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Ousted Federal Vaccine Chief Testifies In Whistleblower Hearing. Aired 1-1:30p ET

Aired May 14, 2020 - 13:00   ET

THIS IS A RUSH TRANSCRIPT. THIS COPY MAY NOT BE IN ITS FINAL FORM AND MAY BE UPDATED.


[13:00:00]

UNIDENTIFIED MALE: This is a bipartisan issue.

UNIDENTIFIED MALE: Thank you.

UNIDENTIFIED MALE: 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?

REP. ANNA ESHOO (D-CA): I'm sorry, I didn't hear you.

REP. MORGAN GRIFFITH (R-VA): 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?

ESHOO: We'll follow the rules. How about that?

GRIFFITH: And that is in compliance with Rule 11. Thank you.

ESHOO: Thank you, Sir.

OK, I now have the pleasure of recognizing the only pharmacist in the United States Congress, Mr. Carter.

REP. BUDDY CARTER (R-GA): 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.

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, FORMER DIRECTOR, DHS, BIOMEDICAL ADVANCED RESEARCH AND DEVELOPMENT AUTHORITY: I'm not aware. So are you talking about the ventilators, Sir, that we developed or -- CARTER: 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.

BRIGHT: Sorry, I'm not familiar with that project, re-sanitize the respirators.

CARTER: You're not familiar with that project and you didn't sign off on that project, to your knowledge?

BRIGHT: I'm not familiar with that project, re-sanitize respirators.

CARTER: OK, fair enough. If you're not familiar with it.

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? I see you -- OK.

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?

BRIGHT: 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 these potential adverse events in an emergency --

CARTER: So you're referring, when you say, we should not proceed adversely, you're referring to hydroxychloroquine and the chloroquine?

BRIGHT: 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.

CARTER: Right.

BRIGHT: Yes, so that is what BARDA would --

CARTER: 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?

BRIGHT: 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 with the FDA.

CARTER: So are you saying you were instructed to do that and you did it against your will or --

BRIGHT: 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.

[13:05:00]

CARTER: 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?

BRIGHT: 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.

CARTER: I understand that, but my question was when did you sour on it?

BRIGHT: When it was determined that this drug should be made available to Americans outside the context of a close physician supervision. So, I supported conducting 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 --

CARTER: When was that? When did that directive go out?

BRIGHT: That was March 23rd.

CARTER: 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?

BRIGHT: 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.

CARTER: And who put that directive out?

ESHOO: The gentleman's time has expired.

CARTER: Who put that directive out?

ESHOO: The gentleman's time has expired. You can answer, Dr. Bright.

BRIGHT: Which directive, Sir?

CARTER: That it should be put out to the public without physicians approving it?

BRIGHT: 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.

CARTER: So, was it because the president was encouraged by the use of this drug that you became discouraged by it?

BRIGHT: 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 --

CARTER: But it is a drug that is indicated and has been used successfully in the past.

ESHOO: The gentleman's time has exceeded by almost one and a half minutes. You can finish your answer Dr. Bright and then we're going to move to the next member.

BRIGHT: The drug had been safely for malaria for a number of years. We didn't have a database --

CARTER: But it's being used in the same dosage as it was used for malaria.

ESHOO: 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.

REP. DEBBIE DINGELL (D-MI): 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.

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 is 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. 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, yourself, 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.

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.

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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.

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 cannot, and will not, be tolerated. Dr. Burgess was right then, and our carmakers 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.

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?

BRIGHT: That's true. And, Congresswoman, we still have those challenges.

DINGELL: Do you believe if your suggestions were implemented lives would have been saved and the severity of the pandemic might have been lessened?

BRIGHT: I believe lives would have been saved if we had proper medical protective equipment for our healthcare workers, yes.

DINGELL: So, people died because you weren't listened to?

BRIGHT: People died because they didn't have appropriate protective equipment to save their lives and protect them from getting infected.

DINGELL: 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?

BRIGHT: There still are not enough tests.

DINGELL: 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?

BRIGHT: No.

DINGELL: 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?

BRIGHT: 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.

DINGELL: Will we be able to vaccinate people in the next few months?

BRIGHT: It's very unlikely.

DINGELL: Thank you, Doctor.

ESHOO: Gentlewoman yields back. It's my understanding the minority is assay, reserving, so with pleasure, I recognize the gentlewoman from New Hampshire, Ms. Kuster.

REP. ANN KUSTER (D-NH): (INAUDIBLE) with us today. I want to thank you for your courage for helping us to do our job to protect the American people.

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. And 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.

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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.

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?

BRIGHT: I learned that they placed an order -- The first order for needles and syringes on May 1st and another order was placed today.

KUSTER: And were the amounts adequate?

BRIGHT: I believe that it's for 320 million needles and syringes.

KUSTER: And could you please describe the situation if every American does not have access to the vaccine due to a supply shortage?

BRIGHT: 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 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 --

KUSTER: Does a lack of preparation, and vaccine, and supplies make us more vulnerable to future spikes in COVID-19?

BRIGHT: Absolutely.

KUSTER: And do we have enough supplies to distribute both the flu vaccine next winter, as well as the coronavirus vaccine?

BRIGHT: It's going to be extremely challenging.

KUSTER: Do we know, yet, of the interactions of the full-fledged flu season in combination with COVID-19?

BRIGHT: We haven't seen that yet. Luckily in this spring flu was winding down when COVID-19 was emerging.

KUSTER: 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? BRIGHT: 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.

KUSTER: 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?

BRIGHT: 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.

KUSTER: 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.

BRIGHT: Thank you.

ESHOO: The gentlewoman yields back a minority reserves?

A pleasure to call on the gentlewoman from Illinois, Ms. Kelly, for her five minutes of question.

REP. ROBIN KELLY (D-IL): Thank you so much and thank you for being here, and your patience.

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?

BRIGHT: 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.

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So I think it has a significant chance of increasing the risk in those communities.

KELLY: How have you seen this impact the devastation of the disease in these communities?

BRIGHT: 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. And 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.

KELLY: 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?

BRIGHT: 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.

KELLY: 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?

BRIGHT: That is what's needed.

KELLY: 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?

BRIGHT: Yes, absolutely.

KELLY: And 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?

BRIGHT: I think that's very important. I think it's a wise move.

KELLY: OK, 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.

BRIGHT: I'm not aware of those guidelines, it comes in a different area, but I think reporting and oversight of that is important.

KELLY: Then lastly, you've been sitting in that seat for a while but is there anything that we haven't asked you that you want to say?

BRIGHT: 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 (INAUDIBLE) 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.

KELLY: Right. I know it's very -- I've had three people in my family with it and I lost my uncle maybe like ten days ago now from the virus, so it does definitely touch everybody. Thank you and thank you for your patience.

BRIGHT: Thank you.

ESHOO: The gentlewoman yields back a minority reserve?

All right, then we'll go to the gentlewoman from California, Ms. Barragan, for her five minutes of questions.

REP. NANETTE BARRAGAN (D-CA): 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.

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Dr. Bright you had learned of the COVID-19 threat by early January, is that correct?

BRIGHT: Yes.

BARRAGAN: 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? BRIGHT: 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.

BARRAGAN: 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.

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 U.S. would only need 300 million N95 respirators. That's an order of magnitude so much less than what you stated.

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.

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? BRIGHT: 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 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.

BARRAGAN: 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.

ESHOO: Gentlewoman yields back. Minority reserves.

A pleasure to recognize the gentlewoman from Delaware, Ms. Lisa Blunt Rochester. Five minutes for questions.

REP. LISA BLUNT ROCHESTER (D-DE): Thank you, Madam Chairwoman, and thank you, Dr. Bright, so much for your testimony, but also for your courage here today.

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