WEBVTT - The FDA Under Pressure 0:00:03.960 --> 0:00:09.440 Welcome the prognosis. I'm Laura Carlson. It's day one sixty 0:00:09.520 --> 0:00:15.120 eight since coronavirus was declared a global pandemic. Today's main story. 0:00:16.000 --> 0:00:20.360 An f DA official made a high profile misstatement about 0:00:20.360 --> 0:00:25.160 the efficacy of a COVID treatment this weekend, even after 0:00:25.239 --> 0:00:29.520 he backtracked. The episode has led many to wonder how 0:00:29.600 --> 0:00:36.360 independent the agency really is. But first, here's what happened 0:00:36.400 --> 0:00:50.640 in virus news today. Italy has ruled out imposing a 0:00:50.720 --> 0:00:56.920 new nationwide lockdown despite an increase in coronavirus cases. Today, 0:00:57.280 --> 0:01:00.720 the country recorded its highest number of new cases in 0:01:00.920 --> 0:01:06.640 three and a half months, but the virus and associated 0:01:06.680 --> 0:01:12.520 lockdowns have sent Italy into its worst recession in living memory. 0:01:13.400 --> 0:01:17.600 Italy's Health Minister Roberto Speranza told Bloomberg News that the 0:01:17.720 --> 0:01:21.480 rise in contagion has been limited, with very low impact 0:01:21.560 --> 0:01:24.960 on hospitals. He also said the average age of people 0:01:24.959 --> 0:01:28.000 who have tested positive in the last week is thirty 0:01:28.319 --> 0:01:33.320 and most have mild symptoms or none at all. Authorities 0:01:33.360 --> 0:01:37.640 in Berlin have banned demonstrations that were planned to protest 0:01:37.840 --> 0:01:42.959 COVID related restrictions. Thousands of protesters have clashed with police 0:01:43.000 --> 0:01:46.880 in recent weeks, many of them openly ignore hygiene and 0:01:47.120 --> 0:01:51.800 distancing rules. The city's interior minister said that the ban 0:01:52.040 --> 0:01:55.720 is meant not to limit freedom of assembly, but to 0:01:55.800 --> 0:02:02.520 protect citizens from infection. Separately, the German government is extending 0:02:02.600 --> 0:02:10.760 its coronavirus travel warning for countries outside Europe until September. Finally, 0:02:11.080 --> 0:02:14.959 drug company Moderna presented early data that provides the first 0:02:15.040 --> 0:02:19.639 evidence that its COVID nineteen vaccine stimulates the immune systems 0:02:19.760 --> 0:02:23.960 of older people. In a phase one trial, the vaccine 0:02:23.960 --> 0:02:30.080 produced quote consistently high levels of neutralizing antibodies and older adults. 0:02:30.440 --> 0:02:35.400 According to a statement, antibody levels produced in people older 0:02:35.400 --> 0:02:39.760 than fifty five were comparable to those seen in younger adults. 0:02:40.960 --> 0:02:44.240 The findings are important because those over the age of 0:02:44.280 --> 0:02:48.560 fifty five often don't respond as well to vaccines as 0:02:48.680 --> 0:03:00.800 younger adults. And now for today's main story. This weekend, 0:03:01.040 --> 0:03:05.120 Stephen Hahn, the Commissioner of the US Food and Drug Administration, 0:03:05.440 --> 0:03:10.560 attracted criticism when he substantially overstated the benefits of an 0:03:10.560 --> 0:03:16.280 experimental COVID nineteen therapy at a press conference with President Trump. 0:03:16.520 --> 0:03:20.040 Hans said that a treatment using blood plasma from recovered 0:03:20.080 --> 0:03:24.600 patients could save thirty five of every one hundred people 0:03:24.919 --> 0:03:29.560 who would have died. Those high profile remarks were incorrect, 0:03:30.040 --> 0:03:33.120 and they were repeated by others in the Trump administration. 0:03:34.080 --> 0:03:37.520 Late on Monday, Doctor Han clarified some of what the 0:03:37.640 --> 0:03:42.600 data on blood plasma actually show, but the episode has 0:03:42.720 --> 0:03:46.960 raised questions about how the agency will review a vaccine, 0:03:47.480 --> 0:03:52.520 as well as its overall scientific independence. Senior editor for 0:03:52.640 --> 0:03:56.760 Healthcare Drew Armstrong spoke to Dr Han about the agency's 0:03:56.880 --> 0:04:02.880 role in an increasingly politicized federal virus response. I talked 0:04:02.880 --> 0:04:15.000 to Drew about what his reporting has found. Earlier this week, 0:04:15.120 --> 0:04:19.680 FDA Commissioner Stephen Hahn admitted to overstating the benefits of 0:04:19.880 --> 0:04:25.039 convalescent plasma and treating COVID nineteen. What exactly was incorrect 0:04:25.160 --> 0:04:30.000 about his remarks. The important thing to know is exactly 0:04:30.480 --> 0:04:33.440 what he said at the start and what he said 0:04:33.680 --> 0:04:37.160 at this press conference with President Trump over the weekend, 0:04:37.440 --> 0:04:41.159 was that so plasma is the liquid portion of the 0:04:41.200 --> 0:04:45.760 blood um. That liquid portion contains the natural immunity that 0:04:45.880 --> 0:04:48.800 someone develops in response to an infection, in this case 0:04:48.839 --> 0:04:52.640 COVID nineteen. You can take that and infuse it into 0:04:52.839 --> 0:04:57.400 current patients and hopefully it takes those infection fighting antibodies 0:04:57.680 --> 0:05:00.080 and gives them to the new patient and helps and 0:05:00.160 --> 0:05:03.480 fight off the infection. So around the world this has 0:05:03.520 --> 0:05:08.240 been used by physicians outside of clinical trials. It's always 0:05:08.240 --> 0:05:11.360 been thought of as a promising but unproven therapy for 0:05:11.760 --> 0:05:15.080 COVID nineteen and they've been trying to find out does 0:05:15.320 --> 0:05:18.600 it work and if it works, how effective is it. 0:05:19.160 --> 0:05:23.360 So one of the things that Commissioner Han presented over 0:05:23.400 --> 0:05:26.200 the weekend at the press conference with President Trump was 0:05:26.440 --> 0:05:29.720 a comment that was really really important about how good 0:05:29.800 --> 0:05:31.919 is this thing? And he said, the data continue to 0:05:31.960 --> 0:05:35.400 pan out a hundred people who are sick with COVID 0:05:35.480 --> 0:05:38.240 nineteen thirty five would have been saved because of the 0:05:38.240 --> 0:05:42.160 administration of about plasma. That's a pretty dramatic result. That 0:05:42.200 --> 0:05:44.600 would be one of the most effective treatments we have 0:05:45.160 --> 0:05:48.880 for this disease. Unfortunately, it's not accurate and it's not 0:05:48.960 --> 0:05:52.159 what the data show that FDA have. What the data 0:05:52.400 --> 0:05:57.040 actually show is that the effect of this of the 0:05:57.160 --> 0:06:01.120 highest dose of this blood plasma mu is thirty five 0:06:01.720 --> 0:06:05.599 more effective. It reduces mortality by thirty compared to the 0:06:05.640 --> 0:06:09.080 lowest dose. But we don't have the data to compare 0:06:09.120 --> 0:06:11.520 it to how it works against the standard of care 0:06:11.600 --> 0:06:14.719 of placebo. And that's the gold standard of evidence that 0:06:14.839 --> 0:06:17.560 the f d A really looks at and that physicians 0:06:17.600 --> 0:06:20.640 and patients really want to know when they're assessing does 0:06:20.680 --> 0:06:23.760 something actually work? And that's just something we don't know yet. 0:06:23.960 --> 0:06:28.520 But that Commissioner Hound was really, really, really misleading in 0:06:28.680 --> 0:06:31.480 making that statement in the press conference with President Trump. 0:06:32.160 --> 0:06:35.720 In terms of how this might damage public perception and 0:06:35.839 --> 0:06:39.600 trust of the f d A, particularly during a pandemic. 0:06:39.920 --> 0:06:44.240 What are some of the concerns there. I think there 0:06:44.240 --> 0:06:48.520 are really serious concerns because while these concepts of what 0:06:48.560 --> 0:06:52.320 we call relative risk versus absolute risk are kind of 0:06:52.360 --> 0:06:55.480 technical and maybe a lot of late people don't necessarily 0:06:55.640 --> 0:06:59.920 think about this every day, it's unbelievably important and it's 0:07:00.040 --> 0:07:03.920 incredibly just fundamental if you're a drug researcher or a 0:07:03.920 --> 0:07:07.360 medical researcher. And Steve Hahn over at the fd I mean, 0:07:07.360 --> 0:07:10.840 he's written two hundred and twenty different academic papers, he 0:07:10.880 --> 0:07:14.080 has read thousands. I'm sure he's been in cancer research 0:07:14.200 --> 0:07:17.960 for decades. I mean, this is pretty basic stuff if 0:07:18.000 --> 0:07:20.400 you're in the scientific world, and so it's a pretty 0:07:20.400 --> 0:07:23.080 big screw up, and that's the reason why it's damaging 0:07:23.120 --> 0:07:25.240 to the credibility of the f d A, you know. 0:07:25.320 --> 0:07:28.280 And it also comes at a point when the FDA 0:07:28.400 --> 0:07:32.120 was kind of up there during a political event, you know, 0:07:32.240 --> 0:07:36.840 the administration's um was there with President Trump and his 0:07:36.920 --> 0:07:40.640 re election really hinges on a successful response to this virus, 0:07:40.680 --> 0:07:44.400 and the FDA got dragged into that overstated something that 0:07:44.480 --> 0:07:46.800 wasn't true and about his higher profile setting, as you 0:07:46.840 --> 0:07:50.720 can imagine, and then had to walk it back. That 0:07:50.960 --> 0:07:53.720 is really really not a great place for an agency 0:07:53.720 --> 0:07:57.280 that prides itself on rock solid science and credibility to 0:07:57.440 --> 0:08:01.560 be in Americans, no matter what they're political affiliation, have 0:08:01.800 --> 0:08:04.560 to be able to trust that they have good information 0:08:04.720 --> 0:08:09.400 about the medicine, therapy, medical devices they take. You do 0:08:09.520 --> 0:08:12.560 not want to be in a country where half the 0:08:12.560 --> 0:08:16.960 country doubts whether drug works because of who's in office. 0:08:17.400 --> 0:08:20.040 And let's talk more broadly or generally about the f 0:08:20.160 --> 0:08:23.520 d A in terms of how it does actually function, 0:08:23.960 --> 0:08:29.760 specifically with regard to its independence from political affiliations or 0:08:29.840 --> 0:08:33.559 or who is in office. Yeah, I think the f 0:08:33.720 --> 0:08:37.000 d A has always had a little bit of a 0:08:37.000 --> 0:08:41.000 benefit by being a public health agency and been perhaps 0:08:41.400 --> 0:08:45.200 less susceptible to some of the political pressures that have 0:08:45.360 --> 0:08:48.840 we've seen placed on and you know, other parts of government, 0:08:48.840 --> 0:08:52.400 particularly during this administration. That said, I want to be clear, 0:08:52.480 --> 0:08:56.280 it's certainly not exempt, and it can get hauled in 0:08:56.320 --> 0:09:00.480 front of Congress, criticized by lawmakers, and so it is 0:09:00.520 --> 0:09:03.320 not immune. But one of the Commissioner's real jobs is 0:09:03.360 --> 0:09:07.280 to protect the scientific and professional staff of the agency 0:09:07.440 --> 0:09:11.280 from that so that they can do their jobs. They 0:09:11.320 --> 0:09:15.080 are both a leader and a buffer at the agency. 0:09:15.559 --> 0:09:19.320 And so, turning to the context of the pandemic and 0:09:19.920 --> 0:09:24.600 the concern that politics might actually enter into the f 0:09:24.679 --> 0:09:30.559 d a's reaction or treatments or even vaccines for COVID nineteen, 0:09:31.040 --> 0:09:35.320 I think the worry always is that you have a 0:09:35.520 --> 0:09:40.200 vaccine or a drug or a therapy that is approved 0:09:40.360 --> 0:09:45.040 or allowed out under some kind of emergency program where 0:09:45.080 --> 0:09:48.240 the evidence to support it just asn't there, either because 0:09:48.360 --> 0:09:51.920 of a effectiveness problem or because of an even more 0:09:51.960 --> 0:09:55.319 worryingly a safety problem. One of the things that Commissioner 0:09:55.360 --> 0:09:58.600 hantst in our our lengthy interview this week was that 0:09:58.800 --> 0:10:01.560 he is aware of that. Sure he said that it 0:10:01.600 --> 0:10:05.680 has been uh challenging. He's he's aware that other people 0:10:05.679 --> 0:10:07.880 in the FDA aware of and that he sees one 0:10:07.880 --> 0:10:11.000 of his major jobs to reinforce to the folks at 0:10:11.000 --> 0:10:14.600 the agency that they need to ignore that and and 0:10:14.640 --> 0:10:17.600 do their jobs. He is also very cognizant of the 0:10:17.720 --> 0:10:20.959 unique situation that we're in um with the pandemic in 0:10:21.040 --> 0:10:24.600 the sense that this is urgent, and wants people to 0:10:24.640 --> 0:10:27.040 be able to move quickly, but to move quickly in 0:10:27.080 --> 0:10:30.720 the right way. What kinds of pressure and the Trump 0:10:30.760 --> 0:10:34.560 administration put on the f d A to say, speed 0:10:34.640 --> 0:10:38.440 up the approval process for a COVID nineteen vaccine, Well, 0:10:38.480 --> 0:10:40.800 they can put as much pressure on the f d 0:10:40.800 --> 0:10:45.120 A as the f d A allows them to squeeze. 0:10:45.280 --> 0:10:47.600 It really is up to the f d A. You know, 0:10:47.720 --> 0:10:50.960 the it's a matter of you know, does Commissioner Han 0:10:51.160 --> 0:10:53.360 want to keep his job? Can he take the heat? 0:10:53.720 --> 0:10:56.120 You know? There have been a number of reports out 0:10:56.160 --> 0:10:59.160 there of people in the White House being highly critical 0:10:59.200 --> 0:11:04.520 of the agency. Axios I believe had a report that 0:11:04.840 --> 0:11:08.120 White House Advisor Peter Navarro told some FDA officials that 0:11:08.160 --> 0:11:09.960 you're all deep state and you need to get on 0:11:10.000 --> 0:11:12.960 Trump time. Trump himself put out a tweet over the 0:11:13.000 --> 0:11:16.040 weekend that he had heard some members of the FDA 0:11:16.160 --> 0:11:20.520 were deep staters attempting to slow down work on a 0:11:20.600 --> 0:11:24.080 vaccine or a drug in order to impede his re election. 0:11:24.280 --> 0:11:29.160 UM Commissioner han Um he very definitively said, Um, I'll 0:11:29.200 --> 0:11:30.960 quote from his interview. You said, what I can tell 0:11:31.000 --> 0:11:32.920 you is that I feel very strongly that the seventeen 0:11:32.960 --> 0:11:35.320 thousand plus fd employees are true professionals, and none of 0:11:35.320 --> 0:11:37.320 them wants to delay getting medical products into the hands 0:11:37.360 --> 0:11:40.000 of Americans, and all emphasises, I mean, there is no 0:11:40.120 --> 0:11:43.720 evidence whatsoever, Um that the f d A is slowing 0:11:43.760 --> 0:11:46.680 down work on this. I think everybody in the country 0:11:46.720 --> 0:11:50.160 realizes this is a public health crisis, and the sooner 0:11:50.240 --> 0:11:55.360 there is an effective vaccine UM and additional therapy for 0:11:55.559 --> 0:11:59.040 this disease, the better. And certainly we know from the 0:11:59.080 --> 0:12:02.560 Trump administration that they have their eye on election day 0:12:02.800 --> 0:12:06.720 and there is significant pressure there to have a vaccine 0:12:07.200 --> 0:12:11.840 either approved or even available by that point. And perhaps 0:12:11.880 --> 0:12:16.560 that has led to this question of pressures on the 0:12:16.600 --> 0:12:19.240 f d A and whether or not the FDA needs 0:12:19.280 --> 0:12:22.439 to be even more independent. I was wondering if you 0:12:22.520 --> 0:12:24.480 might be able to go into that of what can 0:12:24.520 --> 0:12:30.160 there be done to ensure this continued independence. I think 0:12:30.200 --> 0:12:32.800 a huge amount of the independence of any agency is 0:12:32.800 --> 0:12:35.440 going to be defined by its leader. You know, there 0:12:35.480 --> 0:12:39.079 are federal agencies and parts of the federal government that 0:12:39.200 --> 0:12:41.400 have more independence. You know, the Federal Reserve is kind 0:12:41.400 --> 0:12:45.400 of a classic example. But it's really up to the commissioner. 0:12:45.840 --> 0:12:49.439 Is the reality and being able to be a strong 0:12:49.559 --> 0:12:52.080 leader who can stand up for the science while being 0:12:52.280 --> 0:12:57.640 cognizant of the real world scenario that they're living in 0:12:58.080 --> 0:13:00.640 is probably at this point in time, I'm the most 0:13:00.720 --> 0:13:03.600 important thing. I asked Commissioner Han, you know, did he 0:13:03.640 --> 0:13:06.480 think that the FDA should be an independent agency instead 0:13:06.480 --> 0:13:09.760 of being a part of the Health and Human Services Department? Um, 0:13:09.800 --> 0:13:12.400 you know, like the Federal Reserve. And you know, he 0:13:12.440 --> 0:13:14.280 said he hadn't really thought about it, but that it 0:13:14.360 --> 0:13:18.640 was worth consideration, um for exactly the reasons we're discussing. 0:13:18.640 --> 0:13:21.160 But he really he backed off on that quite a 0:13:21.160 --> 0:13:23.240 bit and said he didn't really want to rush into 0:13:23.240 --> 0:13:25.839 giving an opinion about it. Uh, it appeared to be 0:13:25.960 --> 0:13:28.679 at least a little bit appealing in that moment. What 0:13:28.800 --> 0:13:33.120 are perhaps the dangers um of this potential political pressure 0:13:33.400 --> 0:13:37.240 on speeding up getting a vaccine out before perhaps it's ready. 0:13:37.840 --> 0:13:40.280 When you're the head of an agency, the reality is 0:13:40.400 --> 0:13:44.760 that you don't have all that many options if an 0:13:44.760 --> 0:13:48.800 administration really does want to pressure your overrule a decision 0:13:49.320 --> 0:13:52.160 that you make. There was a report by Ruters that 0:13:52.200 --> 0:13:55.199 Peter Marks, who is the leader of the group inside 0:13:55.240 --> 0:13:58.240 the FDA that reviews vaccines. The writers reported the HULD 0:13:58.240 --> 0:14:02.439 resign if the agency rubber stamp something. Essentially, our administration 0:14:02.520 --> 0:14:06.120 forced the FDA to rubber stamp something. And I asked 0:14:06.320 --> 0:14:09.640 Commissioner Hot about that, and his response was, you know, 0:14:09.720 --> 0:14:11.480 I'll quote here he said, Peter did not say that 0:14:11.520 --> 0:14:14.400 to me, but it wouldn't surprise me that this is accurate. 0:14:14.400 --> 0:14:16.760 And I asked him the same question. What would he 0:14:16.800 --> 0:14:19.120 do if he was being asked rubber stamp a vaccine? 0:14:19.240 --> 0:14:21.880 And I'll quote again from his answer, it wouldn't be 0:14:21.920 --> 0:14:24.320 okay for me, and I would not participate in any 0:14:24.320 --> 0:14:27.160 decision that was made on anything other than the science. 0:14:27.560 --> 0:14:30.280 So you know, that is kind of the nuclear option 0:14:30.320 --> 0:14:34.000 for an FDA commissioner is to resign or publicly protest 0:14:34.360 --> 0:14:38.440 about a decision where you're either being overruled or forced 0:14:38.440 --> 0:14:42.640 to do something that you don't believe is correct. Hopefully 0:14:42.680 --> 0:14:51.080 we won't be in a situation like that. That was 0:14:51.160 --> 0:14:54.880 Drew Armstrong and that's it for our show today. For 0:14:55.000 --> 0:14:58.080 coverage of the outbreak from one bureaus around the world, 0:14:58.440 --> 0:15:03.040 visit Bloomberg dot com slash Coronavirus and if you like 0:15:03.120 --> 0:15:05.680 the show, please leave us a review and a rating 0:15:05.960 --> 0:15:09.520 on Apple Podcasts or Spotify. It's the best way to 0:15:09.560 --> 0:15:14.680 help more listeners find our global reporting. The Prognosis Daily 0:15:14.800 --> 0:15:19.720 edition is produced by topor foreheads Jordan Gospoure, Magnus Hendrickson 0:15:19.880 --> 0:15:24.400 and me Laura Carlson. Today's main story was reported by 0:15:24.480 --> 0:15:29.760 Drew Armstrong. Original music by Leo Sidrin. Our editors are 0:15:29.800 --> 0:15:34.840 Francesca Levi and Rick Shine. Francesca Levi is Bloomberg's head 0:15:34.880 --> 0:15:37.200 of podcasts. Thanks for listening.