1 00:00:15,356 --> 00:00:22,596 Speaker 1: Pushkin from Pushkin Industries. This is Deep Background the show 2 00:00:22,636 --> 00:00:25,796 Speaker 1: where we explored the stories behind the stories in the news. 3 00:00:26,356 --> 00:00:31,156 Speaker 1: I'm Noah Feldman. The Food and Drug Administration recently issued 4 00:00:31,196 --> 00:00:36,556 Speaker 1: an emergency use authorization for doctors to take blood plasma 5 00:00:36,756 --> 00:00:40,436 Speaker 1: from patients who have recovered from COVID nineteen and use 6 00:00:40,516 --> 00:00:43,516 Speaker 1: it as a therapy for patients who are sick enough 7 00:00:43,596 --> 00:00:46,516 Speaker 1: with the disease right now that they find themselves in 8 00:00:46,596 --> 00:00:52,716 Speaker 1: the hospital. While announcing this authorization, the FDA Commissioner Stephen 9 00:00:52,756 --> 00:00:56,196 Speaker 1: Hahn said that thirty five out of one hundred of 10 00:00:56,236 --> 00:00:59,196 Speaker 1: COVID nineteen patients quote would have been saved because of 11 00:00:59,196 --> 00:01:02,836 Speaker 1: the administration of plasma close quote. This led to an 12 00:01:02,836 --> 00:01:07,516 Speaker 1: outcry from scientists pointing out that this statement vastly overstated 13 00:01:07,796 --> 00:01:11,636 Speaker 1: the treatment benefits, criticism that Han later said was in 14 00:01:11,676 --> 00:01:16,196 Speaker 1: fact justified. So what do we actually know about convalescent 15 00:01:16,196 --> 00:01:20,516 Speaker 1: plasma as a treatment for COVID nineteen, And, perhaps more important, 16 00:01:20,916 --> 00:01:25,196 Speaker 1: what does the mess of politicization around this emergency use 17 00:01:25,276 --> 00:01:29,316 Speaker 1: authorization tell us about what might happen in the future 18 00:01:30,116 --> 00:01:33,596 Speaker 1: if and when the Trump administration seeks to use an 19 00:01:33,596 --> 00:01:38,916 Speaker 1: emergency use authorization to introduce a vaccine. Here to discuss 20 00:01:38,996 --> 00:01:42,996 Speaker 1: these hugely important issues with US is doctor Walid Jelad. 21 00:01:43,916 --> 00:01:46,436 Speaker 1: Doctor Gelatt is an assistant professor of medicine and health 22 00:01:46,436 --> 00:01:48,996 Speaker 1: policy at the University of Pittsburgh, where he leads the 23 00:01:49,076 --> 00:01:52,956 Speaker 1: Center for Pharmaceutical Policy and Prescribing. He has been a 24 00:01:52,956 --> 00:02:02,876 Speaker 1: frequent and astute commentator on treatment statistics and reality. Well, 25 00:02:03,116 --> 00:02:05,996 Speaker 1: thank you so much for being here. It's my pleasure. Today. 26 00:02:06,036 --> 00:02:10,876 Speaker 1: We're going to start with convalescent plasma therapy. And although 27 00:02:10,876 --> 00:02:13,396 Speaker 1: we're going to talk I think at some length about 28 00:02:13,796 --> 00:02:16,916 Speaker 1: what is not true of convalescent plasmo therapy, Let's start 29 00:02:16,916 --> 00:02:20,596 Speaker 1: with what is true of plasma therapy in your view, 30 00:02:20,836 --> 00:02:24,836 Speaker 1: reading the data that has been made publicly available, what 31 00:02:25,076 --> 00:02:28,756 Speaker 1: can plausibly be claimed for this therapy in terms of 32 00:02:28,796 --> 00:02:30,636 Speaker 1: the effect that it could have on people who are 33 00:02:30,676 --> 00:02:33,996 Speaker 1: ill with covid NT. There are different ways to think 34 00:02:34,036 --> 00:02:36,836 Speaker 1: about this. I think so one. I think the claim 35 00:02:36,876 --> 00:02:39,196 Speaker 1: can be made as it was made in the Emergency 36 00:02:39,276 --> 00:02:43,156 Speaker 1: Use Authorization, which is why the EUA is interesting, And 37 00:02:43,196 --> 00:02:46,836 Speaker 1: the claim is simply that the totality of the evidence 38 00:02:46,916 --> 00:02:49,796 Speaker 1: says that it's probably going to help people, and I 39 00:02:49,836 --> 00:02:52,796 Speaker 1: actually think it is fair to say then, and that's 40 00:02:52,836 --> 00:02:54,956 Speaker 1: pretty much a low bar for what you need to 41 00:02:54,996 --> 00:02:57,356 Speaker 1: determine if something is going to be authorized. But the FDA, 42 00:02:57,436 --> 00:02:59,476 Speaker 1: but I think the totality of evidence, based on what 43 00:02:59,516 --> 00:03:02,156 Speaker 1: we've seen in animals, in what was in a small 44 00:03:02,276 --> 00:03:05,596 Speaker 1: randomized trial, and in some of these observational data that 45 00:03:05,716 --> 00:03:08,836 Speaker 1: was seen from the Mayo clinic, is that it probably 46 00:03:08,916 --> 00:03:11,436 Speaker 1: help helps to some extent. And that's really all you 47 00:03:11,476 --> 00:03:15,116 Speaker 1: can say, probably helps to some extent is, as you say, 48 00:03:15,156 --> 00:03:18,196 Speaker 1: a pretty low bar to reach. Does that include also 49 00:03:18,236 --> 00:03:22,036 Speaker 1: the question of whether it could potentially do any harm? Yeah, 50 00:03:22,076 --> 00:03:24,236 Speaker 1: I think that it has a lot of data. Actually, 51 00:03:24,356 --> 00:03:27,156 Speaker 1: it's been used by seventy thousand people at this point, 52 00:03:27,316 --> 00:03:30,156 Speaker 1: and there's a lot of safety data at that point. 53 00:03:30,196 --> 00:03:31,796 Speaker 1: That's a lot of people to use it. And there's 54 00:03:31,876 --> 00:03:36,076 Speaker 1: known problems with when people receive transfusions of blood or 55 00:03:36,076 --> 00:03:39,076 Speaker 1: plasma that there are known side effects and they're pretty 56 00:03:39,116 --> 00:03:41,556 Speaker 1: typical I think for what people know about plasma. So 57 00:03:42,036 --> 00:03:46,316 Speaker 1: I think one of the reasons why both hydroxy chloroquin 58 00:03:46,596 --> 00:03:50,676 Speaker 1: and convalescent plasma meth this bar for the emergency use 59 00:03:50,756 --> 00:03:54,836 Speaker 1: authorization was in part because the data on side effects 60 00:03:54,956 --> 00:03:56,916 Speaker 1: is pretty well known at least they've been used in 61 00:03:56,996 --> 00:04:00,636 Speaker 1: other settings, and so there's not a lot of concern 62 00:04:00,676 --> 00:04:04,716 Speaker 1: about safety other than the known side effects of plasma. Actually, well, 63 00:04:04,716 --> 00:04:06,396 Speaker 1: that's the good news. But you also just mentioned in 64 00:04:06,396 --> 00:04:10,036 Speaker 1: the same sentence as hydroxychloroquin which turned out on closer 65 00:04:10,076 --> 00:04:14,276 Speaker 1: examination of the data not to have positive therapeutic effects. 66 00:04:14,756 --> 00:04:17,076 Speaker 1: What is the aspect of the data that makes you 67 00:04:17,116 --> 00:04:20,076 Speaker 1: think that that is not true of kindless and plasma therapy, 68 00:04:20,116 --> 00:04:22,996 Speaker 1: that in fact there are reasons in the data. Is 69 00:04:22,996 --> 00:04:25,956 Speaker 1: it that small and RCT randomized control trial or is 70 00:04:25,956 --> 00:04:28,876 Speaker 1: it more to do with the observational data on the 71 00:04:29,036 --> 00:04:31,196 Speaker 1: seventy thousand people who have been treated this way. Yeah, 72 00:04:31,236 --> 00:04:34,636 Speaker 1: you know, it's sometimes I sit back and this is 73 00:04:34,636 --> 00:04:36,836 Speaker 1: not the way to judge science. But I'd say, based 74 00:04:36,876 --> 00:04:39,396 Speaker 1: on what I've seen, if I are a family member 75 00:04:39,436 --> 00:04:42,876 Speaker 1: had COVID, what I want them to receive plasma and 76 00:04:42,956 --> 00:04:45,356 Speaker 1: the answer is yes, So I must have some sense 77 00:04:46,116 --> 00:04:49,396 Speaker 1: that it works. But it is partly from the small 78 00:04:49,476 --> 00:04:51,956 Speaker 1: randomized trial. It is partly from what you see in 79 00:04:51,996 --> 00:04:54,516 Speaker 1: the data, which, although there's no control group, which is 80 00:04:54,516 --> 00:04:58,596 Speaker 1: the huge problem, there are some signs that it would work. 81 00:04:58,916 --> 00:05:01,476 Speaker 1: You cannot know for sure. Until you do the randomized trial. 82 00:05:02,396 --> 00:05:05,716 Speaker 1: That's why this is an authorization and not approval, and 83 00:05:06,116 --> 00:05:09,756 Speaker 1: there's a clear distinction between approval and all zation. And 84 00:05:09,876 --> 00:05:12,076 Speaker 1: to authorize it in the setting of a public health 85 00:05:12,116 --> 00:05:15,076 Speaker 1: emergency with no other treatment, you just have to think 86 00:05:15,116 --> 00:05:17,796 Speaker 1: that it's probably going to work and have enough evidence 87 00:05:17,996 --> 00:05:20,196 Speaker 1: that someone at FDA is going to say that it 88 00:05:20,236 --> 00:05:23,956 Speaker 1: probably works. That's a hugely important point that you're making. 89 00:05:23,996 --> 00:05:25,556 Speaker 1: There will lead and I just want to pause and 90 00:05:25,756 --> 00:05:31,276 Speaker 1: emphasize it. Emergency use authorization is its own category, and 91 00:05:31,356 --> 00:05:37,636 Speaker 1: it's different from FDA approval. FDA approval has higher standards 92 00:05:37,676 --> 00:05:41,156 Speaker 1: for whether a treatment is approved, and that includes real 93 00:05:41,236 --> 00:05:46,276 Speaker 1: statistical presumably RCT randomized control trial proof that it actually 94 00:05:46,396 --> 00:05:51,156 Speaker 1: is working, whereas emergency use authorization simply consists of the 95 00:05:51,196 --> 00:05:54,436 Speaker 1: statement that there's more reason to believe than not that 96 00:05:54,676 --> 00:05:57,236 Speaker 1: it's helping. Is that a fair distinction between the two. Yes, 97 00:05:57,276 --> 00:05:59,836 Speaker 1: that there's a reason to believe that the benefits outweigh 98 00:05:59,916 --> 00:06:04,716 Speaker 1: the risks and approval full approval. Regular FDA approval typically 99 00:06:04,716 --> 00:06:07,316 Speaker 1: requires a randomized trial. So yeah, that is a key 100 00:06:07,436 --> 00:06:11,436 Speaker 1: issue with emergency use authorizations. The bar is lower. It's 101 00:06:11,596 --> 00:06:14,956 Speaker 1: very different than FDA approval. And the other thing that's 102 00:06:14,996 --> 00:06:18,316 Speaker 1: really interesting about emergency use authorizations is one of the 103 00:06:18,356 --> 00:06:21,116 Speaker 1: criterias that there is no other approof therapy to treat 104 00:06:21,156 --> 00:06:25,796 Speaker 1: the disease. And what's interesting is that it's approved therapy. 105 00:06:26,236 --> 00:06:29,476 Speaker 1: So even though remdezeviere is the anti viral that is 106 00:06:29,556 --> 00:06:33,796 Speaker 1: authorized also under the emergency use authorization, there is still 107 00:06:33,796 --> 00:06:37,196 Speaker 1: no approved therapy. So as long as nothing is approved, 108 00:06:37,316 --> 00:06:40,196 Speaker 1: they can actually still authorize what they need to because 109 00:06:40,236 --> 00:06:42,996 Speaker 1: there is no approved therapy. While we're on the topic 110 00:06:42,996 --> 00:06:45,796 Speaker 1: of emergency use authorization, let me ask you a question 111 00:06:45,796 --> 00:06:48,396 Speaker 1: that I've been asked repeatedly by other lay people, and 112 00:06:48,436 --> 00:06:50,516 Speaker 1: I have declined to answer because I don't know. But 113 00:06:50,556 --> 00:06:54,436 Speaker 1: I bet you do know. When the time comes to 114 00:06:54,476 --> 00:06:58,676 Speaker 1: try out for the public some of the vaccines that 115 00:06:58,716 --> 00:07:03,476 Speaker 1: are being tested right now for SARS CoV two, is 116 00:07:03,516 --> 00:07:07,796 Speaker 1: it conceivable that the FDA would do emergency use authorizations 117 00:07:07,796 --> 00:07:13,156 Speaker 1: for the vaccines rather than issue full approvals because that 118 00:07:13,156 --> 00:07:16,156 Speaker 1: would lower the standard of proof that needed to be 119 00:07:16,236 --> 00:07:21,116 Speaker 1: met and would also presumably speed up the process. Yes, 120 00:07:21,356 --> 00:07:23,276 Speaker 1: the answer is yes. And this is what I tell 121 00:07:23,316 --> 00:07:27,396 Speaker 1: people is the most people could care less about convalescent plasma. 122 00:07:27,556 --> 00:07:29,756 Speaker 1: Most people will never get it because it's given to 123 00:07:29,836 --> 00:07:32,996 Speaker 1: hospitalize patients. The reason why it matters so much is 124 00:07:32,996 --> 00:07:36,316 Speaker 1: because of exactly what you mentioned, which is everybody is 125 00:07:36,516 --> 00:07:39,836 Speaker 1: really concerned about what this means for the vaccine. The 126 00:07:39,916 --> 00:07:42,956 Speaker 1: answer is yes, that a vaccine can and in my 127 00:07:43,116 --> 00:07:46,596 Speaker 1: view and others, likely will be authorized by the FDA 128 00:07:46,716 --> 00:07:50,876 Speaker 1: through the same mechanism soon actually in terms of months. 129 00:07:51,676 --> 00:07:54,036 Speaker 1: And there's a lot of debate about then, well good, 130 00:07:54,076 --> 00:07:56,796 Speaker 1: because that's where we're headed. In order to get there, 131 00:07:57,196 --> 00:08:00,796 Speaker 1: I think we first need to turn to the very 132 00:08:00,836 --> 00:08:04,156 Speaker 1: troubling way, at least to my mind, that the announcement 133 00:08:04,916 --> 00:08:09,916 Speaker 1: about the convalescent plasma therapy was made in a dramatic 134 00:08:10,596 --> 00:08:15,676 Speaker 1: President of the United States participating press conference with statistics 135 00:08:15,676 --> 00:08:18,916 Speaker 1: cited that, as far as I can make out, we're 136 00:08:18,996 --> 00:08:23,476 Speaker 1: just not substantiated, namely that the treatment had reduced deaths 137 00:08:23,516 --> 00:08:27,156 Speaker 1: by thirty five percent, which is something that the President said, 138 00:08:27,396 --> 00:08:31,476 Speaker 1: the Secretary of HHS said, and then perhaps most disturbingly, 139 00:08:31,876 --> 00:08:37,196 Speaker 1: the Commissioner of the FDA said, talk to us about 140 00:08:37,316 --> 00:08:39,516 Speaker 1: what happened there? Where did this thirty five percent number 141 00:08:39,556 --> 00:08:41,796 Speaker 1: come from? If you have a theory about where and 142 00:08:42,316 --> 00:08:45,556 Speaker 1: why was it wrong, if indeed you believe it was wrong. Yeah, 143 00:08:45,556 --> 00:08:48,276 Speaker 1: this is one of the most astounding things that happened. 144 00:08:48,276 --> 00:08:50,956 Speaker 1: And I've tried to make a very clear distinction personally 145 00:08:50,996 --> 00:08:54,196 Speaker 1: between whether I agree with an emergency use authorization and 146 00:08:54,196 --> 00:08:56,876 Speaker 1: whether I agree with how it was delivered or how 147 00:08:56,916 --> 00:08:59,196 Speaker 1: it was announced, which I do not. So that latter 148 00:08:59,276 --> 00:09:03,756 Speaker 1: part that was just unprecedented, where you had such huge 149 00:09:03,956 --> 00:09:07,476 Speaker 1: errors made in how the FDA talks about data for 150 00:09:07,556 --> 00:09:11,636 Speaker 1: products that is authorized. Doesn't do those mistakes. If you 151 00:09:11,716 --> 00:09:16,276 Speaker 1: read the decisional memo that the FDA puts together when 152 00:09:16,276 --> 00:09:19,196 Speaker 1: they actually write, the FDA staff right, all the reasons 153 00:09:19,196 --> 00:09:21,276 Speaker 1: why it should be authorized, all the data they make 154 00:09:21,316 --> 00:09:25,436 Speaker 1: their decision, it's actually very detailed, very nuanced. But that 155 00:09:25,596 --> 00:09:28,396 Speaker 1: is not what we heard at the press conference. That 156 00:09:28,516 --> 00:09:32,476 Speaker 1: is also why people are so attuned to this issue 157 00:09:32,476 --> 00:09:35,316 Speaker 1: of convalescent plasma, because we need the FDA to be 158 00:09:35,356 --> 00:09:38,276 Speaker 1: telling us what is correct and saying it correctly and 159 00:09:38,436 --> 00:09:40,836 Speaker 1: not misinforming the public, which is what they did here. 160 00:09:41,316 --> 00:09:43,516 Speaker 1: So it's important to talk about that. So a couple 161 00:09:43,516 --> 00:09:47,116 Speaker 1: of things, this thirty five out of one hundred issue 162 00:09:47,636 --> 00:09:52,556 Speaker 1: the data supporting an emergency use authorization, for convalescent plasma 163 00:09:52,596 --> 00:09:55,636 Speaker 1: did not come from a randomized trial, So it is 164 00:09:55,756 --> 00:09:59,036 Speaker 1: very difficult to make conclusions about whether any therapy actually 165 00:09:59,076 --> 00:10:02,156 Speaker 1: reduce mortality because there was no control arm. There was 166 00:10:02,196 --> 00:10:04,756 Speaker 1: no arm that got nothing. So you really shouldn't say 167 00:10:04,796 --> 00:10:08,876 Speaker 1: that there's good evidence that anything reduces mortality. What is 168 00:10:08,876 --> 00:10:11,436 Speaker 1: there in terms of data? There are data that shows 169 00:10:11,436 --> 00:10:15,316 Speaker 1: if you look at a subgroup subgroup of individuals, and 170 00:10:15,396 --> 00:10:20,116 Speaker 1: you compare those who got more antibodies in their plasma 171 00:10:20,276 --> 00:10:24,276 Speaker 1: with those who got fewer antibodies, there is a reduction 172 00:10:24,316 --> 00:10:27,196 Speaker 1: in mortality. That the people who had more antibodies in 173 00:10:27,276 --> 00:10:31,036 Speaker 1: their plasma, which conceivably should have more of an effect 174 00:10:31,116 --> 00:10:35,596 Speaker 1: in reducing the severity disease, they actually had less mortality 175 00:10:35,796 --> 00:10:38,956 Speaker 1: than the people that had lower tighters of anybody. And 176 00:10:39,036 --> 00:10:42,516 Speaker 1: that the people who got the therapy earlier, when theoretically 177 00:10:42,556 --> 00:10:45,276 Speaker 1: it should work better, had lower mortality than those who 178 00:10:45,316 --> 00:10:48,756 Speaker 1: got it later. Still, we cannot be certain. You cannot 179 00:10:48,796 --> 00:10:51,356 Speaker 1: go in front of the American public and say that 180 00:10:51,396 --> 00:10:55,316 Speaker 1: this therapy reduces mortality when there's that possibility that it 181 00:10:55,436 --> 00:10:59,156 Speaker 1: might not, and the audience that's listening does not understand 182 00:10:59,196 --> 00:11:02,196 Speaker 1: all these nuances we've talking about about the bar emergency 183 00:11:02,276 --> 00:11:07,076 Speaker 1: use authorization, randomized trials necessarily, So that is a key issue. 184 00:11:07,396 --> 00:11:10,716 Speaker 1: Here's a question if the head of the FDA or 185 00:11:10,716 --> 00:11:12,876 Speaker 1: the head of HHAs or the President for that matter, 186 00:11:13,196 --> 00:11:16,996 Speaker 1: had not said this reduces mortality, but had said, we 187 00:11:17,076 --> 00:11:20,876 Speaker 1: have reason to think that it might reduce mortality. Would 188 00:11:20,916 --> 00:11:23,076 Speaker 1: that have made you less upset without it satisfied you. 189 00:11:23,196 --> 00:11:25,476 Speaker 1: Is this a question of the clarity of the claim. Yes. 190 00:11:25,596 --> 00:11:27,916 Speaker 1: So that's the thing is that the FDA had no 191 00:11:28,036 --> 00:11:31,316 Speaker 1: reason to try and inflate the claim. The data as 192 00:11:31,796 --> 00:11:34,756 Speaker 1: they stand are enough to say we're going to authorize it. 193 00:11:34,796 --> 00:11:36,996 Speaker 1: We believe that in the case of an emergency people 194 00:11:36,996 --> 00:11:39,356 Speaker 1: are dying. We want to get this to you. All 195 00:11:39,396 --> 00:11:42,076 Speaker 1: of that is reasonable. That the problem was is going 196 00:11:42,116 --> 00:11:45,796 Speaker 1: and saying that it reduces mortality when we don't know that. 197 00:11:46,276 --> 00:11:48,516 Speaker 1: You know, even the bigger problem was saying that thirty 198 00:11:48,516 --> 00:11:51,516 Speaker 1: five out of one hundred people will survive if they 199 00:11:51,556 --> 00:11:55,756 Speaker 1: get the therapy. That is just nowhere near correct. That 200 00:11:55,876 --> 00:11:57,996 Speaker 1: just flat out false. As far as I can make out, 201 00:11:58,316 --> 00:12:02,076 Speaker 1: it's false. So not only was the certainty about the 202 00:12:02,156 --> 00:12:07,756 Speaker 1: mortality benefit misstated, but the actual magnitude of that was misstated. 203 00:12:08,276 --> 00:12:21,196 Speaker 1: We'll be right back. Let's turn now from what happened 204 00:12:21,356 --> 00:12:25,436 Speaker 1: in this rollout to its implications for the really massive 205 00:12:25,596 --> 00:12:30,556 Speaker 1: question of what's going to happen for vaccines. What consequences 206 00:12:30,996 --> 00:12:35,156 Speaker 1: do you think this to a certain degree botched emergency 207 00:12:35,236 --> 00:12:40,876 Speaker 1: use authorization rollout for the convalescent plasma has for the 208 00:12:40,996 --> 00:12:44,796 Speaker 1: question of how much the public can, should, or will 209 00:12:44,836 --> 00:12:50,156 Speaker 1: trust a potential emergency use authorization for vaccines. Yeah, one 210 00:12:50,196 --> 00:12:53,076 Speaker 1: of the real problems we've had in the public health 211 00:12:53,436 --> 00:12:57,636 Speaker 1: approach or has been the politicization of the entire thing. 212 00:12:58,556 --> 00:13:01,196 Speaker 1: The problem with what happened here is that it just 213 00:13:01,676 --> 00:13:05,876 Speaker 1: gave an opening of even more politicization, even more criticizing, 214 00:13:05,916 --> 00:13:08,076 Speaker 1: so that it was the same thing with hydroxy clark, 215 00:13:08,116 --> 00:13:11,516 Speaker 1: when there was huge criticism of the FDA from one side, 216 00:13:12,596 --> 00:13:16,116 Speaker 1: huge applauding from the other side, and you have these 217 00:13:16,116 --> 00:13:19,676 Speaker 1: two sides that are just completely different saying completely different things, 218 00:13:19,756 --> 00:13:21,716 Speaker 1: you know, one saying it's the best thing ever, one 219 00:13:21,836 --> 00:13:24,716 Speaker 1: saying it's the worst thing ever. And what happened here 220 00:13:24,836 --> 00:13:28,356 Speaker 1: was just yet another opportunity for that to happen. Instead 221 00:13:28,356 --> 00:13:32,076 Speaker 1: of having a message that is clear, that is correct, 222 00:13:32,716 --> 00:13:35,996 Speaker 1: that is not overhyping things. It just contributed to the 223 00:13:36,076 --> 00:13:38,756 Speaker 1: hype on one side about the benefit and so then 224 00:13:38,796 --> 00:13:42,036 Speaker 1: the other side started a pile on the FDA. So 225 00:13:42,116 --> 00:13:44,836 Speaker 1: that's part of the problem is that it's just adding 226 00:13:45,436 --> 00:13:49,716 Speaker 1: to the politicization of public health. So what happens is 227 00:13:49,916 --> 00:13:52,516 Speaker 1: it just leads to further distrust and you don't know 228 00:13:52,516 --> 00:13:54,476 Speaker 1: who to trust, and so I think people end up 229 00:13:54,516 --> 00:13:56,836 Speaker 1: just going to listen to who they trust, which is 230 00:13:56,876 --> 00:14:00,036 Speaker 1: a problem. So all of this is leading up to 231 00:14:00,076 --> 00:14:03,596 Speaker 1: this issue about what's going to happen when the FDA announces, 232 00:14:03,836 --> 00:14:07,396 Speaker 1: When there's a press conference at the end of October 233 00:14:07,436 --> 00:14:10,876 Speaker 1: and the president announces and the head of the FDA, 234 00:14:10,916 --> 00:14:13,116 Speaker 1: they head the CDC is there and they announced that 235 00:14:13,196 --> 00:14:16,436 Speaker 1: they have authorized a vaccine and they say that the 236 00:14:16,516 --> 00:14:21,756 Speaker 1: vaccine is safe and effective. Ideally, we'd want the public 237 00:14:21,836 --> 00:14:24,156 Speaker 1: to say, the President, the head of the CDC, the 238 00:14:24,156 --> 00:14:26,036 Speaker 1: head of the FDA are telling us a vaccine is 239 00:14:26,076 --> 00:14:29,476 Speaker 1: safe and effective. Great, we can all celebrate. The problem 240 00:14:29,636 --> 00:14:32,996 Speaker 1: is is that that's not what's going to happen, and 241 00:14:33,316 --> 00:14:37,996 Speaker 1: that's going to make this issue of vaccine so dicey. 242 00:14:38,876 --> 00:14:41,916 Speaker 1: How our scientists going to respond about the vaccine when 243 00:14:41,956 --> 00:14:44,276 Speaker 1: there's going to be nuanced date on safety and efficacy. 244 00:14:44,756 --> 00:14:47,156 Speaker 1: What we don't want is scientists going out and saying 245 00:14:47,196 --> 00:14:49,636 Speaker 1: this vaccine is not safe when they want people to 246 00:14:49,636 --> 00:14:52,316 Speaker 1: take other vaccines, and the public will not get the nuance. 247 00:14:52,796 --> 00:14:55,996 Speaker 1: That's the larger issue for me is this issue about 248 00:14:56,116 --> 00:15:01,436 Speaker 1: polarization of science and public health, distrust, mistrust, confusion, and 249 00:15:01,516 --> 00:15:04,516 Speaker 1: what that means for the vaccine, which is really the 250 00:15:04,556 --> 00:15:06,716 Speaker 1: way that we're going to finish with this whole COVID 251 00:15:06,756 --> 00:15:09,676 Speaker 1: thing and be able to get back to normal. You've 252 00:15:09,756 --> 00:15:11,556 Speaker 1: kind of blown my mind in what you just said. 253 00:15:11,596 --> 00:15:15,076 Speaker 1: So I want to walk through your scenario, which let's 254 00:15:15,076 --> 00:15:17,636 Speaker 1: call the October surprise, which to you is not going 255 00:15:17,636 --> 00:15:20,436 Speaker 1: to be such a surprise. You pick the end of October, 256 00:15:20,476 --> 00:15:23,876 Speaker 1: I presume not solely because you think that by then 257 00:15:24,316 --> 00:15:27,276 Speaker 1: will have enough preliminary data to make some kind of 258 00:15:27,276 --> 00:15:30,876 Speaker 1: an initial judgment about the vaccines, but rather because it's 259 00:15:30,876 --> 00:15:34,996 Speaker 1: approximate to the beginning of November and then the president 260 00:15:35,036 --> 00:15:38,276 Speaker 1: wants to be reelected. So if I'm right about that, 261 00:15:38,516 --> 00:15:42,756 Speaker 1: what you're picturing is a nationally televised press conference. The 262 00:15:42,836 --> 00:15:44,676 Speaker 1: President's going to get up there and sort of like 263 00:15:44,756 --> 00:15:48,316 Speaker 1: do his version of Barack Obama. You know, ladies and gentleman, 264 00:15:48,436 --> 00:15:49,676 Speaker 1: we got him. He's going to go up there and 265 00:15:49,676 --> 00:15:52,476 Speaker 1: he's going to say, in your scenario, ladies and gentlemen, 266 00:15:52,636 --> 00:15:56,516 Speaker 1: we cured it. All problems solved. So, first of all, 267 00:15:56,716 --> 00:16:00,756 Speaker 1: is that indeed something like the October surprise scenario that 268 00:16:00,756 --> 00:16:02,836 Speaker 1: you're describing. Let me make sure I'm hearing you correctly. 269 00:16:02,996 --> 00:16:06,116 Speaker 1: That is like the October surprise that I'm talking about. 270 00:16:06,196 --> 00:16:08,596 Speaker 1: But the reason why I say late October is because 271 00:16:08,636 --> 00:16:11,796 Speaker 1: there is already a meeting schedule of the FDA Advisory 272 00:16:11,796 --> 00:16:16,076 Speaker 1: Committee that advises the FDA on vaccines, and the specific 273 00:16:16,196 --> 00:16:21,916 Speaker 1: topic is the authorization of COVID vaccines. Now they have 274 00:16:22,036 --> 00:16:25,636 Speaker 1: said specifically, the FDA Commissioner has said specifically that no 275 00:16:25,716 --> 00:16:30,196 Speaker 1: specific application is going to be discussed, So it's as 276 00:16:30,196 --> 00:16:33,356 Speaker 1: of now, there is no plan to discuss a specific 277 00:16:33,636 --> 00:16:36,596 Speaker 1: vaccine that's going to be authorized. From what they said now, 278 00:16:36,596 --> 00:16:40,276 Speaker 1: the FDA has said multiple settings of written and verbal 279 00:16:40,716 --> 00:16:43,636 Speaker 1: that they will have an advisory committee meeting to review 280 00:16:43,676 --> 00:16:47,156 Speaker 1: the safety and efficacy of a vaccine before anything is authorized. 281 00:16:47,236 --> 00:16:51,036 Speaker 1: So they've made that commitment. So those pieces of data 282 00:16:51,076 --> 00:16:53,436 Speaker 1: are they've said there's going to be advisory committee meeting 283 00:16:53,436 --> 00:16:56,876 Speaker 1: before they authorize a vaccine. There is a vaccine Advisory 284 00:16:56,876 --> 00:16:59,556 Speaker 1: Committee meeting scheduled for October twenty second. They're going to 285 00:16:59,596 --> 00:17:03,676 Speaker 1: discuss the COVID vaccine in general. So that's one part 286 00:17:03,756 --> 00:17:05,636 Speaker 1: of the puzzle. The other part of the puzzle is 287 00:17:05,676 --> 00:17:08,396 Speaker 1: there's little snippets of what you call them rumor or 288 00:17:08,476 --> 00:17:13,596 Speaker 1: news come out about the idea of using data from 289 00:17:13,716 --> 00:17:18,356 Speaker 1: trials overseas to authorize a therapy if the trials here 290 00:17:18,396 --> 00:17:21,356 Speaker 1: are not finished. There's a vaccine out of the University 291 00:17:21,356 --> 00:17:24,476 Speaker 1: of Oxford that is doing trials outside of the US 292 00:17:24,596 --> 00:17:27,796 Speaker 1: but hasn't really advanced trials inside the US, and there's 293 00:17:27,796 --> 00:17:30,356 Speaker 1: some talk about that one of the trial sites was 294 00:17:30,436 --> 00:17:33,476 Speaker 1: stopped because the FDA is saying, maybe we can use 295 00:17:33,556 --> 00:17:37,796 Speaker 1: data from overseas. The other issue is that we've heard 296 00:17:37,956 --> 00:17:41,956 Speaker 1: more and more just this opening about we would consider 297 00:17:42,076 --> 00:17:45,476 Speaker 1: an emergency use authorization for the vaccine. So we keep 298 00:17:45,596 --> 00:17:48,436 Speaker 1: hearing that, and that we keep hearing that there is 299 00:17:48,436 --> 00:17:51,476 Speaker 1: a push politically to have a vaccine before the election. 300 00:17:51,636 --> 00:17:55,076 Speaker 1: So whether it happens or not, no one knows, but 301 00:17:55,236 --> 00:17:59,036 Speaker 1: everything is aligned in terms of a low bar for 302 00:17:59,116 --> 00:18:03,396 Speaker 1: an authorization a Vaccine Advisory Committee meeting, trials that are 303 00:18:03,516 --> 00:18:06,436 Speaker 1: quite advanced, and I could argue one could make the 304 00:18:06,556 --> 00:18:09,116 Speaker 1: argument that it could fit the bar for an emerge 305 00:18:09,356 --> 00:18:12,836 Speaker 1: use authorization. The stage is set that this could actually 306 00:18:12,836 --> 00:18:18,076 Speaker 1: happen politically. Now if I can put my unofficial pundit head, 307 00:18:18,076 --> 00:18:20,996 Speaker 1: and I'm not a pundit, but for the President to 308 00:18:21,036 --> 00:18:24,196 Speaker 1: go up and announce that there's a vaccine does not 309 00:18:24,356 --> 00:18:27,076 Speaker 1: require that it's a vaccine that everyone has access to 310 00:18:27,236 --> 00:18:30,556 Speaker 1: or will take. So what some people have talked about 311 00:18:30,716 --> 00:18:34,276 Speaker 1: is an emergency use authorization that is first very specific, 312 00:18:34,316 --> 00:18:39,036 Speaker 1: tailored population, a small group of individuals, that allows the 313 00:18:39,076 --> 00:18:42,556 Speaker 1: administration to say, look, we got a vaccine, but without 314 00:18:42,596 --> 00:18:45,676 Speaker 1: having to deal with all the issues of well is 315 00:18:45,676 --> 00:18:48,236 Speaker 1: it really safe? Is the entire public going to get it? 316 00:18:48,236 --> 00:18:51,636 Speaker 1: It will just be authorized for a small population. Those 317 00:18:51,636 --> 00:18:54,396 Speaker 1: are many reasons to think that it's at least possible 318 00:18:54,596 --> 00:18:59,036 Speaker 1: that after the October twenty two Vaccine Committee FDA meeting, 319 00:18:59,716 --> 00:19:03,156 Speaker 1: if the agenda is tweaked a little bit in the 320 00:19:03,236 --> 00:19:05,916 Speaker 1: run up to that meeting such that's specific and concrete 321 00:19:06,116 --> 00:19:08,556 Speaker 1: vaccines or discussed rather than the issue in the abstract, 322 00:19:09,156 --> 00:19:12,036 Speaker 1: that there could be as a result potentially of White 323 00:19:12,076 --> 00:19:14,796 Speaker 1: House pressure. But maybe, I mean, let's not be totally cynical. 324 00:19:15,076 --> 00:19:18,356 Speaker 1: Maybe as a result of early findings from around the 325 00:19:18,396 --> 00:19:22,636 Speaker 1: world that seemed plausible that there could be some kind 326 00:19:22,676 --> 00:19:27,356 Speaker 1: of an announcement of an emergency use authorization with enough 327 00:19:27,396 --> 00:19:30,036 Speaker 1: time before the election for that to affect people's minds. 328 00:19:30,876 --> 00:19:34,956 Speaker 1: What do you see as the potential upsides or downsides 329 00:19:35,156 --> 00:19:39,996 Speaker 1: of an announcement like that, Right, the whole point is 330 00:19:40,156 --> 00:19:42,596 Speaker 1: we're in an emergency and a thousand people that they 331 00:19:42,636 --> 00:19:45,596 Speaker 1: are dying. If there is something that can stop that, 332 00:19:45,596 --> 00:19:48,436 Speaker 1: that is good. So the upside if there is really 333 00:19:48,436 --> 00:19:52,276 Speaker 1: good data from overseas and it just doesn't fulfill the 334 00:19:52,356 --> 00:19:55,636 Speaker 1: requirements of a full approval in the FDA here, well, 335 00:19:55,676 --> 00:19:58,036 Speaker 1: I mean most people would agree that that should be authorized. 336 00:19:58,556 --> 00:20:01,716 Speaker 1: That would require a full Phase three trial that's completed, 337 00:20:01,756 --> 00:20:03,996 Speaker 1: where you give it to enough people and you have 338 00:20:04,156 --> 00:20:07,476 Speaker 1: enough cases to say that there really is a reduction 339 00:20:08,236 --> 00:20:11,076 Speaker 1: in the evalence of COVID or the severity of COVID. 340 00:20:11,076 --> 00:20:13,636 Speaker 1: If you give people a vaccine and the FDA has 341 00:20:13,636 --> 00:20:17,196 Speaker 1: made specific guidelines on how much of an effect they want, 342 00:20:17,196 --> 00:20:20,596 Speaker 1: they want at least a fifty percent effect. Fifty percent 343 00:20:20,636 --> 00:20:23,596 Speaker 1: fewer cases among those who are vaccinated versus non vaccinated. 344 00:20:24,156 --> 00:20:27,676 Speaker 1: So that's a clear upside. If there's a vaccine that works, 345 00:20:27,756 --> 00:20:30,316 Speaker 1: we feel good that it works. Well, then let's get 346 00:20:30,356 --> 00:20:32,316 Speaker 1: it available so people don't have to wait for all 347 00:20:32,356 --> 00:20:35,716 Speaker 1: the red tape to happen. Then I guess it's a 348 00:20:35,756 --> 00:20:38,276 Speaker 1: spectrum of things. So go down the spectrum a little bit, 349 00:20:38,356 --> 00:20:41,556 Speaker 1: and well, the Phase three trials are not completed, but 350 00:20:41,636 --> 00:20:45,516 Speaker 1: they're almost completed. There maybe is an effect, but there's 351 00:20:45,556 --> 00:20:48,676 Speaker 1: not enough cases to know for sure, but there's no 352 00:20:48,716 --> 00:20:52,556 Speaker 1: real safety issues. I can easily see an argument there 353 00:20:52,676 --> 00:20:56,636 Speaker 1: being made that, well, we have data so far in 354 00:20:56,676 --> 00:20:59,076 Speaker 1: the data, we don't have any big safety issues. We 355 00:20:59,156 --> 00:21:02,276 Speaker 1: have the early trials, and we have the Phase three 356 00:21:02,316 --> 00:21:05,156 Speaker 1: trials saying yeah, there may be an effect. It may 357 00:21:05,196 --> 00:21:08,276 Speaker 1: not reach statistical significance because there's not enough people, but 358 00:21:08,396 --> 00:21:11,316 Speaker 1: it's it's almost there, and then it goes all the 359 00:21:11,316 --> 00:21:14,116 Speaker 1: way down. How far you want to think about what 360 00:21:14,156 --> 00:21:17,436 Speaker 1: the administration could say that would still fit the criteria 361 00:21:17,476 --> 00:21:21,676 Speaker 1: for an emergency use austhorization? Is it reasonable to say 362 00:21:22,116 --> 00:21:25,676 Speaker 1: that the probability of a benefit outweighs the probability of 363 00:21:25,716 --> 00:21:29,316 Speaker 1: a risk with some lesser kind of data, and it's possible. 364 00:21:29,636 --> 00:21:32,276 Speaker 1: And it depends on which vaccine they're talking about, because 365 00:21:32,276 --> 00:21:33,996 Speaker 1: some of them are new vaccines that have never been 366 00:21:34,116 --> 00:21:36,756 Speaker 1: used before. Some of them are just variants of another vaccine. 367 00:21:37,796 --> 00:21:42,756 Speaker 1: So the downsides are One is side effects. You do 368 00:21:42,796 --> 00:21:45,756 Speaker 1: not want a vaccine to be authorized people excited and 369 00:21:45,796 --> 00:21:48,236 Speaker 1: then all of a sudden people die or become paralyzed 370 00:21:48,356 --> 00:21:51,796 Speaker 1: when they start taking a vaccine. That would be a disaster. 371 00:21:52,716 --> 00:21:56,516 Speaker 1: The other issue is, let's say there's a vaccine where 372 00:21:56,516 --> 00:22:00,036 Speaker 1: the preliminary data is positive, but it ends up being 373 00:22:00,236 --> 00:22:03,876 Speaker 1: just a little effective. It maybe reduces the chance of 374 00:22:03,956 --> 00:22:08,516 Speaker 1: having COVID by twenty percent, but there's still trials ongoing 375 00:22:08,676 --> 00:22:11,596 Speaker 1: to test the vaccine that might be better. The problem 376 00:22:11,676 --> 00:22:12,996 Speaker 1: is you're going to have people who want to get 377 00:22:13,036 --> 00:22:14,956 Speaker 1: back to their lives and they're going to have a 378 00:22:15,036 --> 00:22:17,596 Speaker 1: vaccine on the market, and the question is are they 379 00:22:17,596 --> 00:22:20,116 Speaker 1: going to take that vaccine and then not enroll in 380 00:22:20,196 --> 00:22:23,276 Speaker 1: other trials that might get us a better vaccine, and 381 00:22:23,316 --> 00:22:26,836 Speaker 1: then we'll never know. We'll never get to that better vaccine. 382 00:22:27,596 --> 00:22:30,636 Speaker 1: That's one concern is that the randomized trials will not 383 00:22:30,756 --> 00:22:34,116 Speaker 1: fully enroll and we end up authorizing a vaccine that's okay, 384 00:22:34,596 --> 00:22:38,276 Speaker 1: and not really getting those vaccines to market that are really, 385 00:22:38,316 --> 00:22:41,436 Speaker 1: really good and maybe a little safer. What about the 386 00:22:41,516 --> 00:22:46,196 Speaker 1: risk that politicization just engulfs the announcement. I think the 387 00:22:46,276 --> 00:22:48,316 Speaker 1: thing that's most striking to me is, you know, we 388 00:22:48,396 --> 00:22:51,476 Speaker 1: spent the first part of our conversation talking about just 389 00:22:51,516 --> 00:22:54,836 Speaker 1: how bad it was that there's this politicization surrounding I 390 00:22:54,836 --> 00:22:57,076 Speaker 1: think your phrase was, I jotted it down, the politicization 391 00:22:57,116 --> 00:22:59,716 Speaker 1: of the entire thing, the entire thing being, you know, 392 00:22:59,756 --> 00:23:04,116 Speaker 1: the whole question of treatment of COVID. If the President 393 00:23:04,436 --> 00:23:08,876 Speaker 1: announces an EUA for a vaccine in late October, I 394 00:23:09,276 --> 00:23:12,276 Speaker 1: know how you avoid radical politicization, and I don't know 395 00:23:12,316 --> 00:23:15,356 Speaker 1: how you avoid Democrats, maybe not Joe Biden, but certainly 396 00:23:15,396 --> 00:23:19,636 Speaker 1: other Democrats saying it's too soon, this isn't safe, you 397 00:23:19,676 --> 00:23:21,756 Speaker 1: shouldn't do it. And then that really could create a 398 00:23:21,796 --> 00:23:25,636 Speaker 1: circumstance where many many people, like roughly half the people, 399 00:23:25,956 --> 00:23:29,716 Speaker 1: have some deep skepticism about the vaccine. Can you imagine 400 00:23:29,756 --> 00:23:31,996 Speaker 1: this scenarrea where the Democrats were at least some Democrats 401 00:23:31,996 --> 00:23:35,836 Speaker 1: would go down that road. Yes, yes, And that's the problem. 402 00:23:35,956 --> 00:23:39,036 Speaker 1: I've already seen it in politicization of other issues in 403 00:23:39,036 --> 00:23:42,516 Speaker 1: public health. And it's not only what they say, it's 404 00:23:42,556 --> 00:23:46,956 Speaker 1: how they say it and in what context they say it. 405 00:23:47,076 --> 00:23:49,876 Speaker 1: A lot of the decisions that Democrats and those that 406 00:23:49,996 --> 00:23:54,556 Speaker 1: lean Democrat have disagreed with, the criticism has been couched 407 00:23:54,796 --> 00:24:00,516 Speaker 1: in the language that is about how the president is terrible, etc. Etc. 408 00:24:01,316 --> 00:24:04,196 Speaker 1: So the problem is is that will definitely happen with 409 00:24:04,236 --> 00:24:07,316 Speaker 1: the vaccine, and it will be things like no one 410 00:24:07,356 --> 00:24:09,876 Speaker 1: should take this vaccine, no one should trust Trump, the 411 00:24:09,956 --> 00:24:14,476 Speaker 1: data are terrible. Trump has let us astray. The problem 412 00:24:14,516 --> 00:24:17,996 Speaker 1: is where is the nuance? Where is the truth going 413 00:24:18,076 --> 00:24:20,796 Speaker 1: to come from? And that's what I meant before about 414 00:24:20,836 --> 00:24:23,036 Speaker 1: the problem with thirty five out of one hundred thing 415 00:24:23,116 --> 00:24:25,836 Speaker 1: from the head of the FDA about plasma. Where is 416 00:24:25,876 --> 00:24:27,796 Speaker 1: the truth going to come from? I mean, what you're 417 00:24:27,796 --> 00:24:31,836 Speaker 1: just described sounds great from the standpoint of Trump, especially 418 00:24:31,876 --> 00:24:34,636 Speaker 1: if he's pulling closer in the polls but is still down. 419 00:24:34,716 --> 00:24:37,836 Speaker 1: And now you know, imagine if you will, being inside 420 00:24:37,916 --> 00:24:42,436 Speaker 1: Joe Biden's strategy session as Donald Trump is calling this 421 00:24:42,476 --> 00:24:45,156 Speaker 1: press conference and holding it, his advisors are going to 422 00:24:45,196 --> 00:24:48,836 Speaker 1: be telling him, well, mister Biden, if you don't challenge this, 423 00:24:49,356 --> 00:24:51,916 Speaker 1: it may hurt you in the vote in the next week. 424 00:24:52,316 --> 00:24:54,276 Speaker 1: But if you do challenge it, if you do say 425 00:24:54,316 --> 00:24:57,436 Speaker 1: it's too soon, and then you're elected, then by the 426 00:24:57,516 --> 00:25:01,396 Speaker 1: time whatever vaccine the president is talking about is actually available, 427 00:25:01,396 --> 00:25:04,716 Speaker 1: because the vaccines themselves doesn't seem plausible, would be available 428 00:25:04,876 --> 00:25:07,036 Speaker 1: at the end of October. It would just be the 429 00:25:07,036 --> 00:25:11,156 Speaker 1: announcement that was happening then at the time the vaccines 430 00:25:11,156 --> 00:25:14,116 Speaker 1: were actually being produced in sufficient quantities and distributed with 431 00:25:14,156 --> 00:25:17,956 Speaker 1: sufficient efficiency to reach Americans. Joe Biden could be president 432 00:25:17,996 --> 00:25:20,636 Speaker 1: and then he would be in a disastrous position if 433 00:25:20,636 --> 00:25:22,796 Speaker 1: he had first said that we shouldn't take the vaccine, 434 00:25:22,796 --> 00:25:24,036 Speaker 1: and then he were president and he wanted to hand 435 00:25:24,036 --> 00:25:26,716 Speaker 1: out the vaccine. So you can imagine that strategy session 436 00:25:26,716 --> 00:25:30,116 Speaker 1: being frankly, a bit of a nightmare. Two. So what 437 00:25:30,156 --> 00:25:33,276 Speaker 1: you're describing is making me. With everything you say, I'm 438 00:25:33,276 --> 00:25:37,156 Speaker 1: getting more and more concerned that this could actually happen. Yeah, 439 00:25:37,196 --> 00:25:39,636 Speaker 1: and I am not a political pundit, but I, like 440 00:25:39,756 --> 00:25:41,996 Speaker 1: many people, think a lot about these things. But I 441 00:25:42,676 --> 00:25:45,556 Speaker 1: have the same concern, and I think, what will happen 442 00:25:46,156 --> 00:25:49,876 Speaker 1: in October? If there is an announcement like this, it 443 00:25:49,916 --> 00:25:53,316 Speaker 1: will inevitably be politicized, and the vaccine is our way out, 444 00:25:53,396 --> 00:25:55,516 Speaker 1: and we just don't want to mess this up. We 445 00:25:55,596 --> 00:25:58,636 Speaker 1: have messed up so much in the response to this pandemic. 446 00:25:59,156 --> 00:26:01,996 Speaker 1: The vaccine is the way out. We do not want 447 00:26:01,996 --> 00:26:05,436 Speaker 1: to mess that up. But yet to be able to 448 00:26:05,436 --> 00:26:08,396 Speaker 1: be the president and stand up a week or two 449 00:26:08,396 --> 00:26:12,356 Speaker 1: before you're election and say we from day one put 450 00:26:12,356 --> 00:26:15,556 Speaker 1: in billions of dollars and warp speed. Look what we've done. 451 00:26:15,636 --> 00:26:18,356 Speaker 1: We've authorized the vaccine for a small group that that 452 00:26:18,476 --> 00:26:21,036 Speaker 1: obviously will bring a lot of benefits. Thank you a 453 00:26:21,156 --> 00:26:26,076 Speaker 1: lead for genuinely powerful analysis, and thank you for your 454 00:26:26,156 --> 00:26:30,236 Speaker 1: clarity and your even handedness around these really challenging questions. 455 00:26:30,276 --> 00:26:32,596 Speaker 1: I hope he'll come back and talk more with us 456 00:26:32,596 --> 00:26:36,316 Speaker 1: if indeed there is an October surprise. It's a pleasure 457 00:26:36,356 --> 00:26:38,236 Speaker 1: to talk to you. Yet, I'd be happy to come back, 458 00:26:38,316 --> 00:26:47,316 Speaker 1: and hopefully the October surprise is a good one. Listening 459 00:26:47,316 --> 00:26:50,596 Speaker 1: to doctor Jelat describe what went wrong in the rollout 460 00:26:50,636 --> 00:26:55,196 Speaker 1: of convalescent plasma therapy was pretty eye opening. First of all, 461 00:26:55,236 --> 00:26:57,516 Speaker 1: he pointed out that when it comes down to it, 462 00:26:57,596 --> 00:27:01,396 Speaker 1: convalescent plasma therapy may actually be a good thing, he 463 00:27:01,596 --> 00:27:04,996 Speaker 1: supported and said it was correct for the FDA to 464 00:27:05,156 --> 00:27:09,316 Speaker 1: issue its emergency use authorization. At the same time, he 465 00:27:09,316 --> 00:27:12,196 Speaker 1: didn't pull any punches in saying that it was astounding 466 00:27:12,596 --> 00:27:16,036 Speaker 1: and unprecedented for the head of the FDA to make 467 00:27:16,316 --> 00:27:19,596 Speaker 1: flatly false statements about the degree of efficacy of a 468 00:27:19,636 --> 00:27:26,756 Speaker 1: treatment and then not fully back away subsequently from those claims. Yet, 469 00:27:26,836 --> 00:27:30,276 Speaker 1: for all the importance of these events, what most stunned 470 00:27:30,316 --> 00:27:35,156 Speaker 1: me in my conversation with Walid was his very close 471 00:27:35,196 --> 00:27:38,076 Speaker 1: to a prediction, or at least his alerting us to 472 00:27:38,116 --> 00:27:42,596 Speaker 1: the possibility that after the special October twenty second meeting 473 00:27:42,636 --> 00:27:46,676 Speaker 1: of the FDA's Vaccines Committee, there could well be a 474 00:27:46,756 --> 00:27:52,796 Speaker 1: presidential announcement of an emergency use authorization for a vaccine. Now, 475 00:27:52,876 --> 00:27:55,436 Speaker 1: to be sure, we don't know whether that will happen, 476 00:27:55,796 --> 00:27:57,556 Speaker 1: and while he did not say that he knew that 477 00:27:57,596 --> 00:28:00,236 Speaker 1: it would. Instead, what we were doing was trying to 478 00:28:00,276 --> 00:28:04,436 Speaker 1: pull together probabilistic evidence based on the incentives of the parties, 479 00:28:04,676 --> 00:28:07,396 Speaker 1: based on what had been said and announced publicly, and 480 00:28:07,476 --> 00:28:10,196 Speaker 1: based on what we think Trump like to do if 481 00:28:10,196 --> 00:28:14,276 Speaker 1: he were able. It's important to note that Wali did 482 00:28:14,316 --> 00:28:17,116 Speaker 1: not say that would necessarily be a bad thing for 483 00:28:17,156 --> 00:28:20,516 Speaker 1: the President to issue this emergency use authorization. If indeed 484 00:28:20,516 --> 00:28:23,276 Speaker 1: he did, that would all depend on what the data 485 00:28:23,356 --> 00:28:27,116 Speaker 1: showed at the relevant time. We all want to get 486 00:28:27,156 --> 00:28:30,156 Speaker 1: this vaccine to as many people as possible, even if 487 00:28:30,196 --> 00:28:34,116 Speaker 1: in practice it seems extremely unlikely that vaccines would actually 488 00:28:34,196 --> 00:28:38,836 Speaker 1: be available in October. Yet there is simultaneously a really 489 00:28:38,996 --> 00:28:42,716 Speaker 1: significant risk that if a vaccine will rolled out too soon, 490 00:28:43,276 --> 00:28:47,916 Speaker 1: it might crush public confidence in the FDA and eventually 491 00:28:47,956 --> 00:28:51,116 Speaker 1: public confidence in the efficacy of a vaccine, and that 492 00:28:51,196 --> 00:28:56,596 Speaker 1: too has potentially very serious public health effects. The upshot 493 00:28:56,636 --> 00:28:59,116 Speaker 1: is that we should all be watching much more closely 494 00:28:59,156 --> 00:29:02,156 Speaker 1: than I have been until this moment to figure out 495 00:29:02,276 --> 00:29:04,756 Speaker 1: what the FDA is actually going to do at its 496 00:29:04,796 --> 00:29:08,676 Speaker 1: committee's October twenty second meeting, And we should be watching 497 00:29:08,716 --> 00:29:11,996 Speaker 1: the press residence moves very carefully to see whether the 498 00:29:12,036 --> 00:29:14,596 Speaker 1: White House thinks it has something to gain from an 499 00:29:14,596 --> 00:29:18,836 Speaker 1: emergency use authorization. Then at the same time, we'll all 500 00:29:18,916 --> 00:29:22,156 Speaker 1: keep hoping that the data is good and that the 501 00:29:22,276 --> 00:29:24,956 Speaker 1: vaccines work, and that it is possible to get them 502 00:29:24,956 --> 00:29:29,516 Speaker 1: to people as soon as possible. I make no secret 503 00:29:29,556 --> 00:29:32,116 Speaker 1: of my desire to see Donald Trump out of office, 504 00:29:32,676 --> 00:29:35,996 Speaker 1: but It's in the end much more important to save lives. 505 00:29:37,036 --> 00:29:39,596 Speaker 1: Until the next time I speak to you, be careful, 506 00:29:40,116 --> 00:29:43,516 Speaker 1: be safe, and be well. Deep Background is brought to 507 00:29:43,516 --> 00:29:46,956 Speaker 1: you by Pushkin Industries. Our producer is Lydia gene Cott, 508 00:29:47,076 --> 00:29:51,236 Speaker 1: with mastering by Jason Gambrell and Martin Gonzalez. Our showrunner 509 00:29:51,276 --> 00:29:54,396 Speaker 1: is Sophie mckibbon. Our theme music is composed by Luis 510 00:29:54,476 --> 00:29:58,796 Speaker 1: GERA special thanks to the Pushkin Brass, Malcolm Gladwell, Jacob Weisberg, 511 00:29:58,836 --> 00:30:02,396 Speaker 1: and Mia Lobel. I'm Noah Feldman. I also write a 512 00:30:02,396 --> 00:30:05,196 Speaker 1: regular column for Bloomberg Opinion, which you can find at 513 00:30:05,196 --> 00:30:10,076 Speaker 1: Bloomberg dot com slash Feldman. To discover bloom original slate 514 00:30:10,076 --> 00:30:14,756 Speaker 1: of podcasts, go to Bloomberg dot com slash Podcasts. And 515 00:30:14,876 --> 00:30:17,156 Speaker 1: one last thing. I just wrote a book called The 516 00:30:17,196 --> 00:30:20,076 Speaker 1: Arab Winter, a Tragedy. I would be delighted if you 517 00:30:20,196 --> 00:30:22,956 Speaker 1: checked it out. If you liked what you heard today, 518 00:30:22,996 --> 00:30:25,996 Speaker 1: please write a review or tell a friend. You can 519 00:30:26,036 --> 00:30:27,996 Speaker 1: always let me know what you think on Twitter. My 520 00:30:28,076 --> 00:30:31,996 Speaker 1: handle is Noah R. Feldman. This is Deep Background.