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Trump Accuses FDA As Part Of Deep State; Trump's Misleading Tweet On Mail Boxes Not COVID-Safe; Republican National Convention Kicks Off On Monday; Trump Gets Criticized By His Sister; Convalescent Plasma Gets Nod From FDA. Aired 5-6p ET
Aired August 23, 2020 - 17:00 ET
THIS IS A RUSH TRANSCRIPT. THIS COPY MAY NOT BE IN ITS FINAL FORM AND MAY BE UPDATED.
[17:00:00]
ANA CABRERA, CNN HOST: Sources tell CNN this announcement is expected to be the Emergency Use Authorization of convalescent plasma, which is made from the blood of those who have recovered from COVID-19.
However, the press conference comes after a series of surreal headlines this weekend including the president accusing members of the FDA of being part of the deep state. And without evidence, suggesting they're going slow on testing vaccines and therapeutics so that they can delay them until after the election.
In addition, Twitter had to stop a warning on a different tweet from the president after he suggested ballot drop boxes weren't COVID sanitized. Twitter saying this claim was misleading and could dissuade people from voting during a pandemic.
Adding to all of that, a secret recording of the president's sister, a respected former federal judge calling him cruel, and an asteroid expected to pass by Earth on the day before the election. That about sums up 2020 for you, doesn't it?
More on the comments from the president's sister in just a moment. But first, let's go to CNN's Jeremy Diamond at the White House. And Jeremy, what more can you tell us about the president's news conference set to begin in about 3220 minutes from now?
JEREMY DIAMOND, CNN WHITE HOUSE CORRESPONDENT: That's right, Ana. Well, two sources familiar with the matter are telling us that the president is expected to announce that the FDA has authorized an Emergency Use Authorization for this convalescent plasma.
Now, this is treatment that has already been used in about 70,000 patients across the United States and this Emergency Use Authorization will simply make it easier and perhaps expand access to this treatment. But it is by no means an official FDA approval for this treatment.
That's because these randomized controlled clinical trials still haven't been completed. So, it appears that this is an effective treatment, but the jury is still out. Nonetheless, the president describing this as a major breakthrough. Not quite the case. It certainly is an incremental step here and the president definitely eager to tout that.
Now, the timing of this is what is interesting, of course. Just yesterday the president was accusing the FDA of political motivations for not quickly enough approving treatments and vaccines for the coronavirus. Listen to how the White House chief of staff, Mark Meadows, addressed those comments just yesterday or today.
And I'm sorry, I don't think we have that sound, but Ana, certainly we are expecting to hear from the president in a few moments. And the major question that he will have of course is whether that political pressure played into this decision from the FDA to approve this product or whether it was something that the FDA, a conclusion that they arrived at on their own.
CABRERA: And we will play that sound from Mark Meadows coming up here in just a moment, but while I have you, Jeremy, the president again, today, doubled down on his attacks against mail-in voting. He's even now pushing this idea that mail drop boxes or the ballot drop boxes are a health risk. What more can you tell us about this baseless claim?
DIAMOND: Well, look, what is so remarkable about this, Ana, is the fact that the president has consistently downplayed the health threat to Americans if they go to the polling location themselves.
If they stand in line alongside other people, which is one of the ways that coronavirus could potentially spread as he has fought this notion of expanding mail-in ballot, which many Democrats and some Republicans are pushing for because of the threat of this pandemic.
Now, the president has insisted in his tweet that somehow there is a coronavirus health risk and also claiming that there is an election security risks. Both of those claims are completely bogus. There is no evidence to back these claims up.
And of course, it is notable because the president has recently made a series of claims about mail-in voting accusing -- suggesting that there has been widespread fraud, which is not the case.
And remember, Ana, all of this with the backdrop that the president has suggested that if he loses in November, the only way he could lose is if there is a rigged election. So the president certainly seems to be setting things up for an excuse, an explanation, or perhaps something more if he loses in November.
CABRERA: OK, Jeremy Diamond at the White House, thanks. With us now, Dr. Jonathan Reiner, director of the Cardiac Catheterization Lab and professor of medicine at George Washington University. As Jeremy just reported, this announcement tonight is expected to be an Emergency Use Authorization for convalescent plasma to treat COVID-19.
The administration has built this as a major therapeutic breakthrough. Is that how you see it?
JONATHAN REINER, CNN MEDICAL ANALYST: No, not at all. I think it's a step in the right direction. The problem is we don't really have enough data to really understand how effective convalescent plasma.
So plasma is the fluid that's left behind when you remove the red cells and the white cells and the platelets from blood. And that fluid contains various proteins and clogging factors and antibodies.
And the convalescent plasma, with these antibiotics, has been used in the past for diseases like SARS in 2003 and MERS and H1N1 with some success. So that's what's fueled the excitement for using this in COVID-19.
[17:05:03]
And it's been used widely in the United Sates since the pandemic began through an expanded access program via the NIH and administered by the Mayo clinic. And almost 100,000 patients have received convalescent plasma, but not in a randomized way. So we don't know compared to not -- compare to a placebo, whether convalescent plasma is effective.
But we have recent data that suggests that people who receive convalescent plasma early or earlier do better than those that get it later. And there is some data from -- yes, I'm sorry, go ahead, Ana.
CABRERA: No, please, I didn't mean to interrupt. I think you have important information. Why don't you finish your thought?
REINER: Well, I was going to say that the same study also suggests that when they look at the level of these neutralizing antibodies in the plasma that was received by those patients, the people who did best were those that got sort of the most powerful plasma, so to speak, the plasma with the highest amounts of neutralizing antibodies.
So, it's suggestive, but because there's no randomized on to placebo, we don't know for sure the magnitude of the benefit. That's the problem with this. But this has been used in a lot of people and the EUA, I am not sure it's going to change access all that much. It's mostly symbolic.
CABRERA: I mean, do you think it's surprising that we don't have a better sense about its effectiveness given, as you laid out, there have been tens of thousands of people who have been treated with this?
REINER: Oh, I think it's -- I think it's -- I'm embarrassed that we don't have a better sense about its effectiveness given as you laid out, that there's, you know, there have been tens of thousands of people who've been treated with this.
Look, there are over 5 million people in this country have been infected with this virus. Hundreds of thousands have been hospitalized. Many hundreds of thousands have been hospitalized. And the fact that we don't have a randomized trial to show once and for all the role of this agent in this illness is really unacceptable and really cannot happen going forward.
So this the best data that we have. And the best data that we have seems to suggest that it's safe. But as recently as four days ago, the FDA stated on their website that it has not been proven that this therapy is both safe and effective. I doubt we're going to see data tonight that will show otherwise.
CABRERA: And that is the thing because it was the president last week really upset that they weren't giving this Emergency Use Authorization, accusing health officials of playing politics over the EUA of convalescent plasma specifically, and so now this announcement today.
It also comes the day after the president accused the FDA, without evidence, of being part of the deep state and of delaying trials for potential vaccines and therapeutics. I want you to listen to how chief of staff Mark Meadows defended the president today.
(BEGIN VIDEO CLIP)
MARK MEADOWS, WHITE HOUSE CHIEF OF STAFF: What happens is, is that we continue to look at some of the trials and what's happening and we want to wear a belt and suspenders the way that some of these bureaucrats want to look at it. They want to do things the way they have always done it.
This president is about cutting red tape. That's what the tweet was all about. And I think you're going to hear an announcement later today, which really he had to make sure that they felt the heat. If they don't see the light, they need to feel the heat.
(END VIDEO CLIP)
CABRERA: They need to feel the heat he says. What's your reaction?
REINER: Well, I'll remind you that the FDA under pressure from this administration this spring approved a EUA for hydroxychloroquine with no data, which was subsequently removed. So unfortunately, this agent, which may have some efficacy, again, we don't know how much efficacy, has been contaminated by the taint of this partisan politics.
We can't have that going forward. The public has to have confidence that when the FDA approves an agent, it's both safe and effective. We especially need that. We spoke about this yesterday. We especially need that as we move towards the approval of a vaccine. It cannot seem that the vaccine is being rushed onto the market.
The public has to understand that we have data to show efficacy and safety. So, this kind of partisan arm twisting of the FDA is transparent. It's happening on the eve of the Republican National Convention. So, it's unfortunate, but ultimately the voice of scientists should be listened to by the public.
CABRERA: Before I let you go, I do have to ask you about the president warning of people catching coronavirus by using ballot drop boxes. How big is that risk, really?
REINER: I don't think it's any risk at all. Look, we advise everyone to carry a little bottle of hand sanitizer with them. And any, you know, public, you know, doorknob or mailbox, if you touch it you sanitize your hand afterwards. There's almost no chance you're going to catch coronavirus from a depository for a ballot. Again, that's coming from the person who two days ago was surrounded
by a throng of people without masks at a rally in Virginia, right.
[17:10:04]
Worry about that. Don't worry about the ballot boxes. Ballot boxes are safe.
CABRERA: Dr. Reiner, always good to have you here. I appreciate you very much. Thank you.
REINER: My pleasure, Ana.
CABRERA: We are awaiting the president who is expected to speak momentarily. Sources telling CNN Trump is expected to speak about and Emergency Use Authorization for the use of convalescent plasma to treat COVID-19. We'll bring it to you live. Stay with us. You are live in the CNN NEWSROOM.
(COMMERCIAL BREAK)
CABRERA: Welcome back. The spotlight now on Republicans ahead of the party's national convention, which kicks off tomorrow. CNN learning that President Trump is expected to make an appearance every night this week, including at tomorrow's roll call vote in Charlotte, North Carolina. And that's where we have CNN's Ryan Nobles joining us live. Ryan, give us a taste of what we can expect.
[17:14:59]
RYAN NOBLES, CNN CORRESPONDENT: Well, Ana, we are here in Charlotte where the Republican National Convention is set to kick off. Now, this is not nearly the party they expected to be throwing here in Charlotte when they announced plans to hold the convention here more than a year ago.
And the Republican National Convention planners have been forced to start and stop a number of different plans all because of the coronavirus pandemic. They initially moved all of the big festivities, including President Trump's acceptance speech to Jacksonville, Florida.
But those plans were stymied because of a rising number of cases in Florida and the threat of potential weather because they were going to hold the event outdoors.
So that means the bulk of what's going to take place this week will actually happen in Washington, D.C. including the president accepting the nomination from the White House south lawn on Thursday.
Still, there is some activity taking place here in Charlotte tomorrow. In fact, a very important part of the process, that's the roll call vote, and some 300 delegates from around the country are here in Charlotte to cast their ballots to nominate President Trump once again as the Republican Party's nominee. And President Trump is expected to travel here with Vice President Pence tomorrow to thank those delegates and begin this process of the convention.
Now, what we're waiting to see, Ana, is how the Republicans pull this all together because they were -- been forced to go back to the drawing board so many different times, and President Trump himself has set very high expectations for how he wants this convention to be pulled off. He wants it to be bigger and better than what we saw from the Democrats last week.
So what we are expecting is a lot more in-person live speeches than what we saw from the Democrats last week and we're also going to see them stoking some of the cultural wars with some of their speakers including Nicholas Sandman who was the young man that got into a confrontation with Native Americans on the National Mall during the "March for Life."
Also we're going to hear from the McCloskey couple, that couple from St. Louis, who was out in their front yard waving firearms as Black Lives Matter protesters went by. This is the Trump campaign officially coronating (ph) President Trump to a second term.
And basically, every night of the week we're going to hear from President Trump and we're going to hear from someone from his family. This is all about the Trump family and President Trump as he attempts -- as he wins this nomination with the goal of winning a second term in the White House, Ana.
CABRERA: Ryan Nobles in Charlotte, North Carolina. Thank you for that preview.
And speaking of family, on the eve of the Republican National Convention, the headline is coming from another Trump voice, who most likely will not be at the convention, his sister. Retired federal judge, Maryanne Trump Barry, who is slamming the president, calling him cruel, among many other shocking things. Have a listen.
(BEGIN AUDIO CLIP)
MARYANNE TRUMP BARRY, SISTER OF PRESIDENT TRUMP: This goddamn tweet and the lying. Oh, my god, I'm talking too freely, but you know. The change of stories, the lack of preparation, the lying. The -- holy (BLEEP).
(END AUDIO CLIP)
CABRERA: The president's sister was secretly recorded there by their niece, Mary Trump. "The Washington Post" was first to report on this audio. Mary Trump has recently released a scathing book about the Trump family.
The president, who is also mourning the loss of his brother, responded with this. "Every day it's something else, who cares? I miss my brother, and I'll continue to work hard for the American people. Not everyone agrees, but the results are obvious. Our country will soon be stronger than ever before."
Joining us now, April Ryan, CNN political analyst and the White House correspondent for American Urban Radio Networks and David Gergen, CNN senior political analyst and a former adviser to four presidents, both Republican and Democrat.
So David, it's not the first time the president has been criticized by a family member. Do you think this will detract or take away at all from the RNC's efforts to rally voter enthusiasm or will it not even make a dent?
DAVID GERGEN, CNN SENIOR POLITICAL ANALYST: Well, the president likes to invent distractions, he must hate this one because this cuss is so personal and it's vicious. And she didn't know. It came from her gut. This is what she truly believed.
And after all, she grew up with him. She knows him better than almost anybody else. Most people around him now are people who came into his life since he was young. And it's a remarkable statement. I do think it's going to -- certainly doesn't help.
I do think it's going to hurt some, but I think he had bigger challenges at this convention, trying to get the wheels back on the wagon. There are a lot of things here that are loose when coming down on this caravan.
CABRERA: I want to play a little bit more about of what Mary Trump Barry said. Let's listen.
(BEGIN AUDIO CLIP)
M. TRUMP: Donald is out for Donald, period. When he said -- he started to say something to me, boy, look at what I have done for you. And I said, you have done nothing. Deliberately, I have never asked him for a favor since 1981 when I was being highly considered to go on the federal court, on my own merit.
(END AUDIO CLIP)
[17:20:06]
CABRERA: April, do you think hearing a tape like this resonates with voters at all?
APRIL RYAN, CNN POLITICAL ANALYST: Most definitely. Who knows you best in most cases other than your family, and this is his sister. She has credibility just by being his blood. And two, because she is a federal judge, she has the utmost credibility.
And for her to say the things that she said, she even has receipts about who possibly did those SAT exams or entrance exams to college for him. This is damning. But the question is, can he overshadow what Maryanne Trump Barry is saying and the book that Mary Trump has written?
And I think he's trying to overshadow that today with this press conference that we're seeing, leading into this convention trying to deflect from what his sister said about him on a tape. And also by being on the convention every night. Is it ego or is it trying to rally the base to support him yet again, or is it just both?
CABRERA: There is a lot of anticipation for what this convention will look like, the tone that it will take, the presentation, obviously, with the president's background.
David, we've learned that Trump's team has been working on a nomination speech for him that is similar to the tone he struck for the Fourth of July speech he gave at Mt. Rushmore. And so, I want to remind folks what that speech was like. Listen.
(BEGIN VIDEO CLIP)
DONALD TRUMP, PRESIDENT OF THE UNITED STATES: Their goal is not a better America. Their goal is to end America. In its place, they want power for themselves. But just as patriots did in centuries past, the American people will stand in their way and we will win and win quickly and with great dignity.
(END VIDEO CLIP)
CABRERA: David, how does that square with the Trump campaign promise of a great, uplifting message at the convention?
GERGEN: I think he wants to have it both ways, Ana. He wants to talk about this dystopian world, that we're being assaulted in our cities, we're all about to be now run over, that we're being held hostage by the socialists.
I think that Joe Biden in his convention dispelled most of that. That is just simply is not true. And I think Biden was good about painting a more optimistic picture. But it's really important for Donald Trump. After four years in office, he can't just say how terrible things are.
He's got to say we're moving and we're -- you know, that's why he's got different themes each night about America, land of opportunity, the land of greatness and so forth. He's trying to have it both ways and he may wind up having it neither way.
CABRERA: There's no bigger issue right now facing the American people than the coronavirus, but we've been told it won't be front and center at the RNC. And there is this new CBS/YouGov poll out which asks voters if they thought the U.S. fatalities from coronavirus were acceptable or unacceptable.
Now, Democrats heavily lean towards unacceptable, 90 percent to 10. But look at this, 57 percent of Republicans polled said it was acceptable, 43 percent unacceptable. Let that sit with you, 57 percent of Republicans polled called the deaths of more than 176,000 fellow Americans acceptable. April, how can that be?
RYAN: First of all, you know, we look at politics as party, but I've said this over and over again. It's not about party, it's about people. And beyond that, it's about humanity. One person dead is one too many. And the numbers are rising.
And the reason why many of these Republicans or anyone who supports the president is dismissing this is because he's dismissed about it. And the main reason why you're not going to hear it at this RNC convention, this convention of hate, is because this president doesn't want to own it.
But he owns this. Front and center he owns this. He has blood on his hands from Herman Cain to the two friends of mine at the church that I attended who are dead, to many people around this nation who have loved ones and friends who have died from this.
This is not a president who can stand strong and talk like he's the leader of the free world when he has people dying and he still doesn't have a handle on a pandemic that he did not deal with adequately at the very beginning. He has blood on his hands and it's not acceptable.
CABRERA: April Ryan and David Gergen, thank you both.
[17:25:01]
GERGEN: Thank you.
CABRERA: Thank you so much. We'll have you back soon, as you know.
With the Democratic National Convention behind us, it is the Republicans turn to take the virtual stage. Stay with us all week long, we are covering big speeches, the important moments, and of course President Trump. It all starts tomorrow with our special coverage beginning at 7:00 p.m. eastern live on CNN.
And coming up, let's take another live look at the White House briefing room where you can see they are gearing up for an announcement. The president expected to speak any moment now on a coronavirus treatment. But is it really the major breakthrough the White House says it is? Don't go anywhere.
(COMMERCIAL BREAK)
[17:30:00]
CABRERA: Breaking news, we are just learning the FDA has officially issued and Emergency Use Authorization for convalescent plasma for COVID-19 treatment and we are waiting President Trump who is set to give a press conference any minute now.
And while we wait, let me just go to CNN's chief medical correspondent, Dr. Sanjay Gupta, who is standing by with us. And Sanjay, I have to warn you, I may have to interrupt you to take this press conference live. We've been given warning it's going to start any moment now.
But what more can you tell us about this announcement. Is this the major therapeutic breakthrough that the administration touted it would be? Sanjay, hold on. We got to get your mic working. I can't hear you. I don't believe our viewers can hear you either. SANJAY GUPTA, CNN CHIEF MEDICAL CORRESPONDENT: Sorry. Can you hear me,
Ana? Sorry. Ana, can you hear me?
CABRERA: We can hear you now. Please take it away. Yes, go ahead, Sanjay.
GUPTA: Sorry. Yes. This -- I think it's a very important question, Ana. This is the Emergency Use Authorization for convalescent plasma. Whether or not it's going to be a significant breakthrough, I don't think we can say that. That has been the concern even over the last couple of days.
As you know Ana that the FDA said they are going to halt this Emergency Use Authorization because there wasn't clear enough evidence that there was benefit to this. It is true that tens of thousands of people have been taking this under expanded access programs.
But when you do that, you also want to collect data. Is this actually helping or not? When this data was reviewed, and I'm saying just over the last couple of days, it wasn't very compelling. And that's why the FDA sort of put the brakes on this.
I got to tell you, I'm very surprised that this is happening tonight. I don't know of new data that has been submitted or certainly not analyzed. I've talked to several sources today, sources close to the task force who say they haven't seen new data. If the FDA hasn't either, that's going to be a big question mark.
CABRERA: OK, Sanjay. And now we have the president. Let's listen.
DONALD TRUMP, PRESIDENT OF THE UNITED STATES: And good to see you all. Hope you had a great weekend at your convention, and we're going to have a great convention coming up and I look forward to it. But before I discuss a very historic breakthrough in our fight against the China virus, I'd like to provide and update on the recent wildfires in California and the storms in the Gulf of Mexico.
Yesterday I approved a major disaster declaration for California, spoke to Governor Newsom as they battled two of the worst wildfires in the history of the state. That continues. The federal government has already deployed over 26,000 first responders and personnel to battle the wildfires. We're working very closely with the governor and very closely with a lot of great state representatives and local representatives and we'll take care of the situation, but we have 26,000 first responders already.
Our hearts go out to the thousands of families who have lost their homes as we grieve for the families of two first responders and five residents who have tragically lost their lives in a very horrific fire, one of the biggest we've ever seen.
My administration is also closely monitoring Hurricane Marco and Tropical Storm Laura, which are coming in rapidly. Hurricane Marco is expected to make landfall in Louisiana tomorrow and Tropical Storm Laura is expected to hit Louisiana two days later. This is somewhat unprecedented. The scope of the storms and also the
fact that they come so quickly after one another, both storms have the potential of gathering strength before they make landfall and could cause significant damage across the gulf coast and also in Puerto Rico.
We have everybody stationed and ready to go in Puerto Rico and the gulf coast, and we have tremendous people. We have -- FEMA is lined up and we have the Coast Guard ready. The Coast Guard has done a fantastic job. They do so many -- they do such good work and we want to thank our Coast Guard.
I'm asking all Americans in the storm's path to follow the instruction of your state and local governments closely. And I've approved emergency declarations for Puerto Rico and for Louisiana. FEMA is mobilized on the ground and is ready to help. They will be in there very quickly, very, very quickly.
And I spoke to Governor John Bel Edwards also of Louisiana and I've informed him and at his request also, a major disaster declaration is signed and ready to go. We have everybody ready in Puerto Rico, the gulf coast, Louisiana, and also on the forest fires in California. So, we have a great team. Unfortunately we have some very, very powerful natural disasters.
[17:35:02]
On the therapeutics front, this is what I've been looking to do for a long time. This is a great thing. Today, I'm pleased to make a truly historic announcement in our battle against the China virus that will save countless lives.
The FDA has issued an Emergency Use Authorization, and that's such a powerful term. Emergency Use Authorization for a treatment known as convalescent plasma. This is a powerful therapy that transfuses very, very strong antibodies from the blood of recovered patients to help treat patients battling a current infection.
It's had an incredible rate of success. Today's action will dramatically expand access to this treatment. And I want to thank Dr. Hahn and Secretary Azar. I want to thank the FDA, all of the people that have been working very hard on this.
It showed tremendous potential. This is the only possible and it's only made possible because of "Operation Warp Speed." That is everybody working together. We're years ahead of approvals than we would be if we went by speed levels of past administration. We'd be two years, three years behind where we are today.
And that includes vaccines that you'll be hearing about very soon, very shortly. To deliver treatments and vaccines to save lives, we're removing unnecessary barriers and delays not by cutting corners, but by marshaling the full power of the federal government.
We provided $48 million to fund the Mayo Clinic study that tested the efficacy of convalescent plasma for patients with the virus. Through this study over, 100,000 Americans have already enrolled to receive this treatment and it is proven to reduce mortality by 35 percent.
It's a tremendous number. The FDA, MIT, Harvard and Mount Sinai hospital have also found convalescent plasma to be a very effective method of fighting this horrible disease. Based on the science and the data, the FDA has made the independent determination that the treatment is safe and very effective.
Recently, we provided up to $270 million to the American Red Cross and America's blood centers to support the collection of up to 360,000 units of plasma. In late July, we launched a nationwide campaign to ask patients to have -- who have recovered, and these are patients that have been incredible the way they have donated, but these are people recovered from the virus to donate plasma.
Since then, weekly plasma donations have doubled. And today, I once again urge all Americans who have recovered from the virus to go to coronavirus.gov and sign up and donate plasma today, please. It's been really an incredible -- just incredible people. The country has united so strongly behind this.
And I'll go over the numbers, but if you look at what's happened and the success that we've had that people don't talk about, the United States has experienced the lowest case fatality rate of any major country in the world. You don't hear that.
The European Union's case fatality rate is estimated to be three times higher than that in the United States. Europe has seen 33 percent more fatalities compared to a typical non-pandemic year than the United States.
And I just want to ask two of our people that have done such a fantastic job, Alex Azar and Stephen Hahn to say a few words. And Stephen, I want to thank you because the FDA really stepped up and especially over the last few days in getting this done. The results have been incredible. And I think you'll see the results even go up very substantially. So, we appreciate it. And maybe I'll ask Alex to go first, and then Stephen. Thank you very much. Alex.
ALEX AZAR, HHS SECRETARY: Well, thank you very much Mr. President. Thanks for the bold leadership that allowed us to deliver this very happy news today. Thanks to your all of America approach. America has done more than any other country to expand the arsenal that we have to battle COVID-19.
And thanks to early efforts by your administration, Americans have broader access to these treatments, including convalescent plasma than patients anywhere else in the world. In early April, early in our fight against COVID-19, the FDA, BARDA, the Mayo Clinic and other partners sprang into action to set up an expanded access protocol for this promising treatment.
[17:40:00]
President Trump is the right to try president and he's fought hard to ensure Americans can have access to promising COVID-19 treatments. Convalescent plasma has been a tried and true therapeutic method in prior outbreaks.
But the president wanted to ensure that we developed the data to support its use and this FDA authorization is one result of that effort. The data we gathered suggest that patients who were treated early in their disease course within three days of being diagnosed with plasma containing high levels of antibodies benefited the most from treatment.
We saw about a 35 percent better survival in the patients who benefited most from the treatment, which were patients under 80 who were not on artificial respiration. I just want to emphasize this point because I don't want you to gloss over this number.
We dream in drug development of something like a 35 percent mortality reduction. This is a major advance in the treatment of patients. This is a major advance. Convalescent plasma is one new tool that we've added to our arsenal against COVID-19 alongside remdesivir, steroids and a number of other promising options currently studied.
Because of the president's "Operation Warp Speed," we expect to have other new results and new options reaching patients as soon as this fall. "Operation Warp Speed" is supporting experimental therapeutics all the way through to manufacturing so that if they meet FDA's gold standard for safety and efficacy, they can begin reaching patients without a day wasted.
Americans who tested positive for and recovered from COVID-19 can go to coronavirus.gov to find out a quick, convenient way to play a potentially lifesaving role in our fight. Know if you donate plasma, you could save a life.
We've also provided guidance so health care providers can contact patients who have recovered from COVID-19 and give them information on how they can donate. So thank you again, Mr. President, for supporting this remarkable progress against COVID-19.
And I want to thank Dr. Hahn, Dr. Marks and the entire team at the FDA for the speed with which they've approached this, the diligence to ensure that this meets the standards at FDA, and I'll turn it over to Dr. Hahn if it's okay, Mr. President.
STEPHEN HAHN, FDA COMMISSIONER: Thank you, Mr. President, for your leadership. It's good to be here today to announce FDA's recent decision. From the beginning of this pandemic, the president has asked FDA to cut back red tape to try to speed medical products into the hands of providers, patients, and American consumers.
And I just want to echo the president's thanks to the more than 17,000 men and women who work at FDA. They have worked day and night to in fact do that. So, plasma is the liquid portion of the blood. That liquid portion contains the natural immunity that someone develops in response to an infection. In this case, COVID-19.
I mean, that liquid portion can be extracted and for many years, as the president and Secretary Azar said, it's been given to patients with infectious diseases for more than 100 years. So there was a really good rational for why this might work.
And in fact, as was mentioned in early April, an expanded access program was started at the Mayo Clinic with the support of the federal government under President Trump's leadership. And that has gone on for the last four months.
More than 90,000 -- close to 100,000 Americans have enrolled in this program and over 70,000 have received treatment. This is one of the largest expanded access programs in the history of FDA, so very successful approach to evaluating how convalescent plasma would work.
So, in the independent judgment of experts and expert scientists at FDA who have reviewed the totality of data, not just the data from this expanded access program, but more than a dozen published studies as well as the historical experience associated with this.
Those scientists have concluded that COVID-19 convalescent plasma is safe and shows promising efficacy thereby meeting the criteria for Emergency Use Authorization. In the optimal treatment -- the optimal patients as described by Secretary Azar, treating with convalescent plasma at the highest titers, there was a 35 percent improvement in survival, which is a significant clinical benefit.
Now, we're waiting for more data. We're going to continue to gather data, but this clearly meets the criteria that we've established for Emergency Use Authorization and we're very pleased with this result. So let me just put this in perspective.
Many of you know I was a cancer doctor before I became FDA commissioner, and a 35 percent improvement in survival is a pretty substantial clinical benefit. What that means is and if the data continue to pan out, 100 people who are sick with COVID-19, 35 would have been saved because of the administration and about plasma.
[17:45:00]
We've seen a great deal of demand for this from doctors around the country. And what this EUA does, Emergency Use Authorization today does, it allows us to continue that and meet the demand.
And again, I want to echo the president and the secretary's ask of the American people, if you've recovered from COVID-19, please donate. It could save a life. And Mr. President, thank you again.
TRUMP: Thank you very much. Okay, any questions?
UNIDENTIFIED FEMALE: Mr. President --
UNIDENTIFIED MALE: Thank you Mr. President. I want to first ask you about the COVID-19 drug therapy in phase three. Are they going to be available to the American population on -- you and I talked previously about this idea of right to try.
TRUMP: Right.
UNIDENTIFIED MALE: Can we assure the American people that if it's being studied and it's in phase three you have that right?
TRUMP: Yes, that's a great question, and I'm not sure. A lot of people have been thinking about right to try. We're all waiting for the final answer. And maybe I could ask Stephen, but I would say that right to try is exactly -- if somebody is virtually terminal, in other words, they're not going to make it, and if we have these incredible therapies and drugs that are happening, Alex, I think it's a very interesting question.
I congratulate you for that question because I think we're all waiting for that exact final endpoint. What about that, Stephen? We have all of these great, seemingly great answers that are ready to come up, but because of the process it takes -- look, can we use some of this early under right to try, please?
HAHN: Such a really good question. And of course it all depends on the clinical circumstances and what a doctor and a patient together decide with respect to the administration of any agent. But if you think about what happened with convalescent plasma and the expanded access program, this is exactly what happened.
This program -- so we have ongoing clinical trials that are randomized between placebo or an inactive substance and the convalescent plasma. While that was going on, we knew that there was great demand from patients and doctors. The expanded access program is a way of actually doing that and fits perfectly with what the president just said about allowing people to be able to use something that we have now determined to be very safe.
TRUMP: I think it's something we have to move considerably strong.
HAHN: Yes, sir.
TRUMP: I think it's fantastic. You should get credit for that.
UNIDENTIFIED MALE: Thank you Mr. President.
TRUMP: Thank you. That's very good.
UNIDENTIFIED FEMALE: Thank you, Mr. President. Convalescent plasma as a treatment has been on (inaudible) for nearly 100 years. You mentioned "Operation Warp Speed" which enabled this process to move along a lot faster. What went into the effort for this to be approved for COVID-19 and was that hold up political in nature?
TRUMP: Well, I think that there might have been a holdup, but we broke the logjam over the last week to be honest. I think that there are people in the FDA and actually in your larger department that can see things being held up and wouldn't mind so much is my opinion, strong opinion, and that's for political reasons.
This has nothing to do with politics. This has to do with life and death. So, we are being very strong and we are being forthright. And we have got some incredible answers and we're not going to let them be held up because every day is lives and we're not going to let that happen. Okay? UNIDENTIFIED MALE: Thank you.
TRUMP: Thank you.
UNIDENTIFIED MALE: Mr. President, in announcing this today, you said that the FDA has made the independent examination that the treatment is safe and very effective, yet Dr. Hahn just said it was showing promising efficacy. So, which of the two is correct?
TRUMP: Well, I think I'll let Dr. Hahn answer that question?
HAHN: so, under our legal authority for Emergency Use Authorization, this is not the same as an approval, but it's an authorization and allows us to expand the access to this. In our data, we know we're going to continue to collect data. We knew that for all of our Emergency Use Authorization.
So for example, remdesivir, which was approved or authorized on May 1st, we're still collecting data and we will continue to do that with plasma as well. So, it's the nuances of the language around the authorization that we use and the legal aspects to it.
UNIDENTIFIED MALE: It's a promising treatment. It's not you can say it's very effective just yet.
HAHN: So, I would say that if 35 -- if you're one of those 35 out of 100 pool who these data suggest or show survives as a result of it, this is pretty significant for that person and their family.
TRUMP: This is a very big day. It's a day we've been looking forward to. Thank you very much. Great question.
UNIDENTIFIED MALE: Was there pressure on you, Dr. Hahn, to authorize this? Dr. Hahn, could you answer that?
(CROSSTALK)
WOLF BLITZER, CNN HOST: There you have the announcement from the president of the United States that the Food and Drug Administration has issued what's called an Emergency Use Authorization for convalescent plasma insisting it's potentially promising as a COVID treatment for those patients who are already in the hospital.
[17:49:58]
The president insisting this is a historic day, a very significant development he says. He's very pleased, very, very happy news. We heard that echoed from the Secretary of Health and Human Services, Alex Azar, and the FDA commissioner, the Food and Drug Administration commissioner, Stephen Hahn.
We want to welcome our viewers here in the United States and around the world. I'm Wolf Blitzer in "The Situation Room." This is a special edition. Dr. Sanjay Gupta is with us. Sanjay, you were listening very carefully to the precise words what the president said and what the two experts, Alex Azar, the Secretary of Health and Human Services and Dr. Stephen Hahn, the FDA commissioner had to say. What's your reaction? Is this a huge breakthrough?
GUPTA: Well, it was a little confusing, Wolf, to be honest. First, I don't think this is a huge breakthrough in the sense that as Dr. Hahn mentioned, this convalescent plasma has been available. It's been used in over 70,000 people already under these expanded access programs.
So, it is a therapy that is out there and correctly, as mentioned, has been used to treat other infectious diseases. The confusing part a little bit, Wolf, is that as you know, just a couple of days ago, the FDA sort of put the brakes on Emergency Use Authorization.
They were looking at the same data, I think, that a lot of people had been looking at, data that came out of the Mayo Clinic. And the concerning thing was that there wasn't a lot of what's called randomized trials, right?
You put some people in one group and they get the medication and another group of people, similar people, don't get the medication. And you compare them to make sure, in fact, it's the convalescent plasma that is helping. If you don't randomize control like that, then you don't know. Could it be something else? Could it be another medication that's helping?
We still don't have that data. I think what confused me, Wolf, a couple of days ago they said put the brakes on it. Today, they're saying full steam ahead with this Emergency Use Authorization. I don't know what changed. I talked to sources on the task force who said they haven't seen any new data.
So, what inspired this significant change within a couple of days in terms of going from no Emergency Use Authorization to absolutely going forward on a Sunday night? That was the confusing part. They did explain what it is, how it might work, but we need that data, Wolf.
BLITZER: And it's interesting because earlier in the week, I think last Wednesday or so, "The New York Times" was reporting, Sanjay, and I'm sure you read the article. I did and I've got it right here, that experts from the coronavirus task force including Dr. Francis Collins, head of the National Institutes of Health, Dr. Anthony Fauci, Dr. Clifford Lane of NIH also, they stepped in to argue because there was this debate going on at the FDA.
They stepped in to argue that the emerging data on the treatment was simply too weak -- too weak to go forward with this announcement and now all of a sudden the president and Alex Azar and Dr. Stephen Hahn, they are going forward with it. So that's raising questions. And further raising questions is the tweet the president just posted yesterday.
And let me read it to our viewers once again because it's very disturbing what the president said about the Food and Drug Administration. He said this, the deep state, or whoever over at the FDA is making it very difficult for drug companies to get people in order to test the vaccines and therapeutics. Obviously, they are hoping to delay the answer until after November 3rd. That's the presidential election. Must focus on speed and saving lives. And then the president tagged Dr. Stephen Hahn, @SteveFDA. So, it's
raising all sorts of questions about the political -- the potential political impact of this decision just announced by the president.
GUPTA: Yes. I mean, that's exactly right, Wolf. I mean, that's the thing I think as a medical reporters were trying to grapple with. We're trying to look at this evidence and say, okay, well, here is the evidence that you were looking at as you point out just a few days ago, now it's Sunday night, was there new evidence that was submitted?
See, the thing is that, Wolf, there is what are called observational studies, tens of thousands of people have used this and they sort of observed this to say, hey, look, yes, these people over here, if they get it within three days, if they are not on a ventilator, they're under the age of 80, they seem to be doing better. That's observational data.
But that's not the sort of date that is typically the standard by which you make these authorizations. You want to have some evidence that it's actually working because you randomize patients. It wasn't they also got steroids, it wasn't that they also got another treatment.
You want to make sure it's the convalescent plasma itself that's working. I don't know if there was new data that was submitted. I can tell you again, Wolf, talking to sources close to the task force, they didn't see any new data. You mentioned Dr. Collins, Dr. Fauci, I don't know that anybody else on the task force saw any of those new data just over the last few days.
I should also point out this, Wolf. I know this is a bit of a nuanced point, but once you issued the Emergency Use Authorization, it's going to make it more challenging to actually do these randomized trial. Why? Because everybody then obviously wants this plasma.
[17:55:00]
So how do you then stratify people into groups saying you're going to get it, you're not going to get it. That makes it challenging to actually collect the data to go forward with actual approval. So, you know, it's going to be in this sort of gray area now, Wolf. But still, no clear evidence that it actually works.
BLITZER: So basically the bottom line is this is not a huge breakthrough. It's sort of promising in the sense that they've been testing this. They don't have a lot of data to confirm that it's a huge breakthrough. So, we shouldn't necessarily accept the words of the president that it's going to cure a lot of people hospitalized for COVID-19 right now.
GUPTA: Yes. I mean, I think the point is that there's tens of thousands of people who have already gotten it, right. So first, you say, we now we got an authorization. Now people can go out and get it. Well, truth is they could have already gone out and get it -- receive this. There's been tens of thousands of people. I think over 70,000 people, Dr. Hahn mentioned, that have already received it. So in that sense, this EUA, this Emergency Use Authorization doesn't
suddenly make something available to people that wasn't available. That's the first part of it. The second part of it is, okay, do we have evidence that it works?
And you heard, based on observational data, that, you know, people who are under the age of 80 that received this quickly within three days, you know, seem to have decrease in mortality, 35 percent decrease in mortality. That sounds very promising, certainly, but that's not the sort of data upon which the FDA typically relies.
They want to know, yes, it's good that 35 percent of the people, they had a reduction in mortality, but was it the plasma that did that or was it something else? I mean, this is a basic question in medical science. Wolf, I mean, everybody wants to be hopeful about these things, I mean, no one more than me.
But, you know, the idea that you have to prove that it works so that people aren't, you know, making their bets on something that ultimately doesn't turn out to work, or they are taking their eyes off the ball on something that could be potentially much more beneficial. That's the issue here.
So this is a confusing story that's emerging, wolf. We don't have the data. A week ago, you know, a few days ago there wasn't the data. The FDA said not ready, put the brakes on it. A few days later, all of a sudden presumably looking at the same data, they are saying move forward with an EUA, which is going to make it harder to collect data.
And it's not going to do anything to actually make this available to more people because it already was available to tens of thousands of people.
BLITZER: The EUA, the Emergency Use Authorization. So just to be precise, Sanjay, this has not been approved. This is just -- basically, we're going ahead with more testing of this convalescent plasma to see if it works. They've got to do a lot more testing.
Dr. Hahn said, Dr. Hahn of the FDA himself said, I'm looking at my notes, this is not the same as approval. We are still collecting data. So when the president says this has nothing to do with politics, this is life or death. What's your reaction to that?
GUPTA: Well, You know, it is one of those things where, you know, Dr. Hahn is well within his right. The FDA is well within their right to issue an Emergency Use Authorization. As you know and as Dr. Hahn mentioned, they have done it for other things. They did it for hydroxychloroquine, as you know, they subsequently rescinded that Emergency Use Authorization.
They have done it for therapeutics. They have done it for various types of test, coronavirus tests. I think that the idea that you could say -- I guess the question is this, Wolf. Can you say for sure right now that this stuff works?
I mean, there's a lot of promise around it. It's encouraging because of how it's behaved with other diseases so that's why you study it. You've got a lot of reasons to study it. I mean, that much is true. But then you want to get results of the studies to be able to make definitive statements like some of the ones you just heard.
I don't think you can see things definitively. People are going to take away this stuff, you know, cuts down mortality by 35 percent. I wish I could say that definitively but I don't think you can right new because that data, at least I haven't seen it.
People in the Coronavirus Task Force haven't seen it. So maybe the FDA is looking at new data that just came in over the last, you know, 24, 48 hours perhaps, and that would be great. But keep in mind as well, Wolf, once you issue the EUA, it becomes harder to collect data. It becomes harder to randomize people.
Who's going to say, hey, look, I want to go into a trial if I can just go ahead and get this stuff and I heard that it saves 35 percent of people who take it? Who's going to say I'd rather just be, you know, potentially in the placebo group? Nobody would say that, right, Wolf. That makes it harder to actually collect the data that is needed to get to that approval.
I know that this is nuanced. There's a lot baked into that, but this is hugely important, Wolf. What is happening is hugely important because this is going to come up again and again over the next few weeks and months especially with regards to a vaccine.
What is going to be the bar at which, you know, these Emergency Use Authorization are granted and are they going to be adequate?
BLITZER: Because they did say, Secretary Azar, that this convalescent plasma treatment now joins remdesivir and steroids.
[17:59:59]
Remdesivir and steroids, they are considered much more effective in dealing with this at least for now. Hydroxychloroquine was approved for emergency use.
