it is good to be here today to announce the fda's recent decision. from the beginning of this pandemic, the president has asked fda to cutback redtape, to speed products into the hands of patients and american consumers. i want to echo the president's thanks to the more than 17,000 men and women who work at the fda. they work day and night to 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. that liquid portion can be extracted. and for many years, it's been given to patients with infectious diseases for more than 100 years. so there was a really good rationale for why this might work. and 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. thi

to ensure that this meets the standards at fda. and i'll turn it over to dr. hahn if that's okay, mr. president. >> good. thank you very much. please, doctor. >> thank you, mr. president, for your leadership.er it's good to be here today too announce fda's recent decision. from the beginning of this pandemic, the president has asked fda to cut back red tapeci 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, and that liquid portion can be extracted. and for many years, as thewi 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 rationale for why this might work. and, in fact, a

the fda said not ready. a few days later all of a sudden presumably looking at the same data they say move forward with a uae and it is not going to do anything to make it available to more people because it was available to tens of thousands of people. >> the emergency use authorization. eua. it is not approved, this is just basically going ahead with more testing of this convalescent plasma to see if it works, they have to do more testing and dr. hahn of the fda himself said from looking at the 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? >> it is where dr. hahn is well within the right, fda well within the right to issue an emergency use authorization and they have done it for other things. they did it for hydroxychloroquine as you know and subsequently rescinded that emergency use authorization and other therapeutics and types of tests, coronavirus tests. i think

marx from the fda. dr. gupta, still facing the problem of what is the control group and the details around that for smart folks like yourself. you give them this cplasma. >> the reality across the country is that it won't change a lot. maybe slightly easier for certain hospitals to get access to convalescent plasma but this is largely widely available and in most cases i think i infuse this in my patients that are critically ill on ventilators within 24 hours. we think that maybe there is marginal benefit. is it a miracle cure, absolutely not. it is going to say give me the placebo now. it will be harder to convince people to say let's get science first and move on to clear therapies with evidence. >> doctor, what was the news conference about. what will you tell them in 30 seconds? >> the best thing we are developing the knowledge base. we are still waiting for the final answer. it is positive news. unfortunately it still means that every day we will have to take the measures that we have to take to make s

you're the former fda commissioner. in your time at the fda, did you ever get political pressure from the white house to take a step like this? >> well, wolf, the issues that fda deals with are ones that really matter to people, especially ones like this, unmet medical needs in a pandemic. so there is always going to be pressure, but it's very important to remember that the agency has science at its heart and is doing a tremendous amount of work to make progress. just in the case of this pandemic, we've seen more than 25,000 people enroll in multiple vaccine large trials already. and this is just months after the pandemic began. that's a record pace and that's because of the actions of people at the fda. so we need to support them. >> but would anyone at the fda do what the president alleged, namely, purposely slow down a potential treatment or a vaccine to simply try to hurt the president's chances of getting re-elected? >> the actions at the fda are driven by science and driven by the fastest way to make progress on t

the fda is also wise in not yet giving an approval. an approval means that we have compared it to patients that did not get this and got over the other treatment in the same manner. with this pandemic being so vast and so fast moving, no patients or doctors would like to be denied convalescent plasma. remember, the first of medicine is first do no harm, and that is exactly what was just said about convalescent plasma, so everybody wants to receive this and wants to have access for it. for us to sift through the data and give official fda approval will be coming in the next months to years but that doesn't mean we should deny it or vilify it. jon: all right. so what about dangers? are there dangers associated with using convalescent plasma? >> so plasma transfusions have been so commonly given. they are about the same risk as giving somebody a blood transfusion. so there can be risks of an allergic reaction. there can be risks of a lung injury which we can recognize and manage. the benefits far outweigh the risks. that's what has to be

the fda has had it since april. 100%. you are just misconstrued because the media trying to take away this amazing cure that works for everybody. >> you have no medical background. you are not a scientist. a guy called in april saying he had this product. you are now on the board and going to make money from the sale of this product. >> no, no, no. >> the reason he reached out to you is because you have the ear of the president and get a meeting with the president and you stand to make money from it. how do you sleep at night? >> anderson, that is your narrative. this is -- >> you're not going to make money from this? >> i don't care about the money. i think i've proven that. from hurricanes to $4 million worth of masks i gave out. if you let me talk here -- >> sure. >> they put me on the board last week because when this gets approved by the fda, which it will, it's passed every safety test. >> doesn't really approve subpoe supplements. >> i help people. that's my passion and i can scale things to get it to everybody to

highly disturbing insinuating that people at the fda are part of the deep seat. it is yet another conspiracy theory from a president whose back is against the wall on this coronavirus issue, wolf. >> yesterday once again the president's tweet saying obviously they referring to experts at the food and drug administration are hoping to delay the answer until after november 3rd. must focus on speed and saving lives. and he's using the phrase deep state. very worrisome. i want to bring in dr. paul offitt. doctor, you are an expert in this area. you heard what the president said, you heard what dr. hahn to say, what secretary alex azar had to say earlier in the week "the new york times" reported that dr. fauci, dr. collins head of nih, dr. lane, another top official at nih were worried about a speedy approval because enough data had not yet collected. what do you think? >> it's certainly makes sense if you administer some serum that has high levels of neutralizing antibodies against the virus and early enough in the process when someone is mildly ill and the virus is

we hear how the head of the fda describes it. >> he said that the fda has made the independent determination 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? >> well, i think i'll let dr. hahn answer that question. >> 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. and our data, we know we're going to continue to collect data. we knew that for all our emergency use authorizations. for example, remdesivir approved on authorized on may 1st, we're still collecting data and will continue to do that with plasma as well. >> cnn's jeremy diamond has more on the announcement from the white house. >> reporter: president donald trump on sunday announcing that the fda has approved an emergency use authorization for a potential coronavirus treatment, and that is convalescent plasma. now, convalescent plasma certainly has been used already in about 70,000 patients here in the united states. and ther

hahn, the head of the fda, he said it's not the same as approval. they're still collecting, he said, data, on all of this. the treatment actually has been available, as we note, to thousands of americans since march. explain what exactly this emergency use authorization right now -- how it changes anything -- if it does change anything, because 70,000 hospitalized patients have been getting this plasma. >> yeah, so, wolf, up until this emergency use authorization was passed, folks could only get the convalescent plasma through a special program that was really run out of mayo clinic based in minnesota. with the emergency use authorization, now hospitals across the country can use convalescent plasma without having to go through that complicated process of registering and working with mayo. so it makes it easier to get, basically, which has benefits for patients and for physicians, but it has drawbacks. by passing this eua, it makes it less likely that patients will enroll in trials and so we may not get that gold standard evidence that we're looking

so one can only conclude that there had to be pressure on the fda. and looking at donald trump's tweets, you can only conclude that. and it is worrisome, especially as we move to the notion of a vaccine. we can't do that anymore. there's too much at stake with the vaccine. >> so, i want to get to a vaccine in a second. but on the subject of hydroxychloroquine, obviously, that can do harm to an individual. so i understand what you're saying there. what is the risk of approving the blood plasma treatment? i understand that it's not following scientific protocol. but i guess what's the worst thing that happens? >> well, i think as a generally safe product, although we all know that once that any medical product that has a positive effect can have a negative effect. you are giving a lot of foreign protein to somebody who gets this plasma. you can always be surprised unpleasantly on what the side effects can be once you put it into a lot of people. i don't think that's really going to be the issue. it's more of an issue of we have another example of absen

an emergency authorization does not require the same amount of evidence as fda approval. according to bloomberg news, quote, researchers fear that the fda's decision to issue an emergency waiver will make it harder to get patients into clinical trials and get a clear picture on weathhether and how convalescent plasma actually works to treat covid-19. so far, clinical trials have not proven whether plasma can help patients battle the coronavirus. all right, so that announcement about plasma treatment coming as the president ramps up pressure on the fda, accusing the agency, without any evidence, of delaying coronavirus vaccine development. on saturday, he tweeted 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 of therapeutics. obviously, they are hoping to delay the answer until after november 3rd, most focus on speed and saving lives. last night, the president appeared to double down on those accusations while his chief of staff, mark meadows, defended them. >> i think that there ar

[overlapping shouts] [upbeat music] >> the fda has issued an emergency use authorization and that's such a powerful term, for a treatment. >> bt just topped the stock 600 on the report with the biggest group preparing to fend off a $15 billion take over bid. >> getting back, bytedance plans to sue the u.s. government as they look to fight the executive order banning american companies from working with it and oil stocks jump as the u.s. prepares for a twin storm scenario the gulf coast braces impact for two tropical storms set to hit at almost the same time this week >> a vaccine developed in the u.k. ahead of november's presidential election. according to the financial times, the u.k. food and drug administration is awarding emergency use authorization in october for the vaccine that was developed by astrazeneca here's how it's trading near the session. 2.4 plus% on the boards and also across to the european markets this morning optimism around vaccines and treatments right on the outset and some of the gains continue 1.4% not much as you can tell not even one along the boards here let'

hahn, who heads the fda, do you think he buckled under pressure? >> i think -- you could say that again so i think i had a little problem -- >> dr. stephen hahn, who heads the fda, he denied he buckled under pressure but i wonder if you share the view of other medical experts who think maybe he did. >> it is hard to know. he misstated the magnitude of the benefit in the press conference last night which is something that i think people are even more upset about when he said there was a 35% reduction, that 35 out of 100 people would be saved, right. if they got plasma. that is a compete misrepresentation of what the data actually showed. so when he obviously doesn't really understand or can't convey the type of benefit that this type of study showed, one has to wonder what went into his thinking about actual making this decision. so i agree, the whole thing is concerning. >> okay, dr. jean, thank you very much. >>> we're also monitoring a disturbing story out of wisconsin. yet another unarmed black man shot by white police officers and in this case

and the problem that we're seeing here is that, you know, the fda may have the data. we haven't seen it. and the perception that the white house is pushing the fda is going to have major repercussions for how everyone feels about fda approvals and emergency use authorizations. >> was there any information that came out between the time that the fda was saying no, this isn't ready, and the time there was suddenly an emergency use authorization? in those days, was there new information that came to light to make it more understandable to approve this? >> katy, that's exactly the problem. we don't have any new data that is suggesting that this is more effective than what we had when dr. fauci, dr. collins, dr. lane, these venerated, very respected scientists, felt that it was not yet time to do this. the crux of it is the mayo clinic has published an observational study which suggests that there may be benefit if convalescent plasma is given early and given in the right dose. but the conclusion of this publication still in preprint is that these data can inform clinical

no indication the white house was pushing the fda. the opposite, there was concerns that things were not being allowed. i'm seeing a lot of people who deal with the fda and people who deal with public health and doctors in general who are very concerned that the fda might be being pushed to do things for political reasons rather than just call the balls and strikes, which is what the fda's job is. >> it's remarkable that during the aids crisis there were a lot of men who died. now we have a lot of health care workers trying to get us to protect ourselves. appreciate you both being with us. thanks very much. let's talk now about the postal service. the post master general faces more questions tomorrow over the future of the postal service. louis dejoy appeared on friday. a house committee will question him in the morning. it's actually older than america itself. thousand it get to this point? our first post master gem, ben franklin, would be pleased at how much we love the post office. it remains one of our most beloved american instit

in the fda making independent science based decisions. that confidence is going to be critical both for any safe, effective covid vaccine helping us get out of the pandemic but it's critical for americans in the world on an everyday basis. the fda is a trusted agency that makes sure our foods and medicines are safe. threatening to create a perception the fda is acting under political pressure rather than according to the science. >> the fda commissioner says that all of the decisions being made are based on science and data and is defending the fda, but you have been there. you've been in the ranks. you've been in the trenches with these people. can you say with confidence that, unfortunately, politics is impacting decision making by the fda? >> well, i have to say i have tremendous confidence and respect for the scientists at the fda and i think they will only speak the truth. however, relentless pressure affects people and it also affects the public's trust even if they are made by fda staff. i think fda leadership needs to stand up aga

now on top of all of that, yesterday, what a disappointment the commissioner of the fda was to stand there with the president and validate the statement -- >> we'll get to that in just a moment. but i do want to get a few other points. as you know, 500,000 mail-in ballots reject in this year's primaries, we're anticipating even more come this november, it could delay or call some results into questions for weeks, similar to what happened in florida back in 2000, you obviously received continuation of government breechiefings, ar as a government prepared for this? >> we have to be. >> are we? >> we would if the president would agree to what we have in the heroes act to aid the states to conduct their elections according to the way they do and that is, to have safety if people want to vote in person, so they have distancing, that means they have to have more space, more days, more time, more polling places in order to enable people to vote safely and have a vote by mail so people don't have to choose between their health and their vote. but in addition to that, we also have to have peo

over the weekend the president was not only pressuring the fda but accusing the fda of being part of this deep state. lo and behold sunday evening we have a press conference at the white house where the president announces the fda has approved emergency use authorization for convelescent plasma. i tried to ask the fda commissioner whether or not he had been pressured into this. he didn't answer the question at the press conference but later on gave us an on the record statement saying that is not the case. back to this vaccine and the idea of pressure or racing against timelines we reported earlier today, sources telling us that on july 30th mark meadows the chief of staff over here at the white house gave the impression to the house speaker nancy pelosi and the senate majority leader chuck schumer that the white house was optimistic about moving ahead with a vaccine before all of the trials are completed. that obviously concerned people inside the democratic party on capitol hill. the speaker told mark meadows no cutting corners here. this is part of a theme that the president wants

this is the same thing that the fda has done. it's outrageous. people need to be writing or calling their congressman and senator and complaining this is not the way the country should work, that bureaucracy in bed with other forces are causing us to make decisions that are not based on science and it's killing americans and it's not acceptable. >> at a minimum they ought to be reaching out to experts like you and all over the country who have something to contribute to this. after all it's a pandemic and constantly going on tv and telling them to wear a mask over and over again and social distancing, that doesn't sound very scientific to me. i want to thank you doctor harvey risch for your courage and insight for publishing what you're publishing. i know that it can't be easy but it's a very, very important public service. god bless you. we'll be right back. >> tech: at safelite, we're committed to taking care of you and your car. >> tech: we'll fix it right with no-contact service you can trust. >> tech: so if you have auto glass damage, stay s

>> there are several at the fda that are really -- we are really trying to encourage the fda to approve so that we can get these rapid testings. people are very worried at the fda that they're not accurate enough and they may not be accurate enough to diagnose somebody in the intensive care unit but they would work great if you were using them for surveillance. i want to comment that the countries which are patient right now is hemorrhaging and the executive order gave us a band-aid but didn't give us a way to stop the hemorrhaging. there are places out there that have over 100 cases per hundred thousand people. most countries that have opened schools successfully have done so when disease levels are at 1 case per 100,000 people. >> yeah. numbers that we should probably let sink in for a minute. there is still so much work to be done and part of that work is acknowledging that there's a problem. dr. rochelle walensky, thank you. >>> just a few moments ago, president trump said he expects a vaccine, quote, very soon. so, is that realistic, and just because there is a vaccine, does that m

but the head of the fda said this weekend it's ready. here's steve osunsami. >> reporter: a florida judge tonight has sided with teachers who were ordered back to class by the governor and then sued. for now, in-person instruction is up to each school board. today was the first day back for the teacher who took this striking photo of their classroom south of jacksonville. students sitting at these desks would not be required to wear masks. in washington, the president has pushed the fda, and now they're giving doctors the okay to use plasma therapy as emergency treatment for covid-19. he's accused the agency of holding things up until after the election. >> this is a powerful therapy. >> reporter: less than a week ago, this same fda was saying that this same therapy was "promising," but "has not yet been shown to be safe and effective." >> what happened yesterday is you saw the fda being bullied by the president of the united states. he's trying to now bully the fda into approving a vaccine or vaccines before they've been adequately test

do you believe that there are political reasons in the fda, or deep state in the fda, that would hold up plasma authorization because of dislike of the president? >> well, i can tell you, because in the company that you mentioned that i work with, we do a lot of work with seaver, which is the blood products division of the fda. i've never met finer people in government than the people who run seaver. i can tell you that i have absolutely zero belief that seaver was doing anything to block that. look, having said that, you know, there are legitimate reasons for this to be approved. and, you know, with all due respect to the professor, throwing out the potential of people getting aids from these convalescent transfusions is completely irresponsible, by the way. the reality is people should be donating their convalescent plasma, that we do know these antibodies do have a beneficial effect, and that we also know that this is safe. plasma is given to millions and millions of people in america, has been for decades. so the idea that this is somehow unsafe and that the president is putting t

which is significant now we see the fda commissioner along side him in the briefing room continuing to praise him and seemingly they were getting along perfectly well. the president made the argument without providing evidence to support it and now is coming out of here with this notable development. you didn't see dr. anthony fauci or deborah birx. who you did see there was spot atlas, a new doctor brought on to advise the president and somebody that eespouses the president's own views rather than fauci's or birx's. why now. we have know about the effects of convalescent plasma for some time. but a lot of study needs to be done and comes on the heels of the summer as the fda issued an emergency use for hydroxchloroquine that the president touted before revoking it. that is the backdrop of all of this. the president is now coming out with the announcement. what could happen down the line, that is the major question tonight. >>> right. there is a question that a lot of reporters were trying to get to which is whether or not pressure was put on the fda. what can your reporting tell us

this is fda approved, fda lan licensed product in the united states. again, it's up to doctors and patients to determine whether any product is safe and effective to use under that patient's individual circumstance. >> was it advisable for him to retweet the video of the houston doctor who has had bizarre theories? >> well, i'm not going to get into tweets. what's important is that we're all out there communicating the core public health messaging, andrea, right now. if we want to get these outbreaks under control that we're facing, it's about wearing your face coverings, social distancing, good personal hygiene, and staying away from settings like bars or overcrowded indoor dining establishments where you're not going to be doing those things. that's what we all need to be talking about right now. that's what we saw yesterday. governor ducey went in from arizona and met with president trump. you know, they had a very dramatic spike in cases as you know in phoenix. but with those simple measures, those simple individual empowerment measures that don't

this is the same thing the fda has done, it's outrageous. people need to call their congressmen and senators and complain this is not the way the country should work. ase c bureaucracy in bed with or forces causing them to make decisions that are not basing on science and killing americans, it's not acceptable. >> they ought to reach out to experts like you and experts all over the country who have something to contribute to this. it is a pandemic. constantly going on tv and telling everybody to wear a mask over and over and social distancing, it doesn't sound very scientific to me. out to thank you for your courage, insight or publishing for your publishing, i know it can't be easy but it's very important public service. god bless you. we'll be right back. ♪ ... up to 60% on top hotels. and when you save up to 60%... let's play. you're always a winner. you got... up to 60% off your hotel! but isn't that the only one? you're a winner! priceline. every trip is a big deal. whether we see them or not, we need to know that they're always there

data to support its use. >> the fda has issued an emergency use authorization. that's such a powerful term, emergency use authorization for a treatment known as convalescent plasma. this is a powerful therapy that transfusions very, very strong antibodies from the blood of recovered patients to help treat patients battling a current infection. >> several medical experts believe the fda's decision was made under pressure from the white house. the head of that agency denies it and defends the move saying all decisions are based solely on data. >> we know we're going to continue to collect data. we do that for all of our emergency use authorizations. recommemdesivir was authorized y 1st. it's the nuances of the language around the authorization that we use in the legal aspect. >> it's a promising treatment. you can't say it's very effective yet. >> i would say if you're one of those 35 out of 100 people who these data suggest show survive as a result of it, this is pretty significant for that person and their family. >> jeremy diamond has more on the announcement f

i've never been asked to make a decision at the fda based on politics. the decisions the scientists at the fda are making are done on data only. >>> i'm joined by dr. jorge rodriguez, an internal medicine and viral specialist in los angeles. good to see you again, doctor. let's talk about this announcement. it is a known potential therapy. it's been given to i think 80,000 or 90,000 patients already. not historic nor a breakthrough as the president says, but talk about the fact that in a medical sense shouldn't it be trial to actually confirm its efficacy? >> absolutely. i think what is alarming most people in the medical field is the fact that it does appear that politics is pushing science. so let's start off with this is not a china virus. this is the sars covid ii virus. we'll start from there. and people that have had it, most of them have antibodies that with other infections, other viruses have been able to give that plasma to people and those antibodies can help lessen if not cure the disease. well, right now since we're in such a state of alert

the fda issuing an emergency use authorization for a coronavirus treatment. but some top experts are concerned it has not been proven effective or safe. we have facts, next. (vo) we've got your back, road warriors. because we know you want to get back to going your speed... ...steering life at 10 and 2. you're prepared for this. and so are we. soon you'll get back to skipping the counter without missing a beat. back to choosing any car in the aisle. back to being the boss of you. go national. go like a pro. my gums are irritated. i don't have to worry about that, do i? harmful bacteria lurk just below the gum line. crest gum detoxify works below the gum line to neutralize harmful plaque bacteria and help reverse early gum damage. crest. apps except work.rywhere... why is that? is it because people love filling out forms? maybe they like checking with their supervisor to see how much vacation time they have. or sending corporate their expense reports. i'll let you in on a little secret. they don't. by empowering employees to manage their own tasks, paycom free

it's the way fda operates, the way dr. fauci operates. i've spoken to a number of epidemiologists are frankly shocked that you've moved the bar so much on these trials. let me read what someone wrote me. he said while i can't dismiss this out of hand, in in other words, he can't dismiss out of hand that maybe there is some benefit to some subgroup, for you to discuss it is irresponsible at this point without the public evidence provided by a random placebo controlled trial. >> okay. so in "the new england journal of medicine" the previous head of the cdc, tom frieden, discussed at length evidence beyond randomized controlled trials. randomized z controlled trials are not gold standards. that's a theoretical idea that doesn't play out in the real world. in sepsis studies, nobody uses them to treat sepsis. that's standard. dr. frieden explained that all real world evidence goes into understanding the benefits and harms of medications. that is the standard that scientists use. relying on a so-called theoretical randomized controlled trial is

and politicizing the fda. this was a very dangerous statement on the part of the president, even for him. >>across the country students are making their way back to college campuses despite safety measures in place universities and at least 15 states have reported coronavirus cases some of which have been theresa gatherings or let ix incoming students planning to attend northeastern university in boston, massachusetts this fall only to find another school if they don't agree to follow the university social gathering guidelines. syracuse university in new york has already handed down interim suspensions to 23 students after they gathered on the campus quad wednesday night we cannot go to bars and indoor dining we have to wear masks, we have to do the hard work to do the thing that matters the most which to get our kids through the school year. so i'd like to see people realize that what we do today matters tomorrow, let's put in the work. >>as far as latest numbers in south carolina, the state is nearing 110,00

donald trump puso presiÓn sobre la fda. [habla en inglÉs] pablo: el estado profundo en la fda estÁ siendo difÍcil para las compaÑÍas farmacÉuticas conseguir persona para probar las vacunas y medicamentos. obviamente estÁn esperando retrasar larespuesta para el 3 de noviembre, deben enfocarse en salvar vidas. no es sÓlo la fda, sino tambiÉn otras agencias, apoyÓ y -- hoy a trump su jefe de gabinete. >> desde cuando un presidente no puede controlar las agencias? pablo: los demÓcratas dicen que lo que quiere donald trump school para otro en caso de que la vacuna no llegue a tiempo de las elecciones. los demÓcratas dice que los cientÍficos estÁn siendo mÁs rápido de lo que van generalmente debido a la emergencia, pero el director de la fda advirtiÓ que no va a saltear ningÚn protocolo de seguridad. [habla en inglÉs] pablo: esta es una declaraciÓn muy peligrosa, incluso para donald trump declarÓ pellossi. [habla en inglÉs] pablo: la administraciÓn repite que antes de final de aÑo habrÁ una o dos vacunas.

an emergency use authorization is not a full approval from the fda. and while plasma treatment has seen some success, multiple experts say much more data is needed to determine any clear benefit against covid-19. also to get enough plasma, you need donors. plus the ability to track which ones have the most effective plasma. there's a lot to it. cnn's jeremy diamond with more on the announcement from the white house. >> reporter: president donald trump on sunday announcing that the fda has approved an emergency use authorization for a potential coronavirus treatment, and that is convalescent plasma. now, convalescent plasma certainly has been used already in about 70,000 patients here in the united states. and there is some promising data behind it, but certainly randomized, controlled clinical trials have not yet reached a conclusion about this convalescent plasma's efficacy, but nonetheless, the president insisting this is an historic breakthrough. while this certainly may be an incremental improvement, something that will widen the availability of p

not by a declaration from the white house about speed and politicizing the fda. this was very dangerous statement on the part of the president. even for him, it went beyond the pale. >> i'm joined by dr. kavita patel, a physician and scholar at the brookings institution. and dr. patel, do you have any clue first of all what this therapeutic breakthrough might be. maybe convalescent plasma. do you think that's what it might be? >> that's confirmed by recent reports from the food and drug administration with press that this is going to be an announce want about convalescent plasma, and just for people to recall, that's basically taking parts of the blood from people who had the coronavirus and developed antibodies for it, and giving that to people who are infected by coronavirus but are still kind of in the throngs of infection, in the hospital setting, most likely. so i would hardly call it a breakthrough just because we have got data that shows that it's safe and we have some really positive early signals that it can help decrease mortality if it's used early eno

you know, i've worked with the fda over decades now. i have never seen anything like this, anderson. that is, an fda commissioner who would basically take, not just fl flimsey data but there's no randomized trial to support this. and the only thing that gets at the 35%, a relative reduction, is going through subgroups of subgroups of exploratory datedau, torturing. this isn't right. >> it's more alarming than i realize said. thank you. >> sure. >> wasting no time. >>> president trump hits the stage in charlotte, north carolina after being formally nominated for re-election. and they will not issue a platform. essentially saying whatever the president wants to do, they're fine with that. the question is what does he want to do. the post master general denies sabotaging the postal service leading up to the election. armo is always at the ready. so when they got a little surprise... two!? ...they didn't panic. they got a bigger car for their soon-to-be-bigger family. after shopping around for insurance, they called usaa - who helped find t

eliquis is fda-approved and has both. what's next? i'm on board. don't stop taking eliquis unless your doctor tells you to, as stopping increases your risk of having a stroke. eliquis can cause serious and in rare cases fatal bleeding. don't take eliquis if you have an artificial heart valve or abnormal bleeding. while taking eliquis, you may bruise more easily- -and it may take longer than usual for any bleeding to stop. seek immediate medical care for sudden signs of bleeding, like unusual bruising. eliquis may increase your bleeding risk if you take certain medicines. tell your doctor about all planned medical or dental procedures. ask your doctor about eliquis. and if your ability to afford... ...your medication has changed, we want to help. >>> the world is cheering the rare birth of a giant panda in washington, garrett haake is at the national zoo where excitement is taking over. >> reporter: wrapped up in the mama's arms is the tiny cub who came squealing into the world. >> it's going to be so tiny. >> reporter: the mother had less than a 1%

but really focus on his attacks now against the fda. this is something that you expect to happen in third world countries, not in the united states where the fda is a global gold standard. what is your reaction when you hear this from the president? >> it's concerning to me personally but also for all of us. there have been a lot of totalities already from coronavirus as we know. but another cult fatality within this whole epidemic is the depth of trusted voices. why have people in our government who are empowered to give us information, trusted that we can rely on. and one by one they get attacked any time they say something that goes counter to what the president has to say. that's disturbing to me as an individual but also as a public health representative. we're trying to get information out that's accurate and truthful. if somebody says something that the president doesn't agree with, we end up with this type of character assassination, even within his own administration. and i think that's harmful. >> and when you hear someone lik

president trump hhs secretary alex azar and fda commissioner dr. stephen hahn focused on this number. >> in the study of americans already enrolled to receive this treatment and it's proven to reduce mortality by 35%, that's a tremendous number. >> i just want to emphasize this point, because i don't want to gloss over this number. we dream in drug development of something like a 35% mortality reduction. >> 100 people who are sick with covid-19, 35 would have been saved because of the administration of plasma. >> okay, but that claim was of course taken from a subset of data and hahn actually overstated the outcomes. on twitter, hahn said the criticism of his words are justified and added these comments earlier this morning. >> i personally could have done a better job and should have done a better job at the press conference explaining what the data show regarding convalescent plasma and i can assure the american people that this decision was made based upon sound science. >> all right, joining us is christen welker from the white house. kristen,

fauci and the fda urge caution in fast tracking plasma as a treatment. the president tweeted a deep state conspiracy was at work, an allegation reiterated today by a top trade adviser. >> some of the medical folks would rather have 100,000 people die from the virus than have one person die from some of the therapeutics. >> reporter: the mayo clinic headed trials nationwide with 70,000 patients who received convalescent plasma with the antibodies from people who recovered from covid researchers found plasma is most effective when given early and with a high dose of antibodies but without trials involving patients receiving a placebo it's not conclusive still the fda says the data suggests it may be effective in lessening the severity or shortening the length of covid-19 illnes in some hospitalized patients claudia is convinced the plasma kept her off a ventilator when she was hospitalized with covid. >> and i remember taking that first deep breath, you know i felt like i had oxygen i felt like i won the lottery. immediately i called my son, and i said to

the fda also tracks something called excess deaths. so the fda, the cdc. so the cdc knows in any given period of time how many americans have died. and what we know is that over the past nine months there have been -- there's been excess of about 10% more deaths than usual. actually more than we've tracked simply for covid. so many people think that the actual number of covid deaths is significantly higher than the currently reported number of a little over 180,000. and, you know, we know this from tracking historic controls. >> basically someone is found dead in their home it could have been from covid -- >> who hasn't had a test -- >> and looking at the numbers they are so much higher than this time last year. really quick i want to get to this reporting from "the washington post" that scott atlas one of trump's top medical advisers is urging the white house to embrace herd immunity where you allow the virus to spread while taking steps to protect vulnerable populations. we should note at lance denies this. experts say as many as 2 million americans coul

fda approving the use of plasma therapy. alex azar on that, and the race for a vaccine in a moment, next. ♪ book two separate qualifying stays and earn a free night. the open road is open again. and wherever you're headed, choice hotels is there. book direct at choicehotels.com. >> bill: president trump announcing emergency operations for the use of convalescent plasma to treat covid-19. the most effective a country with more than 5.7 million cases and more than 176,000 deaths blamed on covid. thank you for being here today. a member of the task force. i appreciate you being on. >> thank you for having me. >> bill: the fda playing politics, was that the case? >> what president trump is demanding is that we cut all bureaucratic red tape out of the way. he is demanding that we get therapies and vaccines to the american people as soon as we meet fda safety and regulatory standards. that is what happened yesterday. the fda granted emergency authorization to use the plasma who comes from people who have recovered from covid, be

today the fda fired two of its p.r. people, it's public relations people, one of whom the spokesperson for the fda they recently got from the one america network, which is the pro-trump tv network that among other things airs the stuff that the intelligence community just warned is direct from the kremlin to interfere with the 2020 election too. she worked for the one america network, and that's what qualified her to become the spokesperson for the fda during a global pandemic? she was working as the main spokesperson for the fda during this past week when this debacle happened over convalescent plasma with the fda, including the fda chief spouting wildly inaccurate, wildly exaggerated, just false information about the efficacy of convalescent plasma as a treatment for covid-19. you heard many of those wild exaggerations echoed this week at the republican convention, including from the president himself. the republican convention basically bragged over the course of four nights that trump had this thing cured. this conv

. >> the fda -- >> no, i haven't. >> is it something to support? >> something that people are talking about very strongly? we'll look at it. we'll look at a lot of different things. the fda's been great. they are very close, were very close to a vaccine and a therapeutic. i have heard that name mentioned. we'll find out. >> cnn white house correspondent kaitlan collins with know now. this is pushed by the creator of mypillow. how did it make its way to the white house? >> reporter: he is close to the president and speak relatively aurp and used to come to the old coronavirus task force meetings in the briefings in the rose garden and so he had this july meeting with the president where he shared the find wings the officials and dr. ben carson saying that he looked at this data himself, they brought it to the president and that's when he confirmed today that the president enthusiastic about it and we should note while we discuss this the president hasn't publicly brought this up and reporting on these internal discussions going on over this and mike

a short time from now the president will hold a press conference with the head of the fda. the topic -- a major therapeutic breakthrough, but the timing unusual. just yesterday the president accused members of the fda of being part of the deep state, and without evidence suggested they're going slow on testing vaccines and therapeuticing so they can delay them until after the election. the president reupping attacks on mail-in voting, suggesting against without evidence, not only fraud but that ballot drop boxes are a health risk, saying in part, they are not covid sanitized. twitter actually slapped a label on this tweet for being misleading. top clear, the president wants you to think that ballot drop boxes will get you sick, yet when it comes to having supporters pile in a room close together to hear him speak, there's no problems? over the next four days the republican party and the president will have to contract what we heard repeatedly in the democratic convention. the president's sister, a respected former federal judge slamming him in a secret recording. >> -- it's