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Ousted Federal Vaccine Chief Testifies in Whistleblower Hearing; Dr. Bright: I Believe We Could Have Done Better. Aired 10:30- 11a ET

Aired May 14, 2020 - 10:30   ET

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

[10:30:00] WALDEN: We granted new authorities, we followed your recommendations and those of others who played a key role this combined effort.

Unfortunately some of the systems we put in place to prepare for a pandemic, systems designed without actually living through something like this, did not performed as expected. We've learn we didn't have enough of the basic supplies that we've always taken for granted. 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.

I'm thankful that President Trump invoked the Defense Production Act or ramp up U.S. manufacturing of masks and ventilators. And the president has use emergency powers and money Congress has provided to launch unprecedented efforts to search the globe for supplies to rapidly advanced 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. We have asked for, and this committee should hold hearings to find a path toward 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 health care providers on the front lines treating COVID-19 cases and our health care workers who have been furloughed because their hospitals are closed.

We should be conducting rigorous oversight of the trillions of dollars and a myriad new policies Congress has 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 nations coronavirus response. That does not appear to be why we're actually here today and frankly it saddens me. 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 will hear you out; and importantly will 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 learn from a tweet this hearing was scheduled in the wake up your complaint.

As you know, that's certainly not how we do things 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 are not representing the government, but yourself.

The hearing title suggests the hearing is about protecting scientific integrity, yet the chair invited a witness who will not be speaking to that issue; so it's all pretty confusing and unusual to say the least. Here we are in the middle of a pandemic and we aren't given time to secure our witnesses, conduct appropriate research or required documents that could aid in our understanding of the situation you face and the country face.

The first discussion with 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 Congress and the country, what can we band together and fix before fall arrives.

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 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.

ESHOO: 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.

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. 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. So 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 got the microphone on? There we go. Good morning to you.

[10:35:00]

BRIGHT: 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 a Ph.D. in immunology and molecular pathogenesis. I've led teams of scientist 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 3.5 years until April 21st of this year, I had the privilege of serving as its director. BARDA partners with private industry and others and governments to address national health security threats. Today the world is confronting a public health emergency unlike any we have 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 health 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 coordinated response and a dearth of accurate, clear communication about the path forward.

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 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 worst and be prolonged. There'll likely be resurgence of COVID-19 this fall and be greatly compounded by the challenges of seasonal influenza.

Without better planning 2020 could be the darkest winter in modern history. 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 scientists -- let us lead. Let us speak without fear of retribution.

We must listen. Each of us can and must do our part now. On Tuesday, Dr. Fauci delivered a message in a voice that is clear and trustworthy has encouraged us to act with caution as we return to our daily lives. We should listen to him and other scientists sharing their expertise.

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're simple but critical steps to buy valuable time until there is vaccine.

We need to ramp up production, essential equipments, and supplies including raw materials and critical components. Shortages of these increase the risk for front-line health care workers.

They deserve the best equipment to protect themselves. We need to facilitate equable distribution of essential equipment and supplies. And finally we need a national testing strategy. 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 appropriately while striving to develop a cure.

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.

There'll be plenty of time to look back and 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 report the response.

And there is much more we can do. With your help we can get through this crisis. 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 what we failed to do to address this crisis. I call on all of us to act to ensure the health and safety and prosperity of all Americans. You can count on me to do my part.

[10:40:00]

BRIGHT: Thank you.

ESHOO: Thank you, Dr. Bright.

We'll now move to member questions, and I recognize myself for five minutes for questions.

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, seen everything firsthand, to come forward and share unvarnished experiences about what really happened from January to the time you departed BARDA in -- 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 -- in your written testimony a -- 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?

BRIGHT: Chairwoman Eshoo, 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.

My concern about this fall is compounded by my knowledge and preparation in 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 U.S. from influenza. That, coupled with a COVID-19 resurgence this fall, could be devastating for our health care systems and for Americans. We have a limited window of opportunity to get plans in place to address both of those.

ESHOO: 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?

BRIGHT: I believe we could have done better. I believe there were (ph) critical steps that we did not take in time.

ESHOO: Was there a failure to respond when you correctly pushed to claim early virus samples from -- or to obtain early virus samples from China so we could develop critical medical countermeasures?

BRIGHT: From my perspective in working with companies to develop drugs and vaccines and diagnostic, 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.

ESHOO: And when did you do that?

BRIGHT: 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.

ESHOO: And was there a failure to respond with the needed urgency when you correctly pushed to ramp up production of masks, respirators, syringes, swabs?

BRIGHT: Congresswoman, we've known for quite some time that our stockpile is insufficient in having those critical personal protective equipment.

So once this virus began spreading it became known to be a threat, I did feel quite concerned that we didn't have those supplies.

I began pushing urgently in January along with some industry colleagues as well; and those urges, those alarms were not responded to with action.

ESHOO: Was there a failure to take immediate action when you correctly pushed to acquire additional doses of the drug remdesivir, which is the only drug so far that has -- appears to be at least mildly effective, thank God, for treating people with COVID-19.

BRIGHT: There was no action taken on the urgency to come up with a plan for acquisition of limited doses of 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.

[10:45:00]

ESHOO: And instead of acting on your recommendations, was the response of others to try to cut you out of key meetings, marginalize your participation?

BRIGHT: I was told that my urgings were causing a commotion and I was removed from those meetings.

ESHOO: My time has expired, I now recognize the gentlemen -- the ranking member of the subcommittee, Dr. Burgess.

BURGESS: I thank the Chair and Dr. Bright; I hope, as it is clear to you everyone on this dais, on both sides, appreciates you coming before us today even if we frustrated 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.

BRIGHT: That's correct sir.

BURGESS: 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 that -- 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 blocking the virus at the -- at the point of contact with the cell, certainly something that deserves a little investigation.

But again, it's not the only one, there were some other drugs and I think, if I'm correct, are 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?

BRIGHT: There are a number of drugs that we're evaluating initially, Congressman, that we were considering for -- to conduct clinical studies to get further information that they really had an impact.

And if they were safe to use in patients in fact, it would inspire us.

BURGESS: Do you have available to you the dollar amounts that BARDA appropriated or authorized for each of those two drugs; Actemra and Kevzara?

BRIGHT: I don't have those numbers available with me, no.

BURGESS: Would you be able to make them available to the Committee?

BRIGHT: I believe HHS could make those available, BARDA could probably make those investments available.

BURGESS: Were you concerned with hydroxychloroquine when at the time you made those awards for Actemra and Kevzara?

Was a concern for hydroxychloroquine which became the paramount in your disagreement with the Administration? Was it already established when you made these other investments in similar medications?

BRIGHT: The -- my concern is around the safety of hydroxychloroquine in people infected with the COVID-19 virus reflective of the scientific review that we received from interagency 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 randomized control clinical study.

It'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 control study -- to evaluate remdesivir and so with hydroxychloroquine, but that was also our preferred plan of action.

BURGESS: And you, of course, offered the letter to the FDA asking for the emergency use authorization for hydroxychloroquine.

BRIGHT: I was directed, as a BARDA director from the office of the HHS secretary to put in place an expanded access I&D program to make chloroquine donation from Bayer available to American's through a unique opportunity that would utilize an app and perhaps even make it available to American's who were not under close supervision of a health care provider.

During that...

BURGESS: I just...

BRIGHT: Sorry.

BURGESS: Of course this hearing is not really a hearing on hydroxychloroquine and 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, which has -- what has not.

[10:50:00]

On 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 how (inaudible) 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.

My state, around the country, who have experienced using hydroxychloroquine and chloroquine coupled with ricin and zinc and they're reporting significant benefit if it is used early enough in the course.

And it may eliminate the need for hospitalization and ventilatory (ph)...

ESHOO: Gentlemen's time has expired.

BURGESS: I don't know if that's right, 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.

ESHOO: The gentlemen's time has expired. The Chair now...

BURGESS: May the gentlemen answer the question?

ESHOO: ... recognizes...

BURGESS: Would the witness be able to answer the question?

ESHOO: OK.

BRIGHT: 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 and 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.

BURGESS: Those studies are at the end when someone is...

ESHOO: Gentlemen's time is expired.

BURGESS: You can't do those studies without the drug, though...

ESHOO: The chair recognizes the...

BURGESS: ... and you did need to acquire the drug for this (ph)...

ESHOO: ... the ranking...

BURGESS: ... to perform this study...

ESHOO: ...the gentleman's time -- please. Let's -- 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.

PALLONE: 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 you know, your courage in being here reminds me of some of the people I read about in that book.

I am concerned, Dr. Bright that the Trump administration does not have plans for a nationwide vaccine program to ensure that once a 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, "without proper scientific vetting," or that lacked scientific merit.

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?

BRIGHT: 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 (inaudible) to try to make a vaccine. There are many diseases we've attempted to make vaccines for through 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 the various ingredients that go in to a vaccine, as well as the glass vials that the vaccines are put in to -- 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. 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.

[10:55:00]

It was highlighted that we would need at least $10 billion from the outset of the pandemic to start the development of drugs and vaccines. Every day we delay delays the output of that vaccine or drug.

And so in those early days my first meeting with Secretary Azar, I asked for funding for people and for those viruses. The three (ph) critical thing is to get the vaccine started. It took some time to get the funding available through various processes.

What BARDA did is we began to look internally at other contracts and other programs we had to redirect some available funding, some minimal (ph) funding to even as early as January 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.

PALLONE: And I guess my concern is, I'm very critical of the (ph) administration in terms of their -- I call it incompetence with the supply chain with lack of testing. I'm afraid the same thing is going to happen with vaccines, and once this -- and the distribution. I mean, should I be concerned, based on your experience?

BRIGHT: Absolutely, sir. I'm -- 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 vaccine becomes available, there's no one company that can produce enough for our country, or for the world. There'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, distribute it -- but administer it in a fair and equitable plan.

PALLONE: And that's not the case at this point (ph)?

BRIGHT: We don't have that yet and it is a significant concern.

PALLONE: Thank you. Thank you, Madam Chair.

ESHOO: 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 questioning...

WALDEN: 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?

BRIGHT: That is one of BARDA's roles, yes. To support industry, to make the vaccines.

WALDEN: OK. Is it BARDA's responsibility to direct the personal protective equipment acquisition distribution, the PPE? Is that part of your responsibility at BARDA?

BRIGHT: 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...

WALDEN: OK.

BRIGHT: So 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 ASPR, the Strategic National Study (ph)...

WALDEN: But ASPR 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 housed right in BARDA, right?

BRIGHT: It's my responsibility to raise a significant concern about a limited supply or a shortage that I think will affect the lives of Americans.

WALDEN: Did you raise that concern with people up here on Capitol Hill? And if so, who and when?

BRIGHT: 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...

WALDEN: But not up -- not up here?

BRIGHT: 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.

WALDEN: 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.

BRIGHT: Yes.

WALDEN: On the first case of SARS-CoV-2 in the U.S. it was identified, I believe January 22nd in Washington state. CDC put the positive specimen in culture that day, correct?

BRIGHT: I believe so, I think it's January 20th.

WALDEN: OK. It's my understanding the samples from the virus were made available to the U.S. 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 U.S. government, from the Washington state case, and potentially even after the CDC's effort to grow the virus and then share with the BEI biorepository, you were still seeking --

[11:00:00]