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Dr. Rick Bright's Testimony On Coronavirus Pandemic. Aired 11:30a-12p ET

Aired May 14, 2020 - 11:30   ET

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

[11:30:00]

MATSUI: 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?

BRIGHT: I'm 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 the Defense Production Act or other mechanisms. It should have been a high priority.

MATSUI: Well, thank you very much, Dr. Bright, I run out of time, and thank you very much for appearing before us today.

ESHOO: The gentlewoman yields back.

Pleasure to recognize the gentleman from Florida, Mr. Bilirakis, for his five minutes.

BILIRAKIS: Thank you, Madam Chair. I appreciate very much and I want to thank Dr. Bright as well for your service to our country.

I have a few questions and am 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?

BRIGHT: I believe it's probably mid-March, between March 10th and March 17th, somewhere in that timeframe.

BILIRAKIS: And not prior to that?

BRIGHT: 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'd heard of the drug and I hadn't heard of 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 had forwarded a manuscript, a draft manuscript, and that's the first I learned the drug itself. BILIRAKIS: So, you won't -- you didn't -- you weren't aware of any news articles and research papers in January discussing the potential benefits of the drug.

BRIGHT: I heard anecdotal stories and reports, sir.

BILIRAKIS: You had?

BRIGHT: I had -- probably -- I can't recall if I did specifically for chloroquine but I'd 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 had 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 that they have evidence 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.

BILIRAKIS: OK. Now, again, what was your reaction personally? Did you think it was something worth pursuing initially when you heard it from Dr. Woodcock?

BRIGHT: Initially, I said that I do believe -- I mean, I trust Dr. Woodcock and her scientific judgment immensely and if she mentioned that there's something that we should look and there'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.

BILIRAKIS: Sir, I understand -- I've heard from experts and I'm certainly not an expert in this area that the drug, 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 patient, 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? Have you -- can you elaborate a little bit on that if you've heard that? And, again, this is not from a layperson, this is from an expert.

BRIGHT: We have seen anecdotal, heard of anecdotal data from different physicians that they believe they've seen benefit or patient improvement from use of this drug in either combination with antibiotic azithromycin or combination with zinc or other vitamin C or other things.

But there was never sufficient evidence from a randomized controlled study to show us benefit would actually outweigh the potential risk. That is why the NIH and probably for the 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. It doesn't mean that it my 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. But in the context of a randomized controlled study, we haven't seen an overwhelming level of benefit.

[11:35:00]

BILIRAKIS: Have you reviewed the studies in other countries such as France and possibly Japan on these -- I mean, are you -- I just want to know because my constituents ask these questions. Do you take those studies into consideration when you make these decisions?

BRIGHT: We absolutely do. We look at the quality of those studies. We 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 people or was it 20 people or was it 2,000 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.

So, it's really difficult to understand the impact, the benefit. We also saw a study that V.A. hospital conducted with hydroxychloroquine that showed people who are treated with hydroxychloroquine up here to have a higher rate of death than people who are not treated with hydroxychloroquine.

So, that study too has weaknesses. No study 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.

BILIRAKIS: It is my understanding that, not my constituent but a U.S. citizen who's a veteran which was cured, again, this is just from what I've heard from the drug, and that was at late stage case but I've also heard of early stage cases as well. So, I want to get that on record.

Thank you, Madam Chair.

ESHOO: The gentleman yields back.

Pleasure to recognize the gentlewoman from Florida, Ms. Castor, for her five minutes of questions.

CASTOR: 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 N95 respirators.

These are -- these respirators are essential personal protective equipment. They're not the cloth mask or surgical mask that every day Americans are encouraged to wear by the CDC.

Dr. Bright, are N95 respirators necessary to protect the lives of nurses, doctors, EMTs and those on the front lines? BRIGHT: Yes. They're required essential personal protective equipment to protect those front-line health care workers from getting infected.

CASTOR: 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 N95 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 health care workers had already contracted COVID and dozens have died.

And I checked with my Tampa Bay area health providers and one Tampa hospital said N95s are still very difficult to procure. She said there's a dire need for N95s. One of my community health centers says, we continue to struggle to get N95s. And there's 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 they remain concern as we head into the fall for N95 masks. The demand will continue due to the flu season and the continued presence of COVID-19.

Dr. Bright, you understood that America would face a shortage of respirators in January, is that right?

BRIGHT: We understood America would face a shortage of N95 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 late -- as early as 2019, August, in Crimson Contagion that we would need 3.5 billion N95 respirators in our stockpile to protect our health care workers for pandemic response.

[11:40:00]

CASTOR: 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 in the response you received.

BRIGHT: We knew going to this pandemic that a critical medical equipment would be in short supply. I began getting alerts from industry colleagues in mid and early -- mid and late January telling me that from an outside view, from the industry view that the 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 can make more and each of these alerts and there were dozens of these alerts, I pushed those forward to our leadership in ASPR, to Dr. Kadlec and the 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 in difference 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 will have 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.

CASTOR: In your whistleblower filing, you discussed a February 7th meeting of the Department leadership group at which you urged the Department to focus on securing N95 masks. Can you describe what happened at that meeting?

BRIGHT: They informed me that they did believe there was a critical urgency to procure masks. They 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 health care workers.

My response was I cannot believe you can sit and say that with a straight face. That was absurd.

CASTOR: 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 N95 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?

BRIGHT: Lives are in danger and I believe lives were lost. And not only that, we were forced to procure these supplies from other countries without the right quality standards. So, even our doctors and nurses in the hospitals a day are wearing N95 marked mask from other countries that are not providing the sufficient protection that a U.S. standard N95 mask would provide them. Some of those masks were only 30 percent effective. Therefore, nurses are rushing in the hospitals thinking they're protected and they're not.

CASTOR: Thank you for your courageous efforts.

ESHOO: The gentlewoman's time is expired.

Pleasure to recognize our colleague from Indiana, Dr. Bucshon, for his five minutes of questions. BUCSHON: Thank you, Madam Chairwoman, and thank you, Dr. Bright, for testifying. I appreciate it.

I was a cardiovascular and thoracic surgeon. I've been in health care for over 37 years. So, I want to comment on -- I'm not going to ask question about hydroxychloroquine. I 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 hear -- 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. 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 is -- can lead to cardiac arrhythmias if not used properly.

[11:45:00]

But I 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 of things are working even anecdotally. They're noggin away for the government bureaucracy to approve it. I just want 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.

I want to talk about the supply chain issues and -- 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 for -- after H1N1 where national stockpiles were depleted, we didn't replenish them. We've had people on both sides of the aisle talking about this and it's -- I think there's something to -- 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 situation as it relates to the masks, OK, and according to "Washington Post" report, in 2015, the Obama administration and a company now known as O&M Halyard, H-A-L-Y-A-R-D, announced the project to develop rapid pandemic mask 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 turn out millions of protective respiratory masks at a hybrid 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?

BRIGHT: So, that project with Halyard was to build a novel new machine to make respiratory protection facemasks faster as you described accurately.

BUCSHON: Right.

BRIGHT: 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 the machine and I'm not even sure if it was to build an actual...

BUCSHON: And at that time in September 2018, were you the head of BARDA?

BRIGHT: In 2018, I was the director of BARDA.

BUCSHON: Right. So, 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? So, did you sign off on it? It's a yes or no question.

BRIGHT: Not necessarily scrapped the project, sir. I don't know what the proposal was. We rely on a very thorough vetting process...

BUCSHON: Understood.

BRIGHT; ... through 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.

BUCSHON: OK. I find that surprising but I'll take your word for it. Nicole Lurie who hired you told the "Washington Post" that how your contract was part of an explicit strategy to ensure we could surge mask production in the next crisis. Well, now, we're here and we don't have it. So, we're dealing with the consequences of that decision.

And in addition, I guess, to the Halyard, I keep saying that wrong, it is my understanding -- 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 we're 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 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. And whether that's right or wrong, we might take us years to prove. But in the meantime, people can die.

So, I yield back.

ESHOO: The gentleman's time is expired.

It's a pleasure to recognize the gentleman from Maryland, Mr. Sarbanes, for his five minutes of questions.

SARBANES: 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 to the nation to promote effective government and to protect the public interest, in this instance, to protect the public health.

As a scientist and public health official, that was your charge and you took it seriously.

[11:50:00]

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, amounts 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. 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.

And they sent you an errant mission 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. Ignoring, dismissing your input was not harmless malpractice because there is a reason to believe that if that input had been heated, 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. I am sure there are specific conversations, e-mails, moments in time that you remember like they happened yesterday. The inflection points where if the response to your warnings have been heated, things might have 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.

BRIGHT: Congressman, I'll never forget the e-mails I received from Mike Bowen indicating that we are -- mask supplier -- N95 respirator supplier was completely decimated and he said, we're in deep shit, the world is, and we need to act. And I pushed that forward to the highest levels I could in HHS. I got no response. From that moment, I knew that we were going to have a crisis for our health care workers because we were not taking action. We're already behind the ball. That was our last window of opportunity to turn on that production to save the lives of those health care workers and we didn't act.

SARBANES: Thank you. Listening 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.

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. right, when the counsel that you and others offer is cast aside, and I know you know this, it means that science and a reason are also being cast aside. That's a dangerous impulse.

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's 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?

BRIGHT: Congressman, we need to install and empower leadership. We need to unleash the voices of the sciences and are public health system in the United States so they can be heard. There are 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.

[11:55:00]

And 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 this response. Large sums of funding have been -- become available to help us, as sciences 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.

So, I would encourage Congress to continue and increase their oversight in how those funds are being spent to making sure their prioritized and used appropriately in this pandemic.

SARBANES: Thanks for that caution. I yield back.

ESHOO: The gentleman's time is expired and he yields back.

Pleasure to recognize the gentlewoman from Indiana, Ms. Brooks, for five minutes for her questions.

BROOKS: 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.

They 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. And 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, Congressman Eshoo, Dr. Burgess, so many of us, relied on you all to share with us what we needed to do to reauthorize PAHPA , which most members of Congress really know what that was, Pandemic and All Hazard Preparedness Act.

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?

BRIGHT: Yes.

BROOKS: And Dr. Bright, you joined BARDA to lead the influenza division 2010 right after H1N1 because of your expertise and we rely on your expertise and you became director in 2016. After-- and 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 you've had problems since '07.

But I have to share with you, members like Congresswoman Eshoo and I who've had discussions about this then -- we 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 work 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?

BRIGHT: Before 2017, we actually held an annual review of the Strategic National Stockpile. It was chaired by Dr. Lurie of the previous ASPR. Since we moved the Strategic National Stockpile from the CDC management under the ASPR management, we have not yet had an interagency across departmental review of the supplies in that Strategic National Stockpile.

We went through an annual prioritization process. There has always been limited funding and never enough to completely top off the stockpiles.

BROOKS: Did you know Greg Burrell?

BRIGHT: I do.

BROOKS: He retired...

BRIGHT: Yes.

BROOKS: ... prior to all of this happening. He led the Strategic National Stockpile.

BRIGHT: Yes.

BROOKS: Did you have conversations with Greg Burrell from 2009 until 2020 about what was in the Strategic National Stockpile?

BRIGHT: Absolutely. The Blue Risk Management meeting met on a monthly basis and each year, they review and prioritize items that should be purchased by the Strategic National Stockpile.

BROOKS: OK.

BRIGHT: That body which I actually directed for some time made recommendations and prioritizations to the Strategic National Stockpile. However, it was the Strategic National Stockpile's responsibility to make these purchases.

BROOKS: And how about PHEMCE?

[12:00:00]

END