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Dr. Bright Says Window Of Opportunity Is Closing To Address The Pandemic. Aired 11-11:30a ET

Aired May 14, 2020 - 11:00   ET

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

[11:00:00]

WALDEN: and potentially even after the CDC's effort to grow the virus and then share with the BEI biorepository, you were still seeking to obtain a sample of the virus, correct?

BRIGHT: That's true, sir, but we need more than one virus.

WALDEN: Right. I'm going to get to that. Why were the strains not available within the U.S. government, not available to you. Were -- were they available to you?

BRIGHT: Sir, I was asking for viruses in January because we wanted to make sure that we had a head start on developing the vaccine.

WALDEN: Yes. No, I get that.

BRIGHT: And they became available in February. I believe it was February 6th through the BEI resources. Then those were distributed to laboratories...

WALDEN: Did you ask for the virus sample from -- from Washington State as it was part of that.

BRIGHT: Absolutely.

WALDEN: You did, OK.

BRIGHT: I imparted that we ask to make sure we had access to those viruses and they were distributed to the right laboratories and the right companies.

WALDEN: And where did you ultimately get the virus that you distributed sample?

BRIGHT: Some of those virus came from the BEI resources at NIH and some of those viruses came from laboratories that received initial seed form CDC.

WALDEN: OK. That's helpful to know. In some conversations I've been a part of with some 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 believed that the delay in getting the virus sample actually didn't set them back.

Is that an accurate assessment or do you just have a disagreement in -- in that view. And I know scientist disagree, so do we up here. But I'm kind of hearing that -- that having the sequencing really mattered most and getting the virus important but did not set them back in proceeding to get the vaccine -- vaccine development underway.

BRIGHT: Sir, the -- China posted the first sequence on January 11th, I believe or made it available January 10th or January 11. It's import to understand that the sequences available -- when a sequence is available some companies with some technologies can get started with that sequence information.

You still are vulnerable because you have another country in their laboratories that posted on the internet or a database their sequence. So there could still be challenges, especially for national security about the integrity of that sequence.

WALDEN: Yes. 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.

BRIGHT: 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 synthesis a virus with a sequence but it's never going to be represented of the actual virus.

And we're spending billions of dollars on drugs, vaccines, and diagnostics; we want to have the most credible information possible.

WALDEN: Sure. Right. Thank you, Madam Chair.

ESHOO: The gentleman yields back. Pleasure to recognize the gentleman from New York, Mr. Engel, for his five minutes of questions.

ENGEL: Thank you, Madam -- thank you, Madam Chair, for holding today's hearing.

Doctor, if you were a betting man -- sorry. Thank you. Doctor, if you were a betting man when would you bet that we would time and we would have a vaccine.

We've done it faster in emergency situations.

But from -- we had starting material in the freezer for Ebola but for a novel virus, it's actually haven't been done yet that quickly. So, a lot of optimism is swirling around 12 to 18-month timeframe 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.

ENGEL: Twelve to 18 months from now or 12 to 18 months from when this all started, the beginning of the year?

BRIGHT: 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 know -- when we say 12 to 18 months, that doesn't mean for an FDA approved vaccine.

[11:05:00]

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 are -- we have in mind or we talk about in accelerated timeline.

ENGEL: Thank you. I represent in New York Bronx County and Westchester County which is at the epicenter of U.S. coronavirus outbreak, New Rochelle, New York. While New Yorkers have really rallied together in support of their neighbors, the administration has failed at every turn.

The President has sidelined our best scientists, pushed spaces 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 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?

BRIGHT: 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 safety use of chloroquine in malaria patients and other patients and other indications.

We also knew that there were potential safety risks for chloroquine that causes 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 at risks.

Then we should make sure that any studies with that drug were done in a carefully controlled clinical study under close watchful eye of a physician so they can 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.

ENGEL: And when you raised that issue of chloroquine use in coronavirus patients with HHS leadership, what happened to you? You're removed as a director of BARDA, is that not true?

BRIGHT: I believe part of the removal process for me was it's initiated because of a push back that I gave when they asked me to put in place the 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 sciences at the FDA, BARDA and NIH and CDC worked hard to switch that to an emergency use authorization with strict guardrails that the patient 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.

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 the straw that broke the camel's back and escalated my removal.

ENGEL: Thank you. Thank you, Madam Chair.

ESHOO: The gentleman's time is expired.

Pleasure to recognize the gentleman from Kentucky, Mr. Guthrie, for his five minutes of questions.

GUTHRIE: Thank you very much. Thank you, Dr. Bright for being here. We appreciate it very much.

I'll ring to your complaint, I just wanted (ph) 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 the leadership at Health and Human Services and you're given them recommendations. So, if they're not accepting your recommendations to them, I would, I think, fairly surmise or not passing that on the White House.

So, the President was unaware of what you're putting forth because it says in written from your complaint on Page 23, unfortunately, White House Trade advisor Peter Navarro shared Dr. Bright's sense of urgency. So, that's sense of urgency.

[11:10:00]

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. We have -- you prepared your recommendations in a memo from Mick Mulvaney, Chief of Staff, so essentially the President, and then -- so you meet with -- you get around the leadership of HHS, meet essentially with the President since with Mick Mulvaney and he says, you have the meeting with Navarro on Saturday, the memorandum of Mick Mulvaney on Sunday and on Monday, he says, the National Security Council Policy Coordinating Committee met 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 it could be more urgent in government than having a meeting on Saturday and memorandum on Sunday and actions on Monday once they got to the President's attention and the President's level. So, we appreciate the President moving forward on that.

I'm on -- the Ranking Member and I which -- the investigations which you testified in front of us before and we 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 talked about and we're having hearing today and there are actually 33 exhibits referenced in your complaint that's not public. I think we got the majority through the "Washington Post" or something like that. That's how we made documents available for this hearing in my understanding.

So, the 33 exhibits that are not made public that go -- that you're referencing in your complaint, would you make those available to the Committee? Do you have those and make them available to the Committee?

I mean, if you're using your complaint for this hearing, we need to have the documentation.

KATZ: May I address that?

GUTHRIE: Let the Chair -- I don't have a problem with you addressing.

KATZ: Yes. We will take that under advisement and get back to you.

GUTHRIE: OK. Also, when we read through the...

KATZ: There may be privacy considerations in some of the documents. So, we do need to look at these documents carefully.

GUTHRIE: So, let me -- so, also, if you read through the e-mail chains that are made available. Some up here complete but some truly aren't -- they apparently not full e-mail chains.

And so, we wonder if the context of the e-mail would relate to the inferences taken from the e-mails. Would you make all the complete e- mail chains available to us?

KATZ: 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 e-mail. He does not have access to his full e-mail.

GUTHRIE: So, the e-mail chain -- so, the e-mail chains that you have available we have...

KATZ: That's correct.

BRIGHT: I can address...

KATZ: He does not have a full set of his e-mail.

BRIGHT: I can address this, too, and that's exactly right side. So, I was immediately locked out of my e-mail on April 20th of this year. And so, I didn't have full records available to me on that.

However, I believe I'd 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 e-mails and individuals to get a full story and get the full information they can get to the bottom...

GUTHRIE: 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?

BRIGHT: Sir, I believe you have. Probably, it was 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.

ESHOO: To the gentleman, the minority and majority members all received the same packet of information, the e-mails...

GUTHRIE: Which was available in public.

ESHOO: Yes. That was available -- that was in the public domain.

GUTHRIE: So, 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 and so we provide those to the Committee?

BRIGHT: I believe I provided the information I have available to me at this point if I had access to my e-mail from HHS. There might be additional supporting information in that e-mail. I do not know the status if that's been deleted or wiped or I just haven't had access to HHS...

GUTHRIE: OK. Once you have access to. I appreciate your answers. Thank you very much. I yield back.

ESHOO: The gentleman yields back.

Pleasure to recognize the gentleman from North Carolina, Mr. Butterfield, for his five minutes of questions.

BUTTERFIELD: 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 test. According to your count, 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.

[11:15:00]

You learned that the national stockpile did not stop these items. After that, you learned the FDA's 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?

BRIGHT: 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 mention, 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 a shortage of swabs and I was even more surprised that our Strategic National Stockpile did not plan or have any of those in supply.

So, my urgency to find a solution to that was supported by our -- the FDA director, the Center for -- CDRH for these 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 work 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. So, it was a natural occurrence or response for me and my colleagues in BARDA to come up with a solution to that critical supply chain.

BUTTERFIELD: Let me ask you this, were there any restrictions in place in Italy that would require Secretary Azar to move forward with the requested DOD?

BRIGHT: What we needed to enact that air bridge with the Department of Defense was we needed our secretary of -- Secretary Azar to make a request of the secretary of defense.

And my -- I and my colleague, Dr. Gary Disbrow, raised this issue with our -- at our senior leadership meeting with Dr. Kadlec who chairs that meeting, the ASPR, and it clearly was not a topic of -- 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. So, 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 can 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 of Defense, we were able to start those flights within two days. We now transport back over 25 million swabs.

BUTTERFIELD: So, you're saying that you alerted White House adviser Peter Navarro about this issue, is that right?

BRIGHT: Yes.

BUTTERFIELD: And within hours, literally within hours. He had coordinated with DOD to start these flights to transport the swabs.

BRIGHT: Yes, sir.

BUTTERFIELD: 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. 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?

BRIGHT: It seems 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 about -- it includes every component to make sure we can respond and protect the American lives.

BUTTERFIELD: Thank you, Dr. Bright. You're a great American. Thank you very much. I yield back.

ESHOO: The gentleman yields back.

Pleasure to recognize the gentleman from Virginia, Mr. Griffith, for his five minutes of questions.

[11:20:00]

GRIFFITH: Thank you, Mr. Chair -- Madam Chairman. I appreciate that. 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 regular channels. But I would ask this with some of the questions that were just asked about supplies being available.

I kind of got the impression from prior testimony that Project BioShield, which you urged us to put money into and we put 700 million in '18 and 735 in '19, was supposed to take care some of that. Am I misunderstanding Project BioShield?

BRIGHT: Project BioShield is used to invest in late stage development of drugs and vaccines...

GRIFFITH: So, those are for the drugs...

BRIGHT; ... primarily and some diagnostics and...

GRIFFITH: So, they didn't help on this at all?

BRIGHT: It didn't help on this at all, sir.

GRIFFITH: OK. All right. Now, that being said, and I did say -- and I would hope that we would have everything available to us and I understand that may not be your fault, but it does create issues. But everything is going crazy. People have all kinds of things going on and this hydrochloroquine (sic) comes up and there's some e-mail exchanges in Exhibit 54 from your documents indicate that a Christopher Houchens writes and he says, we should probably take a look at this, I'm paraphrasing, but the line I took out of it was, especially when we have few or no options.

One of the frustrations 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 and if hydrochloroquine (sic) is one at one point, then remdesivir, I'm assuming, has been under 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 doses of vitamin C and a drug called Actemra, also an -- Actemra. All of this are floating our 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 even if any totally (ph) was having some effect. Wouldn't you want 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?

BRIGHT: 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 reports we had did not include a thorough safety vetting of those drugs.

There are some known side effects for 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 infected with this virus.

As the virus takes over a lot of your body, it actually infects multiple organs in your body and causes significant inflammation and multiorgan shutdown in some cases before death. In acute respiratory distress syndrome, it really turns your lungs into a brick.

GRIFFITH: It's a serious stuff and you said the hydrochloroquine (sic) that -- one of the problems is we might have a heart -- irregular heartbeat. If you're worried about not having a heart beat at all, that's really not -- we're not worried about irregular if you don't have one at all, am I not correct about that?

I mean, 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 doctor shows just like the doctor in "Richmond" that didn't work in that case. They actually used it there in that case and didn't work. So, he tried something else.

I mean, I think that's really what we're going have to do in an emergency situation, am I not correct?

BRIGHT: We need to do it carefully, sir. We have to make sure that when we have those added information available with those potential drugs available, we are thinking outside of the box...

GRIFFITH: Can't we be so careful that we accidentally kill people?

BRIGHT: We need to move swiftly, sir, and actually, this shows that we could up a clinical study in a matter -- less than a week.

GRIFFITH: OK.

BRIGHT: 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.

GRIFFITH: And I appreciate that. And let me just say this, it's our job to ask some tough questions sometimes but you -- just like you found friendly years at the White House, you might have found some friendly years 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 offshore production and I said, let me know what I can do to help get more production on shore 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.

[11:25:00]

We've got to investigate that.

Today, unfortunately, was not the day to do that investigation. We don't have enough information. A lot of staff 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.

BRIGHT: Thank you.

ESHOO: Gentleman yields back.

Pleasure to recognize the gentlewoman from California, Ms. Matsui, for her five minutes of questions.

MATSUI: 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 your country woefully unprepared for the pandemic impact. Many Americans are eager to return to normalcy as we could all understand.

But even to begin safely reopening, we need widespread testing capacity and organize contract tracing workforce and a health care 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 a scenario will ultimately shorten or lengthen the time it takes for our country to safely reopen and recover from the coronavirus pandemic.

On January 10th, you began pushing HHS leadership to obtain sequencing of virus samples. Given importance of these samples for vaccine and diagnostic development, has the administration's inaction shorten or lengthen our timeline for reopening?

BRIGHT: The samples are critical to get started as early as possible. If there was delay in getting those samples, that means there will be delay in getting this countermeasures and countermeasures are critical to reopening our country.

MATSUI: OK. Throughout the month of January, you made HHS aware 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 shorten or lengthen our timeline for reopening?

BRIGHT: The delaying of these resources had extended the ability -- the timeline to make drugs available and vaccines. Therefore, it's extended our ability to respond to respond to this pandemic. MATSUI: On January 10th, 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?

BRIGHT: That lengthen the timeline for reopening. We needed those early policy discussions to happen as soon as possible.

MATSUI: From January through March, you pushed for HHS to ramp up production of N95 masks, swabs and syringes. HHS failed to act quickly. Has this inaction shorten or lengthen our timeline to reopening?

BRIGHT: That inaction has put a lot of lives at risk in our front-line health care workers. In no time to reopen our country will bring those people back to us.

BRIGHT: Certainly. Thank you, Dr. Bright. Of course, there's many decisions made outside of these scenarios to influence when we can safely reopen. But from what I'm hearing today, HHS, if they heated your warnings early, we could have proactively limited the toll this pandemic has taken on our country.

It appears clear from the whistleblower report that the Trump administration prioritized political calculations about public health with regard to chloroquine and hydrochloroquine (sic). Despite the lack of data supporting, the clinical benefits for the treatment and prevention of COVID-19, the Trump administration promoted the drug's use to the American people because it was seen as a big immediate way.

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?

BRIGHT: 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 -- to 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 sciences 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.

MATSUI: Certainly. The Trump administration waited until April to invoke the Defense Production Act to increase the production of life- saving medical supplies like masks

END