The FDA Under Pressure

new nationwide lockdown despite an increase in coronavirus cases. Today, the country recorded its highest number of new cases in three and a half months, but the virus and associated lockdowns have sent Italy into its worst recession in living memory. Italy's Health Minister Roberto Speranza told Bloomberg News that the rise in contagion has been limited, with very low impact on hospitals. He also said the average age of people who have tested positive in the last week is thirty

and most have mild symptoms or none at all. Authorities in Berlin have banned demonstrations that were planned to protest COVID related restrictions. Thousands of protesters have clashed with police in recent weeks, many of them openly ignore hygiene and distancing rules. The city's interior minister said that the ban is meant not to limit freedom of assembly, but to protect citizens from infection. Separately, the German government is extending

its coronavirus travel warning for countries outside Europe until September. Finally, drug company Moderna presented early data that provides the first evidence that its COVID nineteen vaccine stimulates the immune systems of older people. In a phase one trial, the vaccine produced quote consistently high levels of neutralizing antibodies and older adults. According to a statement, antibody levels produced in people older than fifty five were comparable to those seen in younger adults.

The findings are important because those over the age of fifty five often don't respond as well to vaccines as younger adults. And now for today's main story. This weekend, Stephen Hahn, the Commissioner of the US Food and Drug Administration, attracted criticism when he substantially overstated the benefits of an experimental COVID nineteen therapy at a press conference with President Trump.

Hans said that a treatment using blood plasma from recovered patients could save thirty five of every one hundred people who would have died. Those high profile remarks were incorrect, and they were repeated by others in the Trump administration. Late on Monday, Doctor Han clarified some of what the data on blood plasma actually show, but the episode has raised questions about how the agency will review a vaccine,

as well as its overall scientific independence. Senior editor for Healthcare Drew Armstrong spoke to Dr Han about the agency's role in an increasingly politicized federal virus response. I talked to Drew about what his reporting has found. Earlier this week, FDA Commissioner Stephen Hahn admitted to overstating the benefits of convalescent plasma and treating COVID nineteen. What exactly was incorrect

about his remarks. The important thing to know is exactly what he said at the start and what he said at this press conference with President Trump over the weekend, was that so plasma is the liquid portion of the blood um. That liquid portion contains the natural immunity that someone develops in response to an infection, in this case

COVID nineteen. You can take that and infuse it into current patients and hopefully it takes those infection fighting antibodies and gives them to the new patient and helps and fight off the infection. So around the world this has been used by physicians outside of clinical trials. It's always been thought of as a promising but unproven therapy for COVID nineteen and they've been trying to find out does it work and if it works, how effective is it.

So one of the things that Commissioner Han presented over the weekend at the press conference with President Trump was a comment that was really really important about how good is this thing? And he said, the data continue to pan out a hundred people who are sick with COVID nineteen thirty five would have been saved because of the administration of about plasma. That's a pretty dramatic result. That would be one of the most effective treatments we have

for this disease. Unfortunately, it's not accurate and it's not what the data show that FDA have. What the data actually show is that the effect of this of the highest dose of this blood plasma mu is thirty five more effective. It reduces mortality by thirty compared to the lowest dose. But we don't have the data to compare it to how it works against the standard of care

of placebo. And that's the gold standard of evidence that the f d A really looks at and that physicians and patients really want to know when they're assessing does something actually work? And that's just something we don't know yet. But that Commissioner Hound was really, really, really misleading in making that statement in the press conference with President Trump. In terms of how this might damage public perception and trust of the f d A, particularly during a pandemic.

What are some of the concerns there. I think there are really serious concerns because while these concepts of what we call relative risk versus absolute risk are kind of technical and maybe a lot of late people don't necessarily think about this every day, it's unbelievably important and it's incredibly just fundamental if you're a drug researcher or a medical researcher. And Steve Hahn over at the fd I mean, he's written two hundred and twenty different academic papers, he

has read thousands. I'm sure he's been in cancer research for decades. I mean, this is pretty basic stuff if you're in the scientific world, and so it's a pretty big screw up, and that's the reason why it's damaging to the credibility of the f d A, you know.

And it also comes at a point when the FDA was kind of up there during a political event, you know, the administration's um was there with President Trump and his re election really hinges on a successful response to this virus, and the FDA got dragged into that overstated something that wasn't true and about his higher profile setting, as you

can imagine, and then had to walk it back. That is really really not a great place for an agency that prides itself on rock solid science and credibility to be in Americans, no matter what they're political affiliation, have to be able to trust that they have good information about the medicine, therapy, medical devices they take. You do not want to be in a country where half the country doubts whether drug works because of who's in office.

And let's talk more broadly or generally about the f d A in terms of how it does actually function, specifically with regard to its independence from political affiliations or or who is in office. Yeah, I think the f d A has always had a little bit of a benefit by being a public health agency and been perhaps less susceptible to some of the political pressures that have we've seen placed on and you know, other parts of government,

particularly during this administration. That said, I want to be clear, it's certainly not exempt, and it can get hauled in front of Congress, criticized by lawmakers, and so it is not immune. But one of the Commissioner's real jobs is to protect the scientific and professional staff of the agency from that so that they can do their jobs. They are both a leader and a buffer at the agency.

And so, turning to the context of the pandemic and the concern that politics might actually enter into the f d a's reaction or treatments or even vaccines for COVID nineteen, I think the worry always is that you have a vaccine or a drug or a therapy that is approved or allowed out under some kind of emergency program where the evidence to support it just asn't there, either because of a effectiveness problem or because of an even more

worryingly a safety problem. One of the things that Commissioner hantst in our our lengthy interview this week was that he is aware of that. Sure he said that it has been uh challenging. He's he's aware that other people in the FDA aware of and that he sees one of his major jobs to reinforce to the folks at the agency that they need to ignore that and and

do their jobs. He is also very cognizant of the unique situation that we're in um with the pandemic in the sense that this is urgent, and wants people to be able to move quickly, but to move quickly in the right way. What kinds of pressure and the Trump administration put on the f d A to say, speed up the approval process for a COVID nineteen vaccine, Well, they can put as much pressure on the f d A as the f d A allows them to squeeze.

It really is up to the f d A. You know, the it's a matter of you know, does Commissioner Han want to keep his job? Can he take the heat? You know? There have been a number of reports out there of people in the White House being highly critical of the agency. Axios I believe had a report that White House Advisor Peter Navarro told some FDA officials that you're all deep state and you need to get on

Trump time. Trump himself put out a tweet over the weekend that he had heard some members of the FDA were deep staters attempting to slow down work on a vaccine or a drug in order to impede his re election. UM Commissioner han Um he very definitively said, Um, I'll

quote from his interview. You said, what I can tell you is that I feel very strongly that the seventeen thousand plus fd employees are true professionals, and none of them wants to delay getting medical products into the hands of Americans, and all emphasises, I mean, there is no evidence whatsoever, Um that the f d A is slowing down work on this. I think everybody in the country realizes this is a public health crisis, and the sooner there is an effective vaccine UM and additional therapy for

this disease, the better. And certainly we know from the Trump administration that they have their eye on election day and there is significant pressure there to have a vaccine either approved or even available by that point. And perhaps that has led to this question of pressures on the f d A and whether or not the FDA needs to be even more independent. I was wondering if you might be able to go into that of what can

there be done to ensure this continued independence. I think a huge amount of the independence of any agency is going to be defined by its leader. You know, there are federal agencies and parts of the federal government that have more independence. You know, the Federal Reserve is kind of a classic example. But it's really up to the commissioner.

Is the reality and being able to be a strong leader who can stand up for the science while being cognizant of the real world scenario that they're living in is probably at this point in time, I'm the most important thing. I asked Commissioner Han, you know, did he think that the FDA should be an independent agency instead of being a part of the Health and Human Services Department? Um,

you know, like the Federal Reserve. And you know, he said he hadn't really thought about it, but that it was worth consideration, um for exactly the reasons we're discussing. But he really he backed off on that quite a bit and said he didn't really want to rush into giving an opinion about it. Uh, it appeared to be at least a little bit appealing in that moment. What are perhaps the dangers um of this potential political pressure on speeding up getting a vaccine out before perhaps it's ready.

When you're the head of an agency, the reality is that you don't have all that many options if an administration really does want to pressure your overrule a decision that you make. There was a report by Ruters that Peter Marks, who is the leader of the group inside the FDA that reviews vaccines. The writers reported the HULD resign if the agency rubber stamp something. Essentially, our administration

forced the FDA to rubber stamp something. And I asked Commissioner Hot about that, and his response was, you know, I'll quote here he said, Peter did not say that to me, but it wouldn't surprise me that this is accurate. And I asked him the same question. What would he do if he was being asked rubber stamp a vaccine? And I'll quote again from his answer, it wouldn't be okay for me, and I would not participate in any decision that was made on anything other than the science.

So you know, that is kind of the nuclear option for an FDA commissioner is to resign or publicly protest about a decision where you're either being overruled or forced to do something that you don't believe is correct. Hopefully we won't be in a situation like that. That was Drew Armstrong and that's it for our show today. For coverage of the outbreak from one bureaus around the world, visit Bloomberg dot com slash Coronavirus and if you like the show, please leave us a review and a rating

on Apple Podcasts or Spotify. It's the best way to help more listeners find our global reporting. The Prognosis Daily edition is produced by topor foreheads Jordan Gospoure, Magnus Hendrickson and me Laura Carlson. Today's main story was reported by Drew Armstrong. Original music by Leo Sidrin. Our editors are Francesca Levi and Rick Shine. Francesca Levi is Bloomberg's head of podcasts. Thanks for listening.