WEBVTT - “Where Is The Truth Going to Come From?” 0:00:15.356 --> 0:00:22.596 Pushkin from Pushkin Industries. This is Deep Background the show 0:00:22.636 --> 0:00:25.796 where we explored the stories behind the stories in the news. 0:00:26.356 --> 0:00:31.156 I'm Noah Feldman. The Food and Drug Administration recently issued 0:00:31.196 --> 0:00:36.556 an emergency use authorization for doctors to take blood plasma 0:00:36.756 --> 0:00:40.436 from patients who have recovered from COVID nineteen and use 0:00:40.516 --> 0:00:43.516 it as a therapy for patients who are sick enough 0:00:43.596 --> 0:00:46.516 with the disease right now that they find themselves in 0:00:46.596 --> 0:00:52.716 the hospital. While announcing this authorization, the FDA Commissioner Stephen 0:00:52.756 --> 0:00:56.196 Hahn said that thirty five out of one hundred of 0:00:56.236 --> 0:00:59.196 COVID nineteen patients quote would have been saved because of 0:00:59.196 --> 0:01:02.836 the administration of plasma close quote. This led to an 0:01:02.836 --> 0:01:07.516 outcry from scientists pointing out that this statement vastly overstated 0:01:07.796 --> 0:01:11.636 the treatment benefits, criticism that Han later said was in 0:01:11.676 --> 0:01:16.196 fact justified. So what do we actually know about convalescent 0:01:16.196 --> 0:01:20.516 plasma as a treatment for COVID nineteen, And, perhaps more important, 0:01:20.916 --> 0:01:25.196 what does the mess of politicization around this emergency use 0:01:25.276 --> 0:01:29.316 authorization tell us about what might happen in the future 0:01:30.116 --> 0:01:33.596 if and when the Trump administration seeks to use an 0:01:33.596 --> 0:01:38.916 emergency use authorization to introduce a vaccine. Here to discuss 0:01:38.996 --> 0:01:42.996 these hugely important issues with US is doctor Walid Jelad. 0:01:43.916 --> 0:01:46.436 Doctor Gelatt is an assistant professor of medicine and health 0:01:46.436 --> 0:01:48.996 policy at the University of Pittsburgh, where he leads the 0:01:49.076 --> 0:01:52.956 Center for Pharmaceutical Policy and Prescribing. He has been a 0:01:52.956 --> 0:02:02.876 frequent and astute commentator on treatment statistics and reality. Well, 0:02:03.116 --> 0:02:05.996 thank you so much for being here. It's my pleasure. Today. 0:02:06.036 --> 0:02:10.876 We're going to start with convalescent plasma therapy. And although 0:02:10.876 --> 0:02:13.396 we're going to talk I think at some length about 0:02:13.796 --> 0:02:16.916 what is not true of convalescent plasmo therapy, Let's start 0:02:16.916 --> 0:02:20.596 with what is true of plasma therapy in your view, 0:02:20.836 --> 0:02:24.836 reading the data that has been made publicly available, what 0:02:25.076 --> 0:02:28.756 can plausibly be claimed for this therapy in terms of 0:02:28.796 --> 0:02:30.636 the effect that it could have on people who are 0:02:30.676 --> 0:02:33.996 ill with covid NT. There are different ways to think 0:02:34.036 --> 0:02:36.836 about this. I think so one. I think the claim 0:02:36.876 --> 0:02:39.196 can be made as it was made in the Emergency 0:02:39.276 --> 0:02:43.156 Use Authorization, which is why the EUA is interesting, And 0:02:43.196 --> 0:02:46.836 the claim is simply that the totality of the evidence 0:02:46.916 --> 0:02:49.796 says that it's probably going to help people, and I 0:02:49.836 --> 0:02:52.796 actually think it is fair to say then, and that's 0:02:52.836 --> 0:02:54.956 pretty much a low bar for what you need to 0:02:54.996 --> 0:02:57.356 determine if something is going to be authorized. But the FDA, 0:02:57.436 --> 0:02:59.476 but I think the totality of evidence, based on what 0:02:59.516 --> 0:03:02.156 we've seen in animals, in what was in a small 0:03:02.276 --> 0:03:05.596 randomized trial, and in some of these observational data that 0:03:05.716 --> 0:03:08.836 was seen from the Mayo clinic, is that it probably 0:03:08.916 --> 0:03:11.436 help helps to some extent. And that's really all you 0:03:11.476 --> 0:03:15.116 can say, probably helps to some extent is, as you say, 0:03:15.156 --> 0:03:18.196 a pretty low bar to reach. Does that include also 0:03:18.236 --> 0:03:22.036 the question of whether it could potentially do any harm? Yeah, 0:03:22.076 --> 0:03:24.236 I think that it has a lot of data. Actually, 0:03:24.356 --> 0:03:27.156 it's been used by seventy thousand people at this point, 0:03:27.316 --> 0:03:30.156 and there's a lot of safety data at that point. 0:03:30.196 --> 0:03:31.796 That's a lot of people to use it. And there's 0:03:31.876 --> 0:03:36.076 known problems with when people receive transfusions of blood or 0:03:36.076 --> 0:03:39.076 plasma that there are known side effects and they're pretty 0:03:39.116 --> 0:03:41.556 typical I think for what people know about plasma. So 0:03:42.036 --> 0:03:46.316 I think one of the reasons why both hydroxy chloroquin 0:03:46.596 --> 0:03:50.676 and convalescent plasma meth this bar for the emergency use 0:03:50.756 --> 0:03:54.836 authorization was in part because the data on side effects 0:03:54.956 --> 0:03:56.916 is pretty well known at least they've been used in 0:03:56.996 --> 0:04:00.636 other settings, and so there's not a lot of concern 0:04:00.676 --> 0:04:04.716 about safety other than the known side effects of plasma. Actually, well, 0:04:04.716 --> 0:04:06.396 that's the good news. But you also just mentioned in 0:04:06.396 --> 0:04:10.036 the same sentence as hydroxychloroquin which turned out on closer 0:04:10.076 --> 0:04:14.276 examination of the data not to have positive therapeutic effects. 0:04:14.756 --> 0:04:17.076 What is the aspect of the data that makes you 0:04:17.116 --> 0:04:20.076 think that that is not true of kindless and plasma therapy, 0:04:20.116 --> 0:04:22.996 that in fact there are reasons in the data. Is 0:04:22.996 --> 0:04:25.956 it that small and RCT randomized control trial or is 0:04:25.956 --> 0:04:28.876 it more to do with the observational data on the 0:04:29.036 --> 0:04:31.196 seventy thousand people who have been treated this way. Yeah, 0:04:31.236 --> 0:04:34.636 you know, it's sometimes I sit back and this is 0:04:34.636 --> 0:04:36.836 not the way to judge science. But I'd say, based 0:04:36.876 --> 0:04:39.396 on what I've seen, if I are a family member 0:04:39.436 --> 0:04:42.876 had COVID, what I want them to receive plasma and 0:04:42.956 --> 0:04:45.356 the answer is yes, So I must have some sense 0:04:46.116 --> 0:04:49.396 that it works. But it is partly from the small 0:04:49.476 --> 0:04:51.956 randomized trial. It is partly from what you see in 0:04:51.996 --> 0:04:54.516 the data, which, although there's no control group, which is 0:04:54.516 --> 0:04:58.596 the huge problem, there are some signs that it would work. 0:04:58.916 --> 0:05:01.476 You cannot know for sure. Until you do the randomized trial. 0:05:02.396 --> 0:05:05.716 That's why this is an authorization and not approval, and 0:05:06.116 --> 0:05:09.756 there's a clear distinction between approval and all zation. And 0:05:09.876 --> 0:05:12.076 to authorize it in the setting of a public health 0:05:12.116 --> 0:05:15.076 emergency with no other treatment, you just have to think 0:05:15.116 --> 0:05:17.796 that it's probably going to work and have enough evidence 0:05:17.996 --> 0:05:20.196 that someone at FDA is going to say that it 0:05:20.236 --> 0:05:23.956 probably works. That's a hugely important point that you're making. 0:05:23.996 --> 0:05:25.556 There will lead and I just want to pause and 0:05:25.756 --> 0:05:31.276 emphasize it. Emergency use authorization is its own category, and 0:05:31.356 --> 0:05:37.636 it's different from FDA approval. FDA approval has higher standards 0:05:37.676 --> 0:05:41.156 for whether a treatment is approved, and that includes real 0:05:41.236 --> 0:05:46.276 statistical presumably RCT randomized control trial proof that it actually 0:05:46.396 --> 0:05:51.156 is working, whereas emergency use authorization simply consists of the 0:05:51.196 --> 0:05:54.436 statement that there's more reason to believe than not that 0:05:54.676 --> 0:05:57.236 it's helping. Is that a fair distinction between the two. Yes, 0:05:57.276 --> 0:05:59.836 that there's a reason to believe that the benefits outweigh 0:05:59.916 --> 0:06:04.716 the risks and approval full approval. Regular FDA approval typically 0:06:04.716 --> 0:06:07.316 requires a randomized trial. So yeah, that is a key 0:06:07.436 --> 0:06:11.436 issue with emergency use authorizations. The bar is lower. It's 0:06:11.596 --> 0:06:14.956 very different than FDA approval. And the other thing that's 0:06:14.996 --> 0:06:18.316 really interesting about emergency use authorizations is one of the 0:06:18.356 --> 0:06:21.116 criterias that there is no other approof therapy to treat 0:06:21.156 --> 0:06:25.796 the disease. And what's interesting is that it's approved therapy. 0:06:26.236 --> 0:06:29.476 So even though remdezeviere is the anti viral that is 0:06:29.556 --> 0:06:33.796 authorized also under the emergency use authorization, there is still 0:06:33.796 --> 0:06:37.196 no approved therapy. So as long as nothing is approved, 0:06:37.316 --> 0:06:40.196 they can actually still authorize what they need to because 0:06:40.236 --> 0:06:42.996 there is no approved therapy. While we're on the topic 0:06:42.996 --> 0:06:45.796 of emergency use authorization, let me ask you a question 0:06:45.796 --> 0:06:48.396 that I've been asked repeatedly by other lay people, and 0:06:48.436 --> 0:06:50.516 I have declined to answer because I don't know. But 0:06:50.556 --> 0:06:54.436 I bet you do know. When the time comes to 0:06:54.476 --> 0:06:58.676 try out for the public some of the vaccines that 0:06:58.716 --> 0:07:03.476 are being tested right now for SARS CoV two, is 0:07:03.516 --> 0:07:07.796 it conceivable that the FDA would do emergency use authorizations 0:07:07.796 --> 0:07:13.156 for the vaccines rather than issue full approvals because that 0:07:13.156 --> 0:07:16.156 would lower the standard of proof that needed to be 0:07:16.236 --> 0:07:21.116 met and would also presumably speed up the process. Yes, 0:07:21.356 --> 0:07:23.276 the answer is yes. And this is what I tell 0:07:23.316 --> 0:07:27.396 people is the most people could care less about convalescent plasma. 0:07:27.556 --> 0:07:29.756 Most people will never get it because it's given to 0:07:29.836 --> 0:07:32.996 hospitalize patients. The reason why it matters so much is 0:07:32.996 --> 0:07:36.316 because of exactly what you mentioned, which is everybody is 0:07:36.516 --> 0:07:39.836 really concerned about what this means for the vaccine. The 0:07:39.916 --> 0:07:42.956 answer is yes, that a vaccine can and in my 0:07:43.116 --> 0:07:46.596 view and others, likely will be authorized by the FDA 0:07:46.716 --> 0:07:50.876 through the same mechanism soon actually in terms of months. 0:07:51.676 --> 0:07:54.036 And there's a lot of debate about then, well good, 0:07:54.076 --> 0:07:56.796 because that's where we're headed. In order to get there, 0:07:57.196 --> 0:08:00.796 I think we first need to turn to the very 0:08:00.836 --> 0:08:04.156 troubling way, at least to my mind, that the announcement 0:08:04.916 --> 0:08:09.916 about the convalescent plasma therapy was made in a dramatic 0:08:10.596 --> 0:08:15.676 President of the United States participating press conference with statistics 0:08:15.676 --> 0:08:18.916 cited that, as far as I can make out, we're 0:08:18.996 --> 0:08:23.476 just not substantiated, namely that the treatment had reduced deaths 0:08:23.516 --> 0:08:27.156 by thirty five percent, which is something that the President said, 0:08:27.396 --> 0:08:31.476 the Secretary of HHS said, and then perhaps most disturbingly, 0:08:31.876 --> 0:08:37.196 the Commissioner of the FDA said, talk to us about 0:08:37.316 --> 0:08:39.516 what happened there? Where did this thirty five percent number 0:08:39.556 --> 0:08:41.796 come from? If you have a theory about where and 0:08:42.316 --> 0:08:45.556 why was it wrong, if indeed you believe it was wrong. Yeah, 0:08:45.556 --> 0:08:48.276 this is one of the most astounding things that happened. 0:08:48.276 --> 0:08:50.956 And I've tried to make a very clear distinction personally 0:08:50.996 --> 0:08:54.196 between whether I agree with an emergency use authorization and 0:08:54.196 --> 0:08:56.876 whether I agree with how it was delivered or how 0:08:56.916 --> 0:08:59.196 it was announced, which I do not. So that latter 0:08:59.276 --> 0:09:03.756 part that was just unprecedented, where you had such huge 0:09:03.956 --> 0:09:07.476 errors made in how the FDA talks about data for 0:09:07.556 --> 0:09:11.636 products that is authorized. Doesn't do those mistakes. If you 0:09:11.716 --> 0:09:16.276 read the decisional memo that the FDA puts together when 0:09:16.276 --> 0:09:19.196 they actually write, the FDA staff right, all the reasons 0:09:19.196 --> 0:09:21.276 why it should be authorized, all the data they make 0:09:21.316 --> 0:09:25.436 their decision, it's actually very detailed, very nuanced. But that 0:09:25.596 --> 0:09:28.396 is not what we heard at the press conference. That 0:09:28.516 --> 0:09:32.476 is also why people are so attuned to this issue 0:09:32.476 --> 0:09:35.316 of convalescent plasma, because we need the FDA to be 0:09:35.356 --> 0:09:38.276 telling us what is correct and saying it correctly and 0:09:38.436 --> 0:09:40.836 not misinforming the public, which is what they did here. 0:09:41.316 --> 0:09:43.516 So it's important to talk about that. So a couple 0:09:43.516 --> 0:09:47.116 of things, this thirty five out of one hundred issue 0:09:47.636 --> 0:09:52.556 the data supporting an emergency use authorization, for convalescent plasma 0:09:52.596 --> 0:09:55.636 did not come from a randomized trial, So it is 0:09:55.756 --> 0:09:59.036 very difficult to make conclusions about whether any therapy actually 0:09:59.076 --> 0:10:02.156 reduce mortality because there was no control arm. There was 0:10:02.196 --> 0:10:04.756 no arm that got nothing. So you really shouldn't say 0:10:04.796 --> 0:10:08.876 that there's good evidence that anything reduces mortality. What is 0:10:08.876 --> 0:10:11.436 there in terms of data? There are data that shows 0:10:11.436 --> 0:10:15.316 if you look at a subgroup subgroup of individuals, and 0:10:15.396 --> 0:10:20.116 you compare those who got more antibodies in their plasma 0:10:20.276 --> 0:10:24.276 with those who got fewer antibodies, there is a reduction 0:10:24.316 --> 0:10:27.196 in mortality. That the people who had more antibodies in 0:10:27.276 --> 0:10:31.036 their plasma, which conceivably should have more of an effect 0:10:31.116 --> 0:10:35.596 in reducing the severity disease, they actually had less mortality 0:10:35.796 --> 0:10:38.956 than the people that had lower tighters of anybody. And 0:10:39.036 --> 0:10:42.516 that the people who got the therapy earlier, when theoretically 0:10:42.556 --> 0:10:45.276 it should work better, had lower mortality than those who 0:10:45.316 --> 0:10:48.756 got it later. Still, we cannot be certain. You cannot 0:10:48.796 --> 0:10:51.356 go in front of the American public and say that 0:10:51.396 --> 0:10:55.316 this therapy reduces mortality when there's that possibility that it 0:10:55.436 --> 0:10:59.156 might not, and the audience that's listening does not understand 0:10:59.196 --> 0:11:02.196 all these nuances we've talking about about the bar emergency 0:11:02.276 --> 0:11:07.076 use authorization, randomized trials necessarily, So that is a key issue. 0:11:07.396 --> 0:11:10.716 Here's a question if the head of the FDA or 0:11:10.716 --> 0:11:12.876 the head of HHAs or the President for that matter, 0:11:13.196 --> 0:11:16.996 had not said this reduces mortality, but had said, we 0:11:17.076 --> 0:11:20.876 have reason to think that it might reduce mortality. Would 0:11:20.916 --> 0:11:23.076 that have made you less upset without it satisfied you. 0:11:23.196 --> 0:11:25.476 Is this a question of the clarity of the claim. Yes. 0:11:25.596 --> 0:11:27.916 So that's the thing is that the FDA had no 0:11:28.036 --> 0:11:31.316 reason to try and inflate the claim. The data as 0:11:31.796 --> 0:11:34.756 they stand are enough to say we're going to authorize it. 0:11:34.796 --> 0:11:36.996 We believe that in the case of an emergency people 0:11:36.996 --> 0:11:39.356 are dying. We want to get this to you. All 0:11:39.396 --> 0:11:42.076 of that is reasonable. That the problem was is going 0:11:42.116 --> 0:11:45.796 and saying that it reduces mortality when we don't know that. 0:11:46.276 --> 0:11:48.516 You know, even the bigger problem was saying that thirty 0:11:48.516 --> 0:11:51.516 five out of one hundred people will survive if they 0:11:51.556 --> 0:11:55.756 get the therapy. That is just nowhere near correct. That 0:11:55.876 --> 0:11:57.996 just flat out false. As far as I can make out, 0:11:58.316 --> 0:12:02.076 it's false. So not only was the certainty about the 0:12:02.156 --> 0:12:07.756 mortality benefit misstated, but the actual magnitude of that was misstated. 0:12:08.276 --> 0:12:21.196 We'll be right back. Let's turn now from what happened 0:12:21.356 --> 0:12:25.436 in this rollout to its implications for the really massive 0:12:25.596 --> 0:12:30.556 question of what's going to happen for vaccines. What consequences 0:12:30.996 --> 0:12:35.156 do you think this to a certain degree botched emergency 0:12:35.236 --> 0:12:40.876 use authorization rollout for the convalescent plasma has for the 0:12:40.996 --> 0:12:44.796 question of how much the public can, should, or will 0:12:44.836 --> 0:12:50.156 trust a potential emergency use authorization for vaccines. Yeah, one 0:12:50.196 --> 0:12:53.076 of the real problems we've had in the public health 0:12:53.436 --> 0:12:57.636 approach or has been the politicization of the entire thing. 0:12:58.556 --> 0:13:01.196 The problem with what happened here is that it just 0:13:01.676 --> 0:13:05.876 gave an opening of even more politicization, even more criticizing, 0:13:05.916 --> 0:13:08.076 so that it was the same thing with hydroxy clark, 0:13:08.116 --> 0:13:11.516 when there was huge criticism of the FDA from one side, 0:13:12.596 --> 0:13:16.116 huge applauding from the other side, and you have these 0:13:16.116 --> 0:13:19.676 two sides that are just completely different saying completely different things, 0:13:19.756 --> 0:13:21.716 you know, one saying it's the best thing ever, one 0:13:21.836 --> 0:13:24.716 saying it's the worst thing ever. And what happened here 0:13:24.836 --> 0:13:28.356 was just yet another opportunity for that to happen. Instead 0:13:28.356 --> 0:13:32.076 of having a message that is clear, that is correct, 0:13:32.716 --> 0:13:35.996 that is not overhyping things. It just contributed to the 0:13:36.076 --> 0:13:38.756 hype on one side about the benefit and so then 0:13:38.796 --> 0:13:42.036 the other side started a pile on the FDA. So 0:13:42.116 --> 0:13:44.836 that's part of the problem is that it's just adding 0:13:45.436 --> 0:13:49.716 to the politicization of public health. So what happens is 0:13:49.916 --> 0:13:52.516 it just leads to further distrust and you don't know 0:13:52.516 --> 0:13:54.476 who to trust, and so I think people end up 0:13:54.516 --> 0:13:56.836 just going to listen to who they trust, which is 0:13:56.876 --> 0:14:00.036 a problem. So all of this is leading up to 0:14:00.076 --> 0:14:03.596 this issue about what's going to happen when the FDA announces, 0:14:03.836 --> 0:14:07.396 When there's a press conference at the end of October 0:14:07.436 --> 0:14:10.876 and the president announces and the head of the FDA, 0:14:10.916 --> 0:14:13.116 they head the CDC is there and they announced that 0:14:13.196 --> 0:14:16.436 they have authorized a vaccine and they say that the 0:14:16.516 --> 0:14:21.756 vaccine is safe and effective. Ideally, we'd want the public 0:14:21.836 --> 0:14:24.156 to say, the President, the head of the CDC, the 0:14:24.156 --> 0:14:26.036 head of the FDA are telling us a vaccine is 0:14:26.076 --> 0:14:29.476 safe and effective. Great, we can all celebrate. The problem 0:14:29.636 --> 0:14:32.996 is is that that's not what's going to happen, and 0:14:33.316 --> 0:14:37.996 that's going to make this issue of vaccine so dicey. 0:14:38.876 --> 0:14:41.916 How our scientists going to respond about the vaccine when 0:14:41.956 --> 0:14:44.276 there's going to be nuanced date on safety and efficacy. 0:14:44.756 --> 0:14:47.156 What we don't want is scientists going out and saying 0:14:47.196 --> 0:14:49.636 this vaccine is not safe when they want people to 0:14:49.636 --> 0:14:52.316 take other vaccines, and the public will not get the nuance. 0:14:52.796 --> 0:14:55.996 That's the larger issue for me is this issue about 0:14:56.116 --> 0:15:01.436 polarization of science and public health, distrust, mistrust, confusion, and 0:15:01.516 --> 0:15:04.516 what that means for the vaccine, which is really the 0:15:04.556 --> 0:15:06.716 way that we're going to finish with this whole COVID 0:15:06.756 --> 0:15:09.676 thing and be able to get back to normal. You've 0:15:09.756 --> 0:15:11.556 kind of blown my mind in what you just said. 0:15:11.596 --> 0:15:15.076 So I want to walk through your scenario, which let's 0:15:15.076 --> 0:15:17.636 call the October surprise, which to you is not going 0:15:17.636 --> 0:15:20.436 to be such a surprise. You pick the end of October, 0:15:20.476 --> 0:15:23.876 I presume not solely because you think that by then 0:15:24.316 --> 0:15:27.276 will have enough preliminary data to make some kind of 0:15:27.276 --> 0:15:30.876 an initial judgment about the vaccines, but rather because it's 0:15:30.876 --> 0:15:34.996 approximate to the beginning of November and then the president 0:15:35.036 --> 0:15:38.276 wants to be reelected. So if I'm right about that, 0:15:38.516 --> 0:15:42.756 what you're picturing is a nationally televised press conference. The 0:15:42.836 --> 0:15:44.676 President's going to get up there and sort of like 0:15:44.756 --> 0:15:48.316 do his version of Barack Obama. You know, ladies and gentleman, 0:15:48.436 --> 0:15:49.676 we got him. He's going to go up there and 0:15:49.676 --> 0:15:52.476 he's going to say, in your scenario, ladies and gentlemen, 0:15:52.636 --> 0:15:56.516 we cured it. All problems solved. So, first of all, 0:15:56.716 --> 0:16:00.756 is that indeed something like the October surprise scenario that 0:16:00.756 --> 0:16:02.836 you're describing. Let me make sure I'm hearing you correctly. 0:16:02.996 --> 0:16:06.116 That is like the October surprise that I'm talking about. 0:16:06.196 --> 0:16:08.596 But the reason why I say late October is because 0:16:08.636 --> 0:16:11.796 there is already a meeting schedule of the FDA Advisory 0:16:11.796 --> 0:16:16.076 Committee that advises the FDA on vaccines, and the specific 0:16:16.196 --> 0:16:21.916 topic is the authorization of COVID vaccines. Now they have 0:16:22.036 --> 0:16:25.636 said specifically, the FDA Commissioner has said specifically that no 0:16:25.716 --> 0:16:30.196 specific application is going to be discussed, So it's as 0:16:30.196 --> 0:16:33.356 of now, there is no plan to discuss a specific 0:16:33.636 --> 0:16:36.596 vaccine that's going to be authorized. From what they said now, 0:16:36.596 --> 0:16:40.276 the FDA has said multiple settings of written and verbal 0:16:40.716 --> 0:16:43.636 that they will have an advisory committee meeting to review 0:16:43.676 --> 0:16:47.156 the safety and efficacy of a vaccine before anything is authorized. 0:16:47.236 --> 0:16:51.036 So they've made that commitment. So those pieces of data 0:16:51.076 --> 0:16:53.436 are they've said there's going to be advisory committee meeting 0:16:53.436 --> 0:16:56.876 before they authorize a vaccine. There is a vaccine Advisory 0:16:56.876 --> 0:16:59.556 Committee meeting scheduled for October twenty second. They're going to 0:16:59.596 --> 0:17:03.676 discuss the COVID vaccine in general. So that's one part 0:17:03.756 --> 0:17:05.636 of the puzzle. The other part of the puzzle is 0:17:05.676 --> 0:17:08.396 there's little snippets of what you call them rumor or 0:17:08.476 --> 0:17:13.596 news come out about the idea of using data from 0:17:13.716 --> 0:17:18.356 trials overseas to authorize a therapy if the trials here 0:17:18.396 --> 0:17:21.356 are not finished. There's a vaccine out of the University 0:17:21.356 --> 0:17:24.476 of Oxford that is doing trials outside of the US 0:17:24.596 --> 0:17:27.796 but hasn't really advanced trials inside the US, and there's 0:17:27.796 --> 0:17:30.356 some talk about that one of the trial sites was 0:17:30.436 --> 0:17:33.476 stopped because the FDA is saying, maybe we can use 0:17:33.556 --> 0:17:37.796 data from overseas. The other issue is that we've heard 0:17:37.956 --> 0:17:41.956 more and more just this opening about we would consider 0:17:42.076 --> 0:17:45.476 an emergency use authorization for the vaccine. So we keep 0:17:45.596 --> 0:17:48.436 hearing that, and that we keep hearing that there is 0:17:48.436 --> 0:17:51.476 a push politically to have a vaccine before the election. 0:17:51.636 --> 0:17:55.076 So whether it happens or not, no one knows, but 0:17:55.236 --> 0:17:59.036 everything is aligned in terms of a low bar for 0:17:59.116 --> 0:18:03.396 an authorization a Vaccine Advisory Committee meeting, trials that are 0:18:03.516 --> 0:18:06.436 quite advanced, and I could argue one could make the 0:18:06.556 --> 0:18:09.116 argument that it could fit the bar for an emerge 0:18:09.356 --> 0:18:12.836 use authorization. The stage is set that this could actually 0:18:12.836 --> 0:18:18.076 happen politically. Now if I can put my unofficial pundit head, 0:18:18.076 --> 0:18:20.996 and I'm not a pundit, but for the President to 0:18:21.036 --> 0:18:24.196 go up and announce that there's a vaccine does not 0:18:24.356 --> 0:18:27.076 require that it's a vaccine that everyone has access to 0:18:27.236 --> 0:18:30.556 or will take. So what some people have talked about 0:18:30.716 --> 0:18:34.276 is an emergency use authorization that is first very specific, 0:18:34.316 --> 0:18:39.036 tailored population, a small group of individuals, that allows the 0:18:39.076 --> 0:18:42.556 administration to say, look, we got a vaccine, but without 0:18:42.596 --> 0:18:45.676 having to deal with all the issues of well is 0:18:45.676 --> 0:18:48.236 it really safe? Is the entire public going to get it? 0:18:48.236 --> 0:18:51.636 It will just be authorized for a small population. Those 0:18:51.636 --> 0:18:54.396 are many reasons to think that it's at least possible 0:18:54.596 --> 0:18:59.036 that after the October twenty two Vaccine Committee FDA meeting, 0:18:59.716 --> 0:19:03.156 if the agenda is tweaked a little bit in the 0:19:03.236 --> 0:19:05.916 run up to that meeting such that's specific and concrete 0:19:06.116 --> 0:19:08.556 vaccines or discussed rather than the issue in the abstract, 0:19:09.156 --> 0:19:12.036 that there could be as a result potentially of White 0:19:12.076 --> 0:19:14.796 House pressure. But maybe, I mean, let's not be totally cynical. 0:19:15.076 --> 0:19:18.356 Maybe as a result of early findings from around the 0:19:18.396 --> 0:19:22.636 world that seemed plausible that there could be some kind 0:19:22.676 --> 0:19:27.356 of an announcement of an emergency use authorization with enough 0:19:27.396 --> 0:19:30.036 time before the election for that to affect people's minds. 0:19:30.876 --> 0:19:34.956 What do you see as the potential upsides or downsides 0:19:35.156 --> 0:19:39.996 of an announcement like that, Right, the whole point is 0:19:40.156 --> 0:19:42.596 we're in an emergency and a thousand people that they 0:19:42.636 --> 0:19:45.596 are dying. If there is something that can stop that, 0:19:45.596 --> 0:19:48.436 that is good. So the upside if there is really 0:19:48.436 --> 0:19:52.276 good data from overseas and it just doesn't fulfill the 0:19:52.356 --> 0:19:55.636 requirements of a full approval in the FDA here, well, 0:19:55.676 --> 0:19:58.036 I mean most people would agree that that should be authorized. 0:19:58.556 --> 0:20:01.716 That would require a full Phase three trial that's completed, 0:20:01.756 --> 0:20:03.996 where you give it to enough people and you have 0:20:04.156 --> 0:20:07.476 enough cases to say that there really is a reduction 0:20:08.236 --> 0:20:11.076 in the evalence of COVID or the severity of COVID. 0:20:11.076 --> 0:20:13.636 If you give people a vaccine and the FDA has 0:20:13.636 --> 0:20:17.196 made specific guidelines on how much of an effect they want, 0:20:17.196 --> 0:20:20.596 they want at least a fifty percent effect. Fifty percent 0:20:20.636 --> 0:20:23.596 fewer cases among those who are vaccinated versus non vaccinated. 0:20:24.156 --> 0:20:27.676 So that's a clear upside. If there's a vaccine that works, 0:20:27.756 --> 0:20:30.316 we feel good that it works. Well, then let's get 0:20:30.356 --> 0:20:32.316 it available so people don't have to wait for all 0:20:32.356 --> 0:20:35.716 the red tape to happen. Then I guess it's a 0:20:35.756 --> 0:20:38.276 spectrum of things. So go down the spectrum a little bit, 0:20:38.356 --> 0:20:41.556 and well, the Phase three trials are not completed, but 0:20:41.636 --> 0:20:45.516 they're almost completed. There maybe is an effect, but there's 0:20:45.556 --> 0:20:48.676 not enough cases to know for sure, but there's no 0:20:48.716 --> 0:20:52.556 real safety issues. I can easily see an argument there 0:20:52.676 --> 0:20:56.636 being made that, well, we have data so far in 0:20:56.676 --> 0:20:59.076 the data, we don't have any big safety issues. We 0:20:59.156 --> 0:21:02.276 have the early trials, and we have the Phase three 0:21:02.316 --> 0:21:05.156 trials saying yeah, there may be an effect. It may 0:21:05.196 --> 0:21:08.276 not reach statistical significance because there's not enough people, but 0:21:08.396 --> 0:21:11.316 it's it's almost there, and then it goes all the 0:21:11.316 --> 0:21:14.116 way down. How far you want to think about what 0:21:14.156 --> 0:21:17.436 the administration could say that would still fit the criteria 0:21:17.476 --> 0:21:21.676 for an emergency use austhorization? Is it reasonable to say 0:21:22.116 --> 0:21:25.676 that the probability of a benefit outweighs the probability of 0:21:25.716 --> 0:21:29.316 a risk with some lesser kind of data, and it's possible. 0:21:29.636 --> 0:21:32.276 And it depends on which vaccine they're talking about, because 0:21:32.276 --> 0:21:33.996 some of them are new vaccines that have never been 0:21:34.116 --> 0:21:36.756 used before. Some of them are just variants of another vaccine. 0:21:37.796 --> 0:21:42.756 So the downsides are One is side effects. You do 0:21:42.796 --> 0:21:45.756 not want a vaccine to be authorized people excited and 0:21:45.796 --> 0:21:48.236 then all of a sudden people die or become paralyzed 0:21:48.356 --> 0:21:51.796 when they start taking a vaccine. That would be a disaster. 0:21:52.716 --> 0:21:56.516 The other issue is, let's say there's a vaccine where 0:21:56.516 --> 0:22:00.036 the preliminary data is positive, but it ends up being 0:22:00.236 --> 0:22:03.876 just a little effective. It maybe reduces the chance of 0:22:03.956 --> 0:22:08.516 having COVID by twenty percent, but there's still trials ongoing 0:22:08.676 --> 0:22:11.596 to test the vaccine that might be better. The problem 0:22:11.676 --> 0:22:12.996 is you're going to have people who want to get 0:22:13.036 --> 0:22:14.956 back to their lives and they're going to have a 0:22:15.036 --> 0:22:17.596 vaccine on the market, and the question is are they 0:22:17.596 --> 0:22:20.116 going to take that vaccine and then not enroll in 0:22:20.196 --> 0:22:23.276 other trials that might get us a better vaccine, and 0:22:23.316 --> 0:22:26.836 then we'll never know. We'll never get to that better vaccine. 0:22:27.596 --> 0:22:30.636 That's one concern is that the randomized trials will not 0:22:30.756 --> 0:22:34.116 fully enroll and we end up authorizing a vaccine that's okay, 0:22:34.596 --> 0:22:38.276 and not really getting those vaccines to market that are really, 0:22:38.316 --> 0:22:41.436 really good and maybe a little safer. What about the 0:22:41.516 --> 0:22:46.196 risk that politicization just engulfs the announcement. I think the 0:22:46.276 --> 0:22:48.316 thing that's most striking to me is, you know, we 0:22:48.396 --> 0:22:51.476 spent the first part of our conversation talking about just 0:22:51.516 --> 0:22:54.836 how bad it was that there's this politicization surrounding I 0:22:54.836 --> 0:22:57.076 think your phrase was, I jotted it down, the politicization 0:22:57.116 --> 0:22:59.716 of the entire thing, the entire thing being, you know, 0:22:59.756 --> 0:23:04.116 the whole question of treatment of COVID. If the President 0:23:04.436 --> 0:23:08.876 announces an EUA for a vaccine in late October, I 0:23:09.276 --> 0:23:12.276 know how you avoid radical politicization, and I don't know 0:23:12.316 --> 0:23:15.356 how you avoid Democrats, maybe not Joe Biden, but certainly 0:23:15.396 --> 0:23:19.636 other Democrats saying it's too soon, this isn't safe, you 0:23:19.676 --> 0:23:21.756 shouldn't do it. And then that really could create a 0:23:21.796 --> 0:23:25.636 circumstance where many many people, like roughly half the people, 0:23:25.956 --> 0:23:29.716 have some deep skepticism about the vaccine. Can you imagine 0:23:29.756 --> 0:23:31.996 this scenarrea where the Democrats were at least some Democrats 0:23:31.996 --> 0:23:35.836