{"id":106043,"date":"2020-08-24T07:27:48","date_gmt":"2020-08-24T14:27:48","guid":{"rendered":"http:\/\/69.46.6.243\/?p=106043"},"modified":"2020-08-24T07:27:48","modified_gmt":"2020-08-24T14:27:48","slug":"president-trump-in-august-23rd-press-briefing","status":"publish","type":"post","link":"https:\/\/new.thepinetree.net\/?p=106043","title":{"rendered":"President Trump in August 23rd Press Briefing"},"content":{"rendered":"<p>Washington, DC&#8230;Thank you very much.\u00a0 And it\u2019s good to see you all.\u00a0 Hope you had a great weekend at your convention.\u00a0 And we\u2019re going to have a great convention coming up, and I look forward to it.\u00a0 But before I discuss a very historic breakthrough in our fight against the China virus, I\u2019d like to provide an update on the recent wildfires in California and the storms in the Gulf of Mexico.<\/p>\n<p><iframe loading=\"lazy\" width=\"640\" height=\"360\" src=\"https:\/\/www.youtube.com\/embed\/B_pTECx8RH4\" frameborder=\"0\" allow=\"accelerometer; autoplay; encrypted-media; gyroscope; picture-in-picture\" allowfullscreen><\/iframe><\/p>\n<p>Yesterday, I approved a major disaster declaration for California.\u00a0 I spoke to Governor Newsom as they battle two of the worst wildfires in the history of their state.\u00a0 That continues.\u00a0 The federal government has already deployed over 26,000 first responders and personnel to battle the wildfires.\u00a0 We\u2019re working very closely with the governor and very closely with a lot of great state representatives and local representatives, and we\u2019ll take care of the situation.\u00a0 But we have 26,000 first responders already.<\/p>\n<p>Our hearts go out to the thousands of families who have lost their homes.\u00a0 As we grieve for the families of two first responders and five residents who have tragically lost their lives in a very horrific fire \u2014 one of the biggest we\u2019ve ever seen \u2014 my administration is also closely monitoring Hurricane Marco and Tropical Storm Laura, which are coming in rapidly.\u00a0 Hurricane Marco is expected to make landfall in Louisiana tomorrow, and Tropical Storm Laura is expected to hit Louisiana two days later.\u00a0 This is somewhat unprecedented \u2014 the scope of the storms and also the fact that they come so quickly after one another.<\/p>\n<p>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.\u00a0 We have everybody stationed and ready to go in Puerto Rico and the Gulf Coast, and we have tremendous \u2014 tremendous people.<\/p>\n<p>We have \u2014 FEMA is lined up.\u00a0 We have the Coast Guard ready.\u00a0 The Coast Guard has \u2014 has done a fantastic job.\u00a0 They do so many \u2014 they do such good work, and we want to thank our great Coast Guard.<\/p>\n<p>I\u2019m asking all Americans in the storm\u2019s path to follow the instructions of your state and local governments very closely.\u00a0 And I\u2019ve approved emergency declarations for Puerto Rico and for Louisiana.\u00a0 FEMA is mobilized on the ground and is ready to help.\u00a0 They will be in there very quickly \u2014 very, very quickly.<\/p>\n<p>And I spoke to Governor John Bel Edwards also, of Louisiana, and I\u2019ve informed him.\u00a0 And at his request, also, a major disaster declaration is signed and ready to go.\u00a0 We have everybody ready in Puerto Rico, the Gulf Coast, Louisiana, and also on the forest fires in California.\u00a0 So we have a great team.\u00a0 Unfortunately, we have some very, very powerful natural disasters.<\/p>\n<p>On the therapeutics front, this is what I\u2019ve been looking to do for a long time.\u00a0 This is a great thing.\u00a0 Today, I\u2019m pleased to make a truly historic announcement in our battle against the China virus that will save countless lives.\u00a0 The FDA has issued an emergency use authorization \u2014 and that\u2019s such a powerful term: emergency use authorization \u2014 for a treatment known as convalescent plasma.\u00a0 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.\u00a0 It\u2019s had an incredible rate of success.<\/p>\n<p>Today\u2019s action will dramatically expand access to this treatment.\u00a0 And I want to thank Dr. Hahn and Secretary Azar.\u00a0 I want to thank the FDA \u2014 all of the people that have been working very hard on this.\u00a0 It showed tremendous potential.<\/p>\n<p>This is the only possible \u2014 and it\u2019s only made possible because of Operation Warp Speed that has everybody working together.\u00a0 We\u2019re years ahead of approvals.\u00a0 We would be \u2014 if we went by the speed levels of past administration, we\u2019d be two years, three years behind where we are today, and that includes in vaccines that you\u2019ll be hearing about very soon, very shortly.<\/p>\n<p>To deliver treatments and vaccine to save lives, we\u2019re removing unnecessary barriers and delays not by cutting corners, but by marshaling the full power of the federal government.<\/p>\n<p>We\u2019ve provided $48 million to fund the Mayo Clinic study that tested the efficacy of convalescent plasma for patients with the virus.\u00a0 Through this study, over 100,000 Americans have already enrolled to receive this treatment, and it has proven to reduce mortality by 35 percent.\u00a0 It\u2019s a tremendous number.<\/p>\n<p>The FDA, MIT, Harvard, and Mount Sinai hospital have also found convalescent plasma to be a very effective method of fighting this horrible disease.<\/p>\n<p>Based on the science and the data, the FDA has made the independent determination that the treatment is safe and very effective.\u00a0 Recently, we provided up to $270 million to the American Red Cross and America\u2019s Blood Centers to support the collection of up to 360,000 units of plasma.<\/p>\n<p>In late July, we launched a nationwide campaign to ask patients to have \u2014 who have recovered \u2014 and these are patients that have been incredible, the way they\u2019ve donated \u2014 but these are people recovering from the virus \u2014 to donate plasma.\u00a0 Since then, weekly plasma donations have doubled.<\/p>\n<p>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.\u00a0 It\u2019s been really an incredible \u2014 just incredible people.\u00a0 The country has united so strongly behind this.<\/p>\n<p>And I\u2019ll go over the numbers, but if you look at what\u2019s happened and the success that we\u2019ve had that people don\u2019t talk about \u2014 the United States has experienced the lowest case-fatality rate of any major country in the world.\u00a0 You don\u2019t hear that.<\/p>\n<p>The European Union\u2019s case-fatality rate is estimated to be three times higher than that in the United States.\u00a0 Europe has seen 33 percent more fatalities, compared to a typical non-pandemic year than the United States.<\/p>\n<p>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.\u00a0 And, Stephen, I want to thank you because the FDA really stepped up \u2014 and especially over the last few days \u2014 in getting this done.\u00a0 The results have been incredible, and I think you\u2019ll see the results even go up very substantially.\u00a0 So we appreciate it.<\/p>\n<p>And maybe I\u2019ll ask Alex to go first, and then Stephen.\u00a0 Thank you very much, Alex.<\/p>\n<p>SECRETARY AZAR:\u00a0 Well, thank you very much, Mr. President.\u00a0 Thanks for the bold leadership that allowed us to deliver this very happy news today.<\/p>\n<p>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.\u00a0 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.<\/p>\n<p>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.<\/p>\n<p>President Trump is the Right to Try President, and he\u2019s fought hard to ensure that Americans can have access to promising COVID-19 treatments.\u00a0 Convalescent plasma has been a tried-and-true therapeutic method in prior outbreaks, but the President wanted to ensure that we develop the data to support its use, and this FDA authorization is one result of that effort.<\/p>\n<p>The data we gathered suggests that patients who were treated early in their disease course \u2014 within three days of being diagnosed \u2014 with plasma containing high levels of antibodies benefited the most from treatment.\u00a0 We saw about a 35 percent better survival in the patients who benefited most from the treatment \u2014 which were patients under 80 who were not on artificial respiration.<\/p>\n<p>I just want to emphasize this point because I don\u2019t want you to gloss over this \u2014 this number.\u00a0 We dream, in drug development, of something like a 35 percent mortality reduction.\u00a0 This is a major advance in the treatment of patients.\u00a0 This is a major advance.<\/p>\n<p>Convalescent plasma is one new tool that we\u2019ve added to our arsenal against COVID-19, alongside remdesivir, steroids, and a number of other promising options currently being studied.\u00a0 Because of the President\u2019s Operation Warp Speed, we expect to have other new results and new options reaching patients as soon as this fall.<\/p>\n<p>Operation Warp Speed is supporting experimental therapeutics all the way through to manufacturing so that if they meet FDA\u2019s gold standard for safety and efficacy, they can begin reaching patients without a day wasted.<\/p>\n<p>Americans who have 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.\u00a0 Know: If you donate plasma, you could save a life.<\/p>\n<p>We\u2019ve also provided guidance so healthcare providers can contact patients who have recovered from COVID-19 and give them information on how they can donate.<\/p>\n<p>So, thank you again, Mr. President, for supporting this remarkable progress against COVID-19.\u00a0 And I want to thank Dr. Hahn, Dr. Marks, and the entire team at the FDA for the speed with which they\u2019ve approached this, the diligence to ensure that this meets the standards at FDA.<\/p>\n<p>And I\u2019ll turn it over to Dr. Hahn if that\u2019s okay, Mr.\u00a0 President.<\/p>\n<p>THE PRESIDENT:\u00a0 Good.\u00a0 Thank you very much.<\/p>\n<p>Please, Doctor.<\/p>\n<p>DR. HAHN:\u00a0 Thank you, Mr. President, for your leadership.\u00a0 It\u2019s good to be here today to announce FDA\u2019s recent decision.\u00a0 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.\u00a0 And I just want to echo the President\u2019s thanks to the more than 17,000 men and women who work at FDA.\u00a0 They have worked day and night to, in fact, do that.<\/p>\n<p>So, plasma is the liquid portion of the blood.\u00a0 That liquid portion contains the natural immunity that someone develops in response to an infection \u2014 in this case, COVID-19 \u2014 and that liquid portion can be extracted.\u00a0 And for many years, as the President and Secretary Azar said, it\u2019s been given to patients with infectious diseases \u2014 for more than 100 years.\u00a0 So there was a really good rationale for why this might work.<\/p>\n<p>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\u2019s leadership, and that has gone on for the last four months.\u00a0 More than 90,000, close to 100,000 Americans have enrolled in this program and over 70,000 have received treatment.\u00a0 This is one of the largest expanded-access programs in the history of FDA.\u00a0 So, a very successful approach to evaluating how convalescent plasma would work.<\/p>\n<p>So, in the independent judgment of experts and expert scientists at FDA who have reviewed the totality of data \u2014 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.\u00a0 Those \u2014 those scientists have concluded that COVID-19 convalescent plasma is safe and shows promising efficacy, thereby meeting the criteria for an emergency use authorization.<\/p>\n<p>In the optimal treatment \u2014 the optimal patients, as described by Secretary Azar, treated with convalescent plasma at the highest titers, there was a 35 percent improvement in survival, which is a significant clinical benefit.<\/p>\n<p>Now, we\u2019re waiting for more data.\u00a0 We\u2019re going to continue to gather data.\u00a0 But this clearly meets the criteria that we\u2019ve established for emergency use authorization, and we\u2019re very pleased with these results.<\/p>\n<p>So, let me just put this in perspective.\u00a0 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.\u00a0 What that means is \u2014 and if the data continue to pan out \u2014 100 people who are sick with COVID-19, 35 would have been saved because of the administration of plasma.<\/p>\n<p>We\u2019ve seen a great deal of demand for this from doctors around the country.\u00a0 And what this EUA does \u2014 EUA \u2014 emergency use authorization today does: It allows us to continue that and meet the demand.<\/p>\n<p>And again, I want to echo the President\u2019s and the Secretary\u2019s ask of the American people: If you\u2019ve recovered from COVID-19, please donate.\u00a0 It could save a life.<\/p>\n<p>And, Mr. President, thank you again.<\/p>\n<p>THE PRESIDENT:\u00a0 Thank you very much, Stephen.\u00a0 I appreciate it.<\/p>\n<p>Okay, any questions, please?\u00a0 Please, go ahead.<\/p>\n<p>Q\u00a0\u00a0\u00a0 Thank you, Mr. President.\u00a0 I want to first ask you about the COVID-19 drugs that are in phase three.\u00a0 Are they going to be available to the American population on \u2014 you and I talked previously about this idea of Right to Try.<\/p>\n<p>THE PRESIDENT:\u00a0 Right.<\/p>\n<p>Q\u00a0\u00a0\u00a0 Can we assure the American people that if it\u2019s being studied and it\u2019s in phase three, you have that right?<\/p>\n<p>THE PRESIDENT:\u00a0 You know, it\u2019s a great question.\u00a0 And I\u2019m not sure a lot of people have been thinking about Right to Try.\u00a0 We\u2019re all waiting for the final answer.\u00a0 And maybe I could ask Stephen, but I would say that Right to Try is exactly \u2014 if somebody is virtually terminal \u2014 in other words, they\u2019re not going to make it \u2014 and if we have these incredible therapies and drugs that are happening, Alex, I think it\u2019s a very interesting question.<\/p>\n<p>I congratulate you for that question because I think \u2014<\/p>\n<p>Q\u00a0\u00a0\u00a0 Thank you, Mr. President.<\/p>\n<p>THE PRESIDENT:\u00a0 \u2014 we\u2019re all waiting for that exact final endpoint.<\/p>\n<p>What about that, Stephen?\u00a0 We have all of these great \u2014 seemingly great answers that are ready to come out, but because of the process, it takes \u2014 can we use some of this early, under Right to Try?\u00a0 Please.<\/p>\n<p>DR. HAHN:\u00a0 So it\u2019s a really good question.\u00a0 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.<\/p>\n<p>But if you think about what happened with convalescent plasma and the expanded-access program, this is exactly what happened.\u00a0 This program \u2014 so, we have ongoing clinical trials that are randomized between placebo \u2014 or an inactive substance \u2014 and the convalescent plasma.\u00a0 While that was going on, we knew that there was great demand from patients and doctors.\u00a0 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.<\/p>\n<p>THE PRESIDENT:\u00a0 I think it was something we have to really consider very strongly.<\/p>\n<p>DR. HAHN:\u00a0 Yes, sir.<\/p>\n<p>THE PRESIDENT:\u00a0\u00a0 I think it\u2019s fantastic.<\/p>\n<p>You should get credit for that.<\/p>\n<p>Q\u00a0\u00a0\u00a0 Thank you, Mr. President.<\/p>\n<p>THE PRESIDENT:\u00a0 Thank you.\u00a0 That\u2019s very good.<\/p>\n<p>Q\u00a0\u00a0\u00a0 Mr. President?<\/p>\n<p>THE PRESIDENT:\u00a0 Please, in the back.\u00a0 OAN, please.<\/p>\n<p>Q\u00a0\u00a0\u00a0 Thank you, Mr. President.\u00a0 Convalescent \u2014 convalescent plasma, as a treatment, has been around for, you know, over 100 years.\u00a0 You mentioned Warp \u2014 Operation Warp Speed, which enabled this process to move along a lot faster.\u00a0 What into the \u2014 what went into the effort for this to be approved for COVID-19?\u00a0 And was that holdup political in nature?<\/p>\n<p>THE PRESIDENT:\u00a0 Well, I think that there might have been a holdup, but we broke the logjam over the last week, to be honest.\u00a0 I think that there are people in the FDA and actually in your larger department that can see things being held up and wouldn\u2019t mind so much.\u00a0 That\u2019s my opinion \u2014 a very strong opinion.\u00a0 And that\u2019s for political reasons.\u00a0 This has nothing to do with politics; this has to do with life and death.<\/p>\n<p>So we are being very strong, and we are being very forthright, and we have got some incredible answers.\u00a0 And we\u2019re not going to let them be held up because every day is lives.\u00a0 And we\u2019re not going to let that happen.\u00a0 Okay?<\/p>\n<p>Very good.\u00a0 Thank you.<\/p>\n<p>Q\u00a0\u00a0\u00a0 Mr. President?<\/p>\n<p>THE PRESIDENT:\u00a0 Please, go ahead.<\/p>\n<p>Q\u00a0\u00a0\u00a0 Mr. President, in announcing this today, you said that \u201cthe FDA has made the independent determination that the treatment is safe and very effective.\u201d\u00a0 Yet, Dr. Hahn, just said it was showing \u201cpromising efficacy.\u201d\u00a0 So which of the two is correct?<\/p>\n<p>THE PRESIDENT:\u00a0 Well, I think I\u2019ll let Dr. Hahn answer that question.<\/p>\n<p>DR. HAHN:\u00a0 So, under our legal authority for emergency use authorization, this is not the same as an approval, but it\u2019s an authorization.\u00a0 And it allows us to expand the access to this.\u00a0 And our data \u2014 we know we\u2019re going to continue to collect data.\u00a0 We knew that for all of our E- \u2014 emergency use authorizations.<\/p>\n<p>So, for example, remdesivir, which approves \u2014 was approved or authorized on May 1st, we\u2019re still collecting data.\u00a0 And we will continue to do that with plasma as well.<\/p>\n<p>So it\u2019s the nuances of the language around the authorization that we use and the legal aspects, too.<\/p>\n<p>Q\u00a0\u00a0\u00a0 So it\u2019s a promising treatment; it\u2019s not \u2014 you couldn\u2019t say it\u2019s very effective just yet?<\/p>\n<p>DR. HAHN:\u00a0 So I would say that a 35 \u2014 if you\u2019re one of those 35 out of 100 people who these data suggest or show survive as a result of it, this is pretty significant for that person and their family.<\/p>\n<p>THE PRESIDENT:\u00a0 Okay?\u00a0 This is a very big day.\u00a0 It\u2019s a day we\u2019ve been looking forward to.\u00a0 Thank you very much.\u00a0 Great question.\u00a0 Thank you very much.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Washington, DC&#8230;Thank you very much.\u00a0 And it\u2019s good to see you all.\u00a0 Hope you had a great weekend at your convention.\u00a0 And we\u2019re going to have a great convention coming up, and I look forward to it.\u00a0 But before I discuss a very historic breakthrough in our fight against the China virus, I\u2019d like to [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":106045,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_cbd_carousel_blocks":"[]","jetpack_post_was_ever_published":false,"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_memberships_contains_paid_content":false,"footnotes":""},"categories":[20,5,1],"tags":[],"class_list":["post-106043","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-featured","category-government","category-news","last_archivepost"],"jetpack_featured_media_url":"https:\/\/new.thepinetree.net\/wp-content\/uploads\/2020\/08\/Fullscreen-capture-8242020-72612-AM.jpg","jetpack_sharing_enabled":true,"jetpack-related-posts":[],"_links":{"self":[{"href":"https:\/\/new.thepinetree.net\/index.php?rest_route=\/wp\/v2\/posts\/106043","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/new.thepinetree.net\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/new.thepinetree.net\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/new.thepinetree.net\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/new.thepinetree.net\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=106043"}],"version-history":[{"count":0,"href":"https:\/\/new.thepinetree.net\/index.php?rest_route=\/wp\/v2\/posts\/106043\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/new.thepinetree.net\/index.php?rest_route=\/wp\/v2\/media\/106045"}],"wp:attachment":[{"href":"https:\/\/new.thepinetree.net\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=106043"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/new.thepinetree.net\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=106043"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/new.thepinetree.net\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=106043"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}