Speaker 1: Pushkin from Pushkin Industries. This is Deep Background the show
Speaker 1: where we explored the stories behind the stories in the news.
Speaker 1: I'm Noah Feldman. The Food and Drug Administration recently issued
Speaker 1: an emergency use authorization for doctors to take blood plasma
Speaker 1: from patients who have recovered from COVID nineteen and use
Speaker 1: it as a therapy for patients who are sick enough
Speaker 1: with the disease right now that they find themselves in
Speaker 1: the hospital. While announcing this authorization, the FDA Commissioner Stephen
Speaker 1: Hahn said that thirty five out of one hundred of
Speaker 1: COVID nineteen patients quote would have been saved because of
Speaker 1: the administration of plasma close quote. This led to an
Speaker 1: outcry from scientists pointing out that this statement vastly overstated
Speaker 1: the treatment benefits, criticism that Han later said was in
Speaker 1: fact justified. So what do we actually know about convalescent
Speaker 1: plasma as a treatment for COVID nineteen, And, perhaps more important,
Speaker 1: what does the mess of politicization around this emergency use
Speaker 1: authorization tell us about what might happen in the future
Speaker 1: if and when the Trump administration seeks to use an
Speaker 1: emergency use authorization to introduce a vaccine. Here to discuss
Speaker 1: these hugely important issues with US is doctor Walid Jelad.
Speaker 1: Doctor Gelatt is an assistant professor of medicine and health
Speaker 1: policy at the University of Pittsburgh, where he leads the
Speaker 1: Center for Pharmaceutical Policy and Prescribing. He has been a
Speaker 1: frequent and astute commentator on treatment statistics and reality. Well,
Speaker 1: thank you so much for being here. It's my pleasure. Today.
Speaker 1: We're going to start with convalescent plasma therapy. And although
Speaker 1: we're going to talk I think at some length about
Speaker 1: what is not true of convalescent plasmo therapy, Let's start
Speaker 1: with what is true of plasma therapy in your view,
Speaker 1: reading the data that has been made publicly available, what
Speaker 1: can plausibly be claimed for this therapy in terms of
Speaker 1: the effect that it could have on people who are
Speaker 1: ill with covid NT. There are different ways to think
Speaker 1: about this. I think so one. I think the claim
Speaker 1: can be made as it was made in the Emergency
Speaker 1: Use Authorization, which is why the EUA is interesting, And
Speaker 1: the claim is simply that the totality of the evidence
Speaker 1: says that it's probably going to help people, and I
Speaker 1: actually think it is fair to say then, and that's
Speaker 1: pretty much a low bar for what you need to
Speaker 1: determine if something is going to be authorized. But the FDA,
Speaker 1: but I think the totality of evidence, based on what
Speaker 1: we've seen in animals, in what was in a small
Speaker 1: randomized trial, and in some of these observational data that
Speaker 1: was seen from the Mayo clinic, is that it probably
Speaker 1: help helps to some extent. And that's really all you
Speaker 1: can say, probably helps to some extent is, as you say,
Speaker 1: a pretty low bar to reach. Does that include also
Speaker 1: the question of whether it could potentially do any harm? Yeah,
Speaker 1: I think that it has a lot of data. Actually,
Speaker 1: it's been used by seventy thousand people at this point,
Speaker 1: and there's a lot of safety data at that point.
Speaker 1: That's a lot of people to use it. And there's
Speaker 1: known problems with when people receive transfusions of blood or
Speaker 1: plasma that there are known side effects and they're pretty
Speaker 1: typical I think for what people know about plasma. So
Speaker 1: I think one of the reasons why both hydroxy chloroquin
Speaker 1: and convalescent plasma meth this bar for the emergency use
Speaker 1: authorization was in part because the data on side effects
Speaker 1: is pretty well known at least they've been used in
Speaker 1: other settings, and so there's not a lot of concern
Speaker 1: about safety other than the known side effects of plasma. Actually, well,
Speaker 1: that's the good news. But you also just mentioned in
Speaker 1: the same sentence as hydroxychloroquin which turned out on closer
Speaker 1: examination of the data not to have positive therapeutic effects.
Speaker 1: What is the aspect of the data that makes you
Speaker 1: think that that is not true of kindless and plasma therapy,
Speaker 1: that in fact there are reasons in the data. Is
Speaker 1: it that small and RCT randomized control trial or is
Speaker 1: it more to do with the observational data on the
Speaker 1: seventy thousand people who have been treated this way. Yeah,
Speaker 1: you know, it's sometimes I sit back and this is
Speaker 1: not the way to judge science. But I'd say, based
Speaker 1: on what I've seen, if I are a family member
Speaker 1: had COVID, what I want them to receive plasma and
Speaker 1: the answer is yes, So I must have some sense
Speaker 1: that it works. But it is partly from the small
Speaker 1: randomized trial. It is partly from what you see in
Speaker 1: the data, which, although there's no control group, which is
Speaker 1: the huge problem, there are some signs that it would work.
Speaker 1: You cannot know for sure. Until you do the randomized trial.
Speaker 1: That's why this is an authorization and not approval, and
Speaker 1: there's a clear distinction between approval and all zation. And
Speaker 1: to authorize it in the setting of a public health
Speaker 1: emergency with no other treatment, you just have to think
Speaker 1: that it's probably going to work and have enough evidence
Speaker 1: that someone at FDA is going to say that it
Speaker 1: probably works. That's a hugely important point that you're making.
Speaker 1: There will lead and I just want to pause and
Speaker 1: emphasize it. Emergency use authorization is its own category, and
Speaker 1: it's different from FDA approval. FDA approval has higher standards
Speaker 1: for whether a treatment is approved, and that includes real
Speaker 1: statistical presumably RCT randomized control trial proof that it actually
Speaker 1: is working, whereas emergency use authorization simply consists of the
Speaker 1: statement that there's more reason to believe than not that
Speaker 1: it's helping. Is that a fair distinction between the two. Yes,
Speaker 1: that there's a reason to believe that the benefits outweigh
Speaker 1: the risks and approval full approval. Regular FDA approval typically
Speaker 1: requires a randomized trial. So yeah, that is a key
Speaker 1: issue with emergency use authorizations. The bar is lower. It's
Speaker 1: very different than FDA approval. And the other thing that's
Speaker 1: really interesting about emergency use authorizations is one of the
Speaker 1: criterias that there is no other approof therapy to treat
Speaker 1: the disease. And what's interesting is that it's approved therapy.
Speaker 1: So even though remdezeviere is the anti viral that is
Speaker 1: authorized also under the emergency use authorization, there is still
Speaker 1: no approved therapy. So as long as nothing is approved,
Speaker 1: they can actually still authorize what they need to because
Speaker 1: there is no approved therapy. While we're on the topic
Speaker 1: of emergency use authorization, let me ask you a question
Speaker 1: that I've been asked repeatedly by other lay people, and
Speaker 1: I have declined to answer because I don't know. But
Speaker 1: I bet you do know. When the time comes to
Speaker 1: try out for the public some of the vaccines that
Speaker 1: are being tested right now for SARS CoV two, is
Speaker 1: it conceivable that the FDA would do emergency use authorizations
Speaker 1: for the vaccines rather than issue full approvals because that
Speaker 1: would lower the standard of proof that needed to be
Speaker 1: met and would also presumably speed up the process. Yes,
Speaker 1: the answer is yes. And this is what I tell
Speaker 1: people is the most people could care less about convalescent plasma.
Speaker 1: Most people will never get it because it's given to
Speaker 1: hospitalize patients. The reason why it matters so much is
Speaker 1: because of exactly what you mentioned, which is everybody is
Speaker 1: really concerned about what this means for the vaccine. The
Speaker 1: answer is yes, that a vaccine can and in my
Speaker 1: view and others, likely will be authorized by the FDA
Speaker 1: through the same mechanism soon actually in terms of months.
Speaker 1: And there's a lot of debate about then, well good,
Speaker 1: because that's where we're headed. In order to get there,
Speaker 1: I think we first need to turn to the very
Speaker 1: troubling way, at least to my mind, that the announcement
Speaker 1: about the convalescent plasma therapy was made in a dramatic
Speaker 1: President of the United States participating press conference with statistics
Speaker 1: cited that, as far as I can make out, we're
Speaker 1: just not substantiated, namely that the treatment had reduced deaths
Speaker 1: by thirty five percent, which is something that the President said,
Speaker 1: the Secretary of HHS said, and then perhaps most disturbingly,
Speaker 1: the Commissioner of the FDA said, talk to us about
Speaker 1: what happened there? Where did this thirty five percent number
Speaker 1: come from? If you have a theory about where and
Speaker 1: why was it wrong, if indeed you believe it was wrong. Yeah,
Speaker 1: this is one of the most astounding things that happened.
Speaker 1: And I've tried to make a very clear distinction personally
Speaker 1: between whether I agree with an emergency use authorization and
Speaker 1: whether I agree with how it was delivered or how
Speaker 1: it was announced, which I do not. So that latter
Speaker 1: part that was just unprecedented, where you had such huge
Speaker 1: errors made in how the FDA talks about data for
Speaker 1: products that is authorized. Doesn't do those mistakes. If you
Speaker 1: read the decisional memo that the FDA puts together when
Speaker 1: they actually write, the FDA staff right, all the reasons
Speaker 1: why it should be authorized, all the data they make
Speaker 1: their decision, it's actually very detailed, very nuanced. But that
Speaker 1: is not what we heard at the press conference. That
Speaker 1: is also why people are so attuned to this issue
Speaker 1: of convalescent plasma, because we need the FDA to be
Speaker 1: telling us what is correct and saying it correctly and
Speaker 1: not misinforming the public, which is what they did here.
Speaker 1: So it's important to talk about that. So a couple
Speaker 1: of things, this thirty five out of one hundred issue
Speaker 1: the data supporting an emergency use authorization, for convalescent plasma
Speaker 1: did not come from a randomized trial, So it is
Speaker 1: very difficult to make conclusions about whether any therapy actually
Speaker 1: reduce mortality because there was no control arm. There was
Speaker 1: no arm that got nothing. So you really shouldn't say
Speaker 1: that there's good evidence that anything reduces mortality. What is
Speaker 1: there in terms of data? There are data that shows
Speaker 1: if you look at a subgroup subgroup of individuals, and
Speaker 1: you compare those who got more antibodies in their plasma
Speaker 1: with those who got fewer antibodies, there is a reduction
Speaker 1: in mortality. That the people who had more antibodies in
Speaker 1: their plasma, which conceivably should have more of an effect
Speaker 1: in reducing the severity disease, they actually had less mortality
Speaker 1: than the people that had lower tighters of anybody. And
Speaker 1: that the people who got the therapy earlier, when theoretically
Speaker 1: it should work better, had lower mortality than those who
Speaker 1: got it later. Still, we cannot be certain. You cannot
Speaker 1: go in front of the American public and say that
Speaker 1: this therapy reduces mortality when there's that possibility that it
Speaker 1: might not, and the audience that's listening does not understand
Speaker 1: all these nuances we've talking about about the bar emergency
Speaker 1: use authorization, randomized trials necessarily, So that is a key issue.
Speaker 1: Here's a question if the head of the FDA or
Speaker 1: the head of HHAs or the President for that matter,
Speaker 1: had not said this reduces mortality, but had said, we
Speaker 1: have reason to think that it might reduce mortality. Would
Speaker 1: that have made you less upset without it satisfied you.
Speaker 1: Is this a question of the clarity of the claim. Yes.
Speaker 1: So that's the thing is that the FDA had no
Speaker 1: reason to try and inflate the claim. The data as
Speaker 1: they stand are enough to say we're going to authorize it.
Speaker 1: We believe that in the case of an emergency people
Speaker 1: are dying. We want to get this to you. All
Speaker 1: of that is reasonable. That the problem was is going
Speaker 1: and saying that it reduces mortality when we don't know that.
Speaker 1: You know, even the bigger problem was saying that thirty
Speaker 1: five out of one hundred people will survive if they
Speaker 1: get the therapy. That is just nowhere near correct. That
Speaker 1: just flat out false. As far as I can make out,
Speaker 1: it's false. So not only was the certainty about the
Speaker 1: mortality benefit misstated, but the actual magnitude of that was misstated.
Speaker 1: We'll be right back. Let's turn now from what happened
Speaker 1: in this rollout to its implications for the really massive
Speaker 1: question of what's going to happen for vaccines. What consequences
Speaker 1: do you think this to a certain degree botched emergency
Speaker 1: use authorization rollout for the convalescent plasma has for the
Speaker 1: question of how much the public can, should, or will
Speaker 1: trust a potential emergency use authorization for vaccines. Yeah, one
Speaker 1: of the real problems we've had in the public health
Speaker 1: approach or has been the politicization of the entire thing.
Speaker 1: The problem with what happened here is that it just
Speaker 1: gave an opening of even more politicization, even more criticizing,
Speaker 1: so that it was the same thing with hydroxy clark,
Speaker 1: when there was huge criticism of the FDA from one side,
Speaker 1: huge applauding from the other side, and you have these
Speaker 1: two sides that are just completely different saying completely different things,
Speaker 1: you know, one saying it's the best thing ever, one
Speaker 1: saying it's the worst thing ever. And what happened here
Speaker 1: was just yet another opportunity for that to happen. Instead
Speaker 1: of having a message that is clear, that is correct,
Speaker 1: that is not overhyping things. It just contributed to the
Speaker 1: hype on one side about the benefit and so then
Speaker 1: the other side started a pile on the FDA. So
Speaker 1: that's part of the problem is that it's just adding
Speaker 1: to the politicization of public health. So what happens is
Speaker 1: it just leads to further distrust and you don't know
Speaker 1: who to trust, and so I think people end up
Speaker 1: just going to listen to who they trust, which is
Speaker 1: a problem. So all of this is leading up to
Speaker 1: this issue about what's going to happen when the FDA announces,
Speaker 1: When there's a press conference at the end of October
Speaker 1: and the president announces and the head of the FDA,
Speaker 1: they head the CDC is there and they announced that
Speaker 1: they have authorized a vaccine and they say that the
Speaker 1: vaccine is safe and effective. Ideally, we'd want the public
Speaker 1: to say, the President, the head of the CDC, the
Speaker 1: head of the FDA are telling us a vaccine is
Speaker 1: safe and effective. Great, we can all celebrate. The problem
Speaker 1: is is that that's not what's going to happen, and
Speaker 1: that's going to make this issue of vaccine so dicey.
Speaker 1: How our scientists going to respond about the vaccine when
Speaker 1: there's going to be nuanced date on safety and efficacy.
Speaker 1: What we don't want is scientists going out and saying
Speaker 1: this vaccine is not safe when they want people to
Speaker 1: take other vaccines, and the public will not get the nuance.
Speaker 1: That's the larger issue for me is this issue about
Speaker 1: polarization of science and public health, distrust, mistrust, confusion, and
Speaker 1: what that means for the vaccine, which is really the
Speaker 1: way that we're going to finish with this whole COVID
Speaker 1: thing and be able to get back to normal. You've
Speaker 1: kind of blown my mind in what you just said.
Speaker 1: So I want to walk through your scenario, which let's
Speaker 1: call the October surprise, which to you is not going
Speaker 1: to be such a surprise. You pick the end of October,
Speaker 1: I presume not solely because you think that by then
Speaker 1: will have enough preliminary data to make some kind of
Speaker 1: an initial judgment about the vaccines, but rather because it's
Speaker 1: approximate to the beginning of November and then the president
Speaker 1: wants to be reelected. So if I'm right about that,
Speaker 1: what you're picturing is a nationally televised press conference. The
Speaker 1: President's going to get up there and sort of like
Speaker 1: do his version of Barack Obama. You know, ladies and gentleman,
Speaker 1: we got him. He's going to go up there and
Speaker 1: he's going to say, in your scenario, ladies and gentlemen,
Speaker 1: we cured it. All problems solved. So, first of all,
Speaker 1: is that indeed something like the October surprise scenario that
Speaker 1: you're describing. Let me make sure I'm hearing you correctly.
Speaker 1: That is like the October surprise that I'm talking about.
Speaker 1: But the reason why I say late October is because
Speaker 1: there is already a meeting schedule of the FDA Advisory
Speaker 1: Committee that advises the FDA on vaccines, and the specific
Speaker 1: topic is the authorization of COVID vaccines. Now they have
Speaker 1: said specifically, the FDA Commissioner has said specifically that no
Speaker 1: specific application is going to be discussed, So it's as
Speaker 1: of now, there is no plan to discuss a specific
Speaker 1: vaccine that's going to be authorized. From what they said now,
Speaker 1: the FDA has said multiple settings of written and verbal
Speaker 1: that they will have an advisory committee meeting to review
Speaker 1: the safety and efficacy of a vaccine before anything is authorized.
Speaker 1: So they've made that commitment. So those pieces of data
Speaker 1: are they've said there's going to be advisory committee meeting
Speaker 1: before they authorize a vaccine. There is a vaccine Advisory
Speaker 1: Committee meeting scheduled for October twenty second. They're going to
Speaker 1: discuss the COVID vaccine in general. So that's one part
Speaker 1: of the puzzle. The other part of the puzzle is
Speaker 1: there's little snippets of what you call them rumor or
Speaker 1: news come out about the idea of using data from
Speaker 1: trials overseas to authorize a therapy if the trials here
Speaker 1: are not finished. There's a vaccine out of the University
Speaker 1: of Oxford that is doing trials outside of the US
Speaker 1: but hasn't really advanced trials inside the US, and there's
Speaker 1: some talk about that one of the trial sites was
Speaker 1: stopped because the FDA is saying, maybe we can use
Speaker 1: data from overseas. The other issue is that we've heard
Speaker 1: more and more just this opening about we would consider
Speaker 1: an emergency use authorization for the vaccine. So we keep
Speaker 1: hearing that, and that we keep hearing that there is
Speaker 1: a push politically to have a vaccine before the election.
Speaker 1: So whether it happens or not, no one knows, but
Speaker 1: everything is aligned in terms of a low bar for
Speaker 1: an authorization a Vaccine Advisory Committee meeting, trials that are
Speaker 1: quite advanced, and I could argue one could make the
Speaker 1: argument that it could fit the bar for an emerge
Speaker 1: use authorization. The stage is set that this could actually
Speaker 1: happen politically. Now if I can put my unofficial pundit head,
Speaker 1: and I'm not a pundit, but for the President to
Speaker 1: go up and announce that there's a vaccine does not
Speaker 1: require that it's a vaccine that everyone has access to
Speaker 1: or will take. So what some people have talked about
Speaker 1: is an emergency use authorization that is first very specific,
Speaker 1: tailored population, a small group of individuals, that allows the
Speaker 1: administration to say, look, we got a vaccine, but without
Speaker 1: having to deal with all the issues of well is
Speaker 1: it really safe? Is the entire public going to get it?
Speaker 1: It will just be authorized for a small population. Those
Speaker 1: are many reasons to think that it's at least possible
Speaker 1: that after the October twenty two Vaccine Committee FDA meeting,
Speaker 1: if the agenda is tweaked a little bit in the
Speaker 1: run up to that meeting such that's specific and concrete
Speaker 1: vaccines or discussed rather than the issue in the abstract,
Speaker 1: that there could be as a result potentially of White
Speaker 1: House pressure. But maybe, I mean, let's not be totally cynical.
Speaker 1: Maybe as a result of early findings from around the
Speaker 1: world that seemed plausible that there could be some kind
Speaker 1: of an announcement of an emergency use authorization with enough
Speaker 1: time before the election for that to affect people's minds.
Speaker 1: What do you see as the potential upsides or downsides
Speaker 1: of an announcement like that, Right, the whole point is
Speaker 1: we're in an emergency and a thousand people that they
Speaker 1: are dying. If there is something that can stop that,
Speaker 1: that is good. So the upside if there is really
Speaker 1: good data from overseas and it just doesn't fulfill the
Speaker 1: requirements of a full approval in the FDA here, well,
Speaker 1: I mean most people would agree that that should be authorized.
Speaker 1: That would require a full Phase three trial that's completed,
Speaker 1: where you give it to enough people and you have
Speaker 1: enough cases to say that there really is a reduction
Speaker 1: in the evalence of COVID or the severity of COVID.
Speaker 1: If you give people a vaccine and the FDA has
Speaker 1: made specific guidelines on how much of an effect they want,
Speaker 1: they want at least a fifty percent effect. Fifty percent
Speaker 1: fewer cases among those who are vaccinated versus non vaccinated.
Speaker 1: So that's a clear upside. If there's a vaccine that works,
Speaker 1: we feel good that it works. Well, then let's get
Speaker 1: it available so people don't have to wait for all
Speaker 1: the red tape to happen. Then I guess it's a
Speaker 1: spectrum of things. So go down the spectrum a little bit,
Speaker 1: and well, the Phase three trials are not completed, but
Speaker 1: they're almost completed. There maybe is an effect, but there's
Speaker 1: not enough cases to know for sure, but there's no
Speaker 1: real safety issues. I can easily see an argument there
Speaker 1: being made that, well, we have data so far in
Speaker 1: the data, we don't have any big safety issues. We
Speaker 1: have the early trials, and we have the Phase three
Speaker 1: trials saying yeah, there may be an effect. It may
Speaker 1: not reach statistical significance because there's not enough people, but
Speaker 1: it's it's almost there, and then it goes all the
Speaker 1: way down. How far you want to think about what
Speaker 1: the administration could say that would still fit the criteria
Speaker 1: for an emergency use austhorization? Is it reasonable to say
Speaker 1: that the probability of a benefit outweighs the probability of
Speaker 1: a risk with some lesser kind of data, and it's possible.
Speaker 1: And it depends on which vaccine they're talking about, because
Speaker 1: some of them are new vaccines that have never been
Speaker 1: used before. Some of them are just variants of another vaccine.
Speaker 1: So the downsides are One is side effects. You do
Speaker 1: not want a vaccine to be authorized people excited and
Speaker 1: then all of a sudden people die or become paralyzed
Speaker 1: when they start taking a vaccine. That would be a disaster.
Speaker 1: The other issue is, let's say there's a vaccine where
Speaker 1: the preliminary data is positive, but it ends up being
Speaker 1: just a little effective. It maybe reduces the chance of
Speaker 1: having COVID by twenty percent, but there's still trials ongoing
Speaker 1: to test the vaccine that might be better. The problem
Speaker 1: is you're going to have people who want to get
Speaker 1: back to their lives and they're going to have a
Speaker 1: vaccine on the market, and the question is are they
Speaker 1: going to take that vaccine and then not enroll in
Speaker 1: other trials that might get us a better vaccine, and
Speaker 1: then we'll never know. We'll never get to that better vaccine.
Speaker 1: That's one concern is that the randomized trials will not
Speaker 1: fully enroll and we end up authorizing a vaccine that's okay,
Speaker 1: and not really getting those vaccines to market that are really,
Speaker 1: really good and maybe a little safer. What about the
Speaker 1: risk that politicization just engulfs the announcement. I think the
Speaker 1: thing that's most striking to me is, you know, we
Speaker 1: spent the first part of our conversation talking about just
Speaker 1: how bad it was that there's this politicization surrounding I
Speaker 1: think your phrase was, I jotted it down, the politicization
Speaker 1: of the entire thing, the entire thing being, you know,
Speaker 1: the whole question of treatment of COVID. If the President
Speaker 1: announces an EUA for a vaccine in late October, I
Speaker 1: know how you avoid radical politicization, and I don't know
Speaker 1: how you avoid Democrats, maybe not Joe Biden, but certainly
Speaker 1: other Democrats saying it's too soon, this isn't safe, you
Speaker 1: shouldn't do it. And then that really could create a
Speaker 1: circumstance where many many people, like roughly half the people,
Speaker 1: have some deep skepticism about the vaccine. Can you imagine
Speaker 1: this scenarrea where the Democrats were at least some Democrats
Speaker 1: would go down that road. Yes, yes, And that's the problem.
Speaker 1: I've already seen it in politicization of other issues in
Speaker 1: public health. And it's not only what they say, it's
Speaker 1: how they say it and in what context they say it.
Speaker 1: A lot of the decisions that Democrats and those that
Speaker 1: lean Democrat have disagreed with, the criticism has been couched
Speaker 1: in the language that is about how the president is terrible, etc. Etc.
Speaker 1: So the problem is is that will definitely happen with
Speaker 1: the vaccine, and it will be things like no one
Speaker 1: should take this vaccine, no one should trust Trump, the
Speaker 1: data are terrible. Trump has let us astray. The problem
Speaker 1: is where is the nuance? Where is the truth going
Speaker 1: to come from? And that's what I meant before about
Speaker 1: the problem with thirty five out of one hundred thing
Speaker 1: from the head of the FDA about plasma. Where is
Speaker 1: the truth going to come from? I mean, what you're
Speaker 1: just described sounds great from the standpoint of Trump, especially
Speaker 1: if he's pulling closer in the polls but is still down.
Speaker 1: And now you know, imagine if you will, being inside
Speaker 1: Joe Biden's strategy session as Donald Trump is calling this
Speaker 1: press conference and holding it, his advisors are going to
Speaker 1: be telling him, well, mister Biden, if you don't challenge this,
Speaker 1: it may hurt you in the vote in the next week.
Speaker 1: But if you do challenge it, if you do say
Speaker 1: it's too soon, and then you're elected, then by the
Speaker 1: time whatever vaccine the president is talking about is actually available,
Speaker 1: because the vaccines themselves doesn't seem plausible, would be available
Speaker 1: at the end of October. It would just be the
Speaker 1: announcement that was happening then at the time the vaccines
Speaker 1: were actually being produced in sufficient quantities and distributed with
Speaker 1: sufficient efficiency to reach Americans. Joe Biden could be president
Speaker 1: and then he would be in a disastrous position if
Speaker 1: he had first said that we shouldn't take the vaccine,
Speaker 1: and then he were president and he wanted to hand
Speaker 1: out the vaccine. So you can imagine that strategy session
Speaker 1: being frankly, a bit of a nightmare. Two. So what
Speaker 1: you're describing is making me. With everything you say, I'm
Speaker 1: getting more and more concerned that this could actually happen. Yeah,
Speaker 1: and I am not a political pundit, but I, like
Speaker 1: many people, think a lot about these things. But I
Speaker 1: have the same concern, and I think, what will happen
Speaker 1: in October? If there is an announcement like this, it
Speaker 1: will inevitably be politicized, and the vaccine is our way out,
Speaker 1: and we just don't want to mess this up. We
Speaker 1: have messed up so much in the response to this pandemic.
Speaker 1: The vaccine is the way out. We do not want
Speaker 1: to mess that up. But yet to be able to
Speaker 1: be the president and stand up a week or two
Speaker 1: before you're election and say we from day one put
Speaker 1: in billions of dollars and warp speed. Look what we've done.
Speaker 1: We've authorized the vaccine for a small group that that
Speaker 1: obviously will bring a lot of benefits. Thank you a
Speaker 1: lead for genuinely powerful analysis, and thank you for your
Speaker 1: clarity and your even handedness around these really challenging questions.
Speaker 1: I hope he'll come back and talk more with us
Speaker 1: if indeed there is an October surprise. It's a pleasure
Speaker 1: to talk to you. Yet, I'd be happy to come back,
Speaker 1: and hopefully the October surprise is a good one. Listening
Speaker 1: to doctor Jelat describe what went wrong in the rollout
Speaker 1: of convalescent plasma therapy was pretty eye opening. First of all,
Speaker 1: he pointed out that when it comes down to it,
Speaker 1: convalescent plasma therapy may actually be a good thing, he
Speaker 1: supported and said it was correct for the FDA to
Speaker 1: issue its emergency use authorization. At the same time, he
Speaker 1: didn't pull any punches in saying that it was astounding
Speaker 1: and unprecedented for the head of the FDA to make
Speaker 1: flatly false statements about the degree of efficacy of a
Speaker 1: treatment and then not fully back away subsequently from those claims. Yet,
Speaker 1: for all the importance of these events, what most stunned
Speaker 1: me in my conversation with Walid was his very close
Speaker 1: to a prediction, or at least his alerting us to
Speaker 1: the possibility that after the special October twenty second meeting
Speaker 1: of the FDA's Vaccines Committee, there could well be a
Speaker 1: presidential announcement of an emergency use authorization for a vaccine. Now,
Speaker 1: to be sure, we don't know whether that will happen,
Speaker 1: and while he did not say that he knew that
Speaker 1: it would. Instead, what we were doing was trying to
Speaker 1: pull together probabilistic evidence based on the incentives of the parties,
Speaker 1: based on what had been said and announced publicly, and
Speaker 1: based on what we think Trump like to do if
Speaker 1: he were able. It's important to note that Wali did
Speaker 1: not say that would necessarily be a bad thing for
Speaker 1: the President to issue this emergency use authorization. If indeed
Speaker 1: he did, that would all depend on what the data
Speaker 1: showed at the relevant time. We all want to get
Speaker 1: this vaccine to as many people as possible, even if
Speaker 1: in practice it seems extremely unlikely that vaccines would actually
Speaker 1: be available in October. Yet there is simultaneously a really
Speaker 1: significant risk that if a vaccine will rolled out too soon,
Speaker 1: it might crush public confidence in the FDA and eventually
Speaker 1: public confidence in the efficacy of a vaccine, and that
Speaker 1: too has potentially very serious public health effects. The upshot
Speaker 1: is that we should all be watching much more closely
Speaker 1: than I have been until this moment to figure out
Speaker 1: what the FDA is actually going to do at its
Speaker 1: committee's October twenty second meeting, And we should be watching
Speaker 1: the press residence moves very carefully to see whether the
Speaker 1: White House thinks it has something to gain from an
Speaker 1: emergency use authorization. Then at the same time, we'll all
Speaker 1: keep hoping that the data is good and that the
Speaker 1: vaccines work, and that it is possible to get them
Speaker 1: to people as soon as possible. I make no secret
Speaker 1: of my desire to see Donald Trump out of office,
Speaker 1: but It's in the end much more important to save lives.
Speaker 1: Until the next time I speak to you, be careful,
Speaker 1: be safe, and be well. Deep Background is brought to
Speaker 1: you by Pushkin Industries. Our producer is Lydia gene Cott,
Speaker 1: with mastering by Jason Gambrell and Martin Gonzalez. Our showrunner
Speaker 1: is Sophie mckibbon. Our theme music is composed by Luis
Speaker 1: GERA special thanks to the Pushkin Brass, Malcolm Gladwell, Jacob Weisberg,
Speaker 1: and Mia Lobel. I'm Noah Feldman. I also write a
Speaker 1: regular column for Bloomberg Opinion, which you can find at
Speaker 1: Bloomberg dot com slash Feldman. To discover bloom original slate
Speaker 1: of podcasts, go to Bloomberg dot com slash Podcasts. And
Speaker 1: one last thing. I just wrote a book called The
Speaker 1: Arab Winter, a Tragedy. I would be delighted if you
Speaker 1: checked it out. If you liked what you heard today,
Speaker 1: please write a review or tell a friend. You can
Speaker 1: always let me know what you think on Twitter. My
Speaker 1: handle is Noah R. Feldman. This is Deep Background.