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Oversight of COVID-19 Financial Relief Packages — Senate Finance Committee Hearing
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S. Hrg. 116-557, a Senate hearing volume printed for the use of the Committee on Homeland Security and Governmental Affairs, One Hundred Sixteenth Congress, Second Session, published by the U.S. Government Publishing Office in 2022. The volume lists hearings and roundtables from February 12, 2020 to December 8, 2020 with witness lists, prepared statements and appendices. It includes the July 28, 2020 hearing Oversight of COVID-19 Financial Relief Packages, at which the committee met by videoconference with Chairman Ron Johnson presiding. Witnesses came from the Committee for a Responsible Federal Budget, the Mercatus Center, the Project on Government Oversight, Jenner & Block and the American Enterprise Institute. Johnson's opening statement says the Paycheck Protection Program was designed for an 8-week period.
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[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 ------ Opening statements: Page Senator Johnson Senator Peters Senator Hassan Senator Carper Senator Scott Senator Harris Senator Rosen Senator Hawley Senator Sinema Senator Romney Senator Lankford Senator Portman Senator Enzi................................................. 1174 Senator Paul................................................. 1976 Prepared statements: Senator Johnson Senator Peters 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 ---------- [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. --------------------------------------------------------------------------- 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 ---------- [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. --------------------------------------------------------------------------- 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 ---------- [GRAPHICS NOT AVAILABLE IN TIFF FORMAT] [all]
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