is a paper showing that of the more 900,000 
hydroxychloroquine users that showed no acts of mortality and 
no increased cardiac arrhythmias. Also please put into the 
record my article from the American Journal of Epidemiology 
where I discuss the Lane paper.
    In spite of the safety, surprisingly, in July the FDA 
posted a warning against outpatient hydroxychloroquine use on 
its website, and they did this while at the same time the FDA 
actually had no systematic evidence of adverse events in 
outpatients, and the website itself says that it justifies the 
warning based on evidence that it had in hospital patients, it 
justified it for use in outpatients, which is what I said 
before was invalid.
    There are now seven studies of early use of 
hydroxychloroquine in high-risk outpatients, and every one of 
these studies has shown significant benefit. This includes 636 
outpatients in Sao Paulo, Brazil; 199 clinic patients in 
Marseille, France; 717 patients in a large health maintenance 
organization (HMO) network in Brazil; 226 nursing home patients 
in Marseille; more than 1,200 outpatients in New Jersey; 100 
long-term-care institution patients in Andorra; and almost 
8,000 patients across the entire country of Saudi Arabia. All 
of these studies showed about a 50-percent or greater reduction 
in risk of hospitalization or death. In fact, the Saudi study 
was, as I said, a national study, and it demonstrated a 
fivefold reduction in mortality for hydroxychloroquine plus 
zinc, the two of them used together, versus zinc and standard 
of care alone. None of these studies have shown a single fatal 
cardiac arrhythmia among the thousands of patients that were 
treated in these studies that was attributable to 
hydroxychloroquine.
    In fact, in addition to this, there have been six 
outpatient randomized controlled trials. We have heard a lot 
about this. These trials individually were small and incomplete 
and were stopped early, but together, when analyzed together, 
as we did, they show a statistically significant reduction in 
risk, and that is what matters. So that is the Ladapo paper, if 
that could be entered into the record also.
    This body of evidence for hydroxychloroquine dramatically 
outweighs the risk/benefit ratio for remdesivir, for monoclonal 
antibodies, and for the difficult-to-use bamlanivimab that the 
FDA has approved for emergency use authorizations (EUAs) while 
denying the emergency use authorization for hydroxychloroquine. 
This is an egregious double standard that FDA did on 
hydroxychloroquine that needs to be overturned immediately and 
its emergency use authorization application approved.
    I am restating that every outpatient study of 
hydroxychloroquine has shown benefit. There are no studies, as 
far as I know of as of last night, that are of high-risk use in 
outpatients that do not show benefit at all.
    Now we have spent the last 6 months with formal government 
policies and warnings against outpatient treatment. The 
government has invested very large amounts in vaccines and 
expensive new treatments which have yet to be proven, while 
there has been almost no support for evaluating inexpensive but 
useful medications. A quarter of a million Americans have died 
from this mismanaged approach. Even if we find that the 
vaccines eventually work effectively and safely, as we all 
hope, myself included, people will still get sick and die, and 
early outpatient treatment is still and will be continuing an 
essential part of ending this pandemic.
    Thank you very much.
    Chairman Johnson. Thank you, Dr. Risch.
    Our next witness is Dr. George Fareed. Dr. Fareed is a 
family medicine specialist in Brawley, California, with over 50 
years of experience in the medical field. He graduated with 
honors from Harvard Medical School in 1970. After two decades 
of teaching and researching in academia, he returned to 
clinical medicine and established a general practice. Dr. 
Fareed is currently the medical director and family medicine 
specialist at Pioneers Medical Center in the Imperial Valley. 
In the past few months, Dr. Fareed has treated countless COVID-
19 patients, both outpatient and inpatient. Dr. Fareed.

   TESTIMONY OF GEORGE FAREED, M.D.,\1\ MEDICAL DIRECTOR AND 
      FAMILY MEDICINE SPECIALIST, PIONEERS MEDICAL CENTER

    Dr. Fareed. Thank you. Mr. Chairman, Senators, and 
colleagues, thank you for----
---------------------------------------------------------------------------
    \1\ The prepared statement of Dr. Fareed appears in the Appendix on 
page 1201.
---------------------------------------------------------------------------
    Chairman Johnson. By the way, I know you have longer 
testimony. I know you have different attachments to that. All 
that will be entered into the record. Dr. Fareed.
    Dr. Fareed. Again, thank you, Mr. Chairman, Senators, and 
colleagues. Thank you for convening this hearing.
    I have a background in virology, as you mentioned, an 
academic background, research standpoint from work at the 
National Institute of Allergy and Infectious Disease (NIAID) 
and as a professor performing research at Harvard Medical 
School--after I graduated from Harvard in 1970, I became a 
professor there--and later at the University of California, Los 
Angeles (UCLA) School of Medicine. About 30, 31 years ago, I 
decided to go into clinical medicine, which is my real passion. 
I chose a rural area underserved where I thought I could make a 
difference. I have had experience in that 30 years treating 
human immunodeficiency syndrome (HIV) and other infectious 
diseases and practicing as a primary care medicine provider and 
being a hospitalist.
    My experiences during the pandemic treating COVID patients 
both in the COVID flu stage as outpatients and also as 
hospitalized patients in the ICU made me determined to prevent 
the COVID flu from progressing to the horrible, lonely cytokine 
storm suffering that I saw in the ICU, and I still see it. We 
accomplished this with what I present here today.
    Like everything else in medicine, the goal is to treat 
early. COVID patients are difficult to treat when they get very 
sick.
    The Imperial Valley where I work, where we work, became the 
COVID epicenter for California in June and July.
    Since early March both in my Brawley clinic and Dr. Brian 
Tyson's All Valley Urgent Care Clinic in El Centro, where I 
also work, over 25,000 fearful people were screened, over 2,400 
were COVID-19 positive, and we treated successfully over 1,000 
high-risk and symptomatic ones.
    The interesting thing to me is that Dr. Tyson and I 
independently came to the same protocol for that purpose back 
in March. We based it upon the great work from Dr. Zelenko and 
Dr. Raoult. They are our heroes, actually. It was a triple 
hydroxychloroquine cocktail: HCQ (3200 milligrams over 5 days), 
azithromycin or doxycycline and especially zinc, which is often 
left out in the studies. The cocktail is best given early, as 
Dr. McCullough has indicated, within the first 5 to 7 days 
while the patient is in the flu stage.
    The timing of the drug is when the virus is in the very 
active maximal replication phase in the upper respiratory 
tract, and our goal has been and still is to prevent it from 
entering the lower respiratory tract and to prevent 
hospitalization. We achieved this in over 1,000 patients, and 
that involved reevaluating them at 2-to 3-day intervals.
    We blend in corticosteroids and prolong the HCQ treatment 
for 5 or more days if symptoms warrant, but they generally did 
not and do not. We use it especially in the high-risk 
individuals, as Dr. McCullough indicated, those over 50 to 60, 
those with co-morbidities, or actually anyone with moderate to 
severe flu symptoms. We want to avoid the long COVID syndrome 
in all patients that happens after they recover. The healthy do 
not need the treatment.
    I used this regimen to treat 31 elderly nursing home 
residents in an outbreak in June, and 29 recovered fully.
    The drug works mechanistically through multiple actions: 
the ionophore HCQ (the ``gun'') and zinc (``the bullet''), HCQ 
blocks the sigma 1 receptor and has several other direct 
antiviral effects. The antibiotic also has an antiviral effect 
and potentiates the action of the HCQ and zinc. As additional 
anti-COVID agents become available, they can be added to this 
regimen to enhance its efficacy. We are routinely now combining 
ivermectin, which you mentioned, Chairman, in a quadruple 
hydroxychloroquine and Ivermectin (HCQ/IVM) cocktail with 
excellent results since ivermectin is safe and has a different 
anti-COVID action. This becomes analogous to the use of 
multiple agents for HIV treatment. Monoclonal antibodies from 
Regeneron and Lilly will be suitable also when readily 
available.
    The results are consistently good, often dramatic, with 
improvement within 48 hours. We would not have stayed with this 
if it were not helping people and always reliable.
    We have seen very few hospitalizations. We have seen not a 
single negative cardiac event.
    Our experiences are in line with all the studies that Dr. 
Risch has mentioned concerning early use of the HCQ cocktail.
    Let me be clear. This is only about the science--the 
science of viral replication, the science of the stages of 
COVID, and the science why early treatment works. Early 
treatment has led us to actually try to communicate our 
approach, and we think it should be on a national level. We 
wrote a letter with my colleagues to the President, a letter to 
Congressmen, a letter the to California Health Department, an 
Open Letter to Dr. Fauci, and a National Plan for COVID-19.
    As we describe in the National Plan, this approach would be 
part of the solution to the pandemic: protect the vulnerable, 
and if high-risk individuals get sick, there is a solution for 
them with early treatment with the antiviral cocktail.
    If early treatment becomes widely available, people will be 
much more confident going back to work and sending their kids 
back to school.
    Thank you.
    Chairman Johnson. Thank you, Dr. Fareed.
    Our final witness is Dr. Ashish Jha. Dr. Jha is the dean of 
the Brown University School of Public Health, a practicing 
physician, and a health policy researcher. Dr. Jha received his 
M.D. from Harvard Medical School and his M.P.H. from Harvard 
T.H. Chan School of Public Health. In 2013, he was elected to 
the National Academy of Medicine. Dr. Jha is a globally 
recognized expert on pandemic preparedness response, has led 
ground-breaking research regarding the Ebola response, and is 
now on the front lines of the COVID-19 response effort. His 
research focuses on improving the quality and cost of health 
care systems with a specialization on the impact of public 
policy on these systems. He currently practices as a general 
internist at the Veterans Administration Medical Center in 
Providence, Rhode Island. Dr. Jha.

 TESTIMONY OF ASHISH K. JHA, M.D., M.P.H.,\1\ DEAN, SCHOOL OF 
                PUBLIC HEALTH, BROWN UNIVERSITY

    Dr. Jha. Good morning. Chairman Johnson, Ranking Member 
Peters, I am sorry I cannot be there with you in person today, 
but it is my honor to be part of this hearing.
---------------------------------------------------------------------------
    \1\ The prepared statement of Dr. Jha appears in the Appendix on 
page 1203.
---------------------------------------------------------------------------
    As you have heard, we are entering the most difficult days 
of this pandemic, and so I am so pleased that the Committee has 
met to discuss the value of outpatient therapies, treatments 
that can begin early in the disease course. By treating people 
early, we can prevent hospitalization and save lives. The good 
news is that there are outpatient therapies that are being 
evaluated, and we should be hopeful, I am hopeful that some of 
them will work.
    One area where outpatient therapy has largely not been 
useful is hydroxychloroquine. Earlier in the year, the FDA 
issued a surprising emergency use authorization for this 
medicine, and as subsequent data came in, the EUA was revoked 
because it became clear that hydroxychloroquine was unlikely to 
be effective for COVID-19. Was the FDA justified in issuing an 
EUA in March? I believe it was not.
    EUAs are contingent on three interrelated questions.
    First, is there sufficient data to even make a judgment? Do 
we have enough evidence?
    Second, do the potential benefits outweigh the risks?
    Finally, will there be an opportunity to collect more data 
over time so we can refine any EUA decisions?
    For hydroxychloroquine, there was not sufficient evidence, 
and the evidence that was there certainly did not suggest 
benefits would outweigh the risks. The basis for the 
hydroxychloroquine EUA was some laboratory studies and really 
ultimately one small nonrandomized, nonblinded study of 
hospitalized patients in France, findings that were later 
discredited, and the scientist who led that work is now facing 
disciplinary actions.
    Since then, dozens of studies have examined the efficacy of 
hydroxychloroquine, and here is the bottom line: Every single 
high-quality study has failed to find any benefit of 
hydroxychloroquine for COVID-19, and I have to say I am 
disappointed. Hydroxychloroquine is a cheap and widely 
available medicine. Had it been effective, it would have been 
made an enormous difference in this pandemic. Unfortunately, it 
is not effective, and it has not made a difference. There is 
now clear consensus in the medical and scientific community 
based on overwhelming evidence that hydroxychloroquine provides 
no benefit in treating COVID-19, including in the outpatient 
setting.
    Let us talk evidence. A large randomized controlled trial 
published in the New England Journal of Medicine found no 
benefit of hydroxychloroquine given to outpatients who had been 
exposed to Severe Acute Respiratory Syndrome (SARS) CoV-2. The 
recovery trial found higher rates of death among hospitalized 
patients on hydroxychloroquine. But this included people whose 
symptoms had begun within the past 7 days, that early phase of 
the disease that Dr. Risch talked about. Other inpatient trials 
have found similar results.
    There are outpatient high-quality, randomized, double-blind 
controlled trials, and they have also failed to find a benefit.
    Now, Dr. Risch talked about observational studies, and we 
should talk about observational studies. Can they be helpful? 
The answer is they can. Now, we do not generally use them for 
treatments because we want high-quality data, but maybe it is 
possible to use high-quality observational studies. High-
quality observational studies require control groups that are 
comparable and use sophisticated statistical techniques and 
look for things like natural experiments to help us understand 
whether something is likely to be useful.
    I am not aware of any observational study of 
hydroxychloroquine that is of particularly high quality. For 
every poorly done observational study that shows benefits, we 
can find poorly done observational studies that show harm.
    The way out of the low-quality evidence quagmire is to 
generate higher-quality data. It turns out the history of 
medicine is replete with treatments that we all thought worked 
but turned out not to. Anecdotal evidence, it turns out, is not 
actually evidence. The miracles of American medicine have come 
from applying rigorous scientific standards to our ideas. Each 
time hydroxychloroquine has been subjected to such a test, it 
has failed.
    Let me make two more points as I finish up.
    One is that I am often asked by people, in the middle of a 
crisis, how can it hurt? The FDA issued its EUA for 
hydroxychloroquine in March of this year. In April, there was a 
93-percent increase in related calls to the U.S. Poison Control 
Centers. These things can hurt.
    Finally, a word about the EUA process. When the FDA's 
scientists are left alone to examine the science and data, the 
process largely works. They understand the urgency of the 
moment and the need for faster approvals. But authorizing 
therapies due to political pressure or with little to no data 
does far more harm than good.
    As a physician, I have been troubled by the politicization 
of hydroxychloroquine. It is a potential therapy. We should 
study it, and if it works, we should use it. If it does not, we 
should not. But I have to be honest. Given the dismal failure 
of hydroxychloroquine to date, there is little scientific basis 
to think it will be effective for anybody. At this point in the 
pandemic, with so much suffering and death, we should focus our 
efforts on promising approaches to help Americans get through 
this crisis.
    Thank you very much.
    Chairman Johnson. Thank you, Dr. Jha.
    As I said in my opening statement, I kind of figured this 
was going to not necessarily be as broad a discussion based on 
other early treatments, and we are going to get into a dispute 
on hydroxychloroquine, so I guess so be it. Obviously, we have 
a huge disconnect between testimony here, between experts, 
Harvard-and Yale-educated doctors and PhDs.
    Dr. McCullough, I know the 93-percent increase in poison 
reportings sounds pretty scary. You had mentioned before the 
hearing a little bit about what that is based on. Can you talk 
about that? Also, I guess you have had COVID. You have 
recovered from it--not totally. You tested negative, so you do 
not represent a danger. But can you, first of all, talk about 
that 93-percent increase in poison reportings? And then also 
just talk about your own personal experience with your own 
treatment.
    Dr. McCullough. Senator, I want my testimony to clearly be 
on the record that I think Dr. Jha's testimony is reckless and 
dangerous for the Nation, and his comment regarding the Poison 
Control reporting is exactly what Dr. Peters is interested in. 
You are interested in misinformation regarding COVID. In the 
middle of the pandemic, when hydroxychloroquine early on was 
appropriately used, that first wave of the pandemic, that is 
what kept it from skyrocketing. Hydroxychloroquine was widely 
used early on. That is what kept the March, April, May curve 
down, OK? When it was used. We had 500,000 dose administrations 
of hydroxychloroquine. The Poison Control Center received, I 
think the number was, 77 additional calls. When the reviewer 
looked at it, two-thirds of them, somebody took an extra dose, 
and they were concerned.
    So it boiled down to 17 cases out of over 500,000 
administrations, and yet Dr. Jha holds that up to the American 
public as a scare point, to scare the public away from a safe 
and effective therapy for COVID-19.
    As you mentioned, I had it myself. I am 57. I have asthma. 
I have atherosclerotic cardiovascular disease. I can tell you, 
Senator Peters, I was not falsely reassured sitting at home. 
Believe me, when I got that test result, I was terrified. Every 
American is terrified. Every older patient with heart and lung 
disease, when they get the report, they are not falsely 
reassured and sit at home and think this is going to be a 
picnic. They are scared to death. By the time they come to the 
hospital, it is frank terror because they know they are going 
to be isolated, and they will never see their family members 
again.
    What did I do? I did the right thing. I got myself rapidly 
into an FDA-approved treatment protocol through a study--hard 
to do, by the way, because the government offers no resources 
to the public to quickly get into clinical trials. I got into a 
clinical trial. I took hydroxychloroquine as part of a multi-
drug sequenced program, which is exactly what is in the peer-
reviewed literature, which is the framework of how Americans 
should be treated.
    While I was a few days behind in recognizing what was going 
on, the virus got into my lungs. I had pulmonary involvement, 
and I got anxious. I got to the point where I thought maybe I 
could be hospitalized. I can tell you firsthand this cocktail 
of drugs works for sure, but hydroxychloroquine dose by dose 
settles down that fever, reduced the amount, the severity 
intensity of symptoms. By that mechanism, that is the reason 
why hydroxychloroquine reduces hospitalizations and death. When 
patients get anxious and they cannot breathe anymore, they go 
to the hospital.
    This is not complicated. There are over 100 studies. They 
are all supportive. The EUA says when the preponderance of 
evidence shows the drug works and has acceptable safety, we 
ought to go. My view is we need to go with this on everybody 
high-risk in America.
    Chairman Johnson. Dr. Risch, when you listen to Dr. Jha, he 
sounds very authoritative. Do you have a response?
    Dr. Risch. Yes, thank you. I think that what I said early 
on about the conflation of hospital with outpatient studies is 
apparent, that there has been lots of studies, and there is no 
doubt that there are plenty of hospital studies, and some of 
those hospital studies indeed show no benefit, if not harm. 
There are reasons for that, and I do not want to get into the 
technical issues of these studies, but just to say it is 
irrelevant. Studies of hospital patients are irrelevant. We are 
considering outpatient disease and outpatient treatment, 
treatment that starts in the first 5 days. There are only seven 
studies. Now Dr. Jha says, oh, well, these are not high-quality 
studies. But, in fact, they are high-quality studies. These are 
controlled studies. They are tantamount to randomized except 
that the patients chose whether to take the medications or not, 
consulting with their doctors.
    Now, you may say, well, couldn't that lead to biases? The 
answer to that is yes, but the bias is that when patients are 
sick they are more likely to take the medication they are 
offered, and when not quite as sick but they know they have the 
virus, they will say, ``Maybe I will just see how it goes, and 
maybe I will not have to take the medications.'' And so what 
you have is a built-in bias to doing worse for the people who 
take the medications. In spite of that built-in bias, the 
patients do better. The studies in Brazil and the various other 
studies all show that the bias there is against finding a 
benefit of the drugs, and in spite of that bias, the studies 
show benefit of the drugs.
    Furthermore, these studies all measure all of the different 
variables about the State of the patients, both on the 
conditions, the chronic conditions that they have, about the 
progression of their illness and so on that reflects how likely 
they are to be hospitalized or not, independent of the drug. 
The studies address that by what we call ``statistical 
adjustment.'' So these studies--we are not back in 1950 doing 
epidemiology. We are back in 2020 doing epidemiology where we 
know all of the advanced statistics and all the methods for 
removing potential biases in these kinds of studies. These are 
the studies that were done and how they were analyzed, and 
these are what studies show the benefit, and these are the 
studies--the kinds of studies that the Cochrane organization, 
the Cochrane Library Consortium, compared in tens of thousands 
of studies of modern epidemiologic studies, compared those 
kinds of studies to their corresponding randomized trials and 
showed no difference. You cannot label these studies as poor-
quality studies and give a blanket on that. If you want to say 
a study in particular is poor, as the original study of 40 
patients in Marseille was that no one is now including, that 
was a motivating study but not an evidential study, that there 
is--no one is claiming these are poor studies. These are good, 
modern studies. The only difference is the randomization which 
instead we adjust for and have shown by the Cochrane analysis 
that they are equivalent to randomized trials.
    Chairman Johnson. OK. We do need to stay on time, so my 7 
minutes are up. But I do want to just quickly go to Dr. Fareed. 
I would ask the witnesses to kind of watch the clock as you are 
answering questions as well to stay on time. But just very 
quickly, Dr. Fareed, do you believe you put any of your 
patients at risk by treating them the way you have? As a doctor 
who looks at patients with compassion, do you believe it would 
have been better for you to do nothing and just send your 
patients home with no treatment whatsoever, hopefully to 
survive this without having to go in the hospital? Can you just 
kind of comment on that?
    Dr. Fareed. I am concerned for safety of my patients, and I 
have not ever wanted to put any patient at risk. I was 
concerned early slightly, but not very much, because of the 
results I had researched, and my colleague also, Dr. Tyson, had 
taken the same approach. The answer to your question is that I 
have no qualms, no concern whatsoever. I am very pleased to put 
the patient on the protocol and to enhance it with the other 
agents that we can blend in, because I know they will get 
better, and they are so appreciative. It is very gratifying, 
quite frankly. It is almost like being--I treat HIV patients, 
and it has been very gratifying to treat HIV patients because 
they can go into complete remission. When I started, it was a 
full-blown epidemic, and people were dying right and left. But 
now for COVID-19, I am happy to get a call from Kansas or 
somewhere else where the doctors are not providing them with 
treatment and to immediate call it in, because I know it is 
safe and it is only going to help.
    Chairman Johnson. OK. Thank you. Again, I believe patients, 
Americans, have the right to try these things that have already 
been FDA approved. Senator Peters.
    Senator Peters. Thank you, Mr. Chairman.
    I have a number of questions for Dr. Jha. Dr. Jha, since 
the start of this pandemic, there have been reports of pressure 
by this White House on both the CDC and the FDA to influence 
what should be independent, evidence-based public health 
decisions. Dr. Jha, my first question is: What impact does 
political interference have on our Nation's ability to 
effectively respond to a health emergency?
    Dr. Jha. Senator Peters, thank you for that question. 
Science has always been bipartisan, and we have seen the 
scientific agencies--the Food and Drug Administration, the 
CDC--be safeguarded from politicization under President Bush, 
under President Obama. These agencies have largely been left to 
do their job because we believe and we know that the American 
people benefit when the best scientific minds apply their 
expertise to the problems at hand. I believe that in each of 
those administrations, you could disagree with policy ideas, 
but the fundamental underlying scientific work of those 
agencies was always left intact.
    That has been different in this administration. We have 
seen the CDC pressured not to speak out about things where the 
evidence is very clear on certain issues. We have seen the FDA 
be pressured around emergency use authorizations, for instance. 
What happened with convalescent plasma with Dr. Stephen Hahn 
going to the White House and saying things that were clearly 
not accurate, and everybody in the medical community knew they 
were not accurate was baffling. I think it was upsetting 
because throughout my entire medical career, saying something 
like, ``This is FDA approved,'' was a gold standard. It meant 
that it had gone through a vigorous scientific review and had 
passed that review. Those words have become less powerful now.
    I believe that politicization of our scientific agencies 
has hampered our response. It has made it far less effective. 
It is one of the reasons why America continues to have one of 
the worst responses in the world with 250,000 Americans dead 
and more than 11 million Americans infected with this virus.
    Senator Peters. Dr. Jha, last month I released a report on 
the development and the distribution of COVID-19 vaccines which 
found that the administration's politicization of the COVID-19 
response that you have just referred to has actually 
contributed to a sharp decline in Americans' receptiveness to 
an eventual vaccine.
    My question to you, Dr. Jha: Would you agree with that 
conclusion? What can the Federal Government do to rebuild trust 
and ensure Americans can feel confident that any vaccine 
authorized or approved by the FDA is one that they should feel 
comfortable taking?
    Dr. Jha. Yes, Senator Peters, I would first begin by 
talking about the whole vaccine development process, which I 
think has been done with incredible scientific integrity. It 
has been done extremely well, overseen by this White House, and 
I think the science behind what has happened, the partnership 
between the Federal Government and academia and industry has 
been a model for how we should behave. On the one hand, I think 
that has been terrific.
    I think what has gotten us into a bit of trouble in the 
last couple of months is, as election time was nearing, you 
started hearing political leaders talk about having a vaccine 
before the election or pressures to get the vaccine out before 
the election. I think that created a real concern among the 
American people that we were not going to use a scientific 
timeline but a political timeline to make a decision. I think 
the FDA again has done a very good job. They laid out criteria 
for what they would need to see before they would authorize a 
vaccine. When those criteria are met, I expect that the FDA 
will authorize vaccines.
    Ultimately, if we want to build confidence with the 
American people, whether you are a Democrat or Republican, 
liberal or conservative, what you want to know is: Are 
scientists getting to evaluate the data and make scientific 
recommendations free of political pressure from any side of the 
political aisle? If we can let the FDA do that, I think it will 
go a long way toward building confidence in this vaccine.
    Senator Peters. Dr. Jha, misinformation and disinformation 
surrounding COVID-19 treatments and vaccine runs rampant across 
the Internet. Americans clearly need to have clear information 
about treatments that have been scientifically shown--and put 
the emphasis on ``scientifically shown''--to benefit patients 
and certainly not unproven remedies that you can find on the 
Internet. That is why I introduced the COVID-19 misinformation 
and disinformation task force. My question to you, Dr. Jha, is: 
What impact does false and misleading information about COVID-
19 treatments have on the American public?
    Dr. Jha. Yes, Senator Peters, this has been a huge 
challenge. We are facing the biggest global public health 
crisis of a century, and it has been compounded substantially 
by the sheer amount of misinformation and disinformation that 
is out there. In order for us to have gotten through this 
pandemic without suffering the staggering losses we have 
suffered, what we needed was collective action. What we needed 
was people pulling in the same direction guided by science and 
evidence.
    But when we have had things like politicization of mask 
wearing, we know that there is now very compelling evidence 
that if people wear masks in the right setting, it can make a 
very big difference. We know that social distancing can make a 
big difference in reducing infections. We know that testing and 
tracing can work. We have seen it in parts of the United 
States. We have seen it in other countries. But the 
misinformation makes it harder for people to know what is right 
and what is wrong. It makes it harder for people to know what 
the right thing to do is. That has really created a problem for 
us as an American people to do the things that will keep our 
population safe. The impact is obvious. The impact is, 11 
million Americans infected, 250,000 Americans dead. Right now 
we are in the worst phase of the pandemic.
    We can get out of this. We have more than enough capability 
and capacity as an American people, but the misinformation is 
really what is killing us at this point.
    Senator Peters. Dr. Jha, while the FDA has issued four 
emergency use authorizations for COVID-19, one has since been 
rescinded, and another has been criticized as premature due to 
weak data. The Government Accountability Office (GAO) report 
issued earlier this week found that FDA's decisionmaking 
process for issuing these emergency use authorizations lack 
transparency.
    Do you believe the FDA's EUA process is working as 
intended? What potential reforms should we consider?
    Dr. Jha. Yes, so the EUA mechanism is really important, 
right? Because in an emergency, you do not need nor do you want 
to necessarily wait for full approval that you might under 
nonemergency circumstances. But whenever you lower the bar of 
evidence, whenever you use an alternative mechanism, in order 
to build confidence with the American people--because at the 
end of the day, it is all about confidence; it is all about 
trust. What you need is a process that is transparent. What I 
believe we need to hear is less from the political appointees 
and more from career scientists, and what we need is very clear 
criteria. I think if those are things, those are guiding 
principles that we use, I have no doubt we can build back all 
of the confidence that has been lost in the FDA, in the CDC, in 
other agencies.
    But we have to go back to that. It has worked for us for a 
very long time, and we have to go back to first principles of 
transparency, openness, and letting the scientists do the 
talking and letting the scientists do the decisionmaking.
    Senator Peters. Thank you, Dr. Jha. I appreciate it.
    Thank you, Mr. Chairman.
    Chairman Johnson. Senator Romney.
    [No response.]
    Is Senator Romney no longer on?
    Senator Carper.
    [No response.]
    I will just go down the list. Senator Hassan.
    [No response.]
    Just to let the witnesses know, there is a--Lankford is 
available? I will go to Senator Lankford.

             OPENING STATEMENT OF SENATOR LANKFORD

    Senator Lankford. Mr. Chairman, thank you. For all the 
witnesses, I appreciate very much your engagement and for the 
work on this.
    There are obviously lots of questions just on the process. 
We have every confidence that there is work being done both in 
the science community, in the private sector, and in the 
Federal side, and, quite frankly, quite a few States as well 
that are trying to do what they can to be able to help in the 
process.
    The challenge that we have right now is trying to be able 
to get all these things happening at once. It has been a 
remarkable year for these things to be able to move.
    Much of what we have talked about today is an area that has 
not been discussed much, and that is, what can be done in the 
earliest phases of a virus, any virus, at this point COVID-19, 
SARS-2, to be able to help diminish its effects or its 
replication? We have talked a lot about how to protect each 
other by wearing a mask, which is a good idea; washing hands, 
all of those things. There is a lot of research going on on the 
mortality side. What can be done in the hospital once we have 
blood-thickening and inflammation in organs, all those things? 
But it is the in-between, and I appreciate the dialogue about 
the in-between at this point.
    What I would like to be able to talk about with the 
physicians that are here is just take a normal virus. What 
would you recommend for cold and flu season, whatever it may 
be, that individuals should take to be able to help their 
bodies fight off a normal virus? Then add to that what would be 
in addition to in particular what we have gained from this 
virus as well as we go through this? I just do not think there 
has been enough research and conversation about those two 
aspects. I would be interested in any or all of our physicians 
just answering those questions because I think that is the key 
issue. What is typical for a normal virus? What is helpful to 
help the body fight off a virus in your own system to fight it 
off? What are we finding helpful--even if it is only a little 
bit, what are we finding helpful with this particular virus? I 
will let everybody just take it in any order they want to take 
that in.
    Chairman Johnson. We will start with Dr. McCullough.
    Dr. McCullough. Thank you for the question, Senator. Let me 
say I think we should probably narrow the question to serious 
and potential fatal viral infections. So acute HIV, which is an 
acute serious problem, three to five drugs. Three to five 
drugs. Hepatitis C, three drugs, four drugs. Even shingles, 
acute shingles, which can be a real painful problem later on, 
two drugs. But the principle is always early.
    I cannot think of a single viral infection where the best 
advice is to wait 2 weeks before we start treatment in the 
hospital. That is the current NIH recommendations. Americans 
are appalled by this. We always treat serious viral infections 
with multiple drugs up front early. These are principles of 
treatment.
    Chairman Johnson. Dr. Risch, quickly.
    Dr. Risch. I would like to defer to Dr. Fareed, I think, on 
this.
    Chairman Johnson. Dr. Fareed.
    Dr. Fareed. That is a great question. It is, I believe, 
important for people to be proactive. We have learned a lot of 
what is good to help protect people from COVID-19, and what we 
have recommended to the general population where I practice is 
applicable to helping protect against other viral infections at 
this time, like influenza. That is a good, strong multivitamin, 
particularly zinc supplement, 15 to 25 milligrams a day, 
Vitamin D3, 2,000 to 5,000 units a day, and an antioxidant like 
quercetin or Epigallocatechin gallate (EGCG). That is a 
supplement that helps bring zinc intracellular, but they are 
helpful anticancer purposes, too.
    But beyond that, I think that I have learned so much from 
use of the cocktail, the hydroxychloroquine cocktail, that I am 
convinced that it is a broad spectrum antiviral that is so well 
tolerated. I see patients now that are acutely ill. They look 
like they are COVID-19. I treat them. They get better in 24 
hours, and then they are COVID negative. They have had some 
other virus, another rhinovirus or coronavirus or possibly 
influenza. We have learned a lot about the value of broad 
spectrum antiviral that is well tolerated, and I am a proponent 
of even making it useful for influenza.
    Chairman Johnson. Dr. Jha, do you want to chime in on this?
    Dr. Jha. I would love to. Senator Lankford, thank you for 
your question. So antivirals are tough. As opposed to 
antibacterial therapy where we have a broad set of antibiotics, 
antivirals take a long time to develop. It took us about 15 
years to develop antivirals that were really effective for HIV. 
It has taken us a long time to develop them for hepatitis C and 
hepatitis B. We do not have good ones for most outpatient 
viruses. If you think about the common cold, which thankfully 
is not fatal but can make you feel pretty lousy for a couple of 
days, we do not have good treatments for this outside of 
supportive therapy like Tylenol or other things that just help 
manage the symptoms.
    They are difficult to develop. I think we all agree, there 
is no question on this panel or among the entire medical 
community that finding early therapies for SARS-CoV-2, the 
virus that causes COVID-19, is absolutely critical. It would 
make an enormous difference. I had actually been early on very 
hopeful that hydroxychloroquine might be one of those things, 
that it would change the course of this disease. It just has 
not panned out, and there is a lot of work going on. There are 
a lot of things being said. I think we should continue studying 
them. When the evidence says that something works, we should 
use it. And when it does not, we should not.
    Senator Lankford. All right. That is very helpful. One more 
quick question in the minute I have left here. There is a lot 
of hope out there because of the vaccines that are coming. 
Obviously, we have two vaccines that are on the horizon 
quickly. They could be here by the end of the year with FDA--
pending FDA final approval in this process. We have four more 
in the queue at this point. That hope is--one of the 
misinformation pieces that is out there publicly is be scared 
because this was a fast-developed vaccine and so you should be 
frightened of it.
    I do not share that from what I have seen with my own 
oversight. I am pleased that there has been no short-cut in the 
science and the process on this, and it has gone through all 
the studies and such on it.
    Does anyone here have any concern on the vaccines that are 
coming at all that they have not gone through the proper 
science?
    Chairman Johnson. I would say the absence of response means 
nobody has a concern.
    Senator Lankford. That is how I would take that as well. I 
am pleased to be able to hear that, and I look forward to those 
vaccines actually coming to market and us moving forward in the 
days ahead.
    Gentlemen, thank you for your opinions. I appreciate your 
insight.
    Chairman Johnson. Senator Carper.

              OPENING STATEMENT OF SENATOR CARPER

    Senator Carper. Mr. Chairman, Ranking Member Peters, 
colleagues, and to our guests today, our witnesses, thank you. 
Thank you all for joining us. Thank you for what you do.
    About 8 months ago, almost to the day, our President said 
these words. He said, ``It is going to disappear one day. It is 
like a miracle. It will disappear.'' That was February 27th, 
earlier this year, and since that time, we have suffered the 
loss of 250,000 people in this country as of this week, 
250,000. Somebody's mother and father, grandmother, 
grandfather, aunt and uncle, child, nephew, niece, 250,000 of 
them.
    My colleagues have heard me say this rhetorical question: 
``Compared to what?'' Compared to Taiwan, 7; compared to South 
Korea, 498; compared to Singapore, 28; compared to New Zealand, 
25; compared to Australia, 907; compared to Japan, 1,908; 
compared to China, 4,500; India, 132,000; Canada, 11,000; 
Mexico, 99,000.
    If you add all those numbers up, we have actually suffered 
more deaths since the beginning of this year from coronavirus 
than all those other countries combined. We are four times the 
number of men and women who died in the Vietnam War. More than 
four times. All year long, this has been an opportunity for us 
to start being divided by this against one another, arguing 
about stuff. We ought to have done a better job of figuring out 
how to deal with it. We should be guided by science.
    Every now and then I hear a song on the radio, an old song, 
one-hit wonder, Thomas Dolby, and his one hit was ``She Blinded 
Me with Science.'' I have always said we ought to be not 
blinded by science but guided by science.
    As we can hear today, there is not absolute agreement on 
science, unfortunately. But there is one thing that we, I hope, 
can agree on. We need a vaccine, and we need it badly. We need 
a vaccine, we need a couple of vaccines, if at all possible. We 
need for them to work. We need to be able to reach out to 
people who are afraid to take any vaccines, including two that 
are 95 percent effective. We need to be able to message to the 
American people in the weeks and months to come so that when 
the vaccine is available, people will take it. Right now, about 
half the people in this country say they would not take it. We 
have to make sure that when it is available in great 
quantities, almost everyone will be willing to take it.
    The second thing that we need to do is to figure out in a 
country of 300 million people living in it, how do we get the 
vaccine distributed and administered to the people most in 
need? How do we make sure that they do not just get one shot 
but they get two shots? How do we do that? How do we keep track 
and do it in a way that increases the confidence of the 
American people in the way to deal with this?
    I would just suggest, as interesting as this hearing is 
today, what I think, Mr. Chairman and Ranking Member, I would 
just urge us to focus the hearing on, maybe in December, 
certainly in January, that actually focuses on how do we 
actually convince the American people that the vaccines are 
going to be safe, that they ought to take them? The second 
thing, how do we figure out the distribution system to be able 
to administer the vaccine successfully and quickly and 
effectively?
    I want to ask a question, if I could, of Dr. Jha. Great to 
see you. Dr. Jha, you talked today about the need for detailed 
vaccine distribution plans and public education campaigns to 
reverse universally high levels of vaccine hesitancy among 
Americans. I just referred to that. What steps do we need to 
take now to ensure that States have what they need in financial 
logistics, logistical and technological support to provide 
COVID-19 vaccines to every American who wants to be vaccinated?
    Dr. Jha. Yes, Senator Carper, thank you for that really 
important question. This pandemic is going to come to an end in 
2021, or let us just say we will bring it under control in 
2021, and we will do it through highly effective vaccines if 
they are widely distributed and accepted by the American 
people, because the old line, that vaccines do not save lives, 
vaccinations do, and there are many steps between a vaccine 
becoming available and Americans getting vaccinated.
    I think there are two broad sets of issues that really need 
addressing. First is getting States ready to receive the 
vaccines, to distribute the vaccines, to have a clear game plan 
for who gets it first, who gets it second, what the protocols 
are going to be, and how it is going to be distributed. Those 
are critical issues. I am talking to State health departments 
around the country, and there is a lot of confusion and lack of 
clarity about exactly how all of this is going to work. I think 
that needs to be dealt with effectively soon. Yesterday would 
have been a good day. Today is better. We have to get going on 
that.
    But the other part that goes beyond distribution is 
communicating with the American people about this, and I think 
where the other panelists and I may disagree about the value of 
science and scientific evidence for hydroxychloroquine, we all 
agree, everybody I know agrees that the scientific process 
behind the vaccines has been done with incredible integrity. We 
have to communicate that to the American people. We have to 
bring in trusted voices, religious leaders, civil society 
leaders, political leaders to voice that information, and help 
people understand and answer their questions about the 
vaccines.
    If we do all of that, I believe that Americans will be open 
to getting vaccinated, and most of them will step up to be 
vaccinated, and that is how we are going to bring this pandemic 
under control.
    Senator Carper. Thank you. Dr. Jha, a follow-on question. 
Minority populations are understandably skeptical about 
government-run campaigns, and mass vaccination surveys indicate 
that minority populations demonstrate significantly higher 
hesitancy than white Americans in receiving the COVID-19 
vaccine. How should Federal, State, and local governments work 
with these communities, minority communities, to improve their 
awareness and acceptance of potential vaccines?
    Dr. Jha. Yes, there is a really critical issue, Senator. 
There is a long history of distrust born out of some very 
troubling practices that have been directed toward minority 
communities. These areas of concern are not born out of 
nothing.
    I believe the best way to engage members of communities of 
color is through direct sharing of information, through 
openness and transparency, and through engagement of trusted 
voices. Because while the message is important, the messenger 
is every bit as much so. And so that does mean in my mind 
reaching out to religious leaders and political and civil 
society leaders in those communities, working through the 
evidence and data with them so they feel comfortable becoming 
advocates.
    Of course, we have to still do other things like make sure 
that we deal with financial barriers and eliminate them and 
other logistical things to make it easier. But it is really a 
combination of both those logistical financial issues, but also 
really getting trusted voices to address these things.
    Senator Carper. Mr. Chairman and Ranking Member, thank you 
for convening this hearing. Thanks to our panelists. Thanks 
very much, Dr. Jha, for those responses.
    I would again urge us maybe as early as next month to begin 
a series of hearings that focus on communicating, messaging, 
particularly to populations that are reluctant to take the 
vaccine. When half the people in this country say they are not 
going to take any vaccine, we have a lot of work to do.
    Chairman Johnson. Senator Carper, I am----
    Senator Carper. We have 300 million people to distribute it 
to. That is a lot of work to do, and we need to work together 
to make it work.
    Chairman Johnson. Senator Carper, I appreciate your 
questioning here, and I am happy to hold a follow-on hearing. I 
am happy to schedule it right away. But I will say that, I have 
heard it now said repeatedly that we have to convince the 
American public that the vaccines are safe. I do not recall 
anybody on my side of the aisle questioning the safety of the 
vaccine process. That seems to have been coming from elected 
officials on the other sides of the aisle and your Presidential 
and Vice Presidential candidates. If we have to repair the 
damage of the credibility of people's confidence in the 
vaccine, it is not because of what Republicans have said. I am 
sorry to say it is what folks on your side of the aisle have 
said.
    With that, Senator Hassan.
    Senator Carper. Mr. Chairman, let me just say, this is not 
a Democrat-versus-Republican issue.
    Chairman Johnson. You have made it that. Senator Hassan.
    Senator Carper. We have to work together. That is all I am 
saying.

              OPENING STATEMENT OF SENATOR HASSAN

    Senator Hassan. Thank you, Mr. Chair. Just checking my 
sound. Can everybody hear me?
    Senator Carper. Yes.
    Chairman Johnson. Loud and clear.
    Senator Hassan. Thank you. Thanks to our witnesses for 
being here today. Thanks to the Chairman and Ranking Member 
Peters for holding this hearing. But I would like to just start 
by expressing my deep concern over the President's decision to 
fire Director Krebs of the Cybersecurity and Infrastructure 
Security Agency (CISA).
    Director Krebs and his cybersecurity team helped protect 
our election infrastructure from cyber threats. Moreover, they 
did an admirable job of combating the plague of disinformation 
that some sought to push in order to undermine our election 
process, the bedrock of our democracy.
    Director Krebs' leadership at CISA is to be commended, and 
his firing is unwarranted and it makes our country less safe. 
The Director's firing and the future of CISA would be a more 
appropriate topic for a hearing in this Committee than what we 
are focusing on today.
    Now, turning to the topic of today's hearing, over the past 
2 weeks we have received encouraging news of potentially 
promising vaccine candidates. However, even under the best 
circumstances, researchers suggest that a vaccine will not be 
widely available until mid-2021. COVID-19 infections, 
hospitalizations, and deaths throughout the country have 
skyrocketed, and experts agree that we have a very difficult 
winter ahead of us.
    The Senate should encourage people to make evidence-based 
decisions about treatment and care and take precautions that 
keep themselves and their families safe, such as practicing 
social distancing and wearing masks.
    I have two questions to Dr. Jha. First, Dr. Jha, as we 
learn more about how COVID-19 is transmitted in communities 
across the country, it is becoming increasingly clear that 
small gatherings with friends and families are driving much of 
the spread we are currently seeing. It is understandable that 
people feel comfortable gathering with friends and family who 
they know and they trust, but I am concerned that Americans are 
not getting the information that they need to fully assess 
risks associated with these types of gatherings.
    Doctor, can you talk specifically about why it appears that 
these smaller types of gatherings have been such a driver of 
community spread and what steps people should be taking to 
reverse this trend?
    Dr. Jha. Senator Hassan, thank you for that question, and 
this is, in fact, a really troubling issue because, of course, 
we are at more than 150,000 infections a day. Hospitals are 
really starting to get full. When you look at where a lot of 
the spread is happening, as you said Senator, a lot of it is 
happening in people's homes.
    The reason is what we know about this virus at this point 
is that spread happens when people gather indoors and are not 
wearing masks. That is the major risk factor for spread.
    Now, it has been a long pandemic already, and a lot of 
people are tired. There is a sense that your home is your safe 
place, and I understand that sense. But when you invite friends 
and family, you again make the assumption that they are safe, 
and I understand that.
    The problem is that there is so much asymptomatic spread of 
this virus, there are so many people who spread the virus 
without even feeling any symptoms at all, and when you bring 
friends over, you get together or you have a meal, you share 
some drinks, and eventually, obviously, the masks come off and 
people get close because those are natural patterns that feel 
normal to us. That has become a major source of spread of this 
virus leading to a lot of infections and deaths.
    Beyond better communication under really stopping the 
disinformation and stopping the undermining of science, I think 
at this point the critical issues really are about telling 
people where the risks are and helping people make better 
decisions. This is not forever. This is really for the next few 
months until we have a vaccine.
    Senator Hassan. Thank you. I want to follow up on this. The 
risks associated with the pandemic have led millions of 
Americans to make the difficult decision to adjust Thanksgiving 
celebrations and other holiday gatherings. Many others, 
however, are still struggling to determine whether there is a 
way to travel or celebrate safely. What advice do you have for 
those who remain uncertain about whether to travel over the 
Thanksgiving holiday?
    Dr. Jha. Yes, Senator, this is one I have struggled with 
myself. During Thanksgiving we usually get together either with 
my in-laws or my own elderly parents, and I have thought a lot 
about is there a way to do it safely and have concluded I 
cannot figure out how to do that safely. As much as I would 
love to see my family, my extended family for Thanksgiving, I 
also want them around in 2021. I believe that household 
gatherings of people who are not part of your nuclear family, 
who do not live at home with you, is just very hard to do 
safely right now. I have come to the unfortunate conclusion 
that I am recommending to people that people not do that.
    They can get together outdoors if that is possible, go for 
walks, spend time outdoors with masks. But indoor gatherings, a 
traditional Thanksgiving family meal, I just do not know how to 
do that safely this year.
    Senator Hassan. My family is making similar determinations. 
The usual group of 30 of us who gather is not going to be what 
we are doing this year.
    Let me follow up with you. For those who will be hosting 
gatherings, if they do feel it is necessary for some reason, 
what specific accommodations and modifications to their normal 
plans do you believe are essential to help mitigate the risk of 
transmission over the holidays?
    Dr. Jha. Yes, so there are things that can be done to lower 
the risk. Again, in some places in the country, it may be 
possible to do it outside, and that would make an enormous 
difference. Keeping the number of people at a minimum, small, 
would be helpful. If you can keep windows open, have people 
wearing masks most of the time, sit somewhat separate for 
meals--none of this feels like a normal Thanksgiving. But this 
is not a normal Thanksgiving. We are in the worst pandemic in a 
century. The key here is while we want to enjoy a normal 
Thanksgiving, what we really want is our family and friends 
around in 2021 so we can celebrate with them once the pandemic 
really gets under control.
    Senator Hassan. Thank you for that, and thank you for your 
work and your advice. My family will be Zooming while we eat, 
which is going to be our way of sharing the meal. But thank you 
again for all you are doing to help keep Americans informed and 
safe.
    Mr. Chair, I yield the rest of my time. Thank you.
    Chairman Johnson. Thank you, Senator Hassan.
    Dr. McCullough has been trying to be recognized. I will 
give you a minute before I turn it over to Senator Enzi.
    Dr. McCullough. Senators, listening to that last exchange 
of questions and answers, I want my testimony to be clear. This 
entire hearing was about early treatment, and what those last 
set of exchanges showed is a complete lack of focus. It went 
over to the vaccine, and then it wandered over to wearing masks 
and even what is being offered at the Thanksgiving dinner.
    One of the reasons why America is failing colossally in 
handling the pandemic is a lack of focus exemplified by the 
last series of exchanges.
    Senator Hassan. Mr. Chair, I will just say that I think it 
is critically important that accurate information get out to 
the American people about what the best science tells us about 
avoiding getting the disease in the first place and taking 
precautions to keep our loved ones safe. That was the purpose 
of my questions, and I thank you for holding this hearing.
    Chairman Johnson. I appreciate that. What I have found, 
though, because I have heard the term ``disinformation'' thrown 
around in this hearing a lot, I know oftentimes those accusing 
somebody of doing something are even more guilty of doing 
exactly what they are accusing others of, and I will use the 
disinformation as an example. I was accused repeatedly of 
accepting and then disseminating Russian disinformation. I did 
no such thing, a completely false allegation, when, in fact, it 
was Senator Peters and his staff that introduced Russian 
disinformation into our investigatory records. I just get a 
little tired of hearing all the accusations coming from the 
other side, on the credibility of the vaccine. It is not 
Republicans that are questioning the validity of the science on 
the vaccines, the credibility of it. It is Democrats, and I 
need to put that on the record.

               OPENING STATEMENT OF SENATOR ENZI

    Senator Enzi. Thank you, Mr. Chairman, and thank you very 
much for holding this hearing. It is a different hearing than 
anything that I have seen and critically needed.
    Dr. Jha, I want to thank you for the positive comments 
about the speed of the process for a vaccine. We never hear 
that from the other side. When the media wants a person to 
fail, there is little recourse, and if this had happened in a 
nonelection year, it might be totally different. Politics has 
played a role in this.
    One of my first introductions to any kind of a pandemic was 
with AIDS, and I remember President Bush shocking all of us at 
a State of the Union speech when he said, ``We are going to 
spend $15 billion to solve the problem of AIDS in Africa and 
around the world.'' Now, back then, $15 billion was a lot of 
money. Not anymore. But as a result, I got to be involved in 
that process, and after it passed the House and the Senate 
unanimously, unamended, they sent me to Africa to see what the 
problem was. I got to meet with some traditional healers. We 
would probably call them ``medicine men,'' the most powerful 
person in a tribe, because they can poison the chief and do 
their own autopsy.
    But I asked them what they had learned about AIDS, and they 
said, ``We now know that we should not bleed two people with 
the same knife.'' I do not think bleeding people was an 
acceptable method of solving the problems of the people that 
were infected.
    But at any rate, if this had happened in a nonelection 
year, I think it would have been different. I really appreciate 
you holding the hearing on what people can do when they first 
find out that maybe they are infected. That is always when we 
have tried to do something, even with critical things like 
cancer. Early treatment has been important. We have not had any 
discussions on early treatment. I appreciate all this 
information on early treatment. Some of it works, some of it 
does not. That is with everything that we know about when you 
get sick. Some of it works, some of it does not.
    But when people are thinking that maybe they are going to 
die, they would like to have some kind of a solution. They 
would be willing to try some things. But obviously good news 
does not sell because you will not see it anywhere. People are 
not looking for next year's answer. They are looking for this 
year's answer.
    Yes, they are trying to figure out how they can get 
together for Thanksgiving. My family is trying to figure that 
out, and I see a real state of panic, mostly because they think 
that until the vaccine comes out, there is no answer. Thank you 
for answers of what can be done, and as far as studies, actual 
use is probably a pretty good study.
    Dr. Fareed, could you repeat once more what this cocktail 
is that you have been using and what the results have been?
    Dr. Fareed. Yes, I would be happy to. The cocktail 
developed from the work of Drs. Raoult and Zelenko who are our 
heroes consists of hydroxychloroquine. The actual algorithm now 
that is promulgated by the American Association of Physicians 
and Surgeons presents the details but our cocktail may be a 
little bit different, and there is flexibility. It consists of 
hydroxychloroquine that we found 100 percent effective, 3200 
milligrams over a 5-day period, and then doxycycline, 100 
milligrams twice a day for 5 to 7 days, or azithromycin, 500 
milligrams once a day for 5 days, and zinc that is extremely 
important. We have been giving a rather high dose, but it is 
very well tolerated, 50 milligrams three times a day for that 
5-day period.
    So that is it. It is simple and it is extremely well 
tolerated.
    Senator Enzi. How can people get these early intervention 
drugs? Are they strictly prescription? How would you go about 
it? How would you get your doctor to prescribe it?
    Dr. Fareed. The doctor prescribes hydroxychloroquine, and 
there is a growing acceptance among pharmacies to dispense it. 
There was quite a problem early on because of the stigma that 
was applied to it, and misunderstandings. But in any case, the 
hydroxychloroquine is a prescription agent in the United 
States. In other countries, it is over the counter. There are 
countries now that are dispensing packets that they take home, 
that they provide off the shelf to contain all of the 
components, including this ivermectin that is another 
attractive agent for anti-COVID purposes. But if they do not 
have the hydroxychloroquine, they can take a flavonoid like 
quercetin or EGCG that are antioxidants that help bring zinc 
into the cell, and that is what actually is an antiviral 
component of the treatment, one of them. But the quercetin can 
be taken three times a day, and that is over the counter, 500 
milligrams three times a day during the acute infection. But it 
is much more effective using the agent that has multiple 
actions as an antiviral hydroxychloroquine.
    Senator Enzi. Dr. McCullough, would you be willing to 
provide us with a copy of that chart that you have?\1\
---------------------------------------------------------------------------
    \1\ The chart referenced by Senator Enzi appears in the Appendix on 
page 1582.
---------------------------------------------------------------------------
    Dr. McCullough. Let me just say----
    Senator Enzi. And to comment on this?
    Dr. McCullough. The word ``science'' has been used multiple 
times in the hearing. In medicine, we have a fair scientific 
process of vetting, and that is called ``peer-reviewed 
publication.'' What I am holding up is a peer-reviewed 
publication of a treatment algorithm that was fully vetted by a 
journal listed in the National Library of Medicine. The first 
version was in the American Journal of Medicine. This updated 
version will appear in the proceedings of the Baylor University 
Medical Center. This is the best available science, and as a 
doctor, the accumulation of a doctor's career on science is 
actually their publication record. At this hearing, I hold the 
senior publication record. Dr. Jha, the minority witness, has 
never published on the treatment of COVID-19 at home. There is 
evidence to support each and every one of these components.
    I would say in addition to Dr. Fareed, because you look 
like you are older and maybe a patient that would be in my 
practice as a cardiologist, I can tell you that it is likely, 
in addition to what he mentioned, you would get to the second 
or third levels of the protocol, which would involve the use of 
steroids as well as blood thinners. For my patients who have 
heart or lung disease, kidney disease, who are ill, typically 
in their 70s and 80s, it is going to involve four prescription 
drugs, all of which have support from the scientific evidence. 
What the hearing is, this is a call for not just a small group 
of innovative doctors and researchers, but for the broad 
medical community. We have a million doctors and half a million 
nurse practitioners sitting on the sidelines right now. Their 
patients are calling them, and they are saying, ``We do not 
know what to do. The government is telling us to do nothing. We 
do not treat COVID.'' We are building up to mass panic in the 
United States. I do not hear a sense of urgency on this 
Committee call at all. We are weeks away from mass panic and 
massive mortality. People are talking about Thanksgiving 
dinner. Come on. There are so many infected people now. Labs 
are hitting 20 percent positive rates. That means the number of 
people coming to the lab that are testing positive is 20 
percent, and the average person infects many more people. This 
is a massive calamity that is right around the corner, and I am 
asking them, pleading for the Senate and America right now, in 
between administrations, which is a very vulnerable time, to 
not absolutely get clobbered with a tsunami of mortality, 
particularly for our elder citizens.
    Senator Enzi. I know I have run over, but I think I am the 
last person, so I would like to ask Dr. Risch a question.
    Senator Rosen. Senator, you are not the last person.
    Chairman Johnson. I realize that, but I will give him 
another minute here.
    Senator Enzi. Sorry. Dr. Risch, is there any of these kind 
of studies about the effect of blood thinners? If people are on 
blood thinners already, do they have less incidence of having 
COVID?
    Dr. Risch. That is an interesting question. I am not 
familiar with studies of existing patients. I have seen one 
hospital-based study of a difference in benefit between regular 
heparin as an anticoagulant and another drug, enoxaparin, and 
the enoxaparin showed a two-third reduction in mortality in 
this one study. It is promising to look at. I do not know 
whether it would be useful in regular use as outpatients. The 
clotting mechanism is complicated in COVID, and we are not 
really fully on top of it, and so we try a number of different 
medications for anticoagulation, including aspirin.
    Dr. McCullough. I can follow up on that and just enter into 
the record Billett,\1\ et al., 2020, 3,625 patients who were 
treated with low-molecular-weight heparin or novel 
anticoagulant drugs. There was a 50-percent relative risk 
reduction for mortality. So blood thinners in high-risk 
patients--in fact, we have published on this. There is a 
stratification that we can identify who is more likely to need 
these blood thinners, and they are older patients with heart 
and lung disease, and there is a dramatic benefit.
---------------------------------------------------------------------------
    \1\ The article referenced by Dr. McCullough appears in the 
Appendix on page 1590.
---------------------------------------------------------------------------
    So early sequenced multi-drug therapy is not all about 
hydroxychloroquine, and it is not all about the virus. It is 
handling the complications that the virus creates.
    Dr. Fareed. Could I just----
    Senator Enzi. Thank you all for your----
    Dr. Fareed. In our protocol, we start the patient on 
aspirin, enteric-coated aspirin at the beginning, 325 
milligrams every day, and that is found to be very helpful for 
prevention of a coagulation problem.
    Senator Enzi. Thank you all for your positive answers.
    Chairman Johnson. Senator Enzi, thanks for attending the 
hearing. And you know, as I have spoken in conference, I have 
been pushing early intervention, early treatment, whatever it 
is, whatever works, because to me that was going to always be 
the key component of ending this COVID crisis, and we have 
ignored it. It has baffled me, and I will just point out again 
maybe part of the reason is the hydroxychloroquine cocktail--it 
is about $20, right? Certainly no more than $50. Remdesivir--
and we will talk about that a little bit later in terms of the 
side effects of that and studies, the science behind that--
costs over $3,000. Could that maybe be one of the reasons why 
all the effort is put on these more exotic therapeutics that 
cost thousands of dollars versus something that is off the 
shelf that costs $20? Something to consider. Senator Rosen.

               OPENING STATEMENT OF SENATOR ROSEN

    Senator Rosen. Thank you, Mr. Chairman, and I want to thank 
all the physicians here. I know that your dedication, the 
reason you went into medicine, your dedication and care and 
commitment to your patients and to their recovery is--I can 
hear it; I can feel it. I am happy for the robust discussion.
    But one thing that I would like to bring up that I think is 
key to possible early treatment is robust testing. I want to 
talk about our at-home testing options because this could be a 
critical component before you wait to have some more difficult 
symptoms, because COVID-19, of course, like you said, is 
spreading rapidly. We are about to hit the holiday season. 
These are events for a highly contagious disease, and we need 
to do more at the Federal level to support testing, prevention, 
and the treatment options, and some things that we can deliver 
at home that perhaps you can then be on the lookout if your 
symptoms begin to get more difficult or if you have some other 
underlying co-morbidities that may contribute to a bad outcome 
for this disease.
    Dr. Jha, could you please speak to how widely available a 
rapid at-home test might change the way that people access 
tests and how it might change the way that doctors can do early 
intervention depending on whether you have cardiac issues or 
other issues, asthma, whatever that may be? We know FDA just 
announced this week that the prescription at-home test is 
positive news. How close are we to other types of saliva tests 
that people might be able to give themselves over the counter 
and help us get treatment for everyone, Dr. Jha?
    Dr. Jha. Yes, Senator Rosen, thank you for that really 
important question. There are many things we could have really 
done to change the trajectory of this pandemic, and one of them 
certainly would have been if we could have made widespread home 
testing available. If those tests were available, it would 
allow people to self-quarantine, and so they would not be 
infecting others. It would allow people to seek early 
therapies. One of the key points of this entire hearing is 
about early treatment. Early treatment is only possible if you 
get an early diagnosis. Our testing infrastructure really is no 
longer managing to be able to provide that.
    Now, I am heartened by the Lucira EUA from the FDA. It is 
really the first true home test, and it is going to be months 
before it is widely available, and it is going to be 
prescription only. What many of us have been calling for is 
toward new technologies that are emerging and available that 
would allow for widespread availability of home tests. That 
would make a tremendous difference, and they would be much 
cheaper. It has not happened. I believe we have the technology 
to do it, and we need those tests, but that is going to be a 
critical part of controlling this pandemic.
    Senator Rosen. I hope that this Congress, maybe in one of 
our packages we could fund that, because I do think that that 
would really help us, just give us another tool in the toolbox 
to tamp down the disease.
    Another thing that I want to talk about is treatment, but 
treatment also takes health care workers right across the 
medical spectrum, from people who would administer the test, 
read the test, analyze it, phlebotomists, technicians, and 
highly skilled physicians. I want to talk about our health care 
capacity, the role of our caregivers in this mix.
    I have a lot of bipartisan bills that provide tax credits, 
training, and support of caregivers and others that also 
support increasing our medical infrastructure, provider 
shortages, like our Conrad 30 program, extra graduate medical 
education (GME) slots, Federal funding for rural areas to 
improve nursing. Of course, all of this, more tools in the 
toolbox. Many people see our health care system kind of 
buckling under, and so what kind of investments would you hope 
that we might put forward in a future COVID package to support 
training across the medical spectrum to deliver vaccines and 
treatments and services and all of that? Because you cannot do 
it without support, right? Pharmacists, you name it. If you 
could address that, I think that is also key, too.
    Dr. Jha. Senator, absolutely, the health care system, we 
often think about it as hospitals and doctors' offices and 
pharmacies. But what it really is is nurses and doctors and 
pharmacists who work in these places. In fact, one of the 
things I have been very worried about is we are not paying 
enough attention to the health care workforce right now.
    For instance, when we think about hospital capacity in the 
middle of this surge, we often say, well, that hospital has 
plenty of beds available. Those beds are not going to do 
anybody any good if there is not a nurse to take care of a 
patient in that bed, if there is not a physician to take care 
of that patient.
    We have not been paying enough attention to health care 
workers. I think that point is absolutely critical, and I think 
finding ways of supporting them--obviously, a critical thing is 
we need to make sure they are protected, so personal protective 
equipment (PPEs), but there are more things that we could be 
doing.
    And then when I think about the distribution challenges--we 
have all talked about the incredible vaccines that are coming 
and the importance of getting them out quickly. We are going to 
want to vaccinate hundreds of millions of Americans over the 
next 6 months. They are going to have to be done in all sorts 
of places, including pharmacies, including doctors' offices, 
hospitals. We are going to have to find ways of training and 
supporting these workers who can actually deliver these kinds 
of services.
    In any package that supports the health care system, 
thinking about the health care workers first and really making 
sure that they are getting what they need is absolutely central 
to the success of such a package.
    Senator Rosen. Thank you. I see that I have just about a 
minute left, because I am trying to think about all the support 
systems for early detection, for treatment, for vaccines, 
whatever that is. I also think about in my community and, of 
course, communities across the country--families are struggling 
economically, and that means increased food insecurity and 
those other kinds of existential things that families need in 
order to stay healthy, even to get to a doctor in case they do 
not have health care, they have lost their job. Our food banks 
are Three Square, Food Bank of Northern Nevada, United Ways 
across the country doing that.
    Can you talk about some of the things that people should be 
able to do in their home? We talk about whether maybe vitamin 
supplements, other things that people might take. They are not 
even able to purchase those if they do not have a job. They may 
not even be able to put food on the table. That contributes to 
bad health outcomes, too. Please speak about that.
    Dr. Jha. I will say, Senator Rosen, that a critical part of 
this response is getting people through this time period. We 
have seen very long lines at food banks. We have seen people 
going to work in dangerous situations because they do not have 
any choice, because they have to put food on the table. In the 
middle of the biggest public health crisis of a century, I 
think all of us agree that helping people through this time 
period--we are not talking about forever. We are not talking 
about for years. We are really now talking about the next 3 to 
6 months as the critical period, making sure people have enough 
food, making sure people have access to health care. Those are 
central, because if people do not--people are going to make 
tough choices that will make the whole pandemic worse and 
really leave everybody worse off, certainly those individuals 
worse off.
    Any comprehensive strategy on pandemic preparedness and 
response needs to take in issues, exactly the ones that you 
have laid out.
    Senator Rosen. Thank you.
    I appreciate your indulgence, Mr. Chairman. I have gone 
over my time as well. But I like to think of it that we do not 
live in a vacuum, so there are other things that are going to 
help us succeed, and I want to be sure that we look at those, 
at whatever treatments are right, whatever vaccines, that we 
are prepared to have everyone get them and be able to get 
through this pandemic together as a country.
    Thank you.
    Chairman Johnson. Thank you, Senator Rosen.
    I have a number of questions that I will continue to ask. I 
think the point about testing, I think everybody agrees it 
would have been great to have hundreds of millions of tests 
available day one, but it is just not practical. It did not 
happen. This is not Star Trek where you just say, ``Computer, 
300 million tests.'' So it has taken time.
    What did not necessarily have to take time was using off-
the-shelf drugs for early treatment. But yet somehow, I guess 
it was because President Trump allowed the word 
``hydroxychloroquine'' to flow out of his mouth, all of a 
sudden that was attacked and that was poison. We never, ever 
had the NIH, CDC, FDA put their full weight behind an 
investigation of that the full clinical trials. I was pushing 
for that--not pushing hydroxychloroquine, pushing for the 
science, for studies, but it never happened because, again, it 
was censored. We talk about disinformation. Not providing the 
public information is disinformation as well.
    Again, why I fault the agencies is because they turned a 
blind eye toward simple, cheap, possibly effective treatments 
that, by the way, created no harm.
    Dr. Risch, I think you mentioned--I have a lot to go over 
here. You mentioned, I guess, the nonrandomized trials. I guess 
we would call that ``observational studies,'' ``real-world 
experience,'' really involving thousands of patients, indicated 
that there was a 50-percent reduction in hospitalization 
deaths; in the Saudi Arabia study, a five-time reduction.
    Now, let us just assume that that is true. I think we can 
also take a look at the billions of doses a year that are 
prescribed of hydroxychloroquine. Any Member of Congress who 
has gone to Africa, they have just been handed 
hydroxychloroquine as an antimalarial. We treat lupus, we treat 
rheumatoid arthritis. We do not give EKGs before that.
    The studies I saw early on were designed to fail in 
hydroxychloroquine, late in treatment when people were 
basically ready to die or when their heart was already affected 
by the virus. Of course, hydroxychloroquine does have an impact 
on arrhythmia at that late stage, but not early, which is when 
it was being recommended for early use, first 5 days.
    When you take a look at the risk-reward, now that these 
other observational nonrandomized trials have been--or studies 
have been conducted, 50 percent or a fivefold reduction in 
death and hospitalization versus the almost infinitesimal risk 
of hydroxychloroquine and zinc, this has made no sense to me 
whatsoever. The only explanation is the politicization of it, 
which I opened up my opening comments saying that has been such 
a shame.
    I do want to, before I forget, I received a letter and an 
article from the Economic Standard submitted by Dr. Steven 
Hatfill.\1\ The letter kind of explains what I have known about 
a whistleblower, Dr. Rick Bright, who was asked by his 
superiors to work on establishing an FDA expanded access 
investigational new drug protocol. But by his insubordination, 
he instead went to Janet Woodcock and people in the FDA and got 
the emergency use authorization, which sounds like, hey, we are 
going to expand the use of this. No, he dramatically restricted 
the use of hydroxychloroquine only in-hospital, when I think we 
all recognize it is probably not particularly effective, 
possibly dangerous, and only out of the national stockpile. He 
knew what he was doing. That is what poisoned the well. That is 
what created what I have called the ``prescription logjam'' 
here on hydroxychloroquine, and I think it affected all early 
treatment options. It took them off the table. We took our eye 
off the ball. That is why I say our agencies failed us. These 
individuals and these agencies failed us.
---------------------------------------------------------------------------
    \1\ The letter referenced by Senator Johnson appears in the 
Appendix on page 1226.
---------------------------------------------------------------------------
    Here is the question I want to ask for you, Dr. McCullough, 
because you mentioned this. The circle of empathy, can you just 
talk about how you described that to me before the hearing?
    Dr. McCullough. Let me just say, before I answer that, that 
this is not just a government culpability and malfeasance with 
respect to hydroxychloroquine. This is academic malfeasance. 
There were two fraudulent papers, one in the New England 
Journal of Medicine, one in Lancet, published by individuals 
interested in doing evil to the world with respect to a 
beneficial treatment of hydroxychloroquine. In an unprecedented 
manner, these two manuscripts were withdrawn after 2 weeks 
where they could scare the public and the world's physician 
audience.
    Since that time, there have been dozens of fraudulent----
    Chairman Johnson. Re-emphasize that. They were then 
withdrawn.
    Dr. McCullough. They were withdrawn, and the New England 
Journal of Medicine and Lancet acknowledged that they were 
fraudulent papers. They were scare papers to scare people on 
hydroxychloroquine. Since that time, there has been dozens of 
pile-on scare tactics in academics. This is not the government. 
This is people in my field, in academic medicine, who are 
committing academic fraud.
    I reviewed a paper--I am a cardiologist. I reviewed a paper 
that made it into the medical literature demonstrating that 
hydroxychloroquine causes a heart attack, that 
hydroxychloroquine causes a giant scar in the heart. I can tell 
you I am at Baylor in Dallas. We have the world's most 
recognized cardiac pathology program in the world. Our senior 
examiner has held in his hands more human hearts than anybody 
in the history of mankind. I can tell you firsthand 
hydroxychloroquine does not cause giant scars in the heart.
    Academic medicine is committing fraud; it is committing, I 
think, a crime against humanity. There must be a motivation 
behind this that is much bigger than just Democrat versus 
Republican. I am extremely concerned, honestly, about the 
academic contribution to scare tactics in the world.
    Now, it is not working everywhere. In India, it is given 
first line. India is such a crowded country. I have been there 
myself. Their deaths per million population is a tiny fraction 
of America.
    Chairman Johnson. Isn't it 95 versus over 700?
    Dr. McCullough. Yes, so we----
    Chairman Johnson. They are using hydroxychloroquine.
    Dr. McCullough. Right. We have nearly 800 deaths per 
million population in the United States, and we are all spread 
out. In India, they are on top of each other. They have less 
than 100 deaths per million population. The leading doctor in 
India is willing to come testify to the United States and tell 
you the reason why. They have tons of COVID. It is spreading 
like crazy. But they are treating it at home with 
hydroxychloroquine and other drugs. Remember, it is a multi-
drug program, probably about four or so drugs plus supplements. 
They have handled the infection.
    Everyone has traveled to Europe. Greece is not a Third 
World country. First line you are given hydroxychloroquine, OK? 
We have missed the ball. There are 30 countries that have 
approved an oral version of remdesivir called ``favipiravir.'' 
Thirty countries, including Japan. Every country that is 
actually having a reasonable public health response is treating 
this problem at home.
    Now, none of these drugs are a cure, but they allow the 
patient to get through the illness, like myself--I missed 10 
days off of work, and I returned to the workforce. I did not go 
to the hospital for 4 weeks. They allow people to stay at home 
and not go out and contaminate other people. My wife and I got 
it at the same time, and because we were treated at home, we 
were actually able to stay at home so we did not contaminate 
other people.
    The current program that is supported by the minority 
witness and the National Institutes of Health and all 
government bodies is that patients go home, they get no help 
whatsoever, doctors are not supposed to treat them. They go out 
in a panic to urgent cares and emergency rooms (ERs), 
contaminate more people, and then they are hospitalized and 
die. America has to wake up right here right now. We are 
getting buried, and we need home treatment.
    Chairman Johnson. OK. Dr. Jha, let me have you jump in 
here. We have Dr. McCullough, again, vice chair of medicine at 
Baylor, I believe Harvard trained; Dr. Harvey Risch train at 
Yale; Dr. Fareed, Harvard trained. Completely different 
assessment of literature and studies versus what you are 
talking about, and you say it with a great deal of authority.
    First, what is your opinion of these three gentlemen in 
front of us, these three doctors? This is not pejorative to you 
three gentlemen. Do you think they are just idiots?
    Dr. Jha. Senator Johnson----
    Chairman Johnson. Again, you are very authoritative in 
completely refuting what these three gentlemen are talking 
about. This is the disconnect, and this is what America needs 
to evaluate. OK? Tell me what your opinion of these three 
gentlemen are here.
    Dr. Jha. Senator Johnson, I do not know these three 
gentlemen. They are all clearly well qualified, they are 
clearly smart, and I believe they are all clearly committed to 
the right issues. I have no reason to doubt any of that.
    My problem here is not so much that we have a differing 
reading of the literature, which we clearly do. It is this idea 
that there is this broad conspiracy across, hundreds of 
thousands of doctors, the NIH, the CDC, all academic 
institutions, the Infectious Disease Society of America (IDSA), 
we are all in on this conspiracy to prevent Americans from 
getting a life-saving therapy.
    As you might imagine, pulling off a conspiracy like that 
would be extremely difficult. Doctors and academics are way too 
disorganized to pull off such a thing.
    Chairman Johnson. By the way, I never used the word 
``conspiracy.''
    Dr. Jha. I understand, Senator.
    Chairman Johnson. I do not think anybody on this--so quit 
using that word.
    Dr. Jha. OK, fair enough.
    Chairman Johnson. Something has happened where we have not 
devoted any time or energy or resources to doing what could 
have stopped this COVID crisis very quickly, and that is called 
``early intervention, early treatment.'' OK?
    Dr. Jha. Yes, so, Senator, I agree. I will not use the word 
``conspiracy,'' and I apologize if that was at all offensive. I 
did not mean it to be.
    The point is we have tried, there are ongoing randomized 
controlled trials of outpatient therapy. What I have said 
literally from March, when this issue first came up--and I have 
a long track record on this--is I hope this works, I pray it 
works; if it works, it is going to make a massive difference. 
The literature on this--it is not like no one has studied this. 
We have had multiple randomized trials, including some in the 
outpatient setting. They just have not worked, and----
    Chairman Johnson. But, again, so that is disputed. In your 
testimony, you came up--and I am telling you this is--I 
consider it disinformation and scare tactic, a 93-percent 
increase in reports of poisoning. Then you heard what Dr. 
McCullough talked--we are talking about out of about half a 
million people that took hydroxychloroquine, another 77 called 
in, and about two-thirds of that was because they thought they 
maybe took an extra dose and they were concerned about it.
    Again, you use a scare tactic of saying 93-percent increase 
in poisoning of hydroxychloroquine, when it is not even--it is 
an infinitesimal impact. But it is an enormous and I would call 
it ``disinformation impact'' in terms of your communication.
    Dr. Jha. Can I just have a chance to respond to that? First 
of all, I have never made the claim that the problem with 
hydroxychloroquine----
    Chairman Johnson. You made the claim that it was unsafe in 
your testimony.
    Dr. Jha. Sir, yes, I agree. Let me just finish that 
thought. I did not mention the 93 percent, because it is 
correct. I could have mentioned the fact that there have been 
more than 76,000 instances of toxicity reported to the World 
Health Organization (WHO) across the world from 
hydroxychloroquine during the middle of this pandemic.
    The bottom line is that every drug has some safety issues, 
including hydroxychloroquine. If it is effective, we should use 
it. To me, that is not the most compelling issue. Most of my 
testimony was about the effectiveness. Yes, I did throw in a 
statistic which turns out to be correct, and I could use 
others, but I do not think we should focus excessively on that. 
I think we should focus on the fact that the evidence so far is 
very clear that this therapy does not work. If future data show 
that it does, I will be delighted and be the first to promote 
it. But I have to be driven by the data and the science and not 
what I hope is to be true.
    Chairman Johnson. Again, there is a real dispute by the 
four members of this panel. I realize I selected three and 
Senator Peters, selected you. But there is a real dispute--and, 
by the way, these are not the only three people that--take a 
look at the potential risk-reward ratio here, take a look at 
the observational success, the firsthand knowledge of treating 
people with success, and realize really the risk-reward ratio 
would be in favor of give it a shot.
    Let me make this point, and then I will turn it over to 
Senator Peters. I see he is back onscreen here. I think me, as 
a human being, as an American citizen, with the freedom, with 
the bill that I helped pass, Right to Try, should have the 
right to access this without the interference of bureaucrats 
and the CDC, NIH, and the FDA. That is exactly what has 
happened. I cannot get it. Millions of Americans cannot access 
it because of the disinformation, the scare-mongering, and the 
prescription logjam that has been created by bureaucrats.
    So you can sit back and go, ``Oh, but, it has not been 
proven effective.'' They have never pushed trials to really 
analyze it, and I have some pretty eminent people in front of 
me that have looked at the observational data and completely 
dispute that.
    Now, you can sit there with all the authoritative voice 
that you possibly have, but we have some gentlemen here that 
are treating patients within that empathy circle, and they 
completely disagree with you.
    I will turn it over to Senator Peters.
    I guess he dropped off. Dr. Jha, do you want to respond to 
that?
    Dr. Jha. Yes, I do. I do, sir. Look, I think you can say, 
well, I disagree with Dr. Risch, and we have our disagreement. 
The way I generally tend to adjudicate these things--so I will 
read the literature, and I will form an opinion. But one of the 
questions I ask myself is: Am I missing the boat on this? It is 
always possible that any one of us can be wrong. At that point 
I look to consensus opinion among experts. For instance, on 
infectious disease issues like this, I will go to the 
Infectious Disease Society of America because they are made up 
of our leading infectious disease experts. IDSA does not 
recommend the use of hydroxychloroquine for outpatient therapy 
for COVID-19, and they recommend against it for inpatient 
therapy.
    I will turn to agencies like the National Academy of 
Medicine. I will turn to the National Institutes for Health. I 
will listen to people like Dr. Francis Collins.
    The point is that the idea is that these are all 
individuals with incredible expertise looking at the data. 
Could it be that I am wrong and Dr. Risch is right? Sure, 
people can disagree. But when you look at the broad consensus 
in the American scientific community, basically the scientific 
consensus is very clear that hydroxychloroquine is not 
effective.
    Now, when we have looked at it in the outpatient setting--
and I started with this in my testimony--we do not have great 
data on the outpatient setting. We have a small number of 
settings. But the best one of those show that it does not work.
    Could we get better data? Absolutely. Senator, I would love 
it if you would push for better-quality randomize trials----
    Chairman Johnson. By the way, I have. I have, and they 
would not do them. OK? I have had a direct pipeline to Dr. 
Hahn, and I cannot get them to do it, which, again, begs the 
question: Why not? That is why I say this has been an enormous 
dereliction.
    Again, what I would say, you can maybe turn to those 
different places, but as a patient myself, I wanted to get 
hydroxychloroquine, and I could not get it. OK? I think I 
should have the right to try in dealing with my doctor, who I 
trust, I am sorry, more than some of these people who are so 
outside the circle of empathy and for whatever reason. Again, I 
am sorry it is just me. I question the fact that because this 
cocktail costs about $20 and remdesivir costs $3,000, maybe 
there is a little bias. Maybe there is a little conflict. Maybe 
there is a little agenda that is outside of really what is 
treating a patient when you are in the ivory tower and you are 
not dealing with sick and dying and ventilated patients.
    Now I want to talk about remdesivir. The three of you here, 
talk about what the study was on remdesivir, how strong a 
science that is, and what kind of dangerous side effects 
remdesivir causes, and yet that is the drug that has been 
pushed. That is the one that got the emergency use 
authorization. Whichever one of you feel you are most 
qualified, talk about remdesivir.
    Dr. McCullough. I will just make a few comments, to just 
say that with any one of these randomized trials, even 
remdesivir, in my view, my judgment of the evidence is that 
they are all inconclusive. If you look at remdesivir, in many 
of the inpatient studies, do you know the endpoint that they 
use? They actually use an endpoint that the physician decides. 
The physician decides how much oxygen the patient needs, and if 
the patient changes in a grade of oxygen, they change on an 
ordinal scale. The entire randomized biopharmceutical complex 
right now is basically corrupt.
    The data on remdesivir are mixed, but I just had a patient 
die last week, who received remdesivir. The difficulty is it is 
too toxic. It causes liver toxicity. He had liver toxicity, 
cannot get through the five-dose administration, and the drug 
is administered too late. The problem is the virus was 
replicating 2 weeks ago. By the time that he got into the 
hospital, the virus has already done its job. It is a fool's 
errand to test a single drug like remdesivir late in the 
illness. This is no different than HIV. We need multiple drugs 
early up front, and the best we have right now are these mixes 
of vitamin supplements and then the generic medications, the 
best we have.
    Now, listen, the NIH has some oral drugs that they are 
sponsoring with pharmaceutical trials to move forward. If there 
is an oral drug tomorrow that can fit into a treatment 
protocol, it is ready to go. We can plug it right in. The NIH 
and biopharmaceuticals right now have delivered zero oral 
medications to doctors in practice. Zero. That is our batting 
average right now.
    For all the science we have put into this as a country, 
with the greatest pharmaceutical companies in the world, zero 
oral drugs for the next patient who gets sick with COVID-19.
    Chairman Johnson. Isn't it also true that in the study that 
was being conducted on remdesivir, very late in the trial 
because it was showing no improvement in terms of reducing 
deaths, but it was showing improvement in terms of reduction of 
number of hospital days, that they actually switched, the 
outcome that they were going to judge the----
    Dr. McCullough. There are so many flaws to the clinical 
trials that people are looking to. One of the rules is we never 
change the primary endpoint. The second rule is we have an 
objective endpoint. The number of days someone stays in the 
hospital is not objective. That is determined by whether or not 
the patient feels they are ready to go home or the doctor 
discharges them, social delays and everything else. None of 
these trials, the minority witness says he wants to use the 
word ``evidence, evidence, evidence.'' Listen, we are in a 
crisis. We need both the art and the science of medicine. What 
these doctors are telling you and what the real-world evidence 
is telling you is that patients using a sequenced multi-drug 
approach at home is the only chance to reduce hospitalization. 
Remdesivir does not prevent a hospitalization because you have 
to be in the hospital to get it.
    Chairman Johnson. One thing I completely agree with Dr. Jha 
on is the workforce issue. The doctors I am talking to in 
Wisconsin say our hospitals currently are not being 
overwhelmed, but they may, based on the uptick, the surge in 
cases. But the biggest problem they have in hospitals is they 
do not have the workforce, which, again, speaks to had we 
really focused on early treatment and prophylaxis, you might 
have a more ready workforce. But you have nurses and doctors 
that have to stay home because schools are closed, they have to 
take care of their kids.
    Again, we have not from my standpoint done a very good job 
of really addressing this in any logical way. ``It has got to 
be testing.'' ``Now it has to be vaccine.'' But we are missing, 
to me, the key ingredient to solving this crisis, which is 
early effective treatment. We ought to be pouring billions of 
dollars, but because of the scare tactics on 
hydroxychloroquine--I know because I talked about, why have we 
not done the studies? Because we scared people away from 
participating in the trials in the United States. They tried to 
do a study, and they could not get people participating.
    Dr. Risch, can you talk about the difference between a 
random controlled trial and a nonrandom or just observational 
studies or just real-world experience and the validity of all?
    Dr. Risch. Let me start with the last point, real-world 
experience. After I had published my paper in the American 
Journal of Epidemiology in May, I got emails from a number of 
clinicians across the country saying that they had been using 
hydroxychloroquine very effectively. Now, the criticism of that 
is those people cherry-picked themselves to tell me that they 
were doing well, and all the people who were not doing well did 
not report it and they did not tell me.
    I said to two of them, ``OK, why do you not go back, keep 
doing what you are doing, and I will follow up with you in a 
month or 6 weeks and see how you have done after that.'' We are 
no longer cherry-picking. We are setting them as test 
candidates for their treatment plans. After about 6 weeks, I 
went back--this was Dr. Zelenko in New York and Dr. Procter in 
Texas. After 6 weeks, what I found is Dr. Zelenko had treated 
another 400 patients and had no deaths in those--another 400 
high-risk patients. He has treated 3,000 patients now, but 
those were 400 patients since the first time that I talked to 
him and no deaths. Dr. Procter had at that time about 180 
patients subsequent to when I first talked to him again, and I 
think he had one death in that.
    Their real-world evidence is such that no rational person 
would say, ``I am not going to go to them.'' If I got sick, 
they will be the first person that I would go to because they 
have already proved that they can do this. Whatever it is they 
are doing, they are magic. Whatever their treatment recipes 
are, it is working, and they are saving their patients.
    Chairman Johnson. Just real quick, you said there was one 
death from COVID, not from hydroxychloroquine.
    Dr. Risch. Actually, it is not even clear that it was a 
death from COVID. The person had a heart attack out of the blue 
that was unrelated. It was 2 weeks past. They had finished all 
the treatment, and so he was not even sure whether it was 
related to COVID. But to be conservative, he put it in. It is 
not even clear. It was an elderly man. So that is the first 
thing.
    The second part about real-world evidence and nonrandomized 
trials is the only benefit of a randomized trial is if there 
are some unknown variables that you cannot control for. All the 
known things that you can measure on people you can adjust for 
in your study, you can match on in the study, and you can 
remove them for bias so that you can have a pure treatment 
between the people who take the drug and the people who do not. 
It is only the unknown variables. The reason why these 
nonrandomized but controlled studies have converged to 
randomized ones is we have learned enough about the diseases 
that we study that we know what else to measure by and large in 
every one of them, and so we measure everything in the world, 
and we control for them. That has removed the so-called 
unknowns of bias, and this is why there is a difference in 
nonrandomized trials now compared to in the 1950s when we did 
not know enough about what to measure and how to control for 
it. That is the second issue, that empirically we know that 
nonrandomized but well-controlled trials work just as well as 
randomized ones.
    Chairman Johnson. Let us talk about----
    Dr. McCullough. Let me mention Dr. Procter's data are 
submitted and fully under the peer-reviewed process, his 
spectacular outcomes in suburban Dallas, as Dr. Risch has 
mentioned.
    Chairman Johnson. I want to talk a little bit about the 
practice of medicine versus following protocols, which I think 
we all agree, I mean, if you have a scientifically based random 
controlled trial, protocol on treating people, you do it. But 
not every human body is the same. Not every person is the same, 
and they do not all react to those protocols, correct? At that 
point in time, even with a well-established protocol, doctors 
have to shift to the art and practice of medicine--correct?--
and particularly in an epidemic.
    Dr. Fareed, can you talk a little bit more just from 
layman's terms about how medicine has advanced based on just 
doctors being doctors and practicing medicine, and in an 
emergency, whether World War II it was penicillin or, as we 
were talking about, the cholesterol-lowering drugs, how those 
doctors using their training, seeing a drug that can do 
something with this drug for an approved use over here, and he 
says, ``You know, it just might work over here,'' or, ``I have 
a patient where the protocol is not working. I have to try 
something. I want to save this patient's life.''
    Can you just kind of talk about as a practicing physician 
how you approach those situations?
    Dr. Fareed. Yes, that is so important, particularly when 
you are on the front line. It was a war. We were at war in this 
pandemic, and my colleague Dr. Brian Tyson and I took an 
aggressive approach, and it implied using the art of medicine, 
the principles that we had learned. I learned those principles 
50 years ago, and I was lucky to have gone to Harvard. I wonder 
if Dr. Jha actually treats patients actually the way he talks. 
But regardless, the issue that I have found to be so important 
in all my years of practice is to be adaptable, to bring in 
approaches that I am recommended from other people and other 
examples of where there has been a benefit, if it requires in 
HIV modifying a cocktail to be more effective for a patient to 
be continually suppressed, or in the COVID situation it is--we 
have continually found our treatment, the Zelenko-type 
treatment, to be very effective and reliable, and we adapt it.
    Now, when I am in the hospital seeing patients come in, I 
do not immediately put them on remdesivir. If it is a mild type 
of pneumonia that they have, I actually will prescribe our 
cocktail in the hospital along with convalescent plasma and 
budesonide inhalation, and those patients walk out in 4 days.
    It is important that people be respectful of the options 
that maybe are there and use an art in their approach.
    Chairman Johnson. Dr. Jha, Dr. Fareed mentioned you. Do you 
want to respond? He asked whether you were treating patients.
    Dr. Jha. I do, sir. I have spent the last 20 years taking 
care of veterans in the VA health care system and recently 
switched from the Boston VA to the Providence VA. But as a 
practicing physician, I think a lot about the evidence. I think 
that my patients want me to give them science-based treatments, 
and obviously, every patient is different. Obviously, every 
single time I see a patient, I do think about how to make 
adjustments. But I am always guided by the science and 
evidence. When there is no science or evidence on something and 
if I am going to think about an off-label use, I am very 
careful about that because the history of medicine is one of 
often doing more harm than good, and my first oath as a 
practicing physician was to do no harm.
    I am very much driven by that, and I started off saying 
that all three of these gentlemen strike me as both smart and 
committed and caring. I would appreciate a similar sort of 
respect back. I do take care of patients, and I try to do my 
best by them. Obviously, I am not perfect, but I try to use 
science as well as compassion to guide me.
    Chairman Johnson. We appreciate that. Have you treated any 
COVID patients?
    Dr. Jha. I have not, sir.
    Chairman Johnson. OK. Dr. Fareed, you talked about Dr. 
Raoult--I think I am pronouncing that right--and Dr. Zelenko. 
You referred to them as heroes. I am aware of the fact that Dr. 
Raoult in France is now being prosecuted.
    Dr. Fareed. Evidently that is the case. That is so tragic 
and inappropriate because he is a high-caliber, esteemed doctor 
in tropical medicine and infectious diseases, and his 
dedication to his patients is impeccable, so that he guided me. 
I can only credit him for leading me in the right direction, 
and Dr. Tyson in our area.
    So these are men that will be accoladed incredibly when 
this is all over.
    Chairman Johnson. He is being prosecuted right now for 
using a drug that has been around for 65 years, being 
prescribed safely without EKGs. Dr. McCullough.
    Dr. McCullough. I am in close communication for this 
worldwide disaster with many countries, and I can tell you I 
did a program with Eamonn Mathieson and the COVID Medical 
Network in Australia. To show you how off-kilter the world is, 
in Queensland, Australia, a doctor will be put in jail for 
prescribing hydroxychloroquine. To show you how, if you go over 
to India, they are going to give it to you right away. In 
Greece, they are going to give it to you right--it is in their 
guidelines in Greece.
    Chairman Johnson. It is over the counter in some countries, 
right?
    Dr. McCullough. Yes. But my point is we are all the way 
from--they give it first line in their guidelines. The Greek 
guidelines give hydroxychloroquine, but in Queensland you get 
put in jail. In the United States, we are caught up in this 
flurry of data and confusion. Something is going very wrong in 
this world.
    Chairman Johnson. I was contacted by a doctor who I think 
had written four prescriptions for hydroxychloroquine--and she 
was issued a grand jury subpoena by the Homeland Security 
Investigations (HSI) department, if you can believe that. A 
doctor prescribing an approved drug, and she gets a grand jury 
subpoena. Something is not right about that, OK?
    Now, because I checked into it, they withdrew that 
subpoena, but there is something that has gone wrong here. 
There is something that is not right. I for one intend to get 
to the bottom of it.
    So, again, gentlemen, all of you, Dr. Jha, all of you, 
thank you for being doctors. I mean that sincerely. People who 
have dedicated their lives to help save other people's lives is 
something to be celebrated. You should not be persecuted 
because you are trying to save lives, because for whatever 
reason there has been some politicization of a particular drug 
that has been around for 65 years. There is something wrong 
here. But I want to thank all of you for being doctors. I want 
to thank you for your testimony. I hope people pay attention to 
this hearing.
    Again, I am not pushing one drug over the other. What I am 
pushing for is robust studies and investigation into early 
treatment of COVID so we can prevent deaths, we can prevent 
hospitalization. I am for letting doctors be doctors and 
practice medicine and have the courage, when there is no other 
option--and let us face it, right now for early treatment there 
is no other option. I think it is inhumane to basically tell 
somebody who is fearful, and justifiably so--I tested positive 
for COVID. Is my oxygen level going to drop below 94? Can I do 
nothing to try and prevent that? I cannot try a drug that has 
been prescribed for 65 years? I do not have the right to do 
that in some States? I just think that is unconscionable. It 
makes no sense. The risk-reward ratio is so in favor of giving 
these things a shot.
    When I tested positive because I had one episode of atrial 
fibrillation (AFIB), my cardiologist talked me out of using 
hydroxychloroquine, and so I used quercetin instead, with zinc, 
with Vitamin D, with Vitamin C. I never developed a symptom. 
Now, maybe I am just one of those lucky 40 percent that never 
did. I will tell you one thing, though. Had I developed 
symptoms, I would have found a doctor--I might have called up 
one of you, and I would have tried hydroxychloroquine. From 
what I know, I think the risk is so unbelievably low. Even 
though I have AFIB, I would have tried it because I do not want 
to go into the hospital. I think most Americans, if they know 
about things, if they think rationally about things, are going 
to want some type of treatment.
    Again, with that, I just want to thank all of you for being 
doctors, for putting yourself on the line, because you will be 
criticized, I will be criticized. We are going to be raked over 
the social media. We will probably be censored. I know, Dr. 
McCullough, you already have been censored. I mean, your video 
describing what you did as part of a trial was pulled off of 
YouTube, and we helped you get back on YouTube. There is 
something going on here. I hope the American public listen. I 
hope they pay attention. I hope we end up developing early 
treatment for COVID so we can get this behind us. We are all 
sick of it. We want cures, we want therapies, we want the 
vaccine. But we cannot wait for the vaccine. We have to take 
action now. Again, thank you all.
    The hearing record will remain open for 15 days, until 
December 4th at 5 p.m., for the submission of statements and 
questions for the record.
    This hearing is adjourned.
    [Whereupon, at 11:27 a.m., the Committee was adjourned.]

                            A P P E N D I X

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[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]


                      EARLY OUTPATIENT TREATMENT:
                    AN ESSENTIAL PART OF A COVID-19
                           SOLUTION, PART II

                              ----------                              


                       TUESDAY, DECEMBER 8, 2020

                                     U.S. Senate,  
                           Committee on Homeland Security  
                                  and Governmental Affairs,
                                                    Washington, DC.
    The Committee met, pursuant to notice, at 10:03 a.m., via 
videoconference and in room SD-342, Senate Dirksen Building, 
Hon. Ron Johnson, Chairman of the Committee, presiding.
    Present: Senators Johnson, Paul, Lankford, Scott, Hawley, 
Peters, Hassan, and Rosen.

            OPENING STATEMENT OF CHAIRMAN JOHNSON\1\

    Chairman Johnson. Good morning. This hearing is called to 
order. Let me start by thanking our witnesses, first and 
foremost, for being doctors. I just have the greatest respect 
for anybody that has dedicated their lives to saving other 
people's lives and improving the health of their patients, and 
focusing, first and foremost, on their patients. I really want 
to thank you for that. I want to thank you for taking the time 
to prepare testimony and appear before us in person and via 
WebEx.
---------------------------------------------------------------------------
    \1\ The prepared statement of Senator Johnson appears in the 
Appendix on page 2003.
---------------------------------------------------------------------------
    In our first hearing on early treatment of Coronavirus 
Disease (COVID), Dr. Peter McCullough presented two slides--if 
we can bring the first one up here. The first slide showed the 
four pillars of pandemic response.\2\ The first pillar is 
contagion control, and, of course, we have done that with 
social distancing and economic shutdowns, masks, all those 
types of things. The second pillar is early home treatment, the 
third is late-stage hospital treatment, and the fourth is 
vaccination.
---------------------------------------------------------------------------
    \2\ The slide referenced by Senator Johnson appears in the Appendix 
on page 2047.
---------------------------------------------------------------------------
    If you want to put up the next slide.
    The second slide displayed the three stages of COVID, of 
the disease.\3\ The first stage is viral replication, the 
second, cytokine storm, and the third, microthrombosis. The 
goal of this hearing is identical to the goal of our first 
hearing, to discuss early treatment options that attack the 
disease in the first stage, by limiting viral replication. 
Doing so would hopefully prevent progression to cytokine storm, 
microthrombosis, and possibly death.
---------------------------------------------------------------------------
    \3\ The slide referenced by Senator Johnson appears in the Appendix 
on page 2048.
---------------------------------------------------------------------------
    This is how Tamiflu works in limiting the severity of the 
flu. It is how we approach every other disease. Early detection 
allows for early treatment and better outcomes.
    It seems like a pretty common-sense approach to me, yet 
this is not how we have attacked COVID. Instead, we have 
impoverished millions by shutting down economics, poured 
billions of dollars into ventilator production and new drug and 
vaccine development, but spent virtually nothing on research 
and trials using existing drugs and nutraceuticals. In fact, 
there has been a concerted effort to block doctors who actually 
treat COVID patients from compassionately using their off-label 
prescription rights for early treatment protocols. Why?
    In his ``Reflections on Progress, Peaceful Coexistence and 
Intellectual Freedom,'' Russian dissident Andrei D. Sakharov 
wrote, ``The second basic thesis is that intellectual freedom 
is essential to human society--freedom to obtain and distribute 
information, freedom for open-minded and unfearing debate, and 
freedom from pressure by officialdom and prejudices. Such a 
trinity of freedom of thought is the only guarantee against an 
infection of people by mass myths, which, in the hands of 
treacherous hypocrites and demagogues, can be transformed into 
bloody dictatorship. Freedom of thought is the only guarantee 
of the feasibility of a scientific democratic approach to 
politics, economics, and culture.''
    In today's biased news media and social media, within 
academic journals, on college campuses, in government agencies 
and ivory towers, we are losing the freedom to obtain and 
distribute information. The reaction to our first hearing on 
early treatment is but one example. Although not surprising in 
today's hyper-partisan climate, it is still shocking.
    In that hearing, we heard from Dr. McCullough, a 
cardiologist and Vice Chair of Medicine at Baylor University 
Medical Center; Dr. Harvey Risch, Senior Professor of 
Epidemiology at Yale University; and Dr. George Fareed, trained 
at Harvard University and the National Institutes of Health 
(NIH). Combined, these doctors have more than 900 scientific 
research publications, extensive drug development experience, 
more than 80 years' clinical practice, including treating more 
than 1,000 high-risk COVID patients, along with thousands of 
other lower-risk COVID patients.
    I was hoping that, post-election, by asking such eminently 
qualified doctors to testify about the rationale for and 
growing effectiveness of early treatment, minds could be opened 
and lives could be saved. Unfortunately, the Democrat witness, 
Dr. Ashish Jha, began tweeting his negative viewpoint of early 
treatment before the hearing even began and continued his media 
blitz for days afterward. Most obnoxiously--and it was 
obnoxious--he penned an op-ed that The New York Times ran and 
headlined ``The Snake-Oil Salesmen of the Senate.''
    The absurdity of calling Dr. Jha as a witness or paying any 
attention to him in the media was demonstrated when I asked 
him, during the hearing, ``Have you treated any COVID 
patients?'' His reply, ``I have not, sir.''
    Dr. McCullough also talked about the circle of empathy in 
medicine. Those who actually treat COVID patients are in the 
center. Not only have they shown extraordinary courage, 
exposing themselves to the disease, they also have the greatest 
empathy for patients who experience the fear and loneliness of 
a COVID diagnosis. These are the medical practitioners, the 
heroes, that ``experts'' in the ivory towers and media have 
chosen to ignore and vilify. The experts, far outside the 
circle of empathy, have developed and supported the current 
National Institute of Health guideline of providing no 
treatment at all until patients are sick enough to require 
hospitalization. As we are all aware, at that point treatment 
is often too late.
    So here we are again, holding a second hearing to obtain 
and distribute information on what is known about early 
treatment of COVID. What could possibly be controversial about 
that? Yet some are calling this hearing dangerous, and instead 
of waiting until after the hearing to trash this information 
and our witnesses, The New York Times and other publications 
have already run pre-emptive attacks, implying this hearing is 
anti-vaccine.
    Let me be clear. This hearing, like the first hearing, is 
focused on early treatment of COVID. It is not about vaccines. 
End of story. In my opinion, discouraging, and in some cases 
prohibiting, the research and use of drugs that have been 
safely used for decades has cost tens, if not hundreds of 
thousands of people their lives. By the time any vaccine is 
fully deployed, no matter how successful, how effective, how 
safe, millions more will become infected. With effective early 
treatment, fewer people will get seriously ill and fewer will 
die. So why not give early treatment a shot? What have we got 
to lose?
    Finally, why is there such a concerted effort to silence 
the voices of courageous health professionals promoting early 
treatment? It makes no sense.
    Let me make just a final point. At the beginning of this 
epidemic, when I first heard about the potential 
hydroxychloroquine (HCQ), it intrigued me because, to me, a 
drug like that, that has been around for 65 years, shown to be 
safe, it is cheap, billions of tablets are produced every year. 
We could have ramped up production. If that could be proven to 
be effective, would not that be the dream solution? Why did we 
not we pursue that, and ivermectin and favipiravir? Why did we 
not look at these drugs that were already there--generic, 
cheap, mass producible? Again, it makes no sense.
    With that I will turn it over to Senator Peters.

             OPENING STATEMENT OF SENATOR PETERS\1\

    Senator Peters. Thank you, Mr. Chairman. Our nation 
continues to battle a worsening public health and economic 
crisis that has taken the lives of nearly 284,000 Americans. 
Over 2,200 Americans are dying every day from this deadly 
virus. Thanks to the tireless work of our public health 
agencies, the private sector, and our scientific and medical 
communities, we have made progress in treating this disease.
---------------------------------------------------------------------------
    \1\ The prepared statement of Senator Peters appear in the Appendix 
on page 2005.
---------------------------------------------------------------------------
    The Food and Drug Administration (FDA) continues to use 
scientific standards to authorize innovative and effective 
early treatments. Unfortunately, today's discussion will not 
meet those same standards.
    Mr. Chairman, I certainly share your goal of ensuring 
patients across the country have access to early and effective 
treatments for coronavirus, but those statements must be based 
on evidence and not on politics. The American people are 
looking to Congress for accurate information, for leadership, 
and for relief.
    Last month, this Committee held a hearing that was billed 
as a review of early outpatient treatments for coronavirus. 
Unfortunately, that hearing amplified unverified theories about 
treatments that are not supported by the scientific community. 
Instead of hearing from expert witnesses about scientific 
developments in coronavirus treatments, or how we can improve 
the pandemic response, the Committee was used as a platform to 
attack science and promote discredited treatments.
    The minority witness, an expert in his field, was subjected 
to personal attacks from other witnesses and from this dais. 
After testifying, he faced an online harassment campaign, 
unlike anything he had ever experienced in any prior 
congressional testimony. This behavior damages the credibility 
of this Committee and does nothing to advance the health and 
the safety of the American people.
    Sadly, it appears that today's hearing is going to follow 
the same path, playing politics with public health, and will 
not give us the information that we need to take on this 
crisis. The minority was not consulted about the scope of this 
hearing before it was noticed. The panelists have been selected 
for their political, not their medical, views, and for that 
reason the composition of the panel creates a false and 
terribly harmful impression of the scientific and medical 
consensus.
    The witnesses have made many harmful, inflammatory 
statements. Those statements include undermining a COVID-19 
vaccine, promoting unproven therapeutics, discouraging common-
sense measures to stop the spread of the virus, like social 
distancing and masks, and even comparing physicians who support 
these interventions to supporters of a Nazi regime.
    Now I certainly welcome diverse perspectives, but we have a 
responsibility to follow science, and to follow facts, not 
conspiracy theories, and not disinformation. To that end, I 
would like to enter, Mr. Chairman, into the record, this 
statement from 50 public health experts\1\ about the importance 
of science in our pandemic response. I would also like to enter 
into the record an op-ed written by Dr. Jha, the minority 
witness in the prior hearing, regarding his experience before 
this Committee. Finally, I would like to enter statements from 
four public health and scientific organizations that discuss 
scientific integrity and the needs of our communities during 
this pandemic. Without objection, they could be entered into 
the record, Mr. Chairman.
---------------------------------------------------------------------------
    \1\ The statements submitted by Senator Peters appear in the 
Appendix on page 2049.
---------------------------------------------------------------------------
    Chairman Johnson. Without objection.
    Senator Peters. Mr. Chairman, Senate hearings, like medical 
treatments, should be based on evidence. This hearing, like the 
hearing before it, and the hearing before that, is 
unfortunately not. I very much regret that in this time of need 
Americans cannot turn to this Committee for some sound 
guidance.
    Mr. Chairman, we can still turn the tide of this pandemic. 
We can work together to ensure that scientists have the 
resources that they need to conduct research, and Federal 
agencies have the resources they need to support and evaluate 
these efforts. We should be working to ensure that doctors, 
nurses, and first responders have personal protective equipment 
(PPE) that they need to care for patients in a safe manner. We 
should be passing bipartisan legislation that provides 
desperately needed financial relief to families, States, and 
small businesses.
    In the coming weeks, we expect that the first coronavirus 
vaccines will become available. We should be conducting strong 
oversight, including hearing testimony from government 
officials responsible for vaccine development and distribution. 
The Commerce Committee will be holding a Subcommittee hearing 
on how we will ensure every American can get a vaccine. Later 
this week we will be discussing that. I look forward to 
participating in a robust discussion with both scientific and 
logistics experts.
    We owe it to the American people to get this right, and 
sadly, today's hearing will not provide accurate scientific 
information or advance any useful efforts to slow the spread of 
the coronavirus pandemic.
    Thank you, Mr. Chairman.
    Chairman Johnson. Thank you, Senator Peters. I hope anybody 
who listened to that opening statement, anybody who has read 
the articles prior to this hearing, will actually go back and 
take a look at the video that we edited of our previous 
hearing, that I hope they actually listen to the witnesses and 
to their testimony and to the questions and answers, and just 
really understand how far from reality the Ranking Member's 
opening statement truly was.
    Now it is the tradition of the Committee to swear in 
witnesses, so those of you on WebEx if you will just raise your 
right hand. Two witnesses here, if you will stand and raise 
your right hand.
    Do you swear that the testimony you will give before this 
Committee will be the truth, the whole truth, and nothing but 
the truth, so help you, God?
    Dr. Orient. I do.
    Dr. Kory. I do.
    Dr. Rajter. I do.
    Dr. Oskoui. I do.
    Dr. Bhattacharya. I do.
    Dr. Balboni. I do.
    Chairman Johnson. Please be seated.
    Our first witness is Dr. Ramin Oskoui--at best I get them 
50 percent right. Dr. Oskoui is a native Washingtonian. He is a 
graduate of Georgetown University College of Arts and Sciences 
and Columbia University College of Physicians and Surgeons. He 
trained at Georgetown University Hospital in internal medicine 
and cardiovascular disease at Washington Hospital Center. He is 
board-certified in internal medicine and cardiovascular 
diseases. He is Chief Executive Officer (CEO) of Foxhall 
Cardiology in Washington, DC. He is a past president of the 
medical staff at Sibley Memorial Hospital, and was Physician of 
the Year for 2015 for Sibley Memorial Hospital Johns Hopkins.
    Since 1996, his peer have continuously voted him as one of 
Washingtonian magazine's top doctors in cardiology. He has 
treated several dozen COVID-19 patients and has published in 
the area. Since I announced your presence at this hearing I 
have heard from all kinds of patients what a fabulous doctor 
you are.
    Dr. Oskoui. You are very kind.
    Chairman Johnson. Thank you for coming here. Thanks for 
being a doctor, Dr. Oskoui.

 TESTIMONY OF RAMIN OSKOUI, M.D.,\1\ VICE PRESIDENT OF MEDICAL 
 STAFF, SIBLEY MEMORIAL HOSPITAL, AND CHIEF EXECUTIVE OFFICER, 
                       FOXHALL CARDIOLOGY

    Dr. Oskoui. It is my honor. I am going to just read from my 
brief personal statement.
---------------------------------------------------------------------------
    \1\ The prepared statement of Dr. Oskoui appears in the Appendix on 
page 2009.
---------------------------------------------------------------------------
    My name is Dr. Ramin Oskoui. I am a board-certified 
cardiologist and internist who is licensed to practice in 
Maryland, D.C., and Virginia, and as the Senator correctly 
stated, I have treated several dozen COVID patients since the 
outbreak of the pandemic.
    My remarks are directed, in part, to the differing roles 
and responsibilities of scientific researchers and government 
agencies, and practicing physicians, in a health care crisis. 
Whenever there is a health crisis, whether it is a worldwide 
pandemic or a family member hit with stroke or heart attack, 
our nation's practicing physicians are not only the critical 
first responders, in many cases they are the only ones on the 
line, working with and for the patient.
    There are brilliant practitioners of academic medicine and 
Doctor of Medicine-Doctor of Philosophy (MD-PhDs), many of them 
employed by our most profitable drugs companies who develop 
seemingly miraculous cures or therapies. But it is the front-
line physicians who certainly, with the help of scientific 
researchers and billion-dollar drug pharmaceutical companies, 
must fight and win the war against disease, particularly a 
disease or ailment that is new and we do not have decades of 
research to look back on, with patients who, if we do nothing, 
may suffer and die needlessly.
    Why then, with a disease we had never seen before, in late 
March, are practicing physicians being condemned, ridiculed, or 
shamed, in some cases, for doing what practicing physicians 
have always done--using their professional skills and expertise 
to make the best practical, life-saving use of the existing 
scientific research.
    It would be wonderful if, last March, the FDA or the NIH or 
a few big drug companies could have announced an instant cure 
for a disease that had just been discovered, or, of course, in 
that event we would have all prescribed it. Easy-peasy.
    But they did not have it then, and they do not have it now. 
That is one reason why the FDA encourages the use of FDA-
approved drugs approved for one disease to be responsibly and 
ethically used in the field for other ailments not yet 
researched or approved. In fact, that is how many cures or 
treatments get discovered. Drugs or treatments invented and 
tested for one disease or ailment are applied in a novel way, 
or for an ailment or disease they have not yet been approved 
for or tested with.
    The health policy establishment's criticism of the front-
line doctors was over the top, and it was unfounded. First, for 
example, drugs like hydroxychloroquine and ivermectin, which 
are FDA-approved for certain uses, have extensive safeguards, 
even for non-approved uses. They were both approved decades ago 
and have an established record of efficacy and a comprehensive 
information on possible side effects that physicians can 
review, and are legally and ethically required to review before 
prescribing.
    Second, the fact is that no doctor should be prescribing 
these drugs, or, in fact, any drug, without following standard 
protocols observed for any drug or any patient. Even if there 
is FDA-approved scientific research proving that 
hydroxychloroquine works for malaria, its approved use, or 
lupus, a longstanding alternative use, one must do a case 
history and consider the individual patient before prescribing 
it. Practicing medicine may be an art as much as a science but 
it is certainly not, ``paint by the number.''
    Earlier this year we faced a new, dangerously infectious 
virus and such a health crisis. Like any other crisis with an 
unknown and unproven enemy, we cannot rely exclusively on the 
tried and true. But it was worse than that. Affirmative steps 
to keep physicians and patients ignorant were taken. Indeed, 
censorship of scientific research, indeed, medical McCarthyism, 
became the norm. It is not an insult against science to 
conclude that actions should be taken in the midst of an 
emergency based on the best facts available, nor any more than 
it is an insult to against history to use tactics or strategy 
in our national defense that have not been peer reviewed. I 
believe that landing craft were rarely used in the full-scale 
amphibious invasion before D-Day. The ones we developed 
specifically for that purpose obviously could not be tested in 
full battlefield conditions. Does that mean we could not go 
ahead with the Normandy invasion because we had no double-blind 
peer reviewed studies for these vehicles? I think weather 
forecast that day was a bit sketchy too.
    Even outside of emergency, it is no disrespect to science 
to say some medical treatments that some physicians deem 
prudent for their patients should be allowed, and yes, 
promoted, even if those have not been the subject of someone's 
peer-reviewed Ph.D. thesis or years of regulatory process. Very 
few of us will become drug company executives, top medical 
researchers, or high-ranking health bureaucrats, but it is 
almost guaranteed that each of us is quite likely, sometime, 
somewhere, to be a patient under the care of a trusted 
physician who will hopefully have the help, not the hindrance, 
of the research establishment.
    Thank you, Senator.
    Chairman Johnson. Thank you, Dr. Oskoui.
    Our next witness, via WebEx, is Dr. Jean-Jacques Rajter. 
Dr. Rajter is a Broward Health Medical Center physician who 
specializes in pulmonary medicine, internal medicine, and 
critical care. He previously served as the Chief Medical 
Information Officer for Broward Health and as an assistant 
professor at Drexel University College of Medicine.
    Dr. Rajter serves as a speaker for GlaxoSmithKline, 
AstraZeneca, and Forest Laboratories, as well as serves on 
advisory boards for Pfizer. His publications most recently 
include a study titled, ``Use of Ivermectin is Associated With 
Lower Mortality in Hospitalized Patients with Coronavirus 
Disease,'' 2019.
    Dr. Rajter received his M.D. from the Drexel University 
College of Medicine and has accumulated over 22 years of 
experience in this field. Dr. Rajter.

   TESTIMONY OF JEAN-JACQUES RAJTER, M.D.,\1\ PULMONOLOGIST, 
                 BROWARD HEALTH MEDICAL CENTER

    Dr. Rajter. Thank you very much. Honorable Chairman and 
Senators of the Committee on Homeland Security, my name is 
Dr. Jean-Jacques Rajter. I am unfortunately unable to attend 
this hearing in person as I am currently taking care of over 35 
hospitalized patients. And it is an honor and privilege to 
stand here in front of the Committee providing firsthand 
experience on the early treatment for COVID-19.
---------------------------------------------------------------------------
    \1\ The prepared statement of Dr. Rajter appears in the Appendix on 
page 2017.
---------------------------------------------------------------------------
    My team has gained extensive experience with the treatment 
of COVID-19 in both inpatients and outpatients during this 
pandemic. Back in April, we were faced with a rapidly 
deteriorating patient population with no effective treatment. 
Extraordinary times call for extraordinary measures. I could 
not stand idly by as I have seen more people die in these last 
6 months than I have seen in my entire medical career combined.
    Using in-vitro data by Dr. Wagstaff, my team was able to 
develop and implement an ivermectin-based protocol that showed 
tremendous success in treating COVID-19. This laid the 
foundation for the peer-reviewed Ivermectin in COVID Nineteen 
(ICON) study, which was published in Chest, a major, U.S.-based 
medical journal.
    The overall mortality in that study decreased from 25 
percent in the conventional care group to 15 percent in the 
ivermectin-treated group. In patients with severe pulmonary 
disease at onset, the mortality decreased from 81 percent to 39 
percent.
    During the second wave of the pandemic it was common for my 
team to treat in excess of 40 patients with COVID-19 on a daily 
basis. This ICON protocol has been optimized since and we have 
learned a lot from our successes and failures. The success rate 
of the ivermectin-based protocol is now far superior to what it 
was in its early days.
    Ivermectin-based protocols have now been studied across the 
world, yet no major large-scale, double-blind, randomized 
controlled trials (RCT) has yet been published in a peer-
reviewed journal. I will defer more review of the literature to 
Dr. Kory, who is going to be testifying later.
    Recent in-vitro studies confirmed our clinical experience 
that the dosing regimen of ivermectin, 200 mcg/kg on two 
consecutive days, was clinically effective. Of the hundreds of 
outpatients treated by my team, only 2--I repeat, 2--were 
admitted to the hospital, one due to heart failure, the other 
one due to symptomatic delay over a week before seeking medical 
attention. Neither one of them died. Neither one of them needed 
intubation. Both of them have now been discharged to home 
without complications.
    Ivermectin is widely used medication with excess of 3.7 
billion doses administered worldwide. It is currently part of 
the World Health Organization (WHO) model list of essential 
medications. The ICON dosing regimen is based on currently 
accepted dosing regimen for Norwegian scabies. The dosing 
regimen has longstanding safety data. Safety of a medication is 
due to its pharmacokinetics and possible interactions, but not 
on its intended use.
    As is the case with any infection, early intervention has 
been proven, time and again, that it is of critical importance. 
The same is true for COVID-19. Early intervention increases the 
likelihood of keeping people out of the hospital and, hence, 
decreasing the pressure on the health care system. Early 
intervention is cost effective, as it decreases the overall 
health care expenditure. Early intervention decreases viral 
shedding and viral transmission in the home setting, which is 
currently believed to be a major site of transmission. Early 
intervention increases survival. Early intervention decreases 
the economic impact.
    Notwithstanding impending vaccination programs, vaccines 
are not 100 percent effective and may not be widely available 
for many months. Many patients may be unable to take the 
vaccines for health care reasons or opt not to do so. Long-term 
immunity of these vaccines has not yet been documented.
    Based on these factors, treatment for COVID-19 will need to 
remain on the forefront, even after vaccination programs are 
initiated. Ivermectin is effective in early disease, mid 
disease, post-exposure prophylaxis, and pre-exposure 
prophylaxis. Ivermectin is an oral medication requiring no 
monitoring. Ivermectin is safe. Ivermectin is inexpensive and 
widely available.
    The United States has spent billions of dollars on a 
multitude of treatment options. My team is ready to proceed 
with randomized controlled trials to address any residual doubt 
relating to ivermectin use. Yet we are unable to do so due to 
lack of funding and support.
    A few hundred thousand dollars may definitively proof or 
disprove the effectiveness of ivermectin for early treatment. 
With a properly designed and implemented randomized controlled 
trial, a little bit more funding could look at the 
effectiveness of pre-and post-exposure prophylaxis using 
ivermectin. A couple million dollars could complete a 
multicenter, double-blind, inpatient, placebo control trial for 
ivermectin.
    Ladies and gentlemen, I implore you, as a front-line 
provider of COVID-19, to do better, to provide us the answers 
we need, as health care providers, to help your constituents 
survive this horrible pandemic in great numbers. After 
personally witnessing the results of ivermectin-based 
protocols, I cannot stand by and allow hundreds of thousands of 
people to go untreated.
    Thank you.
    Chairman Johnson. Thank you, Dr. Rajter.
    Our next witness is here in person, Dr. Pierre Kory. Dr. 
Kory is the former Associate Professor and Chief of the 
Critical Care Service and Medical Director of the Trauma and 
Life Support Center at the University of Wisconsin, and 
recently joined the Intensive Care Unit (ICU) service at Aurora 
St. Luke's Medical Center in Milwaukee. He is board-certified 
in critical medicine, pulmonary diseases, and internal 
medicine.
    Dr. Kory has traveled across multiple States in the United 
States to care for COVID-19 patients throughout the pandemic. 
He is also the President of the Front Line COVID-19 Critical 
Care Alliance, a nonprofit organization of critical care 
specialists led by Professor Paul Marik, whose mission over the 
past 9 months has focused on the research and development (R&D) 
of effective treatment protocols for COVID-19 using repurposed 
drugs.
    He received his M.D. from St. George's University School of 
Medicine, and I will only add that we added Dr. Kory very late 
to, I think, our hearing in May, because I had heard of his 
development of, I guess, anti-inflammatory steroids in critical 
care on COVID. Dr. Kory, I have to tell you, I have had doctors 
come up to me and thank me for holding that hearing where they 
listened to you change their thinking. They believe they have 
saved their patients' lives because of your testimony at that 
hearing. I hope your testimony will be as impactful today. Dr. 
Kory.

   TESTIMONY OF PIERRE KORY, M.D.,\1\ ASSOCIATE PROFESSOR OF 
           MEDICINE, ST. LUKE'S AURORA MEDICAL CENTER

    Dr. Kory. Senator, thank you and thank you for holding this 
hearing.
    I just want to start out--I did not think I would have to 
say this, but I want to register my offense at the Ranking 
Member's opening statement. I was discredited as a politician. 
I am a physician and a man of science. I have done nothing--
nothing but commit myself to scientific truth and the care of 
patients. And to hear that I am here because of a political 
angle--I am not a politician. I am a physician.
---------------------------------------------------------------------------
    \1\ The prepared statement of Dr. Kory appears in the Appendix on 
page 2023.
---------------------------------------------------------------------------
    I want to start out by saying that I am not speaking as an 
individual. I am speaking on behalf of the organization that I 
am a part of. We are a group of some of the most highly 
published physicians in the world. We have near 2,000 peer-
reviewed publications among us. Led by Professor Paul Marik, 
who is our intellectual leader, we came together early on the 
pandemic, and all we have sought is to review the world's 
literature on every facet of this disease, trying to develop 
effective protocols.
    You just mentioned that I was here in May, and I touted--I 
would not say touted--I recommended that it was critical that 
we use corticosteroids in this disease, when all of the 
national and international health care organizations said we 
cannot use those. That turned out to be a lifesaving 
recommendation.
    I am here again today with a new recommendation. In the 
last 9 months, in our review of all of the literature, as a 
group, again, we are some of the most highly published 
physicians in our specialty and the world. We have done nothing 
but try to figure out how to identify a repurposed and 
available drug to treat this illness.
    We have now come to the conclusion, after 9 months--and I 
have to point out, I am severely troubled by the fact that the 
NIH, the FDA, and the Centers for Disease Control and 
Prevention 
(CDC)--I do not know of any task force that was assigned or 
compiled to review repurposed drugs in an attempt to treat this 
disease. Everything has been about novel and/or expensive, 
pharmaceutically engineered drugs, things like tocilizumab and 
remdesivir and monoclonal antibodies and vaccines. We have 100 
years of medicine development. We are expert in all the 
medicines we use, and I do not know of a task force that has 
been focused on repurposed drugs.
    I will tell you that my group and our organization, I will 
say that we have filled that void. That is all we have done is 
focus on the things we know and things we do. I am here to tell 
you, Dr. Rajter, he has one study of the many that I want to 
talk about, and I want to talk about that we have a solution to 
this crisis. There is a drug that is proving to be of 
miraculous impact, and when I say miracle I do not use that 
term lightly. I do not want to be sensationalized when I say 
that, but it is a scientific recommendation based on mountains 
of data that has emerged in the last 3 months.
    When I am told--and I just had to hear this in the opening 
sentence--that we are touting things that are not FDA-or NIH-
recommended, let me be clear. The NIH, their recommendation on 
ivermectin, which is to not use it outside of controlled 
trials, is from August 27th. We are now in December. This is 3 
to 4 months later. Mountains of data have emerged from many 
centers and countries around the world, showing the miraculous 
effectiveness of ivermectin. It basically obliterates 
transmission of this virus. If you take it, you will not get 
sick.
    I want to briefly summarize the data. My manuscript, again, 
published by some of the most--we have contributed more to the 
medical knowledge of our specialty and our careers than anyone 
else can claim as a group, and our manuscript, which was posted 
on medicine pre-print server, details all of this evidence. I 
want to briefly summarize it.
    No. 1, we have evidence that ivermectin is effective not 
only in prophylaxis, in the prevention. If you take it, you 
will not get sick. We just came across a trial last night from 
Argentina, by the lead investigator of ivermectin in Argentina, 
Dr. Hector Carvallo. They prophylaxed 800 health care workers. 
Not one got sick. In the 400 that they did not prophylax with 
ivermectin, 58 percent got 
sick--237 of those 400 got sick. If you take it, you will not 
get sick. It has immense and potent antiviral activity. We know 
that from the first study at Monash. It has made the bench to 
the bedside.
    Prophylaxis, we now have four large randomized controlled 
trials totaling over 1,500 patients, each trial showing that as 
a prophylaxis agent it is immensely effective. You will not get 
sick. You will be protected from getting ill if you take it.
    In early outpatient treatment, we have three randomized 
controlled trials and multiple observation, as well as case 
series, showing that if you take ivermectin, the need for 
hospitalization and death will decrease.
    The most profound evidence we have is in the hospitalized 
patients. We have four randomized controlled trials there, 
multiple observation trials, all showing the same thing. You 
will not die, or you will die at much lower rates, 
statistically significant, large-magnitude results, if you take 
ivermectin.
    It is proving to be a wonder drug. It has already won the 
Nobel Prize in medicine in 2015 for its impacts on global 
health in the eradication of parasitic diseases. It is proving 
to be an immensely powerful antiviral and anti-inflammatory 
agent. It is critical for its use in this disease.
    We, again, stand by our manuscript. It is a scientific 
manuscript. It has been submitted for peer review. But please 
recognize, peer review takes time. It takes months. We do not 
have months. We have 100,000 patients in the hospital right now 
dying.
    I am a lung specialist. I am an ICU specialist. I have 
cared for more dying COVID patients than anyone can imagine. 
They are dying because they cannot breathe. They cannot 
breathe. They are on high-flow oxygen delivery devices. They 
are on non-invasive ventilators and/or they are sedated and 
paralyzed and attached to mechanical ventilators that breathe 
for them. I watch them every day. They die. By the time they 
get to me in the ICU they are already dying. They are almost 
impossible to recover.
    Early treatment is key. We need to offload the hospitals. 
We are tired. I cannot keep doing this. If you look at my 
manuscript, and if I have to go back to work next week, any 
further deaths are going to be needless deaths, and I cannot be 
traumatized by that. I cannot keep caring for patients when I 
know that they could have been saved with earlier treatment, 
and that drug that will treat them and prevent the 
hospitalization is ivermectin.
    I am here today, I am calling to action. The NIH, their 
last recommendation was August 27th. I want to be clear. I am 
not here as a politician or a dramatists or sensationalizing 
what I am recommending. I am going to be very clear and very 
simple. All I ask is for the NIH to review our data that we 
have compiled, of all of the emerging data. We have almost 30 
studies. Every one is reliably and reproducibly positive 
showing the dramatic impacts of ivermectin.
    Please, I am just asking that they review our manuscript. 
It is a serious manuscript, by serious, highly experienced 
physicians and researchers. I cannot call on more credibility 
than we have. We are not just a random doctor who is saying 
that we have a cure. I do not want to say I have a cure. I am 
just asking, review our data. We have immense amounts of data 
to show that ivermectin must be implemented, and implemented 
now.
    Senator, the last thing I want to say is, you know who is 
dying here? It is our African American and Latino and elderly. 
It is some of the most disadvantaged and impoverished members 
of our society. They are dying at higher rates than anyone 
else. It is the most severe discrepancy I have seen in my 
medical career. We are responsible to protect those 
disadvantaged members. We have a special duty to provide 
countermeasures.
    The amount of evidence to show that ivermectin is 
lifesaving and protective is so immense, and the drug is so 
safe. My colleagues have talked about it. It must be instituted 
and implemented. I am asking the NIH to review our data and 
come with recommendations for society. Thank you.
    Chairman Johnson. Thank you, Dr. Kory. I will make you this 
guarantee, that before the day is out we will have a letter. 
First of all, we will enter all your data into our hearing 
record, and then I will have a letter to the NIH asking them to 
review it. Hopefully I will have some Senators join me in that.
    Our next witness is Dr. Armand Balboni. Dr. Balboni is the 
Chief Executive Officer for Appili Therapeutics. His career has 
included medical research and drug development experience in 
civilian, academic, and military organizations. He is a partner 
and a member of the board of directors of Bloom Burton & 
Company where he is the firm's senior advisor for regulatory 
medical affairs.
    As an active duty military officer, Dr. Balboni served as a 
staff officer in the U.S. Army Research Institute of Infectious 
Diseases. He completed a military staff fellowship at the U.S. 
Food and Drug Administration and went on to serve as the Deputy 
Director of Clinical and Regulatory Affairs for the U.S. Army.
    Dr. Balboni has held multiple academic positions at 
Westfield State University, the University of Maryland, 
University College, and the United States Military Academy at 
West Point. Dr. Balboni completed his doctoral work in the MD/
PhD program at the Icahn School of Medicine at Mount Sinai, and 
earned his law degree at Brooklyn Law School. Dr. Balboni.

 TESTIMONY OF ARMAND BALBONI, M.D., PH.D.,\1\ CHIEF EXECUTIVE 
               OFFICER, APPILI THERAPEUTICS, INC.

    Dr. Balboni. Thank you, Mr. Chairman, Ranking Member 
Peters, and the entire Committee for your leadership and the 
opportunity to speak today about the need for early treatment 
of COVID.
---------------------------------------------------------------------------
    \1\ The prepared statement of Dr. Balboni appears in the Appendix 
on page 2039.
---------------------------------------------------------------------------
    As you have noted, I have worked in the infectious disease 
front lines in many roles. I am a simple drug development 
physician and scientist, and I say that with all humility.
    As a military fellow at the FDA during the Ebola crisis, we 
looked at some of these drugs, broad spectrum antivirals, to 
include things like favipiravir and remdesivir. We are no 
further along now than we were then with getting those drugs 
approved because of the very fragmented nature of what we do as 
our approach to treating these kinds of illnesses.
    I have to say, I never thought I would have to say this, 
but I am a life-long Democrat with a subscription to The New 
York Times. I have to say I was quite dismayed this morning, 
and almost did not participate, when I saw the news that I was 
participating as a fringe member of an antivaxxer group. That 
could not be further from the truth.
    I read further down in The New York Times and saw that 
202,000 new cases were presented yesterday in the United 
States, and I am confronted with the motto that accompanied me 
in over 17 years as a physician and scientist in the U.S. Army, 
``One Team, One Fight, and Mission First.'' We have to get this 
right, and I remain deeply concerned with our long-term 
viability to combat not only COVID-19 but other pandemics that 
inevitably will happen.
    We have to take a whole-of-government approach. The last 11 
months have shown us what we can do when we do that. It has 
redefined what is possible for vaccine development. We may be 
on the precipice of new technologies that will absolutely 
inform how we develop vaccines in the future, but we are not 
done.
    Many are ready to say that we did it with vaccines and some 
effective treatments that have been noted to be quite expensive 
and useful in limited situations. But we are failing to 
adequately build a continuum of solutions, data-driven 
solutions, for COVID-19 and the inevitable future pandemics. We 
need options now, at every stage, and in scalable and readily 
implementable ways as the crisis worsens.
    We need oral, broad spectrum therapeutics to be able to 
treat patients in the outpatient setting. We cannot treat them 
adequately, and we cannot continue to send newly infected 
patients home with this potential hope of an IV infusion, and 
say, ``Put on a mask and wait for the vaccine.'' We cannot live 
with the outcomes there.
    I tip my hat to my colleagues at infusion clinics and those 
setting up clinics in tents, in parking lots, but the drugs are 
too expensive, not available, and unlikely to help the hundreds 
of thousands of patients that are coming out of this.
    The vast majority of Americans, just to be clear, who test 
positive, we tell them to self-quarantine, employ watchful 
waiting, and then go to the hospital, if they have beds, if 
their symptoms worsen. This protocol confirms that we have a 
gap in our treatment landscape. We need an oral Severe Acute 
Respiratory Syndrome (SARS)-CoV-2-specific treatment right now 
that helps to treat those with confirmed infections, and one 
that is practicable, scalable, and can bring a plug-and-play 
type of approach to our health care system.
    As this Committee addressed, and my colleagues that are 
witnesses here have also addressed, we have to include vaccines 
and best medical practices. Nobody is denying that. Nobody here 
is an antivaxxer. Again, I have to say I take great offense to 
that statement, as a scientist and physician.
    Oral antivirals targeting SARS-CoV-2 offer a strong 
solution. We have the potential to play an important role in 
the hands of physicians treating the COVID-19 patients outside 
of the hospital.
    Again, these drugs are not intended to replace COVID-19 
vaccines, and many promising oral antivirals are most effective 
when used early. Most patients will never have access to them 
as we attempt to wring all the risk out of our large randomized 
controlled trials to fully read out. We, as a group, are 
running two large Phase 3 trials in the United States under 
Investigational New Drug (IND) and a Phase 2 post-exposure 
prophylaxis trial on long-term care. We are doing that work, 
and I do not suggest that we abandon our gold standard RCTs. 
However, to singularly rely on RCTs in the middle of a pandemic 
is just not common sense.
    We need to develop hybrid trial methodologies by combining 
the best parts of RCTs and observational studies to produce 
real-world data, right now, that can, together with our RCTs 
present real-world evidence about how these things can be used. 
It is our best chance to save lives now and during future 
outbreaks. If we fail to change our approach we are going to be 
talking about this the next time there is an outbreak. It is 
going to happen. It is unfortunate but we have to utilize this 
pandemic to bring solutions to these patients right now.
    Thank you, Mr. Chairman, and thank you, Committee, for your 
consideration.
    Chairman Johnson. Thank you, Dr. Balboni.
    Our next witness is Dr. Jane Orient. Dr. Orient has served 
as the Executive Director of the Association of American 
Physicians and Surgeons (AAPS), since 1989, and is current 
President of Doctors for Disaster Preparedness. More than 200 
of her papers and op-ed pieces have been published in the 
scientific and popular literature on a variety of subjects, 
including risk assessment, natural and technological hazards 
and non-hazards, and medical economics and ethics.
    She is the editor of AAPS News, the Doctors for Disaster 
Preparedness newsletter, Civil Defense Perspectives, and is the 
managing editor of the Journal of American Physicians and 
Surgeons.
    Dr. Orient obtained her undergraduate degrees in chemistry 
and mathematics from the University of Arizona in Tucson and 
her M.D. from Columbia University College of Physicians and 
Surgeons in 1974. Dr. Orient is formally clinical faculty in 
the Department of Internal Medicine at the University of 
Arizona College of Medicine and has been in solo private 
practice of general internal medicine since 1981. Dr. Orient.

   TESTIMONY OF JANE M. ORIENT, M.D.,\1\ EXECUTIVE DIRECTOR, 
        ASSOCIATION OF AMERICAN PHYSICIANS AND SURGEONS

    Dr. Orient. Thank you, Chairman Johnson and Ranking Member 
Peters and Committee Members for allowing me to present the 
plea of practicing physicians for early and prophylactic home 
treatment for COVID-19, and also thanks to the witnesses for 
the opportunity to learn from you. We urge the Committee to 
exercise your oversight functions over Federal agencies that 
are effectively blocking treatment that could prevent 100,000 
needless deaths and stop the crippling fear and the destruction 
of millions of livelihoods.
---------------------------------------------------------------------------
    \1\ The prepared statement of Dr. Orient appears in the Appendix on 
page 2041.
---------------------------------------------------------------------------
    On August 18th, Senator Ron Johnson, Senator Mike Lee, and 
Senator Ted Cruz asked the FDA to ``provide any studies and 
data that informed the FDA's apparent determination that giving 
hydroxychloroquine to infected outpatients within 7 days from 
the onset of symptoms will have no clinical effect and may be 
harmful to the patient.''
    FDA's tardy response provided no references pertaining to 
the question. The only logical conclusion is that FDA's 
extremely influential determination that prevented treatment 
for untold thousands of patients was without foundation.
    FDA Commissioner Stephen Hahn has stated, correctly, that 
FDA has no authority to regulate the practice of medicine and 
that doctors have the right to prescribe approved drugs for 
off-label uses. But as AAPS has shown in its lawsuit against 
the FDA, State agencies have used the FDA's language as the 
basis of regulations to block or forbid prescribing or 
dispensing of hydroxychloroquine.
    In March, the Department of Health and Human Services (HHS) 
Secretary Azar asked Biomedical Advanced Research and 
Development Authority (BARDA) for a nationwide Expanded Access 
Investigational New Drug protocol for hydroxychloroquine and 
chloroquine in the Strategic National Stockpile (SNS). This 
would have legitimized these drugs for the treatment of COVID-
19 outside of a hospital.
    But instead, influential officials, non-physicians, 
transformed the request into an Emergency Use Authorization 
(EUA), only for hospitalized patients, to the patients who were 
the least likely to benefit. So instead of expanding access, 
the EUA restricted access. And later, FDA withdrew the EUA, 
further impeding its use, and HHS is presumably still hoarding 
more than 50 million doses of hydroxychloroquine while people 
are complaining about a potential shortage.
    At its November meeting, the American Medical Association 
(AMA) refused to rescind its unprecedented statement calling 
for physicians to stop prescribing hydroxychloroquine until 
sufficient evidence becomes available to conclusively 
illustrate that benefit outweighs harm. Yet, there have been 
192 studies compiled on hydroxychloroquine, with all showing 
some benefit when used early, in contrast to the handful of 
studies on remdesivir or monoclonal antibodies, which are the 
only things that the NIH recommends.
    More than 65 years of experience in hundreds of millions of 
patients have demonstrated safety. Hydroxychloroquine is safer 
than most over-the-counter drugs, including acetaminophen. 
However, organized medicine and academic physicians such as Dr. 
Ashish Jha have stated that the evidence is insufficiently 
``scientific.'' It does not meet their ``gold standard'' of the 
randomized controlled trial. But the fact is that most of the 
guidelines that we use for most diseases have relied on lower 
orders of evidence necessarily, and studies with appropriately 
analyzed data give results identical to RCTs. And RCTs 
themselves are not infallible, because they can be designed to 
succeed or designed to fail.
    Researchers in two hydroxychloroquine trials even used 
toxic or lethal doses of the drug, and then noticed that, yes, 
it did harm. Publication in the most prestigious journals does 
not assure reliability. There were huge studies that were based 
on probably fabricated data, with flaws that were undetected by 
the peer reviewers or the editors, were rushed into publication 
and had to be retracted by Lancet and the New England Journal 
of Medicine, but not quickly enough to prevent their 
significant misleading and harmful effect.
    RCTs are useful for testing, but they not for making 
discoveries, which are often serendipitous, like the use of 
ivermectin, for example, in patients with scabies. The smallpox 
vaccine was discovered because general practitioners (GPs) were 
sharing observations--now we call them ``anecdotes''--at the 
pub. They noticed that farmers who had had cow pox did not seem 
to get smallpox. Or they may result from the study of basic 
science and observation on patients, like today's protocol for 
Wegener granulomatosis was based on a 1973 article of 
nonrandomized patients, which was written by none other than 
Dr. Anthony Fauci.
    Today we have top-down, authority-based standard of care 
for early COVID, promulgated in NIH guidelines, which is 
therapeutic nihilism. We have lately added the expensive, 
largely unavailable monoclonal antibodies, but other than that, 
before the patient is in the hospital and on oxygen, the NIH 
recommends nothing. This is shocking and unprecedented, but in 
today's litigious environment, doctors who follow the standard 
of care are protected, and those who dare prescribe outside of 
it could be fired, removed from insurance panels, investigated, 
or even delicensed.
    Patients nationwide are calling on us at AAPS, searching 
for a doctor who will treat them. One patient told me he had 
had his wife drive him all the way to Dallas when all the 
doctors he knew in Tucson refused to prescribe for him, and his 
severe symptoms got better within hours of getting 
hydroxychloroquine from the doctor in Dallas.
    Doctors are reporting to us that they cannot get 
hydroxychloroquine for their nursing home patients, and that 
family doctors even told us that infectious disease specialists 
have refused to treat COVID patients. We are relying on 
quarantines, masks, and lockdowns. These are not backed by 
RCTs. They have not stopped the pandemic. They are not 
sustainable. Vaccines are touted as a great hope, but we do not 
have them yet, and they have not been shown to prevent 
contagion.
    What we need now is effective, early treatment for COVID-
19. Hydroxychloroquine and other safe, long-used agents, such 
as ivermectin--which is showing particular promise, but there 
are others--they could be immediately available if the 
government stopped blocking access and deterring their use. 
Physicians need to do as they have always done. They need to 
respond to the needs of their patients, use the best available 
information, share that information, and continuously strive to 
do better.
    Thank you so much for this opportunity.
    Chairman Johnson. Thank you, Dr. Orient.
    Our final witness is Dr. Jayantha Bhattacharya. Dr. 
Bhattacharya is Professor of Medicine at Stanford University 
and a research associate at the National Bureau of Economics 
Research. Dr. Bhattacharya's research focuses on the health and 
well-being of vulnerable populations with a particular emphasis 
on the role of government programs, biomedical innovation, and 
economics.
    Dr. Bhattacharya's recent research focuses on the 
epidemiology of COVID-19, as well as an evaluation of policy 
responses to the epidemic. Dr. Bhattacharya was the senior 
author of the first studies of the seroprevalence of COVID-19 
in Los Angeles County and Santa Clara County, as well as the 
Major League Baseball Seroprevalence study.
    He is the co-author of the Great Barrington Declaration, 
which urges an end to lockdowns and the adoption of a focused 
protection strategy to address the COVID-19 epidemic. He has 
published 135 articles top peer-reviewed scientific journals in 
medicine, economics, health, policy, epidemiology, statistics, 
law and public health, among other fields. He holds and M.D. 
and Ph.D. in economics, both earned at Stanford University. Dr. 
Bhattacharya.

TESTIMONY OF JAYANTA BHATTACHARYA, M.D., PH.D.,\1\ PROFESSOR OF 
  MEDICINE, STANFORD UNIVERSITY, AND SENIOR FELLOW, STANFORD 
             INSTITUTE FOR ECONOMIC POLICY RESEARCH

    Dr. Bhattacharya. Thank you, Senator. Thank you for the 
opportunity to testify. I feel a little bit out of place 
because I am going to be talking about how well we have done, 
or how dangerous the epidemic is as far as patients are 
concerned. I will cite some statistics on that and I will talk 
about the policy response. But I will also return to the theme 
of this hearing, which is on the incentives to evaluate 
therapies, especially therapies that do not have a financial 
interest behind them.
---------------------------------------------------------------------------
    \1\ The prepared statement of Dr. Bhattacharya appears in the 
Appendix on page 2043.
---------------------------------------------------------------------------
    Let me first start with some comments on how dangerous 
COVID-19 is at an individual level. Early in the epidemic, the 
World Health Organization publicized a very misleading, 3.4 
percent case fatality rate that panicked the world. The number 
is misleading because for the typical person infected, the 
usual outcome spans a range from no symptoms whatsoever to a 
mild cold to severe viral pneumonia, which the media highlights 
and that we have heard about in this hearing. Many infections 
are not identified as cases, especially in the early days, 
because they did not come to the attention of doctors or public 
health authorities.
    We know from a series of studies, the specific SARS-CoV-2 
antibodies in the blood, which provide evidence of prior COVID 
infections, this is true, and within these studies we can 
estimate the true COVID infection survival rate.
    Because of a recent publication in the Bulletin of the 
World Health Organization, surveying 61 of these studies 
worldwide, we now have a good estimate of the infection 
survival rate. It turns out to vary by orders of magnitude by 
age, which is the single most important risk factor, although 
there are others. For people 70 and over, the infection 
survival rate is 95 percent. It is a deadly disease especially 
for older people. For people under 70, though, the infection 
survival rate is 99.95 percent--let me say that number again, 
99.95 percent--and with improvements in treatment and patient 
management, like dexamethasone, as we have heard about, and 
also improved ventilator protocols, these numbers are improving 
all the time, and they could be better.
    At the same time, the harms of the lockdown are manifold 
and devastating, including plummeting childhood vaccination 
rates, worse cardiovascular disease outcomes, less cancer 
screening, deteriorating mental health, to name just a few. The 
toll is already high, and it will get worse in coming years as 
more people come in with late-stage cancer, worsening diabetes, 
and advanced heart disease that should have been identified and 
treated this year.
    The social isolation induced by lockdown has led to a sharp 
rise in opioid and drug-related overdoses, similar to the 
``deaths of despair'' that occurred in the wake of the 2008 
Great Recession. Social isolation of the elderly has 
contributed to a sharp rise in dementia-related deaths around 
the country. For children, the cessation of in-person schooling 
since the spring has led to ``catastrophic'' learning losses, 
with severe projected adverse consequences for affected 
students' lifespans.
    According to a CDC estimate, one in four young adults 
seriously considered suicide this past June, one in four. Among 
25- to 44-year-olds, the CDC reports that a 26 percent increase 
in excess all-cause mortality relative to past years, even 
though fewer than 5 percent of the 2020 deaths in this age 
group have been due to COVID-19.
    The two main planks of the Great Barrington Declaration and 
the focused protection ideas follow logically from these facts. 
For older people, COVID-19 is a deadly disease that should be 
met with overwhelming resources aimed at protecting them 
wherever they are, whether in nursing homes or their home, 
their workplace, or multi-generational homes. They should be 
prioritized for vaccines, and we should be actively seeking 
widely available and effective treatments, as we have heard in 
this Committee.
    For the non-vulnerable, those people who face far greater 
harm from the lockdowns than they do from COVID-19 infection 
risk, the lockdown should be lifted, and for those who so 
decide, normal life resumed.
    But what about better treatments for COVID-19 patients? I 
said earlier we have made a lot of progress in learning how to 
manage and treat the disease over the past months, but I think 
it has been a lot less than it should have been. Strikingly, 
the most useful advance in treatment involves the repurposing 
of a drug that is already in widespread use and entirely off 
patent--the steroid, dexamethasone, which is effective in 
helping severely ill COVID patients avoid a deadly and 
detrimental immune response.
    As a professor of medicine, my inbox is filled with 
scientists and physicians who have ideas for similarly 
repurposing existing drugs, vitamins, minerals, and other 
therapies for early treatment of COVID-19 infection. For many 
of these ideas there are good pathophysiological reasons and 
observational evidence to believe they might work. However, 
there is no randomized trials to evaluate whether they work. 
Doctors are free to use them off-label, that is, the FDA 
approved them for use in the past for some other indication, 
but they lack a gold standard evaluation of the efficacy of 
outpatient management, so most doctors will not use them.
    So, to me, the question is, before dismissing these 
treatments as ineffective because of lack of randomized 
evidence, I think the question we need to answer is, why have 
there been so few randomized evaluations, especially large-
scale ones, of these therapies?
    For that answer I am going to put on my economist hat. For 
drugs and therapies on patent, the patent holder has a strong 
interest in running randomized evaluations, navigating the 
drugs through the FDA's approval process. By contrast, for 
drugs and therapies with no patent holder, no one has much 
interest in funding expensive randomized trials or working 
assiduously to move the FDA regulatory process for rapid 
approval, or even slow approval.
    The bottleneck is not the FDA. It is the lack of a residual 
claimant for these drugs and treatment. Investigators working 
at academic medical centers may have a reputational interest in 
evaluating these drugs, and as you have seen, front-line 
doctors have an incentive to find good treatments for their 
patients. But they must find funds from somewhere for them, and 
pharmaceutical companies typically have no interest in it.
    In principle, the NIH exists to solve this market failure. 
It could and should use its resources to help fund randomized 
evaluations of these drugs for off-label purposes. It has 
funded some important drug evaluation work, such as a study to 
determine the right dosage and metabolism of drugs prescribed 
to children with 
COVID-19. It has also funded some trials for drugs for 
hospitalized patients. For the most part, though, they funded 
trials for on-patent drugs.
    The NIH has made comparatively little effort to catalyze 
randomized evaluations of off-patent drugs for COVID-19 
therapeutics. By contrast, the NIH has devoted considerable 
resources to aid the COVID-19 vaccine randomized trial studies. 
Even the highest-profile randomized evaluation of dexamethasone 
was not funded by the NIH. The NIH's relative lack of interest 
in the rapid randomized evaluation of non-patented drug 
evaluation represents a government failure that has likely led 
to worse COVID-19 outcomes than we would have had otherwise.
    Thank you for the opportunity to testify
    Chairman Johnson. Thank you, Dr. Bhattacharya. In an 
interesting display of close-mindedness I do not believe we 
have any Democratic Senators that really are inquisitive enough 
to even ask any questions of this distinguished panel. I 
appreciate the fact that the Senator and Dr. Paul is here. So 
what I will do is I will defer my questioning for Senator Paul.

               OPENING STATEMENT OF SENATOR PAUL

    Senator Paul. Thank you, Mr. Chairman.
    I would like to begin by apologizing for the juvenile 
diatribe from the Ranking Member. Science is about having an 
open mind. Science is about disputation, debate, evidence, and 
it is discussed. And the contention and the back-and-forth is 
how we determine what the truth is. But if you close your mind 
completely to this and are not willing to listen, I think that 
is how science dies. That is when we say, well, the government 
consensus, or the scientific consensus is this. That is the 
closing of the scientific mind, and that is a recipe for 
disaster.
    Science is also not about ad hominum and attacks, so by 
attacking this panel without listening to it, leaving in a 
huff, and having no questions shows a small-mindedness, a 
closed-mindedness, and really it should be everything that we 
should avoid.
    I am not here to be an advocate for one treatment over the 
other, and I will ask some tough questions to the panel. But I 
am open-minded enough to listen to their side and try to 
determine whether or not it is a good treatment or bad. But to 
immediately close our mind is a bad way of looking at this.
    I had a good friend die yesterday from this, so I am not 
one who is saying this is not a deadly disease. She lived a 
couple doors down, and we are sad. Kelley and I are both sad 
about what happened.
    About 6 months ago, we had a friend who died in their 30s, 
not from the disease but from lack of a stress 
electrocardiogram (EKG). She died from a terminal arrhythmia in 
her 30s, with two young children, but her stress EKG was 
canceled because the government decided that we should not do 
it. It was an elective procedure, it was delayed, and she died 
from a terminal arrhythmia. So people do also die from the 
decisions that people make.
    The most important thing is no one person is right. The 
panelists are not all right, and people should question them 
and go back and forth, and we try to figure out the truth from 
that. But it is a mistake to say that one person should have 
all the power to determine what we should do, when we place too 
much confidence in government doctors, such as Dr. Fauci. Dr. 
Kory mentioned that he mentioned in June about steroids. I 
mentioned it in March. When Dr. Fauci came into my committee 
hearing, my first thought about the final pathway here with 
COVID in the end stages is it is not too dissimilar from other 
final pathways of adult respiratory distress syndrome.
    I had a friend who is a surgeon who got the strep-eating 
flesh from operating on somebody who had it, and a blood 
spatter. He got it. The chance of losing your limbs is like 50 
to 70 percent. It is like a 50 percent chance of losing all 
your limbs. I mean, it is a devastating disease. But one of the 
final common pathways, like COVID, is your blood vessels leak 
fluid into your lungs. It is sort of a toxic shock kind of 
syndrome. They treated him with high-dose steroids. And so I 
raised my hand to Dr. Fauci and said, ``Do you think steroids 
might have a role in this?'' and he sort of dismissed me, and 
said that the studies were showing that it probably would not 
work.
    But I would think most people would argue now that one of 
the most significant developments in the acute care of the 
COVID patient has been the steroids, actually, and trying to 
get them the steroids before they have gotten into the full 
acute respiratory distress syndrome (ARDS). Some are even 
getting it at a very early stage in the disease.
    But that came from people asking questions, being 
skeptical, and not letting one doctor, such as Dr. Fauci, say, 
``Oh, that is not right, young man. Go sit in the corner.'' We 
need to have an open mind. I am not saying I am always right. I 
am a bystander and I am not an expert, but I try to ask the 
important questions.
    One of the questions that I would like to ask, and I think 
this is the difficulty of proving the situation on either 
ivermectin or hydroxychloroquine is that because so many people 
get better, the control group might be 99 percent of the people 
who get better. Then you give hydroxychloroquine to this same 
group and you might get 99.5 percent. It is going to be a 
difficult thing to actually prove in trials that you get a 
benefit. It sounds like, in some of the sicker patients, where 
you had a mortality, where you had a 25 percent mortality down 
to 15 percent, that does sound significant. Now you are getting 
into the sicker patients.
    With the outpatient studies, one of the critiques is that 
so many people get better naturally, how are you proving that 
it is statistically significant? What comes to my mind is sort 
of like when we wanted to prove that aspirin, taking an aspirin 
a day was good to prevent heart attacks, it took like 10 years 
and 10,000, people in the study, because it was just hard to 
show the differences in whether an aspirin worked or not. I 
think the same thing is true with either hydroxychloroquine or 
ivermectin in an outpatient setting, is that because so many 
people get better on their own. The converse is when you are 
really sick, because it is hard to treat people who are very 
sick. It is hard to prove that anything works when people are 
very sick.
    I guess what I would like to do is open it for the panel, 
one by one, to explain how we answer the critique that most of 
these people are getting better anyway so how are you proving 
that your treatment works in a group of people who did not go 
to the hospital, so you are selecting out, actually, for the 
people who may well then--did you prevent them from getting 
seriously sick or have you selected out, as your patient pool, 
because they are outpatient, tending to be people who are going 
to get better?
    We will start with those who are here. We will start with 
Dr. Oskoui and then we will go to Dr. Kory.
    Chairman Johnson. Let me quick interject, because we have 
such low participation, take whatever time you have for 
whatever questions you have.
    Dr. Oskoui. Thank you very much, Senator Paul, and I 
appreciate your introduction. I am not here as a politician. I 
am here as a treater. I will be very practical and I will defer 
to Dr. Kory, from his experiences as an intensivist.
    My clinical approach to patients are that they have 
symptoms, that I treat them early, and I typically restratify 
patients, getting lactic acid dehydrogenase (LDH) levels, 
lymphocyte counts, and other blood panels whenever possible.
    When I have used hydroxychloroquine, and often times 
ivermectin, I have had patients go to the hospital, if I did 
not have an EKG or another good assessment. I have always 
clinically evaluated the patients I have treated, but I risk 
stratify them.
    You may or may not know, a husband and wife couple, that I 
know Senator Johnson knows, who I treated the wife and not the 
husband, because I did not deem the husband to be sick enough 
to warrant treatment, although perfectly safe to, but his wife 
was much sicker. I think this has to be, to some degree, left 
in the discretion of the clinicians.
    In terms of the data, I provided the clerk of this 
Committee, Ms. Kilbride, portable document formats (PDFs) of 
numerous clinical trials on many of these drugs, not limited 
but including hydroxychloroquine, ivermectin, vitamin D, zinc, 
and a few other medications, and those trials are there.\1\
---------------------------------------------------------------------------
    \1\ The documents referenced by Dr. Oskoui appears in the Appendix 
beginning on page 2136.
---------------------------------------------------------------------------
    But the fact that we have had third-world countries, 
second-world countries, that have been more innovative and have 
outperformed us in terms of survival I think is something that 
warrants questioning. One has to wonder if our bloated 
research, academic bureaucracy, has been more of a hindrance 
than a help during this health care crisis. But I will turn 
this to whomever.
    Senator Paul. Dr. Kory.
    Dr. Kory. Senator Paul, I appreciate your question, and it 
is critical the content of your question, which is how can we 
tell when something is working when many patients get better? 
And there is only one answer to that, and we know what that is, 
and it is one of the central tenets of science, which is you 
need a control group. You need to have a group that is 
comparable to those that you treat and then you compare them to 
those that you do not treat.
    What I am trying to message today is in our manuscript we 
now have 11 randomized controlled trials. Every one of those 
controlled trials show that in the ivermectin-treated group 
lives are saved, there is less need for hospitalization, there 
is less transmission, less case counts. It is a fundamentally 
and powerfully effective therapy against COVID-19. We need the 
NIH to review these data. We have the data.
    Let me say, the amount of patients in those randomized 
controlled trials, the 11 trials, total nearly 4,000, with over 
half treated with ivermectin. Let's remind ourselves that the 
treatment of COVID-19 fundamentally changed after the 
Randomized Evaluation of COVID-19 Therapy (RECOVERY) trial was 
announced in June. That was a trial of 6,000 patients. Two 
thousands were treated with steroids and it showed the dramatic 
and lifesaving properties of corticosteroids. Almost overnight, 
the treatment of COVID-19 changed as a result of that trial. 
That was the RECOVERY trial.
    I am presenting a paper today with more patients treated 
with ivermectin, with larger magnitudes of benefit than the 
RECOVERY trial. I will maintain that ivermectin should be the 
standard of care of this disease, based on these data. It is 
not my opinion. It is the data. We have the data. If you give 
anyone else a placebo, based on the data that is in our 
manuscript, I believe that would be malpractice it would lead 
to the heightened risk of death. No more placebo is needed.
    Senator Paul. So the 11 studies are inpatient or inpatient 
and outpatient?
    Dr. Kory. They vary. The randomized controlled trials--I 
almost cannot describe what this data shows. People need to 
read the manuscript. We have four randomized controlled trials 
in prophylaxis, each and every one highly statistically 
significant. Patients, or people even, healthy citizens on 
ivermectin do not get COVID.
    Senator Paul. And you are comparing it to placebo in these 
studies?
    Dr. Kory. Yes. In the prophylaxis studies alone, which is 
four, they took COVID-19 patients who tested positive for 
COVID-19. They identified their household members. They gave 
them ivermectin. So they had a whole group of household 
contacts of COVID-19 patients who took ivermectin. The other 
households, they did not give ivermectin. Every single 
randomized controlled trial shows that in the households that 
were on ivermectin, drastically reduced rates of transmission. 
The households did not get sick. You can protect people from 
this disease with ivermectin. That is just the prophylaxis 
trials.
    The outpatient trials----
    Senator Paul. So the outcome tested was how many people 
turned up positive?
    Dr. Kory. How many people were positive or how many people 
got symptoms, and they were drastically statistically 
significant. These are from multiple centers in countries 
around the world. That is just the prophylaxis.
    We also have trials on early outpatient as well as 
hospital. The most dramatic is the hospital. Almost every 
single one, we have four large randomized controlled trials in 
the hospital, all statistically significant reductions in 
mortality. Dr. Rajter has a large observational controlled 
trial from Broward County, and he is here on the panel today. 
In his trial, he also showed the same. The patients who got 
ivermectin died at far less rates.
    Senator Paul. And opponents of using ivermectin, have they 
responded to these, critiqued these? Has there been a 
generalized argument that they make, or has there been silence?
    Dr. Kory. So, the opponents. Again, I want to call 
attention to the NIH and their recommendation. I do not want to 
say that they are an opponent. They made their last 
recommendation on ivermectin on August 27th, which is either 10 
years or 4 months ago. I do not know which. August 27th, this 
was their recommendation: ``We recommend against the use of 
ivermectin outside of clinical trials.'' That recommendation 
was based on expert opinion only. There was no data to 
recommend or recommend against. It was an expert opinion.
    Senator Paul. I will be happy to join with the Chairman in 
sending a letter to try to get an evaluation.
    If we could go to the same question, if we have time. Do 
you mind? Why do we not go to the rest of the panel and ask the 
same question. The problem, sort of from my perspective, still 
being how do you determine an outcome of something that, when 
you do nothing, the vast majority of outpatients actually get 
better also?
    Chairman Johnson. Let us start with Dr. Rajter.
    Dr. Rajter. Thank you for allowing me to speak. To clarify 
something, people talk about asymptomatic patients, but I have 
kind of stopped using that nomenclature. I call them pre-
symptomatic patients. We do not know offhand which one of these 
asymptomatic patients are going to develop severe disease and 
become symptomatic. That is problem number one.
    Problem number two, when I put in my written testimony, and 
also during my earlier testimony, I talk about the early 
intervention and treatment to decrease viral shedding and viral 
transmission in the home setting, and that is currently 
believed to be the largest numbers of people getting infected 
are getting infected in the home setting. So that means a 20- 
or 30-year-old may do fine, but now comes Christmas, there is a 
family meeting, and that asymptomatic individual now infects 
other family members, including their 70-, 80-, 90-year-old 
grandma, and now we have a real problem.
    What we do know about ivermectin is that it literally 
destroys the virus in most people within 48 hours. So, hence, 
you take somebody who is asymptomatic but a carrier with a risk 
of transmission, and you essentially stop that right in their 
tracks. So you do not have an issue about that person now 
contaminating other people down the line, or you significantly 
decrease that risk. So that is really even a very different 
spin on that question that was asked.
    Now, to continue as far as the data, you right, Senator, it 
will be difficult. My team currently has a study in place. We 
have the protocols written and we are ready to go. The only 
limiting factor was to get funding. I have tried everywhere. 
Getting the funding is extremely difficult. What we need to do 
is a large study, a large, randomized controlled study, to 
confirm the findings, to prove to the naysayers, you know what, 
here is your golden standard.
    Now, the study that I did was an observational study but it 
was propensity matched. That is the highest standard for a non-
randomized controlled trial. Even there it shows tremendous 
benefit. You spoke about the reduction in the overall 
mortality, from 25 down to 15. If you look at the overall 
mortality in people with severe lung involvement, that went 
from 81 percent down to 39 percent, that is even a more 
dramatic decrease, in even these more severe individuals.
    It is a safe drug, a track record that is phenomenal, with 
3.7 billion doses administered. I think we need to do those 
studies, with the help of the NIH, CDC, or any one of those 
regulatory agencies. A study like that could be implemented 
within 30 days. Within another 30 days from that we could have 
collected all the data. Within another 2, 3 weeks from that we 
should be able to have answers. If things are moved forward 
through the regulatory agencies we can have our answers before 
this tragedy even worsens.
    Chairman Johnson. Dr. Balboni.
    Dr. Balboni. Great. Thank you, and thank you, Senator Paul, 
for the question. I think I will speak to the trials that we 
are running for favipiravir, broad-spectrum antiviral, 
targeting Ribonucleic Acid (RNA)-dependent polymerase. We are 
running, currently, two large, placebo-controlled, randomized 
Phase 3 trials in the outpatient setting, early treatment and 
close exposure prophylaxis. In addition, there are two Phase 
2's, one at Stanford in the outpatient setting, and in long-
term care as well. There are observational studies with 
thousands of data points, and hundreds of smaller trials having 
been run in many countries around the world.
    We need to develop hybrid trial methodologies to combine 
all of these traditional RCTs and observational study designs 
to gather real-world evidence for the regulators. If we do not 
pool all of these data we are going to see COVID-19 in our 
rear-view mirror, we are going to quickly forget about it, and 
all of these potential treatments are going to fall by the 
wayside.
    I agree with you. We need to gather the data. It will be 
large populations, but we have to make that commitment. The 
only way we can make these studies work is a true public-
private partnership. Single companies, as we have heard, do not 
have the ability or the incentive to run these trials. 
Favipiravir, by the way, is off patent. We are doing this at 
risk, as a consortium. There is very little support for this 
kind of work, and as soon as it falls away we have to be 
beholden to our shareholders and our boards. In the meantime, 
as a physician, I am trying to do the right thing for patients.
    We need the assistance. We need government help. This has 
to be a whole-of-government approach and a commitment to going 
beyond this immediate problem, which is pressing and in our 
faces. But to do the right thing over the long haul to gather 
the data to silence the criticisms of these kinds of settings. 
Multiple small studies will not work, as you correctly point 
out. So this is what we need, gather the data, bundle it 
together, and make this available for future outbreaks.
    The last thing I will say is that as part of our trials, it 
is true that if we were to look only at mortality data these 
trials would be unacceptably large and would take too long to 
run. We have been working with the regulators to look at time 
to resolution of symptoms, similar to what was done with also 
Tamivir or Tamiflu. We believe that that is a stepwise 
approach, but it is taking too long to do this. We do not have 
a whole-of-government approach to this problem.
    I ask the Committee, those present and those who have 
decided not to ask questions, to just please internalize this 
message. We need a whole-of-government approach, similar to 
what was done with vaccines, to gather the data, to do exactly 
what you said, which is get to these large populations to show 
a difference.
    Senator Paul. So next Dr. Orient. I see Senator Hawley on 
the computer so we are going to check to see whether he wants 
to ask questions. But, Dr. Orient, do you want to answer that 
question?
    Dr. Orient. Senator Paul, that is an excellent question 
that certainly applies to all types of research. I would say if 
you have a really sick patient, and a sense you have a 
historical control on that patient, if the patient is going 
downhill and you do something and the patient gets better, then 
that is evidence that maybe you did something right. On the 
other hand, if you have a patient who is doing pretty well and 
you do something and the patient suddenly gets worse, then you 
have to be worried that you might have caused that problem.
    If you have a bunch of patients who are healthy and they 
are going to do well no matter what, then I guess you really 
need to have a large study, and it looks like with ivermectin 
they have done that. There are, of course, many confounding 
variables, and then there are the ethical questions. Do you 
have something that is going to protect your grandma if it 
works, and doing nothing is going to put your grandma at risk, 
then are you engaging in some kind of human sacrifice to use a 
placebo? At what point does that become the thing?
    Some people have even suggested that maybe the RCT is 
outdated and we should be looking at other statistical 
approaches like Bayesian analysis, so that we can get good data 
without running into this ethical dilemma, and deal with the 
need, maybe, to have combination therapies and to deal with 
confounding variables.
    Senator Paul. Dr. Bhattacharya.
    Dr. Bhattacharya. Thank you, Senator Paul, for that 
question. I think that the gist of your question is right. When 
you have an outcome that is relatively rare, what you need is 
very large samples in order to test--and a control group--to 
test whether the treatment actually works. You can get some 
indication with observational studies. There the difficulty is 
that the treatment is not randomly assigned. But there are 
statistical methods to address that, and the great advantage of 
observational studies is that with these statistical methods, 
correcting for the sort of selection bias in treatment, you 
actually can get very large samples relatively inexpensively.
    There is a procedure here I think we could follow. I mean, 
we could use datasets like the Medicare claims data, other 
claims datasets and other readily available, large-scale 
datasets to check for, in sort of well-designed observational 
settings, observational studies, to see if there is some 
promise to the kinds of treatments that people are thinking 
about. And you can do this for many treatments, in principal--
lots of people with different ideas can 
check--and then use that to inform where the large trial should 
be run. I think that is one procedure. There are others that 
potentially could follow.
    But the key thing I want to get across is that it is 
possible, if you just choose to do it, and the incentives to do 
this have not been great, and as a result we have much less 
information than we probably should have about the 
effectiveness of various treatments that are proposed, that we 
should have had by this time. In part, also, I think that has 
been driven by this group think, that you mentioned, that it 
was decided that there was only a small set of things that are 
going to work, even before any of the evidence has been 
evaluated. I think all of that is to be regretted.
    I think we have to go back to the principles we know about 
how sound science works. You have to do control groups, you 
have to do studies, but you have to have incentives to run 
those studies or else they are not going to get done.
    Senator Paul. Senator Hawley, are you there? We will check 
with his staff.
    One thing I think we lose in these discussions about 
observational versus random controlled studies is the 
difference between a pandemic situation and a non-pandemic 
situation. When you have these off-the-shelf drugs that have 
been prescribed safely for decades, it is kind of like, why not 
give it a shot? I mean, it should be a completely different 
mindset, and we just went the other way.
    Senator Hawley, thanks for joining the hearing. Go ahead.

              OPENING STATEMENT OF SENATOR HAWLEY

    Senator Hawley. Yes. Thank you, Mr. Chairman. Thanks for 
holding this hearing. Dr. Bhattacharya, I want to ask you about 
some of the points that you made in your written testimony, 
which I thought were quite striking, about the challenges of 
mitigation strategies, particularly mitigation strategies that 
involve lockdowns, full lockdowns. Of course, we experienced, 
in virtually every part of the country, certainly my home 
State, earlier this year, that many have been advocating as a 
mitigation strategy again now.
    You write about the data, the consequences of social 
isolation and deteriorating mental health that is associated 
with these lockdowns. I was particularly struck by the CDC data 
that you cite that says--let me get this right--that 1 in 4 
young adults seriously considered suicide this past June, when 
much of the country was locked down. That is a really stunning 
number. These impacts that you talk about in your testimony are 
really stunning.
    So can you speak to the challenges that maybe young people, 
in particular, but all Americans face from lockdowns as a 
mitigation strategy?
    Dr. Bhattacharya. I think lockdowns as a mitigation 
strategy are a failure of policy imagination, and they have had 
absolutely devastating effects. Humans are not meant to live in 
isolation, and that is the main focus of the lockdown 
strategies. Now I think there are some folks who are high risk 
from this disease, as I said, older people, some people with 
chronic conditions. For instances, 40 percent of deaths that 
happened in nursing homes, there we actually do need to do some 
sort of isolation, but we have to be careful there as well. 
There has been a 20 percent increase in dementia-related deaths 
in nursing homes, apart from COVID.
    The key failure, I think, is a failure of public health to 
recognize that there are dangers other than COVID--heart 
disease. The psychological distress to young people is 
devastating. We basically made them feel guilty for doing 
normal, young people things. As a result, it has had, as you 
can see, 1 in 4 seriously considered suicide. That number is 
absolutely shocking. I mean, it should shock the imagination of 
everyone listening, into thinking creatively about policy 
alternatives to lockdown. The lockdown should be a very last-
ditch effort, not the thing that we decide we should do all the 
time.
    Senator Hawley. I noticed that now even the World Health 
Organization, which I have to say is a body in which I place 
very little trust, and for which given its conduct in this 
pandemic I have very little respect. But nonetheless, even the 
WHO, I believe, has now said that mass lockdowns as a 
mitigation strategy, they do not recommend them. I mean, quite 
the contrary. They think the consequences, some of which you 
have just outlined, from these lockdowns, are devastating.
    Dr. Bhattacharya. There is an estimate that the United 
Nations (UN) put out in April, actually, I think, saying that 
there were 130 million people at risk of starvation as a 
consequence of the economic damage from the epidemic. I mean, 
these are 
lives--130 million, I mean, that is two orders of magnitude 
more than the number of people that have died from COVID-19. 
And to not put that in a policy response I think is utterly 
irresponsible.
    Senator Hawley. Can you talk to me a little bit about some 
of the other health care effects associated with lockdowns and 
decisions to cancel elective surgeries? I know in my home State 
of Missouri, many hospitals canceled elective surgeries back in 
the spring, and they tried to prepare, based on the data at the 
time, for what they thought would be an absolutely massive 
surge. Even now, as we are seeing cases rising quite 
significantly across the country, and again in my home State, a 
number of hospitals, as a precaution, have curbed elective 
surgeries and in some cases delayed them, which I totally 
understand.
    But speak to, if you could, the issues that come with the 
problem of deferring health care, when you have, again, 
especially in a lockdown situation, when you have tens of 
thousands of Americans, millions of Americans maybe, deferring 
what would otherwise be fairly routine health care procedures, 
health care visits. What is the cumulative effect of that over 
weeks and months, as it builds up?
    Dr. Bhattacharya. We are going to be paying the toll for 
that for a very long time. Just to make one example that is 
striking to me, mammography, mammograms, to check for breast 
cancer, declined by I think something like 80 percent 
nationwide. What is the consequence of that? Many women, who 
would have been diagnosed with earlier-stage breast cancer now 
will come in with late-stage breast cancers next year.
    We actually had made a lot of progress in reversing 
mortality for breast cancer and other cancers in the recent 
last decade. That is going to get reversed, with 100 percent 
certainty, as basic preventative measures--colonoscopies, 
mammography--have gone by the wayside because of COVID--I 
should just be clear--because of the COVID lockdowns.
    I think the public health should think about all of public 
health, all of health, not simply one disease. Public health is 
not just about infection control. I think that has been a major 
mistake that we have made all through this pandemic.
    Senator Hawley. Very good. Thank you for that.
    Dr. Kory, could I just ask you a question or two about 
social media? You wrote in your testimony, I noticed, that one 
of the barriers to using already-existing therapeutics, 
whatever they may be--there is an array of them--has been 
social media. You say that your pages, in particular, have been 
repeatedly blocked on Facebook. I wonder if you could just 
elaborate on your experience with Facebook or any other social 
media on this topic.
    Dr. Kory. Yes. I want to try to be respectful, because I 
think the intention is correct. The execution is unfortunately 
damaging. Which is, my guess at what the social media outlets, 
in particular it is Facebook, is that they want to cut down on 
misinformation, which is many doctors are out there claiming X, 
Y, and Z work in this disease.
    The challenge is you are also silencing those of us who are 
expert, reasoned, researched, and extremely knowledgeable. And 
so my group, our Facebook page--and again, I repeat, we are 
some of the most highly published physicians in our specialty. 
We have spent decades in academic medicine. We are not just 
some random doctor. But our group, every time we mention 
ivermectin we have been put in Facebook jail. Currently, as of 
this moment, our Facebook page is shut down to the point where 
we cannot post anything. We have asked the Senator for help in 
that, because we are trying to disseminate expert opinion, 
heavily researched insights into the therapeutics of this 
disease, and we are unable to do that on social media.
    Senator Hawley. Dr. Kory, what reason have they given, if 
any, for putting you in Facebook jail?
    Dr. Kory. I do not know that we have gotten specific 
reasons, but the best that we can tell is that we were 
mentioning ivermectin. So any claims to a simple solution--and, 
by the way, I am going to stand by my professional reputation, 
my decades in medicine, and I am going to tell you that I 
believe, not only I believe but my group of doctors, and there 
are at least nine of us who co-authored this manuscript, we are 
telling the world this is the solution to COVID-19, and it can 
be implemented rapidly. However, social media does not want to 
hear that from doctors. I do not blame them, because otherwise 
you are going to have doctors coming along and saying, I do not 
know, soda water or this is the next solution.
    I understand the intent. However, I just wish some 
credibility would be applied to us, and I do not know how to 
solve that answer, because I do think misinformation is a 
problem. It is a deep and significant problem in this pandemic. 
However, we are not propagators of misinformation.
    Senator Hawley. Is Facebook staffed with expert 
epidemiologists and infectious disease researchers, to your 
knowledge?
    Dr. Kory. Not to my knowledge. Certainly not.
    Senator Hawley. I mean, should Facebook be the arbiter of 
what counts as medical research, in your opinion?
    Dr. Kory. Of course I do not think that they should be the 
arbiters, but I am trying to be fair, and I do think their 
intent is to protect people from misinformation. However, they 
are also blocking good information. It is a very hard filter to 
put on, and I can understand their challenges. I just wish they 
did better at it.
    Senator Hawley. All right. Thank you, Dr. Kory, for your 
work, and thank you for sharing that. Unfortunately, this is a 
pattern that we see with Facebook and the other social media 
giants, which have now decided that they will be the arbiters 
of all information, news, journalism, and the rest, in the 
United States, and that they will determine what counts as 
accurate, reliable news, research, and everything else, despite 
usually having zero expertise in any of these areas. By the 
way, with zero desire for the American public that they should 
be deciding what we read, what we consume, what we learn about, 
what we share. It is really unbelievable.
    Mr. Chairman, thank you very much for holding this hearing.
    Chairman Johnson. Thank you, Senator Hawley, for 
participating.
    I want to quick go to Dr. Rajter, who has treated patients 
both in-hospital and also as an outpatient. Just describe, in 
human terms, what happens to a COVID patient. I think it is one 
of the more heartbreaking aspects of the disease, and quite 
honestly, it is one of the reasons I know people that will not 
get tested, because they do not want to become a COVID patient 
because they do not want to be separated from their family. But 
can you just describe what happens? People are dying alone. 
Does that continue to be necessary? But just describe what 
happens when you have somebody go into the hospital. Take it 
from there.
    Dr. Rajter. Yes. Thank you, Senator. So let me talk about a 
specific patient, a specific example, because that is very 
vivid in my mind.
    Chairman Johnson. Talk as loud as you can.
    Dr. Rajter. This lady that came in. She was in her 50s, no 
significant medical problems. I believe she had slight 
hypertension and diabetes but everything was very well 
controlled. The lady was initially diagnosed with COVID when 
she presented, and was on room air. Within a few hours she 
ended up on 2 liters worth of oxygen, and that is the point at 
which I got consulted to help with her management.
    Over the course of the next 24 hours, this lady went from 2 
liters of oxygen all the way up to 50 percent of oxygen. That 
is a very rapid decline. At the time, the hospital was in 
lockdown, meaning there were no visitors allowed into the 
hospital, so this lady knew that things were going very badly 
for her. The medical staff was limiting access to the rooms 
because we had very limited PPE supplies. So there she was with 
a disease that she was well aware of was quite critical, with 
no family at bedside, very limited interaction with health care 
workers and nurses entering that room.
    I was there, looking at her, and I am like this is bad 
news. Based on my experience, this lady would be facing near 
certain intubation, and back in April, intubation made a 90 
percent chance of dying. I called her son up and I got an iPad 
into the room so they can Facetime and have a discussion. That 
is the point at which the son broke down in tears. He was like, 
``Doctor, you have to do something for her. You have to. 
Doctors always have something they can do.'' I am like, ``Sir, 
with all due respect, I have nothing else to offer.''
    Luckily, my wife, who is also a doctor, Dr. Cepelowicz 
Rajter, just read the article about Dr. Wagstaff in Australia 
the day before, and, as the patient's family was pleading with 
me I am like, you know what, we have this. We have this one 
hope. I do not know what to do with this. There is no clinical 
data. The dosing in that trial is not something I can 
administer to humans. It is toxic. And then he was like, ``But 
it has other indications, right?'' I am like, ``Yes, there 
is.'' And then we started talking about other indications. He 
said, ``You know what? Give her the shot. Try. Please. I beg of 
you, try.''
    So I got informed consent from him, informed consent from 
her, administered the drug, and allowed to establish that 
connectivity between that family. Luckily, that lady did very 
well. She did not get intubated. She went up to 90 percent 
oxygen, but subsequently improved and was discharged to home 
maybe a week later.
    But you see that social isolation, where those people are 
away from family, and even today visitors are allowed back into 
the hospital but they are not allowed into the COVID rooms. 
That means that those patients are away from family, and 
because of all the measures that health care workers need to 
take, even now we still have a policy of limiting entry into 
the room. For example, the nurse will group all the lab draws 
and all the medications and try to enter the room maybe three 
or four times a day, at most. The residents, which are part of 
the institution, are asked not to enter the room. There is 
going to be one or two physicians that are going to do the 
physical exam, which is taken over by the other physicians. 
Usually I am one of those physicians that has to enter the room 
on all these patients and expose myself.
    But once again, it is very isolating for these people. We 
all know that besides all the medical problems that COVID 
causes--the kidney problems, the heart problems, the lung 
problems--we also know that it creates tremendous amounts of 
problems with mental status. These people, their mind is not 
quite right, and we have seen this, a tremendous amount of 
anxiety.
    So yes, it has been emotionally draining, both for the 
patients and their families, and frankly, for health care 
workers, as myself. I have a young family. I have a young wife 
and children. At the end of the day I want to go home and be 
safe. That is why I have become such a major proponent of early 
treatment, because with early treatment I will not expose the 
health care workers, including myself and my staff, 
unnecessarily to these people now admitted to the hospital with 
more advanced disease. That is why I feel it is so critical to 
have that early intervention, because we do know that treatment 
works much better earlier on than later on. Even later on, you 
can see on my data that I published, that the results are quite 
staggering.
    Chairman Johnson. Dr. Rajter, you just made a pretty 
convincing case, from my standpoint, of why we should 
concentrate on early treatments, because if we can we avoid 
that type of human toll.
    Dr. Orient, one of the reasons I got in contact with you, 
became aware of you, was through Dr. Lee Vliet, who was early 
advocating early treatment, in particular with 
hydroxychloroquine. And your organization allowed me to get, I 
think it was like 1,300 or 1,700 doctors very quickly signing a 
letter that we sent to the President of the United States, 
encouraging doing something to allow doctors to have access to 
these types of drugs, to use their off-label prescription 
rights.
    But I think one of the things that always impressed me 
about your organization, AAPS, was its pretty simple mission 
statement. So can you first describe that, then also what you 
are hearing from that network of doctors that have the courage 
and compassion to treat patients early, and basically answer my 
question that I asked Dr. Rajter about, what is happening to 
these COVID patients, and is there a better approach?
    Dr. Orient. AAPS was founded in 1943 to preserve private 
medicine, and that means the physician is working for the good 
of his patients, like it says in the Oath of Hippocrates, not 
for the good of the organization or society or the political 
party or the advancement of science, but each individual 
patient is the doctor's first priority. The doctor has to have 
the authority to go along with his responsibility to that 
patient, to look into the best methods, to communicate with his 
colleagues, and sometimes, or a lot of times, you just have to 
guess about what is the best thing to do for your patient and 
keep a careful watch on what works best.
    We found that physicians in independent practice are able 
to do this, but once the doctor has an employer or he has a 
managed care plan or he is restricted to what is on the drop-
down menu, then his hands are really tied. If the NIH is the 
authority that their employer respects then if he goes outside 
those rules, no matter how much his patient needs it, he is 
putting his life at risk, and it is becoming more and more.
    We used to worry about malpractice liability but that is a 
minor thing compared with being peer-reviewed by your hospital 
in a way just to get rid of you, that destroys your whole 
career forever, or for being before the licensure board because 
you deviated from the standard of care, which used to be 
determined by what doctors in a similar situation, rational, 
well-trained people would do. But now it is dictated more and 
more by single authorities from on high, whose opinions keep 
just getting carried on along, like the Arizona Medical 
Association (AMA).
    I am learning about ivermectin here. Arizona Medical 
Association, our county medical society, the AMA will say 
nothing about this. And you asked about, what are doctors 
doing, and the answer is, nothing that is not recommended by 
the FDA.
    For a patient to have an independent doctor who is not 
under quite so much severe restrictions on what he can do is 
extremely important. Occasionally a patient will tell me, 
``Well, I begged and pleaded with the hospital to do this for 
my person, my husband who was dying. Please, give him some 
intravenous vitamin C.'' Sometimes the patient's suggestion 
works. I mean, it does not always, but if the doctor is afraid 
that he dare not do something that is very safe or that is even 
being clinically trialed or has been reported in the 
literature, even from a long time ago, that he will lose his 
job, then he has every incentive to say, ``Well, there is 
nothing more that I can do.''
    So keeping this option open for patients is extremely 
important.
    Chairman Johnson. Thank you, Dr. Orient.
    I championed S. 204, Trickett Wendler, Frank Mongiello, 
Jordan McLinn, and Matthew Bellina Right to Try Act of 2017, 
and Dr. Rajter, basically that is what you practiced in. I 
mean, you had a patient there and you had to do something with 
that patient, and the patient's son begged you to do something, 
and you did something. I think that is exactly your right. We 
certainly are seeing a different type of medical establishment, 
where we have fewer doctors practicing medicine and more 
associated with these hospitals where they follow protocols, 
which makes perfect sense. But in a pandemic you have to think 
outside the box. You have to do other things.
    Dr. Balboni, I want to ask you, because I thought our phone 
conversation on Sunday was pretty interesting. You have been in 
the FDA. You have been a physician in the Department of Defense 
(DOD). You have been in government but now you are on the 
outside. I really want to ask you two questions. One, can you 
describe why government does not have the incentive to run 
these trials? We know the private sector does not. They cost 
millions and millions of dollars. If it is a generic drug there 
is no incentive, other than in government. It should be the 
NIH, the CDC, or the FDA that advocates for all citizens, for 
all patients, regardless of the financial incentive, but to 
look at repurposing drugs.
    Can you describe why that did not occur? Because one of the 
things we talked about is we have these drugs in our toolkit 
for a pandemic. I think Dr. Fauci talked about 
hydroxychloroquine, the drug that your company is trying to go 
through trial now. That was kind of in the toolkit. It was 
designed for pandemics, and all of a sudden we hit COVID and it 
is like that toolbox drawer was shut and locked and we ignored 
it. So can you just kind of describe that process and lack of 
incentives?
    Dr. Balboni. Sure, and great question, and I will try and 
do so with the utmost respect for my colleagues and former 
colleagues in government. Because I think, at the end of the 
day, people are trying to do the right thing, and I have to say 
that. Sometimes it does not always work out that way, and to 
your question about why, we are working on favipiravir. I first 
saw that as part of the Ebola outbreak in 2014, and it showed 
an effect in treating Ebola, and then everyone kind of forgot 
about it, and the pressure to move quickly went away. It is 
approved for pandemic flu in Japan. It is approved for COVID-19 
in India and Russia. It is likely to be approved in Japan for 
COVID-19 imminently. The FDA is not moving as quickly, although 
we are having very fruitful discussions with them.
    I think that we are treating, unfortunately, many of these 
products as if they were for chronic diseases, and that may 
work well in a non-pandemic situation, and that is the 
structure of these organizations, is to review thoughtfully and 
take the time to look at all the data. Again, I am not 
suggesting we do not do that, but in addition to that we have 
to push these agencies. There has to be a forcing function for 
change, and when under stress I think they fall back on what 
they know, which is reviewing and approving drugs like 
cardiovascular drugs, which they can take more time with.
    I think there needs to be both a forcing function for 
supporting their efforts to move outside of what is tried and 
true in their review process. I think, you, as a Committee, and 
as politicians, have your hands on that lever. Whether it is 
policy or law, there needs to be a forcing function to move 
them out of the ways that they do things, which again, work in 
a non-pandemic situation.
    I would point to two things, Senator. Public Law 115-92. I 
worked on that when I was inside the DOD. That was a law signed 
into effect in 2017, which mandates that the DOD and FDA hold 
discussions and talks around regulated products that are of 
particular interest to the war fighter, and it puts them on an 
accelerated approval track. It does not cut corners but it 
allows the regulator to devote resources to those kinds of 
accelerated discussions.
    I would also point to a very recent development, and 
politics notwithstanding, it should not matter, a very 
pragmatic approach to doing the same kind of work as, S. 2388, 
the Reciprocity Ensures Streamlined Use of Livesaving 
Treatments (RESULT) Act, submitted by Senators Cruz and Lee. 
And, without having done--I did some reading of that and it 
seems like a very pragmatic approach to push and force some 
change on the regulatory agencies to move things along more 
quickly.
    I have to say, the last thing I will say here is I received 
17 emails over the weekend and calls requesting compassionate 
use and single-use investigational new drug (INDs) for 
favipiravir. In the middle of running randomized controlled 
trials I cannot possible entertain all of those. My colleagues, 
many of whom you have heard today, are treating those patients. 
I cannot entertain all of those compassionate use, single-
patient INDs. So we have to move the regulators outside of 
their comfort zone, work with them to develop new policies, and 
I am hopeful that you and your colleagues, with your hands on 
those levers, can force that policy and get them out of what 
they know, and start thinking a bit creatively in the middle of 
the pandemic.
    Chairman Johnson. I am quite sure that the RESULT Act--I 
think I am a co-sponsor of that--ties in very nicely with Right 
to Try. That allows patients and doctors to use a drug that is 
approved by another body, whatever the FDA equivalent is for 
the European Union (EU). Correct?
    Dr. Balboni. Right. So drugs that are approved in other 
well-established jurisdictions like Europe, Canada, or Japan, 
for example. It would move the agency, the FDA, to review and 
treat as equivalent that review and approval, and so greatly 
speed the process of getting drugs available.
    Chairman Johnson. Yes. I am a big supporter of allowing 
doctors to be doctors and allowing patients to make these 
decisions, because it is their lives, or it is their families' 
lives.
    We talked about other world bodies or other things that are 
happening globally. In our last hearing, Dr. McCullough pointed 
out that the death rate in India is about 95 per million. In 
the United States and other advanced nations it is closer to 
800 per million. I am not sure who to direct this question to, 
but are you aware of us actually studying what these other 
countries are doing?
    One thing I have been struck with is I have been kind of at 
the tip of the spear here, so I get a lot of information. I am 
not a doctor, but it is an awful lot of interesting 
information. One of the things that I have found out or heard 
is some of these less-developed countries that just do not have 
the type of money to throw at a medical system like the United 
States, all they have are these cheap, generic drugs, and they 
are using them and doing quite well.
    Does anybody have some expertise to kind of speak to that? 
Dr. Bhattacharya.
    Dr. Kory. Senator, if I can have an opportunity after Dr. 
Bhattacharya.
    Chairman Johnson. Sure.
    Dr. Bhattacharya. Sure. I have been reading the scientific 
evidence on this. There is a debate going on about what exactly 
is there. So part of the difference is that they have a younger 
population. For instance, the low rate of mortality in African 
COVID is almost certainly partly due to that, because there are 
so relatively few elderly.
    But also I agree with you, the use of other medications 
that appear promising are certainly going to end up what I 
think could play a role in explaining why places like India, 
countries in Africa have done better.
    There is another explanation, a couple of other 
explanations that I have heard in the scientific literature--
again, this is still all being sorted out--is the prevalence of 
cheap vaccinations. There is a vaccination called Bacille 
Calmette Guerin (BCG) vaccination, which apparently has played 
some role, at least that is the hypothesis that people have put 
forward and there is some evidence in favor of that, in 
preventing bad outcomes of disease and actually preventing the 
disease at all.
    And the other hypothesis I have heard is the prevalence of 
preexisting other--of immunity based on cross-reactive 
protection from other coronavirus infections. So there are 
higher rates of that in many poorer countries.
    I think all of those, we are going to sort out how much 
each of those explanations end up playing a role. I do not 
think we yet have a definitive answer, but I think that plus 
things we have not thought of yet are going to end up playing 
an important role in understanding of this.
    Notice I did not say lockdowns, because in many of those 
places lockdowns are not actually feasible as a long-term 
outcome, and have probably not played a role in explaining why 
they have done better. Lockdowns are sort of a luxury of the 
rich, and a very expensive one at that.
    Chairman Johnson. Dr. Kory.
    Dr. Kory. Yes. Senator, my organization, the Frontline 
COVID-19 Critical Care Alliance, we have worked with a number 
of analysts, and two analysts that are part of our organization 
have been doing numerous epidemiologic analyses throughout the 
pandemic. Their data, which, again, I have to say, is free to 
share--we can share with the NIH and the FDA so they can verify 
and validate the data--but if I could go through that data very 
briefly right now I would appreciate it. I brought slides. I 
will go through them very quickly. They are visual and easy to 
understand.
    Chairman Johnson. Do we have slides available? Is this the 
one on Peru?
    Dr. Kory. Yes, and let us start with that, because Dr. 
Bhattacharya just mentioned something, is that one hypothesis 
for why we are seeing lower rates is that potentially there are 
younger populations. I want to show data to show that that is 
not true in these regions.
    Chairman Johnson. Is this the right slide?
    Dr. Kory. Yes. Number one, this is only in patients over 
60. We know the mortality rates in patients over 60. They are 
fundamentally different than in younger patients. When you only 
look at patients over 60 and you look at this slide, this is in 
the eight regions of Peru, eight States in Peru, that initiated 
ivermectin distribution campaigns throughout their population. 
If you look at each graph, the shaded area to the left of the 
graph is before the ivermectin distribution. To the right of 
that shaded area is after they initiated ivermectin 
distribution campaigns, in each of the eight States. You see 
what we call a temporally associated reduction. There is a peak 
in deaths, a peak in case counts, and a peak in case fatality 
rates, which rapidly decreased to pre-pandemic levels. This is 
powerful data.
    If you could go to the next slide, the next slide, I 
believe if you could show me--that is actually a skip, but I 
will say this has been replayed. We have data from many 
countries. On my website, our analysts have numerous examples. 
This is one in Paraguay. There was a State in Paraguay called 
Alto Parana. The Governor there got COVID. His brother got 
COVID. They took ivermectin and felt immediately better. And so 
they concluded that ivermectin was an effective treatment. I am 
not saying that is how we determine treatments, but that is 
what they did.
    The Governor did something really dramatic. He immediately 
began what he called a deworming campaign through his State, 
because he did not want to go against the Federal Health 
Ministry, which was against ivermectin. In his State, he began 
to distribute ivermectin to the population. If you look at that 
graph----
    Chairman Johnson. That is the blue line.
    Dr. Kory [continuing]. Deaths, peak, and they rapidly 
decrease. A month and a half later, he found almost no cases in 
the hospitals. That was in Paraguay.
    If you can go to another slide I can show--are there any 
more slides that you have?
    Chairman Johnson. This is the one----
    Dr. Kory. Yes, this is in Mexico. So this is deaths in 
Mexico, and the left side of the graph is before August 1st and 
the right is after. The green-shaded State is the State of 
Chiapas, in Mexico, in southern Mexico. That State alone, 
amongst all the States in Mexico, decided to incorporate 
ivermectin in its treatment protocols, and if you look, the 
case counts--and these are widely available and globally used 
databases of case counts and deaths--you can see the deaths 
plummeted, while in all the surrounding regions in Mexico the 
deaths either decreased only slightly or in the majority they 
increased.
    So you are seeing this play out on population-wide basis, 
in many regions of the world. If there is another slide, please 
advance.
    Here, going back to Peru, if you look at the blue lines and 
graphs, those are those eight States that I presented, whose 
regional health ministries decided to widely distribute 
ivermectin. The red bars refer to Lima, the biggest city in 
Peru. Guess what happened in Lima? The Health Ministry of Lima 
did not employ ivermectin in the treatment of COVID-19, and if 
you can see, throughout the summer and throughout this 
pandemic, the case counts rapidly rise and remain high, and 
only recently have come down but they are nowhere near the 
regions in which ivermectin was widely used.
    We have this data. It is showing that we have an effective 
treatment against this pandemic. I cannot overemphasize that.
    Chairman Johnson. OK. Thank you.
    I think I have one question for Dr. Oskoui, and then what I 
will offer is all of you an opportunity, a couple minutes, try 
and keep it to a couple of minutes, of just something that you 
still want to say that you have not had an opportunity to do 
so.
    Dr. Oskoui, I have a couple of questions for you. First of 
all, on asymptomatic spread, I think just heard that we have 
180-degree turn on that, where somebody--announced that they 
really do not believe that asymptomatic spread is that big a 
deal, and we were earlier told that that is one of the biggest 
problems with COVID is people that do not even know they have 
the illness are walking around and they are spreading it. Can 
you discuss what you believe is the current science on that?
    Dr. Oskoui. I think the current science, and there is a 
large population-based study out of China that suggests that 
asymptomatic spread is extremely uncommon. I think one of the 
reasons why literature has not clearly supported masking--and I 
will review that in my final comments--as a significant 
preventative, is that I think that early on we got it wrong as 
to what is the predominant mechanism of spread. I believe what 
the Oxford University white paper, by Thomas Jefferson, 
believes, and which I provided to Ms. Kilbride, the clerk of 
this Committee, that I think that oral-fecal transmission, much 
like norovirus and polio, is the predominant mechanism of 
spread, and that is one of the reasons why masking does not 
work and why asymptomatic spread is not predominant.
    I think that makes much more sense. The white paper was 
provided to Ms. Kilbride,\1\ and I provided it to your aide, 
and I hope it will be disseminated among Members of the 
Committee. But I think the science behind that paper, Tom 
Jefferson and the rest of the Oxford group, Center for 
Evidence-Based Medicine, is actually pretty compelling. We have 
had that since March.
---------------------------------------------------------------------------
    \1\ The document referenced by Dr. Oskoui appears in the Appendix 
beginning on page 2136.
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    I think the ramifications of that are that aggressive use 
of chlorine-based cleaners and other things would really be 
very helpful in transmission, and really need to be properly, 
effectively promulgated.
    Chairman Johnson. So can you, and again, I am not a doctor 
and this is not a medical class here, but can you just describe 
the biology in terms of COVID and why some, whether it is 
ivermectin or hydroxychloroquine or zinc, whether it is 
favipiravir--and I probably mispronounced that but I am 
actually doing better than I thought--can you describe, in 
layman's terms, how that might work? Can you lay this out 
simply enough, or is it just a bad question?
    Dr. Oskoui. It is rather complicated to do so in a short 
period. There was a pangolin tissue model that a number of 
Chinese scientists published about, that I referenced, in the 
Journal of Medical Virology, that showed that three drugs--a 
drug similar to ivermectin, a drug similar to 
hydroxychloroquine--actually had local effects.
    Hydroxychloroquine's mechanism is just probably 
multifactorial. It prevent viral autophagy. It also is an anti-
inflammatory and it has some benefits there. Also, ivermectin 
has some important effects as well. But there is strong basic 
science, in addition to the clinical studies, that I presented 
to your clerk, and which Dr. Kory has referenced, that suggest 
mechanisms for significant efficacy. I will provide that 
separately as an addendum to my testimony.
    Chairman Johnson. But is it safe to say that all these off-
the-shelf, generic drugs, in some way, shape, or form they 
limit or halt the viral replication? Is that the mechanism 
going on?
    Dr. Oskoui. We have known since 2005 that zinc was an 
effective inhibitor for cleavage, an important mechanism that 
makes these viruses more virulent. That is something that our 
Fort Detrick colleagues published and did not do much with. But 
there is good literature that suggests zinc itself is very 
effective.
    I personally recommend to my patients that all of them take 
50 mg of chelated zinc a day if they can tolerate the dyspepsia 
and to keep their vitamin D levels over 30. There is 
significant data, a very nice study in the United States, large 
study, as well as one out of Israel, that if one keeps one's 
vitamin D3 level over 30, that one cuts the relative risk of 
getting COVID by 50 to 55 percent. So simple public health 
measure that could be undertaken easily.
    Chairman Johnson. So let me ask, of all these things that 
people have talked about--zinc, vitamin D, vitamin C, 
quercetin, ivermectin, hydroxychloroquine, favipiravir--are 
there any real dangers? I did talk to Dr. Balboni on 
favipiravir that certainly you should not give it to women that 
are pregnant. But these other ones, how safe are they, or is 
there really any danger that prescribing these at the proper 
levels? In other words, to give it a shot, as opposed to doing 
nothing, which is what NIH guidelines is right now?
    Dr. Oskoui. The short answer, I think, is there is really 
trivial, if any, risk, at all. The reality is that our academic 
colleague who have not discussed vitamin D and some of these 
other interventions are not, but it need not be a binary 
choice, obviously. We do not have to decide hydroxychloroquine 
versus remdesivir versus vaccines. We need all hands on deck.
    What I would say is that there are nuanced arguments about 
quercetin. I think the data about vitamin D toxicity is 
trivial, and really, the real problem is vitamin D deficiency.
    Dr. Kory, in his testimony, mentioned that two groups in 
the United States have been hardest hit--African Americans and 
Hispanics. African Americans, 81 percent of African Americans 
in the United States suffer from vitamin D deficiency, 60 
percent of Hispanics, 40 percent of Caucasians. Nursing home 
patients are notorious for being vitamin D deficient. Military, 
servicemembers, are also known to be vitamin D deficient. You 
would think they were sunning themselves on these aircraft 
carriers, but obviously quite the contrary.
    I think that we should follow the example of the National 
Health Service in the United Kingdom (UK) and Scotland, which 
is currently distributing vitamin D supplements to their 
elderly. They have been doing that for a couple of weeks now. 
Why we are not pressing this simple point, while we go over 
these other issues, fails to meet my level of understanding.
    Dr. Kory. Senator, can I answer your question?
    Chairman Johnson. Go ahead, Dr. Kory.
    Dr. Kory. You have said repeatedly, and you and I have a 
strong kinship on that approach, which is does it hurt to try? 
What are the risks of treatment with these agents? I will tell 
you, in medicine, as a physician, every decision I make 
therapeutically, it involves exactly that question, which is a 
risk-benefit analysis. And so if the therapy I have is either 
low-cost, low-resource, or extremely safe, and its potential 
for benefit is high, it would win the risk-benefit analysis, 
and you should be given it. I think that is what you have been 
arguing.
    I tell you, with these agents the answer is unequivocally 
yes. When you look at the mortality and morbidity of this 
disease, which is unparalleled, we are seeing countless deaths, 
and it is horrific the way they are dying. And you look at the 
safe and low-cost agents, it seem like a no-brainer that you 
should try it.
    Here is the thing about ivermectin, going back to 
ivermectin, because, that is my message today, that it is the 
cure for this----
    Chairman Johnson. By the way, you support ivermectin, 
right?
    Dr. Kory. Of course. You are not confused about that, 
right, Senator? [Laughter.]
    You have to understanding something about ivermectin--3.7 
billion doses have been administered since it was first 
developed in 1987, 3.7 billion. Something like over 60 percent 
of sub-Saharan Africa takes it on a yearly basis. It has an 
unparalleled safety profile, with almost no side effects. The 
only side effects that have been attributed to it are those 
that are considered to be part of the diseases they treat, 
which is the ridding of the parasites.
    And so given the mountain of evidence that I have 
presented, as well as the safety profile, on a risk-benefit 
therapeutic analysis, you cannot come up with a credible 
argument to not give it.
    Chairman Johnson. Hydroxychloroquine, I think, in 
testimony, Dr. Risch talked about tens of billions of doses of 
that. I was concerned. When we first started talking about that 
it was a legitimate concern. If everybody started using that in 
the United States or worldwide as a prophylaxis, you could not 
produce enough and so people with lupus and rheumatoid 
arthritis may not get it. So that was a legitimate concern and 
maybe required government intervention to ration.
    But, what I thought was interesting about it is--and I kind 
of lost my train of thought. I will move on.
    Let's go to my final round of questioning, and we will 
start with Dr. Bhattacharya. By the way, real quick, because I 
want to ask you, I thought in your testimony two things were 
very stark, and I know you mentioned this with Senator Hawley. 
The 130 million people that the U.N. study showed were going to 
starve to death because of the economic devastation of the 
shutdowns, that now the World Health Organization says we 
should not be shutting down, and yet there are so many 
Governors that are still pursuing that path.
    The other one was--and I do not think this was in your 
testimony but I saw this in another writing--I have certainly 
been following it, and I have actually, in a couple of op-eds 
talked about the case fatality rate versus the infection 
fatality rate. I have been monitoring what the estimate is. The 
prediction is from Oxford Center for Evidence-Based Medicine, 
for months now they have been predicting the infection fatality 
rate is going to be somewhere between 0.1 and 0.4. I think now 
it is between 0.1 and 0.35. You talked about, in an article, 
about these seroprevalent studies, 82 of them now, are kind of 
pointing to a 0.2 percent infection fatality rate.
    Seasonal flu--and I have printed this out from the CDC 
website--a bad year is about 0.18. So again, I am not 
downplaying COVID. As Senator Paul talked about, people he 
knows, as those of you who have treated, it is a deadly 
disease, and particularly for over 70, 5 percent of the people 
with COVID die from it, or with it. I am not downplaying this. 
But I think you have to look at those numbers and ask, what 
have we done, and what is the human toll of our actions on a 
disease that long-term it looks like it is certainly worse than 
the flu, but is it that much worse, to cause that much economic 
devastation with that severe a human toll, 130 million people 
starving, and, of course, we heard all the other follow-ons.
    But anyway, Dr. Bhattacharya, if you have your closing 
thoughts.
    Dr. Bhattacharya. Sure. Thank you for this opportunity to 
testify and thank you for that lead-up. I mean, I think it is 
worse than the flu, but it has very different properties than 
the flu. Older people have a much higher rate of death from 
this than younger people. I mean, the flu also has that pattern 
but not quite so pronounced.
    But the most striking difference in how we have dealt with 
the flu versus how we deal with this is not actually in the 
treatments and all that. I mean, there are obviously vaccines 
and other things. That is different. But the most striking 
thing is that in the case of the flu we do not induce panic, 
and in this case we have. Panic has been part of the policy, it 
has been part of the lockdown, and I think it has caused 
enormous harm. It is a violation of all I have ever learned 
about standard mental health practice, which is generally to 
reassure the public, provide good information, and seek to 
develop good treatments and preventative activities. Instead we 
have just panicked the public.
    Let me close by just remarking on how civil and interesting 
this conversation has been. You have heard disagreement a 
little bit among us, but we have been talking about hypotheses 
on complicated issues. I have learned from the panel, and I 
think this kind of conversation ought to be the standard, 
instead of this sort of close-minded--like we heard from the 
Ranking Member, sort of a close-minded decision that experts 
who decided what the truth is and we just stop the 
conversation. I would just really note that.
    And the second thing, and what I would end with, is we 
talked about how should we do evaluation in the midst of a 
pandemic versus in the midst of normal times. I think there is 
always this tradeoff of risks and reward in this. When we are 
deciding whether a treatment works, and we are telling patients 
or public health authorities that we should adopt this or that 
thing, we want to have the best possible information available.
    At the same time, even outside of a pandemic, if you are 
really sick and there is not a good treatment for you, you 
would like to be able to see things that generally you would 
not use, because, the potential reward from it working is so 
great and really there is no cost, or much less cost because 
you are at great risk already.
    I think the major problem is the structures we have in 
place to do this kind of rapid evaluation and develop evidence, 
there are not sufficient incentives in place to do this kind of 
evaluation, as I said in my opening testimony. I think that is 
for both economic reasons and sort of government failure 
reasons, that is true.
    We absolutely have to fix that. We need a system that 
allows for this kind of conversation, formal conversation, with 
rapid evaluation of reasoning observational data, rapid 
funding, larger-scale studies for the most promising things, to 
be done sort of all the time, not just during a pandemic. I 
hope that the pandemic, one lesson we come out of it is, let's 
be more humble about whether expert opinion actually can be 
correct and instead be more open to novel ideas, even ones that 
seem, to some part of experts, as not actually going to work. 
Let us try it. Let us do studies around it and then decide, and 
on that basis make decisions, as opposed to just closing debate 
altogether, as we saw sort of the Ranking Member tried to do.
    Chairman Johnson. It amazes me how these hearings have been 
attacked, really how close-minded this has been, how our 
colleagues have boycotted this. It is pretty amazing to me.
    Dr. Orient, I actually did remember what I was leading to 
in terms of talking about hydroxychloroquine. I just wanted to 
ask, it was originally approved for antimalarial. Correct?
    Dr. Orient. Yes. That is correct.
    Chairman Johnson. It has never been FDA approved for what 
it is primarily used for nowadays, because antimalarial use is 
small in comparison to its application to rheumatoid arthritis 
and lupus.
    Dr. Orient. That is exactly right.
    Chairman Johnson. Those are off-label applications and it 
works. And so we are just suggesting, maybe it might work for 
COVID too. Why not give it a shot?
    By the way, I have a vote in about 10 minutes, so if you 
can kind of stay within that 2-minute constraint I would 
appreciate that, in your closing comments. But Dr. Orient.
    Dr. Orient. That is exactly right that it is off-label used 
for many things.
    About hydroxychloroquine, there are graphs of that that 
look quite a bit like the graphs for ivermectin, that when 
countries, like in Brazil, one part of it uses 
hydroxychloroquine and the other part really forbids it. You 
see a big difference in the mortality rates. And most 
impressive, probably, was in Switzerland. The mortality rate 
went up when they stopped using it because of the terror 
provoked by that Lancet study that was withdrawn. Then it came 
down again when the Swiss went back to using it.
    I think both drugs have a lot of potential, and sometimes 
patients respond better to one than to other.
    The big difference between India and the United States 
bears repeating, 10 times higher mortality in the United States 
and Western Europe compared with third-world countries. Part of 
the reason may be the age distribution but part of it may be 
sunshine and less vitamin D deficiency in India and Africa.
    I wanted to follow up a little bit on the poison thing that 
Dr. Jha made a big deal about in the last hearing, and Dr. 
McCullough answered it quite competently. But just to reiterate 
that Dr. Jha was concerned that the rate of Poison Control 
Center reports for hydroxychloroquine went up, doubled. 
Actually, it went up from 35 to 76. But if you look at hand 
sanitizer, there were 33,000 hand sanitizer reports to the 
Poison Control Center, which was an increase of 73 percent. And 
for acetaminophen, which everybody recommends that you take 
instead of some of the drugs that might help you, there were 
50,000 cases of just exposure to that alone, and another 23,000 
in combination, and 65 and 42 deaths, respectively.
    But people are terrified of the cardiac effects, even 
though reviews have shown that hydroxychloroquine may actually 
protect the heart rather than be a danger to the heart. And if 
you are worried about QT intervals you ought to worry about a 
lot of common antibiotics and antidepressants also, which we do 
not.
    Chairman Johnson. Thank you.
    Dr. Orient. One other thing I might mention is somebody 
mentioned the oral-fecal transmission, which I think is very 
interesting, that has been coming to light. Back in the SARS 
epidemic there were cases that broke out in an apartment 
building, and they could not figure out why, and it was 
probably because of the flushing toilets putting aerosols into 
the ventilation system. Maybe this has a lot to do with it. 
Maybe instead of putting masks on everybody we should be 
putting lids on the toilet or pouring Clorox into it before you 
flush it.
    I think our epidemiologists have not been doing a very good 
job of figuring out just exactly how does the transmission 
occur, so that we can be sure that our mitigation methods are 
targeted to the needs. And going back to all of this, I think 
doctors need to use their own judgment and look at all of these 
things.
    Chairman Johnson. I think I read an article about the high-
pressure flushes inside hospitals might be a problem.
    Dr. Balboni, again, a couple of minutes, please.
    Dr. Balboni. Sure. Thank you, and thanks to you for your 
support. In 17 years in the Army I have lived by the motto 
``One Team, One Fight.'' At DOD, everybody became an Ebola 
scientist or physician. Everybody became a COVID-19 physician 
at United States Army Medical Material Agency (USAMMDA) as they 
tried to fight this.
    There is an urgent need to develop hybrid trial 
methodologies, new approaches to public policy, and I think, 
from my perspective, most importantly, to fit the regulatory 
approaches to the threat that we are faced with, in this case a 
pandemic. If we fail to change our approach and develop an 
appropriate and safe use of these drugs, including oral 
antiviral therapeutics, we are going to be having this 
conversation again for COVID-20 or--21 or Virus X. It is 
unfortunate and I have seen it already. We cannot continue to 
send 170,000 COVID-positive patients home with the hope that 
they will be OK. It is just not going to work.
    So we need, in closing, your assistance and the continued 
leadership of, frankly, this entire Committee and the whole of 
government to finally build this toolbox. And so I thank you 
for reaching out and thank you to all of my colleagues here 
that have testified, and I hope the message has come across.
    Chairman Johnson. I hope they are not vilified for doing 
so. Dr. Kory.
    Dr. Kory. Yes, so I will be brief, to your request, 
Senator.
    Two things I want to mention. This is not the flu. I have 
been a doctor for a long time. I will tell you, from the 
earliest onset in this country, in New York, in one major 
health care system that I helped work with, they went from 95 
ICU beds in a span of 2\1/2\ weeks to 350 ICU beds. 
Gastroenterologists were taking care of dying patients on 
ventilators. We do not do that with the flu. I have done 
nothing but take care of COVID patients since the beginning. We 
have ICUs dedicated to COVID patients on ventilators. That is 
not what happens with the flu.
    The last thing I want to say is, again, I am just going to 
reiterate, because repetition is key. The amount of patients in 
the randomized controlled trials whose results are now 
available, and again, they have come out recently, they are 
emerging--I do not want to attack the NIH for getting it wrong. 
They did not necessarily get it wrong. They are just not 
keeping up with the data. My message today is that the recently 
emerging data has enough randomized controlled trial patients 
enrolled, they exceed the 
RECOVERY trial, which changed the face of treatment of COVID. 
If you look at the summation of all those trials, ivermectin 
has shown itself to be a highly effective preventative and 
early treatment agent. It needs to be immediately adopted, 
systematically, nationally, and globally, period.
    Chairman Johnson. By the way, I just wanted to clarify, I 
am in no way, shape, or form downplaying COVID. I do not want 
to get it. I do not want anybody to get it. I understand how 
serious, and I was just making the data comparison. Dr. Rajter.
    Dr. Rajter. Thank you, Chairman, for allowing me to 
participate in these hearings. As a frontline provider, I have 
been treating COVID pretty much every single day since the 
onset. I have only had pretty much 7 days off since December 
31st. Every other day has been taking care of these COVID 
patients in the hospital.
    This is heartbreaking. This is really difficult. Initially, 
we had to fight to get what I deemed appropriate treatment at 
the time. Now I have the endorsement of the medical staff at my 
facility, who are using these medications. I have the 
endorsement of some of my colleagues who have seen the response 
of this medication.
    Ivermectin is effective. It is effective in early disease. 
It is effective in late disease. It is effective in 
prophylaxis. It is an oral medication. You do not need to 
monitor anything. There is hardly any interaction. You can use 
this medication in just about any condition, with the exception 
of people on warfarin. It is safe, inexpensive, widely 
available. Manufacturers are able to ramp up production of 
this, if need be, besides the United States. It is something 
that could be implemented as a World Health Organization 
measure. The data is out there.
    The unfortunate thing is that we need more funding to be 
able to provide more studies, to look at people that are still 
naysayers. We need to get people at the regulatory agencies to 
review the current data, to see how effective this is, to talk 
to people that have been using this in certain areas. For 
example, compare the geographic area where I live and work with 
my colleagues to other areas in Florida. See if it actually 
makes a difference. It is very easy to do.
    I implore you, Senators, to really help us frontline 
providers, to get us the answers we need. I think we have the 
answers, but to prove it, to make other regulatory agencies 
come on board. Do not chastise physicians that have been 
thinking outside of the box, because honestly, the box has 
failed us. The medications that were promised to be the game-
changers, to date, have not done so--remdesivir, convalescent 
plasma, to just name a few.
    We really need to attack this together, and we need to try 
to save as many people as we can, because I cannot continue to 
stand by and see hundreds upon hundreds of people die in 
hospitals, thousands of people, hundreds of thousands of people 
dying across the country. This is not sustainable, and there 
are easy solutions, inexpensive solutions, and it is time for 
people to start taking a second look at it and finally 
believing that this data is real, that it works.
    Thank you for giving us an opportunity to talk about this.
    Chairman Johnson. Doctor, thank you for being compassionate 
and for treating patients, and I would argue, yes, money is 
definitely a problem, but the root cause is closed minds. Dr. 
Oskoui.
    Dr. Oskoui. I want to thank the Committee, specifically 
you, Dr. Paul, and everyone who actually attended this meeting, 
for allowing me to speak.
    I did want to hit, very briefly, on a comment that Senator 
Peters made and then ran out, and I did not have a chance to 
respond. You showed us a New York Times article that quoted me 
briefly but tremendously out of context, about masking. I want 
to say the foundation for that was actually an article 
published in mid-November in the New England Journal of 
Medicine, run by Mount Sinai at Paris Island, for the Marines.
    I am going to read briefly from my notes: The study found 
that 16 of the recruits tested positive for COVID-19 upon 
enrollment within 2 days of arrival, despite them having been 
quarantined for 4 weeks beforehand. Another 24 tested positive 
7 days after their arrival on the base. This study says, and 11 
more recruits tested positive on Day 14. Just 5 participants 
reported any symptoms. Another 26 recruits who did not 
participate in the study tested positive.
    So despite a hard quarantine, including 2 weeks of 
supervised confinement, and the four social distancing and mask 
protocols, you have a higher transmission rate, not a lower 
one. This is not common sense substantiated by science. This is 
not a roadmap to success.
    So to recap, hard, supervised quarantines do not work, even 
when under full-time supervision, for 2 weeks, at a closed 
college, followed by two more weeks of self-quarantine. 
Quarantines are ineffective. Masks do not work. We have known 
that actually for 40 years. Even in a military-supervised boot 
camp environment with enforced mask wearing, they were 
ineffective.
    Social distancing does not work. Even when enforced by the 
military and boot camp with a six-foot separation, it is 
worthless to prevent infection.
    I think, in other words, all the claims of so-called 
interventions and mitigations, such as referred to by the 
minority ranking leader, do not work when tested in the most 
favorable set of conditions where compliance is monitored and 
reinforced by Marine boot camp instructors. That is the end, I 
think, of the discussion on these matters, and to paraphrase 
The New York Times, that is the settled science in reality.
    The second thing I would refer to is Dr. Bhattacharya's 
comment about lockdowns. I absolutely concur with him that 
lockdowns are inappropriate. There is one time that we have 
done lockdowns previously like this, and that was in Mexico in 
2009. They abandoned them within a month because they caused 
both economic and medical devastation. Lockdowns do not make 
scientific sense. I believe they go against the WHO's 2019 
pandemic guidelines, and, as we have seen, it has thrown tens 
of millions of Americans out of work and have devastated this 
economy. To further continue it I think does not make either 
military, scientific, or economic sense.
    Thank you, Senator.
    Chairman Johnson. Thank you, and again, it seems like we 
have this pandemic playbook that we just threw out the window, 
and as I said before, I think the root cause of our problem is 
just closed minds. I mean, people always preach at me like, 
follow the science. I think I do. I have a very open mind. I 
realize the term ``settled science'' is a very unscientific 
term.
    Dr. Oskoui. It is.
    Chairman Johnson. Again, we practice medicine. We keep 
advancing it. But you only advance it if you have an open mind.
    I will never forget, in my previous life I used to listen 
to a radio talk show, a medical doctor, Dr. Dean Edell. And so 
many times he would say, ``When you hear hoofbeats, think 
horses, not zebras.'' I think what has happened here is the 
people in the agencies, they are all thinking zebras. They are 
all looking for the silver-bullet solution, to the exotic, new 
biologic medicine, the perfect vaccine, when we have a herd of 
horses that are just there, plow horses that can be used, and 
they are safe, and they are cheap, and they just might be 
incredibly effective, as Dr. Kory was talking about ivermectin 
and others have argued on hydroxychloroquine and others. Why do 
we not look at the herd of horses?
    Tens of thousands, probably hundreds of thousands of people 
have lost their lives because we took the eye off the ball. We 
refused to look at the obvious, and trying to embrace what 
would have been the dream solution, something available, 
something cheap, something that would work. Why did we not give 
it a shot? That, to me, is the question of this hearing.
    I really have to go vote, so I have to close out the 
hearing. This hearing record will remain open for 15 days, 
until December 23rd, at 5 p.m., for submission of statements 
and questions for the record. This hearing is adjourned.
    [Whereupon, at 12:35 p.m., the hearing was adjourned.]

                            A P P E N D I X

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