U.S. Senate Committee - Dr. Pierre Kory CRITICAL Witness Testimony May 6, 2020

[0:00] Dr. Pierre Correa. I just spoke with him last week. He's affiliated with the University of Wisconsin-Madison, but he's a New Yorker, and he's currently on the front lines in New York. [0:12] And the reason I wanted to put him first is to give us a little bit of hope. [0:16] What he is talking about in terms of effective therapy once individuals have been hospitalized, I think is very encouraging. [0:25] And I wanted to give him enough time to kind of speak to that before we kind of open up into sort of the main purpose of what this hearing was all about, [0:34] which was really taking a look at the data and taking a look at the policy choice and decisions that we've made and that we need to make based on what that information, what that data tells us and instructs us. [0:44] So, again, our next witness is Dr. Pierre Correa. [0:47] He is the Chief of Critical Care Service and Medical Director of the Trauma and Life Support Center and Associate Professor of Medicine at the University of Wisconsin School of Medicine and Public Health. [0:56] He is board certified in critical medicine, pulmonary diseases, and internal medicine. [1:01] He previously served as Director of the Advanced Courses sponsored by the American College of Chest Physicians. [1:06] Dr. Correa received an MD at the St. George's University School of Medicine. Dr. Correa. [1:13] All right. Yeah, thank you. I believe I'm unmuted. [1:16] So, thanks for the invitation. I really appreciate the opportunity to talk about COVID. [1:21] I do want to start out by saying that I'm really – I'm speaking today as part of a group. [1:27] I have bonded with five colleagues. [1:30] They're some of the most well-known and highly published and most impactful critical care experts in the world. [1:37] And I do want to make sure that I mention them. [1:39] So, one is my colleague, Dr. Paul Marrick. [1:42] He's from the Eastern Virginia Medical School, very well-known in our specialty. [1:45] Also, Dr. Humberto Maduri, who's from the University of Tennessee in Memphis. [1:49] And then also, Dr. Joe Verone in Houston. [1:51] And then, Dr. Jose Iglesias from Hackensack. [1:55] Now, the five of us, we came together early on in COVID. [1:59] And we've been trying to figure out this disease. [2:01] And I got to tell you, we came up with a protocol. [2:04] And I want to talk about that protocol. [2:05] But with some other issues that I think the healthcare system needs to be aware of. [2:09] So, first of all, let me just tell you about some of the results of our protocol. [2:12] So, members of our group have now treated in excess of 100 hospitalized patients with our treatment protocol. [2:19] And we're going to report that nearly all survived. [2:22] The two that died were in their 80s and had advanced chronic medical conditions. [2:25] None of the patients had long stays in the ventilators. [2:28] None are ventilator-dependent. [2:29] And most of them had short hospital stays and were discharged in general good health. [2:33] And so, I'm going to say that is good news. [2:36] Many people are going to be skeptical and ask about that. [2:38] But let me talk about a little bit more about why we are seeing that. [2:41] So, the first thing is, I just want to say how troubled we were. [2:47] I appreciate your comments, Senator Johnson, about, you know, how we're all doing the best we can with the data we have. [2:53] And so, it's hard to point fingers. [2:55] But I have to say that we're a little bit – we are dismayed by the lack of a proposal for an effective treatment protocol. [3:06] There's three critical things that we've seen over the last month that we really want to talk about. [3:10] So, number one – and, again, I do not want to diminish the value and the expertise of our national healthcare societies [3:17] and international healthcare societies like the WHO and the CDC. [3:20] However, they – I think those are bodies that are built for peacetime and not for war. [3:26] And we're at war right now with this virus. [3:28] And one of the main issues that we've seen is that they initially came out – all of the national healthcare societies came out with recommendations [3:36] that focuses on supportive care only, which is generally you give Tylenol for fever, you treat symptoms, [3:42] you might give a little hydration, nutrition, and you give oxygen and ventilators for support when they can't breathe. [3:48] And that's reasonable for viral syndrome, but this thing is different, number one. [3:53] Number two, that strategy is failing. [3:56] I don't think I need to spend a lot of time showing how badly that's failing. [4:00] The mortality and morbidity rates of this disease are unprecedented. [4:04] I've been doing critical care for a decade and a half. [4:06] I do not see mortality rates associated with any severe illness that I see in this one. [4:12] Supportive care is not working. [4:13] We're just trying to put a call out to the world to rethink this supportive care-only strategy. [4:17] So that's one major concern we've had. [4:19] The second is we want to call attention to the world to what we think is a tragic error in analysis of medical data. [4:26] And that is the fact that all societies from the beginning of COVID had revised against the use of corticosteroids in COVID-19. [4:34] We think that is a fatal and tragic flaw. [4:37] And I will tell you why. [4:38] One of the members of my group, Dr. Umberto Marduri, who's probably the world expert on corticosteroid therapy and critical illness, [4:44] three weeks ago, he published a paper along with five other internationally known experts. [4:50] They published a paper in Critical Care Explorations, which essentially reviewed the role and impact of corticosteroid therapy in all the prior pandemics, [4:59] including the coronavirus pandemics of SARS, MERS, and H1N1. [5:03] And contrary to the conclusion of the reviews done by all those national societies, [5:07] they showed that in the two largest and most carefully executed studies of all of the impacts of corticosteroid, [5:15] that corticosteroids are actually life-saving in these severe viral syndromes. [5:20] They showed drastic reductions in mortality in anyone who had anything beyond mild disease. [5:25] You shouldn't use it early as an outpatient. [5:27] But once you hit the hospital, it's life-saving. [5:29] And just this week, we're starting to get even more really impressive data showing the importance of corticosteroid therapy in these syndromes. [5:36] So, for instance, just this week, Surin Dragici, he's the CEO of Advaita Bioinformatics. [5:43] And this is fascinating stuff. [5:45] And this is about as cutting-edge and futuristic medicine that you can imagine. [5:48] But they have this sophisticated artificial intelligence platform called iPathway Guide. [5:54] What they did is they cultured human cells, and they infected them with coronavirus. [6:00] And they were able to analyze the genes that were activated by the coronavirus. [6:05] They were able to do this with multiple viruses. [6:07] And what they saw is that in the coronavirus cell types, the types of genes that were activated, [6:15] they were able to match that against medicines that suppressed the activation of those genes. [6:19] And the one drug that they found that perfectly met the ability to counteract that gene activation was methylprednisolone, which is a corticosteroid. [6:29] At the same time that they did that, Dr. Mayur Ramesh at the Henry Ford Hospital, he's an infectious disease, [6:36] a transplant infectious disease expert and immunologist, he implemented a methylprednisolone protocol. [6:41] Their study just came out this week. [6:42] And what they showed, and I even talked to them in personal communication, is once they started using methylprednisolone, [6:48] their needs for ventilators went down, their mortality went down, and they're reporting this in a study that's right now just a pre-publication. [6:57] But in over 200 patients, they saw dramatic effects. [6:59] He said the entire environment changed. [7:01] There was less codes, less need for ventilators. [7:04] Their ventilators peaked and decreased. [7:06] So they came out of a mass casualty environment to a much more controlled condition. [7:11] And then right now we're also getting word that there's a paper under review from our colleagues in Spain, [7:18] critical care experts, all of them, who are now reporting that when they use methylprednisolone therapy earlier and longer than in the Henry Ford study, [7:25] they're showing absolutely dramatic reductions in mortality. [7:28] So those mortality rates that you're seeing, we think that there's a really strong answer to that, [7:34] and we need to change our treatment strategy, which is one where we did not use corticosteroids, [7:38] which we think are critical, and we want to use them. [7:40] You know, again, this is the standards of medical evidence have changed a little bit in this crisis, [7:46] and so I'm going to use some Facebook posts. [7:48] But these were posted anonymously by doctors who are in the middle of this surge, [7:52] and this is what one of them posted two weeks ago. [7:55] This is a hospitalist from southeast Michigan, and he wrote, [7:57] We floundered for two weeks, lots of codes, intubations, and death, maybe 15 discharges. [8:03] We started steroids and discharged 250 patients. [8:06] Less intubations, less codes. [8:08] And the ones that ended up on a ventilator, not as serious. [8:11] If they have chest X-ray or CAT scan changes, start steroids. [8:15] If they are hypoxic, start steroids. [8:17] If they are ambulatory and hypoxic, start steroids. [8:20] This completely changed our trajectory. [8:22] Steroids are a game changer. [8:24] This critical efficacy is being noticed more and more around the world. [8:28] We're seeing it pop up in new protocols and guidelines. [8:31] Another post from a doctor in New Orleans who also got inundated in the surge, [8:35] they found, he writes, I'm here in New Orleans. [8:37] Since we started using steroids, we were able to free ventilators [8:40] and get elderly patients out of the hospital without needing a ventilator. [8:44] Patients that were obviously crashing quickly, [8:46] who we had to have end-of-life talks with, [8:49] were able to walk out of the hospital. [8:51] At no point did any of our patients worsen because of steroids. [8:55] These patients shed viruses four weeks later with or without steroids. [8:59] The virus doesn't kill anybody. [9:00] It's the inflammation that does. [9:02] You know, so those two things that I just reviewed, which is one, [9:05] the fact that supportive care only is failing. [9:08] Two, the lack of steroids may be a critical absence in the treatment strategy of these patients. [9:14] And then number three, the other thing that we've seen all around the world [9:17] in many institutions and medical journals and editorials is this constant cry [9:21] for randomized controlled trials or prospective trials. [9:24] Listen, we in our group, we all know the critical need for data and trials, [9:28] but we think there's an overemphasis. [9:30] And we're forgetting some of the ethics of doing research in a pandemic [9:33] when patients are dying and they're very sick. [9:35] And I want to remind us of a few ethical principles that the world has agreed on. [9:39] So number one, the Declaration of Geneva of the WMA, which is the World Medical Association, [9:45] binds the physician with the words, the health of my patient will be my first consideration. [9:50] Number two, the International Code of Medical Ethics declares that a physician shall act [9:55] in the patient's best interest when providing medical care. [9:58] And then most importantly, this is where everyone's getting confused, [10:00] is that this idea that what we're doing is unproven or experimental therapies. [10:04] I want to call particular attention to Article 37 of the World Medical Association Declaration of [10:09] Helsinki, first approved in 1964 and most recently approved in 2013. [10:14] And in that Article 37, which is titled Unproven Interventions in Clinical Practice, [10:19] it reads, and I paraphrase, in the treatment of an individual patient where proven interventions [10:24] do not exist, a physician may use an unproven intervention if in the physician's judgment, [10:30] it offers hope of saving life, reestablishing health, or alleviating suffering. [10:35] You know, having said that, let me just talk about what our group did. [10:38] And I'm sorry if I'm going a little bit over time, but this is what we did. [10:41] So myself and Dr. Marek and Dr. Baduri and Dr. Iglesias and Dr. Varun, [10:47] we got together early on and all we did is talk COVID 24 hours a day. [10:52] We exchanged emails and papers and clinical discussions. [10:55] Probably my biggest contribution to the group is that I am a New Yorker. [10:58] I've trained with, I've been trained by, and I've trained almost every person in every ICU [11:04] in New York City. [11:04] And from the beginning, while I was in Madison preparing for the surge, I got to talk to them [11:09] each and every day. [11:10] And the accumulating clinical experiences, the impressions, the responses to different [11:14] treatment strategies, we all got to observe. [11:17] And we convened a group and we came up with a treatment protocol. [11:20] It's based on decades of our experience at taking care of patients, our research, [11:25] as well as hundreds of publications. [11:27] What we noticed was three things that I think people are not recognizing, is that the way [11:32] that this virus is killing people and causing all these ordered failures, there's three major [11:37] pathologic processes that we're seeing, which is this state of extreme hyper and dysregulated [11:42] inflammation. [11:43] Some people are calling it a cytokine storm. [11:45] That's number one. [11:46] Number two, we're seeing hypercoagulability with frequent and excessive clotting. [11:50] And number three, we're seeing this outsized hypoxemia, which approaches to treating that [11:55] have sort of been evolving, but I think we failed in the beginning. [11:59] And so based on those three processes and based on our knowledge of therapies and therapeutics, [12:04] we came up with what we call it our math plus protocol. [12:07] It's on our website. [12:08] It's covid19criticalcare.com. [12:11] But I'm going to go through it really quickly. [12:12] Number one, the three critical medicines is methylprednisolone. [12:16] I just gave you some of the evidence and some of the rationale why that's critical. [12:19] We know it worked in SARS, MERS, and H1N1. [12:22] And the fact that we're not using it here, I think, is causing some of this needless death. [12:26] So methylprednisolone, number one, it's a powerful anti-inflammatory drug that we use [12:30] to suppress the immune system and prevent organ damage. [12:33] This condition in COVID-19, which is the cytokine storm, a cortisoscleroid is the standard [12:38] recommended treatment accepted around the world for cytokine storm. [12:41] Ascorbic acid, although known as vitamin C, everyone dismisses it as a vitamin. [12:45] Those of us who use it and know its physiology and its potency, it's not only a vitamin. [12:50] It acts as a stress hormone in fighting off infections. [12:54] It's critical and has synergistic capabilities along with steroids. [12:57] And so we strongly promote that. [12:59] It prevents the development of leaky blood vessels within the lung and avoids the development [13:03] of lung failure. [13:04] It should always be used when paired with corticosteroids. [13:07] Heparin is another one. [13:08] It's a blood thinner. [13:09] We're seeing excessive blood clotting. [13:10] And almost all centers and institutions around that have promoted the use of some amount of [13:16] blood thinners. [13:17] Some are more cautious than others. [13:18] Some are more aggressive than others. [13:20] But we all recognize the critical need. [13:22] And then the last thing is what a lot of us got wrong. [13:25] I'm going to say at the University of Wisconsin, we didn't. [13:27] I'm going to toot my own horn here. [13:29] But we avoided the early intubation. [13:31] Early intubation with these patients is harming them. [13:33] The machine makes the disease worse. [13:35] And so we should try to avoid intubating until last resort. [13:39] And as we do that, we are seeing that we're able to alter the trajectory of these patients [13:43] away from the ventilators. [13:45] And we're seeing lives saved. [13:47] So I'm just going to summarize by saying our treatment is not unique. [13:50] We're starting to see it pop up in centers and protocols in countries around the world. [13:55] The most recent Italian guidelines were extremely aggressive. [13:58] They're mandating an overall focus on treating inflammation with tocilizumab and mandatory steroid [14:04] to produce early on a disease. [14:06] They're saying to do it as soon as someone's oxygen level dropped. [14:10] And this is what I want to say. [14:11] This is the last tragedy. [14:12] And I know that probably what I've said is a little bit heated. [14:15] I'm emotional. [14:16] But this is absolutely a calamity that's going on in medicine. [14:19] But I've been in New York City for two weeks trying to treat these patients with COVID. [14:23] Either I've been inundated with patients who are chronically on the vent who are dying [14:26] of end-stage fibrotic lung disease, or I'm seeing patients who are crashing into my ICU. [14:31] But as opposed to a month ago where they were coming in with these mild abnormalities on [14:36] chest x-ray and maybe mild abnormalities in their oxygen intake, now we're seeing floridly [14:41] abnormal x-rays with very advanced disease. [14:44] I'm throwing the book at them, and it's not working. [14:47] I have to emphasize that the timing of initiation of this theory is critical. [14:51] The world needs to know this. [14:53] What happened here in New York is that initial surge caused so many terrible reports of patients [14:59] being unattended to, running out of resources, not enough physicians and nurses. [15:03] And now the population is scared. [15:06] They're not coming to the hospital early enough. [15:08] And now when they're coming, they're so far advanced that the medicines don't work as well. [15:13] And so we need to get the word out that things are better on the ground. [15:17] We're definitely much more stable in the hospitals. [15:19] We're much more resourced. [15:21] We're regrouped. [15:22] We're ready to take care of patients, but the patients have to come. [15:25] If they wait at home with these symptoms, we're not going to be able to save them. [15:29] And so I just want to finish by saying, finally, our group, and what we've tried to do was put [15:33] an effective, sound, physiologic, and evidence-based protocol, and we've been trying to disseminate [15:39] it. [15:40] We've sent it. [15:40] It's gone to the White House three times now. [15:43] You know, a month ago, it was given to a member of, I think, Kushner's team. [15:47] They brought it to the White House. [15:48] They apparently liked it. [15:49] However, they got pushback from the NIH and the CDC, who I think were cautious on the [15:53] steroids. [15:54] And then two weeks ago, Dr. Merrick was interviewed by Newt Gingrich, a former speaker, Newt Gingrich, [15:58] who also brought it to the White House. [16:00] We still haven't heard. [16:01] And then this week, our protocol and our group's efforts were published in the American [16:05] Spectator, and the editor of the American Spectator also brought it to the White House. [16:08] We still haven't heard anything. [16:10] We do think that we need to develop a national effective treatment strategy. [16:14] And with that, I think I'm just going to end there and just say we're experts in our [16:18] field. [16:19] This is what we do. [16:20] We know how to take care of patients. [16:21] Let us take care of these patients. [16:23] We know that these medicines are sound. [16:25] We know the safety profile. [16:26] Everything in our protocol is safe. [16:28] FDA approved, has been used for decades. [16:31] Yes, it's off-label, but we do off-label stuff every day. [16:34] And with that, I probably took too much time. [16:36] I'm done. [16:36] Thank you. [16:36] Well, first of all, thank you, Dr. Corey, for just being a doctor, for your passion. [16:45] I can tell you now your protocol has been sent to the White House four times. [16:48] I sent it to Mark Meadows today with the text that I pray somebody in the White House will [16:53] pay attention to this and give it very serious attention. [16:55] So, again, thank you for that. [16:58] Again, thank you. [16:58] Our next... [16:59] Thank you. [17:00] Thank you. [17:00] Thank you. [17:00] Thank you. [17:00] Thank you.