May 14, 2020
Dr. Rick Bright Testimony Transcript – Vaccine Expert Whistleblower Ousted by Trump Testifies
Dr. Rick Bright, former director of an important vaccine agency who was fired by Donald Trump, testified before Congress today. He warned 2020 “could be the darkest winter in modern history” without proper planning. He said the US currently has no master plan to mass distribute a vaccine for COVID-19. Read the testimony transcript here.
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Chairwoman Eshoo: (00:18)
… too many scientists and public health experts in January. That basic delay costs precious lives and is continuing to cost lives. We can’t have a system where the price paid is unconscionable. Mothers losing daughters, daughters losing fathers because of incompetence, denial, delay, and a disorganized response. Frankly, I’m tired of those who bear the responsibility accepting none of it, while deflecting blame on others. The previous administration, the World Health Organization, the Wuhan Lab, anywhere but where the blame belongs.
Chairwoman Eshoo: (01:03)
Second, the United States has and remains dangerously dependent on foreign countries for our supply of critical lifesaving drugs and lifesaving equipment: masks, gloves, PPE, and ventilators. As a result, we can’t treat our own people without relying on China and others to supply us. We can’t outfit our first responders, our hospital workers, our nurses, our doctors. We can’t care for our own nation and crisis. This surely is a national security issue.
Chairwoman Eshoo: (01:45)
I want to thank the gentlewoman from Indiana, Ms. Brooks, for her bipartisan work with me to address the drug supply chain issue as well as other members on a bipartisan basis for their legislation on those issues as well.
Chairwoman Eshoo: (02:02)
Today, we’re going to hear about the disastrous federal response to an approaching pandemic. Dr. Bright has filed one of the most specific and troubling whistleblower complaints I’ve ever seen. He was the right person, with the right judgment, at the right time. He was not only ignored, he was fired for being right. We can’t have a system where the government fires those who get it right, and reward those who get it completely wrong.
Chairwoman Eshoo: (02:37)
Mr. Michael Bowen, the executive vice president of Prestige Ameritech will speak to America’s crippling dependence on foreign countries for critical medical supplies, a public health issue and a national security issue.
Chairwoman Eshoo: (02:54)
Our country is paying a terrible price today, and it rests on Congress to address this threat where any effort of an adversary can cut off our supply of lifesaving drugs and supplies, our lifeline; and this would create a healthcare disaster on a scale never experienced before.
Chairwoman Eshoo: (03:18)
I bear this responsibility, as does every member of Congress. This subcommittee has jurisdiction over our country’s most prestigious healthcare institutions, FDA, NIH, CDC, and BARDA. We have to listen, we have to learn, and we must work together for the people of our country who need us so, so much, regardless of inconvenient truths.
Chairwoman Eshoo: (03:52)
Finally, I regret that Secretary Azar, Dr. Robert Kadlec and Dr. Peter Navarro have all refused to testify today. I now ask for a moment of silence in honor of the over 80,000 Americans who have lost their lives from COVID-19.
Chairwoman Eshoo: (04:26)
The chair now recognizes-
Dr. Burgess: (04:27)
Madam Chair, before I’m recognized for an opening statement, I wonder if I might be recognized for a parliamentary inquiry.
Chairwoman Eshoo: (04:33)
The gentleman’s recognized. State his parliamentary inquiry.
Dr. Burgess: (04:40)
Madame Chair, as the inquiry is, I would like clarification with this witness before us today, is this witness testifying as a government witness or as an individual?
Chairwoman Eshoo: (04:52)
Dr. Bright is testifying as a federal employee. Correct? He is a federal employee representing himself.
Chairwoman Eshoo: (05:09)
I now recognize the ranking member of the subcommittee.
Speaker 1: (05:13)
Chairwoman Eshoo: (05:14)
Speaker 1: (05:15)
Just a question. Normally we have name plates identifying who’s at the table. I know Dr. Bright, of course, but I’m not sure who’s next to him.
Chairwoman Eshoo: (05:25)
You’re correct. I don’t know why we don’t have name plates. I didn’t notice that when I came into the hearing room, can the staff provide them? Is there any way the staff can provide them? I think we can.
Speaker 1: (05:40)
Chairwoman Eshoo: (05:45)
I also would like to inform the members that Dr. Bright’s attorney, Debra Katz, is at the table. She’s requested a microphone. She is not here as a witness, so we will not be asking her questions. She is simply here representing her client.
Chairwoman Eshoo: (06:10)
I now would like to recognize the ranking member of the subcommittee, Dr. Burgess, for his five minutes for an opening statement.
Dr. Burgess: (06:20)
I think thank the chair; and the Energy and Commerce, particularly the subcommittee on health is the premier health subcommittee in the Congress. We have a broad jurisdiction, a longstanding tradition of tackling important healthcare issues in a bipartisan manner. I personally, like our witness today, have been very, very concerned. And in fact, sounding the alarm about this novel coronavirus since January.
Dr. Burgess: (06:47)
I ask why is this the first official hearing that we’re having on this topic? To say this is a disappointment would be an understatement. But not only disappointment, but quite frankly, I’m concerned it took five months to have a hearing on this novel coronavirus. Instead of tackling any of the issues suggested in the letters that I’ve sent to you this week, we are examining a whistleblower complaint that is only one week old before a proper investigation.
Dr. Burgess: (07:17)
In these letters, I outlined the importance of addressing the strategic national stockpile; COVID-19’s impact on mental health; testing, certainly we should have a hearing on testing; racial disparities and provider relief. The lack of attention to these details is detrimental to our nation’s overall response to this pandemic, and it is the responsibility of this house and the responsibility of this committee.
Dr. Burgess: (07:42)
We continue to stand on the sidelines instead of becoming fully engaged. Every whistleblower deserves to be heard. Dr. Bright has raised serious allegations and they deserve investigation. Whistleblowers must have their rights protected and deserve to have their allegations investigated with policies and procedures that have been long established and upheld as independent and fair.
Dr. Burgess: (08:13)
Madame Chair, on April 23rd, CNN reported that you planned to call Dr. Bright to testify. Dr. Bright did not actually file his whistleblower complaint with the Office of Special Counsel until Tuesday, May 5th. That same day, it was announced on social media that you planned to hold a hearing, but it was not officially noticed until two days later. By Friday, May 8th, the Office of Special Counsel recommended that Dr. Bright be temporarily reinstated as director of BARDA so that it could thoroughly conduct its investigation and move forward with its usual processes of reviewing whistleblower complaint.
Dr. Burgess: (08:52)
Despite the hearing memo, no final determination of a violation of a whistleblower statute actually has been made. Following a robust investigation process, the customary setting for a whistleblower hearing would be in our Energy and Commerce Committee under oath in the Oversight and Investigation Subcommittee. To say this hearing is premature and it is a disservice to the investigations of Dr. Bright’s complaint, I think goes without saying.
Dr. Burgess: (09:21)
You have trampled on minority rights. You would have never tolerated that when you were in the minority. You neglected the tradition of this committee and in the manner this hearing was called. The number of procedural fouls committed in advance of this hearing would certainly have led the chair to have fouled out of multiple basketball games. Apparently in a world without sports, this subcommittee has become political sport.
Dr. Burgess: (09:45)
More than 80,000 American lives have been lost to this pandemic. It continues to wreak havoc on our communities, not only in terms of physical health, but mental health and certainly financial health. We should be conducting a hearing on the real time implementation of the Pandemic All-Hazard Preparedness and Advancing Innovation Act, And we should have done it in February. As a democratic counterpart to the primary author, Dr. Susan Brooks, on this legislation, you, Madam Chair, should have a great interest in holding such a hearing.
Dr. Burgess: (10:19)
In my district, we’ve seen deaths amongst young African-Americans from COVID-19. We’re hearing about a new phenomenon of very young individuals who are dying from an intense inflammatory response apparently sparked by infection with this virus. Well we should hear from some of these families and the medical professionals to analyze why this virus has disproportionately affected some communities, particularly minority communities.
Dr. Burgess: (10:49)
I’ve said it before, not all heroes wear capes. Hospitals, doctors, and other healthcare providers are on the front lines every single day battling this virus. They go to work so we can stay home, which we’ve done very successfully. The inability to conduct non-essential procedures and visits has led to financial harm to our hospitals and doctors. How are states and the country preparing to ease back into providing medical care? Is the distribution of the Provider Relief Fund and the CARES Act working? These are the questions we should be asking the experts today.
Dr. Burgess: (11:22)
I appreciate Chairman Pallone’s willingness to hold telephone briefings since we all have our own questions. But let me just say, this pandemic is about the public health of our nation, and thank you for your commitment to hold future hearings on the strategic national stockpile, mental health and racial disparities. I’m happy to help you set the agenda for the rest of the year. I hope you will commit to additional hearings on testing and the provider relief fund. And I request that my letters and your responses be part of the record. I yield back.
Chairwoman Eshoo: (11:54)
The gentleman yields back. I think the gentleman will recall that I called for a hearing on January 30th. And on the heels of that, it was to be with Dr. Kadlec, Dr. Fauci, all the heads of our health agencies. And it was Secretary Azar that said, They cannot come. I’m the top person. And when I come, they will come with me.” That was January 30th. I want to-
Dr. Burgess: (12:27)
Madam Chair, if I may, [crosstalk 00:12:27] they managed to go to the Oversight Government Reform Subcommittee for two days.
Chairwoman Eshoo: (12:29)
I’m not finished yet. I’m not finished. I’m not finished yet. I’m not finished yet, Dr. Burgess. You’ve written several letters to me in the last week and I’ve communicated to you. I’m happy to sit down with you to review and to come up with all the appropriate hearings that this subcommittee should hold, and we will work together on that. We have a lot of work to do. You’re absolutely right. The stockpile, testing, the list is as long as Pennsylvania Avenue. We will work together on that, rest assured.
Chairwoman Eshoo: (13:11)
Now, I’d like to recognize the chairman of the Full Committee, Mr. Pallone for his five minutes for opening statement.
Mr. Pallone: (13:20)
Thank you, Madam Chair, and thank you, Ms. Eshoo, for initiating this hearing and putting all your energy into it so that we’re here today with Dr. Bright.
Mr. Pallone: (13:31)
We are here as part of the Energy and Commerce Committee’s ongoing work to confront the largest public health and economic crisis of our lifetimes. It has been mentioned more than 80,000 Americans have lost their lives, but more than 36 million others have lost their jobs as of today. This is a national emergency that requires every aspect of government to work together to reduce the spread of this terrible virus so we can confidently begin to reopen our economy.
Mr. Pallone: (13:58)
And while this Congress and the president have worked together to enact four laws to combat the pandemic and provide economic assistance to the American people, new laws are simply not enough. President Trump and his administration have failed to provide the consistent and stable leadership that is necessary to guide our nation through this public health and economic crisis.
Mr. Pallone: (14:19)
For months, the president has delivered mixed messages and misinformation to the American people, creating confusion across the nation. Instead of showing leadership, competence and vision in a time of crisis, the administration has abdicated its responsibility, and forced states to fend for themselves and find their own way out of this pandemic. And while states and frontline healthcare workers were pleading for personal protective equipment, testing supplies and other resources to protect them and their patients, President Trump’s response was let states fight it out on the open market.
Mr. Pallone: (14:53)
For months, the president has refused to develop and implement a national testing program. For months, we’ve been promised millions of tests were right around the corner. The promises have been hollow. Testing is getting better, but nowhere near what it needs to be. It doesn’t help that the president proclaimed about testing earlier this week, and I quote, “We have met the moment and we have prevailed.” That could not be further from the truth, Mr. President.
Mr. Pallone: (15:17)
Dr. Rick Bright, the former director of BARDA, has come forward as a whistleblower and made serious allegations, including a lack of urgency by administration officials to respond to the virus, mismanagement and failure to procure necessary supplies, and disregard for public health and scientific integrity. His claims lie at the heart of this committee’s concerns regarding the administration’s response to the COVID-19 pandemic. We’re here today to hear the perspective of Dr. Bright, who is positioned to discuss the administration’s preparations and response to this pandemic.
Mr. Pallone: (15:52)
Now, the failures we’ve seen simply cannot persist. That’s why the Energy and Commerce Committee continues to conduct robust oversight and to propose bold legislative solutions. We’ve been domaining answers and information from the administration on testing, contact tracing, the supply chain, food safety and the safety of food production workers, and attempts to undermine science and public health.
Mr. Pallone: (16:15)
To date, we have yet to receive any sufficient responses from the Trump administration. And as for legislation, Congress has already passed four major coronavirus response packages that were improved by the work of this committee. And now with the sense of urgency this moment requires, earlier this week we propose the HEROES Act, which is to be voted on tomorrow by the full House.
Mr. Pallone: (16:37)
The HEROES Act continues our ongoing commitment to providing the healthcare resources and support needed to combat the coronavirus crisis. Our legislation will strengthen testing and contact tracing by finally requiring the administration to develop comprehensive plans with clear benchmarks and timelines and public reporting of key metrics. This will allow transparency so we can see if the Trump administration is fulfilling their promises and hold them accountable if they’re not. We also provide $75 billion to support robust testing, contact tracing, surveillance, and containment activities. This is beyond the 25 that was in the last bill. And we simply cannot this beat this virus without these efforts in place.
Mr. Pallone: (17:19)
Our legislation also ensures that all COVID-19 treatments, drug, and vaccines are free of costs for patients. The bill will help us shore up our public health infrastructure for the long road ahead. Our top priority is the health and safety of the American people. The HEROES Act builds on the progress we have made and lays the foundation we will need to ease social distancing and safely reopen the economy.
Mr. Pallone: (17:42)
I just want to thank Dr. Bright for coming forward and for being here today. I want to thank you Madam Chair for bringing him here. And I’m hopeful that this hearing will help us better understand the failures of the Trump administration, so that collectively we can find solutions that will help us finally get a handle on this virus. It’s the only way we’ll be able to protect the American people, and safely and confidently reopen our communities. And I thank you, Madam Chair, and yield back.
Chairwoman Eshoo: (18:08)
Gentleman yields back. It’s been a pleasure to recognize the gentleman from Oregon, the ranking member of the full committee, Mr. Walden.
Mr. Walden: (18:18)
Thank you very much, Madam Chair. Before I use my time, I do have just a parliamentary question for you. If you would yield to that, Madam Chair?
Chairwoman Eshoo: (18:29)
You can state your parliamentary inquiry.
Mr. Walden: (18:32)
I know we’re operating under really unusual conditions-
Chairwoman Eshoo: (18:36)
Mr. Walden: (18:36)
… because of the masks and everything else, which also affects the layout of the room. I know when we do oversight and investigation hearings, I know that’s not what we’re doing here, there is a script about whether an individual is accompanied by counsel, whether they want that counsel represented. I’ve got that script. The reason I’m asking is we’re not in O&I, but it is extraordinarily unusual to have a government witness as an individual with private counsel at the witness table and with a microphone. And so I’m just trying to get clarification for future precedent setting for the committee, and that’s the only reason I’m asking this. He obviously has the counsel. If we should follow the protocol that is prescribed for the Oversight and Investigations Committee in similar circumstances.
Chairwoman Eshoo: (19:28)
Well, I think this is the first time-
Mr. Walden: (19:29)
That’s why I asked.
Chairwoman Eshoo: (19:32)
… we have another first here. When Dr. Bright came in this morning with his attorney, she requested the microphone. And so as a courtesy, I extended the microphone to her.
Mr. Walden: (19:48)
Chairwoman Eshoo: (19:48)
Now, she’s not a witness. We are not going to ask her questions. She’s simply accompanying her client. Is it a problem?
Mr. Walden: (20:01)
I have no objection to any of that. It’s just that… Could I read you what this text is and maybe that resolves it?
Chairwoman Eshoo: (20:11)
Well, this isn’t O&I. Are you suggesting that we need to follow what O&I does?
Mr. Walden: (20:19)
I’m just saying that the witness is not here in his whistleblowing capacity, is what I’m told. It’s what you indicated. But this is his personal attorney, if I understand correctly, but we still don’t even know for sure. I know who you are, but we haven’t identified that for the record. All we do in O&I, as you know, is you ask if the witness wants be accompanied by council. They respond yes or no. And then council is allowed to move forward, sit at the table. And then the question is asked, will you give testimony or not? And if so, raise your hand, do all these things.
Mr. Walden: (20:59)
That’s all I’m doing here is just… We don’t usually do this type of activity in the other policy committees, and we are not usually set up this way. But because of the pandemic-
Chairwoman Eshoo: (21:09)
Would you like to ask-
Mr. Walden: (21:12)
I just think we ought to follow that, for future precedent issues. Nothing to do with this hearing, but future precedent is what we’re dealing with.
Chairwoman Eshoo: (21:17)
It’s a good suggestion.
Mr. Walden: (21:18)
We’re all learning how to operate in this environment.
Chairwoman Eshoo: (21:20)
Exactly. All right, the gentleman is recognized for his five minutes for an opening statement.
Mr. Walden: (21:26)
Chairwoman Eshoo: (21:27)
You don’t think it’s resolved?
Mr. Walden: (21:28)
Well, are we going to ask if he wants to be represented by counsel and then who the council is?
Chairwoman Eshoo: (21:34)
Dr. Bright, do you wish to be represented by counsel?
Dr. Rick Bright: (21:38)
Mr. Walden: (21:39)
Okay, and then can she identify herself for the record?
Chairwoman Eshoo: (21:44)
And for the record would counsel please state your name?
Debra Katz: (21:51)
My name is Debra Katz. I’m an attorney representing Dr. Rick Bright, with the Law Firm of Katz, Marshall and Banks.
Mr. Walden: (21:57)
Chairwoman Eshoo: (21:58)
Mr. Walden: (21:59)
I think that’s all we needed to do.
Chairwoman Eshoo: (22:04)
Good. [crosstalk 00:22:01]. All right, the gentlemen-
Speaker 2: (22:04)
Chairwoman Eshoo: (22:04)
Well, the gentleman is recognized for his five minutes-
Mr. Walden: (22:07)
Well, if you’ve got a parliamentary-
Speaker 2: (22:08)
A parliamentary question.
Mr. Walden: (22:09)
… express it.
Chairwoman Eshoo: (22:11)
The gentlemen will state his parliamentary-
Speaker 2: (22:14)
Will the witness be under oath. Because if you have a witness whistleblower testimony under O&I, a witness would normally be under oath. And if not today, he’s not under oath, then if we get into whistleblower allegations, how can we be sure that the witness is telling the truth under oath if they’re not under oath? And if they’re not under oath, then how can you talk about the whistleblower complaints [crosstalk 00:22:40] in a fair and equitable manner?
Chairwoman Eshoo: (22:42)
I thank the gentleman for his inquiry. All witnesses know that it is illegal to lie to Congress. and in our subcommittee, unlike O&I, they are the only subcommittee that… I mean, it’s a practice.
Speaker 2: (23:01)
Chairwoman Eshoo: (23:02)
It’s a tradition, but we don’t swear people in. But witnesses know that it is illegal to lie to Congress.
Speaker 2: (23:12)
USC 1003 or something, I believe.
Mr. Walden: (23:18)
Speaker 2: (23:18)
I’m ready to proceed.
Chairwoman Eshoo: (23:18)
Speaker 2: (23:19)
Chairwoman Eshoo: (23:19)
Gentlemen is recognized for his five minutes opening.
Speaker 2: (23:21)
Well, thank you, Madam Chair.
Chairwoman Eshoo: (23:22)
Speaker 2: (23:23)
And I know we’re operating under unique circumstances. The world is coping with an historic deadly pandemic that we always knew was possible, but we prayed would not happen. In a bipartisan way, we did everything the experts said we needed to do to be prepared should a pandemic or other hazards strike.
Speaker 2: (23:41)
Madam chair, the work you, Dr. Burgess, Representative Susan Brooks and I, and others did over two congresses, when each party has controlled the House resulted in one product, the Pandemic All-Hazards Preparedness Act. Dr. Bright, I know you were part of our efforts in writing and reauthorizing that law, and we thank you for your work. In fact, given the role you once played at ASPR before going to BARDA, you had a big responsibility to make sure Congress provided the strategic national stockpile that it needed, or to inform us if there were shortcomings, especially as we were modernizing the Pandemic All-Hazards Preparedness Act.
Speaker 2: (24:19)
I went back over three hearings we held in the Oversight and Investigation Subcommittee of this committee, where you testified regarding the Zika outbreak in May 23rd of 2017, the seasonal flu on March 8, 2018, and the hearing on June 15, 2018 entitled, “The State of US Public Health Bio-preparedness Responding to Biological Attacks, Pandemics and Emerging Infectious Disease Outbreaks.”
Speaker 2: (24:44)
Let me see, I wanted to make sure we hadn’t missed anything. Nothing jumped out at me as I reread the records. Congress dramatically increased funding to ASPR and BARDA. We granted new authorities. We followed your recommendations and those of others who played a key role in this combined effort.
Speaker 2: (24:59)
Unfortunately, some of the systems we put in place to prepare for a pandemic, systems designed without actually living through something like this, have not performed as expected. We’ve learned. We didn’t have enough of the basic supplies that we’ve always taken for granted. And while Chair Eshoo and I have warned about the potential vulnerabilities of our medical supply chains, especially from China, not enough was done to address the problem. And it still hasn’t been fully addressed.
Speaker 2: (25:25)
I’m thankful that President Trump invoked the Defense Production Act to ramp up US manufacturing of masks and ventilators. And the president’s used the emergency powers and money congress has provided to launch unprecedented efforts to search the globe for supplies to rapidly advance development of treatments and vaccines. But we still have much bipartisan work to do to respond and adapt to the challenges presented by COVID-19 and the lessons we’re learning.
Speaker 2: (25:52)
We have asked for, and this committee should hold hearings to find a path forward to reform the strategic national stockpile, to increase domestic manufacturing of critical supplies and disentangle our supply chains from China. We should be exploring strategies for increased testing so we can begin to safely reopen our economy. We need to find ways to improve access to mental health and provide relief, both for our healthcare providers on the front lines treating COVID-19 cases and our healthcare workers who have been furloughed because their hospitals are closed.
Speaker 2: (26:21)
We should be conducting rigorous oversight of the trillions of dollars in myriad new policies congress is appropriated and enacted in the last three months, and we should be investigating, really investigating, allegations like Dr. Bright’s that raise concern about our nation’s coronavirus response. That does not appear to be why we’re actually here today, and frankly, it saddens me.
Speaker 2: (26:42)
Dr. Bright, your allegations are serious. They deserve a real investigation. I know the Office of Special Counsel with whom you filed your complaint will do just that, and I know they take their work seriously and we’ll hear you out. And importantly, we’ll give those named in your complaint an opportunity to have their side heard as well. I must tell you that many of us on our committee were confused when we learned from a tweet this hearing was scheduled in the wake of your complaint. As you know, that’s certainly not how we do things at the Energy and Commerce Committee. Not long after the notice of this being a whistleblower hearing, we were advised you were here as a government witness, not a whistleblower. But then we were told you were not representing the government but yourself. The hearing title suggest the hearings about protecting scientific integrity, yet the Chair invited a witness who will not be speaking to that issue. It’s all pretty confusing and unusual, to say the least.
Speaker 2: (27:34)
Here we are in the middle of a pandemic, and we aren’t given time to secure our witnesses, conduct appropriate research or require documents that could aid in our understanding of the situation you face and the country face. Our first discussion with the majority, unfortunately, just occurred three days ago. This is really serious business. But in my opinion, this is not the way we should run an investigation. We need to get to the heart of the matter and we need to look forward to see what haven’t we done right as a Congress and the country, and what can we band together and fix before fall arrives.
Speaker 2: (28:07)
And so I thank you for being here. I’ve enjoyed working with you over the years, and continue to look forward to working with you and others to get this right. And Madam Chair, we have a letter for you asking for a Rule 11 hearing that we’ll provide to you. And with that, I yield back.
Chairwoman Eshoo: (28:26)
Thank you. The gentleman yields back. The Chair would like to remind members that pursuant to committee rules, all members’ written opening statements will be made part of the record.
Chairwoman Eshoo: (28:38)
I would now like to introduce our witness, the first panel today. Dr. Rick Bright is a highly regarded scientist with expertise in the fields of immunology, therapeutics, vaccine, and diagnostic development. For the last decade, he’s been a career civil servant at the Department of Health and Human Services. In 2016, Dr. Bright was appointed director of BARDA, the third director of BARDA, the Biomedical Advanced Research and Development Authority.
Chairwoman Eshoo: (29:13)
As director of BARDA, he has testified before Congress as a government expert numerous times, including before this subcommittee. I share a special pride with Senator Richard Burr because together it was our legislation that created BARDA. Thank you for your willingness to join us today and to offer testimony, Dr. Bright. We look forward to your testimony. You’re certainly familiar with the lights. I don’t need to explain those to you. You have five minutes for your statement. Welcome, and you got the microphone on? There we go. Good morning to you.
Dr. Rick Bright: (29:57)
Good morning, Chairwoman Eshoo and Ranking Member Burgess and distinguished members of the subcommittee. I am Dr. Rick Bright, a career public servant and a scientist who has spent 25 years of my career focused on addressing pandemic outbreaks. I have a bachelor’s degree in biology and physical sciences and the PhD in immunology and molecular pathogenesis. I’ve led teams of scientists developing drugs, vaccines, and diagnostics in government, private industry, and for nonprofit organizations. I’m here today in my private capacity. The views are my own and not those of the Department of Health and Human Services. I joined BARDA in 2010; and for the last three and a half years, until April 21st of this year, I had the privilege of serving as its director. BARDA partners with private industry and others in governments to address national health security threats.
Dr. Rick Bright: (30:54)
Today, the world is confronting a public health emergency unlike any we’ve seen in over a century. We are facing a highly transmissible and deadly virus, which not only claims lives but also disrupts the very foundations of our society. The American healthcare system is being taxed to the limit. Our economy is spiraling downward, and our population is being paralyzed by fear stemming from a lack of a coordinated response and a dearth of accurate, clear communication about the path forward.
Dr. Rick Bright: (31:26)
Americans yearn to get back, to work, to open their businesses and to provide for their families. I get that. However, what we do must be done carefully and with guidance from the best scientific minds. Our window of opportunity is closing. If we fail to improve our response now, based on science, I fear the pandemic will get worse and be prolonged. There will be likely a resurgence of COVID-19 this fall. It will be greatly compounded by the challenges of seasonal influenza. Without better planning, 2020 could be the darkest winter in modern history.
Dr. Rick Bright: (32:06)
First and foremost, we need to be truthful with the American people. Americans deserve the truth. The truth must be based on science. We have the world’s greatest scientist, let us lead. Let us speak without fear of retribution. We must listen. Each of us can and must do our part now.
Dr. Rick Bright: (32:28)
On Tuesday, Dr. Fauci delivered a message in a voice that is clear and trustworthy, as he encouraged us to act with caution as we returned to our daily lives. We should listen to him and other scientists sharing their expertise.
Dr. Rick Bright: (32:41)
While waiting for a cure and a vaccine, which I believe will come, there are things we must do immediately. We must increase the public education about the basics, washing hands, social distancing, appropriate face covering. They are simple but critical steps to buy valuable time until there’s vaccine.
Dr. Rick Bright: (33:01)
We need to ramp up production of essential equipment and supplies, including raw materials and critical components. Shortages of these increased the risk of our frontline healthcare workers, and they deserve the best equipment to protect themselves. We need to facilitate equitable distribution of essential equipment and supplies. And finally, we need a national testing strategy.
Dr. Rick Bright: (33:24)
The virus is here. It’s everywhere. We need to be able to find it, isolate it and stop it. We need to have the right testing for everyone who needs it. We need to be able to trace contacts, isolate, quarantine and appropriately while striving to develop a cure.
Dr. Rick Bright: (33:43)
Initially, our nation was not as prepared as we should have been, as we could have been. Some scientists raised early warning signals that were overlooked, and pages from our pandemic playbook were ignored by some in leadership.
Dr. Rick Bright: (34:02)
Were ignored by some in leadership.
Dr. Rick Bright: (34:04)
There will be plenty of time to look back to assess what has happened so we can improve, but right now we need to focus on getting things right going forward. We need a comprehensive plan that everyone knows and everyone participates in. Congress has taken important steps to support the response, and there’s much more we can do. With your help, we can get through this crisis.
Dr. Rick Bright: (34:26)
Working cooperatively with our global partners, we can and will succeed in finding a cure for COVID-19. But that success depends on what we do today. We will either be remembered for what we did, or for what we failed to do to address this crisis. I call on all of us to act, to ensure the health, safety, and prosperity of all Americans. You can count on me to do my part. Thank you.
Chairwoman Eshoo: (34:54)
Thank you, Dr. Bright.
Chairwoman Eshoo: (34:56)
We’ll now move to member questions, and I recognize myself for five minutes for questions.
Chairwoman Eshoo: (35:02)
Thank you again, Dr. Bright. You have a distinguished career. You’re one of our country’s leading public health experts on how to respond to pandemics and national security health threats. You’re the first government official who’s been on the inside, seeing everything firsthand, to come forward and share unvarnished experiences about what really happened from January to the time you departed BARDA in April this year in dealing with the virus. So I want to make sure I understand what you’re telling us. You stated in your written testimony, “A window of opportunity is closing, but it is not yet closed.” What do we need to do with the time left to get it right? And if we don’t, what do you mean when you say 2020 will be the darkest winter in modern history?
Dr. Rick Bright: (36:15)
Chairwoman [inaudible 00:00:36:17], thank you for your question. The window is closing to address this pandemic because we still do not have a standard, centralized, coordinated plan to take our nation through this response. I believe with proper leadership and collaboration across government, with the best science leading the way, we can devise a comprehensive strategy, we can devise a plan that includes all of Americans and help them help us guide us through this pandemic. But time is running out because the virus is still spreading everywhere. People are getting restless to leave their homes, and we have to make critical decisions on how to balance the economy and science.
Dr. Rick Bright: (37:08)
My concern about this fall is compounded by my knowledge and preparation and response to many years of influenza outbreaks, pandemic influenza outbreaks and seasonal influenza outbreaks. In our country in 2017, we had nearly 79,000 people die in the US from influenza. That coupled with a COVID-19 resurgence this fall, could be devastating for our healthcare systems and for Americans. We have a limited window of opportunity to get plans in place to address both of those.
Chairwoman Eshoo: (37:41)
Thank you. When you look at the first four months of this year, would you describe the government’s and the administration’s response as a success or a failure?
Dr. Rick Bright: (37:56)
I believe we could have done better. I believe there were critical steps that we did not take in time.
Chairwoman Eshoo: (38:03)
Was there a failure to respond when you correctly pushed to obtain early virus samples from China so we could develop critical medical countermeasures?
Dr. Rick Bright: (38:17)
From my perspective in working with companies to develop drugs and vaccines and diagnostics, viral samples are critical. As soon as we were aware that this virus could pose a significant threat to human lives, I began pushing for those virus samples and I met frustration and dismissal.
Chairwoman Eshoo: (38:32)
When did you do that?
Dr. Rick Bright: (38:34)
I did that in the office of the Secretary Azar in January. The push for the virus samples initially mentioned on January 23rd and a strong push on January 27th for those virus samples.
Chairwoman Eshoo: (38:46)
And was there a failure to respond with the needed urgency when you correctly pushed to ramp up production of masks, respirators, syringes, swabs?
Dr. Rick Bright: (38:59)
Congresswoman, we’ve known for quite some time that our stockpile was insufficient in having those critical personal protective equipment. So once this virus began spreading and became known to be a threat, I did feel quite concerned that we didn’t have those supplies. And I began pushing urgently in January, along with some industry colleagues, as well. And those urges, those alarms, were not responded to with action.
Chairwoman Eshoo: (39:23)
Was there a failure to take immediate action when you correctly push to acquire additional doses of the drug remdesivir, which is the only drug so far that appears to be at least mildly effective, thank God, for treating people with COVID-19?
Dr. Rick Bright: (39:43)
There was no action taken on the urgency to come up with a plan for acquisition of limited doses that remdesivir nor to distribute those limited doses of remdesivir once we had the scientific data to support their use for people infected with this virus.
Chairwoman Eshoo: (40:00)
And instead of acting on your recommendations, was the response of others to try and cut you out of key meetings, marginalize your participation?
Dr. Rick Bright: (40:11)
I was told that my urgings were causing a commotion and I was removed from those meetings.
Chairwoman Eshoo: (40:20)
My time has expired. I now recognize the ranking member of the subcommittee, Dr. Burgess.
Dr. Burgess: (40:30)
I thank the Chair. And Dr. Bright, I hope as it is clear to you, everyone on this dais, on both sides, appreciate you coming before us today even if we are frustrated with having this hearing without a full understanding of the facts. Again, just to clarify, you’re testifying in your personal capacity and not on behalf of the agency or the administration.
Dr. Rick Bright: (40:53)
That’s correct, sir.
Dr. Burgess: (40:55)
Thank you for that. Let me ask you a question about hydroxychloroquine, really even maybe a little bit more broadly, the disease modifying anti-rheumatic drugs that have been looked at for therapy for this disease. I ask about hydroxychloroquine because it does seem to be central to whatever disagreement you had with Department of HHS and the administration. But hydroxychloroquine was initially identified as a potential therapeutic because, number one, of it’s anti-inflammatory effects and its ability to calm things in the immune system. And as we know, one of the features of this disease is the overwhelming cytokine response that overwhelms the host. There also may be an effect of blocking the virus at the point of contact with the cell. Certainly something that probably deserves a little investigation, but again, it’s not the only one. There were some other drugs. And I think, if I’m correct, part of them supported with investments, Actemra and Kevzara, which are thought to have similar impacts on the ability to suppress the cytokine response as hydroxychloroquine. Am I correct in that?
Dr. Rick Bright: (42:23)
There are a number of drugs that we were evaluating initially, Congressman, that we were considering to conduct clinical studies to get further information if they really had an impact and if they were safe to use in patients infected with this virus.
Dr. Burgess: (42:38)
Do you have available to you the dollar amounts that BARDA appropriated or authorized for each of those two drugs, Actemra and Kevzara?
Dr. Rick Bright: (42:51)
I don’t have those numbers available with me now.
Dr. Burgess: (42:53)
Would you be able to make them available to the committee?
Dr. Rick Bright: (42:57)
I believe HHS could make those available. BARDA could probably make those investments available.
Dr. Burgess: (43:02)
Where are you concerned with hydroxychloroquine at the time you made those awards for Actemra and Kevzara? It was the concern with hydroxychloroquine which became then paramount in your disagreement with the administration. Was it already established when you made these other investments in similar medications?
Dr. Rick Bright: (43:20)
My concerns around the safety of hydroxychloroquine in people infected with the COVID-19 virus were reflective of the scientific review that we received from an inner agency group of clinicians and regulatory experts and scientists. At the time that we learned about hydroxychloroquine and chloroquine, there was limited data available, and our proposal and actions were to see if we could identify a source of that drug so the NIH could conduct a randomized, controlled clinical study. That’s a similar action we took with remdesivir. Once we thought remdesivir had promise from data coming from China, NIH quickly established a clinical study, a randomized controlled study, to evaluate remdesivir. So with hydroxychloroquine, that was also our preferred plan of action.
Dr. Burgess: (44:15)
And you, of course, authored the letter to the FDA, asking for the emergency use authorization for hydroxychloroquine.
Dr. Rick Bright: (44:24)
I was directed, as the BARDA director, from the office of the HHS secretary, to put in place an expanded access I and D program to make chloroquine donation from Bayer available to Americans through a unique opportunity that would utilize an app and perhaps even make it available to Americans who were not under close supervision of a healthcare provider. During that-
Dr. Burgess: (44:52)
Of course, this hearing is not really a hearing on hydroxychloroquine. I, of course, would welcome a robust hearing on therapeutics and the research that’s going on, what we’ve invested in, what seems to be panning out, what has not. I’ll note that both Kevzara and the other medication may not have panned out. And I think the manufacturing company for Kevzara announced that they’ll discontinue part of the clinical study because it looked unlikely to help COVID patients. But I will tell you, since starting this, since you identified yourself and this hearing got noticed, I’m hearing from a lot of doctors in my state, around the country, who have experience using hydroxychloroquine and chloroquine coupled with as erythromycin and zinc, and they’re reporting significant benefit if it is used early enough in the course and may eliminate the need for hospitalization and ventilatory [crosstalk 00:45:50].
Chairwoman Eshoo: (45:49)
The gentleman’s time is expired.
Dr. Burgess: (45:51)
I don’t know if that’s right.
Chairwoman Eshoo: (45:52)
The gentleman’s time is expired.
Dr. Burgess: (45:52)
But I think it’s important enough that we should look into it and would just be interested if you did that as part of your duties at BARDA.
Chairwoman Eshoo: (46:00)
The gentleman’s time has expired. The chair now recognizes-
Dr. Burgess: (46:02)
Would the witness be able to answer the question?
Chairwoman Eshoo: (46:10)
Dr. Rick Bright: (46:11)
Sir, I believe it’s important. I’ve heard those anecdotal stories, as well, and they were not conducted in the context of a randomized, controlled clinical study. It’s very difficult to understand data from those types of observational studies or anecdotal stories. So the drug might have some benefit in some populations, but we won’t know that until we have that information from a truly randomized, controlled clinical study. Many of those studies are ongoing now. Some of those studies, we’re starting to see data from. Those studies, in those populations tested, haven’t shown an overwhelming evidence of benefit from the use of hydroxychloroquine in those patients. But the different studies are devised to look at different angles of it as you described.
Dr. Burgess: (46:52)
Most of those studies are at the end when someone is [crosstalk 00:00:46:55].
Chairwoman Eshoo: (46:54)
The gentleman’s time has expired.
Dr. Burgess: (46:55)
You can’t do those studies without the drug, though.
Chairwoman Eshoo: (46:56)
The chair recognizes the ranking-
Dr. Burgess: (46:56)
You need to acquire the drug for the studies.
Chairwoman Eshoo: (46:59)
The gentleman’s time … Please. We all want to be fair to each other. The gentleman’s time has expired. The Chair recognizes the Chairman of the full committee, Mr. Pallone, for his five minutes of questions.
Mr. Pallone: (47:15)
Thank you, Madam Chair. And let me just say, Dr. Bright, thank you for your courage in being here. When I was younger, we used to read a book by President Kennedy called Profiles in Courage, and your courage in being here reminds me of some of the people I read about in that book.
Mr. Pallone: (47:32)
I am concerned, Dr. Bright, that the Trump administration does not have plans for a nationwide vaccine program to ensure that once the vaccine is approved, we’ll be able to quickly make it available to everyone. In other words, I don’t want to see the same mistakes by the Trump administration, the incompetence that they had with the supply chain and the testing, repeated with the vaccine. And you stated at the outset of the pandemic in January, you began urgently pressing HHS officials to provide the necessary resources to begin vaccine development, but that your pleas fell on deaf ears. And as the pandemic progressed, you also stated you were alarmed by the pressures coming from some administration officials for your agency to invest in drugs and vaccines, I quote, “Without proper scientific vetting or that lacked scientific merit.”
Mr. Pallone: (48:23)
Can you tell us where we are now in the hunt for a vaccine and where we could have been had the HHS leaders made investment decisions sooner that were based on scientific merit?
Dr. Rick Bright: (48:37)
Thank you, Congressman. As we all know, vaccines are very difficult to make. It’s nothing that you can do quickly, and you need multiple shots on goal to try to make a vaccine. There are many diseases we’ve attempted to make vaccines for history, and we still haven’t been able to do so. So it takes many opportunities and many different approaches. Right now, there are over 100 different approaches for developing a vaccine for this coronavirus. So we’re confident that … hopefully, I should say, at least one of those or two of those will work, but you’ve identified key critical challenges that we need to anticipate and prepare for early. Number one is the supply chain for those vaccines, needed reagents and buffers and salts and various ingredients that go into a vaccine, as well as the glass vials that the vaccines are put into and needles and syringes, and then a carefully coordinated distribution and administration strategy. We haven’t yet gotten to those downstream strategies yet in our government and I think those are going to become a significant issue down the road if we don’t plan for that now.
Dr. Rick Bright: (49:42)
The urgent need for funding at the outset of a pandemic is something we’ve known about through many years of pandemic exercises. Even in our August, 2019 Crimson Contagion exercise, it was highlighted that we would need at least $10 billion from the outset of a pandemic to start the development of the drugs and vaccines. Every day we delay, delays the output of that vaccine or drug. So in those early days, my first meeting with secretary Azar, I asked for funding for people and for those viruses, the three critical things to get the vaccine started.
Dr. Rick Bright: (50:16)
It took some time to get the funding available through various processes, but what BARDA did is we began to look internally at other contracts and other programs we had to redirect some available funding, some minimal funding, even as early as January, to be able to initiate contracts or agreements with some companies to start working on those vaccines as soon as possible. It’s because of those actions now that not only have those vaccines started and made some progress, but also United States has a placeholder with some of those companies to be able to place orders for those vaccines when they are available. And we did everything possible to ensure that those investments were in companies that would build capacity in the United States to manufacture those vaccines. We had to get in line first, even when the money wasn’t fully there to complete the development program. That’s what we did.
Mr. Pallone: (51:11)
I guess my concern is, I’m very critical of the administration in terms of their, I call it incompetence, with the supply chain with lack of testing. I’m afraid the same thing’s going to happen with vaccines and the distribution. Should I be concerned, based on your experience?
Dr. Rick Bright: (51:30)
Absolutely, sir. We’re already seeing those challenges with limited doses of remdesivir with data that we’re getting that remdesivir has some benefit in people. And we have limited doses and we haven’t scaled up production, and we don’t have a plan on how to fairly and equitably distribute that drug. If you can imagine the scenario this fall or winter, maybe even early next spring, when the vaccine becomes available, there’s no one company that can produce enough for our country or for the world. It’s going to be limited supplies. We need to have a strategy and plan in place now to make sure that we can not only fill that vaccine, make it distributed, but administer it in a fair and equitable plan.
Mr. Pallone: (52:10)
And that’s not the case at this point.
Dr. Rick Bright: (52:12)
We don’t have that yet and it is a significant concern.
Mr. Pallone: (52:16)
Thank you. Thank you. Madam Chair.
Chairwoman Eshoo: (52:17)
The gentleman yields back. I now have the pleasure of recognizing the ranking member of the full committee, Mr. Walden for his five minutes of questions.
Mr. Walden: (52:26)
Thank you, Madam Chair. And again, I thank the witness for being here. I want to get some clarification here. So BARDA’s job is to do the vaccines, right?
Dr. Rick Bright: (52:34)
That is one of BARDA’s roles, yes, to support industry to make the vaccines.
Mr. Walden: (52:38)
Okay. Is it BARDA’s responsibility to direct the personal protective equipment acquisition distribution, the PPE? Is that part of your responsibility at BARDA?
Dr. Rick Bright: (52:50)
BARDA plays a role in pandemic preparedness for our nation and we prepare and align and exercise with our other federal agencies. We also are familiar with the critical gaps in the supply chain. While BARDA isn’t responsible for procuring those items for the strategic national stockpile, we are aware of those shortages and those needs. What I was doing in my capacity as BARDA director was raising those concerns and needs with the appropriate group within [ASPER 00:53:16], the strategic national stock-
Mr. Walden: (53:17)
But ASPER basically has the responsibility to go do that, right? That’s not your direct responsibility. You’re obviously in this discussion, but that’s not how it was right in BARDA, correct?
Dr. Rick Bright: (53:30)
It’s my responsibility to raise a significant concern about a limited supplier shortage that I think will affect the lives of Americans.
Mr. Walden: (53:37)
Did you raise that concern with people up here on Capitol Hill and if so, who and when?
Dr. Rick Bright: (53:42)
I raised that concern with my leadership, sir. I raised it with the appropriate folks in the Strategic National Stockpile and our critical infrastructure protection program.
Mr. Walden: (53:53)
But not up here?
Dr. Rick Bright: (53:56)
My role was to raise it to my supervisor, Dr. Kadlec. I also did raise that concern, though, in the White House with Mr. Navarro.
Mr. Walden: (54:04)
Yeah. I’m interested because we’re passing these bills. In the future, I hope you would … or anybody out there listening in these agencies, if you’re spotting something that’s not working right, we need to know.
Dr. Rick Bright: (54:15)
Mr. Walden: (54:15)
On the first case of SARS, COVID-2 in the US, it was identified … I believe, on January 22nd in Washington State … CDC put the positive specimen in culture that day. Correct?
Dr. Rick Bright: (54:28)
I believe so. I think it was January 20th.
Mr. Walden: (54:31)
Okay. It’s my understanding the samples from the virus were made available to the US government and that the CDC expanded the virus stocks between January 29th and February 3rd, and shared the BEI on February 4th to enable broad sharing. Now, according to your complaint, after virus samples were available to the US government from the Washington State case, and potentially even after the CDC’s effort to grow the virus and then share with the BEI bio repository, you were still seeking to obtain a sample of the virus, correct?
Dr. Rick Bright: (55:06)
That’s true, sir, but we need more than one virus-
Mr. Walden: (55:08)
Right. I’m going to get to that. Why were the strains available within the US government not available to you? Were they available to you?
Dr. Rick Bright: (55:18)
Sir, I was asking for viruses in January because we wanted to make sure that we had a head start on developing the vaccine.
Mr. Walden: (55:24)
Yeah, no, I get that.
Dr. Rick Bright: (55:25)
And they became available in February, I believe it was February 6th, through the BEI resources. Then those were distributed to laboratories.
Mr. Walden: (55:34)
Did you ask for the virus sample from Washington State that was part of that?
Dr. Rick Bright: (55:39)
Mr. Walden: (55:39)
Dr. Rick Bright: (55:41)
BARDA did. We asked to make sure we had access to those viruses and they were distributed to the right laboratories and the right companies.
Mr. Walden: (55:47)
And where did you ultimately get the virus that you distributed sample?
Dr. Rick Bright: (55:51)
Some of those viruses came from the BEI Resources at NIH, and some of those viruses came from laboratories that received the initial seed from CDC.
Mr. Walden: (56:01)
Okay. That’s helpful to know. In some conversations I’ve been a part of with Summit at NIH, they indicated that the real key here was to get the DNA sequence, which China did eventually put up, I believe, at the end of December, early January. And that in terms of going after the vaccine, it was that sequencing that really mattered most to get started on vaccine development. And there are other scientists who are very distinguished who believe that the delay in getting the virus sample actually didn’t set them back. Is that an accurate assessment or do you have a disagreement in that view? And I know scientists disagree, so do we up here, but I’m kind of hearing that having the sequencing really mattered most and getting the virus, important, but did not set them back in proceeding to get the vaccine development underway.
Dr. Rick Bright: (56:57)
Sir, China posted the first sequence on January 11th, I believe, and made it available January 10th or January 11th. It’s important to understand that when a sequence is available, some companies with some technologies can get started with that sequence information.
Mr. Walden: (57:14)
And did they?
Dr. Rick Bright: (57:14)
You still are vulnerable because you have another country in their laboratories that posted on the internet or a database their sequence. So it could still be challenges, especially for national security about the integrity of that sequence.
Mr. Walden: (57:28)
Before my time runs out … It’s run out. I was just going to ask, did they begin efforts at that time, once they got the sequence?
Dr. Rick Bright: (57:34)
The NIH began efforts on a synthetic messenger RNA vaccine candidate. However, without the viruses, you really cannot tell if the neutralizing antibodies listed by that or your diagnostics or your therapeutics can actually work. You can try to synthesize a virus with a sequence, but it’s never going to be representative of the actual virus. And where we’re spending billions of dollars on drugs, vaccines, and diagnostics, we want to have the most credible information possible.
Mr. Walden: (58:01)
Right. Thank you, Madam Chair.
Chairwoman Eshoo: (58:03)
The gentleman yields back. A pleasure to recognize the gentleman from New York, Mr. Engle, for his five minutes of questions.
Mr. Engel: (58:16)
Thank you, Madam Chair for holding today’s hearing. Doctor, if you were a betting man … Oh, sorry. Thank you. Doctor, if you were a betting man, when would you bet that we would … time that we would have a vaccine?
Dr. Rick Bright: (58:47)
That’s a very difficult question to answer. I know that there are companies and academic labs working very hard. Normally it takes up to 10 years to make a vaccine. We’ve done it faster in emergency situations and when we had the starting material in the freezer for Ebola, but for a novel virus, these actually haven’t been done yet that quickly. So a lot of optimism is swirling around a 12 to 18 month time frame if everything goes perfectly. We’ve never seen everything go perfectly. My concern is if we rush too quickly and consider cutting out critical steps, we may not have a full assessment of the safety of that vaccine. So it’s still going to take some time. I still think 12 to 18 months is an aggressive schedule. And I think it’s going to take longer than that to do so.
Mr. Engel: (59:42)
12 to 18 months from now, or 12 to 18 months from when this all started the beginning of the year?
Dr. Rick Bright: (59:48)
It would be 12 to 18 months from when the particular manufacturers first received the material or information that they needed to start developing that vaccine. It’s critical to note, when we say 12 to 18 months, that doesn’t mean for an FDA approved vaccine. That means to have sufficient data and information on the safety and immunogenicity, if not efficacy, to be able to use on an emergency basis. And that is the consideration that we have in mind when we talk about an accelerated timeline.
Mr. Engel: (01:00:17)
Thank you. I represent, in New York, Bronx County and Westchester County, which are at the epicenter of the US Corona virus outbreak, New Rochelle, New York. While New Yorkers have really rallied together and supported their neighbors, the administration has failed at every turn. President has sidelined our best scientists, pushed baseless conspiracy theories, and more recently, prescribed unproven remedies like Lysol to suffering Americans. Since the early days of the outbreak, President encouraged doctors to prescribe chloroquine to suffering Americans, despite a lack of evidence supporting its use. On April 24th, the President’s handpicked FDA commissioner even came out against the use of chloroquine for COVID-19 cases. Doctor, what are the dangers of chloroquine if prescribed incorrectly? And what happened when you raised the issue of chloroquine use in coronavirus patients with HHS leadership?
Dr. Rick Bright: (01:01:28)
Congressman, our concerns centered around the potential use of chloroquine in people who were infected with this coronavirus. There are data of the effective use and safe use of chloroquine in malaria patients and other patients and other indications. We also knew that there were potential safety risks with chloroquine to cause irregular heart rhythms, and even in some cases, death. So our concern was with limited information and knowledge, especially of its use in COVID-19 infected patients and the potential for those risks. Then we should make sure that any studies with that drug were done in a carefully controlled clinical study and a close watchful eye of a physician so they could respond to a patient if they did experience one of those adverse events. There wasn’t sufficient data at that time to support use of this drug in patients with COVID-19 without close physician supervision.
Mr. Engel: (01:02:27)
And when you raised that issue of a chloroquine use in coronavirus patients with HHS leadership, what happened to you? You were removed as a director of BARDA. Is that not true?
Dr. Rick Bright: (01:02:41)
I believe part of the removal process for me was initiated because of a push back that I gave when they asked me to put in place an expanded access protocol that would make chloroquine more freely available to Americans that were not under the close supervision of a physician, and may not even be confirmed to be infected with the coronavirus. The scientists at FDA, BARDA, and NIH, and CDC worked hard to switch that to an emergency use authorization with strict guardrails that the patients would be in a hospital, confirmed to be infected with this virus, under close supervision of a doctor and who could not otherwise participate in a randomized controlled study.
Dr. Rick Bright: (01:03:23)
My concerns were alleviated somewhat by being able to lock that in the stockpile with those conditions. However, my concerns were escalated when I learned that leadership in the Department of Health and Human Services were pushing to make that drug available outside of this emergency use authorization, to flood New York and New Jersey with this drug, regardless of the EUA. And when I spoke outside of our government and shared my concerns for the American public, that, I believe, was a straw that broke the camel’s back and escalated my removal.
Mr. Engel: (01:03:59)
Thank you. Thank you, Madam Chair.
Chairwoman Eshoo: (01:03:59)
Gentleman’s time has expired. A pleasure to recognize the gentleman from Kentucky, Mr. Guthrie, for his five minutes of questions.
Mr. Guthrie: (01:04:07)
Thank you very much. Thank you, Dr. Bright, for being here. We appreciate it very much. Reading through your complaint, I just kind of want to point out I think the Chairman said earlier … talked about the lack of urgency and implies the President’s lack of urgency. I think most of my constituents want to know that things are getting done and where is the President on this. And you’re having issues with that leadership at Health and Human Services and you’re giving them recommendations. So if they’re not accepting your recommendation to them, I would, I think, fairly surmise they’re not passing that on to the White House. So the President is probably unaware of what you’re putting forth because it says, in reading from your complaint on page 23, “Fortunately, White House Trade Advisor, Peter Navarro, shared Dr. Bright’s sense of urgency.” So that’s sense of urgency. So talking about the urgency in the White House, so you have a meeting with him on Saturday. He calls you back in on Sunday.
Mr. Guthrie: (01:05:01)
We have that you prepare your recommendations in a memo for Mick Mulvaney, Chief of Staff, so essentially the President. So you get around the leadership of HHS, meet essentially, with the President, since with Mick Mulvaney. And it says you have the meeting with Navarro on Saturday, the memorandum of Mick Mulvaney on Sunday. And on Monday it says the National Security Council policy coordinating committee met with Dr. Matt and directed Dr. Kadlec and HHS to implement Navarro’s recommendations. The push by the White House for HHS to act more swiftly created tension between Dr. Bright and HHS political leadership. So it seems I don’t know how you could be more urgent in government than having a meeting on Saturday, a memorandum on Sunday and actions on Monday, once they got to the President’s attention, to the President’s level. So we appreciate the President moving forward on that.
Mr. Guthrie: (01:05:54)
I’m on the ranking member of ONI, which the investigations, which you’ve testified in front of us before and I appreciate that very much. So I’m kind of looking more at the process of putting this hearing together and some things. As we read through your complaint, the only way we have it is because you made it public. And in your complaint, there are different exhibits that you talk about. And we’re having a hearing today and there are actually 33 exhibits referenced in your complaint that’s not public. I think we got them from the majority through the Washington Post or something like that. That’s how we were made documents available for this hearing in my understanding. So the 33 exhibits that are not made public that are referenced in your complaint, would you make those available to the committee? Do you have those to make them available to the committee?
Mr. Guthrie: (01:06:45)
If we’re using your complaint for this hearing, we need to have the documentation.
Chairwoman Eshoo: (01:06:51)
May I address that?
Mr. Guthrie: (01:06:52)
That’s the Chair. I don’t have a problem with you addressing.
Chairwoman Eshoo: (01:06:56)
Yes. We will take that under advisement and get back to you.
Mr. Guthrie: (01:06:59)
Okay. Also, when we read through the …
Chairwoman Eshoo: (01:07:03)
There may be privacy considerations in some of the documents, so we do need to look at these documents carefully.
Mr. Guthrie: (01:07:09)
So also, if we read through the email chains that are made available, some appear complete, but some truly aren’t. They’re apparently not full email chains. And so you will wonder if the context of the email would relate to the inferences taken from the emails. Would you make all the complete email chains available to us?
Chairwoman Eshoo: (01:07:28)
I’d like to address that, as well, which is a problem is when Dr. Bright was removed from his position, he was locked out of his email. He does not have access to his full email.
Mr. Guthrie: (01:07:40)
So the email chains that you have available, we have.
Chairwoman Eshoo: (01:07:44)
Dr. Rick Bright: (01:07:45)
I can address-
Chairwoman Eshoo: (01:07:46)
He does not have a full set of his email.
Dr. Rick Bright: (01:07:48)
I can address this, too. And that’s exactly right. So I was immediately locked out of my email on April 20th of this year. And so I didn’t have full records available to me on that. However, I believe I laid a solid foundation.
Dr. Rick Bright: (01:08:02)
And that, however, I believe I laid a solid foundation in my complaint as detailed as I could be for the Office of Special Counsel to be able to conduct an investigation. I believe as part of their investigation, they’ll be able to access those emails and individuals to get a full story and get the full information so they can get to the bottom of [crosstalk 01:08:21]-
Mr. Guthrie: (01:08:20)
It would have been helpful for us as well. Have you shared any of these exhibits with the majority that’s not been shared with us in the minority side?
Dr. Rick Bright: (01:08:28)
Sir, I believe you have probably what’s available in the public domain and I believe the rest has been submitted to the Office of the Special Counsel and I haven’t made it available to anyone directly.
Speaker 4: (01:08:39)
To the gentleman, the minority and majority members all received the same packet of information-
Mr. Guthrie: (01:08:47)
Which is available to the public.
Speaker 4: (01:08:51)
[crosstalk 01:08:51] that was in the public domain.
Mr. Guthrie: (01:08:54)
Just one more. Are there any other documents in your possession or accessible to you that are not included as exhibits in the complaint, but are nonetheless relevant to your allegations? If so, will you provide those to the committee?
Dr. Rick Bright: (01:09:07)
I believe I’ve provided the information that I have available to me at this point. If I had access to my email from HHS, there might be additional supporting information in that email. I do not know the status if that’s been deleted or wiped or I just haven’t had access to it since April 20, sir.
Mr. Guthrie: (01:09:24)
Okay, once you have access to it. I appreciate your answers. Thank you very much. I yield back.
Speaker 4: (01:09:27)
The gentleman yields back. Pleasure to recognize the gentleman from North Carolina, Mr. Butterfield, for his five minutes of questions.
Mr. Butterfield: (01:09:35)
Thank you, chairwoman. And to you, Dr. Bright, thank you sir, for coming today. And thank you, most importantly, for your 25 years of public service. Dr. Bright, I’d like to ask you about your efforts to address supply shortages for administering COVID-19 tests. According to your account, as COVID-19 testing ramped up, you asked for an inventory of the strategic national supply availability of testing supplies, including swabs, viral transport materials, and extraction buffers. You learned that the national stockpile did not stock these items. After that you learned that the FDA source of swabs was a manufacturer in the region of Italy, which was the center of the COVID-19 outbreak in Italy. It is my understanding that this information then prompted you to reach out to the DOD agency that had previously assisted your office with international transportation of supplies related to Ebola. My question is why, why sir did your office contact DOD at this point?
Dr. Rick Bright: (01:10:44)
Sir, it was quite a surprise to me that the urgent ramp up of the testing did not include full consideration of all the critical supplies needed to support that ramp up of testing, including those materials you mentioned, swabs, viral transport media, buffers, et cetera. And I was quite alarmed to learn from sitting behind CDC director Redfield, that we were going to experience this shortage of swabs. And I was even more surprised that there our strategic national stockpile did not plan or have any of those in supply. My urgency to find a solution to that was supported by the FDA director of the center for CDRH for those devices and diagnostics at FDA. And once I confirmed that there was a shortage, it was critical that we find a solution. And that was by partnering with our Department of defense colleagues who worked with us for the Ebola response. We actually worked with them to ship doses of Ebola vaccine from Germany to the United States, so it can be filled rapidly to respond to the outbreak in Africa. I was a natural occurrence or response for me and my colleagues in BARDA to come up with a solution to that critical supply chain.
Mr. Butterfield: (01:12:04)
Let me ask you this. Were there any restrictions in place in Italy that would require Secretary Azar to move forward with the request to DOD?
Dr. Rick Bright: (01:12:12)
What we needed to enact that air bridge with department of defense was we needed Secretary Azar to make a request of the secretary of defense and I and my colleague, Dr. Gary Disbrow raised this issue at our senior leadership meeting with Dr. Kadlec who chairs that meeting, the ASPR. And it clearly was not a topic that he wanted to discuss on that day and actually we were rebuffed by him saying that he did not really want to talk about swabs right now. And both Dr. Disbrow And I raised this concern repeatedly in that call. Knowing that it was critical and time sensitive and we had a critical shortage of these swabs, I placed a call to Mr. Navarro’s office once again and asked if Mr. Navarro could offer some assistance in contacting the secretary of defense to get clearance for DOD to put those airplanes in place under the contract we have. And that happened in a very quick turnaround, in a matter of minutes. With that permission from the secretary defense, we were able to start those flights within two days. We have enow transferred back over 25 million swabs.
Mr. Butterfield: (01:13:23)
So you’re saying that you alerted White House advisor Peter Navarro about this issue, is that right?
Dr. Rick Bright: (01:13:28)
Mr. Butterfield: (01:13:29)
And within hours, literally within hours, he had coordinated with DOD to start these flights to transport the swabs?
Dr. Rick Bright: (01:13:35)
Mr. Butterfield: (01:13:37)
This seems like a logical response to the analysis that you provided. What is truly perplexing to me is why anyone would resist such an initiative. And that’s a rhetorical question. I won’t ask you to answer that. Finally, we still don’t have enough testing supplies. I don’t understand how and why that is possible. I understand that converting an auto plant to build ventilators might take a little time, but how can we be struggling to get adequate supplies of simple supplies like swabs? What does this say about the federal response to the coronavirus outbreak?
Dr. Rick Bright: (01:14:12)
It says to me, sir, that there is no master-coordinated plan on how to respond to this outbreak. We don’t have a strategy or plan in place that identifies each of those critical components and we don’t have a designated agency that is sourcing those critical components and coming up with a strategy to make sure that we have those supplies when we need them. We need this comprehensive national strategy that’s end to end and includes every component to make sure we can respond and protect American lives.
Mr. Butterfield: (01:14:43)
Thank you, Dr. Bright. You’re a great American. Thank you very much. I yield. Back.
Speaker 4: (01:14:45)
The gentleman yields back. Pleasure to recognize the gentleman from Virginia, Mr. Griffith, for his five minutes of questions.
Mr. Giffith: (01:14:53)
Thank you, Madam chairman. It seems like Mr. Navarro’s done a pretty good job in listening to the questions. I do wish we had more of the information available and it’s one of the reasons why it’s not your fault, but why I wish we had done this through the regular channels. But I would ask this on some of the questions that were just asked about supplies being available. I got the impression from prior testimony that Project Bioshield, which you urged us to put money into and we put a 700 million in ’18 and 735 in ’19 was supposed to take care of some of that. Am I misunderstanding Project Bioshield?
Dr. Rick Bright: (01:15:34)
Project Bioshield is used to invest in late stage development of drugs and vaccines-
Mr. Giffith: (01:15:38)
So it’s for the drugs.
Dr. Rick Bright: (01:15:39)
Primarily and some diagnostics and-
Mr. Giffith: (01:15:41)
So that didn’t help on this at all?
Dr. Rick Bright: (01:15:42)
It didn’t help on this at all, sir.
Mr. Giffith: (01:15:45)
Now that being said, and I would hope that we would have had everything available to us and I understand that may not be your fault, but it does create issues, but everything’s going crazy. People have all kinds of things going on and this hydroxychloroquine comes up and there’s some email exchanges in exhibit 54 from your documents indicate that a Christopher [inaudible 01:16:13] writes and he says, we should probably take a look at this. I’m paraphrasing. But the line that I took out of it was especially when we have few or no options. One of the frustrations that I have had for years with our community trying to respond to all kinds of different diseases is we want to have the double blind studies in place. We want to have all the science there, which makes sense if you have an alternative, but when you have few or no options, it seems to me you would go after those things that are available.
Mr. Giffith: (01:16:41)
And if hydroxychloroquine is one at one point, then remdesivir, I’m assuming, have they done the double blind studies with related to COVID on remdesivir? Has that already happened? And then I’ve got an article from the Richmond Times Dispatch, April 15th, where a doctor used high does of vitamin C and a drug called Actemra. All of these are floating out there. Doctors are using all kinds of things because we don’t have other options. And so I’m wondering what was the great hesitancy to at least let doctors try and even if anecdotally it was having some effect, wouldn’t you have to have that available in order to be able to do the tests? And if you’ve got few or no options, why wouldn’t you want to go down that pathway?
Dr. Rick Bright: (01:17:35)
We want to make sure that the drugs that we consider are safe and effective. The highest priority is safety. So many of these studies that we had or anecdotal evidence or reports we had did not include a thorough safety vetting of those drugs. There are some known side effects with some of the drugs. Many of these drugs were repurposed, so they weren’t built de novo. So we knew about some of those potential safety concerns and we didn’t have any evidence of how those safety concerns would appear in people. In fact, with this virus, this virus takes over a lot of your body. It actually infects multiple organs in your body and causes significant inflammation and multi-organ shut down, in some cases, before death and acute respiratory distress [inaudible 01:18:18] really turns your lungs into a brick-
Mr. Giffith: (01:18:20)
It’s serious stuff. And you said the hydroxychloroquine that one of the problems was you might have a irregular heartbeat. If you’re worrying about not having a heartbeat at all, you’re not worried about irregular, if you don’t have one at all, am I not correct about that? That’s the concern. People were dying out there and here was the first one that showed some promise. Why wouldn’t we want to accept an offer from a manufacturer to give us a lot of this and have it out there for widespread use if the doctors chose just like the doctor in Richmond. That didn’t work in that case, they actually used it in there in that case and it didn’t work. He tried something else. I think that’s really what we’re going to have to do in an emergency situation. Am I not correct?
Dr. Rick Bright: (01:19:02)
We need to do it carefully, sir. We have to make sure that when we have that information available with those potential drugs available, we are thinking outside the box-
Mr. Giffith: (01:19:11)
Can’t we be so careful that we accidentally kill people?
Dr. Rick Bright: (01:19:14)
We need to move swiftly, sir. And we’ve actually did show that we could put up a clinical study in the matter of less than a week. It’s important to use the available clinical data. And if we know there are potential risks, we need to make sure that we’re cognizant of those risks and make sure those drugs are used in a very safe and controlled manner.
Mr. Giffith: (01:19:31)
Yes, sir. And I appreciate that. And let me just say this, it’s our job to ask some tough questions sometimes, but just like you found friendly ears at the White House, you might’ve found some friendly ears on our side of the aisle here as well. And I would note that in 2018 you were talking about vaccines and you were talking about off shore production. And I said, let me know what I can do to help get more production onshore, but I never heard from you. I’m happy to help. I want onshore production. I’m with you on a lot of these issues. I don’t know what’s going on behind the scenes. We’ve got to investigate that. Today, unfortunately, it was not the day to do that investigation. We don’t have enough information. A lot of stuff is not here for us. But don’t hesitate in the future, if you see something, let us know on both sides of the aisle what’s going on. I appreciate it. And I yield back.
Dr. Rick Bright: (01:20:17)
Speaker 4: (01:20:18)
Gentleman yields back. Pleasure to recognize the gentlewoman from California, Ms. Matsui for her five minutes of questions.
Ms. Matsui: (01:20:26)
Thank you very much, madam chair. And thank you, Dr. Bright for appearing before us today. And thank you for your public service. Dr. Bright, you described a series of missed opportunities that have left our country woefully unprepared for the pandemic’s impact. Many Americans are eager to return to normalcy as we can all understand. But even begin safely reopening, we need widespread testing capacity and organized contract tracing workforce and a healthcare system that can handle further surge and ultimately, a vaccine or therapeutic cure is required. I’d like to ask you a series of questions about your warnings to the administration while at BARDA. I’m hoping you can succinctly answer whether you believe each scenario will ultimately shorten or lengthen the time it takes for our country to safely reopen and recover from the coronavirus pandemic.
Ms. Matsui: (01:21:22)
On January 10th, you began pushing HHS leadership to obtain sequencing and virus samples. Given the importance of these samples for vaccine and diagnostic development, has administration’s inaction shortened or lengthened our timeline for reopening?
Dr. Rick Bright: (01:21:40)
Those samples were critical to get started as early as possible. If there was delay in getting those samples, that means there’ll be a delay in getting those counter measures. Those counter measures are critical to reopening our country.
Ms. Matsui: (01:21:50)
Throughout the month of January, you made HHS aware of the urgent need to increase funding to combat the virus. HHS leadership believed that BARDA’s budget was sufficient. Has the delay of these resources shortened or lengthened our timeline for reopening? Shorten or lengthen?
Dr. Rick Bright: (01:22:08)
The delay of those resources have extended the timeline to make drugs available and vaccines. Therefore, has extended our ability to respond to this pandemic.
Ms. Matsui: (01:22:17)
On January, 18th, you pushed Dr. Kadlec to coordinate COVID-19 planning activities across the government. Dr. Kadlec initially rejected your request suggesting it was not time sensitive. Did this delay in coordination shorten or lengthen our timeline for reopening?
Dr. Rick Bright: (01:22:35)
That lengthened the timeline for our reopening. We needed those early policy discussions to happen as soon as possible.
Ms. Matsui: (01:22:42)
From January through March, you pushed for HHS to ramp up production in 95 masks, swabs and syringes. HHS failed to act quickly. Has this inaction shortened or lengthened our timeline to reopening?
Dr. Rick Bright: (01:22:56)
That inaction has put a lot of lives at risk and our frontline healthcare workers in no time to reopen our country will bring those people back to us.
Ms. Matsui: (01:23:04)
Certainly. Thank you, Dr. Bright. Of course, there are many decisions made outside of these scenarios that influence when we can safely reopen, but from what I’m hearing today, HHS, if they heeded your warnings early, we could have proactively limited the toll this pandemic has taken on our country.
Ms. Matsui: (01:23:21)
It appears clear from the whistleblower report that the Trump administration prioritized political calculations above public health with regard to chloroquine and hydroxychloroquine. Despite the lack of data supporting the clinical benefits for the treatment of prevention of COVID-19, the Trump administration promoted the drug’s use to the American people because it was seen as a big immediate win. Dr. Bright, do you believe there are other instances where the administration relied on politics rather than science to make coronavirus response decisions and what consequences might those decisions have had on public health?
Dr. Rick Bright: (01:24:02)
We have a very rigorous scientific review process for all of the investments that we make for the drugs, vaccines and diagnostics through BARDA and through our department, actually. And so there were some attempts to bypass that rigorous vetting process that caused me great concern and actually increased the tension between me and Dr. Kadlec. Without that scientific vetting that does increase the risk of a drug being evaluated or supported. That could have safety concerns and we really needed to have the best scientists in our country weigh in on whether or not that drug should be evaluated and how it should be evaluated to address those safety concerns.
Ms. Matsui: (01:24:43)
Certainly. The Trump administration waited until April to invoke the Defense Production Act to increase the production of lifesaving medical supplies like masks months after doctors began experiencing shortages and three months after your initial January warnings. Should HHS have invoked the Defense Act earlier to increase the domestic production of critical medical supplies like masks and swabs?
Dr. Rick Bright: (01:25:12)
Actually, I’m not an expert on the Defense Production Act and how it’s used most effectively. I do believe that we should have been doing everything possible, placing orders early, ramping up supply, ramping up production of those critical medical equipment as quickly as possible, whether or not that’s through the Defense Production Act or other mechanisms, it should have been a high priority.
Ms. Matsui: (01:25:32)
Well, thank you very much, Dr. Bright. I ran out of time. And thank you very much for appearing before us today.
Speaker 4: (01:25:38)
The gentlewoman yields back. A pleasure to recognize the gentleman from Florida, Mr. Bilirakis, for his five minutes.
Mr. Bilirakis: (01:25:44)
Thank you madam chair, I appreciate it very much and I want to thank Dr. Bright as well for your service to our country. I have a few questions and I’m focusing on the hydroxychloroquine. When was the potential use of chloroquine and hydroxychloroquine as treatment for the COVID-19 first brought to your attention, sir?
Dr. Rick Bright: (01:26:10)
I believe it was probably mid-March, between March 10th and March 17th, somewhere in that timeframe.
Mr. Bilirakis: (01:26:18)
Not prior to that?
Dr. Rick Bright: (01:26:20)
Not that I recall. The first I heard of the drug itself was a call I received from Dr. Woodcock at the FDA asking if I had heard of the drug and I hadn’t heard of the drug and I hadn’t heard of its potential use for COVID-19 patients. She said there might be something interesting to look at and she’d forward a manuscript and a draft manuscript. And that’s the first I learned about the drug itself.
Mr. Bilirakis: (01:26:43)
So you weren’t aware of any news articles and research papers in January discussing the potential benefits of the drug?
Dr. Rick Bright: (01:26:53)
I heard anecdotal stories and report, sir.
Mr. Bilirakis: (01:26:56)
Dr. Rick Bright: (01:26:57)
I can’t recall if I did specifically for chloroquine, but I tried to track the media and the scientific journal as well. However, I rely on the guidance of the science within HHS. And the first I’d heard of that was from my colleague, Dr. Woodcock at the FDA and then a summary report from our scientists at FDA, CDC, NIH and BARDA that indicated evidenced for its benefit was weak and the evidence for its safety concerns was stronger. And they did not believe at that point it was something that should be supported.
Mr. Bilirakis: (01:27:33)
Now, again, what was your reaction personally? Did you think it was something worth pursuing initially when you heard it from Dr. Woodcock?
Dr. Rick Bright: (01:27:45)
Initially, I said, I do believe. I trust Dr. Woodcock and her scientific judgment immensely. And if she mentioned that this is something that we should look at, then it’s something we should consider testing in a randomized controlled clinical study. I would be supportive of the team reviewing that protocol and that information to see if it should be used.
Mr. Bilirakis: (01:28:08)
Sir, I understand I’ve heard from experts, and I’m certainly not an expert in this area, that the drug or the one that we’re talking about in this case, hydroxychloroquine, if it’s used, first of all, timely, because I know I understand there’s a window there. As far as the efficacy of the drug. Have you heard this, that if it’s administered properly, there’s a small window there for the patients as far as risk is concerned? Can you elaborate a little bit on that if you’ve heard that? And again, this is not from a lay person. This is from an expert.
Dr. Rick Bright: (01:28:58)
We have seen anecdotal, heard of anecdotal data from different positions that they believe they’ve seen benefit or patient improvement from use of this drug in either combination with an antibiotic, azithromycin or a combination with zinc or vitamin C or other things, but there was never sufficient evidence from a randomized controlled study to show its benefit would actually outweigh the potential risk. That is why the NIH and probably 40 other institutions around the world are conducting randomized controlled clinical studies to look at the benefit either in late stage treatment or early stage treatment. Most of the data coming out from those clinical studies to date haven’t shown an overwhelming level of evidence that it has benefits in those patients. Doesn’t mean that it might still have some benefit in individuals or a case or two in different studies or that physicians believe they see a benefit in their patients. In the context of a randomized controlled study, we haven’t seen an overwhelming level of benefit.
Mr. Bilirakis: (01:30:03)
Have you reviewed the studies in other countries such as France and possibly Japan on these? I just want to know, because my constituents ask these questions. Do you take those studies into consideration when you make these decisions?
Dr. Rick Bright: (01:30:27)
We absolutely do. We look at the quality of those studies and look to see if they were done with the right controls in place and the right sample size. Was it statistically relevant or was it just a few of people or was it 20 people or was it 2000 people? All of that adds to the power of the data itself. Many of the studies that we saw early only included a few number of patients. And so it was unclear even from the description of some of those studies that were not in peer reviewed journals, whether all the patients were treated the same, whether they had full participation throughout the clinical study itself and looking at the statistical power of many of those studies, they were very small. It was really difficult to understand the impact, the benefit. We also saw a study that the VA hospital conducted with hydroxychloroquine that showed people who were treated with hydroxychloroquine appeared to have a higher rate of death than people who are not treated with hydroxychloroquine. That’s study, too, has weaknesses, no studying is actually perfect. You take all of that evidence into account when you make a decision on how to further study the drug or how to use that drug.
Mr. Bilirakis: (01:31:40)
It’s my understanding that not my constituent, but a US citizen, a veteran, was cured, again, this is just from what I’ve heard, from the drug and that was a late stage case, but I’ve also heard of early stage cases as well. I wanted to get that on record. Thank you, madam chair.
Speaker 4: (01:32:04)
[inaudible 01:32:04] yield back. A pleasure to recognize the gentlewoman from Florida, Ms. Castor, for her five minutes of questions.
Ms. Castor: (01:32:12)
Thank you, madam chair. Dr. Bright, thank you for speaking out to save lives. I read your whistleblower filing and I want to ask you about the N 95 respirators. These respirators are essential personal protective equipment. They’re not the cloth mask or surgical mask that everyday Americans are encouraged to wear by the CDC. Dr. Bright are N 95 respirators necessary to protect the lives of nurses, doctors, EMTs, and those on the front lines?
Dr. Rick Bright: (01:32:47)
Yes, they’re required essential personal protective equipment to protect those frontline healthcare workers from getting infected.
Ms. Castor: (01:32:55)
And this is not a hypothetical concern, just last week the LA Times reported a tragic story about a heroic nurse, Celia Marcos, who appears to have died because she lacked an N 95 respirator when she rushed into a hospital room to try to save a COVID-19 patient who had stopped breathing. And this brave nurse is not the only one. According to another report, over 700 staff at just one Detroit area health system have tested positive for COVID-19 and the CDC reported over a month ago that over 9,000 healthcare workers had already contracted COVID and dozens have died. And I checked with my Tampa Bay area health providers, and one Tampa hospital said, “N 95s are still very difficult to procure.” She said, “There’s a dire need for N 95s.” One of my community health centers says, “We continue to struggle to get N 95s.” And there are so many folks trying to sell knockoffs. And then a large Tampa Bay area health system said the supply chain remains inconsistent and irregular and [inaudible 01:34:05] remains concerned. As we head into the fall for N 95 masks, the demand will continue to increase due to the flu season and the continued presence of COVID-19. Dr. Bright, you understood that America would face this shortage of respirators in January. Is that right?
Dr. Rick Bright: (01:34:27)
We understood America would face a shortage of N 95 respirators for pandemic response in 2007. And we have exercised and known and evaluated that number almost every year since 2007. It was exercised even as early as 2019 August in the Crimson Contagion that we would need 3.5 billion N 95 respirators in our stockpile to protect our healthcare workers from a pandemic response.
Ms. Castor: (01:34:56)
And you sounded the alarm repeatedly, but were ignored by the senior leadership at the Department of Health and Human Services. Please explain what steps that you took and the response you received.
Dr. Rick Bright: (01:35:09)
We knew going into this pandemic that critical medical equipment would be in short supply. I began getting alerts from industry colleagues in mid and late January telling me that from an outside view from the industry view that the supply chain was diminishing rapidly, telling me that other countries that we relied on to supply many of these masks, were blocking export and stopping transfer of those masks to the United States. I learned that China was trying to buy the equipment from the United States producers to have it shipped to China so they could make more.
Dr. Rick Bright: (01:35:46)
In each of these alerts and there are dozens of these alerts, I pushed those forward to our leadership in ASPR, to Dr. Kadlec and his senior leadership team. I pushed those warnings to our critical infrastructure protection team. I pushed those warnings to our strategic national stockpile team who has the responsibility of procuring those medical supplies for our stockpile. In each of those, I was met with indifference, saying they were either too busy, they didn’t have a plan, they didn’t know who was responsible for procuring those. In some cases, they had a sick child and would get back to it later in the week, a number of excuses, but never any action. It was weeks after my pushing that finally a survey was sent out to manufacturers or producers of those masks, a five page survey, asking producers or companies, if they actually made those masks.
Ms. Castor: (01:36:43)
In your whistleblower filing, you discuss a February 7th meeting of the department leadership group at which you urged the department to focus on securing N 95 masks. Can you describe what happened at that meeting?
Dr. Rick Bright: (01:36:56)
They informed me that they did not believe there was a critical urgency to procure a masks. They’d conducted some surveys, talked to a few hospitals and some companies, and they didn’t yet see a critical shortage. And I indicated that we know there will be a critical shortage of these supplies, we need to do something to ramp up production. They indicated if we notice there is a shortage that we will simply change the CDC guidelines to better inform people who should not be wearing those masks, so that would save those masks for our healthcare workers. My response was, I cannot believe you can sit and say that with a straight face. That was an absurd.
Ms. Castor: (01:37:36)
In fact, it took three months from your initial warnings until mid-April for the federal government to invoke its authority under the Defense Production Act to require the production of millions of more N 95 masks. And even then, the administration required the production of only 39 million masks, which is far fewer that you and other experts said that we would need. What was the consequence of this three month delay and inadequate response? Were lives endangered?
Dr. Rick Bright: (01:38:09)
Lives were endangered and I believe lives were lost and not only that, we were forced to procure the supplies from other countries without the right quality standards. Even our doctors and nurses in the hospitals today are wearing N 95 marked masks from other countries that are not providing the sufficient protection that a US standard N 95 mass would provide them. Some of those masks are only 30% effective. Therefore, nurses are rushing in the hospitals thinking they’re protected and they’re not.
Ms. Castor: (01:38:39)
Thank you for your courageous effort.
Speaker 4: (01:38:41)
Gentlewoman’s time has expired. A pleasure to recognize our colleague from Indiana, Dr. Bucshon, for his five minutes.
Dr. Bucshon: (01:38:50)
Thank you, madam chairwoman. And thank you, Dr. Bright, for testifying. I appreciate it. I was a cardiovascular and thoracic surgeon and had been in healthcare for over 30 some years. I’m not going to ask a question about hydroxychloroquine. I just want to comment on how the medical community responds to this type of thing. Doctors across the country will use drugs off label in a circumstance where they don’t have or they don’t see a viable alternative to that. And I think this is one of those circumstances. I’m hearing from doctors across the country and look, I’m with you. You have to have double blind studies. You have to have proof under normal circumstances, but in this situation, I think a little bit of understanding and leeway from the federal government is in order.
Dr. Bucshon: (01:39:39)
We do want us to ensure the safety. This is a drug that has been proven safe for many, many years in the appropriate doses. It does prolong the QT interval as you’ve outlined, which can lead to cardiac arrhythmias if not used properly. But tell you, when states tried to stop doctors from using this, there was such a backlash they had to back away from it because the physicians in the community wanted to use it. And so doctors like me out in the real world, if things are working, even anecdotally, they’re not going to wait for the government bureaucracy to approve it. I just want to get that on the record. I’m just saying, this is why doctors are using this drug, whether it’s right or not, data will show, but if two years from now we have the studies and we say, “Hey, that stuff really would have worked.” And the government stopped that from being used. If I was a family of a person that was stopped from getting hydroxychloroquine, I’d be pretty mad.
Dr. Bucshon: (01:40:32)
I want to talk about the supply chain issues as it relates to PPE, the personal protective equipment, and I think there’s enough blame to go around in the federal government about what happened there. After H1N1, when our national stockpiles were depleted, we didn’t replenish them. We’ve had people on both sides of the aisle talking about this. And I think there’s some blame to go around, but I don’t want to be accusatory, but I do want to go over some of the facts about BARDA’s situation as it relates to the masks. And according to a Washington Post report in 2015, the Obama administration and a company now known as ONM Howard, Halyard, H-A-L-Y-A-R-D, announced a project to develop rapid pandemic mass production line. According to federal contracting records in 2017, HHS signed off on a 3.3 million, with an M, payment to Halyard to build a machine that could churn out millions of protective respiratory masks at a high rate of speed during a pandemic. However, in September of 2018, CNBC reported that the machine was never built. And despite BARDA’s 1.5 billion, with a B, budget, the Washington Post reported there wasn’t money to pay for the project. Why was the project scrapped? And did you sign off on that decision?
Dr. Rick Bright: (01:41:56)
That project with Halyard was to build a novel, a new machine to make…
Dr. Rick Bright: (01:42:02)
Was to build a novel new machine to make a respiratory protection face mask faster as you described accurately, actually the technical team must have reviewed that proposal on the next step or the further investment in that machine. I believe that the investment to date was made to design the machine, build the blueprint of machine and I’m not even sure if it was to build the actual prototype.
Dr. Bucshon: (01:42:23)
At that time in September 2018 were you the head of BARDA?
Dr. Rick Bright: (01:42:28)
In 2018 I was the director of BARDA. Yes, sir.
Dr. Bucshon: (01:42:30)
Right. Did you sign off on the decision? Because I would expect a decision like that, a contract, money was allocated apparently from HHS to BARDA to do this. I wouldn’t expect that to be scrapped without the director of BARDA signing off on that. Right? Did you sign off on it? It’s a yes or no question.
Dr. Rick Bright: (01:42:49)
Not necessarily a scrapped project, sir. I don’t know what the proposal was. We rely on-
Dr. Bucshon: (01:42:52)
Dr. Rick Bright: (01:42:52)
… a very thorough vetting process-
Dr. Bucshon: (01:42:54)
Dr. Rick Bright: (01:42:54)
… to our contracting office so that proposal to further continue that project never made it to me, so if it wasn’t approved, it didn’t make it through the proper vetting process in BARDA. The decision to end or continue that project was not brought to me.
Dr. Bucshon: (01:43:10)
Okay. I find that surprising, but I’ll take your word for it. Nicole Lurie who hired you told the Washington post that the Halyard contract was part of an explicit strategy to ensure we could surge mass production in the next crisis. Well, now we’re here and we don’t have it. We’re dealing with the consequences of that decision. In addition I guess to the Halyard, I keep saying that wrong, it is my understanding …
Dr. Bucshon: (01:43:38)
Well I’m running out of time, so what I’m going to just say is look, to doctors across America it’s easy for us to sit in Washington, D.C. whether we’re members of Congress or whether there were agencies and talk in the abstract about people dying in our intensive care units. But when you’re the physician at the bedside and there is a medication that has promise and that has a safety profile that we understand, doctors will use this medication offline and that’s what’s happening.
Dr. Bucshon: (01:44:12)
Whether that’s right or wrong, we might take us years to prove, but in the meantime, people can die so I yield back.
Chairwoman Eshoo: (01:44:20)
Gentlemen, time has expired. It’s a pleasure to recognize the gentleman from Maryland, Mr. Sarbanes, for his five minutes of questions.
Mr. Sarbanes: (01:44:33)
Thank you, Madam Chair. Dr. Bright, welcome back to this committee. The United States government deploys millions of dedicated public servants working together to achieve our shared goals as a nation, to promote effective government, and to protect the public interests. In this instance, to protect the public health. As a scientist and public health official, that was your charge and you took it seriously.
Mr. Sarbanes: (01:44:55)
Unfortunately, the record shows that your superiors at HHS and potentially beyond instead of valuing your expertise and experience squandered in ways that in this moment, in the face of this crisis, amount to gross negligence. They ignored your science-based pleas to pursue critical strategies. For example, your repeated calls to obtain virus samples from China and to find supplies, masks, respirators, swabs.
Mr. Sarbanes: (01:45:20)
They dismissed your science-based warnings about pursuing unproven strategies. They dismissed your concern for example, about the stampeding towards hydroxychloroquine. We’ve heard about that today. They sent you on errant missions to find treatments with little therapeutic value, all for the sake of satisfying political cronies and you’ve testified about the miracle cure drug that was an example of that.
Mr. Sarbanes: (01:45:46)
Ignoring, dismissing your input was not harmless malpractice because there is every reason to believe that if that input had been heeded, particularly your pleas for action in the early days of the pandemic, it might have saved thousands of lives. I want to thank you for coming forward. I want to thank you for blowing the whistle on the misguided and chaotic response to this pandemic.
Mr. Sarbanes: (01:46:09)
I am sure there are specific conversations, emails, moments in time that you remember like they happened yesterday. The inflection points where if the response to your warnings have been heeded, things might’ve been different and I’m sure they haunt you and keep you up at night. From January of this year tell me about just one specific moment when you had that sinking feeling in the pit of your stomach because you were not seeing the response that you knew needed to happen.
Dr. Rick Bright: (01:46:39)
Congressman, I’ll never forget the emails I received from him from Mike Bowen indicating that are our mask supplier, N95 respiratory supplier, was completely decimated. He said, “We’re in deep shit, the world is, and we need to act.” I pushed that forward to the highest levels I could in HHS and got no response. From that moment I knew that we were going to have a crisis for our healthcare workers because we were not taking action. We were already behind the ball. That was our last window of opportunity to turn on that production, to save the lives of those healthcare workers and we didn’t act.
Mr. Sarbanes: (01:47:21)
Thank you. Listening to your testimony gives me chills because it all adds up to one inescapable conclusion: it didn’t have to be this way. There was another path. Things could have gone differently. The federal response to the pandemic could have been much more effective, so here we are at a moment when our country needs the kind of expertise and science-based guidance that you and others like you can offer us, these voices are too often being sidelined.
Mr. Sarbanes: (01:47:51)
Things are upside down. In you, we have someone who made the right call in the early days and has been removed from your position while so many people who made the wrong call still have their jobs. Dr. Bright, when the council that you and others offer is cast aside and I know you know this, it means that science and reason are also being cast aside. That’s a dangerous impulse.
Mr. Sarbanes: (01:48:22)
It’s an attitude that deprives our country in this critical moment of any real chance of getting ahead of this pandemic. But hopefully we can learn from this. There is still time to put science and reason back into the national strategy for fighting COVID-19. We need people like you to help lead us through this. The federal response has got to get smarter. It has to put science ahead of politics and cronyism and wishful thinking. Our committee will continue to press for that in the days ahead and I know that you want to look forward, so tell us what can we do now to learn from the mistakes of January and February and March, and make sure that we navigate and lead our country through this public health crisis?
Dr. Rick Bright: (01:49:25)
Congressman, we need to install and empower leadership. We need to unleash the voices of the scientists in our public health system in the United States so they can be heard and their guidances need to be listened to, and we need to be able to convey that information to the American public so they have the truth about the real risk and dire consequences of this virus, and they have the truth about the consequences of their actions if they don’t follow those guidances. We don’t have a single point of leadership right now for this response and we don’t have a master plan for this response, so those two things are absolutely critical. I would also encourage Congress to ensure there is oversight in this response. Large sums of funding have become available to help us as scientists and others respond to this outbreak and without proper oversight of those dollars, I’m concerned that they could be misdirected and lost and not put to the right fight.
Dr. Rick Bright: (01:50:43)
I would encourage Congress to continue and increase their oversight in how those funds are being spent and making sure they’re prioritized and used appropriately to end this pandemic.
Mr. Sarbanes: (01:50:54)
Thanks for that caution. I yield back.
Chairwoman Eshoo: (01:50:56)
The gentleman’s time has expired and he yields back. A pleasure to recognize the gentlewoman from Indiana, Ms. Brooks, for five minutes for her questions.
Ms. Brooks: (01:51:07)
Thank you, Madam chairwoman. Dr. Bright, with all due respect the Vice President was named the head of the Coronavirus White House Task Force, which was actually a recommendation from a bipartisan Blue Ribbon Study Panel that issued recommendations years ago and thought the office of the Vice President ought to be in charge of the response, and so with all due respect I believe there is that coordination.
Ms. Brooks: (01:51:34)
Part of what I’m very, very concerned relative to this hearing is that there is the impression being made that there’s been no plan and in fact, that’s part of what the reauthorization of PAHPA that I worked closely with you, Dr. Kadlec, the Congresswoman Eshoo, Dr. Burgess, so many of us rely on you all to share with us what we needed to do to reauthorize PAHPA, which most members of Congress really didn’t know what that was: Pandemic and All-Hazards Preparedness Act.
Ms. Brooks: (01:52:12)
Most members of Congress and most members of the American public didn’t know we had strategic national stockpiles and that we might actually be short some of these things until this all hit, but we did get that reauthorized and it was signed into law in June of 19. Do you recall that?
Dr. Rick Bright: (01:52:31)
Ms. Brooks: (01:52:32)
Dr. Bright, you joined BARDA to lead the influence of division 2010 right after H1N1 because of your expertise and we rely on your expertise and you became director in 2016. You mentioned it in ’07, but after the 2009 H1N1 pandemic, the supply of masks in the Strategic National Stockpile was not resupplied. You’ve mentioned that actually we’ve had a problem since ’07. But I have to share with you members like Congresswoman Eshoo and I have had discussions about this, many of us really didn’t know that. We, as members of this committee, did not know and were not told of these shortages of masks as we worked through reauthorization of this important law. Were you aware of this issue and did you push HHS to maintain mask production for purposes of replenishing the Strategic National Stockpile before this happened in January?
Dr. Rick Bright: (01:53:36)
Before 2017, we actually held a annual review of the Strategic National Stockpile that was chaired by Dr. Lurie of the previous ASPR. Since we’ve moved the Strategic National Stockpile from the CDC management under the ASPR management, we have not yet had an inner agency across departmental review of the supplies in that Strategic National Stockpile. We went through an annual prioritization process. There’s always been limited funding and never enough to completely top off the stockpile.
Ms. Brooks: (01:54:09)
Doc, did you know Greg Burrell?
Dr. Rick Bright: (01:54:11)
Ms. Brooks: (01:54:12)
He retired prior to all of this happening. He led the Strategic National Stockpile. Did you have conversations with Greg Burrell from 2009 until 2020 about what was in the Strategic National Stockpile?
Dr. Rick Bright: (01:54:28)
Absolutely. The Flu Risk Management Meeting met on a monthly basis and each year they reviewed and prioritized items that should be purchased by the Strategic National Stockpile. That body which I actually directed for some time, made recommendations and prioritizations through the Strategic National Stockpile. However, it was the Strategic National Stockpile’s responsibility to make those purchases.
Ms. Brooks: (01:54:52)
How about PHEMCE? Does BARDA participate in PHEMCE and would you please very, very briefly because my time is limited, explain what PHEMCE is? This is a plan that experts like yourselves participate in so I want the American people to know there have been plans. There have been plans that PHEMCE had forth a 2017, ’18 implementation plan. The White House put forth in September of 2018 a National Biodefense plan. Did you participate in that National Biodefense plan?
Dr. Rick Bright: (01:55:25)
I did. And many of us did.
Ms. Brooks: (01:55:27)
It was the first time that our country had actually put forth a National Biodefense plan. Many said it was kind of landmark and same thing with PHEMCE putting forth many plans, so I want the American people to know a lot of folks over a long period of time have been focused, but yet we did not still have enough. We didn’t have enough swabs. We didn’t have enough masks. We don’t have enough gowns for all of those incredible healthcare providers.
Ms. Brooks: (01:55:56)
I don’t want everyone to be given the impression that you raised the flag just in January, okay, when you saw it was short because you hadn’t gotten the job done prior to January and you were at those tables as were so many others. This happened over a very, very long period of time and those of us have been very disappointed to learn what was and was not in the Strategic National Stockpile.
Ms. Brooks: (01:56:21)
I thank you for your service. I thank you for your expertise, but across the board over many administrations, we did not do enough. I yield back.
Chairwoman Eshoo: (01:56:30)
Do you want to respond, Doctor?
Dr. Rick Bright: (01:56:32)
I could say that those plans have been in place and it’s disappointing they were not pulled out in January of this year and followed. They were not put on the table with a strong leader indicating, “These are our plans. Everyone fall in line and follow through with this plan.” I can also, I think is important to emphasize, the PHEMCE is the Public Health Emergency Medical Countermeasures Enterprise which is comprised of many great scientists from across our government to put these plans in place.
Dr. Rick Bright: (01:57:01)
But since 2017 we have largely disbanded, dismantled that PHEMCE organization. We have not had those interagency discussions for a number of years. The Executive Enterprise Committee and Executive Leadership Committee, we may have had one or two meetings at most in a new restructured or reorganized PHEMCE organization. The partners and colleagues across the government haven’t had those venues to even talk or coordinate for a number of years to understand what that plan looked like and how they would work together to implement that plan when the day came to need it.
Chairwoman Eshoo: (01:57:38)
Okay. The Gentlewoman’s time is expired and she’s yielded back. A pleasure to recognize the gentleman from New Mexico, Mr. Lujan, for your five minutes of questions.
Mr. Lujan: (01:57:50)
Thank you, Madam Chair. Dr. Bright, you’ve described pressure from senior Trump administration officials to promote the malaria drug chloroquine and hydroxychloroquine to treat COVID-19 despite the lack of scientific support for this treatment.
Mr. Lujan: (01:58:06)
According to your account, when Bayer offered to donate chloroquine pills to the Strategic National Stockpile on March 17, your team of experts at HHS determined that “There are safety liabilities associated with the drug,” and that “accepting the donation could lead to widespread use that is not supported by any clinical data.” Further, one of the public health experts advising you said, “No data available to support that chloroquine provides clinical benefit to the treatment or prevention of COVID-19.”
Mr. Lujan: (01:58:35)
Yes or no, Dr. Bright, are there safety liabilities associated with chloroquine?
Dr. Rick Bright: (01:58:40)
There are, yes.
Mr. Lujan: (01:58:42)
According to your whistleblower complaint at the time of the Bayer offer the consensus from BARDA and FDA scientists was that it was advisable to wait for additional clinical data before making any recommendations on the use of chloroquine to treat COVID-19. Is that correct? Yes or no.
Dr. Rick Bright: (01:58:57)
That is correct.
Mr. Lujan: (01:58:59)
Yet on March 19th, the Bayer moved forward and announced the donation of chloroquine and President Trump told the country at a White House press conference that the drug had “shown very, very encouraging early results.” Yes or no, was the president’s statement accurate?
Dr. Rick Bright: (01:59:17)
I do not think that was the best informed statement.
Mr. Lujan: (01:59:21)
In that press conference, the president also said that the drug had “been around for a long time so we know things don’t go as planned. It’s not going to kill anybody.” Yes or no, is that statement accurate?
Dr. Rick Bright: (01:59:33)
The drug had been around a long time for its use in malaria, but it had not been around for a long time for its use in COVID-19 patients. That’s a different indication, different clinical outcome, and the drug can behave differently in those people.
Mr. Lujan: (01:59:45)
Yes or no, is it true that within days of that press conference, you received urgent instructions from HHS General Counsel passed from the White House directing you to obtain the authorization necessary to make the drugs widely available to the public?
Dr. Rick Bright: (01:59:59)
Mr. Lujan: (02:00:00)
Yes or no, did the pressure from the White House and HHS General Counsel put you in a difficult position?
Dr. Rick Bright: (02:00:06)
Mr. Lujan: (02:00:08)
How did you handle this pressure while still trying to protect the American people?
Dr. Rick Bright: (02:00:14)
We had to come up with the alternate solution that our administration would accept.
Mr. Lujan: (02:00:20)
Yes or no, did the administration respect this compromise?
Dr. Rick Bright: (02:00:26)
They accepted eventually. The emergency use authorization option was accepted by Dr. Kadlec And the administration, yes.
Mr. Lujan: (02:00:33)
What I’m aware of and I would agree with, that the HHS Assistant Secretary for Health Admiral Brett Giroir on April 4 said this compromise “matters not” and that the drug had needed to go to pharmacies as well as hospitals. Dr. Bright, they’re only 24 hours in a day and every hour you and your team had to spend on chloroquine is an hour you couldn’t work on fighting this virus.
Mr. Lujan: (02:00:58)
Yes or no, did the President’s obsession with this issue distract you and others on your team from your mission of saving lives?
Dr. Rick Bright: (02:01:05)
The directive we received to prioritize and put an expanded access protocol in place within 48 hours was extremely distracting to dozens of federal scientists who were focused on the coronavirus outbreak. They had to set aside all other work to try to put together this protocol in the 48 hour directive time period.
Mr. Lujan: (02:01:25)
Yes or no, did it distract from efforts to prepare for this crisis, including securing PPE and wrapping up testing and the production of other essential supplies?
Dr. Rick Bright: (02:01:34)
It distracted from their efforts of developing other vaccines and drugs and that they were focused on at that time. It was a different group of individuals who were focused on procuring PPE.
Mr. Lujan: (02:01:43)
Dr. Bright, just yesterday the President questioned the testimony of Dr. Fauci when discussing children and schools. The president insisted that “It has very, very little impact on young people.” Dr. Bright, yes or no, do we know that the President’s statement is accurate?
Dr. Rick Bright: (02:02:04)
There is a lot we don’t yet know about this virus and it’s really concerning over the last few weeks that we’re getting more and more data out of New York and other places where they’ve had high numbers of infections of the impact of this virus in children, is very different presentation and outcome in children that we see in adults and it’s very concerning. We don’t yet have an answer for that, but we should proceed very cautiously and not have any hope or knowledge that we know everything about this virus.
Mr. Lujan: (02:02:32)
Dr. Bright, I want to end by quoting your testimony: “Without clear planning and implementation of the steps that I and other experts have outlined, 2020 will be the darkest winter in modern history, the darkest winter in modern history.” Yes or no, do you believe this administration is doing everything they can to prevent the darkest winter and what more should they be doing?
Dr. Rick Bright: (02:02:54)
I believe there’s a lot of work that we still need to do and I think we need still, I don’t think I know, we need still a comprehensive plan and everyone across the government and everyone in America needs to know what that plan is and what role they play. There are critical steps that we need to do to prepare for that fall, for that winter coming.
Dr. Rick Bright: (02:03:12)
We do not still have enough personal protective equipment to manage our healthcare workers and protect them from influenza and COVID-19. We still do not have the supply chains ramped up for the drugs and vaccines, and we still don’t have plans in place on how we distribute those drugs and vaccines, and we still do not have a comprehensive testing strategy so Americans know which tests do what, what to do with that information and we know how to find this virus and trap it and kill it. There’s a lot of work we still have to do.
Chairwoman Eshoo: (02:03:44)
Gentleman yields back. A pleasure to recognize the gentleman from Oklahoma, Mr. Mullin, for his five minutes of questions.
Mr. Mullin: (02:03:53)
Thank you, Madam Chair, and I’d be remiss not to thank you for your continued prayers for my son. That’s very kind of you and I really appreciate it. Dr. Bright, you’re here on your own time as an individual. Is that correct?
Dr. Rick Bright: (02:04:05)
Mr. Mullin: (02:04:07)
Where are you currently employed?
Dr. Rick Bright: (02:04:10)
I’m currently an employee of the Department of Health and Human Services and I’m in the middle of transition, I guess you would say, between BARDA and the NIH.
Mr. Mullin: (02:04:19)
You’ve accepted the reassigned position to NIH?
Dr. Rick Bright: (02:04:24)
Except that this position is under discussion at this point. I have not yet accepted that role.
Mr. Mullin: (02:04:29)
Are you currently being paid?
Dr. Rick Bright: (02:04:32)
I’m currently being paid.
Mr. Mullin: (02:04:33)
Where are you being paid from? Out of BARDA or from NIH?
Dr. Rick Bright: (02:04:36)
It’s not completely clear to me, but I believe is out of NIH.
Mr. Mullin: (02:04:40)
Are you getting a paycheck since you’ve been … You’ve been over there since mid April. Right? Is that correct?
Dr. Rick Bright: (02:04:47)
I’ve received one paycheck, sir, and from my understanding-
Mr. Mullin: (02:04:49)
What, from NIH?
Dr. Rick Bright: (02:04:51)
I think it was still part BARDA and part NIH. I’ve had discussions about my onboarding process at NIH.
Mr. Mullin: (02:04:58)
At BARDA you made $285,000. Is that correct?
Dr. Rick Bright: (02:05:02)
Mr. Mullin: (02:05:03)
How much are you currently making an NIH?
Dr. Rick Bright: (02:05:06)
I don’t think my salary has changed.
Mr. Mullin: (02:05:08)
It’s still the same? You’ve been over there for approximately four weeks, a month?
Dr. Rick Bright: (02:05:14)
It has been about three weeks since I was removed from my office at BARDA.
Mr. Mullin: (02:05:17)
Have you reported to NIH yet?
Dr. Rick Bright: (02:05:19)
I have checked in with the NIH director’s office and we’ve discussed the onboarding process, the fingerprinting process, and we had a call just last evening to discuss a framework of my responsibilities that they have envisioned for me at NIH.
Mr. Mullin: (02:05:34)
You haven’t actually reported to work, but you’re still getting paid. Correct?
Dr. Rick Bright: (02:05:37)
I have been on sick leave since I was pushed out of my position at BARDA.
Mr. Mullin: (02:05:42)
Sick leave for what?
Dr. Rick Bright: (02:05:43)
For very high blood pressure and I’ve been under treatment from my physician.
Mr. Mullin: (02:05:47)
Dr. Rick Bright: (02:05:48)
For hypertension, sir. Yes.
Mr. Mullin: (02:05:50)
You’re on medical leave?
Dr. Rick Bright: (02:05:51)
I’ve been on medical leave. This week however, I transitioned from that medical leave to annual leave so I can manage this.
Mr. Mullin: (02:05:59)
What does annual leave? What do you mean your-
Dr. Rick Bright: (02:06:01)
It’s vacation time.
Mr. Mullin: (02:06:02)
You’re on vacation time right now?
Dr. Rick Bright: (02:06:03)
I’m on vacation time.
Mr. Mullin: (02:06:04)
Did you inform your supervisors about you coming here today or did you need to do that?
Dr. Rick Bright: (02:06:08)
I have informed them about my leave status and I’ve had a conversation with them last night.
Mr. Mullin: (02:06:13)
You transferred from medical leave to vacation this week or does it start next week?
Dr. Rick Bright: (02:06:19)
I had a conversation with my physician about my hypertension and how we’ve been managing it over the last three weeks, because this has been very stressful to be removed suddenly without explanation from my role and position. It’s a life change for me and my physician’s been working very closely with me to manage my hypertension and stress, and the conversation I had with him last night indicated that-
Mr. Mullin: (02:06:42)
I guess I’m kind of confused there because you say you have hypertension, but yet you were able to do these interviews. You were able to make the report and you’re able to prepare for this hearing, yet you’re too sick to go into work. But you’re well enough to come here while you’re still getting paid from United States government. Is that correct?
Dr. Rick Bright: (02:07:03)
Sir, I’ve been under medical leave until just yesterday.
Mr. Mullin: (02:07:05)
I get that, but if you’ve been under medical leave too sick to do that, but yet you can prepare for a two hour hearing. I’m just having a hard time tracking that. I have a hard time understanding that, and if you have hypertension and you’re too sick to go to NIH but yet you didn’t ever experience that in BARDA. Right? You never had issues in BARDA with hypertension?
Dr. Rick Bright: (02:07:26)
I didn’t have the level of stress of being removed from my position while I was in BARDA, so this has been very stressful and my physician was very concerned and we have been working on managing that.
Mr. Mullin: (02:07:34)
I know. I get it. People handle pressure quite different, but as a director of BARDA, I would feel like you’re in quite a bit of stressful position when you’re trying to manage a pandemic, but you can’t manage that. Or you could manage that, but you can’t manage your own hypertension when it comes because you’ve got removed from the office, but yet you can still receive pay from NIH, but you can’t show up for work.
Mr. Mullin: (02:07:57)
And then all of a sudden, you can prepare for this but you can’t do that. I just have a hard time understanding it. I know you’re a bright individual and very smart, but you are an employee of the federal government and I just want to make sure you’re not doing something to deceive the American people at the same time, getting paid from the United States government. With that, I’m going to yield to Ranking Member Walden.
Mr. Walden: (02:08:20)
I thank the gentleman. Dr. Bright, your lawyer appears to have a pretty substantial binder there and I know Mr. Guthrie asked about the documents there are on the table. Are those the exhibits to your complaint to the Office of Special Counsel?
Dr. Rick Bright: (02:08:36)
I don’t know what my … I don’t know what these are.
Mr. Walden: (02:08:39)
I’ll direct it to the Counsel then since she’s answered other questions. Are those the exhibits to the complaint to the Office of Special Counsel?
Some are. Some are my work product, and some are my notes and they’re not appropriate to turn over to Congress.
Mr. Walden: (02:08:56)
Is it appropriate to turn over the documents that are referenced in the complaint, not your work product, I respect that, to this Committee and would you do that?
You asked that question initially and I said we would look at the documents to determine whether they are appropriate to turn over. Keeping my-
Mr. Walden: (02:09:14)
I’m just talking about the ones that … We have partial email chains, we have screenshots of emails. I think we should have the right to see those documents if we’re going to effectively know the full extent of this complaint and I just wish you would commit to turn those over. Dr. Bright, will you turn those over?
I think I addressed that previously.
Mr. Walden: (02:09:32)
Dr. Bright … I am asking Dr. Bright now. Are you willing to turn over-
Dr. Rick Bright: (02:09:36)
I’ve submitted my full complaint to the Office of Special Counsel and that is the process I know to follow so that is what I followed.
Mr. Walden: (02:09:41)
But you’re here as an individual citizen.
Chairwoman Eshoo: (02:09:43)
Gentleman’s time is expired.
Mr. Walden: (02:09:45)
Whistleblower, we just want to see what you’ve submitted so we can evaluate it ourselves.
Dr. Rick Bright: (02:09:49)
Sir, I don’t understand the full process other than I was supposed to submit it to the Office of Special Counsel, which I’ve done so I don’t understand the legalities of other sharing that before they’ve had their opportunity to review that and-
Mr. Walden: (02:10:02)
Well they’ve certainly been shared out into the public and press. The Washington Post has them from some source that look a lot like what’s referenced in your complaint. None of us, I don’t know where those came from, but other media outlets have certainly seen them. I just think as part of this investigation-
Chairwoman Eshoo: (02:10:17)
Gentleman’s time is expired.
Mr. Walden: (02:10:17)
… Madam Chair, you should request them.
Chairwoman Eshoo: (02:10:20)
We will seek all information that’s appropriate to be submitted to the Committee and what I circulated, or we circulated, to all members of the Sub-Committee were the emails that were public as well as the complaint. That’s what was out there.
Chairwoman Eshoo: (02:10:41)
Now, I haven’t checked daily who says what. I mean, Politico has something too. I don’t know the veracity of things like that.
Mr. Walden: (02:10:50)
But in any other investigation, we’d both be going … Say, we need to see all the documents as a Committee, so that’s all I’m after. Just the facts.
Madam Chairwoman, may I address one point?
Chairwoman Eshoo: (02:11:00)
No. I think we need to move on. The gentleman from Oregon is recognized, Mr. Schrader.
Mr. Schrader: (02:11:08)
Thank you. Thank you for being here, Dr. Bright. Really appreciate it. Tough to do, very impressive that you’re here. Could you describe the tone and reactions of Dr. Kadlec and Dr. Azar at your January 23rd meeting when you had the all agencies meeting the COVID virus. Could you describe how up to speed that they seem to be?
Dr. Rick Bright: (02:11:28)
In that meeting, sir, it was one of our first meetings that we had about how to address the outbreak and because we had practice, I came in with my list of needs in those lists for money people and viruses. My request was met with a bit of surprise and puzzlement. I remember Secretary Azar looking around the room and saying “Money? You need money? Maybe there’s money somewhere.” I mean, it was just something that I can tell hadn’t been thought of.
Mr. Schrader: (02:11:59)
This is despite the fact that we had had the outbreak in China for some time.
Dr. Rick Bright: (02:12:04)
This was January 23rd at this point.
Mr. Schrader: (02:12:07)
Could you describe January 25th, if you remember it, email exchange with Mr. Bowen on the mask situation?
Dr. Rick Bright: (02:12:17)
I don’t remember that specific, but I’m sure it was urgent. I’m sure that Mr. Bowen was sending me a notice asking if this outbreak-
Mr. Schrader: (02:12:25)
You didn’t ask him to come and talk to you, he just reached out to you?
Dr. Rick Bright: (02:12:31)
Mr. Schrader: (02:12:31)
Okay. How about an email exchange with Dr. Kerr on January 27th? Did you reach out to Dr. Kerr? He’d come and wanted to email you?
Dr. Rick Bright: (02:12:41)
Dr. Kerr reached out to me, I believe. This was because again, he is a pandemic influenza expert as well response, and he knows the vital nature of needing those viruses and he was involved in prepping our secretary for a call he had with the Vice Minister of Ma in China. We knew a high priority was for our secretary to ask for those viruses.
Dr. Rick Bright: (02:13:04)
We’ve had challenges in the past of getting viruses from China from avian influenza strains and viruses, so this was a high priority as we needed that to get started. He was alarmed when he wrote to me that morning indicating that the CDC director had reprioritized and actually indicated that we did not need, or the secretary did not need to ask China for viruses. It was alarming to us because we knew how critical it was.
Mr. Schrader: (02:13:31)
Oh, that sounds incredible of light of what has transpired since then. I guess my major point here is that we have a brave individual coming forward as a whistleblower, but he is not alone. There are many others, experts, scientists, and manufacturers that realized we were in, if I may say, deep shit, not a long time ago.
Mr. Schrader: (02:13:53)
Long before the administration and the White House began to wake up. What do you think would have happened if Mr. Navarro had not reached out to you and actually responded to you? Where would we be now if you hadn’t been able to at least get one person in the White House’s attention?
Dr. Rick Bright: (02:14:12)
It’s difficult to speculate where we were so even when Mr. Navarro reached out and strongly suggested action be taken on February 10th, and February 9th is in the email, February 10th it was conveyed to Dr. Kadlec that we needed to ramp up production of N95 masks. That order did not go out. That solicitation did not close until March 18th, so even with the pressure of Mr. Navarro, who I believe shared sense of urgency about this outbreak, that pressure alone still did not spur Dr. Kadlec and our Strategic National Stockpile into that urgently needed to action.
Mr. Schrader: (02:14:50)
Oh, that’s very disconcerting and the reason we’re here today, perhaps. Last question, if I may, and switching gears and going to the other side of the spectrum, while it’s been hard to get folks attention here in Washington, D.C. and the administration on the seriousness of this, I think most people now are convinced this is a very serious issue and I’m a little concerned we’re going too much the other way in terms of information.
Mr. Schrader: (02:15:14)
You alluded to it here on the vaccines. I think some people are under the impression there’s a vaccine going to be developed in a couple of months and everything’s going to be fine. I can go back to work. And I, we, unfortunately have to juxtapose economic issues. They have to have realistic expectations at home and you I think accurately indicated, “Well, it can take up to 10 years,” and the quickest we did I guess, was Ebola and that was I believe, five years.
Mr. Schrader: (02:15:45)
Tough question to ask, I suppose you don’t have to answer it, but I mean I don’t want America to think they can just not get back to some semblance of a new post-COVID life until a vaccine comes out because that could take years and there’s a chance the vaccine will maybe not be as effective.
Mr. Schrader: (02:16:03)
And there’s a chance of vaccine will maybe not be as effective much like our flu vaccine, so with the flu mutating year to year sometimes it’s… So I just want to make sure that you would… Ask you if you would agree that we can’t wait to open up America entirely until a vaccine is here, We have to use some of the other parameters you’ve already suggested.
Dr. Rick Bright: (02:16:20)
We have to make sure that we have some scientifically led and driven decisions on how and when it’s safe to reopen America. If it happens before we have a vaccine, if we have a vaccine faster, that’s great, but if we do need to open America up sooner, we need to make sure everyone understands the risk and understands the risk of their activities. And everyone has to play a critical part in following those activities to reduce the risk. We have to have a testing plan in place, and enough tests, to make sure that we know when people are exposed so they can be quarantined and isolated, and not continue to infect others. And we also are developing a number of therapeutics that could offer some potential benefit prophylactically or protect you almost like a vaccine before you’re infected. Those are being developed and maybe even faster than the vaccine, and if healthcare workers and frontline workers can use those therapeutics, that might offer them some protection as well until there is a vaccine.
Dr. Rick Bright: (02:17:17)
So there’s a number of steps in between now and a vaccine. I believe if we let science lead the discussion and we inform America of the risk and a clear guidance on what needs to happen and people follow that guidance, then there’s a stepwise process of getting back to work and back out of our homes.
Mr. Schrader: (02:17:35)
Great. Thank you very much.
Speaker 7: (02:17:39)
Gentleman’s time has expired, and he yields back. Pleasure to recognize the gentleman from North Carolina, Mr. Hudson, for his five minutes of questions.
Mr. Hudson: (02:17:47)
Thank you, Madam Chair. First, let me say, I believe any whistleblower should be respected and allowed to be heard as a core component of keeping our government accountable and running smoothly. But this hearing is not about a whistleblower complaint, it’s about undermining the administration during a national and global crisis, as evidence by the fact, this hearing is being held in the wrong sub-committee, and well before the office of special counsel finishes its work. To disregard the minority so spectacularly in the organization’s hearing only highlights the partisan and political nature of this hearing. I hope today will be held up in the future as a lesson of what not to do, and the respect and gravity that should be given to whistleblower complaints so they’re not abused for political expediency. More importantly though, we have vital work. We should be doing, my constituents want Congress to get back to work. So I’m glad to be here to highlight the important work that needs to be done. I heard from an ophthalmologist in my district this week about the need for relief. She says, she’ll consider this year a success if her practice group even breaks even. Long story short, we should be examining the 175 billion authorized and appropriated in a bipartisan manner for providers, and what providers still need, and recommendations for moving forward. We should also be examining why there are gaps in outcomes and access from minority communities. [inaudible 02:19:05] North Carolina in my district has a large and diverse community. And understandably the folks back home are scared because Coronavirus hits them hardest. Why are we not spending our time today, examining this crisis within a crisis more closely. I hear from providers and hospitals about issues with PPE. I know this administration has done extraordinary things to secure more PPE. I want to thank President Donald Trump for his strong leadership. Not only did his administration move quickly to coordinate a response, but his travel ban on January, 30th was a bold move, that was [inaudible 02:19:36] by critics as an overreaction at the time.
Mr. Hudson: (02:19:38)
The administration has gone to great lengths to overcoming an inadequate system they inherited. As you testified earlier, move quickly to start programs like project Airbridge to expedite more PPE coming in. The questions remain about why there is a global shortage, and what more Congress can do to support the administration’s efforts to secure sufficient PPE. This committee should be working on that question. We have multiple pieces of bipartisan legislation waiting to be considered to improve the operations of the strategic national stockpile. We should be examining why our Stockpile was allowed to dwindle under previous administrations.
Mr. Hudson: (02:20:10)
The answers to these questions and solutions to these problems are timely and critical to helping this administration combat this virus and the deadly disease that causes. I hear from constituents every day who are suffering under these state home orders. This crisis is hard for anyone, even if they weren’t suffering from substance use disorder or mental health challenges before they were confined to our homes, and this crisis has exacerbated this problem. Why are we not examining access issues to mental health providers, and the effects this crisis has had on our constituent’s mental health?
Mr. Hudson: (02:20:42)
Dr. Bright, you’re no doubt an accomplished scientist, and I appreciate the service you’ve rendered this country. You deserve to be heard, and your whistleblower complaint should be given the serious consideration any whistleblower complaint deserves. But we also deserve to have the opportunity to ask questions about serious allegations that have been made against you, and I’ll note again, this is not the time or place for that hearing. The time is after the office of special counsel has completed its work, and the place is the Oversight and Investigations Committee. But Dr. Bright, building on questions from Mr. Walden and others, a political release an article yesterday stating that your complaint left out a lot of information and context regarding agency decisions to acquire Hydroxychloroquine.
Mr. Hudson: (02:21:21)
You chose not to elevate your concerns to the Office of Inspector General, but instead kept selected screenshots that didn’t include full context. Another example, The Wall Street Journal reported on an email today that seems to show that you were in support of acquiring and using Hydroxychloroquine. Can you elaborate on what was missing from your screenshots and why you didn’t elevate your concerns at any time to the Office of Inspector General?
Dr. Rick Bright: (02:21:47)
So the early days of when I was aware of that Hydroxychloroquine, we were interested in acquiring that drug for its use in a randomized controlled clinical study. Actually, when I heard from Dr. Woodcock, that is something that we should try to investigate in a randomized controlled study, I even reached out to a company that was licensed and approved to make that drug in the United States, to see if they could donate that drug to the NIH, to conduct those clinical studies. I was aware of other efforts that were ongoing to try to acquire some of that drug for its use in randomized controlled clinical studies.
Dr. Rick Bright: (02:22:24)
As long as it was going to be used at that time for those randomized controlled clinical studies, I thought we should look into the supply chain the same way I did with Remdesivier. It was only after I learned that that supply, that was being discussed, was coming in from Pakistan and from India, from facilities that were not approved by the FDA, and the drug was not approved for use in the United States, that I became increasingly alarmed of having that drug in the United States.
Dr. Rick Bright: (02:22:51)
Second, it was when I learned that the plan was to make that drug available through an expanded access program, so people could potentially get that drug and not be under the close supervision of a healthcare provider, that caused significant concern. It’s because of that, in the cascading days afterwards, that we put in that emergency use authorization with the safety bumpers and barriers that we could feel comfortable with that that drug would only be used under close clinical supervision.
Dr. Rick Bright: (02:23:20)
But in the earlier days in that email exchange that you’re referring to was before we knew about this information, the Pakistan, before we knew it was going to be used for expanded access protocol. It was when I thought our efforts to obtain some of that drug would be used at the NIH to conduct randomized controlled clinical studies. So I was relieved that we did identify some supplies of that drug for those clinical studies.
Mr. Hudson: (02:23:49)
My time has expired here, I yield back.
Speaker 7: (02:23:51)
The gentleman yields back. Pleasure to recognize the gentleman from Massachusetts, Mr. Kennedy, for his five minutes of questions.
Mr. Kennedy: (02:24:00)
Dr. Bart, thank you very much for being here, and thank you for your service to our country. Let’s ground this hearing a little bit. As of this morning, which means these numbers have increased, there was nearly 1.4 million cases diagnosed with COVID-19 in the United States, and over 80,000 fatalities. Experts believe both of those numbers are under count because after five months of this virus being on our shores, we still have a systemic problem with regards to robust testing. Is that all right? Cases in many States across the country are still actually increasing in number, despite that lack of testing is that right? You’ve mentioned in your testimony, that, “We missed early warning signs and forgot important pages from our pandemic playbook.” Is that right?
Dr. Rick Bright: (02:24:43)
Mr. Kennedy: (02:24:44)
So you have the head of BARDA since 2016, is that right?
Dr. Rick Bright: (02:24:46)
Mr. Kennedy: (02:24:47)
Until recently. Have you experienced any pandemics prior to this one over your course of time of either there or in your prior government service?
Dr. Rick Bright: (02:24:56)
We responded to the Zika outbreak, we responded to the Ebola outbreak. They didn’t rise to the level of pandemic-
Mr. Kennedy: (02:25:01)
Of course. Thank you for the clarification. So you’re aware at the end of the Obama administration, the Obama team put together a playbook to try to guide succeeding administrations on how to handle an outbreak, correct?
Dr. Rick Bright: (02:25:14)
Mr. Kennedy: (02:25:17)
So you’re also aware that there’s a simulation done from an outgoing Obama administration in January, 2017 with an incoming administration about how to respond to a pandemic. Is that right?
Dr. Rick Bright: (02:25:27)
Mr. Kennedy: (02:25:27)
And you’re aware that the Trump administration cut the number of CDC staff located in China from 47 to 14. Is that right?
Dr. Rick Bright: (02:25:38)
I don’t know the exact number. I know it was reduced.
Mr. Kennedy: (02:25:40)
Okay. And so you referenced already the simulation called Crimson Contagion. That was a simulation done by HHS, and begun in January of 2019. Can you shed, just very briefly, a little bit of light as to what the findings of Crimson Contagion were?
Dr. Rick Bright: (02:25:57)
Significant findings. It was actually the participants were beyond HHS, covered broad areas of government and federal and state and locals. Some of the significant findings were the need for improved coordination and communication and alignment between the federal and state, local, tribal, territorial governments, and the significant need for personal protective equipment, and the shortage, and a significant need for funding in NUSELI.
Mr. Kennedy: (02:26:21)
And so that simulation was based off of a flu like virus that was initially detected in China, spread by global air travel, and resulted in the infection of 110 million Americans, lead into 7.7 million hospitalized and nearly 600,000 dead. Is that right?
Dr. Rick Bright: (02:26:36)
Mr. Kennedy: (02:26:40)
When did you first have concerns about the potential impact of COVID-19 on the United States?
Dr. Rick Bright: (02:26:45)
In early January.
Mr. Kennedy: (02:26:47)
And were you aware that your supervisor, Dr. Kadlec suggested the activation of the Defense Production Act in mid January?
Dr. Rick Bright: (02:26:57)
I wasn’t aware of him doing that, no.
Mr. Kennedy: (02:27:00)
You mentioned that you had two meetings with Secretary Azar, I’m sure you had others, but you referenced so far in your testimony meetings on January, 23rd and 27th, where you raised concerns directly to the secretary. Is that right?
Dr. Rick Bright: (02:27:12)
Yes. The Secretary was not at the second meeting, Deputy Secretary Hargan was there.
Mr. Kennedy: (02:27:16)
Thank you. You’re aware that top national security council staff, including National Security Advisor, Mr. O’Brien and his deputy Matthew Pottenger raised significant warnings that China was downplaying the impacts of this virus?
Dr. Rick Bright: (02:27:28)
I did learn of that in the meeting at the White House, yes.
Mr. Kennedy: (02:27:30)
You’re aware that we sent 17.8 tons of medical supplies to China in early February.
Dr. Rick Bright: (02:27:36)
I’ve learned of that.
Mr. Kennedy: (02:27:38)
Are you aware that the Trump administration budget proposal released in February of 2020 called for a cut to CDC by nearly $700 million?
Dr. Rick Bright: (02:27:46)
I’m not aware of that. I’ve heard of it.
Mr. Kennedy: (02:27:49)
Are you familiar with a memo written by Peter Navarro that warned of the impact of the virus?
Dr. Rick Bright: (02:27:53)
Mr. Kennedy: (02:27:53)
Are you aware that it was spread among senior administration and White House officials?
Dr. Rick Bright: (02:27:57)
Mr. Kennedy: (02:27:58)
Are you aware that it was on or about April, 2nd when the Trump administration finally activated and expanded the Defense Production Act months after being warned by you and other senior administration officials.
Dr. Rick Bright: (02:28:11)
I’ve learned of that.
Mr. Kennedy: (02:28:12)
Are you aware that that order itself did not extend to the full authority of the DPA, and left a haphazard allocation process to States and hospitals to compete against each other?
Dr. Rick Bright: (02:28:22)
I don’t know the details of that authority, sir.
Mr. Kennedy: (02:28:24)
Has a Coronavirus task force actually developed a plan for reopening the country.
Dr. Rick Bright: (02:28:30)
I’m not aware of the full plan to reopen, sir.
Mr. Kennedy: (02:28:33)
Have they developed some principles that the White House has touted as some principles or guidelines as to how to reopen the country?
Dr. Rick Bright: (02:28:39)
I have heard of some principles.
Mr. Kennedy: (02:28:41)
Are States following that plan.
Dr. Rick Bright: (02:28:43)
It doesn’t appear that there is a nationwide coordinated plan that States are following, sir.
Mr. Kennedy: (02:28:48)
So after this recitation of the actions and inactions of this administration over the course of the past six months or so, can we possibly say that this administration has prepared our country for the moment that we are in, and how we can possibly be prepared for the distribution, development, manufacturing, and distribution of a vaccine to try to adjust 330 million Americans over the course of the months ahead?
Dr. Rick Bright: (02:29:11)
I think we have a lot of work to do to be prepared sir. I think we’re fully prepared.
Mr. Kennedy: (02:29:15)
Thank you, sir. I yield back.
Speaker 7: (02:29:18)
Gentleman yields back. A pleasure to recognize the gentleman from Missouri, Mr. Long, for his five minutes of questions.
Speaker 8: (02:29:24)
I do want to [inaudible 02:29:27].
Speaker 7: (02:29:24)
Speaker 8: (02:29:30)
We can go to [inaudible 00:13:30].
Speaker 7: (02:29:31)
Should we go to-
Mr. Long: (02:29:32)
Speaker 8: (02:29:37)
Do want to pass?
Speaker 7: (02:29:38)
Do you want to pass?
Mr. Long: (02:29:38)
I thing I’m going to reserve.
Speaker 7: (02:29:39)
Okay. You can reserve. And we’ll go to the gentleman from California, Mr. Cardenas, for his five minutes of questions.
Mr. Cardenas: (02:29:56)
Thank you, Dr. Bright for being here today, and I just want to tell you that my family, my community and myself, we appreciate your 25 years of focused service, specifically when it comes to addressing pandemic outbreaks. And it’s my understanding that you spent those 25 years leading teams of scientists when it comes to drugs, diagnostics and vaccine development. And we appreciate that. When an administration or decision makers prioritize politics over science, does that tend to increase or decrease the likely results of the loss of life in the middle of a pandemic?
Dr. Rick Bright: (02:30:51)
I believe the scientists are best equipped to understand how to manage a public health crisis, and I believe scientists should lead.
Mr. Cardenas: (02:30:58)
And therefore to my question again, I’ll phrase it differently. If the scientists are not leading and the politicians are leading with the final decisions, when trying to address the issues of pandemics that are taking people’s lives, that way of handling it, does that likely increase the loss of life or is it likely to decrease the loss of life?
Dr. Rick Bright: (02:31:21)
I believe the scientist leading will actually increase the likelihood that we can survive this pandemic and move through it. So if scientists are not allowed to lead and speak up, I believe it could increase the loss of lives.
Mr. Cardenas: (02:31:34)
Thank you. How many times in your career have you personally actively said, “I need to enact my right to be a whistleblower.”
Dr. Rick Bright: (02:31:47)
I’m sorry, could you repeat that?
Mr. Cardenas: (02:31:49)
How many times in the last 25 years have you decided to enact your right to be a whistleblower?
Dr. Rick Bright: (02:31:57)
This is my first time, sir.
Mr. Cardenas: (02:32:00)
I knew that answer was simple, and I think I confused you because I made it so simple, and the reason why I want to say that is because I believe that you’ve been incredibly consistent in your willingness to dedicate yourself, your expertise and your career to saving lives. Is the loss of life on your mind? Was that on your mind when you decided that you needed to enact your right to be a whistleblower?
Dr. Rick Bright: (02:32:33)
I’ve spent my career focused on saving lives. And sir, everything I’ve done does come forward now is to raise awareness of challenges we have, things that are not getting done because I do think it will save more lives.
Mr. Cardenas: (02:32:46)
Are you aware of the fact that the lack of testing in the United States of America is affected by many pieces of the puzzle in order for people to get testing, whether it’s swabs, whether it’s N95 rated equipment for the caregivers to be able to enact safely with the public, are those all factors that have contributed to our lack of having adequate testing in America?
Dr. Rick Bright: (02:33:18)
They are a factor, sir. I don’t think anyone has thought through the entire plan completely to understand those critical components for testing. I think there’s a lot of confusion about the different types of tests. And I think our national narrative is focused on a number of tests, and it’s not about the numbers so much as the right types of tests, and that Americans know how to use them and what they do with that information. And no one has really thought through the raw material supply chain to make sure we can sustain the need to test.
Mr. Cardenas: (02:33:46)
That sounds a little confusing from somebody who actually has been working at a high level of the United States government in this space that we’re discussing at this moment. So my question is, if we’re not implementing in this pandemic to the degree or ability that the United States should or could what’s contributed the most to that, was it the lack of scientists recommending up the chain of command, or was it the people at the top of the chain of command deciding to do things differently than the scientists are strongly recommending?
Dr. Rick Bright: (02:34:24)
There’s evidence of scientists raising concerns about shortages and other actions that are important to take that were not being taken is a different level. Then my personal situation is the leadership at HHS, and then I asked for Dr. Kadlec that I believe was dismissive at the early warnings that I was raising.
Mr. Cardenas: (02:34:43)
And you said early warnings, and despite the early warnings, have there been other examples where warnings and strong recommendations were either being ignored or set aside and other actions were taken?
Dr. Rick Bright: (02:34:57)
So I believe that I’ve learned of others. The CDC has written several guidelines for reopening America and getting people out of their homes and back to work, and I’m not sure if all of those guidelines have been reviewed or being publicly considered at this point. So there’s another example of really hardworking career scientist, and their information and their hard work not probably getting the proper vetting and proper exposure to the American public.
Mr. Cardenas: (02:35:25)
One of the things I have no idea how much time I have, because the clock’s been flipping back and forth, but hopefully I have a little bit of time. We’ve heard boasting from the White House about millions of personal protective equipment, PPEs as everybody knows them as, millions have gone out to America. But fact, to date, we should have had billions gone out throughout America. Isn’t that the disparity?
Dr. Rick Bright: (02:36:02)
That’s a huge disparity, and healthcare workers are having to compromise their protection or their health and safety because they’re having to be creative and reuse a single mass for the entire week, or come up with novel sterilization practices that are not proven or tested yet. So that disparity actually is impacting our frontline workers, and those are the people whose lives we really need to preserve so they can treat others.
Mr. Cardenas: (02:36:26)
I have family members who are working in hospitals today on the front lines who have been telling me that they are wearing equipment for days at a time that they’re supposed to be disposing of several times a day, they’re having to use them over and over.
Speaker 7: (02:36:40)
Gentlemen your time has expired.
Mr. Cardenas: (02:36:42)
Thank you very much madam chairman, and if somebody could do a better job of the clock I’d appreciated it. It kept flipping back and forth. I was trying to-
Speaker 7: (02:36:48)
You’re absolutely right. It got stuck at 4:44, went to zero, and popped up to 1:21. So I’m watching too. My father was a watchmaker, clock repair man, where is daddy when we need him. A pleasure to recognize Mr. Long from Missouri for his five minutes of questions.
Mr. Long: (02:37:13)
Thank you Madam chairwoman. And Dr. Bright, you contend that your removal was because the Trump administration and HHH leadership, in particular lacked scientific integrity. Do you think the Dr. Fauci lacks scientific integrity?
Dr. Rick Bright: (02:37:29)
Sorry. I don’t think my removal has anything associated with Dr. Fauci at all. I think my removal was because of tensions and actions I took between my supervisor, Dr. Kadlec and myself.
Mr. Long: (02:37:39)
Do you know about Dr. Fauci’s testimony two days before at the Senate Health Committee?
Dr. Rick Bright: (02:37:46)
I’m aware of that testimony, yes.
Mr. Long: (02:37:48)
if HHH leadership is so hostile to scientific integrity, as you say, as you allege, how do you explain Dr. Fauci being allowed to testify forthrightly, to serve in a prominent role on the White House task force administration and direct NIAID’s extensive research efforts?
Dr. Rick Bright: (02:38:08)
Sir, I’m not sure what decision are involved in allowing Dr. Fauci to testify or not. That’s not something-
Mr. Long: (02:38:14)
Can you say that again?
Dr. Rick Bright: (02:38:17)
I’m not aware of what process or decisions are involved in allowing Dr. Fauci to testify or not.
Mr. Long: (02:38:22)
He was allowed to testify.
Dr. Rick Bright: (02:38:24)
I know he was, but I thought I understood you asked me if that was appropriate, if he was not being allowed to. Maybe you can repeat your question if I misunderstood it.
Mr. Long: (02:38:34)
What I’m saying is you’re saying HHS is hostile to scientific integrity, and if that’s the case, can you explain why Dr. Fauci was allowed to testify forthrightly in the committee? If they’re hostile to you why would you let him come out and testify without any no holds barred?
Dr. Rick Bright: (02:38:54)
I’m saying that my supervisor was not following proper scientific process that we have in place for BARDA. I’m not actually saying the administration is hostile against scientific integrity in all cases. So I’m saying in my particular situation, in my claim, my supervisor was conducting an inappropriate activity that was going around the proper scientific bedding. That is what I put [inaudible 00:23:21].
Mr. Long: (02:39:21)
Why did you not bring these concerns to Secretary Azar, or his chief, or the Inspector General? Why did you not bring any of them into the loop, say, “Hey, I have these concerns.”?
Dr. Rick Bright: (02:39:33)
I believe some of the activities were not isolated with Dr. Kadlec. I think some of his senior staff was also aware of some of the processes that were being utilized to go our traditional review process, scientific review process.
Mr. Long: (02:39:49)
But what normal protocol in any situation be that you go to the Secretary of HHS, or his chief of staff, or the Inspector General with your concerns instead of just gathering them up and deciding that one day you’re going to-
Dr. Rick Bright: (02:40:08)
I didn’t decide that, I was pushed out, sir, an involuntarily transfer without my knowledge.
Mr. Long: (02:40:14)
But you had these concerns, so why didn’t you take them to your superiors when you had the concerns, and maybe we wouldn’t be here today. It wasn’t easy for any of us to get here today.
Dr. Rick Bright: (02:40:24)
Sir, I requested an IG Investigation, as is my claim, I think it was in 2018, that they look into what I believe was inappropriate pressure, political pressure, on some of our contracting activities, and discussion about procurement integrity. And I do not think that that was ever followed through on. So-
Mr. Long: (02:40:45)
You bring your concerns to the Inspector General.
Dr. Rick Bright: (02:40:48)
I do not believe they were followed up through and submitted to the Inspector General. I raised those concerns to our HHS [crosstalk 02:40:57].
Mr. Long: (02:40:56)
You partially didn’t talk to the Inspector General, didn’t raise any concerns with the Inspector General or with Azar’s chief or with Azar. Correct?
Dr. Rick Bright: (02:41:03)
I raised those with the secretary’s Office of General Counsel. They were present in that meeting, sir.
Mr. Kennedy: (02:41:08)
I’ll take that as a no. You state in your testimony that HHH leadership was dismissive about your predictions, about the broader outbreak and the pressing need to act. However, it’s my understanding that it was Dr. Redfield at CDC who alerted the White House’s National Security Council about the risk of the virus on January the 2nd, and a high level team with in a [inaudible 02:41:31] counter-proliferation and biodefense directorate quickly began meeting to address the possibility of a pandemic. Do you consider Dr. Redfield actions here to be dismissive about the threat of the Coronavirus.
Dr. Rick Bright: (02:41:46)
Sir, our people were aware of the urgency. What was lacking was the action, and how to address the urgency. So when we were raising issues on critical supply chain of medical equipment to protect doctors and nurses, if they’re aware of the urgency of the situation and still failed to act, I think that is even more unconscionable than not being aware of the emergency and not acting
Mr. Kennedy: (02:42:10)
In your new position, I would recommend that if you have issues you might go to the head of the department who’s chief and some folks like that. I yield back.
Speaker 7: (02:42:20)
Gentleman yields back. A pleasure to yield to the gentlemen from Vermont, Mr. Welch.
Mr. Welch: (02:42:28)
Thank you very much. Your job, our job is to protect the American people, and this fierce virus can be managed if done correctly. Correct?
Dr. Rick Bright: (02:42:43)
I believe so.
Mr. Welch: (02:42:44)
And in fact, the playbook is established, it’s testing, contact tracing, and then isolation, starting with first social isolation, correct?
Dr. Rick Bright: (02:43:00)
Yes. Says non-pharmaceutical interventions and testing are critical per steps.
Mr. Welch: (02:43:05)
And in fact, this virus is across the world, in many countries that have followed that tried and true protocol have done far better than the U.S. Is that correct?
Dr. Rick Bright: (02:43:15)
We have seen differences in the response, and the outcomes of that response around the world.
Mr. Welch: (02:43:19)
I’ll go through some of those. The John Hopkins study that said that the U.S. had the best preparedness, it turned out we have the worst response, correct? With the most cases and the most deaths?
Dr. Rick Bright: (02:43:32)
We have the most cases and the most deaths.
Mr. Welch: (02:43:34)
And I did some calculations, on January, 19th, South Korea determined its first case, on January, 19th, the U.S. Determined it’s first case, correct?
Dr. Rick Bright: (02:43:46)
January, 20th was a U.S. Yes.
Mr. Welch: (02:43:49)
And if we had the same response as South Korea, by population, they had 33,000 deaths, that we would have saved 50,000 lives. In Taiwan, they had the same virus, 22,000 deaths, and again, adjusting for population, at 60,000 more deaths we’ve had here. Singapore, 82,000 more deaths, New Zealand, 65,000. The question for us here and for the American people is why? When we had the best plan, we had the worst execution. So let me go through a few things that you’ve established. One beginning in January before that first case here, FDA Chief Hahn asked the HHS if he could start contacting companies about possible shortage of protective equipment, and he got blown off by HHS. Correct?
Dr. Rick Bright: (02:44:45)
That I understand.
Mr. Welch: (02:44:46)
And on January, 18th, before our first case, you push Dr. Kadlec to convene high level meetings about the virus, but that was initially rejected. Correct?
Dr. Rick Bright: (02:44:55)
Mr. Welch: (02:44:56)
And then on January, 23rd, you demanded urgent access to funding personnel and clinical specimens to develop life saving medicines, but you were told that the spread was under control, correct?
Dr. Rick Bright: (02:45:09)
There wasn’t a shared sense of urgency.
Mr. Welch: (02:45:11)
On January, 25th, you warned others in the administration there’s a critical need for procuring surgical mask. That was ignored. Correct?
Dr. Rick Bright: (02:45:19)
Mr. Welch: (02:45:20)
And January, 27th, you participated in the daily COVID-19 meeting where you expressed frustration with the slow pace of accessing virus samples and clinical specimens from China, you were reprimanded and you’re no longer part of those meetings. Is that right?
Dr. Rick Bright: (02:45:37)
Mr. Welch: (02:45:38)
So you and others actually, we’re seeing the horizon what was coming to our shores even before our first case was confirmed. Correct?
Dr. Rick Bright: (02:45:48)
We had spent many years preparing for pandemic, sir, and we understood the threat, and we understood what we needed to do.
Mr. Welch: (02:45:56)
Exactly. It’s knowable and it’s manageable. It’s fierce and fearsome, but what you have to do is established. Is that more or less correct?
Dr. Rick Bright: (02:46:05)
Mr. Welch: (02:46:06)
We just didn’t do it. February, 25th, president Trump gave an assurance that the stock market is starting to look very good, and the Coronavirus was very much under control. Were you aware of any medically involved people who had the view that the virus at that time was very much under control?
Dr. Rick Bright: (02:46:27)
No, sir. I don’t think the virus was under control. I don’t think many people would agree with me in the scientific realm.
Mr. Welch: (02:46:33)
Now in those countries I mentioned, that includes Germany, Taiwan, New Zealand, South Korea, Singapore, the leaders of those countries accepted that there was a role only the nation could play and the provinces would have to depend on them for that. And I’m going to go through some of those things. One, establishing a testing protocol. Was that done here?
Dr. Rick Bright: (02:47:03)
Mr. Welch: (02:47:04)
Two, acquiring, and allocating, and distributing the personal protective equipment to where it was needed when it was needed. Was that done here?
Dr. Rick Bright: (02:47:16)
Mr. Welch: (02:47:16)
In fact, we had governors and hospitals competing with each other to try to get desperately needed equipment. Isn’t that correct?
Dr. Rick Bright: (02:47:23)
There was a lot of confusion and a lot of competition, and bad decisions made to acquire poor quality product.
Mr. Welch: (02:47:29)
In any of those other countries that I just mentioned, are you aware of the leader of that country at a press conference, making recommendations on what kind of medication people should use?
Dr. Rick Bright: (02:47:42)
I don’t know the details of what happened to those countries, sir. So I don’t know.
Mr. Welch: (02:47:47)
We had governors here, Republicans and Democrats, Republicans like Hogan, like Phil Scott from Vermont, who have done a tremendous job, but no matter how good they do their job, can they protect their people without the aggressive intervention of the Federal Government playing its role?
Dr. Rick Bright: (02:48:09)
I think the Federal Government plays a critical role in coordinating, and aligning, and making an equitable distribution, those critical supplies. I believe that’s what we’d practice and exercised in the past, that there would be a critical role for the federal lead in coordination with the state, local, and tribal, and territorial levels.
Mr. Welch: (02:48:26)
Thank you Dr. Bright, I yield back.
Speaker 7: (02:48:27)
Gentleman yields back. A pleasure to recognize the gentleman from Georgia, Mr. Carter, do you wish to question or do you want to pass? You reserve. The gentleman from California, Mr. Ruiz is recognized for five minutes of questions. Dr. Ruiz.
Mr. Ruiz: (02:48:48)
Thank you. Thank you Dr. Bright, thank you for your testimony here, and thank you for your service to our country. My heart aches for the family and friends of the over 80,000 in America who have died of COVID-19 in such a short period of time. In fact, my heartaches for those closer to me, the Riverside County has reported 228 deaths. As a doctor I appreciate your written testimony that states that science, not politics or cronyism, must lead the way to combat this deadly virus. There has been a lot of hype about cures for COVID that have been shown to be ineffective and even dangerous. We are now seeing the very real dangers and consequences of not making decisions based on science. Hydroxychloroquine, which Fox news commentators, and then the White House repeatedly touted and actually encouraged people to use is exhibit A on this list. But there is one drug that appears to provide some therapeutic benefit, Remdesivier. Two weeks ago, Dr. Fauci announced that Remdesivier showed a clearcut significant positive effect in diminishing the time to recovery. My understanding is that in January and early February, you launched a.
Mr. Ruiz: (02:50:03)
… my understanding is that in January and early February you launched a comprehensive review to assess which existing drugs may prove a therapeutic benefit and you quickly identified remdesivir as the most likely drug to be effective against COVID-19. Can you describe how you came to that conclusion? Who you told within HHS and what the response was?
Dr. Rick Bright: (02:50:18)
Yes sir, that conclusion came about by a tactical review from a number of scientists within HHS, and the CDC, FDA, NIH, and BARDA. But it was also aligned with a scientific assessment from WHO and a number of global experts who rapidly looked at every potential drug, and ranked remdesivir as the drug that had the most potential for benefit-
Mr. Ruiz: (02:50:40)
Who did you tell and what was the response?
Dr. Rick Bright: (02:50:42)
We shared that information with Dr. Kadlec, we shared that information within HHS leadership as well. We had discussions about the actions that could be considered for acquiring the limited supply of remdesivir-
Mr. Ruiz: (02:50:55)
So what was the response?
Dr. Rick Bright: (02:50:57)
We had discussions about how to ramp up production of more remdesivir, in case the randomized controlled clinical study that the NIH was conducting came through with positive-
Mr. Ruiz: (02:51:08)
[crosstalk 02:51:08] And so you had a discussion and what was the response? Did anything happen?
Dr. Rick Bright: (02:51:11)
No decision was made-
Mr. Ruiz: (02:51:13)
Dr. Rick Bright: (02:51:13)
… at that time.
Mr. Ruiz: (02:51:14)
My understanding is that Peter Navarro, The White House Trade Advisor, reached out to you on February 7th to seek your counsel. You told him about your top three concerns, the shortage of N95 masks, the need for a, quote unquote, Manhattan Project to develop vaccines, and securing adequate supplies of remdesivir. Can you tell us if Mr. Navarro agreed with you and what steps you, and he, took?
Dr. Rick Bright: (02:51:36)
Mr. Navarro did agree with me on the remdesivir, the N95 masks, and the vaccine Manhattan Project. And he drafted a memo on February 9th-
Mr. Ruiz: (02:51:45)
Dr. Rick Bright: (02:51:46)
… to The White House Chief of Staff and Mick Mulvaney to share with The White House task force.
Mr. Ruiz: (02:51:52)
The directive for HHS to act on remdesivir occurred on February 10th. What happened next and did the department promptly procure the needed supplies of remdesivir?
Dr. Rick Bright: (02:52:02)
We did not proceed with procuring any supplies of remdesivir.
Mr. Ruiz: (02:52:04)
Okay. You were removed from your position on April 22nd. By the time you were removed had the department settled on a plan and procured the remdesivir?
Dr. Rick Bright: (02:52:15)
Mr. Ruiz: (02:52:16)
Dr. Rick Bright: (02:52:16)
… they were still discussing slide presentations about potential donations of remdesivir at that time.
Mr. Ruiz: (02:52:22)
So what you are describing is a gang that couldn’t shoot straight and yet we are in the middle of a pandemic. There is one drug the experts say could make a difference, and in fact has been shown to make a difference, yet the department can’t seem to figure out how to acquire it. A week ago The Washington Post published on article on the rollout of remdesivir, describing it as, quote, “Confusing, unfair, and marred with incomplete medical information,” unquote. Doctors described how they can’t obtain the drug and don’t understand the process for accessing it. Dr. Benjamin Linas from the Boston Medical Center said, quote, “There’s no transparency. The process is just a staggering injustice.”
Mr. Ruiz: (02:52:58)
Dr. Bright you were warning about this over three months ago. If the department had listened to you, and the other experts at your agency, could this fiasco have been avoided?
Dr. Rick Bright: (02:53:06)
We would have had a plan sir. We should have had a plan for that drug and any other drug in limited supply.
Mr. Ruiz: (02:53:12)
So it didn’t have to be this way?
Dr. Rick Bright: (02:53:14)
Mr. Ruiz: (02:53:14)
Here’s what I don’t understand, you were right about the dangers of hydroxychloroquine, you were right about the benefits of remdesivir, you were right about N95 masks and other critical issues, yet you got fired from your job, while officials who botched the response, and ignored your warnings, stay in theirs. Not only is this unfair to you it’s completely dangerous to the American people. I yield back my time.
Chairwoman Eshoo: (02:53:48)
The gentleman yields back. I’d like to clarify something just very quickly, relative to your leave Dr. Bright. Are you on accrued vacation time now?
Dr. Rick Bright: (02:54:01)
Chairwoman Eshoo: (02:54:02)
Are you on accrued vacation time?
Dr. Rick Bright: (02:54:04)
I’m on approved vacation leave today. Yes, I talked to that-
Chairwoman Eshoo: (02:54:08)
Would you be willing to share the exhibits, once you remove personally identifiable information?
Dr. Rick Bright: (02:54:21)
I’m sorry, I’m having trouble understanding you through the mask. I’m sorry-
Chairwoman Eshoo: (02:54:21)
Oh I’m sorry.
Dr. Rick Bright: (02:54:21)
Chairwoman Eshoo: (02:54:22)
I’m getting so comfortable wearing a mask I forgot I had it on. Would you be willing to share the other exhibits once you remove personally identifiable information?
Dr. Rick Bright: (02:54:33)
Chairwoman Eshoo: (02:54:34)
Thank you. All right-
Speaker 11: (02:54:36)
Chairwoman we will make them available after the hearing today, when we’ve had a chance to review it.
Chairwoman Eshoo: (02:54:41)
Speaker 12: (02:54:42)
Madam Chair, will they be made available to the minority as well as the majority?
Speaker 11: (02:54:45)
Chairwoman Eshoo: (02:54:45)
They’ll be made available to the entire committee.
Speaker 12: (02:54:48)
Perfect. Thank you-
Speaker 11: (02:54:49)
[crosstalk 02:54:49] We’ve never shared anything with the majority that hasn’t been shared.
Chairwoman Eshoo: (02:54:51)
Speaker 11: (02:54:51)
This is a bipartisan [crosstalk 02:54:53] issue.
Speaker 12: (02:54:54)
Speaker 13: (02:54:55)
Madam Chair, if there’s anything in those exhibits that hasn’t already been released to the public, that might be degrading, will that be kept in confidence amongst committee members?
Chairwoman Eshoo: (02:55:02)
I’m sorry, I didn’t hear you.
Speaker 13: (02:55:05)
Not knowing what’s in the emails I’m wondering if there’s any information in there that might be deemed to be degrading, would that be kept in confidence amongst the committee members, as opposed to being released to the public?
Chairwoman Eshoo: (02:55:19)
Hm? We’ll follow the rules. How about that?
Speaker 13: (02:55:23)
And that is in compliance with Rule 11. Thank you.
Chairwoman Eshoo: (02:55:25)
Mm-hmm (affirmative), thank you sir. Okay, I now have the pleasure of recognizing the only pharmacist in the United States Congress, Mr. Carter.
Buddy Carter: (02:55:36)
Thank you Madam Chair. Thank you Dr. Bright for being here and thank you for your service to our country. And before I begin let me extend my condolences to those 80,000 plus who have lost their lives, and to their families, as a result of this pandemic. And a shout out to all of our healthcare professionals, as well as our other essential workers who have put their own health in danger in order to provide services to our citizens.
Buddy Carter: (02:56:03)
Dr. Bright it’s my understanding that in 2017 BARDA funded a project with Applied Research Associates of Albuquerque to develop respirators that could be sanitized and reused during public health emergencies, such as what we’re going through today. However, according to recent reports by The Washington Post none of these next generation respirators are available for us today. Why is that? Do you have any idea?
Dr. Rick Bright: (02:56:31)
I’m not aware. So are you talking about the ventilators, sir, that we developed or-
Buddy Carter: (02:56:35)
That’s correct. I’m talking about those that were developed … The respirators that were developed and could be sanitized, and reused, during public health emergencies. It’s my understanding that that was contracted and that that project was scrapped.
Dr. Rick Bright: (02:56:50)
Sorry, I’m not familiar with that project, re-sanitize the respirators.
Buddy Carter: (02:56:54)
You’re not familiar with that project and you didn’t sign off on that project, to your knowledge?
Dr. Rick Bright: (02:56:58)
I’m not familiar with that project, re-sanitize respirators-
Buddy Carter: (02:57:00)
Okay, fair enough. If you’re not familiar with it.
Buddy Carter: (02:57:02)
Let me ask you this, we’ve had a lot of discussion today about hydroxychloroquine, about chloroquine, and I’m a little bit confused here because it’s my understanding that this is what BARDA … Do you want to clarify something here?
Dr. Rick Bright: (02:57:15)
Buddy Carter: (02:57:16)
I see you … Okay. It’s my understanding that that’s what the role of BARDA, the mission of BARDA, is to look at things like this. In fact, when we in Congress appropriate, allocate money to go toward this, that you were supposed to be looking … That BARDA is supposed to be looking at things that could possibly have merit, such as hydroxychloroquine and chloroquine. And early on it appeared that you embraced that and early on it seemed that you were in favor of looking at that. I’m just wondering, because of this pandemic, because we didn’t have any vaccine or any kind of agreed upon treatment, we should be testing and we should … That’s what we are appropriating that money for. Would you agree with that? That that’s what we are trying to do, is to look at what could possibly work and work with public companies to try to encourage them to come up with those kind of solutions?
Dr. Rick Bright: (02:58:12)
Absolutely. We should look at all options and make sure we evaluate the potential risk, and safety, and benefit of those in the context of a randomized controlled clinical study. In the context of an emergency we should move swiftly and get that clinical data as urgently, and quickly, as possible. But we should not proceed recklessly without that clinical data on its potential adverse events in an emergency especially-
Buddy Carter: (02:58:34)
So you’re referring … When you say, “We should not proceed adversely,” you’re referring to hydroxychloroquine and the chloroquine?
Dr. Rick Bright: (02:58:43)
We were promoting the standing up of randomized controlled clinical studies at the NIH with hydroxychloroquine. I worked with a company to even ask if they would donate drug to the NIH to be used in the context of a randomized controlled clinical study.
Buddy Carter: (02:59:02)
Dr. Rick Bright: (02:59:03)
Yes, so that is what BARDA would do-
Buddy Carter: (02:59:05)
And in fact, I think you worked with the FDA to get an emergency use for hydroxychloroquine, is that correct? And it was actually approved by the FDA?
Dr. Rick Bright: (02:59:15)
That was in the context of the directive we received from the Secretary’s Office to stand up an expanded access protocol. Our clinicians worked-
Buddy Carter: (02:59:22)
So are you saying you-
Dr. Rick Bright: (02:59:23)
… with the FDA to-
Buddy Carter: (02:59:24)
… were instructed to do that and you did it against your will or …
Dr. Rick Bright: (02:59:27)
Sir we were instructed to put in place an expanded access protocol, so in the context that the Americans would be able to access this drug and not be under the close supervision of a physician. The scientists at FDA, NIH, CDC, and BARDA worked together to change that directive to the context of emergency use authorization, with guardrails in there so patients would be under the close supervision of a physician.
Buddy Carter: (02:59:53)
Understood. Let me ask you this, initially you appeared to be encouraged by what could possibly be a result of the effect of hydroxychloroquine. When did that change? When did you sour, if you will, on the use of hydroxychloroquine?
Dr. Rick Bright: (03:00:13)
I believe that we’ve seen many drugs that could have benefit, and some of these are really interesting things we’d never heard of, some we have, it had to be tested-
Buddy Carter: (03:00:20)
[crosstalk 03:00:20] I understand that, but my question was when did you sour on it?
Dr. Rick Bright: (03:00:23)
When it was determined that this drug should be made available to Americans outside the context of a close physician supervision. So I supported conducted a randomized controlled clinical study for hydroxychloroquine at the NIH. When I learned that there was a directive to make it more broadly available, not under close supervision of a physician, I was concerned-
Buddy Carter: (03:00:44)
When was that? When did that directive go out?
Dr. Rick Bright: (03:00:47)
That was March 23rd.
Buddy Carter: (03:00:50)
March … And that’s the time that you decided, “No, this is not what we should do and we should not be looking at hydroxychloroquine at all”?
Dr. Rick Bright: (03:00:57)
I didn’t think that was the proper safe way to evaluate that drug, in the context of this outbreak. I believe that it should only be done under close supervision of a physician. When we put the EUA in place, that locked this drug down to only be used in patients under close supervision of a physician, we were satisfied we had those guardrails in place. When an email string followed a week later saying, “Ignore the EUA, push this drug into the retail pharmacies in New York and New Jersey,” that’s when I became more concerned.
Buddy Carter: (03:01:33)
And who put that directive out-
Chairwoman Eshoo: (03:01:34)
The gentleman’s time has expired.
Buddy Carter: (03:01:36)
Who put that directive out?
Chairwoman Eshoo: (03:01:37)
The gentleman’s time has expired. You can answer Dr. Bright.
Dr. Rick Bright: (03:01:42)
Which directive sir?
Buddy Carter: (03:01:43)
That it should be put out to the public without physicians approving it.
Dr. Rick Bright: (03:01:48)
That directive was in an email string that had a number of individuals on it and I believe it first came from Dr. Giroir, the Assistant Secretary of Health, it indicated The White House was asking for that drug to be more broadly available-
Buddy Carter: (03:02:00)
[crosstalk 03:02:00] So was it because the president was encouraged by the use of this drug that you became discouraged by it?
Dr. Rick Bright: (03:02:06)
It had nothing to do with politics sir. I wanted to make sure that Americans were aware of the risk of this drug and it was only available under very safe-
Buddy Carter: (03:02:14)
[crosstalk 03:02:14] But it is a drug that is indicated and has been used successfully in the past-
Chairwoman Eshoo: (03:02:18)
The gentleman’s time has exceeded by almost-
Dr. Rick Bright: (03:02:18)
Chairwoman Eshoo: (03:02:19)
… one and a half minutes. You can finish your answer Dr. Bright and then we’re going to move to the next member.
Dr. Rick Bright: (03:02:25)
The drug had been safely for malaria for a number of years. We didn’t have a database-
Buddy Carter: (03:02:30)
But it’s being used in the same dosage as it was-
Chairwoman Eshoo: (03:02:32)
The gentleman’s time-
Buddy Carter: (03:02:32)
… used for malaria.
Chairwoman Eshoo: (03:02:33)
Please, please. I know that I’m overly generous with both sides of the aisle, but I think that we need to move on. I mean two minutes of extra time is two minutes of extra time and I’m not going to ask that it be shared over here. The gentleman’s time has expired. It’s a pleasure to recognize the gentlewoman from Michigan, Ms. Dingell, for her five minutes of questions.
Debbie Dingell: (03:02:57)
Thank you Madam Chair. Thank you to both, you and ranking member Dr. Burgess. And Dr. Bright for your being here today, you’re doing a great service.
Debbie Dingell: (03:03:06)
I think we’re here today because COVID is real. I share the sentiments of many of my Republican colleagues, that have expressed the thanks to the frontline workers, asking questions. I want to look at the last few months. COVID’s really real in my state. Michigan’s the 10th largest state in the country and we were third in the number of cases for weeks. We were third and remained there, until this week, in the number of deaths. We managed to move to fourth place two days ago, which is not a number anybody wants to be.
Debbie Dingell: (03:03:42)
My family alone, a cousin woke up with 104 temperature and was dead that afternoon. There are people still dying every single day. I have lost someone I’ve known Sunday, Monday a brother, a brother-like friend to me, Tuesday and Wednesday. And then we hear the scientific experts, useful, but Dr. Fauci, other scientists around the country saying to us, if we don’t listen to them we could begin to see … We’re going to see a return. You call it a dark winter. I call it I don’t want to see any more spikes. I don’t want to see anybody else die. I am losing too many friends that I know and people across the country are.
Debbie Dingell: (03:04:33)
So I want to focus on an area that’s not your area of expertise, but it’s mine. Car safety. We expect our cars to be safe and we expect car manufacturers to be responsible in making sure defective cars aren’t sold. And if they fail in that responsibility we hold them accountable. If an engineer in a car company realized a model had serious defects, and warned her management about that, we would all think she had done her job responsibly. And if management ignored her, and our committee found out, I will bet you right now we would be having hearings. And if Americans died driving those cars the companies would be sued and they would be charged with criminal negligence.
Debbie Dingell: (03:05:22)
In fact, several years ago, before my time, this committee investigated airbag defects and vehicle safety. At the time the subcommittee’s ranking member, Dr. Burgess, said, “There is no room for going slow when it comes to safety and certainly deception can not, and will not, be tolerated.” Dr. Burgess was right then and our car makers have to be accountable. But what I’m concerned about is that we aren’t applying these same standards to coronavirus. And I want to learn from what’s happened so we keep that dark winter you’re talking about from happening.
Debbie Dingell: (03:06:03)
It seems to Dr. Bright you acted the same way the auto engineer I mentioned should act. You identified serious problems and then suggested fixes when it came to diagnostics, N95 masks, other equipment and medicines. Is that right?
Dr. Rick Bright: (03:06:20)
That’s true. And congresswoman we still have those challenges.
Debbie Dingell: (03:06:24)
Do you believe if your suggestions were implemented lives would have been saved and the severity of the pandemic might have been lessened?
Dr. Rick Bright: (03:06:33)
I believe lives would have been saved if we had proper medical protective equipment for our healthcare workers, yes.
Debbie Dingell: (03:06:41)
So people died because you weren’t listened to?
Dr. Rick Bright: (03:06:42)
People died because they didn’t have appropriate protective equipment to save their lives and protect them from getting infected.
Debbie Dingell: (03:06:49)
The problems aren’t limited to just ignoring your advice. The American people are confused, given mixed signals, and quite frankly some days too simply deceived. Let me give you an example, there was a visit to the CDC on March 6th. And at that visit the administration said, “Anybody who wants a test will get a test.” Was that true then?
Dr. Rick Bright: (03:07:14)
There still are not enough tests.
Debbie Dingell: (03:07:17)
So even this week, as we’re being told, “Anybody who wants a test can have a test,” is that true in the United States of America?
Dr. Rick Bright: (03:07:26)
Debbie Dingell: (03:07:28)
In fact, all the experts say we are doing is only a small fraction of the tests we need to do to reopen safely. I’m running out of time, so let me ask you about vaccines. We keep being told by The White House that we’ve heard very soon, quick numbers, a matter of months for that vaccine to be developed. This is your area of expertise. You are a top immunologist in the world. Was there any scientific basis to suggest, in March, that we’ll have a vaccine in the next few months?
Dr. Rick Bright: (03:08:01)
There’s a lot of optimism. There’s a lot of hope, but that doesn’t make a vaccine. There’s a lot of work that needs to be done to make a vaccine-
Debbie Dingell: (03:08:08)
Will we be able to vaccinate people in the next few months?
Dr. Rick Bright: (03:08:12)
It’s very unlikely.
Debbie Dingell: (03:08:14)
Thank you Doctor.
Chairwoman Eshoo: (03:08:18)
Gentlewoman yields back. It’s my understanding the minority is assay, reserving, so with pleasure I recognize the gentlewoman from New Hampshire, Ms. Kuster.
Annie Kuster: (03:08:29)
Thank you Madam Chair. [inaudible 03:08:32] with us today. I want to thank you for your courage for helping us to do our job to protect the American people.
Annie Kuster: (03:08:40)
I want to start today by restating what I said at a hearing February 26th with Secretary Azar, right here, right at that table. The key to a public health crisis is trust and credibility. On that day I urged Secretary Azar to provide clear credible updates from this administration to the American public. However, your whistleblower complaint and testimony today unveil unheeded warnings about personal protective equipment, testing supplies, and vaccine supplies. Over the past several months I have held countless conversations with doctors, and nurses, and hospitals, and community health centers, and our Republican governor, and every other person in New Hampshire trying to get access to personal protective equipment to protect our frontline workers, to protect our grocery clerks. We’ve been trying to get testing supplies. And we were told that because we were not a hotspot we were on our own. We literally had to turn to entrepreneurs, thank God they exist, and thank you to them for flying to China and bringing us the equipment we need that should, and could have been distributed had we planned ahead.
Annie Kuster: (03:09:58)
These conversations have informed my roadmap to recovery on how to safely reopen our economy. And key to those efforts is adequate testing, contact tracing, supported isolation, and vaccine development, your specialty. So I want to focus on your role, as director of BARDA, in vaccine development and distribution.
Annie Kuster: (03:10:21)
On page 28 and 29 of your addendum to your complaint it states that BARDA estimated that between 650 million, and 850 million, needles and syringes would be needed for a vaccine to be administered here in the United States, for everyone to be safe. Your team at BARDA also estimates it could take up to two years to manufacture these vaccine delivery supplies. To your knowledge Dr. Bright, at this time, has the administration placed any orders to prepare for how a vaccine will be delivered when one becomes available to every American?
Dr. Rick Bright: (03:11:06)
I learned that they placed an order … The first order for needles and syringes on May 1st and another order was placed today.
Annie Kuster: (03:11:14)
And were the amounts adequate?
Dr. Rick Bright: (03:11:16)
I believe that it’s for 320 million needles and syringes.
Annie Kuster: (03:11:21)
And could you please describe the situation if every American does not have access to the vaccine due to a supply shortage?
Dr. Rick Bright: (03:11:31)
That situation would be catastrophic, honestly. The decisions have not been made yet who to vaccinate first, how to identify those individuals, and how to stretch those limited supplies appropriately. And it’s important-
Annie Kuster: (03:11:44)
Let me ask you a simple question-
Dr. Rick Bright: (03:11:44)
… to remember that it’s not just the United States, so there’s limited supplies. When I said it would take two to two and a half years to make those that was assuming there wouldn’t be global competition for those limited supplies. Those are not made in the United States, some of them, so it’s-
Annie Kuster: (03:11:58)
[crosstalk 03:11:58] Does a lack of preparation, and vaccine, and supplies make us more vulnerable to future spikes in COVID-19?
Dr. Rick Bright: (03:12:04)
Annie Kuster: (03:12:05)
And do we have enough supplies to distribute both the flu vaccine next winter, as well as the coronavirus vaccine?
Dr. Rick Bright: (03:12:12)
It’s going to be extremely challenging.
Annie Kuster: (03:12:15)
Do we know, yet, of the interactions of the full fledged flu season in combination with COVID-19?
Dr. Rick Bright: (03:12:21)
We haven’t seen that yet. Luckily in this spring flu was winding down when COVID-19 was emerging.
Annie Kuster: (03:12:27)
And without adequate supplies to vaccinate all Americans for COVID-19 does this slow down the goal of fully reopening our economy and getting back to the normal that every American wants?
Dr. Rick Bright: (03:12:41)
It certainly brings caution and a significant consideration that must be taken into consideration before reopening. We need to make sure that not only the guidelines for reopening are clear to each individual, and each individual follows those guidelines, otherwise it puts us all at risk.
Annie Kuster: (03:12:58)
So can I ask you a question, and I know you’re not political and certainly we are all trying not to be political … In fact, I’m very proud in our state that our delegation and our governor are working so well together. But Dr. Bright does this virus give a damn whether a patient is Republican or Democrat?
Dr. Rick Bright: (03:13:21)
No it doesn’t. This virus just wants to infect people, and unfortunately a lot of those people get really sick and many of them die.
Annie Kuster: (03:13:27)
Thank you. I’m so grateful, not just for your knowledge, for your humility and for your service to our country. Thank you and I yield back.
Dr. Rick Bright: (03:13:35)
Chairwoman Eshoo: (03:13:35)
The gentlewoman yields back a minority reserves? A pleasure to call on the gentlewoman from Illinois, Ms. Kelly, for her five minutes of question.
Robin Kelly: (03:13:46)
Thank you so much and thank you for being here, and your patience.
Robin Kelly: (03:13:51)
As chair of the Congressional Black Caucus Health Braintrust I’m deeply concerned by the disparities that this pandemic has brought to light, due to our nation’s history of discriminatory policy, leading to differences in health outcomes for people of color. Time and time again when resources are scarce some communities are forced to do without the goods, and services, they need. You identify multiple situations in which the United States would face a shortage of supplies needed to respond to COVID-19, from masks to swabs and other testing materials. And potentially the supplies to deliver a vaccine, when one is ready. During COVID-19 we’ve seen some states forced to pay significantly more because they’re on their own to procure those medical supplies. Not every state or locality can afford to do this. Knowing what we do know about how scarce resources are procured and distributed what impact will shortages have on lower income communities?
Dr. Rick Bright: (03:14:49)
The shortages will impact across all of America, and unfortunately it actually increases the concern in communities that aren’t part of the mainstream and might have lower socioeconomic status, so I think it has a significant chance of increasing the risk in those communities.
Robin Kelly: (03:15:08)
How have you seen this impact the devastation of the disease in these communities?
Dr. Rick Bright: (03:15:14)
These communities have … The data is showing that they’re hit very hard and we don’t actually have the information yet to understand fully what’s behind that or why. Health status, or access to healthcare, or other immunization status, or healthcare status. So we’re still learning a lot about that. However, it’s really important to think about, when we have diagnostic tests and things available, that they are available to everyone. And many of these tests that we’re developing today are very expensive or are in very rare supply, so we need to make sure that we’re developing and making available tests that are, not just rapid and accurate, but low cost and so everyone who needs a test can access those tests.
Robin Kelly: (03:15:56)
Did you attempt to urge HHS leadership or the administration to consider preparedness, outreach, or targeted resources for these populations or are you aware of any HHS/administration actions to target resources, outreach, to these vulnerable groups?
Dr. Rick Bright: (03:16:15)
I’ve had some conversation … There have been some conversations, I should say, focusing on groups that are harder to reach and in a different socioeconomic status. I’m not sure that there is a solidified plan in place just yet, to make sure that it’s more than a conversation.
Robin Kelly: (03:16:31)
Mm-hmm (affirmative). It doesn’t sound like there is. In your testimony you recommend establishing a national standard and coordinate equitable distribution of equipment, and supplies. Will this help to ensure that every community can access the equipment and supplies they need?
Dr. Rick Bright: (03:16:45)
That is what’s needed.
Robin Kelly: (03:16:47)
Will more equitable distribution of equipment and supplies help to address the inequities we are seeing in the impact of COVID-19 on communities of color?
Dr. Rick Bright: (03:16:56)
Robin Kelly: (03:16:57)
Do you feel in the last bill that we passed we made sure that there was passed in the bill better data, as far as race and not just who died but who was hospitalized, and so on and so forth because we’re hoping that better data will inform policy? How do you feel like that will help?
Dr. Rick Bright: (03:17:18)
I think that’s very important. I think it’s a wise move.
Robin Kelly: (03:17:21)
Okay, good. And we’re supposed to get a report 21 days from when the president signed the bill, then 30 days, and then 180 days.
Dr. Rick Bright: (03:17:31)
I’m not aware of those guidelines, it comes in a different area, but I think reporting and oversight of that is important.
Robin Kelly: (03:17:38)
Then lastly, you’ve been sitting in that seat for awhile but is there anything that we haven’t asked you that you want to say?
Dr. Rick Bright: (03:17:48)
That’s a really important question and I’ve thought a lot about that. I want, I think, to highlight the things I talked about in my opening statement. Is we need transparency in the science and America needs to know the truth. This is a devastating pandemic and not just to health but also society, our economy, our jobs, our livelihood. And if we do not take seriously the call for action to put specific things in place, a coordinated national plan for testing, and response, and equitable distribution of these limited supplies, and ramp up and prepare for what will be a very devastating fall if we don’t have the right supplies in place, and raw materials, then this virus will overcome us in significant ways still. So we have limited time. My message is we have limited time. We have the ability to do it. We have the greatest scientific minds in our country to do it. We need to listen to them, put the plan in place, and everyone get busy stopping this virus.
Robin Kelly: (03:18:47)
Right. I know it’s very … I’ve had three people in my family with it and I lost my uncle maybe like 10 days ago now from the virus, so it does definitely touch everybody. Thank you and thank you for your patience.
Dr. Rick Bright: (03:19:01)
Chairwoman Eshoo: (03:19:04)
The gentlewoman yields back a minority reserve? All right, then we’ll go to the gentlewoman from California, Ms. Barragán, for her five minutes of questions.
Nanette Barragán: (03:19:15)
Thank you Madam Chairwoman. Dr. Bright one striking aspect of your account in your complaint to the Office of Special Counsel is the contrast between the public updates by the president and Secretary Azar on COVID-19 versus the analysis you, and other experts, were providing behind the scenes. I’d like to explore this disconnect and ultimately that the administration shared information that I believe was misleading. We need to do this to better understand what happened and how we can ensure that the administration provides the public accurate, and constructive, information going forward.
Nanette Barragán: (03:19:52)
Dr. Bright you had learned of the COVID-19 threat by early January, is that correct?
Dr. Rick Bright: (03:19:58)
Nanette Barragán: (03:19:59)
And according to your complaint it was clear to you, almost immediately, that the, quote, “Virus was highly contagious, spreading rapidly, and could have a high mortality rate,” end quote. Is that correct?
Dr. Rick Bright: (03:20:10)
We were learning that from the outbreak in China at the time, yes. And each day we learned more information it was actually more concerning.
Nanette Barragán: (03:20:17)
And the World Health Organization confirmed your view that the virus was a big problem in a January 20 call to agencies, including HHS. Over the course of January you pressed HHS leadership about the urgent need to devote increased resources to address the outbreak. On January 23rd you briefed Secretary Azar directly that funding, personnel, and clinical specimens, including viruses, were critical necessary to begin development of life saving medicines needed in the likely event the virus spread beyond Southeast Asia. Yet on January 24th, in a tweet regarding the virus, the president asserted, quote, ” It will all work out well,” end quote. On January 29th Secretary Azar reportedly told the president that the epidemic was, quote, “Under control,” and the president echoed that comment publicly the following day. This disconnect between the analysis of public health experts and the public statements by the administration leaders continued through February.
Nanette Barragán: (03:21:25)
Let me give you some more examples. In early February you continued to raise the alarm bell within HHS about the imminent mask shortages and the lack of preparations for the wave of infections that you saw coming. Thank you for doing that. Yet, in public remarks on February the 10th President Trump stated, “It looks like by April, in theory, when it gets a little warmer, it miraculously goes away,” end quote. Then he added, “I think it’s all going to work out good. We only have 11 cases and they’re all getting better,” end quote. You have said that experts knew that the number of N95 respirator masks, needed to protect healthcare workers and other Americans in a pandemic, was close to 3.5 billion. Yet in testimony on February 25th Secretary Azar said the US would only need 300 million N95 respirators. That’s an order of magnitude so much less than what you stated.
Nanette Barragán: (03:22:24)
Throughout February you continued your warnings. I would say that your hair was on fire about the dangers of millions of Americans faced from this virus, but on February 26th President Trump characterized the number of cases this way, quote, “When you have 15 people, and the 15 within a couple of days is going to be down to close to zero, that’s a pretty good job you’ve done,” end quote. By March 10th there were over 1,000 diagnosed COVID-19 cases in the United States and over 30 deaths had been attributed to the virus in this country. Yet the president, that day, told the country, quote, “It will go away. Just stay calm, it will go away,” end quote. He couldn’t have been more wrong. Today we have over 1.4 million cases.
Nanette Barragán: (03:23:16)
Dr. Bright what impact do you believe that statements by the administration leaders downplaying the COVID-19 crisis throughout February had on the ability of our public health system to mount an effective response to the COVID-19 virus?
Dr. Rick Bright: (03:23:37)
I believe Americans need to be told the truth. And I believe that the best scientific guidance and advice was not being conveyed to the American public during that time. I believe by not telling America the truth or being fully transparent, regardless of where the information was coming from, people were not as prepared as they could have been and should have been. We did not …
Dr. Rick Bright: (03:24:03)
… were not as prepared as they could have been and should have been. We did not forewarn people. We did not train people. We did not educate them on social distancing and wearing a mask as we should have in January and February. All of those forewarnings, all those educational opportunities for the American public could have had an impact on further slowing this outbreak and saving more lives.
Nanette Barragán: (03:24:22)
Well, thank you, Dr. Bright. I want to thank you for sharing your perspective with us today. I hope that over the course, I hope that your courage and coming forward helps our country forge a better path than the disastrous course chartered by this administration to date. I yield back.
Chairwoman Eshoo: (03:24:38)
Gentlewoman yields back. Minority reserves. Pleasure to recognize the gentlewoman from Delaware, Ms. Lisa Blunt Rochester. Five minutes for questions.
Lisa Blunt Rochester: (03:24:50)
Thank you, Madam Chairwoman, and thank you, Dr. Bright, so much for your testimony, but also for your courage here today. As you can hear from our colleagues, there’s not a person in this room or in this country who hasn’t been personally touched by COVID-19, and your statement that we need to be told the truth is probably the most important statement we’ve heard all day, because we know that if we don’t face it, we can’t fix it. So I want to personally thank you on behalf of all Americans for your courage to testify before us today.
Lisa Blunt Rochester: (03:25:22)
And I want to say that my focus for this hearing is really on three things. Number one: what have we learned? Number two: What do we need to do now? And number three: What can we do to prevent or mitigate the risks of an additional wave of COVID-19? It’s clear since January of this year that there has been a failure on the part of the administration to use the scientific evidence that’s been prevented by the nation’s top public health officials to take comprehensive, and I’ll use that word again, comprehensive, appropriate, and urgent action to respond to COVID-19.
Lisa Blunt Rochester: (03:26:02)
One of the most pressing outstanding needs that has yet to be addressed is the need for a national testing strategy. Dr. Bright, in your testimony, you mentioned the need for such a strategy that ensures tests are, among other things, available to everyone who needs them. I, along with Congressman Collin Peterson and Representative Failla from Texas wrote a letter to the Democratic and the Republican House leadership in the House and the Senate, and we really impressed upon them the need for outlining the importance of a robust testing plan for our testing and tracing. And while current testing capacity is 1.6 million diagnostic tests per week, healthcare experts say that we’re woefully short of the estimated 30 million tests per week that we need to get America back to work as safely and confidently as possible, and to avert or mitigate a second wave of COVID-19, which is one of my biggest concerns.
Lisa Blunt Rochester: (03:27:06)
Dr. Bright, what are the immediate steps that HHS needs to be taking to ramp up testing capacity now through the fall, and what targets should they be held accountable for?
Dr. Rick Bright: (03:27:19)
I think what’s really interesting about the testing story that gets lost in the narrative sometimes is the confusion about the different types of tests. There’s an antigen test that tells you if you have the virus in you. There’s a PCR test that says if maybe there are fragments of the virus, and there’s this antibody test that looks at your antibody titer to try to tell you you’ve been exposed already, maybe immune to the virus. There’s a lot of confusion, and I think the first thing HHS needs to do is determine which of those tests is most important to achieve which objective. If the antigen test is what is needed because it’s faster and lower cost and more readily available in some cases, what does it tell Americans? What does it tell employers? What does it tell schools about the potential for an individual who has a positive or negative on that test and their potential to have a different result the next day or later that day?
Dr. Rick Bright: (03:28:12)
There’s a lot of confusion about these tests, so I think the first thing that HHS should do is determine the type of test and how that test would be used effectively, and then make sure that we have enough of those types of tests, and they’re in the right place, and the people using them know what the data tells them and how to use it effectively. I think there’s a lot of confusion there, and they need leadership in HHS to distinguish those challenges and clarify that for the American public. It’s not just a test. There are many different tests that tell you different things.
Lisa Blunt Rochester: (03:28:43)
Great. Thank you. Thank you. And why do you think that our nation has struggled with ramping up the testing capacity, unlike other countries? And were there contingencies in place or a backup, in light of this situation we’re in now?
Dr. Rick Bright: (03:28:59)
I think part of the struggle is waiting too late to think about it and to get it started. When we’ve had conversations with some manufacturers, they’ve been very creative in how they can ramp up. Another part of the challenge is, we’ve allowed many of these capabilities to be offshored, and so we have much more capability of expanding domestic capacity when it’s in our country, and we can ramp up and bring innovation to those companies in the US. But if the supply chain is offshore, and there’s a global need and competition for that supply chain, that also significantly impairs our ability to ramp up.
Lisa Blunt Rochester: (03:29:34)
Again, I just want to thank you so much for the time that you have contributed to our country, but also for your courage to be here right now. Many of us are challenged as Democrats and Republicans to make sure that our country is safe and healthy, and it really is … I don’t think I’ve ever in my lifetime seen anything like this, and it does require us to look back, and at the same time look forward and make sure that we have what we need as a country. So I thank you again, and I yield back the balance of my time.
Chairwoman Eshoo: (03:30:12)
The gentlewoman yields back. This is a minority reserve. All right. Then it’s a pleasure to recognize the gentleman from Illinois, Mr. Rush, for his five minutes of questions. Do you have your microphone on?
Mr. Rush: (03:30:39)
Yeah. I have one now.
Chairwoman Eshoo: (03:30:39)
Good. Now I can hear you.
Mr. Rush: (03:30:41)
Thank you, Madam Chairwoman. Dr. Bright, it’s so good to see you. I’ve been watching you this morning, and it just amazes me about your courage and your insight and your commitment. And I’m just so delighted to be in the same room with you. Your contributions are impressive, and your reports of how the scientific process was pushed aside for a short term political point are extremely troublesome to me and to the American people, I’m sure. I’m absolutely convinced that both you and the Chinese doctor, Dr. Li, the doctor who first raised the alarm over the coronavirus in Wuhan, China, you two will be remembered as two titans of this pandemic. You took the path that was right rather than the path that was easy, and I commend you for it, and that’s it.
Mr. Rush: (03:32:00)
It’s been widely reported that President Obama’s White House National Security Council left the administration a detailed, very thorough document on how to proceed through a pandemic. Did you have any input in that playbook?
Dr. Rick Bright: (03:32:23)
Yes, sir. A number of our agencies across the government had input in that playbook.
Mr. Rush: (03:32:28)
And as far as you know, have any of those recommendations been acted upon in this administration?
Dr. Rick Bright: (03:32:36)
I believe some of those principles have been reviewed and considered, but I think the playbook has changed in this outbreak. I don’t think they’ve followed that playbook.
Mr. Rush: (03:32:48)
Thank you. I think it’s critically important that we focus on the path forward. While we must learn from the past and correct injustices as they occur, our response has to be forward thinking, forward moving. And I’m the sponsor of [inaudible 03:33:10] COVID-19 TRACE Act. I have been working on the development of a comprehensive $100 million strategy for mobile testing and door to door tracing, and my legislation, my bipartisan legislation empowers community groups to hire and train and pay workers to engage in testing and contract tracing. It prioritizes hot spots and medically underserved areas, as well as entities who hire locally. And as such, I was very interested in your views on a national testing and tracing strategy. In your testimony, you said the virus is out there. It’s everywhere. We need to be able to find it, to isolate it, and to stop it from affecting more people. And on that, I could not agree with you more.
Mr. Rush: (03:34:14)
While my question might be outside of the scope of the NIH or [inaudible 00:10:20], I believe that it’s a question that is relevant, relevant today. I want to hear more about what you, as an expert on pandemic outreach, believes should be our national strategy for testing and tracing.
Dr. Rick Bright: (03:34:40)
I think it’s important. You’re spot on that we need to have a strategy, that everyone follows the same strategy to test for where the virus is, who’s infected with this virus, and then we have to appropriately isolate that person and quarantine them so they don’t infect others, and we rapidly need to trace their contacts, understand who they may have been exposed to, and be able to test those individuals, and if they’ve been infected as well, we need to be able to isolate those. Through a concerted, coordinated effort across the country, we can be able to identify where that virus is, who’s been exposed, give those people proper treatment and isolation, and can slow the spread of this virus significantly. But that has to be in a coordinated way. We have to have the right tests and enough of those tests. It’s not something we do once and we’re done. It’s something we have to continually do in a community, so it’s not just that we need one test for every person in America. We need multiple tests and the right types of tests, and we need the right types of individuals and professionals who know how to use those tests, to trace the individual contacts and to isolate that virus and stop it from spreading.
Mr. Rush: (03:35:52)
Well, I certainly thank you so very much, and thank you for, again, for being here and letting the American people know what really is going on in our nation with this pandemic. I thank you, and Madam Chairwoman, I yield back the balance of my time.
Dr. Rick Bright: (03:36:07)
Chairwoman Eshoo: (03:36:09)
Gentleman yields back. There is no request from the-
Speaker 15: (03:36:14)
Chairwoman Eshoo: (03:36:15)
You’re out of speakers. Okay. It’s a pleasure to recognize the gentleman from Arizona, Mr. O’Halleran, who is a member of the Energy and Commerce Committee. And according to our rules, we can, as members of the full committee, we can waive on to a subcommittee, and so we welcome you this afternoon and recognize you for five minutes of questions. Put your microphone on.
Mr. O’Halleran: (03:36:46)
Thank you, Madam Chair, and Dr. Bright, thank you for your remarks today, your insight, your knowledge and your caring for the American people. You have touched on several concerns I share with my colleagues about how the United States has responded to COVID-19. We must address the health crisis head-on if we want to tackle the economic crisis that has overtaken our country. We are going to need a coordinated, as you mentioned, national testing and contact tracing a plan spearheaded by the federal government to prevent states from competing with one another for resources and planning for hotspot attacks, and other issues that will come up. This is the only way that people will feel safe returning to work, eating at restaurants, enjoying Arizona’s public lands, and being out in public and close to others. This flexibility piece is critical, and you can’t have that unless you have a coordinated process.
Mr. O’Halleran: (03:37:52)
In my district, the Navajo Nation has for months been going under this process, and it’s 170,000 people. The area is the size of West Virginia, so they’re not all gathered in a group, so this fallacy that only urban areas are impacted and that it can’t spread very fast. 16 people died yesterday, and in fact, this, on a per capita basis, this currently has more cases than any state in the country, and yet this hotspot is still not being addressed in the appropriate way. More resources are needed, and they’re needed now, and they were needed more than a month ago when we started trying to get this done.
Mr. O’Halleran: (03:38:36)
We continue to struggle to see the federal government’s promised payments, each in a timely manner. It came through finally, but it has to be timely in order to respond. This will bolster the health system and provide people with water, food, and supplies during this time of great crisis.
Mr. O’Halleran: (03:38:55)
Dr. Bright, as an infectious disease expert, what is the one thing that the federal government must do to ensure that hotspots like Navajo Nation or anywhere else in our country are successfully mitigated in a timely way, that this virus does not continue to spread throughout communities, and to bring back the faith of the citizens of our country, to be able to understand that we will respond quickly with the necessary supplies.
Dr. Rick Bright: (03:39:24)
Congressman, that’s an excellent question. I believe that there’s a need to recognize that it is a hotspot, and understand the per capita outbreak of a number of infections in different areas, and not treat every area in the United States the same. The rural areas, the less dense areas are not the same as a dense city such as New York City. However, you could have just as significant of challenge in a rural area or less dense area as you described in Arizona.
Dr. Rick Bright: (03:39:55)
So I think the first recommendation is to get the data across the country, into the federal government so they can make the right prioritization decisions and allocation, equitable allocation of those limited supplies and resources to areas such as yours with a hotspot area. I don’t think there’s a full recognition yet of how to define necessarily the hotspots in a standardized way across the country, so we need to have the scientists review this challenge and come up with an equitable distribution and recognition of those areas.
Mr. O’Halleran: (03:40:30)
Thank you, Doctor. I want to point out that this enemy goes much faster than one of our jet plates. Our fighters go fast, but this goes microseconds, one person to another, and it passes on and on and on. So I appreciate your comment, but statistics has to be relevant and timely in order to be able to do that, and it needs a central database.
Mr. O’Halleran: (03:40:55)
Dr. Bright, we are currently seeing the number of COVID-19 tests that are being administered increased nationwide. What major hurdles stand in our way for increasing our testing capacity quickly moving forward, and how can the federal government address these now or within a quick period of time? White Mountain Apache are going through a hotspot right now in my district. They cannot get tests, and they’ve had 400 cases out of 14,000 people. I mean, this is a critical issue. Please.
Dr. Rick Bright: (03:41:31)
I certainly still think we need to recognize the importance of the different types of tests. And when we identify those different types of tests that are essential for what we need to do to isolate the virus or identify people infected with the virus, then we need to put all efforts in the ramping up production of all supplies for those tests. We’ve found many times that we’ve ramped up now test production, but we have not thought about the critical reagents that accompany those tests. We haven’t thought about the swabs. We’re asking equipment, diagnostic equipment that might normally run 100 tests a day to run 10,000 tests a day in a 24-hour period. So there hasn’t been a real thought through plan about how to maintain that equipment, and that equipment now is failing in many places.
Dr. Rick Bright: (03:42:16)
So as we ramp up capacity to test, and we haven’t thought all the way through the raw materials and maintenance of that equipment, those supplies, then we can find ourself in a few days down the road not having the tests we thought we had, not having the supply we thought we needed. So again, this is where a coordinated strategy and plan for testing comes into place. Not just how to use the test, but how to make sure we’re sustaining that supply. How to make sure that we’ve thought of every component if it’s a swab, if it’s a buffer, if it’s a lubricant for the instrument itself. Making sure that all of those things are considered in that national strategy so we don’t ramp up in one area and crash in another. We’ve got to ramp up in all areas at once.
Mr. O’Halleran: (03:43:04)
Thank you, Doctor, and Madam Chair, I yield.
Chairwoman Eshoo: (03:43:06)
I see no other members to speak. I want to close, Dr. Bright. You’ve been here for just shy of four hours of straight testimony, and my observation is the following. I think that you are the finest ambassador in our country for scientists. Your encyclopedic knowledge, the depth and the breadth of it, I think as the American people have listened this morning that you have given them confidence. You’ve also issued your warning, and I pray, and I sincerely mean that word, I pray that we will work together successfully, so that that window that is closing, we will optimize the time that we have while it is still open.
Chairwoman Eshoo: (03:44:09)
You know, facts are really stubborn things, and sometimes it’s uncomfortable to have to deal with the facts that we’re facing, but we, the United States, still has more cases, more deaths by far than any other nation on earth. And by that definition, we have, in my view, a profound failure. You have given this committee a roadmap today, and we all have been witnessed your integrity. So thank you for your service to our country. Thank you for your willingness to testify here today. Thank you for your courage, which has raised your blood pressure with all of contends with when you become a high profile witness, but I think you should rest assured that you’ve made a difference today, and on behalf of all of my colleagues, thank you, and salute you and thank you for your family being here as well. Thank you.
Mr. O’Halleran: (03:45:25)
Chairwoman Eshoo: (03:45:26)
I’ll ask the … Yes?
Dr. Burgess: (03:45:29)
I just was going to ask if I could be recognized for concluding remarks.
Chairwoman Eshoo: (03:45:31)
Yeah. I’d be glad to.
Dr. Burgess: (03:45:32)
Chairwoman Eshoo: (03:45:33)
Dr. Burgess, you’re recognized.
Dr. Burgess: (03:45:36)
As I outlined at the beginning of this hearing, there are a number of things we do need to look into, and I hope that we will. This crisis has been going on for several months. We had an hour packed onto a budget hearing at the end of February, and then this is the first glancing blow we’ve had against this crisis, so I welcome the hearing today. I think it’s important. I appreciate Dr. Bright being here. I appreciate him bringing his guest. I do think we need to look into the issue of testing. I simply do not understand how the CDC got so far behind the curve at the beginning, and I would like to know that.
Dr. Burgess: (03:46:14)
But I also feel like there has been, in previous administration, there was an effort to really regulate what are known as laboratory developed tests and move those away from CLIA regulated products to FDA regulated products, and that really did put us behind. The innovators have now stepped up. I’m thankful that they have, but we shouldn’t have excluded them in the first place, and I think that was … When we look back on this, that is going to be one of the failings at the federal level. And that’s not a recent failing. That goes back to guidances and rules that were issued back in 2012, 2014.
Dr. Burgess: (03:46:59)
As far as testing is concerned and the ancillary supplies, there are tests that might just involve taking a salivary sample. That would be great. Spit into a cup, not have to deal with all of one of obnoxious swabs going halfway down your throat. I suspect those cups are probably in greater supply and more readily available.
Dr. Burgess: (03:47:21)
And then, Dr. Bright, you’ll remember I had an interaction with you in March. I’ve had people pounding on the door with all kinds of ideas. I have people that want to make personal protective equipment. They’ve turned their furniture shop into a PPE manufacturing shop. They had difficulty getting through the bureaucratic cul-de-sacs of the various federal agencies. I’ve got a man that’s got a breathalyzer test for COVID-19. I don’t know whether it works. If it does, it’s pretty intriguing. A mobile unit about the size of a breadbox that you could take from place to place. You simply blow into a tube, and it would have to have more straws. We’ve outlawed them recently, but that could be dealt with.
Dr. Burgess: (03:48:06)
There are some innovative things out on the horizon. The vaccine worries me, too, because I recognize there’s some illnesses for which we have never found a vaccine. H1N1, and I realize that’s different, because that was a flu vaccine, but that did happen in about eight months, if I recall correctly. The outbreak happened at spring break. We didn’t know if we’re going to be able to open the schools in September, but the vaccine was generally available mid-September to early October, depending on what part of the country you were in. So that success story gives me some hope that perhaps there is going to be light at the end of this tunnel in the form of a vaccine.
Dr. Burgess: (03:48:48)
But I do welcome that we had the hearing today. I look forward to a number of additional hearings. The ranking member of the full committee was quite correct to invoke rule 11. We will keep that as an option going forward, and I thank our witnesses for being here today, and I’ll yield back.
Chairwoman Eshoo: (03:49:05)
The gentleman yields back. Thank you, again, Dr. Bright, and the first panel has completed testimony, and I just ask the staff to prepare the table for our next witness, and then we will begin in just a few minutes.