Jun 1, 2020
When Congress (finally) returned from their COVIDcation, experts in medicine, vaccine development, law, and business testified under oath. In this episode, hear the highlights from 17 hours of that expert testimony during which you'll learn about a concerning new vaccine development policy, Mitch McConnell's dangerous demands for the next COVID-19 response law, and how Republicans and Democrats failed for the last two decades to secure the nation's medical mask supply.
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51:40 Rep. Ana Eshoo (CA): Was there a failure to respond with the needed urgency when you correctly pushed to ramp up production of masks, respirators, syringes, swabs. Dr. Rick Bright: Congresswoman, we've known for quite some time that our stockpile is insufficient and having those critical personal protective equipment. So once this virus began spreading and became known to be a threat, I did feel quite concerned that we didn't have those supplies. I began pushing urgently in January along with some industry colleagues as well. And those urges, those alarms were not responded to with action.
52:15 Rep. Ana Eshoo (CA): Was there a failure to take immediate action when you correctly push to acquire additional doses of the drug Remdesivir, which is the only drug so far that has appeared to be at least mildly effective, thank God, for treating people with COVID-19? Dr. Rick Bright: There was no action taken on the urgency to come up with a plan per acquisition of limited doses that Remdesivir nor to distribute those limited doses of Remdesivir once we had the scientific data to support their use for people infected with this virus.
1:04:00 Rep. Frank Pallone (NJ): My concern is, I'm very critical 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 it's in the distribution. I mean, should I be concerned based on your experience? Dr. Rick Bright: Absolutely, sir. We're already seeing those challenges with limited doses of Remdesivir with data that we're getting that Remdesivir has some benefit in people. And we have limited doses and we haven't scaled up production and we don't have a plan and how to fairly and equitably distribute that drug. If you can imagine this 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. It's gonna be limited supplies. We need to have a strategy and plan in place now to make sure that we can not only feel that vaccine, make it, distribute it, but administer it in a fair and equitable plan. And that's not the case at all. We don't have that yet and it is a significant concern.
1:11:50 Dr. Rick Bright: Normally it takes up to 10 years to make a vaccine. We've done it faster in emergency situations. But from when we had starting material in the freezer for Ebola, but for a novel virus is actually haven't been done yet that quickly. So a lot of optimism is swirling around a 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 considered 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. Rep. Eliott Engel (NY): 12 to 18 months from now, or 12 to 18 months from when this all started at the beginning of the year? Dr. Rick Bright: It will be 12 to 18 months from when the particular manufacturers has first received the material or information that they need to start developing that vaccine. It's critical to note when we say 12 to 18 months. That doesn't mean for an FDA approved vaccine. That means to have sufficient data and information on the safety and immunogenicity if not efficacy, to be able to use on an emergency basis. And that is a consideration that we have in mind when we talk about an accelerated timeline.
1:14:20 Dr. Rick Bright: Congressmen our concern's centered around the potential use of chloriquine in people who are infected with this Coronavirus. There are data, the effective use and safe use of chloriquine in malaria patients and other patients and other indications. We also knew that there are potential safety risks with chloriquine they cause irregular heart rhythms, and even in some cases death. So our concern was with limited information and knowledge, especially of its use in COVID-19 infected patients and the potential for those risks, then we should make sure that any studies with that drug are done in a carefully controlled clinical study and a close watchful eye of a physician so they could respond to a patient if they did experience one of those adverse events. There wasn't sufficient data at that time to support use of this drug in patients with COVID-19 without close physician supervision. Rep. Eliott Engel (NY): And when you raised that issue of chloriquine use in Coronavirus patients with HHS leadership. What happened to you you removed as a director of BARDA. Is that not true? Dr. Rick Bright: I believe part of that removal process for me was initiated because of a push back that I forgave when they asked me to put in place an expanded access protocol that would make chloriquine 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, FDA, BARDA, NIH and CDC worked hard to switch that to a emergency use authorization with strict guardrails that the patients would be in a hospital confirmed to be infected with this virus under close supervision of a doctor and who could not otherwise participate in a randomized controlled study. 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 health and human services were pushing to make that drug available outside of this emergency use authorization to flood New York, 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.
1:47:15 Rep. Kathy Castor (FL): Dr. Bright you understood that America would face a shortage of respirators in January? Is that right? Dr. Rick Bright: We understood America would face a shortage of N95 respirators for a pandemic response in 2007. And we have exercise 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 in 95 respirators in our stockpile to protect our healthcare workers from a pandemic response. Rep. Kathy Castor (FL): 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 you took and the responsibilities you received. Dr. Rick Bright: We knew going into this pandemic that critical medical equipment would be in short supply. I began getting alerts from industry colleagues in mid and late January, telling me that from an outside view, from the industry view that the supply chain was diminishing rapidly telling me that other countries that we relied on to supply many of these masks were blocking export and stopping transfer of those masks to the United States. I learned that China was trying to buy the equipment from the United States producers to have it shipped to China so they could make more. In each of these alerts, and there were dozens of these alerts, I pushed those forward to our leadership and asked for Dr. Cadillac and his senior leadership team. I pushed those warnings to our critical infrastructure protection team. I pushed those warnings to our Strategic National Stockpile team who has the responsibility of procuring those medical supplies for our stockpile. In each of those. I was met with indifference, saying they were either too busy they didn't have a plan. They didn't know who was responsible for procuring those. In some cases they had a sick child and we'll 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. Rep. Kathy Castor (FL): In your whistleblower filing you discuss a February 7th meeting of the department leadership group, but which you urge the department to focus on securing and 95 masks. Can you describe what happened at that meeting? Dr. Rick Bright: They informed me that they did not say believe there was a critical urgency to procure mass. 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 healthcare workers. My response was, I cannot believe you can sit and say that with a straight face. That was an absurd. Rep. Kathy Castor (FL): In fact, it took three months from your initial warnings - until mid April for the federal government to invoke its authority under the Defense Production Act, to require the production of millions of more N-95 masks. And even then, the administration required the production of only 39 million masks which is far fewer than you and other experts said that we would need. What was the consequence of this three month delay and inadequate response. Were lives in danger? Dr. Rick Bright: Lives were in danger and I believe lives were lost. And not only that, we were forced to procure the supplies from other countries without the right quality standards. So even our doctors and nurses in the hospitals today are wearing N-95 Mark masks from other countries that are not providing the sufficient protection that a US standard N-95 mask would provide them. Some of those masks are only 30% effective. Therefore, nurses are rushing in the hospitals thinking they're protected and they're not.
2:15:50 Dr. Rick Bright: I believe there's a lot of work that we still need to do. And I think we need still, I don't think I know, we need still a comprehensive plan and everyone across the government and everyone in America needs to know what that plan is and what role they play. There are critical steps that we need to do to prepare for that fall, for that winter coming. We do not still have enough personal protective equipment to manage our healthcare workers and protect them from influenza and COVID-19. We still do not have the supply chains ramped up for the drugs and vaccines and we still don't have plans in place on how we distribute those drugs and vaccines. And we still do not have a comprehensive testing strategy. So Americans know which tests do what, what to do with that information. And we know how to find this virus and trap it and kill it. There's a lot of work we still have to do.
3:40:15 Dr. Rick Bright: I think what's really interesting about the testing story that gets lost in the narrative sometimes is the confusion about the different types of tests. There's an antigen test that tells you if you have the virus in you, there's a PCR test, it says it may the fragments of the virus and there's antibody tests, it looks at your antibody titer to try to tell you you've been exposed already maybe immune to that the virus. There's a lot of confusion, I think the first thing HHS needs to do is determine which of those tests is most important to achieve which objective. If the antigen test is was needed, because it's faster and lower cost, and more readily available, in some cases, what does it tell Americans? What does it tell employers? What does it tell schools about the potential for an individual who has a positive or negative on that test and their potential to have different results the next day or later that day? There's a lot of confusion about these tests. So I think the first thing that HHS should do is determine the type of test and how that test would be used effectively. And then make sure that we have enough of those types of tests and they're in the right place and the people using them know what the data tells them and how to use it effectively. I think there's a lot of confusion there and they need leadership in HHS to distinguish those challenges and clarify that for the American public.
3:41:30 Rep. Blunt Rochester (DE): Why do you think that our nation has struggled with ramping up the testing capacity, unlike other countries, and were there contingencies in place or a backup, in light of this situation we're in now. Dr. Rick Bright: I think part of the struggle is waiting too late to think about it and to get it started. When we've had conversations with some manufacturers, they've been very creative and how they can ramp up. Another part of the challenge is, we have allowed many of these capabilities to be offshore. And so we have much more capability of expanding domestic capacity when it's in our country, and we can ramp up and bring innovation to those companies in the US. But if the supply chain is offshore, and there's a global need and competition for that supply chain, that also significantly impairs our ability to ramp up.
3:47:30 Dr. Rick Bright: We need to have a strategy that everyone follows, the same strategy, to test for the word the viruses who's infected with this virus. And then we have to appropriately isolate that person in quarantine so they don't infect others. And we rapidly need to trace their contacts to understand who they may have been exposed to, and be able to test to those individuals. And if they've been infected as well, we need to be able to isolate those. Through a concerted coordinated effort across the country, we can be able to identify where that virus is who's been exposed, give those people proper treatment and isolation and can slow the spread of this virus significantly. But that has to be in a coordinated way. We have to have the right tests and enough of those tests. It's not something we do once and we're done. It's something we have to continually do in the community. So it's not just that we need one test for every person in America. We need multiple tests and the right types of tests. We need the right types of individuals and professionals who know how to use those tests to trace the individual contacts and to isolate that virus and stop it from spreading.
4:11:00 Mike Bowen: Until 2004, 90% of all surgical masks worn and I'm including surgical respirators, were domestically made. That year, or about around that year. All of the major domestic mask sellers switched from selling domestically made masks to selling imported masks. Prestige Ameritech was founded in 2005 recognized this as a security issue in 2006. We thought that once America's hospitals learned that their mask supplies were subject to diversion by foreign governments, during pandemics, they would switch back to U.S. made masks. We were wrong. In November of 2007, we received a phone call from BARDA asking for a tour of our mask factory. BARDA was acting on George W. Bush's Presidental Directive 21, the purpose of which was to review America's disaster plans. Brenda Hayden with BARDA gave a presentation which showed that BARDA was concerned about the foreign controlled mask supply. We were thrilled that BARDA had discovered the issue until Brenda said that BARDA was only charged with studying the problem. We were disappointed but we took consolation in the fact that finally, a federal agency knew that the mask supply was in danger. We were very happy to have an ally. Two years later, I received a call from Brenda Hayden. She started the conversation by saying, we have a situation. Her serious tone caused me to ask her if she was talking about a pandemic. And she said, Yes. She asked if we could ramp up production, and I said yes. We built more machines bought an abandoned Kimberly Clark mask factory and tripled and tripled our workforce. America's hospitals needed us and we rose to the occasion. We told them about the high cost of ramping up. And they said they would stay with us. Unfortunately most returned to buying cheaper foreign made masks when they became available. The company survived by laying off 150 people who helped save the US mask supply by taking pay cuts. And by taking on more investors. The H1N1 pandemic, this is 2009 2010, wasn't severe enough to cause the foreign health officials to cut off mask shipments to America. So our predictions didn't come true...yet. In a weakened state, but undaunted, Prestige Ameritech continued saying that the US mask supply was headed for failure. We just didn't know when. In 2004 to give my security story more issue, I formed the Secure Mask Supply Association. You can find it at securemasksupply.org. Paraphrasing Ben Franklin, I told three competing domestic mask makers that if we didn't hang together, we would hang separately, as China was poised to put all of us out of business and put the country at even greater risk, Crosstex, Gerson, and Medecom all with domestic mask making factories agreed and joined the SMSA. Unfortunately, the Secure Mask Supply Associations warnings were also unheeded. During my quest to secure the US mask supply, I had the privilege of working with three BARDA directors, Dr. Robin Robinson, Dr. Richard Hatchet, and Dr. Rick Bright. They were helpful and they encouraged me to go continue warning people about the mask supply. I'll say a little bit more about that. After years of doing this, I quit many times. And the only reason I kept doing it is because of the directors of BARDA. They would encourage me and asked me not to not to quit. They said that they would express their concerns about the masks supply to anyone that I could get to call them. Anyone except reporters. They weren't allowed to talk to reporters, which was very frustrating to me. They also weren't allowed to endorse the Secure Mask Supply Association. Dr. Robinson was going to do so until HHS attorneys told him that it could cost him his job. He called me personally on vacation to tell me that I can confirm that the emails and Dr. Bright's complaint are mine. They are merely the latest of 13 years of emails I sent to BARDA in an effort to get HHS to understand that the US mask supply was destined for failure, Robinson, Hatchet and Bright all wanted to remedy the problem. In my opinion, they didn't have enough authority. Their hearts were in the right places. America was told after 911 that governmental silos had been torn down so that different federal federal agencies could work together for national securities. But I didn't see any of that. The DOD, the VA, the CDC and HHS could have worked together to secure America's mask supply. I suggested this to BARDA and to the CDC on several occasions.
4:23:00 Rep. Greg Walden (OR): This is your email to Dr. Bright and to Laura wolf. It says and I quote, "my government strategy is to help the US government if and only if the VA and DOD become my customers after this thing is over. Mike Bowen: Yes, sir. Rep. Greg Walden (OR): So Madam Chair, I'd like to submit the mail for the record. We'll send you an electronic copy as per our agreements here. Now, Mr. Cohen, I'm sorry. You said you want to help the U.S. government, you want to help Americans get the masks. Yet it appears that there seems to be a condition here. I assume that's because in the past, you ramped up, things went away, people bought from other manufacturers. And so here you're saying, and I have it here in the email, 'My strategy is to help my existing customers and bring on new customers who are willing to sign a long term contract. My government strategy is to help the US government if and only if the VA and DOD become my customers after this thing is over.' And here we were in a crisis is masks are going overseas now. The US government's not your only purchaser, right? Mike Bowen: The U.S. government has never bought from me except during a pandemic, sir. Rep. Greg Walden (OR): Okay. And so... Mike Bowen: In that email, and that statement, was basically saying that I don't want the government to only call me in a pandemic. Give me business during peacetime so that I can survive to help you during a pandemic. Rep. Greg Walden (OR): Did you ever ask for a sole source contract? Mike Bowen: I have. I have been on the DOD and the VA business. And I continually lose to masks that are made in Mexico, because the DOD does not obey the Berry Amendment. They buy foreign masks made in Mexico, because Mexico is a friend of ours and is called a TAA compliant country. Made the decision based on price... Rep. Greg Walden (OR): How long...Sir, if I may, can I reclaim my time? How long, you said you couldn't turn on these lines of manufacturing very quickly. How long? If you got a big order from the government today, would it take you to produce masks? Mike Bowen: Three or four months and the government wants to do that right now. HHS is asking me to do that. Rep. Greg Walden (OR): And it will take three to four months? Mike Bowen: Yes, I'm told. I told him it's going to take three or four months. They only want masks to the end of the year. So I would have to hire 100 people to train 100 people and then fire them at the end of the program. I'm not going to do that. Again. I don't want the government to only deal with me when... Rep. Greg Walden (OR): My time is expired. Madam Chair, I yield back.
4:29:45: *Mike Bowen:** Let me say this: China sells a box of masks for $1. I don't think anybody's making any profit doing that, because I sell them for about $5. So if their prices are so cheap that they've captured most of the world's mass market. Rep. Elliot Engel (NY): Does the government subsidize the Chinese government, the Beijing government? Mike Bowen: I don't know that. I don't know. All I know is their masks cost less than than materials. If I take my labor costs totally out, I'm still nowhere near the cost of their products.
4:30:30 Rep. Elliot Engel (NY): What steps can the federal government take to incentivize more medical manufacturing of critical equipment like surgical face masks in the United States? Mike Bowen: Well as in a letter that I sent to President Obama, I don't think it requires money. I think it requires the government saying and it's a national security problem. It requires the CDC telling America's hospitals, they are too dependent on foreign aid masks, and put them in legal liability. They have to protect their patients and staff. If in a public forum like this, you say, this is a national security issue, then those hospitals' attorneys are probably going to get on the ball and tell their hospitals to buy American made products. And they don't cost that much. The whole market is only a couple of hundred million dollars. This whole problem, this is a $30 million problem, folks, just for people trying to save pennies across the whole United States. It's not some multibillion dollar problem.
4:36:20 Rep. Brett Guthrie (KY): Mike Bowen: You thought it was necessary to go through Dr. Bright. You couldn't get anybody else to listen to them and Dr. Bright under No, no, no, you got it all wrong. First of all I wasn't looking for I'm just trying to find the information. Oh yeah. I wasn't looking for business. I opened my email. I don't need your business. My phones are ringing off the wall. I'm just I thought of BARDA - Dr. Robinson, Dr. hatchet and Dr. Bright. I thought of them as brothers in arms, and who they couldn't buy my products. I knew that. But they were the only people who believed it. I would like everybody to go to YouTube, put in Michael Burgess and Prestige Ameritech you'll see Mr. Burgess talking at our factory 10 years ago. You'll see him say that only 10% of the mask supplies are made in the United States. I talked to Michael Burgess. Ron Wright. Joe Barton. Patrick Leahy. My associate Matt Conlin talked to Chuck Schumer. I wrote Barack Obama letters, wrote President Trump and everybody in his early administration, Defense Secretary Mattis, General Jeffrey Clark, Nicole Lurie and Anita Patel with CDC, National Academies of Science. Greg Burrell, hundreds of hospitals, hospital purchasing groups, the hospital risk Managers Association. The hospital risk managers Association. Told them the mask supply is going to collapse, this is a risk. Nobody listened. Association of Operating Nurses, the Defense Department, the Veterans Department, Texas Governor Rick Perry. State Texas Rep. Bill Zedler, by the way, Bill Zedler got in dozens of reporters. I've been in every news show. I've done this for 13 years. Nobody listened. And my conscience is clean, Mr. Guthrie. I've been working on this damn issue for 13 years trying to save lives. Nobody listened. And now, I'm not going to take any of this.
4:46:20 Rep. Morgan Griffith (VA): We can't guarantee you a contract. I think everybody agrees we've got to have more made in America. Why not ramp up with the understanding that the policy is likely to change? I think it will change because I think we don't, whether it be masks or other PPE or drug supply, we're going to have to have a significant portion of these items made in the United States going forward. Knowing that, and your phone's ringing off the hook, why not ramp up those four lines? Mike Bowen: Because one day, the pandemics gonna end and the the usage will go down to the basement again, where it was there'll be 10 times less usage. And I'll have all these machines and people and these materials and have nothing to do with them. That's what happened to us before. It was a very difficult thing to ramp up. And let me say this again, let me remind you that we have ramped up. We've gone from making 75,000 respirators I'm going to about four... In 40 days, we'll be ramped up to making 4 million respirator per month. So don't concentrate on these four Chinese machines that we really don't know much about and would be a total pain to get going on top of... I'm trying not to kill my business partner who is in charge of getting all this stuff done. He's working 20 hours a day now with all the projects we've already got now, to dump this on top for some business that may or may not come? Absolutely not.
4:48:40 Rep. Morgan Griffith (VA): Okay, after H1N1 did you continue to produce masks for purposes of restocking the Strategic National Stockpile? Mike Bowen: I can't do that without the Strategic National Stockpile wanting to buy them. Rep. Morgan Griffith (VA):Did you have conversations with BARDA, SNS and HHS at that time about supplying the masks for the National Stockpile? Mike Bowen: I have talked to Greg Burrell on many occasions, sir. I've also offered those machines to him. And I've offered those machines to the Department of Defense. Rep. Morgan Griffith (VA): You're just gonna give the machines or you're gonna give them the production? Mike Bowen: No, listen to this. Here's what I wanted to do. I wanted CDC and VA and DOD to get together I had four machines, that very little money and that could make a whole bunch of masks and for years, and I got 13 years worth of emails, I can document all this stuff. I said to the CDC Hey, we can fix, we can make sure that the Department of Defense and the Veterans Administration always has masks. I got these four machines sitting here doing nothing. Rep. Morgan Griffith (VA): You were willing to give them the production, but not the machines. Mike Bowen: Let me finish. Rep. Morgan Griffith (VA): I'm just trying to sort it out. Mike Bowen: Well here's what I was gonna say. We must use one machine, you'll make your whole annual usage for one machine, and we'll let three of them sit there in our factory just ready to go. When you need them, we can turn those things on and I couldn't get anybody interested in Rep. Morgan Griffith (VA): Were you going to give them to them or lease them? Mike Bowen: Didn't matter. I didn't have any money in them. I said give me your peacetime military hospital business and we'll give you these machines. I'll just sit there. Now we would have if we would have had had some kind of a plan, you know, to get materials and things like that. But I was basically saying we've got a warm base operation is not going to cost you guys anything. I made that offer to several agencies. Rep. Morgan Griffith (VA): I see my time is up. I yield back, Madam Chair. Mike Bowen: And by the way, let me Forgive me for being angry. I'm angry because I've done this for so, so long. And I've been ignored for so long. And I apologize. Rep. Ana Eshoo (CA): Well, Mr. Bowen, I don't think you need to apologize. At least that's my view. I think shame on us. I think shame on all of us that we've allowed this to happen.
4:58:30 Mike Bowen: America has a weakness for low prices. And I think Chinese prices are so low. A few years ago, I decided to go buy a 12 things from Lowe's Lowe's Home Improvement center, and I decided I was going to pay whatever it took to buy American. I couldn't make that decision. That decision was taken away from me. I bought one item, it was a plunger. A toilet plunger was the only thing I could find it was made in America. And it is what it is. It's the people like the Lowe's and Home Depot and the Walmarts and the medical companies that the way they want to make money is to lower their costs to where they lower their cost to go to China. The line is long and wide for people going to China, and that's why we're dependent on them for everything. I mean, go out and look in your closet. Look at your tools, look at everything. It's all from China. And the stuff that's in Mexico... When I say this, half of the US mask supply's in Mexico, it's got reservations to go to China. Mexico is not cheap enough. And hospitals are cash strapped and they're they're bidding out things. If this hadn't happened, Mexico would have lost their business and everything... China would have been five years China would have made all masks and respirators like they do the gowns.
5:35:40 Mike Bowen: I've dealt with this thing for so long and it's been so illogical. And I've tried to figure it out and who's at fault who's at fault. And so people ask me that, who's to blame? And I got to the point where it's human nature. It's all of us. I couldn't convince doctors. I couldn't. Listen to this. I had three directors of BARDA said that, Mike, if you get somebody to call me, I will verify that what you're saying is true. I'll tell them it was true. Mr. Schrader, I couldn't get him to call. I couldn't get hospitals to make that call. I don't think they wanted to hear it. They're programmed to save money. They're not programmed to say, I want to make sure my masks are gonna be here. It didn't compute. I was speaking Greek everyone. So to look at this story, and look back and blame everybody, I'm not even going to do that. I'm looking at this pandemic. There's a silver lining, the silver lining is - told everybody there's a big problem. And we can fix this problem and never go through this again.
5:50:00 Rep. Buddy Carter (GA): I'm still confused about your current capabilities. You said you've got four lines that are just sitting dormant sitting in the right now, is that correct? Mike Bowen: We have four idle respirator manufacturing lines. Yes, sir. Rep. Buddy Carter (GA): And they're just, I mean, they're not being used right now. Mike Bowen: Yes. But...go ahead, finish your question. Rep. Buddy Carter (GA): Yes, they are not being used, right. Correct? So you said you've already gotten machines for those lines. You don't have to procure them. The only thing you're going to have to do is to get staff in order to use those lines. Mike Bowen: No, now there's three things we need to hire 100 people, we need to train 100 people. We need to get all the materials for that and we need to get NIOSH approval. We bought those systems from a defunct Vermont mask company seven years ago, we really don't even know how to use those machines. They're kind of a last resort. And if you'll go back and look at my email to Dr. Bright, I said this would be a basically a pain to do but they're here. And if we need this for infrastructure, let's talk about it. But what we've done in the meantime, is we've gone from making 75,000 respirators a month. Think of that number 75,000 to 2 million, and then in another 40 days, we'll be at 4 million from 75,000. So that's thousands and thousands of percent. Rep. Buddy Carter (GA): You said you bought those you bought them for a purpose. You bought them to use them, right? Mike Bowen: No. Thank you for asking that question. No, they came as part of an acquisition we bought. We bought a defunct a medical company and those machines came as part of the acquisition. And made in China. But go ahead. Rep. Buddy Carter (GA): Did you say earlier that you phones ringing off the hook you got orders coming out of the yazoo? Mike Bowen: Yeah, okay, but I can't go on a suicide mission. I can't ramp up, hire all these people for something that I don't know how it's going to end or how long it's going to last. And we did this. You gotta remember, we almost went out of business doing this before. We ramped up and we spent money and got a bigger factory, hired 150 people, built more machines. And then one day, the business not only went away, it went smaller than it was. And we had to raise a million dollars. We had to take pay cuts, and we had to fire 150 people. Rep. Buddy Carter (GA): So what you're saying, and I'm not trying to put words in your mouth, but I'm saying I'm not gonna use them, you're not gonna fire them up unless you get a long term contract from the government. Mike Bowen: I'm not going on a suicide mission. Absolutely. Rep. Buddy Carter (GA): So that's yes, you're not going to use them unless you get a long term contract... Mike Bowen: Unless I get a customer who is going to commit to use those machines so I don't have to fire 100 people. Rep. Buddy Carter (GA): So that means that you'd have to have a long term contract from the government in order to do it. Mike Bowen: Yeah. Listen, we've gone from one shift to 3. 80 people to 200. We're making four times the products we made. We're making over a million masks a day, don't you look at me, and act like I'm sitting on my ass and not firing up four machines. It's not like just turning on a switch. It's putting people's lives... It's gonna, I'm not sure...Listen...let me tell you this. Rep. Buddy Carter (GA): I understand. I'm a businessman. And I understand what it takes Mike Bowen: I watched my business partner cry when he had to lay those people off. We're not doing that again. Rep. Buddy Carter (GA): So in order so it's gonna have to be a long term contract from the government, though, that that's my point. Mike Bowen: From somebody. Rep. Buddy Carter (GA): And I get it from somebody Mike Bowen: I can't hire 100 people based on a maybe based on a when's it gonna end who knows? Rep. Buddy Carter (GA): None of us can whether we're in the private sector or the public sector, we can't do that. We all understand that. Mike Bowen: You don't. You're not risking your livelihood and your... Rep. Buddy Carter (GA): I risked my livelihood for 30 years. As an independent retail pharmacist, I never had long... Mike Bowen: You want to buy machines or hire 100 people, I'll tell you what, I'll give you my machines if you want to hire 100 people, Rep. Buddy Carter (GA): But but the point is, is that you're here saying that I'm not gonna do it unless I get a long term contract from the government. Mike Bowen: I'm just gonna wait, no, no, no, go back to the context. The context of that was in those emails in hey, here's four machines. Let's... they're here, but I can't turn them on unless it's a long term deal. I'm not just going to flip them on and have you flip them off and leave me hanging like everybody did last time. And let me tell you what happened last time, the government sits around doesn't buy American made products, comes to me in a pandemic buys millions of masks. In 2010, you know what they do for those masks, they stored them for 10 years, then they auction them to some knucklehead who put them on eBay and sold them for 10 times what they were worth. So not only did I... have I not seen the government in 10 years, I got to compete with my own masks. And I gotta have thousands of phone calls to me from people who bought that 10 year old masks of mine on eBay for 10 times the price yelling at me, and I had nothing to do with it because the government waited and sold this stuff. I've been hit from every side on this thing. We have bled for this country. We have created jobs, we put our factory in Texas when everybody else had already left the country. So don't don't sit here and judge me for four machines that aren't running that I'd have to hire and fire 100 people for. I'm not going to do it. Rep. Buddy Carter (GA): Not unless you have a long term government contract. Rep. Anna Eshoo, Chairwoman: The gentleman's time has expired.
13:15 Professor David Vladeck: My name is David Vladek. I teach at Georgetown Law School mostly litigation related courses. And I spent more than 40 years as a litigator, mostly in state and federal court. Like all Americans, I am anxious to get the nation back on its feet. I applaud the committee for exploring ways to facilitate that process. And I can only imagine the heavy burden that weighs on your shoulders. As my testimony makes clear, businesses like Mr. Smarts that act reasonably to safeguard employees, and the public are already protected from liability. But as all of the panelists have said, We urgently need science-based COVID-19 enforceable guidelines from our public health agencies. Those guidelines not only safeguard the public, but at the same time, they provide the standards of liability that Mr. Tyner was just talking about compliance with those guidelines will eliminate any liability risk. On the other hand, it would be counterproductive for Congress to take the unprecedented act of bestowing immunity on companies that act irresponsibly. Workers and consumers are going to open this economy, not government sponsored immunity. We all know that large segments of the public are still justifiably fearful about reopening. Granting immunity would only feed those fears. Immunity sends the message that precautions to control the spread of virus is not a priority. Even worse, immunity signals to workers and consumers that they go back to work or they go to the grocery store at their peril. Why? Because the Congress has given employers and businesses a free pass the short change safety.
16:30 Professor David Vladeck: The line between unreasonable or negligent misconduct, and gross misconduct is murky, context based, and fact dependent. Any tort claim can constitute gross negligence, depending on the wrongdoer state of mind. Second, differentiating between the two tiers of liability turn on intent, questions of intent, questions of intent are factual questions for a jury, not a judge to resolve and conduct is labeled negligent or grossly negligent only at the end of a case, not at the outset. In other words, we don't know for sure whether conduct is grossly negligent until the jury says so. And third, and most importantly, the difference is utterly meaningless if we care about containing the spread of the virus. Irresponsible acts spread the virus just as easily, just as effectively as reckless acts.
17:45 Professor David Vladeck: Legislation that simply displaces state liability laws is not only unprecedented, it is likely unconstitutional.
30:40 Sen. Diane Feinstein (CA): ...how the corona virus spreads? How could a customer of... Well, given how it spreads, nobody really knows how, could a customer of a particular business prove they were infected at a particular business? If professor Vladeck could respond, I believe he's our legal counsel here. Professor David Vladeck: Yes. So the answer is they can't. See are the viruses so transmissible, that it's very difficult unless you have a situation like you've had in the meatpacking plant to know where the virus comes from. In New York, one of the findings was that even people who had been housebound for a long time contracted the virus, even though they hadn't gone out. And so part of the reason why there have been almost no tort cases, about COVID-19 people have bandied about figures, but the truth is, they're been almost none of these cases and they're likely to be very few, because in order to plead a case in court, you have to be able to establish causation. And if someone who's been out and about walking on the streets, visiting the grocery store, visiting another shop, contracts virus, there's no way in the world they're going to be able to say, it's Mr. Smith's fault.
43:45 Sen. Patrick Leahy (VT): Some people are talking about this wave of COVID-19 litigation as the justification for corporate immunity. Actually about 6% of the COVID-19 related lawsuits are tort related, constantly seeking immunity for 6%. And moreover, the corporation's claiming they need this immunity are often the ones that subjected the employees to mandatory arbitration clause, we know those almost always favor the employer. So, can you tell us how the prevalence of mandatory arbitration clauses actually within or across key industries impacts the likelihood of a so called wave litigation? Rebecca Dixon: Yes, Senator, I would say that the wave of litigation is actually mostly businesses suing other businesses and businesses trying to enforce insurance contracts related to the pandemic. So that's one important thing to put out there. And when you have forced arbitration, you must go through a secret process with an arbitrator. So you are barred from going to court. And we know that employees are being coerced into signing these if they don't sign those, they don't get the job. Sen. Patrick Leahy (VT): So the additional shield against losses would pretty much be done with, is that correct? Rebecca Dixon: Correct. Sen. Patrick Leahy (VT): Thank you.
1:25:15 Rebecca Dixon: For workers in particular, right now, they don't really have any enforceable recourse if their employer is not following the guidelines because they're not enforceable. And if they are injured because of it, they have the workers compensation system or they can file an OSHA complaint, but they're pretty much locked out other than that, so that's going to make it really risky for workers to when they're making a choice between wages and their health to choose to come back to the workplace.
1:36:00 Sen. Chris Coons (DE): Let's just clear the deck on this one. Mr. Smart, Professor, excuse me, President if I could Perrone, do you believe the federal government has set clear, consistent science based enforceable standards for what's expected of employers to protect the safety of their workers during a pandemic? Kevin Smartt: I do not believe so. No. Sen. Chris Coons (DE): Mr. President? Anthony “Marc” Perrone: Senator, I don't think that they've done that for the employees or the customers.
2:08:04 Sen. Kamala Harris (CA): In 49 states employers are required to carry workers compensation insurance. Is that correct? Rebecca Dixon: Yes, that's correct. Sen. Kamala Harris (CA): And is it correct that by and large businesses that carry workers compensation cannot be sued by their workers for negligence? Rebecca Dixon: That's also correct. Sen. Kamala Harris (CA): And is it also correct that forced arbitration agreements also prohibit workers from seeking justice in courtrooms? Rebecca Dixon: That's also correct.
46:45 Sen. Lamar Alexander (TN): Let's look down the road three months, there'll be about 5,000 campuses across the country trying to welcome 20 million college students. 100,000 Public Schools welcoming 50 million students. What would you say to the Chancellor of the University of Tennessee Knoxville, or the principal of a public school about how to persuade parents and students to return to school in August? Let's start with treatments and vaccines first, Dr. Fauci, and if you can save about half of my five minutes for Admiral Giroir's testing I would appreciate it. Anthony Fauci: Thank you very much, Mr. Chairman. Well, I would be very realistic with the chancellor and tell him that when we're thinking in terms. Sen. Lamar Alexander (TN): It's a her in this case. Anthony Fauci: I would tell her, I'm sorry, sir, that in this case, that the idea of having treatments available or a vaccine to facilitate the re-entry of students into the fall term would be something that would be a bit of a bridge too far.
48:30 Anthony Fauci: But we're really not talking about necessarily treating a student who gets ill, but how the student will feel safe in going back to school. If this were a situation where we had a vaccine, that would really be the end of that issue in a positive way, but as I mentioned in my opening remarks, even at the top speed we're going, we don't see a vaccine playing in the ability of individuals to get back to school this term.
52:50 Anthony Fauci: What we have worked out is a guideline framework of how to safely open America again. And there are several checkpoints in that with a gateway first of showing, depending on the dynamics of an outbreak in a particular region, state, city or area that would really determine the speed and the pace with which one does re enter or reopen. So my word has been, and I've been very consistent in this, that I get concerned, if you have a situation with a dynamics of an outbreak in an area such that you are not seeing that gradual over 14 days decrease that would allow you to go to phase one. And then if you pass the checkpoints of phase one, go to phase two and phase three. What I've expressed then and again, is my concern that if some areas city states or what have you jump over those various checkpoints and prematurely opened up without having the capability of being able to respond effectively and efficiently. My concern is that we will start to see little spikes that might turn into outbreaks.
54:30 Anthony Fauci: But this is something that I think we also should pay attention to, that states, even if they're doing it at an appropriate pace, which many of them are and will, namely a pace that's commensurate with the dynamics of the outbreak, that they have in place already The capability that when there will be cases, there is no doubt, even under the best of circumstances. When you pull back on mitigation, you will see some cases appear. It's the ability and the capability of responding to those cases, with good identification, isolation and contact tracing will determine whether you can continue to go forward as you try to reopen America.
1:05:40 Sen. Bernie Sanders (VT): The official statistic, Dr. Fauci is that 80,000 Americans have died from the pandemic. There are some epidemiologists who suggests the number may be 50% higher than that. What do you think? Anthony Fauci: I'm not sure, Senator Sanders if it's gonna be 50% higher, but most of us feel that the number of deaths are likely higher than that number, because given the situation, particularly in New York City, when they were really strapped with a very serious challenge to their healthcare system, that there may have been people who died at home, who did have COVID, who are not counted as COVID because they never really got to the hospital. So the direct answer to your question, I think you are correct, that the number is likely higher. I don't know exactly what percent higher, but almost certainly, it's higher.
1:26:30 Sen. Rand Paul (KY): You've stated publicly that you'd bet at all that survivors of Coronavirus have some form of immunity. Can you help set the record straight that the scientific record as is as being accumulated is supportive? That infection with Coronavirus likely leads to some form of immunity. Dr. Fauci? Anthony Fauci: Yeah, thank you for the question, Senator Paul. Yes, you're correct. That I have said that, given what we know about the recovery from viruses, such as Corona viruses in general, or even any infectious disease, with very few exceptions, that when you have antibody present is very likely indicates a degree of protection. I think it's in the semantics of how this is expressed. When you say has it been formally proven by long term Natural History studies, which is the only way that you can prove one is it protective, which I said and would repeat is likely that it is, but also what is the degree or titer of antibody that gives you that critical level of protection. And what is the durability, as I've often said, and again, repeat, you can make a reasonable assumption that it would be protective. But Natural History studies over a period of months to years will then tell you definitively if that's the case.
1:31:30 Anthony Fauci: You don't know everything about this virus. And we really better be very careful, particularly when it comes to children. Because the more and more we learn, we're seeing things about what this virus can do that we didn't see from the studies in China or in Europe. For example, right now, children presenting with COVID-19, who actually have a very strange inflammatory syndrome, very similar to Kawasaki syndrome. I think we've got to be careful if we are not cavalier in thinking that children are completely immune to the deleterious effects. So again, you're right in the numbers that children in general do much, much better than adults and the elderly, and particularly those with underlying conditions. But I am very careful, and hopefully humble in knowing that I don't know everything about this disease, and that's why I'm very reserved in making broad predictions.
2:30:15 Anthony Fauci: We do the testing on these vaccines, we are going to make production risk, which means we will start putting hundreds of millions of dollars of federal government money into the development and production of vaccine doses before we even know it works. So that when we do and I hope we will and have cautious optimism that we will ultimately get an effective and safe vaccine that we will have doses available to everyone who needs it in the United States, and even contribute to the needs globally because we are partnering with a number of other countries.
2:49:00 Sen. Mitt Romney (UT): Given our history with vaccine creation for other coronaviruses, how likely is it? I mean, is it extremely likely we're going to get a vaccine within a year or two? Is it just more likely than not? Or is it kind of a long shot? Anthony Fauci: It's definitely not a long shot, Senator Romney, the I would think that it is more likely than not that we will, because this is a virus that induces an immune response and people recover. The overwhelming majority of people recover from this virus, although there is good morbidity and mortality at a level in certain populations. The very fact that the body is capable of spontaneously clearing the virus tells me that at least from a conceptual standpoint, we can stimulate the body with a vaccine that would induce a similar response. So although there's no guarantee, I think it's clearly much more likely than not that somewhere within that timeframe, we will get a vaccine for this virus.
3:06:50 Sen. Jacky Rosen (NV): Can you talk about PPE for the general public? Anthony Fauci: Well, you know, the best PPE for the general public, if possible right now is to maintain the physical and social distancing. But as we've said, and I think all of us would agree, there are certain circumstances in which it is beyond your control, when you need to do necessary things. Like go to the drugstore and get the occasion, go to the grocery store and get your food that in fact, you need some supplementation to just physical distancing. That's the reason why some time ago, recommendation was made, I believe it was Dr. Redfield at the CDC, who first said that about getting some sort of a covering we don't want to call it a mask because back then we were concerned, we would be taking masks away from the health care providers with some sort of mask like facial covering, I think for the time being, should be a very regular part of how we prevent the spread of infection. And in fact, the more as you go outside right here and where I'm sitting in Washington DC, you can see many people out there with masks on, which gives me some degree of comfort that people are taking this very seriously.
3:20:00 Sen. Lamar Alexander (TN): You didn't say you shouldn't go back to school because we won't have a vaccine? Anthony Fauci: No, absolutely not. Mr. Chairman, what I was referring to, is that going back to school would be more in the realm of knowing the landscape of infection with regard to testing. And as Admiral Giroir said, it would depend on the dynamics of the outbreak in the region where the school is, but I did not mean to imply at all any relationship between the availability of a vaccine and treatment and our ability to go back to school.
1:36:20 Gary Disbrow: We do know that Coronavirus, the COVID-19, is one the immune system recognizes and eradicate the virus, we do know that people recover from it. And after a while you can't recover the virus anymore. That's good. That tells you the immune system knows what to do with this. It's not like HIV. At the same time, we do know that this virus can mutate. We've already been able to observe that it's an RNA virus. Fortunately, it doesn't mutate the way influenza does. So we don't think it will have this sort of very rapid seasonal change that we have to deal with with influenza, which means last year's vaccine is maybe not the one you want this year. We really don't know the answer, though to a lot of your questions, and they're fundamentally important. Can you get reinfected with this? There have been a few cases of that they're not incredibly convincing. If you do develop immunity, how long does it last? We do not have a good reason... Sen. Bill Cassidy (LA): Can I ask you though there is evidence both from rhesus monkeys that this antibody is protective it and there's also from SARS1 if you will, somebody writes about immunity being for 18 years. So it does seem If the scientific evidence is pointing in that direction, Gary Disbrow: It's pointing in that direction. You're absolutely right. And we're counting on that to be the answer here. But until we know, we will need to know. Sen. Bill Cassidy (LA): Now, let me ask you though what is defined as knowing because knowing may not be for one or two years, and yet we have to make policy decisions, hopefully before then, Gary Disbrow: Indeed, and I think at the present time to be able to evaluate the meaning of a positive antibody test, one should be quite cautious, I think it's going to help a lot to see if there anybody who has such an antibody test, it turns out to get infected again, in the next six months or so because a virus is going to be around, we'll start to get an early warning sign there. But we won't know whether it's three years or five years or 10 years. Sen. Bill Cassidy (LA): So you suggested to me that not only should we test but we should be tracking who is positive so that we can follow them longitudinally to see whether or not they develop once more. Gary Disbrow: With their appropriate consent of course, and this is where the All of Us program that you and I have talked about which is enrolled now 300,000 Americans who are pre consented for exactly this kind of follow up is going to be very useful to track and see what happens.
2:16:00 Sen. Mitt Romney (UT): I was in a hearing yesterday with the Homeland Security Committee. And the suggestion was between 50 and 90% of the people that get COVID-19 have no symptoms. If that's the case, should we let this run its course to the population and not try and test every person. I'm saying that a bit as a straw man, but I'm interested in your perspective. Gary Disbrow: I appreciate you're putting it forward as a straw man, because while it is true, that lots of people seem to get this virus without any symptoms at all. And the estimates are that maybe 60% of new cases are transmitted by such people. It's still the case that 74,000 people have died from this disease. And so the people who are out there infected who may not themselves be suffering or passing this on becoming a vector to others who are vulnerable with chronic illnesses or in the older age group. And sometimes young people too. Let's not say that they're immune. There are certainly plenty of sad circumstances of young people who really you would not have thought would be hard hit by this, who have gotten very little or even died. So I think it is extremely unusual to have a virus like this that is so capable of infecting people without symptoms, but having them then spread it on, we just haven't encountered something like that before. But it doesn't mean that it's not a terribly dangerous virus for those people who aren't so lucky and who get very sick and end up in the ICU and perhaps lose their lives. The only way we're really going to put a stop to that is to know who the people are who are infected, even if they have no symptoms, get them quarantine, follow their contacts. It's just good solid shoe leather public health, and we've learned it over the decades and it applies here too.
2:31:45 Gary Disbrow: In terms of the need to track people to see what happens, and particularly as was brought up earlier, is the presence of antibody actually something you can say makes you immune. I think maybe our best chance at this is this program that Congress has funded, and it's part of 21st Century Cures Act. So I'll have to specifically give a shout out to this committee about that to the chairman. And that is this program called All of Us, which is tracking when we get there a million people over time, we're already up to over 300,000 that have signed up. And those individuals answer lots of questions. Their electronic health records are available for researchers to look at after they've been anonymized. They get blood samples over the course of time, so you can track and see, oh, it didn't have the antibody, then oh, now it does have the antibody, what happened there? We should be able to utilize that for this and many other purposes to try to get some of those answers. And I totally agree. We need those.
47:00 Dr. Caitlin Rivers: You heard from Dr. Frieden that contact tracing is really a key component, a key approach that will allow us to reopen safely. One thing that I don't hear a lot about about contact tracing, though that I want to bring to your attention is that it's also a key source of data that we badly need. We currently have very little understanding about where people are getting infected, our most new cases in long term care facilities or correctional facilities, which we know are high risk settings. But we don't have a good sense of whether 99% of our cases originate in those special settings or whether it's a small fraction. We don't know whether people who are essential workers still performing duties in the community are getting infected, or we don't know whether most infections are happening at home. Getting a better understanding of what that looks like will help us to guide better interventions. If it is special settings. We know we need to be doing more to protect people there. But we might also assess the risk to the general community to be lower. On the other hand, if most people are getting infected at home, that points for a need for some sort of Central Isolation capacity, by which I mean if people feel that they would be safer recovering in a hotel, away from their families, for example, that should be an option that should be made available to them. But we would want to know what fraction of cases are originating in the household to understand whether that is an important investment. This information on where transmission is occurring is of critical importance, but it's not currently being prioritized and it is contact tracing that allows us to collect this data. So in addition to being a key tool for containment, it's also a key tool for helping us to guide our response and the decisions that we need for that.
53:15 Rep. Rosa DeLauro (CT): Is there a single state that has met the necessary parameters to ease restrictions? Dr. Caitlin Rivers: We suggest in our AI report that she mentioned at the beginning of the session that there are four criteria that states should meet in order to safely reopen and not all states have adopted these criteria, but I'll review them just as a starting point. The first is to see the number of nuclear cases declined for at least two weeks, and some states have met that criteria. But there are three other criteria and we suggest they should all be met. The other is enough public health capacity to conduct contact tracing on all new cases, enough diagnostic testing to test everybody with COVID like symptoms, not just those people with severe illness, and enough healthcare system capacity to treat everyone safely. To my knowledge, there are no states that meet all four of those criteria.
1:47:00 Dr. Caitlin Rivers: Thankfully, we are able to observe that children are lower risk of severe illness. That's something we've seen in other countries. It's something we're seeing in the United States. And so that's encouraging. What we don't know is what role children play in transmission. We know from pandemic influenza or rather influenza generally that children are really central to transmission in the community, not just in schools, but the community broadly. We haven't been able to pin down the science yet of what exactly the role is of children in transmission and so that's where you see a lot of the uncertainty. These two factors weigh against each other and make it very difficult to come to a decision. So I suggest that as other countries move toward reopening, which is happening, some countries are going back to school in the coming weeks. They will be collecting data and doing the analysis that will let us understand what the role of children is and I think that will be helpful for informing our decision.
2:06:50 Dr. Caitlin Rivers: I agree that outdoor areas are low risk for transmission and that they're play a really important role in mental health and overall well being. And so I do support the reopening of those outdoor areas.
Design by Only Child Imaginations